1 00:00:05,480 --> 00:00:09,440 I WOULD LIKE TO WELCOME EVERYONE 2 00:00:09,440 --> 00:00:13,360 TO THE MARY FRANCIS PICCIANO 3 00:00:13,360 --> 00:00:14,080 DIETARY SUPPLEMENT RESEARCH 4 00:00:14,080 --> 00:00:15,760 PRACTICUM WHICH IS HOSTED BY THE 5 00:00:15,760 --> 00:00:18,240 NATIONAL INSTITUTE OF OFFICE OF 6 00:00:18,240 --> 00:00:22,440 DIETARY SUPPLEMENTS. 7 00:00:22,440 --> 00:00:25,480 I'M JAMIE GAHCHE, I WORK AT THE 8 00:00:25,480 --> 00:00:26,760 OFFICE OF DIETARY SUPPLEMENTS, 9 00:00:26,760 --> 00:00:29,320 OR I WILL REFER TO IT AS ODS AND 10 00:00:29,320 --> 00:00:31,040 I'M ALSO THE DIRECTOR OF THIS 11 00:00:31,040 --> 00:00:31,800 PRACTICUM. 12 00:00:31,800 --> 00:00:34,360 SO THIS INTENSIVE PRACTICUM WILL 13 00:00:34,360 --> 00:00:36,120 PROVIDE A THOROUGH OVERVIEW 14 00:00:36,120 --> 00:00:39,240 ABOUT DIETARY SUPPLEMENTS AND 15 00:00:39,240 --> 00:00:39,720 SUPPLEMENT INGREDIENTS. 16 00:00:39,720 --> 00:00:41,720 WE'RE GOING TO BE INCLUDING 17 00:00:41,720 --> 00:00:42,360 PRESENTATIONS ON SUPPLEMENT USE 18 00:00:42,360 --> 00:00:44,800 IN THE UNITED STATES, THE 19 00:00:44,800 --> 00:00:46,200 MOTIVATIONS BEHIND WHY PEOPLE 20 00:00:46,200 --> 00:00:48,680 ARE USING THEM, PRESENTATIONS ON 21 00:00:48,680 --> 00:00:52,000 THE REGULATORY FRAMEWORK, 22 00:00:52,000 --> 00:00:53,600 GOVERNING SUPPLEMENTS, SEVERAL 23 00:00:53,600 --> 00:00:54,760 PRESENTATIONS ON THE IMPORTANCE 24 00:00:54,760 --> 00:00:57,080 OF SCIENTIFIC INVESTIGATIONS TO 25 00:00:57,080 --> 00:00:58,320 EVALUATE EFFICACY, SAFETY, THE 26 00:00:58,320 --> 00:01:00,480 VALUE OF THESE PRODUCTS FOR 27 00:01:00,480 --> 00:01:02,080 HEALTH PROMOTION AND DISEASE 28 00:01:02,080 --> 00:01:04,520 PREVENTION AS WELL AS HOW TO 29 00:01:04,520 --> 00:01:07,080 CARRY OUT THIS TYPE OF RESEARCH. 30 00:01:07,080 --> 00:01:08,760 PLUS WE HAVE SEVERAL OTHER 31 00:01:08,760 --> 00:01:13,920 PRESENTATIONS, WE WILL HEAR FROM 32 00:01:13,920 --> 00:01:15,640 VARIOUS STAKEHOLDERS, THE 33 00:01:15,640 --> 00:01:17,360 VARIOUS DIETARY INDUSTRY TRADE 34 00:01:17,360 --> 00:01:18,960 GROUPS, CONSUMER ADVOCABULARYS 35 00:01:18,960 --> 00:01:20,840 KACCTY, GROUP, THE MEDIA, THOSE 36 00:01:20,840 --> 00:01:24,400 WHO STUDY, ADVOCATE OR EDUCATE 37 00:01:24,400 --> 00:01:25,000 ABOUT DIETARY SUPPLEMENTS. 38 00:01:25,000 --> 00:01:29,360 SO JUST TO START OFF, THE 39 00:01:29,360 --> 00:01:31,760 DIETARY RESEARCH PRACTICUM IS 40 00:01:31,760 --> 00:01:34,120 NAMED FOR MARY FRANCIS PICCIANO, 41 00:01:34,120 --> 00:01:37,480 WHO WAS A SENIOR NUTRITION 42 00:01:37,480 --> 00:01:40,680 SCIENTIST FROM THE ODS FROM WENT 43 00:01:40,680 --> 00:01:43,000 TO THOUSAND 1-2010 AFTER A LONG 44 00:01:43,000 --> 00:01:45,240 BATTLE WITH CANCER. 45 00:01:45,240 --> 00:01:46,960 HER CONTRIBUTIONS TO NUTRITION 46 00:01:46,960 --> 00:01:49,240 RESEARCH, TEACHING COMMUNITY 47 00:01:49,240 --> 00:01:50,400 SERVICE AND NUTRITION POLICY DID 48 00:01:50,400 --> 00:01:54,600 MUCH TO SHAPE THE FIELD OF 49 00:01:54,600 --> 00:01:54,960 NUTRITION. 50 00:01:54,960 --> 00:01:55,920 DR. PICCIANO, LED THE CREATION 51 00:01:55,920 --> 00:01:58,640 AND DEVELOPMENT OF THIS 52 00:01:58,640 --> 00:02:01,000 PRACTICUM WHICH WAS FIRST HELD 53 00:02:01,000 --> 00:02:02,200 IN MAY, 2007. 54 00:02:02,200 --> 00:02:03,840 HAS BEEN HELD EVERYWHERE WITH 55 00:02:03,840 --> 00:02:06,840 THE ACCEPTION OF 2015 AND ALSO 56 00:02:06,840 --> 00:02:07,520 IN 2020. 57 00:02:07,520 --> 00:02:10,680 AND IT INITIALLY STARTED AS A 5 58 00:02:10,680 --> 00:02:12,040 DAY ANNUAL COURSE PROVIDE 59 00:02:12,040 --> 00:02:13,800 FUNDAMENTAL SCIENTIFIC KNOWLEDGE 60 00:02:13,800 --> 00:02:15,440 OF DIETARY SUPPLEMENTS TO THOSE 61 00:02:15,440 --> 00:02:17,440 IN ACADEMIA AND THEIR ADVANCED 62 00:02:17,440 --> 00:02:17,960 STUDENTS. 63 00:02:17,960 --> 00:02:19,880 HOWEVER, OWEVER THE YEARS, THE 64 00:02:19,880 --> 00:02:21,320 PRACTICUM HAS CHANGED, IT HAS 65 00:02:21,320 --> 00:02:22,360 BEEN SHORTENED OVER TIME AND 66 00:02:22,360 --> 00:02:25,960 THIS YEAR, FOR THE SECOND YEAR 67 00:02:25,960 --> 00:02:27,240 NOW, IT'S HELD VIRTUALLY AND YOU 68 00:02:27,240 --> 00:02:29,400 KNOW A GOOD WAY TO OPEN TO A 69 00:02:29,400 --> 00:02:31,240 BROADER AUDIENCE THAN BEFORE. 70 00:02:31,240 --> 00:02:32,880 AND SO THIS FIGURE JUST SHOWS 71 00:02:32,880 --> 00:02:35,520 THE NUMBER OF PARTICIPANTS THAT 72 00:02:35,520 --> 00:02:39,160 WE'VE HAD AT THE PRACTICUM SINCE 73 00:02:39,160 --> 00:02:39,440 2007. 74 00:02:39,440 --> 00:02:42,920 AND IN GENERAL, WE'VE HAD ABOUT 75 00:02:42,920 --> 00:02:44,680 90 OR MORE PARTICIPANTINGS EACH 76 00:02:44,680 --> 00:02:44,920 YEAR. 77 00:02:44,920 --> 00:02:46,360 THE PRACTICUM WAS HELD IN PERSON 78 00:02:46,360 --> 00:02:48,600 AT NIH AND WE WERE LIMITED IN 79 00:02:48,600 --> 00:02:50,320 THE NUMBER OF DEATHS AND SPACES 80 00:02:50,320 --> 00:02:51,720 AVAILABLE BUT THEN LAST MAY WE 81 00:02:51,720 --> 00:02:52,920 DID HOLD THE PRACTICUM 82 00:02:52,920 --> 00:02:53,520 VETERINARY RESOURCESSUALLY AND 83 00:02:53,520 --> 00:02:55,240 WE WERE ABLE TO HOLD THE 84 00:02:55,240 --> 00:02:57,800 PRACTICUM UP TO EVERYONE. 85 00:02:57,800 --> 00:03:00,160 WE HAD 478 PARTICIPANTS AT OUR 86 00:03:00,160 --> 00:03:01,320 PEAK DURING THOSE 3 DAYS AND 87 00:03:01,320 --> 00:03:04,480 THIS YEAR WE HOPE TO TOP THAT 88 00:03:04,480 --> 00:03:04,720 NUMBER. 89 00:03:04,720 --> 00:03:07,640 SO JUST TO START OFF WITH A FEW 90 00:03:07,640 --> 00:03:09,680 HOUSEKEEPING ISSUES, THE 91 00:03:09,680 --> 00:03:12,680 PRACTICUM STARTS EVERY DAY AT 11 92 00:03:12,680 --> 00:03:13,040 AMEASTERN TIME. 93 00:03:13,040 --> 00:03:15,480 I JUST WANT TO REMIND EVERYONE 94 00:03:15,480 --> 00:03:16,880 THAT THE WEBEX LINKS ARE 95 00:03:16,880 --> 00:03:18,840 DIFFERENT FOR EACH DAY SO PLEASE 96 00:03:18,840 --> 00:03:20,480 MAKE SURE YOU CLICK ON THE 97 00:03:20,480 --> 00:03:20,920 CORRECT 1. 98 00:03:20,920 --> 00:03:23,320 WE WILL HAVE MODERATORS FOR EACH 99 00:03:23,320 --> 00:03:25,320 SESSION, HOWEVER IN ORDER TO 100 00:03:25,320 --> 00:03:27,720 SAVE TIME, THEY WILL OHM BRIEFLY 101 00:03:27,720 --> 00:03:29,160 INTRODUCE THE SPEAKERS AND THE 102 00:03:29,160 --> 00:03:29,440 SESSIONS. 103 00:03:29,440 --> 00:03:31,600 SO PLEASE REFER MORE TO OUR 104 00:03:31,600 --> 00:03:33,960 OGENDA ONLINE FOR INFORMATION ON 105 00:03:33,960 --> 00:03:35,440 EACH TALK'S OBJECTIVE AND PLEASE 106 00:03:35,440 --> 00:03:38,200 SEE SPEAKER BY OS FOR MORE 107 00:03:38,200 --> 00:03:39,800 INFORMATION ON EACH SPEAKER. 108 00:03:39,800 --> 00:03:41,040 SO HERE'S THE LINKS TO BOTH, 109 00:03:41,040 --> 00:03:42,800 THIS SLIDE WILL ALSO BE UP 110 00:03:42,800 --> 00:03:44,800 DURING ALL THE BREAKS, SO YOU 111 00:03:44,800 --> 00:03:47,440 WILL HAVE THOSE LINKS. 112 00:03:47,440 --> 00:03:48,640 NEXT, PLEASE SUBMIT ANY 113 00:03:48,640 --> 00:03:50,000 TECHNICAL ISSUES OR PROBLEMS 114 00:03:50,000 --> 00:03:52,880 YOU'RE HAVING IN THE CHAT BOX. 115 00:03:52,880 --> 00:03:56,440 AND SUBMIT QUESTIONS FOR THE 116 00:03:56,440 --> 00:03:59,080 PRESENTERS IN THE SESSION IN THE 117 00:03:59,080 --> 00:04:03,200 Q&A PANEL AND DIRECTED IT TO ALL 118 00:04:03,200 --> 00:04:03,480 PANELISTS. 119 00:04:03,480 --> 00:04:04,520 SO ALTHOUGH WE'RE VIRTUAL THIS 120 00:04:04,520 --> 00:04:07,040 YEAR AND LAST YEAR, WE STILL 121 00:04:07,040 --> 00:04:08,800 RELY HEAVILY ON AATTENDEES 122 00:04:08,800 --> 00:04:10,240 PARTICIPATION TO MAKE THIS A 123 00:04:10,240 --> 00:04:11,400 SUCCESSFUL PRACTICUM SO WE 124 00:04:11,400 --> 00:04:13,000 REALLY WELCOME YOUR QUESTIONS, 125 00:04:13,000 --> 00:04:15,800 WE WILL HAVE TIME AFTER SPEAKERS 126 00:04:15,800 --> 00:04:17,880 OR DURING POWER DISCUSSIONS, SO 127 00:04:17,880 --> 00:04:21,080 PLEASE SUBMILT YOUR--PANEL 128 00:04:21,080 --> 00:04:22,080 DISCUSSIONS SO PLEASE SUBMIT 129 00:04:22,080 --> 00:04:22,440 YOUR QUESTIONS. 130 00:04:22,440 --> 00:04:23,880 I WANT TO MENTION THAT THIS WILL 131 00:04:23,880 --> 00:04:24,920 BE RECORDED AND TELL BE 132 00:04:24,920 --> 00:04:26,800 AVAILABLE SOON AFTER SO WE WILL 133 00:04:26,800 --> 00:04:28,200 BE SPENDING LINKS TO WHERE YOU 134 00:04:28,200 --> 00:04:33,840 CAN WATCH THE RECORDED PRACTICUM 135 00:04:33,840 --> 00:04:34,120 AFTERWARDS. 136 00:04:34,120 --> 00:04:37,960 SO, I WANT TO START OFF BRIEFLY 137 00:04:37,960 --> 00:04:40,320 JUST BY INTRODUCING THE DIETARY 138 00:04:40,320 --> 00:04:42,080 SUPPLEMENT, HEALTH AND EDUCATION 139 00:04:42,080 --> 00:04:46,000 ACT OF 1994 OR WHAT WILL REFER 140 00:04:46,000 --> 00:04:47,800 TO AS THE SHEA, AND YOU WILL 141 00:04:47,800 --> 00:04:49,800 HEAR MORE ABOUT THIS IN OTHER 142 00:04:49,800 --> 00:04:50,200 PRESENTATIONS BUT I WILL GIVE A 143 00:04:50,200 --> 00:04:51,280 BRIEF OVERVIEW RIGHT NOW BECAUSE 144 00:04:51,280 --> 00:04:53,080 THIS LAW REALLY CREATED THE 145 00:04:53,080 --> 00:04:53,840 REGULATORY FRAMEWORK FOR THE 146 00:04:53,840 --> 00:04:55,840 SAFETY AND LABELING OF DIETARY 147 00:04:55,840 --> 00:04:57,680 SUPPLEMENTS AND THIS LAW 148 00:04:57,680 --> 00:04:58,880 CONTINUES TO DEFINE SUPPLEMENT 149 00:04:58,880 --> 00:05:00,800 POLICY TO THIS DAY. 150 00:05:00,800 --> 00:05:03,360 AFTER THAT I'M GOING TO PROVIDE 151 00:05:03,360 --> 00:05:05,920 AN OVERVIEW OF OUR OFFICE, 152 00:05:05,920 --> 00:05:06,800 OFFICE OF DIETARY SUPPLEMENTS 153 00:05:06,800 --> 00:05:08,280 AND TELL YOU A BIT ABOUT OUR 154 00:05:08,280 --> 00:05:12,120 MISSION AND SOME OF WHAT WE DO. 155 00:05:12,120 --> 00:05:13,400 SO, DIETARY SUPPLEMENTS HAVE 156 00:05:13,400 --> 00:05:15,920 BEEN MARKETED AND USED FOR 157 00:05:15,920 --> 00:05:18,480 CENTURIES IN ALL DIFFERENT 158 00:05:18,480 --> 00:05:18,760 FORMINGS. 159 00:05:18,760 --> 00:05:19,800 AND IN 1994 CONGRESS PASSED 160 00:05:19,800 --> 00:05:22,840 AND THE PRESIDENT SIGNED THIS 161 00:05:22,840 --> 00:05:26,840 PIECE OF LEGISLATION CALLED 162 00:05:26,840 --> 00:05:30,120 DSHEA, AND IT WAS THE FOOD AND 163 00:05:30,120 --> 00:05:31,040 COSMETIC ACT. 164 00:05:31,040 --> 00:05:33,560 AT THE TIME IT THE IT WAS 165 00:05:33,560 --> 00:05:36,240 GROWING AND A LARGE NUMBER BE OF 166 00:05:36,240 --> 00:05:38,560 U.S. ADULT REPORTED TAKING 167 00:05:38,560 --> 00:05:39,600 DIETARY SUPPLEMENTS SO IT WAS 168 00:05:39,600 --> 00:05:41,440 IMPORTANT TO ESTABLISH STANDARDS 169 00:05:41,440 --> 00:05:43,400 FOR CONSUMERS AS WELL AS EXPLORE 170 00:05:43,400 --> 00:05:45,960 MORE FULLY THE ROLE OF DIETAR I 171 00:05:45,960 --> 00:05:47,160 SUPPLEMENTS IN THE DIETS AND 172 00:05:47,160 --> 00:05:49,760 HEALTH OF THE U.S. POPULATION. 173 00:05:49,760 --> 00:05:53,440 SO IN DOING AND PASSING THIS 174 00:05:53,440 --> 00:05:54,640 LAW, CONGRESS STATED THERE MIGHT 175 00:05:54,640 --> 00:05:56,880 BE A POSITIVE RELATIONSHIP 176 00:05:56,880 --> 00:05:57,800 BETWEEN SOUND DIETARY PRACTICE 177 00:05:57,800 --> 00:05:59,880 AND GOOD HEALTH AND ALTHOUGH 178 00:05:59,880 --> 00:06:01,240 FURTHER RESEARCH IS NEEDED THERE 179 00:06:01,240 --> 00:06:04,680 MAY BE A CONNECTION BETWEEN 180 00:06:04,680 --> 00:06:05,960 SUPPLEMENT USE, REDUCED HEALTH 181 00:06:05,960 --> 00:06:07,480 EXPENSES AND DISEASE PREVENTION. 182 00:06:07,480 --> 00:06:09,680 SO THIS LAW DEFINE WHAT IS WOULD 183 00:06:09,680 --> 00:06:12,200 BE CONSIDERED A DIETARY 184 00:06:12,200 --> 00:06:12,720 SUPPLEMENT. 185 00:06:12,720 --> 00:06:13,840 IT ESTABLISHED A REGULATORY 186 00:06:13,840 --> 00:06:15,760 FRAMEWORK WITHIN THE U.S. FOOD 187 00:06:15,760 --> 00:06:18,520 AND DRUG ADMINISTRATION, FDA, 188 00:06:18,520 --> 00:06:20,280 AND BASICALLY IT'S THAT DIETARY 189 00:06:20,280 --> 00:06:21,400 SUPPLEMENTS ARE A SPECIAL 190 00:06:21,400 --> 00:06:23,440 CATEGORY OF FOODS AND THEY'RE 191 00:06:23,440 --> 00:06:28,360 NOT REGULATED BY DRUGS. 192 00:06:28,360 --> 00:06:29,960 DSHEA ESTABLISHED LABELING RULES 193 00:06:29,960 --> 00:06:31,880 AND CREATED THE OFFICE OF 194 00:06:31,880 --> 00:06:33,200 DIETARY SUPPLEMENTS AT THE 195 00:06:33,200 --> 00:06:34,560 NATIONAL INSTITUS OF HEALTH. 196 00:06:34,560 --> 00:06:37,720 SO IN GENERAL, THE LABELING 197 00:06:37,720 --> 00:06:38,760 GUIDELINE STATE THAD SUPPLEMENTS 198 00:06:38,760 --> 00:06:41,040 HAVE TO BE CLEARLY LABELED AS A 199 00:06:41,040 --> 00:06:42,200 SUPPLEMENT, HAVE A SUPPLEMENT 200 00:06:42,200 --> 00:06:43,720 FACT PANEL THAT LIST ALL 201 00:06:43,720 --> 00:06:45,040 INGREDIENTS IN THE PRODUCT AND 202 00:06:45,040 --> 00:06:47,560 HAVE A DISCLAIMER STATING THAT 203 00:06:47,560 --> 00:06:50,120 THE PRODUCT HAS BEEN--NOT BEEN 204 00:06:50,120 --> 00:06:54,200 EVALUATED BY THE FDA IS NOT 205 00:06:54,200 --> 00:06:57,640 INTEND TO DIAGNOSE, TREAT, OR 206 00:06:57,640 --> 00:06:59,480 CURE CERTAIN DISEASES. 207 00:06:59,480 --> 00:07:01,960 SO DSHEA DEFINED WHAT A DIETARY 208 00:07:01,960 --> 00:07:05,080 SUPPLEMENT IS AND PRIOR TO THAT 209 00:07:05,080 --> 00:07:05,800 THERE WERE SUPPLEMENTSOT MARKET 210 00:07:05,800 --> 00:07:08,400 BUT THERE WAS NO REGULATORY 211 00:07:08,400 --> 00:07:09,080 DEFINITION OF THEM. 212 00:07:09,080 --> 00:07:11,360 SO THEY'RE NOW DEFINED AS A 213 00:07:11,360 --> 00:07:12,920 PRODUCT OTHER THAN TOBACCO THAT 214 00:07:12,920 --> 00:07:14,320 CONTINUES TO SUPPLEMENT THE 215 00:07:14,320 --> 00:07:18,560 DIET, CONTAINS 1 OR MORE DIETARY 216 00:07:18,560 --> 00:07:21,400 INGREDIENTS, SO VITAMINS, WATER, 217 00:07:21,400 --> 00:07:22,920 AMINO ACIDS, BOTANICALS, RGTD 218 00:07:22,920 --> 00:07:24,160 SUBSTANCES, THEY CAN PROVIDE 219 00:07:24,160 --> 00:07:25,800 INDIVIDUAL COMPONENTS OR IT CAN 220 00:07:25,800 --> 00:07:28,480 BE A COMBINATION OF THESE WILL 221 00:07:28,480 --> 00:07:29,440 YOU PLEASE CEMENTS. 222 00:07:29,440 --> 00:07:31,200 AND FINALLY THEY'RE INTENDED TO 223 00:07:31,200 --> 00:07:32,480 BE TAKEN BY MOUTH. 224 00:07:32,480 --> 00:07:38,080 THEY'RE AVAILABLE IN MANY FORMS, 225 00:07:38,080 --> 00:07:40,760 TABLETS, CAPSULES, SOFT 226 00:07:40,760 --> 00:07:41,600 GELSOLINS, LIQUIDS, CHEWS, 227 00:07:41,600 --> 00:07:42,760 POWDERS AND THEN BASICALLY 228 00:07:42,760 --> 00:07:44,520 ALMOST ANY INGREDIENT IN A FOOD 229 00:07:44,520 --> 00:07:46,600 OR PRODUCT OF MAJOR CAN BE 230 00:07:46,600 --> 00:07:49,120 TURNED INTO A DIETARY SUPPLEMENT 231 00:07:49,120 --> 00:07:51,600 AS LONG AS IT'S NOT OBVIOUSLY 232 00:07:51,600 --> 00:07:53,680 POISONOUS AND A WAY TO GET THAT 233 00:07:53,680 --> 00:07:55,240 RAW MATERIAL INTEREST I FINISHED 234 00:07:55,240 --> 00:07:55,480 PRODUCT. 235 00:07:55,480 --> 00:07:57,800 AND WE LIKE TO SHOW THIS SLIDE 236 00:07:57,800 --> 00:07:59,600 BECAUSE THESE ARE MANY EXAMPLES, 237 00:07:59,600 --> 00:08:01,520 WE'RE NOT JUST TALKING ABOUT 238 00:08:01,520 --> 00:08:02,560 VITAMINS AND MINERALS, WE'RE 239 00:08:02,560 --> 00:08:03,760 TALKING ABOUT MANY, MANY 240 00:08:03,760 --> 00:08:08,360 DIFFERENT TYPES OF INGREDIENTS. 241 00:08:08,360 --> 00:08:10,840 SO CONGRESS AS I ALSO STATED 242 00:08:10,840 --> 00:08:14,280 MANDATED THE OFFICE OF DIETARY 243 00:08:14,280 --> 00:08:15,400 SUPPLEMENTS, ODS AND THAT IT 244 00:08:15,400 --> 00:08:17,760 SHOULD BE PLACED IN THE NATIONAL 245 00:08:17,760 --> 00:08:19,800 INSTITUTES OF HEALTH AND OUR 246 00:08:19,800 --> 00:08:21,320 MISSION AT ODS IS TO STRENGTHEN 247 00:08:21,320 --> 00:08:23,160 THE KNOWLEDGE AND UNDERSTANDING 248 00:08:23,160 --> 00:08:24,320 OF DIETARY SUPPLEMENTS, WE DO 249 00:08:24,320 --> 00:08:26,520 THIS IN SEVERAL WAYS THROUGH 250 00:08:26,520 --> 00:08:27,320 STIMULATING AND SUPPORTING 251 00:08:27,320 --> 00:08:29,600 RESEARCH TO VPGHT THE ROLE OF 252 00:08:29,600 --> 00:08:30,600 DIETARY SUPPLEMENTS AND 253 00:08:30,600 --> 00:08:33,760 PROMOTING HEALTH AND REDUCING 254 00:08:33,760 --> 00:08:35,080 DISEASE RISK. 255 00:08:35,080 --> 00:08:37,040 SUPPORTING THE DEVELOPMENT OF 256 00:08:37,040 --> 00:08:37,840 RESEARCH TOOLS, EVALUATING 257 00:08:37,840 --> 00:08:39,760 SCIENTIFIC FINDINGS AND MAKING 258 00:08:39,760 --> 00:08:42,280 THE MOST UP TO DATE SCIENTIFIC 259 00:08:42,280 --> 00:08:46,280 KNOWLEDGE ABOUT SUPPLEMENTS 260 00:08:46,280 --> 00:08:48,480 PUBLICLY AVAILABLE. 261 00:08:48,480 --> 00:08:49,240 THIS SLIDE SHOWS SUPPLEMENT 262 00:08:49,240 --> 00:08:51,520 SALES FROM THE NUTRITION 263 00:08:51,520 --> 00:08:53,560 BUSINESS JOURNAL AND THIS 264 00:08:53,560 --> 00:08:56,480 JOURNAL PUBLISHES SALES 265 00:08:56,480 --> 00:08:56,840 ANNUALLY. 266 00:08:56,840 --> 00:09:01,160 AFTER DSHEA WAS PASSED IN 1994, 267 00:09:01,160 --> 00:09:03,720 YOU CAN SEE 8.6 BILLION DOLLAR A 268 00:09:03,720 --> 00:09:05,320 YEAR INDUSTRY AND YOU CAN SEE 269 00:09:05,320 --> 00:09:07,840 THAT IT'S A REALLY QUITE A 270 00:09:07,840 --> 00:09:08,880 STEADY INCREASE SINCE THEN. 271 00:09:08,880 --> 00:09:12,960 AND WE ARE NOW AT 55.8 BILLION 272 00:09:12,960 --> 00:09:13,200 IN 2020. 273 00:09:13,200 --> 00:09:15,600 AND I WOULD LIKE TO POINT OUT 274 00:09:15,600 --> 00:09:17,080 THAT IN 1994, IT WAS ESTIMATED 275 00:09:17,080 --> 00:09:19,880 THAT THERE WAS A ABOUT 4000 276 00:09:19,880 --> 00:09:21,080 PRODUCTS ON THE MARKET AND NOW 277 00:09:21,080 --> 00:09:23,160 WE ESTIMATE THAT THERE ARE 278 00:09:23,160 --> 00:09:25,480 PROBABLY OVER A HUNDRED THOUSAND 279 00:09:25,480 --> 00:09:28,280 PRODUCTS ON THE MARKET AT A 280 00:09:28,280 --> 00:09:29,240 GIVEN TIME. 281 00:09:29,240 --> 00:09:31,280 SO THE NUTRITION BUSINESS 282 00:09:31,280 --> 00:09:33,680 JOURNAL RECENTLY PUBLISHED 283 00:09:33,680 --> 00:09:36,360 SALINGS FROM 2020--SALES FROM 284 00:09:36,360 --> 00:09:36,600 2020. 285 00:09:36,600 --> 00:09:37,640 IT ACTUALLY PUT GROWTH IN 20 286 00:09:37,640 --> 00:09:39,840 TWEBT AS THE LARGEST EVER, UP 14 287 00:09:39,840 --> 00:09:42,040 AND HALF PERCENT OR ADDING 7 288 00:09:42,040 --> 00:09:43,440 BILLION IN ADDITIONAL SALES. 289 00:09:43,440 --> 00:09:46,320 AND AGAIN, BUILDING A MARKET 290 00:09:46,320 --> 00:09:53,400 NOW, ESTIMATED AT 55.8 BILL 1. 291 00:09:53,400 --> 00:09:55,120 THE INCREASE MOST LIKELY DUE TO 292 00:09:55,120 --> 00:09:56,640 COVID-19 AND A LOT OF ATTENTION 293 00:09:56,640 --> 00:09:58,760 THAT WAS GIVEN TO DIETARY 294 00:09:58,760 --> 00:10:06,000 SUPPLEMENTS, AND NOT PRIZING THE 295 00:10:06,000 --> 00:10:08,600 VITAMIN, DC, BEING BIG LEADERS 296 00:10:08,600 --> 00:10:09,680 AND THEN. 297 00:10:09,680 --> 00:10:11,120 THE NUTRITION BUSINESS JOURNAL 298 00:10:11,120 --> 00:10:14,000 ALSO PROVIDES DATA ON HOW SALES 299 00:10:14,000 --> 00:10:16,720 ARE DISTRIBUTED, AMONG VITAMINS, 300 00:10:16,720 --> 00:10:19,160 MINERALS, HERBS, SPECIALTY OTHER 301 00:10:19,160 --> 00:10:19,440 PRODUCTS. 302 00:10:19,440 --> 00:10:21,960 YOU KNOW SOME OF THESE ARE NOT 303 00:10:21,960 --> 00:10:24,240 HAQUE WE WOULD CONSIDER DIETARY 304 00:10:24,240 --> 00:10:25,960 SUPPLEMENTS FROM A REGULATORY 305 00:10:25,960 --> 00:10:27,080 PURPOSE BUT FOR REPORTING 306 00:10:27,080 --> 00:10:28,760 PURPOSES THEY DO PUT THEM INTO 307 00:10:28,760 --> 00:10:29,840 THE CATEGORIES, BUT YOU KNOW WE 308 00:10:29,840 --> 00:10:31,920 DO LOOK AT THINGS A LITTLE 309 00:10:31,920 --> 00:10:33,520 DIFFERENTLY ABOUT THIS KIND OF 310 00:10:33,520 --> 00:10:37,080 SHOWS YOU THE DISTRIBUTION OF 311 00:10:37,080 --> 00:10:39,480 2020 AND BASICALLY IT'S BEEN 312 00:10:39,480 --> 00:10:41,120 PRETTY STABLE FOR THE SALES OVER 313 00:10:41,120 --> 00:10:43,000 THE YEARS ALTHOUGH THE EXACT 314 00:10:43,000 --> 00:10:43,920 PERCENTAGES CAN CHANGE A BIT. 315 00:10:43,920 --> 00:10:46,880 CAN YOU SEE HERE THAT VITAMINS 316 00:10:46,880 --> 00:10:50,640 ARE THE BIG SELLERS, THIS ALSO 317 00:10:50,640 --> 00:10:51,440 INCLUDES THE MULTIVITAMIN 318 00:10:51,440 --> 00:10:52,560 FORMULATION AND YOU CAN SEE THIS 319 00:10:52,560 --> 00:10:54,680 IS FOLLOWED BY BOTANICAL HERBS 320 00:10:54,680 --> 00:11:00,480 AND THEN THE OTHER SPECIALTY 321 00:11:00,480 --> 00:11:00,880 PRODUCTS. 322 00:11:00,880 --> 00:11:03,120 SO THE ODS HAS BEEN OPERATING 323 00:11:03,120 --> 00:11:03,480 SINCE 1995. 324 00:11:03,480 --> 00:11:04,520 WE'RE ALWAYS GUIDED BY A 325 00:11:04,520 --> 00:11:05,800 TRANSLATIONAL RESEARCH TEEJIC 326 00:11:05,800 --> 00:11:07,400 PLAN, WHICH IS OF COURSE IS 327 00:11:07,400 --> 00:11:08,600 IMPORTANT BECAUSE THERE ARE A 328 00:11:08,600 --> 00:11:10,400 LOT OF PEOPLE INVOLVED IN 329 00:11:10,400 --> 00:11:11,960 DIETARY SUPPLEMENTS FROM 330 00:11:11,960 --> 00:11:15,280 CONSUMERS, TO RESEARCHERS, 331 00:11:15,280 --> 00:11:18,040 REGULATORS, PEOPLE WHO DEVELOP 332 00:11:18,040 --> 00:11:19,160 METHODS AND MEASUREMENTS OF 333 00:11:19,160 --> 00:11:24,440 THINGS IN DIETARY SUPPLEMENTS, 334 00:11:24,440 --> 00:11:24,720 CLINICIANS. 335 00:11:24,720 --> 00:11:26,080 OUR 2017-2021 STRATEGIC PLAN HAS 336 00:11:26,080 --> 00:11:27,280 ENDED. 337 00:11:27,280 --> 00:11:30,840 WE ARE CURRENTLY FINALIZING OUR 338 00:11:30,840 --> 00:11:32,000 2022-2026 PLAN AND THIS WILL 339 00:11:32,000 --> 00:11:34,200 GUIDE US THROUGH THE NEXT 5 340 00:11:34,200 --> 00:11:34,880 YEARS. 341 00:11:34,880 --> 00:11:35,920 OUR GOALS SAID A LITTLE SLIGHTLY 342 00:11:35,920 --> 00:11:37,120 DIFFERENT THAN I MENTIONED 343 00:11:37,120 --> 00:11:40,000 EARLIER BUT IT EXTENDING THE 344 00:11:40,000 --> 00:11:41,120 KNOWLEDGE BASE IN A NUMBER OF 345 00:11:41,120 --> 00:11:45,160 DIFFERENT WAYS AND WE DO THIS 346 00:11:45,160 --> 00:11:46,200 ALWAYS IN COLLABORATION 347 00:11:46,200 --> 00:11:47,160 COLLABORATION WITH OTHER 348 00:11:47,160 --> 00:11:50,000 INSTITUTES AT THE NIH, OTHER 349 00:11:50,000 --> 00:11:52,720 PART OF THE FEDERAL GOVERNMENT, 350 00:11:52,720 --> 00:11:54,400 PRIVATE SECTOR, ACADEMIC SECTOR, 351 00:11:54,400 --> 00:11:57,040 EXPANDING KNOWLEDGE BASE, SO 352 00:11:57,040 --> 00:11:58,200 EXPABDING THE WORKFORCE THROUGH 353 00:11:58,200 --> 00:12:00,160 TRAINING AND CAREER DEVELOPMENT 354 00:12:00,160 --> 00:12:01,120 BY DEVELOPING RESEARCH RESOURCES 355 00:12:01,120 --> 00:12:05,680 AND BASICALLY ALL OF THIS IS IN 356 00:12:05,680 --> 00:12:08,080 SERVICE OF RELY TRANSLATING 357 00:12:08,080 --> 00:12:08,760 INFORMATION INTO USEFUL 358 00:12:08,760 --> 00:12:12,360 INFORMATION FOR A HOST OF END 359 00:12:12,360 --> 00:12:13,840 USERS, CONSUMERS, HEALTH 360 00:12:13,840 --> 00:12:15,560 PROFESSIONALS, RESEARCHERS, 361 00:12:15,560 --> 00:12:16,920 POLICY MAKERS, HEALTHCARE 362 00:12:16,920 --> 00:12:18,680 PROVIDERS. 363 00:12:18,680 --> 00:12:23,120 SO NEW FOR 2022, 2026 STRATEGIC 364 00:12:23,120 --> 00:12:25,160 PLAN, NUMBER 5 IS FUNDING AND 365 00:12:25,160 --> 00:12:27,240 SUPPORT THE DEVELOPMENT OF 366 00:12:27,240 --> 00:12:28,440 COLLABORATIVE INITTIAIVE ITS 367 00:12:28,440 --> 00:12:32,080 ADDRESS GAPS IN DIETARY 368 00:12:32,080 --> 00:12:33,560 SUPPLEMENT RESEARCH. 369 00:12:33,560 --> 00:12:34,640 SO IN IDENTIFYING RESEARCH 370 00:12:34,640 --> 00:12:37,280 NEEDS, YOU KNOW DEVELOPING 371 00:12:37,280 --> 00:12:38,920 RESOURCES, AND ESTABLISHING KEY 372 00:12:38,920 --> 00:12:42,760 PARTNERS AND COMMUNICATION 373 00:12:42,760 --> 00:12:44,320 STRATEGIES, ODS TAKES IT'S 374 00:12:44,320 --> 00:12:45,720 MULTIPRONGED APPROACH AND GUIDED 375 00:12:45,720 --> 00:12:49,440 BY SEVERAL REALLY IMPORTANT KEY 376 00:12:49,440 --> 00:12:50,520 QUESTIONS. 377 00:12:50,520 --> 00:12:51,360 AND GENERALLY SPEAKING, WHAT 378 00:12:51,360 --> 00:12:53,440 DRIVES THE QUESTIONS IF THE 379 00:12:53,440 --> 00:12:55,320 PUBLIC HEALTH ISSUE, SO, ARE 380 00:12:55,320 --> 00:12:57,080 THERE TRENDS IN CERTAIN DIETARY 381 00:12:57,080 --> 00:12:59,080 SUPPLEMENTS THAT WE NEED TO BE 382 00:12:59,080 --> 00:12:59,360 TRACKING? 383 00:12:59,360 --> 00:13:00,400 ARE THERE SAFETY CONCERNS THAT 384 00:13:00,400 --> 00:13:03,680 NEED TO BE CONSIDERED? 385 00:13:03,680 --> 00:13:04,840 ARE THERE EVENTS THAT HAVE 386 00:13:04,840 --> 00:13:07,480 CAUSED PEOPLE TO USE MORE OR 387 00:13:07,480 --> 00:13:11,080 LESS, SO ALL THINGS THAT WE CAN 388 00:13:11,080 --> 00:13:15,000 LOOK AT TO IDENTIFY EMERGING 389 00:13:15,000 --> 00:13:15,520 NEEDS FOR RESEARCH. 390 00:13:15,520 --> 00:13:17,440 WE HAVE LEARNED A LOT ABOUT THE 391 00:13:17,440 --> 00:13:18,320 MEASUREMENT OF NUTRITIONAL 392 00:13:18,320 --> 00:13:21,960 STATUS, THIS APLOYS TO A LOT TO 393 00:13:21,960 --> 00:13:25,160 THE SUBSTANCES IN DIETARY 394 00:13:25,160 --> 00:13:25,920 SUPPLEMENT MARKETPLACE, 395 00:13:25,920 --> 00:13:27,160 SUBSTANCES THAT CAN COME FROM 396 00:13:27,160 --> 00:13:28,760 FOODS BUT ALSO DIETARY 397 00:13:28,760 --> 00:13:30,760 SUPPLEMENTS, BUT IN TERMS OF 398 00:13:30,760 --> 00:13:32,080 FOODS AND DIETARY SUPPLEMENT 399 00:13:32,080 --> 00:13:33,800 SOURCES, IT'S REALLY IMPORTANT 400 00:13:33,800 --> 00:13:34,400 TO MONITOR NUTRITIONAL STATUS 401 00:13:34,400 --> 00:13:37,200 AND BE SURE THAT THE MEASURES OF 402 00:13:37,200 --> 00:13:39,520 THESE THINGS ARE RELIABLE, AND 403 00:13:39,520 --> 00:13:43,120 REHAVE AS AN OFFICE, REALLY 404 00:13:43,120 --> 00:13:44,080 INVESTED IN THAT. 405 00:13:44,080 --> 00:13:46,160 AND THEN THERE'S WHAT EVIDENCE, 406 00:13:46,160 --> 00:13:47,800 THE EVIDENCE FOR HEALTH EFFECTS, 407 00:13:47,800 --> 00:13:49,760 IN ODS, WE TRY AND BE VERY 408 00:13:49,760 --> 00:13:51,160 NEUTRAL, THERE ARE STRONGLY HELD 409 00:13:51,160 --> 00:13:54,520 VIEWS ON HEALTH EFFECTS, OF 410 00:13:54,520 --> 00:13:56,400 DIETARY SUPPLEMENTS, SOMETIMES 411 00:13:56,400 --> 00:14:01,080 POSITIVE USE, NEGATIVE VIEWS AND 412 00:14:01,080 --> 00:14:03,000 WE REALLY AIM TO PIECE THROUGH 413 00:14:03,000 --> 00:14:04,720 THE OPINIONS AND TRY TO HELP 414 00:14:04,720 --> 00:14:05,960 PEOPLE UNDERSTAND WHAT IS THE 415 00:14:05,960 --> 00:14:06,920 EVIDENCE? 416 00:14:06,920 --> 00:14:07,640 AND THEN FINALLY WE'RE ALWAYS 417 00:14:07,640 --> 00:14:11,080 LOOKING FOR WAYS TO REALLY FILL 418 00:14:11,080 --> 00:14:15,280 THE GAPS IN KNOWLEDGE AND 419 00:14:15,280 --> 00:14:16,080 TRANSLATE RESULTS. 420 00:14:16,080 --> 00:14:18,440 SO WE DO SOME OF THIS BY CO 421 00:14:18,440 --> 00:14:19,640 FUNDING GRANTS WITH SOME 422 00:14:19,640 --> 00:14:21,400 INSTITUTES AT THE NIH AND THIS 423 00:14:21,400 --> 00:14:24,720 PIE CHART REFLECTS TYPES OF 424 00:14:24,720 --> 00:14:26,240 SUPPLEMENT INGREDIENTS AND WE 425 00:14:26,240 --> 00:14:27,720 ANNOUNCED WE ARE FUNDED OF SOME 426 00:14:27,720 --> 00:14:29,760 OF THESE IN FISCAL YEAR 2020. 427 00:14:29,760 --> 00:14:31,760 AND IT REFLECTS MORE OR LESS THE 428 00:14:31,760 --> 00:14:35,000 DISTRIBUTION OF USE OF PRODUCTS 429 00:14:35,000 --> 00:14:35,680 IN THE POPULATION. 430 00:14:35,680 --> 00:14:37,200 AND TO COVERS THE LANDSCAPE 431 00:14:37,200 --> 00:14:39,520 ALTHOUGH ON A VERY SMALL SCALE. 432 00:14:39,520 --> 00:14:41,760 SO YOU'LL LEARN MORE ABOUT THE 433 00:14:41,760 --> 00:14:43,280 NIH, THE RESEARCH AND TRAINING 434 00:14:43,280 --> 00:14:45,840 ON NUTRITION AND DIETARY 435 00:14:45,840 --> 00:14:47,360 SUPPLEMENTS WHEN PATRICIA 436 00:14:47,360 --> 00:14:49,560 HAGGATORY TALKS TOMORROW AT 3:45 437 00:14:49,560 --> 00:14:51,080 AND SHE WILL REALLY TALK MORE 438 00:14:51,080 --> 00:14:55,840 ABOUT RESEARCH FUNDING AT THE 439 00:14:55,840 --> 00:14:56,040 NIH. 440 00:14:56,040 --> 00:14:58,080 SO ODS HAS LOTS OF PROGRAMS AND 441 00:14:58,080 --> 00:14:59,880 INITIATIVES IN ORDER TO MEET OUR 442 00:14:59,880 --> 00:15:00,080 GOALS. 443 00:15:00,080 --> 00:15:03,480 AND I WOULD LIKE TO SPEND SOME 444 00:15:03,480 --> 00:15:04,160 TIME TALKING TODAY PARTICULARLY 445 00:15:04,160 --> 00:15:05,640 BECAUSE WE HAVE INDIVIDUALS THAT 446 00:15:05,640 --> 00:15:07,360 WILL BE PRESENTING MORE ON THESE 447 00:15:07,360 --> 00:15:08,280 PROGRAMS DURING THE PRACTICUM, 448 00:15:08,280 --> 00:15:10,880 SO I WILL BE HIGHLIGHTING SOME 449 00:15:10,880 --> 00:15:11,720 OF THESE PROGRAMS. 450 00:15:11,720 --> 00:15:14,200 ONE VERY IMPORTANT PROGRAM IS 451 00:15:14,200 --> 00:15:15,960 THE ANALYTICAL METHODS AND 452 00:15:15,960 --> 00:15:19,640 REFERENCE MATERIALS PROGRAM OR 453 00:15:19,640 --> 00:15:21,040 AMRAM. 454 00:15:21,040 --> 00:15:23,680 SO, THE CHIEWR O ANALYTICAL 455 00:15:23,680 --> 00:15:24,320 CHARACTERIZATION OF DIETARYETARY 456 00:15:24,320 --> 00:15:26,120 SUPPLEMENTS AND A CRITICAL STEP 457 00:15:26,120 --> 00:15:27,440 IN DEMONSTRATING SAFETY AND 458 00:15:27,440 --> 00:15:28,760 UNDERSTANDING THEIR HEALTH 459 00:15:28,760 --> 00:15:33,800 EFFECTS AND THE ODS AMRM IS 460 00:15:33,800 --> 00:15:35,800 FOCUSED ON DEVELOPING AND 461 00:15:35,800 --> 00:15:36,960 DISSEMINATING RESOURCES THAT 462 00:15:36,960 --> 00:15:38,000 SCIENTISTS AND ANALYSTS REALLY 463 00:15:38,000 --> 00:15:41,040 NEED TO INSURE THAT THE 464 00:15:41,040 --> 00:15:43,080 CHARACTERIZATION OF DIETARY 465 00:15:43,080 --> 00:15:44,280 SUPPLEMENTS, NATURAL PRODUCTS 466 00:15:44,280 --> 00:15:45,800 AND NUCLEOTIDES THRIENT 467 00:15:45,800 --> 00:15:48,280 BIOMARKERS ARE PREICIZE, 468 00:15:48,280 --> 00:15:51,240 ACCURATE AND RELIABLE. 469 00:15:51,240 --> 00:15:52,600 AMRM WORKS IN COLLABORATION WITH 470 00:15:52,600 --> 00:15:54,200 OTHERS LIKE THE NATIONAL 471 00:15:54,200 --> 00:15:56,000 INSTITUTES OF STANDARDS AND 472 00:15:56,000 --> 00:15:57,760 TECHNOLOGY OR NIST TO DEVELOP 473 00:15:57,760 --> 00:16:00,120 LABORATORY TOOLS, THESE TOOLS 474 00:16:00,120 --> 00:16:01,200 GIVE RESEARCHERS REGULATORS, 475 00:16:01,200 --> 00:16:02,360 MANUFACTURES, THE TOOLS THEY 476 00:16:02,360 --> 00:16:03,920 REALLY NEED TO EVALUATE THE 477 00:16:03,920 --> 00:16:07,120 INTEGRITY OF THE PRODUCTS THEY 478 00:16:07,120 --> 00:16:08,560 ARE STUDYING. 479 00:16:08,560 --> 00:16:13,120 AMRM HAS FUNDED WORKSHOPS, AND 480 00:16:13,120 --> 00:16:14,760 GUIDELINES ON METHODS WITH A BIG 481 00:16:14,760 --> 00:16:16,400 EMPHASIS ON DEVELOPING METHODS 482 00:16:16,400 --> 00:16:17,960 AS PART OF OUR STRATEGIC PLAN 483 00:16:17,960 --> 00:16:21,960 BUT ALSO AS PART OF AN NIH WIDE 484 00:16:21,960 --> 00:16:26,000 INITIATIVE WHICH IS REALLY TO 485 00:16:26,000 --> 00:16:28,160 IMPROVE REPRODUCIBILITY IN 486 00:16:28,160 --> 00:16:29,520 BIOMEDICAL RESEARCH. 487 00:16:29,520 --> 00:16:31,400 OUR ODS WEBSITE INCLUDES A 488 00:16:31,400 --> 00:16:34,880 SEARCHABLE DATABASE FOR 489 00:16:34,880 --> 00:16:37,560 ANALYTICAL PRODUCTS. 490 00:16:37,560 --> 00:16:39,560 AND DR. ADAM KUSZAK, WE DIRECTS 491 00:16:39,560 --> 00:16:41,200 THIS PROGRAM AND HE WILL PRESENT 492 00:16:41,200 --> 00:16:42,320 TOMORROW AT 11 AMAND SPEAKING 493 00:16:42,320 --> 00:16:44,880 ABOUT THE PRINCIPLES OF DIETARY 494 00:16:44,880 --> 00:16:46,000 SUPPLEMENT CHARACTERIZATION AND 495 00:16:46,000 --> 00:16:50,360 HE WILL BE INTRODUCING CONCEPTS 496 00:16:50,360 --> 00:16:51,560 OF IDENTITY, EQUALITY AND 497 00:16:51,560 --> 00:16:53,920 COMPOSITION, HE WILL GIVE MORE 498 00:16:53,920 --> 00:16:56,720 OF AN OVERVIEW OF THE ANALYTICAL 499 00:16:56,720 --> 00:16:58,920 CHALLENGES AND NEEDS AND DIETARY 500 00:16:58,920 --> 00:17:00,440 SUPPLEMENT RESEARCH AND REALLY 501 00:17:00,440 --> 00:17:01,880 THE IMPORTANCE OF STANDARDS AND 502 00:17:01,880 --> 00:17:03,560 REFERENCE MATERIALS WHEN 503 00:17:03,560 --> 00:17:08,280 STUDYING DIETARY SUPLEAPTS OR 504 00:17:08,280 --> 00:17:08,920 JUST ANALYZING THEM. 505 00:17:08,920 --> 00:17:12,000 SO THE OFFICE OF DIETARY 506 00:17:12,000 --> 00:17:13,840 SUPPLEMENTS ALSO HAS THE 507 00:17:13,840 --> 00:17:14,800 CONSORTIUM FOR ADVANCING 508 00:17:14,800 --> 00:17:17,360 RESEARCH ON BOTANICAL AND OTHER 509 00:17:17,360 --> 00:17:18,080 NATURAL PRODUCTS OR CARBON 510 00:17:18,080 --> 00:17:20,000 PROGRAM AND IN IS IN PARTNERSHIP 511 00:17:20,000 --> 00:17:23,160 WITH THE NATIONAL CENTER IF YOU 512 00:17:23,160 --> 00:17:23,920 COMPLIMENTARY AND INTEGRATIVE 513 00:17:23,920 --> 00:17:25,840 HEALTH, 1 OF THE THE CENTERS AT 514 00:17:25,840 --> 00:17:28,880 NE H AND THIS WAS STARTED IN 515 00:17:28,880 --> 00:17:30,880 1999 IN RESPONSE TO A 516 00:17:30,880 --> 00:17:31,800 CONGRESSIONAL MANDATE. 517 00:17:31,800 --> 00:17:33,760 THE PURPOSE OF THE CARBON 518 00:17:33,760 --> 00:17:36,760 PROGRAM IS TO PROMOTE 519 00:17:36,760 --> 00:17:37,440 COLLABORATIVE AND DISCIPLINARY 520 00:17:37,440 --> 00:17:38,880 RESEARCH ON THE SAFETY, 521 00:17:38,880 --> 00:17:41,600 EFFECTIVENESS AND MECHANISMS OF 522 00:17:41,600 --> 00:17:43,040 ACTION OF BOTANICAL DIETARY 523 00:17:43,040 --> 00:17:45,200 SUPPLEMENTS THAT HAVE HIGH 524 00:17:45,200 --> 00:17:45,840 POTENTIAL TO BENEFIT HUMAN 525 00:17:45,840 --> 00:17:47,120 HEALTH AND TO SUPPORT THE 526 00:17:47,120 --> 00:17:48,680 DEVELOPMENT OF METHODS AND 527 00:17:48,680 --> 00:17:50,400 RESOURCES THAT WILL ENHANCE THE 528 00:17:50,400 --> 00:17:51,600 PROGRESS OF THIS RESEARCH. 529 00:17:51,600 --> 00:17:54,280 THIS PROGRAM IS DIRECTED BY 530 00:17:54,280 --> 00:17:55,680 DR. BARBARA SORKIN AND SHE WILL 531 00:17:55,680 --> 00:17:57,680 BE PRESENTING TOMORROW AT 11:45. 532 00:17:57,680 --> 00:17:59,400 THE TALK WILL PROVIDE MORE 533 00:17:59,400 --> 00:18:00,480 DETAILS ABOUT THE CARBON PROGRAM 534 00:18:00,480 --> 00:18:03,000 BUT WILL ALSO FOCUS ON HOW 535 00:18:03,000 --> 00:18:05,400 CONCEPTS OF EFFICACY, SAFETY AND 536 00:18:05,400 --> 00:18:07,040 IDENTITY ARE ADDRESSED IN 537 00:18:07,040 --> 00:18:11,760 STUDYING BOTANICALS AND PLANT 538 00:18:11,760 --> 00:18:12,280 DERIVED INGREDIENT. 539 00:18:12,280 --> 00:18:16,520 WE ALSO HAVE THE POPULATION 540 00:18:16,520 --> 00:18:17,920 STUDIES PROGRAM, AND THIS 541 00:18:17,920 --> 00:18:22,360 PROGRAM IS DIRECTED BY DR. NANCY 542 00:18:22,360 --> 00:18:23,640 POTTESMAN, AND IT WAS START 543 00:18:23,640 --> 00:18:26,000 INDEED 2008 AND STARTED TO 544 00:18:26,000 --> 00:18:28,120 EXPAND COLLABORATION WITH GROUPS 545 00:18:28,120 --> 00:18:28,600 TO CHARACTERIZE DIETARY 546 00:18:28,600 --> 00:18:29,880 SUPPLEMENT USE IN THE UNITED 547 00:18:29,880 --> 00:18:30,120 STATES. 548 00:18:30,120 --> 00:18:31,560 THE MAIN GOAL OF THIS PROGRAM IS 549 00:18:31,560 --> 00:18:33,200 TO CONDUCT RESEARCH ON PADERNS 550 00:18:33,200 --> 00:18:35,800 OF SUPPLEMENT USE IN THE NEW 551 00:18:35,800 --> 00:18:38,520 UNITED STATES POPULATION AND 552 00:18:38,520 --> 00:18:39,120 SUBGROUPS, IDENTIFY GAPS, 553 00:18:39,120 --> 00:18:41,200 RESEARCH NEEDS FOR THE OFFICE 554 00:18:41,200 --> 00:18:43,400 AND HOW BEST TO ANSWER THEM, 555 00:18:43,400 --> 00:18:45,280 SUPPORT RESEARCH ON BIOMARKERS 556 00:18:45,280 --> 00:18:48,600 OF NUTRIENT EXPOSE AND YOU ARE 557 00:18:48,600 --> 00:18:49,640 NUTRITIONAL STATUS, PROVIDE 558 00:18:49,640 --> 00:18:52,000 GUIDANCE ON TON KACT WITH OTHER 559 00:18:52,000 --> 00:18:53,680 ICs, REPORTED OR REGARDING 560 00:18:53,680 --> 00:18:55,760 STUDIES RELEVANT TO POPULATION 561 00:18:55,760 --> 00:18:57,240 STUDIES, DIET, SUPPLEMENT, 562 00:18:57,240 --> 00:18:58,520 NUTRITIONAL ASSESSMENT AND 563 00:18:58,520 --> 00:19:00,520 BIOMARKERS. 564 00:19:00,520 --> 00:19:02,080 OUR NEXT SPEAKER DR. BAILEY WILL 565 00:19:02,080 --> 00:19:04,120 BE PRESENTING RIGHT AFTER ME, 566 00:19:04,120 --> 00:19:06,160 WAS WITH THE PROGRAM SINCE THE 567 00:19:06,160 --> 00:19:08,960 BEGINNING, HELP SHAPE WHAT IT IS 568 00:19:08,960 --> 00:19:09,320 TODAY. 569 00:19:09,320 --> 00:19:12,440 SHE HAS SINCE LEFT ODS AND 570 00:19:12,440 --> 00:19:13,720 PROFESSOR NOW AT TEXAS A&M 571 00:19:13,720 --> 00:19:14,640 UNIVERSITY. 572 00:19:14,640 --> 00:19:16,680 ONE VERY IMPORTANT PART OF THIS 573 00:19:16,680 --> 00:19:17,680 PROGRAM WHICH SHE REALLY HELPED 574 00:19:17,680 --> 00:19:19,800 TO START IS FUNDING CRITICAL 575 00:19:19,800 --> 00:19:20,960 SURVEYS, LIKE THE NATIONAL 576 00:19:20,960 --> 00:19:22,160 HEALTH AND NUTRITION EXAM NATION 577 00:19:22,160 --> 00:19:24,600 SURVEY AND ALSO AT TIMES THE 578 00:19:24,600 --> 00:19:26,440 NATIONAL HEALTH INTERVIEW 579 00:19:26,440 --> 00:19:28,160 SURVEY, TO COLLECT NATURALLY 580 00:19:28,160 --> 00:19:28,840 REPRESENTATIVE INFORMATION ON 581 00:19:28,840 --> 00:19:33,240 THE U.S. POPULATION ON THE USAGE 582 00:19:33,240 --> 00:19:34,440 OF DIETARY SUPPLEMENTS. 583 00:19:34,440 --> 00:19:36,320 SO DR. BAILEY'S PRESENTATION 584 00:19:36,320 --> 00:19:38,200 WILL REALLY FOCUS ON NHANES AND 585 00:19:38,200 --> 00:19:40,280 WHAT THE DATA HAS SHOWN IN TERMS 586 00:19:40,280 --> 00:19:41,480 OF SUPPLEMENT USE, WHAT PEOPLE 587 00:19:41,480 --> 00:19:44,440 ARE TAKING, THE TRENDS OVER 588 00:19:44,440 --> 00:19:46,080 TIME, AND THEN I ALSO WANT TO 589 00:19:46,080 --> 00:19:48,920 MENTION THAT THE NHANES SURVEY 590 00:19:48,920 --> 00:19:50,480 IS ALSO CRITICAL FROM PROVIDING 591 00:19:50,480 --> 00:19:52,000 INFORMATION ON HOW SUPPLEMENTS 592 00:19:52,000 --> 00:19:54,480 REALLY CONTRIBUTE TO TOTAL 593 00:19:54,480 --> 00:19:56,720 NUTRIENT INTAKE CROSS LINKING, 594 00:19:56,720 --> 00:19:57,360 FOODS, BEVERAGES, SUPPLEMENTS 595 00:19:57,360 --> 00:20:00,320 AND HOW THAT IMPACTS NUTRITIONAL 596 00:20:00,320 --> 00:20:07,000 STATUS AND HEALTH FOR THE U.S. 597 00:20:07,000 --> 00:20:07,320 POPULATION. 598 00:20:07,320 --> 00:20:10,200 OKAY, AND THEN WE ALSO HAVE 599 00:20:10,200 --> 00:20:11,000 DIETARY SUPPLEMENT DATABASES, 600 00:20:11,000 --> 00:20:14,080 THAT WE'VE HELPED TO CREATE IN 601 00:20:14,080 --> 00:20:15,920 COLLABORATION WITH WITH OTHERS. 602 00:20:15,920 --> 00:20:17,920 GREAT RESOURCES FOR RESEARCHERS, 603 00:20:17,920 --> 00:20:21,600 AND CONSUMERS AMONG OTHER 604 00:20:21,600 --> 00:20:22,080 STAKEHOLDERS. 605 00:20:22,080 --> 00:20:22,880 AND 1 THAT PEER PARTICULARLY 606 00:20:22,880 --> 00:20:26,080 PROUD OF IS THE DIETARY 607 00:20:26,080 --> 00:20:28,720 SUPPLEMENT LABELED DATABASE OR 608 00:20:28,720 --> 00:20:31,640 DSLD, EASILY ACCESSIBLE PUBLIC 609 00:20:31,640 --> 00:20:34,400 DATABASE RECREATED TO PROVIDE 610 00:20:34,400 --> 00:20:35,760 INFORMATION ON DIETARY 611 00:20:35,760 --> 00:20:36,640 COMPOSITION FROM THE PRODUCT 612 00:20:36,640 --> 00:20:38,520 LABEL, SO INFORMATION FROM THE 613 00:20:38,520 --> 00:20:40,280 PRODUCTA LABEL AND IT CAN BE 614 00:20:40,280 --> 00:20:44,120 USED BY RESEARCHERS, CONSUMERS, 615 00:20:44,120 --> 00:20:50,400 AND THE AIM IS TO REALLY INCLUDE 616 00:20:50,400 --> 00:20:51,280 ALL AVAILABLE LABELS AND 617 00:20:51,280 --> 00:20:52,120 SUPPLEMENTS THAT ARE MARKETED 618 00:20:52,120 --> 00:20:53,640 AND SOLD IN THE UNITED STATES. 619 00:20:53,640 --> 00:20:57,960 THIS DATABASE RIGHT NOW AS OVER 620 00:20:57,960 --> 00:21:00,280 125,000 LABELS WITH ABOUT A 621 00:21:00,280 --> 00:21:02,040 THOUSAND BEING ADDED EACH MONTH. 622 00:21:02,040 --> 00:21:03,840 IT ALSO INCLUDES NOT JUST 623 00:21:03,840 --> 00:21:06,360 INFORMATION ON THE INGREDIENTS 624 00:21:06,360 --> 00:21:07,920 THAT'S ON THE LABEL, AND THE 625 00:21:07,920 --> 00:21:09,600 AMOUNT AND EVERYTHING BUT IT 626 00:21:09,600 --> 00:21:11,280 ALSO HAS A COMPLETE IMPAG 627 00:21:11,280 --> 00:21:15,560 INCLUDED AS WELL OF THAT LABEL. 628 00:21:15,560 --> 00:21:19,760 THE NEXT DATABASE, ON THE 629 00:21:19,760 --> 00:21:21,640 DIETARY SUPPLEMENT OR DSID, IS 630 00:21:21,640 --> 00:21:24,320 THE INITIATIVE OF THE OFFICE OF 631 00:21:24,320 --> 00:21:25,080 DIETARY SUPPLEMENTS BUT WAS 632 00:21:25,080 --> 00:21:27,160 DEVELOPED BY THE METHODS AND 633 00:21:27,160 --> 00:21:28,880 APPLICATION OF FOOD COMPOSITION 634 00:21:28,880 --> 00:21:31,080 LABORATORY AT THE U.S. 635 00:21:31,080 --> 00:21:32,200 DEPARTMENT OF AGRICULTURE. 636 00:21:32,200 --> 00:21:35,320 AND THIS DATABASE PROVIDES 637 00:21:35,320 --> 00:21:35,920 ANALYTICALLY VALIDATED 638 00:21:35,920 --> 00:21:37,920 ESTIMATINGS OF INGREDIENTS IN 639 00:21:37,920 --> 00:21:40,240 DIETARY SUPPLEMENTS, SO 640 00:21:40,240 --> 00:21:41,320 NOT--IT'S NOT BASING THE 641 00:21:41,320 --> 00:21:43,040 INFORMATION OF INGREDIENTS FROM 642 00:21:43,040 --> 00:21:47,760 THE LABELS BUT ACTUALLY 643 00:21:47,760 --> 00:21:48,960 ANALYZING THE PRODUCTS. 644 00:21:48,960 --> 00:21:51,200 THE CURRENT VERSION OF DSID 645 00:21:51,200 --> 00:21:53,240 PROVIDES ESTIMATE OF INGREDIENTS 646 00:21:53,240 --> 00:21:56,400 FOR CONTENT FOR ADULT AND 647 00:21:56,400 --> 00:21:59,160 CHILDREN MULTIVITAMIN MINERALS, 648 00:21:59,160 --> 00:21:59,800 NONPRESCRIPTION PRENATAL 649 00:21:59,800 --> 00:22:01,960 MINERALS AND THEN AN OMEGA 3 650 00:22:01,960 --> 00:22:02,680 FATTY ACID SUPPLEMENT. 651 00:22:02,680 --> 00:22:06,040 AND THEN I ALSO WANTED TO 652 00:22:06,040 --> 00:22:07,560 MENTION THAT ODS DEVELOPED THE 653 00:22:07,560 --> 00:22:10,040 COMPUTER ACCESS TO RESEARCH ON 654 00:22:10,040 --> 00:22:11,440 DIETARY SUPPLEMENTS OR CARDS 655 00:22:11,440 --> 00:22:12,880 DATABASE AND THIS PROVIDES 656 00:22:12,880 --> 00:22:14,600 INFORMATION ON ALL FEDERALLY 657 00:22:14,600 --> 00:22:16,240 FUNDED RESEARCH ON DIETARY 658 00:22:16,240 --> 00:22:20,160 SUPPLEMENTS THAT HAVE BEEN 659 00:22:20,160 --> 00:22:23,640 CONDUCTED SINCE 1999 AND JOYCE 660 00:22:23,640 --> 00:22:24,600 MERKEL WILL TALK ABOUT ALL OF 661 00:22:24,600 --> 00:22:27,080 THESE AS WELL AS OTHER USEFUL 662 00:22:27,080 --> 00:22:30,760 DATABASES DURING HER TALK TODAY, 663 00:22:30,760 --> 00:22:35,400 LATER TODAY AT 3:15 P.M. 664 00:22:35,400 --> 00:22:37,040 SO ANOTHER VERY IMPORTANT GOAL 665 00:22:37,040 --> 00:22:41,680 OF ODS IS TO ENHANCE THE DIETARY 666 00:22:41,680 --> 00:22:42,880 SUPPLEMENT RESEARCH WORKFORCE 667 00:22:42,880 --> 00:22:45,480 THROUGH TRAINING AND CAREER 668 00:22:45,480 --> 00:22:45,840 DEVELOPMENT. 669 00:22:45,840 --> 00:22:48,080 WE DO THIS IN SEVERAL WAYS, 670 00:22:48,080 --> 00:22:51,280 AGAIN BY USING NIH GRANT AWARDS 671 00:22:51,280 --> 00:22:54,000 THAT SERVES THE EXTRAMURAL 672 00:22:54,000 --> 00:22:57,600 COMMUNITY AND AGAIN PATRICIA 673 00:22:57,600 --> 00:22:58,640 HAGERTY'S TALK AT 3:45 TOMORROW 674 00:22:58,640 --> 00:23:01,200 WILL GO THROUGH THIS. 675 00:23:01,200 --> 00:23:03,240 ODS ALSO SPONSORS INTRAMURAL 676 00:23:03,240 --> 00:23:05,880 SCHOLARS AWARDS WITH OTHER NIH 677 00:23:05,880 --> 00:23:08,200 INSTITUTES AND CENTERS, WE 678 00:23:08,200 --> 00:23:09,920 DEVELOPED THE WORKFORCE BY 679 00:23:09,920 --> 00:23:13,240 COLLABORATING WITH OTHER FEDERAL 680 00:23:13,240 --> 00:23:15,560 AGENCIES, TO SUPPORT MENTOR, OR 681 00:23:15,560 --> 00:23:17,080 PROVIDE TECHNICAL GUIDANCE TO 682 00:23:17,080 --> 00:23:19,080 POST DOC FELLOWS, EARLY CAREER 683 00:23:19,080 --> 00:23:20,960 SCIENTISTS FOR EXAMPLE, OVER THE 684 00:23:20,960 --> 00:23:22,640 YEARS WE HAVE FUNDED POST DOCS 685 00:23:22,640 --> 00:23:24,760 OVER AT THE NATIONAL INSTITUTES 686 00:23:24,760 --> 00:23:25,720 OF STANDARDS AND TECHNOLOGY AS 687 00:23:25,720 --> 00:23:28,920 WELL AS THE U.S. DEPARTMENT OF 688 00:23:28,920 --> 00:23:32,360 AGRICULTURE AND THEN WE CAN ALSO 689 00:23:32,360 --> 00:23:33,840 OFFER SHORT-TERM TRAINING 690 00:23:33,840 --> 00:23:36,040 OPPORTUNITIES FOR ODS STUDENTS 691 00:23:36,040 --> 00:23:38,760 AND FACULTY MEMBERS, SHORT-TERM 692 00:23:38,760 --> 00:23:39,480 TRAINING OPPORTUNITIES. 693 00:23:39,480 --> 00:23:42,880 WE'VE HAD THE GREAT OPPORTUNITY 694 00:23:42,880 --> 00:23:44,200 TO HAVE SEVERAL TRIPLE AF 695 00:23:44,200 --> 00:23:45,480 FELLOWS TO COME AND TRAIN WITH 696 00:23:45,480 --> 00:23:50,640 US AND WE ALSO HOST THIS 697 00:23:50,640 --> 00:23:51,320 PRACTICUM ANNUALLY. 698 00:23:51,320 --> 00:23:54,760 AND THEN THE COMMUNICATING THE 699 00:23:54,760 --> 00:23:56,440 SCIENCE AND SUPLEMS, THE THIS IS 700 00:23:56,440 --> 00:23:58,560 REALLY, REALLY AGAIN A VERY KEY 701 00:23:58,560 --> 00:24:00,360 GOAL, VERY STRONG COMMUNICATION 702 00:24:00,360 --> 00:24:03,040 TEAM WITHIN ODS THAT DO A GREAT 703 00:24:03,040 --> 00:24:03,800 JOB OF GETTING RELIABLE 704 00:24:03,800 --> 00:24:05,200 INFORMATION OUT TO THE PUBLIC TO 705 00:24:05,200 --> 00:24:06,360 RESEARCHERS AND POLICY MAKERS 706 00:24:06,360 --> 00:24:09,600 AND WE HAVE A WEBSITE THAT 707 00:24:09,600 --> 00:24:11,320 RECOMMEND EVERYONE CHECKING OUT 708 00:24:11,320 --> 00:24:15,440 THAT PROVIDES SO MANY RESOURCES. 709 00:24:15,440 --> 00:24:18,080 ONE BEING THE DIETARY 710 00:24:18,080 --> 00:24:18,880 SUPPLEMENTS FACT SHEET 711 00:24:18,880 --> 00:24:20,120 AVAILABLE, AGAIN ON OUR WEBSITE, 712 00:24:20,120 --> 00:24:22,320 RIGHT NOW WE HAVE OVER A HUNDRED 713 00:24:22,320 --> 00:24:24,480 FACT SHEETS ON DIETARY 714 00:24:24,480 --> 00:24:25,960 SUPPLEMENT INGREDIENTS AND 715 00:24:25,960 --> 00:24:27,080 SUPPLEMENTS MARKETED FOR 716 00:24:27,080 --> 00:24:29,760 SPECIFIC PURPOSES, FOR EXAMPLE, 717 00:24:29,760 --> 00:24:31,560 WEIGHT LOSS. 718 00:24:31,560 --> 00:24:34,080 WE OFFER HEALTH PROFESSIONAL AND 719 00:24:34,080 --> 00:24:35,640 CONSUMER VERSION, MANY OF THEM 720 00:24:35,640 --> 00:24:39,720 ARE TRANSLATED INTO SPANISH, THE 721 00:24:39,720 --> 00:24:41,320 FACT SHEET THAT MIGHT BE OF 722 00:24:41,320 --> 00:24:42,120 GREAT INTEREST FOR EVERYONE 723 00:24:42,120 --> 00:24:43,800 RIGHT NOW IS OUR DIETARY 724 00:24:43,800 --> 00:24:48,560 SUPPLEMENTS IN THE TIME OF COVID 725 00:24:48,560 --> 00:24:50,360 FACT SHEET, WHICH WE HAVE FOR 726 00:24:50,360 --> 00:24:51,560 BOTH AVAILABLE FOR HEALTH 727 00:24:51,560 --> 00:24:53,040 PROFESSIONALS AND 1 FOR 728 00:24:53,040 --> 00:24:53,560 CONSUMERS. 729 00:24:53,560 --> 00:24:56,440 WE HAVE A WONDERFUL PRESENTATION 730 00:24:56,440 --> 00:24:58,120 TITLED DIETARY SUPPLEMENTS AND 731 00:24:58,120 --> 00:24:59,200 IMMUNITY LESSONS LEARNED FROM 732 00:24:59,200 --> 00:25:03,760 COVID-19 AND THIS 1 IS SCHEDULED 733 00:25:03,760 --> 00:25:05,960 TOMORROW--I MEAN WEDNESDAY AT 734 00:25:05,960 --> 00:25:07,520 11:45 BY CAROL HIGGINS AND SHE 735 00:25:07,520 --> 00:25:09,600 IS 1 OF THE ODS STAFF THAT PUT 736 00:25:09,600 --> 00:25:11,160 TOGETHER THIS FACT SHEET AND 737 00:25:11,160 --> 00:25:15,000 THEN FINALLY ODS ALSO PROVIDES 738 00:25:15,000 --> 00:25:15,960 ENEWS LETTERS FOR PROFESSIONAL 739 00:25:15,960 --> 00:25:21,320 AUDIENCE AND THE SCOOP FOR 740 00:25:21,320 --> 00:25:21,600 CONSUMERS. 741 00:25:21,600 --> 00:25:24,640 I ALSO WANT TO MENTION OUR ODS 742 00:25:24,640 --> 00:25:26,680 EVIDENCE-BASED REVIEW PROGRAM, 743 00:25:26,680 --> 00:25:29,960 SO IN 2001, THE NIH VUF OFFICE 744 00:25:29,960 --> 00:25:31,520 OF DIETARY SUPPLEMENT RECEIVED 745 00:25:31,520 --> 00:25:33,000 CONGRESSIONAL MANDATE TO REVIEW 746 00:25:33,000 --> 00:25:34,520 THE CURRENT SCIENTIFIC EVIDENCE 747 00:25:34,520 --> 00:25:37,200 ON THE EFFICACY AND SAFETY OF 748 00:25:37,200 --> 00:25:38,520 DIETARY SUPPLEMENTS AND IDENTIFY 749 00:25:38,520 --> 00:25:41,880 RESEARCH NEEDS, SO ODS RESCINDED 750 00:25:41,880 --> 00:25:44,440 BY DEVELOPING AN EVIDENCE-BASED 751 00:25:44,440 --> 00:25:46,920 REVIEW PROGRAM, AND WE BASICALLY 752 00:25:46,920 --> 00:25:47,960 USED EVIDENCE-BASED PRACTICE 753 00:25:47,960 --> 00:25:51,680 CENTERS PROGRAM THAT'S 754 00:25:51,680 --> 00:25:53,760 ESTABLISHED BY ARC, AGENCY FOR 755 00:25:53,760 --> 00:25:54,800 HEALTHCARE RESEARCH AND QUALITY, 756 00:25:54,800 --> 00:25:56,360 THIS IS ALL TO CONDUCT 757 00:25:56,360 --> 00:25:57,880 SCIENTIFIC REVIEWS OF THE 758 00:25:57,880 --> 00:26:00,680 SCIENTIFIC LITERATURE AND REPORT 759 00:26:00,680 --> 00:26:01,240 THEIR FINDINGS. 760 00:26:01,240 --> 00:26:02,400 AND ODS IN COLLABORATION WITH 761 00:26:02,400 --> 00:26:04,120 OTHER INSTITUTES AND CENTERS 762 00:26:04,120 --> 00:26:06,480 HAVE FOUND THESE PREPORTS 763 00:26:06,480 --> 00:26:07,520 BASICALLY INVALUABLE IN 764 00:26:07,520 --> 00:26:08,920 PRESENTING WHAT IS AND WHAT IS 765 00:26:08,920 --> 00:26:13,520 NOT KNOWN IN A RESEARCH AREA. 766 00:26:13,520 --> 00:26:15,360 AND REALLY LAYS SOLID FOUNDATION 767 00:26:15,360 --> 00:26:16,720 FOR IDENTIFYING GAPS IN 768 00:26:16,720 --> 00:26:18,040 KNOWLEDGE, AND PROVIDING A 769 00:26:18,040 --> 00:26:20,880 STRONG SCIENTIFIC BASIS FOR THE 770 00:26:20,880 --> 00:26:23,920 DEVELOPMENT OF I RESEARCH 771 00:26:23,920 --> 00:26:24,160 AGENDA. 772 00:26:24,160 --> 00:26:25,560 AND THAT LEADS ME TO THIS, WE 773 00:26:25,560 --> 00:26:27,440 LEARNED A LOT OVER THE YEARS, 774 00:26:27,440 --> 00:26:29,400 ESPECIALLY FROM THESE FINDINGS 775 00:26:29,400 --> 00:26:31,400 OF THIS THESE REPORTS THAT HAVE 776 00:26:31,400 --> 00:26:32,680 REALLY HIGHLIGHTED THE 777 00:26:32,680 --> 00:26:33,480 CHALLENGES IN STUDYING 778 00:26:33,480 --> 00:26:34,080 SUPPLEMENTS AND HERE'S SCRUOF 779 00:26:34,080 --> 00:26:36,120 THE A LIST OF ISSUES THAT REALLY 780 00:26:36,120 --> 00:26:37,120 CAN IMPACT YOUR RESULTS AND 781 00:26:37,120 --> 00:26:39,280 THESE WILL BE DISCUSSED FURTHER 782 00:26:39,280 --> 00:26:40,920 THROUGHOUT THE PRACTICUM BUT 783 00:26:40,920 --> 00:26:42,360 JUST TO HIGHLIGHT A FEW QUICKLY, 784 00:26:42,360 --> 00:26:47,880 A NUMBER OF STUDIES CAN FAIL 785 00:26:47,880 --> 00:26:51,320 STATUS AT BASE LINE WHICH CAN 786 00:26:51,320 --> 00:26:53,000 REALLY IMPACT RESULTS, STUDIES 787 00:26:53,000 --> 00:26:58,880 MAY NOT BE GENERALIZABLE, PEOPLE 788 00:26:58,880 --> 00:27:01,960 MAY METABOLIZE SUPPLEMENTS AND 789 00:27:01,960 --> 00:27:04,080 INGREDIENTS SNCHTLY WHICH CAN 790 00:27:04,080 --> 00:27:05,000 AFFECT RESULTS DIFFERENTLY. 791 00:27:05,000 --> 00:27:06,440 TIMING AND DURATION, HOW LONG 792 00:27:06,440 --> 00:27:07,880 DOES AN INTERVENTION NEED TO GO 793 00:27:07,880 --> 00:27:09,720 ON FOR TO YOU SEE RESULTS, YOU 794 00:27:09,720 --> 00:27:13,120 NEED TO HAVE A GOOD HYPOTHESIS, 795 00:27:13,120 --> 00:27:14,720 END POINTS CAN BE VERY HARD TO 796 00:27:14,720 --> 00:27:17,680 COME UP WITH, DOSES CAN ALSO BE 797 00:27:17,680 --> 00:27:19,760 AN ISSUE AND CAN IMPACT HOW WE 798 00:27:19,760 --> 00:27:21,200 CAN COMPARE ALSO ACROSS STUDIES 799 00:27:21,200 --> 00:27:24,400 AND THEN FINALLY, MEASUREMENT OF 800 00:27:24,400 --> 00:27:28,880 COURSE, A HUGE, HUGE, ISSUE. 801 00:27:28,880 --> 00:27:30,760 FOR DIETARY SUPPLEMENTS, THERE'S 802 00:27:30,760 --> 00:27:33,680 RESEARCH PRODUCT ISSUES AND 803 00:27:33,680 --> 00:27:35,680 THERE'S A HOW TO CORRECTLY 804 00:27:35,680 --> 00:27:37,000 IDENTIFY THE CONSTITUENTS IN THE 805 00:27:37,000 --> 00:27:38,760 PRODUCT AND THIS CAN BE 806 00:27:38,760 --> 00:27:40,240 CHALLENGING, WE REALLY NEED TO 807 00:27:40,240 --> 00:27:41,720 DO VERY CLEAR CHARACTERIZATION, 808 00:27:41,720 --> 00:27:46,320 THERE CAN BE ISSUES LIKE 809 00:27:46,320 --> 00:27:48,080 CONTAMINATION, BACTERIA, 810 00:27:48,080 --> 00:27:49,360 PRESCRIPTION DRUGS, AND 811 00:27:49,360 --> 00:27:50,120 REPRODUCIBILITY DEPENDS ON ALL 812 00:27:50,120 --> 00:27:52,600 THESE THINGS AND OF COURSE 813 00:27:52,600 --> 00:27:53,600 HAVING VERY, VERY GOOD 814 00:27:53,600 --> 00:27:53,960 PLEASUREMENT. 815 00:27:53,960 --> 00:27:55,120 SO YOU'RE GOING TO HEAR 816 00:27:55,120 --> 00:27:57,080 DEFINITELY MORE ABOUT THIS, 817 00:27:57,080 --> 00:27:58,240 DURING OUR SESSION TOMORROW 818 00:27:58,240 --> 00:28:01,800 MORNING ON RIGOR AND 819 00:28:01,800 --> 00:28:03,200 REPRODUCIBILITY IN DIETARY 820 00:28:03,200 --> 00:28:04,440 SUPPLEMENT RESEARCH. 821 00:28:04,440 --> 00:28:07,880 SO THIS CONCLUDES MY 822 00:28:07,880 --> 00:28:08,920 INTRODUCTION AND DEFINITELY FOR 823 00:28:08,920 --> 00:28:10,000 MORE INFORMATION ABOUT ODS AND 824 00:28:10,000 --> 00:28:11,760 WHAT WE DO AND OUR DIFFERENT 825 00:28:11,760 --> 00:28:13,800 PROGRAMS AND RESOURCES ON 826 00:28:13,800 --> 00:28:15,360 DIETARY SUPPLEMENTS, PLEASE 827 00:28:15,360 --> 00:28:16,200 VISIT OUR WEBSITE. 828 00:28:16,200 --> 00:28:21,080 YOU CAN ALSO JOIN OUR LISTSERV, 829 00:28:21,080 --> 00:28:22,560 IF YOU EVAPORATE ALREADY FOR 830 00:28:22,560 --> 00:28:23,400 INFORMATION AND UPDATES AND WITH 831 00:28:23,400 --> 00:28:25,160 THAT I WOULD LIKE TO START THE 832 00:28:25,160 --> 00:28:27,120 FIRST SESSION WHICH WILL PROVIDE 833 00:28:27,120 --> 00:28:28,200 AN OVERVIEW OF DIETARY 834 00:28:28,200 --> 00:28:28,920 SUPPLEMENT USE IN THE UNITED 835 00:28:28,920 --> 00:28:32,240 STATES AND I WOULD ALSO LYING TO 836 00:28:32,240 --> 00:28:33,120 WELCOME YOU TO--LIKE TO WELCOME 837 00:28:33,120 --> 00:28:34,800 YOU TO THE RESEARCH PRACTICUM. 838 00:28:34,800 --> 00:28:38,480 SO OUR SPEAKER NEXT IS DR. REGAN 839 00:28:38,480 --> 00:28:39,960 BAILEY, SHE'S AN ASSOCIATE 840 00:28:39,960 --> 00:28:42,080 INSTITUTE DIRECTOR FOR THE 841 00:28:42,080 --> 00:28:43,680 INSTITUTES FOR ADVANCING HEALTH 842 00:28:43,680 --> 00:28:45,200 THROUGH AG RICULTURE AND 843 00:28:45,200 --> 00:28:46,840 PROFESSOR OF NUTRITION AT TEXAS 844 00:28:46,840 --> 00:28:47,320 A&M UNIVERSITY. 845 00:28:47,320 --> 00:28:49,320 AS I MENTIONED BEFORE, SHE 846 00:28:49,320 --> 00:28:50,960 WORKED AT THE ODS FOR MANY, MANY 847 00:28:50,960 --> 00:28:53,840 YEARS AND HAS DONE A TREMENDOUS 848 00:28:53,840 --> 00:28:55,640 AMOUNT OF WORK AT CHARACTERIZING 849 00:28:55,640 --> 00:28:56,240 SUPPLEMENT USE IN THE UNITED 850 00:28:56,240 --> 00:28:59,120 STATES AND HOW THESE PROD UBTS 851 00:28:59,120 --> 00:28:59,760 CONTRIBUTE TO NUTRIENT INTAKE, 852 00:28:59,760 --> 00:29:02,280 TODAY SHE WILL BE PRESENTINGOT 853 00:29:02,280 --> 00:29:03,600 PREVALENCE OF DIETARY SUPPLEMENT 854 00:29:03,600 --> 00:29:05,600 USE IN THE U.S. AND SUBGROUPS 855 00:29:05,600 --> 00:29:08,440 AND SOME OF THE CHARACTERISTICS 856 00:29:08,440 --> 00:29:09,040 OF SUPPLEMENT USERS. 857 00:29:09,040 --> 00:29:13,960 THANK YOU OTHER REGAN. 858 00:29:13,960 --> 00:29:16,760 >>IT'S AN HONOR TO BE 859 00:29:16,760 --> 00:29:19,680 WITH YOU TODAY TO DISCUSS USE OF 860 00:29:19,680 --> 00:29:20,720 DIETARY SUPPLEMENTS IN AMERICA 861 00:29:20,720 --> 00:29:23,480 AND HOW THOSE TREND VS CHANGED 862 00:29:23,480 --> 00:29:25,880 OR IN SOME CASES HAVE NOT 863 00:29:25,880 --> 00:29:26,440 CHANGED ACROSS TIME. 864 00:29:26,440 --> 00:29:31,080 MY NAME IS REGAN BAILEY, I'M A 865 00:29:31,080 --> 00:29:32,280 PROFESSOR OF NUTRITION SCIENCE 866 00:29:32,280 --> 00:29:34,360 AT TEXAS A&M, AND 867 00:29:34,360 --> 00:29:35,720 BEFORE TRANSITIONING TO ACADEMIC 868 00:29:35,720 --> 00:29:39,040 LIFE I WAS A POST DOC 869 00:29:39,040 --> 00:29:40,400 FELLOW AND STAFF RESEARCH 870 00:29:40,400 --> 00:29:42,400 SCIENTIST AT ODS. 871 00:29:42,400 --> 00:29:45,800 SO THE 1994 DSH EA REGULATION 872 00:29:45,800 --> 00:29:50,680 CONTINUES TO BE THE LAW THAT 873 00:29:50,680 --> 00:29:51,400 REGULATES DIETARY SUPPLEMENTS IN 874 00:29:51,400 --> 00:29:52,880 THIS COUNTRY. 875 00:29:52,880 --> 00:29:53,960 AND THEY DID AN EXCELLENT JOB 876 00:29:53,960 --> 00:29:54,480 DESCRIBES THIS TO YOU. 877 00:29:54,480 --> 00:29:56,480 I WANT TO START THE PRESENTATION 878 00:29:56,480 --> 00:29:57,400 BY TALKING ABOUT HOW WE KNOW 879 00:29:57,400 --> 00:29:59,160 WHAT PEOPLE ARE USING. 880 00:29:59,160 --> 00:30:01,760 SO THE METHODS TO ASSESS DIETARY 881 00:30:01,760 --> 00:30:02,960 SUPPLEMENTS ARE IN SOME CASES 882 00:30:02,960 --> 00:30:04,480 VERY SIMILAR TO THAT OF FOODS 883 00:30:04,480 --> 00:30:10,680 AND BEVERAGES SO IT COULD BE A 884 00:30:10,680 --> 00:30:11,520 DIETARY RECORD, RECALL, 885 00:30:11,520 --> 00:30:13,240 FREQUENCY QUESTIONNAIRE OR A 886 00:30:13,240 --> 00:30:14,640 HISTORY OR SCREENING METHOD BUT 887 00:30:14,640 --> 00:30:16,120 WHAT'S INTERESTING AND WHAT'S 888 00:30:16,120 --> 00:30:17,440 VERY IMPORTANT TO DISCUSSIONS 889 00:30:17,440 --> 00:30:19,120 WILL BE HAVING TODAY IS THAT 890 00:30:19,120 --> 00:30:20,880 MOST OF THE NATIONAL DATA THAT 891 00:30:20,880 --> 00:30:24,000 WE HAVE ON SUPPLEMENT USE COMES 892 00:30:24,000 --> 00:30:27,360 FROM AN IN-HOME PRODUCT, 893 00:30:27,360 --> 00:30:29,640 INVENTORY IN WHICH TRAINED 894 00:30:29,640 --> 00:30:33,600 INTERVIEWERS VIEW AND RECORD 895 00:30:33,600 --> 00:30:34,640 VERY DETAILED INFORMATION ABOUT 896 00:30:34,640 --> 00:30:39,240 EACH AND EVERY PRODUCT THAT AN 897 00:30:39,240 --> 00:30:41,160 INDIVIDUAL IS USING. 898 00:30:41,160 --> 00:30:44,200 AND WHILE DSHEA DEFINED WHAT A 899 00:30:44,200 --> 00:30:45,600 DIETARY SUPPLEMENT IS, AS AN 900 00:30:45,600 --> 00:30:47,600 UMBRELLA TERM, THERE ARE NO 901 00:30:47,600 --> 00:30:48,800 LEGAL OR REGULATORY DEFINITIONS 902 00:30:48,800 --> 00:30:56,080 FOR WHAT IS A MULTIVITAMIN, 903 00:30:56,080 --> 00:30:59,400 MULTIVITAMIN MINERAL OR A 904 00:30:59,400 --> 00:30:59,920 MULTIVITAMIN MULTIMINNIAL. 905 00:30:59,920 --> 00:31:02,120 THESE ARE OFTEN TIMES 906 00:31:02,120 --> 00:31:02,880 INTERCHANGEABLY USED BUT ALSO 907 00:31:02,880 --> 00:31:04,200 WITHIN THE SCIENTIFIC LITERATURE 908 00:31:04,200 --> 00:31:09,760 AND THERE ARE MANY WAYS THAT 909 00:31:09,760 --> 00:31:10,520 RESEARCHERS OPERATIONALIZE 910 00:31:10,520 --> 00:31:12,520 PRODUCTINGS INTO THESE SPECIFIC 911 00:31:12,520 --> 00:31:13,520 CATEGORIES AND MORE INFORMATION 912 00:31:13,520 --> 00:31:16,000 ON THAT CAN BE FOUND IN THE 913 00:31:16,000 --> 00:31:18,200 REFERENCES LISTED ON THIS SLIDE. 914 00:31:18,200 --> 00:31:19,840 BUT WA'S IMPORTANT IS THAT WE 915 00:31:19,840 --> 00:31:23,480 HAVE THE BEST METHODS TO ASSESS 916 00:31:23,480 --> 00:31:25,800 SUPPLEMENT USE BECAUSE THE SALES 917 00:31:25,800 --> 00:31:28,000 DATA THAT DR. BETS INTRODUCED 918 00:31:28,000 --> 00:31:30,000 AND THE PREVALENCE DATA I WILL 919 00:31:30,000 --> 00:31:32,880 DESCRIBE TO YOU TODAY INDICATE 920 00:31:32,880 --> 00:31:34,000 THAT MICRONUCLEOTIDES KRE TINS 921 00:31:34,000 --> 00:31:35,880 END OR VITAMIN AND MINERAL 922 00:31:35,880 --> 00:31:37,200 SUPPLEMENTS ARE THE MOST 923 00:31:37,200 --> 00:31:38,920 COMMONLY USED PRODUCTS IN THIS 924 00:31:38,920 --> 00:31:40,800 COUNTRY AND THAT THOSE COMMONLY 925 00:31:40,800 --> 00:31:42,200 USED PRODUCTS CAN PROVIDE 926 00:31:42,200 --> 00:31:43,280 UPREGARDS OF A HUNDRED PERCENT 927 00:31:43,280 --> 00:31:45,640 OF THE DAILY VALUE FOR SOME 928 00:31:45,640 --> 00:31:46,040 NUTRIENTS. 929 00:31:46,040 --> 00:31:50,280 SO IF WE DO NOT INCLUDE 930 00:31:50,280 --> 00:31:52,560 SUPPLEMENTS IN OUR TOTAL 931 00:31:52,560 --> 00:31:54,760 ESTIMATES OF NUTRIENT EXPOSURE, 932 00:31:54,760 --> 00:31:55,640 WE OVERESTIMATE THE PROPORTION 933 00:31:55,640 --> 00:32:01,320 OF THE POPULATION AT RISK FOR AN 934 00:32:01,320 --> 00:32:01,960 ADEQUATE. 935 00:32:01,960 --> 00:32:03,400 SO UNDERESTIMATE THE PROPORTION 936 00:32:03,400 --> 00:32:06,360 AT RISK FOR POTENTIALLY 937 00:32:06,360 --> 00:32:06,760 EXCESSIVE INTAKES. 938 00:32:06,760 --> 00:32:08,920 SO MOST OF THE DATA THEY WILL BE 939 00:32:08,920 --> 00:32:10,080 DESCRIBING TODAY COMES FROM THE 940 00:32:10,080 --> 00:32:13,400 NATIONAL HEALTH AND NUTRITION 941 00:32:13,400 --> 00:32:14,920 EXAM NATION SURVEY OR NHANES 942 00:32:14,920 --> 00:32:17,360 WHICH I REFER TO AS OUR NATIONAL 943 00:32:17,360 --> 00:32:20,520 TREASURE BECAUSE IT HAS SUCH 944 00:32:20,520 --> 00:32:21,440 DETAILED INFORMATION ACROSS A 945 00:32:21,440 --> 00:32:22,840 WHOLE HOST OF THE DIFFERENT 946 00:32:22,840 --> 00:32:27,440 NUTRITION AND HEALTH RELATED 947 00:32:27,440 --> 00:32:27,800 TOPICS. 948 00:32:27,800 --> 00:32:29,040 BUT OF COURSE WHAT WE ARE GOING 949 00:32:29,040 --> 00:32:31,560 TO FOCUS ON TODAY IS DIETARY 950 00:32:31,560 --> 00:32:32,240 SUPPLEMENTS. 951 00:32:32,240 --> 00:32:34,440 SO NHANES AND WONDERFUL AND 952 00:32:34,440 --> 00:32:38,800 NATIONALLY REPRESENTATIVE OF THE 953 00:32:38,800 --> 00:32:41,080 U.S. POPULATION, NHANES HAS THAT 954 00:32:41,080 --> 00:32:45,480 GOLD STANDARD IN HOME PRODUCT 955 00:32:45,480 --> 00:32:46,240 DIETARY SUPPLEMENT USE. 956 00:32:46,240 --> 00:32:48,360 WE CAN THEN RELATE DIETARY 957 00:32:48,360 --> 00:32:51,000 SUPPLEMENT USE TO CLINICAL AND 958 00:32:51,000 --> 00:32:52,760 OTHER DIETARY DATA FOR MEDICAL 959 00:32:52,760 --> 00:32:56,600 EXAM NATION CENTER, AS WELL AS 960 00:32:56,600 --> 00:32:59,200 ANOTHER 24 RECALL, SO 961 00:32:59,200 --> 00:33:01,080 SUPPLEMENTS SINCE 2007 HAS BEEN 962 00:33:01,080 --> 00:33:02,840 COLLECTED BOTH AS PART OF A 24 963 00:33:02,840 --> 00:33:08,680 HOUR RECALL AND AS PART OF HOME 964 00:33:08,680 --> 00:33:09,760 PRODUCT INVENTORY. 965 00:33:09,760 --> 00:33:15,600 THIS IS INFORMATION FROM 966 00:33:15,600 --> 00:33:18,320 DR. JAMIE GASHCHE, IN THE OFFICE 967 00:33:18,320 --> 00:33:21,080 OF DIETARY SUPPLEMENTS SHOWING 968 00:33:21,080 --> 00:33:22,720 THEY PRE, POETIC POST, DSHEAA IN 969 00:33:22,720 --> 00:33:26,080 THE USE OF ANY DIETARY 970 00:33:26,080 --> 00:33:26,560 SUPPLEMENTS. 971 00:33:26,560 --> 00:33:27,880 WHAT YOU WILL SEE HERE AT THIS 972 00:33:27,880 --> 00:33:29,920 TIME AND WHAT CONTINUES TO BE 973 00:33:29,920 --> 00:33:32,640 TRUE, IS THAT WOMEN USE MORE 974 00:33:32,640 --> 00:33:33,360 DIETARY SUPPLEMENTS THAN MEN 975 00:33:33,360 --> 00:33:35,000 BOTH IN TERMS OF PREVALENCE OF 976 00:33:35,000 --> 00:33:41,080 USE AND ALSO THE NUMBER OF 977 00:33:41,080 --> 00:33:41,520 PRODUCTS. 978 00:33:41,520 --> 00:33:43,080 IN THIS SLIDE, I'M SHOWING YOU 979 00:33:43,080 --> 00:33:45,960 DATA FROM A PUBLICATION FROM 980 00:33:45,960 --> 00:33:48,640 DR. ELIZABETH CANTER AND HER 981 00:33:48,640 --> 00:33:52,520 TEEM THAT ILTRAIT STRAIGHTS 982 00:33:52,520 --> 00:33:55,720 STRAIGHT--ILLUSTRATES THE USE OF 983 00:33:55,720 --> 00:33:56,360 SUPPLEMENTS FROM 2009-2012. 984 00:33:56,360 --> 00:33:59,800 SO AS I MENTIONED SIGNIFYETARY 985 00:33:59,800 --> 00:34:01,640 USE AFTER DSHEA HAS BEEN 986 00:34:01,640 --> 00:34:04,000 RELATIVELY STABLE WITH WOMEN 987 00:34:04,000 --> 00:34:05,240 CONSISTENTLY REPORTING MORE USE 988 00:34:05,240 --> 00:34:07,600 ARE THAN MEN BUT WE HAVE 989 00:34:07,600 --> 00:34:08,640 OBSERVED A SIGNIFICANT INCREASE 990 00:34:08,640 --> 00:34:11,240 OVER TIME AND THE USE OF ANY 991 00:34:11,240 --> 00:34:13,120 DIETARY SUPLEAPTS FOR OLDER 992 00:34:13,120 --> 00:34:16,760 ADULTS AND NONHISPANIC BLACK 993 00:34:16,760 --> 00:34:17,280 AMERICANS. 994 00:34:17,280 --> 00:34:19,760 ANY SUPPLEMENT USE DECREASED 995 00:34:19,760 --> 00:34:22,080 AMONG ADULTS AGES 20-39 YEARS 996 00:34:22,080 --> 00:34:25,160 WAS STABLE AMONG MIDLIFE, SO 997 00:34:25,160 --> 00:34:28,160 40-64 YEARS, AND INCREASED IN 998 00:34:28,160 --> 00:34:34,080 AMERICAN 65 YEARS OR OLDER. 999 00:34:34,080 --> 00:34:35,840 WHAT I WOULD LIKE TO SHOW YOU 1000 00:34:35,840 --> 00:34:38,120 NOW IS HOW SUPPLEMENT USE 1001 00:34:38,120 --> 00:34:48,600 CHANGES BY LIFE STAGE IN THE 1002 00:34:50,040 --> 00:34:50,480 UNITED STATES. 1003 00:34:50,480 --> 00:34:53,440 AND WHILE THESE BOUNCE AROUND IN 1004 00:34:53,440 --> 00:34:55,880 TIME IN THE USE IT SERVES BUT WE 1005 00:34:55,880 --> 00:34:58,800 SEE USE AND LOW, AND INSTANTS 1006 00:34:58,800 --> 00:35:01,320 SEEMS TO BE HIGHER IN CHILDREN, 1007 00:35:01,320 --> 00:35:02,400 DIPS IN ADOLESCENCE AND 1008 00:35:02,400 --> 00:35:06,400 CONTINUES TO INCREASE ACROSS THE 1009 00:35:06,400 --> 00:35:06,680 LIFE COURSE. 1010 00:35:06,680 --> 00:35:08,840 SO IT'S A BIT IRONIC IS IF WE 1011 00:35:08,840 --> 00:35:10,720 LOOK AT DIET QUALITY FROM FOODS 1012 00:35:10,720 --> 00:35:14,000 AND BEVERAGES, SO NOT INCLUSIVE 1013 00:35:14,000 --> 00:35:15,440 OF DIETARY SUPPLEMENTS SO WE ARE 1014 00:35:15,440 --> 00:35:17,800 LOOKING AT HEALTHY EATING INDEX 1015 00:35:17,800 --> 00:35:20,240 SCORES OR HEI SCORES FOR 1016 00:35:20,240 --> 00:35:23,440 AMERICANS SO THE HEI CONFIRMS TO 1017 00:35:23,440 --> 00:35:25,960 THE U.S. DIETARY GUIDELINES FOR 1018 00:35:25,960 --> 00:35:26,320 AMERICAN. 1019 00:35:26,320 --> 00:35:28,480 MUCH LIKE I TELL MY STUDENTS, 1020 00:35:28,480 --> 00:35:31,320 HEI IS LIKE A DEOF THE OR AN 1021 00:35:31,320 --> 00:35:33,080 EXAM SCORE WITH 0 BEING THE 1022 00:35:33,080 --> 00:35:34,920 WORST AND 100% BEING PERFECT. 1023 00:35:34,920 --> 00:35:37,760 SO AS YOU CAN SEE ACROSS THE 1024 00:35:37,760 --> 00:35:40,800 LIFE COURSE, MOST AMERICANS ARE 1025 00:35:40,800 --> 00:35:44,200 NOT FOLLOWING DIETARY GUIDELINES 1026 00:35:44,200 --> 00:35:46,840 BUT MY POINT HERE IS THAT HIGHER 1027 00:35:46,840 --> 00:35:48,240 DIET QUALITY IS OBSERVED IN 1028 00:35:48,240 --> 00:35:49,360 THOSE LIFE STAGES THAT TEND TO 1029 00:35:49,360 --> 00:35:52,040 BE MORE LIKELY TO REPORT DIETARY 1030 00:35:52,040 --> 00:35:53,000 SUPPLEMENT USE, SO I DON'T HAVE 1031 00:35:53,000 --> 00:35:55,360 TIME TO SHOW YOU THE DATA ON 1032 00:35:55,360 --> 00:35:58,320 THIS, TODAY IN THIS 1033 00:35:58,320 --> 00:36:00,080 PRESENTATION, BUOY WOO WE HAVE 1034 00:36:00,080 --> 00:36:02,000 DONE WORK THAT DEMONSTRATES THAT 1035 00:36:02,000 --> 00:36:03,680 ADULT WHO IS USE SUPPLEMENTS 1036 00:36:03,680 --> 00:36:06,080 TEND TO HAVE HIGHER VITAMIN 1037 00:36:06,080 --> 00:36:08,880 INTAKES FROM FOODS AND BEVERAGES 1038 00:36:08,880 --> 00:36:11,160 BEFORE WE EVEN ACCOUNT FOR 1039 00:36:11,160 --> 00:36:11,560 SUPPLEMENTS. 1040 00:36:11,560 --> 00:36:14,360 SO THAT SAME PHENOMENON IS NOT 1041 00:36:14,360 --> 00:36:15,200 TRUE IN CONCERN CHILDREN. 1042 00:36:15,200 --> 00:36:17,200 SO WHAT I WOULD LIKE TO DO IS 1043 00:36:17,200 --> 00:36:19,120 NOW TRANSITION TO SHOW YOU 1044 00:36:19,120 --> 00:36:20,000 DIFFERENTIAL SUPPLEMENT USE BY 1045 00:36:20,000 --> 00:36:21,720 LIFE STAGES IN THE UNITED 1046 00:36:21,720 --> 00:36:23,480 STATES, STARTING WITH PREGNANCY 1047 00:36:23,480 --> 00:36:24,240 AND LACTATION. 1048 00:36:24,240 --> 00:36:26,160 SO THE DATA ON PREGNANCY AND 1049 00:36:26,160 --> 00:36:28,720 LACTATION, I WILL BE PRESENTING 1050 00:36:28,720 --> 00:36:30,040 COMES FROM 2 RECENT PAPERS IN MY 1051 00:36:30,040 --> 00:36:30,280 LAB. 1052 00:36:30,280 --> 00:36:33,600 THE FIRST IS LED BY DR. JUNE 1053 00:36:33,600 --> 00:36:34,800 PICTURED HERE AND FOCUSED ON DS 1054 00:36:34,800 --> 00:36:36,400 USE AND CHARACTER IEOF THETICS 1055 00:36:36,400 --> 00:36:39,320 OF WEALTH, IN THE SECOND PAPER 1056 00:36:39,320 --> 00:36:41,360 FOCUSES ON TOTAL NUTRIENT 1057 00:36:41,360 --> 00:36:42,520 INTAKES OF PREGNANT U.S. WOMEN. 1058 00:36:42,520 --> 00:36:46,360 SO AS I ALLUDED TO, MOST 1059 00:36:46,360 --> 00:36:47,920 PREGNANT AND LACTATING WOMEN USE 1060 00:36:47,920 --> 00:36:49,200 A DIETARY SUPPLEMENT AND YOU CAN 1061 00:36:49,200 --> 00:36:51,760 SEE IN THE GREEN BARS ARE 1062 00:36:51,760 --> 00:36:53,640 PREGNANT WOMEN, THE DARKER 1063 00:36:53,640 --> 00:36:55,120 ORANGE, LACTATING WOMEN AND THE 1064 00:36:55,120 --> 00:36:56,960 LIGHTER ORANGE WOMEN OF THE SAME 1065 00:36:56,960 --> 00:37:00,240 AGES WHO ARE NEITHER PREGNANT, 1066 00:37:00,240 --> 00:37:02,040 NOR LACTATING SO THERE ARE 1067 00:37:02,040 --> 00:37:02,760 SIGNIFICANT DIFFERENCES BETWEEN 1068 00:37:02,760 --> 00:37:06,000 THOSE GROUPS FOR ANY USE, FOR 1069 00:37:06,000 --> 00:37:08,080 MULTIVITAMIN USE, AND FOR 1070 00:37:08,080 --> 00:37:09,040 PRENATAL SUPPLEMENT USE. 1071 00:37:09,040 --> 00:37:14,560 BUT NOT FOR SINGLE OR MULTIPLE 1072 00:37:14,560 --> 00:37:15,800 MICRONUTRIENT SUPPLEMENTS. 1073 00:37:15,800 --> 00:37:18,240 IN THIS SLIDE, WE ARE PRESENTING 1074 00:37:18,240 --> 00:37:21,200 DATA BY TRIMESTER OF PREGNANCY 1075 00:37:21,200 --> 00:37:23,840 FOR THE SURVEY YEARS IN WHICH IT 1076 00:37:23,840 --> 00:37:26,400 WAS AVAILABLE AND WHAT'S 1077 00:37:26,400 --> 00:37:27,440 INTERESTING HERE IS THE 1078 00:37:27,440 --> 00:37:29,840 PREVALENCE OF USE TENDS TO 1079 00:37:29,840 --> 00:37:33,080 INCREASE WITH TRIMESTER OF 1080 00:37:33,080 --> 00:37:34,440 PREGNANCY, WHAT'S ALSO 1081 00:37:34,440 --> 00:37:35,840 INTERESTING IS THOSE 1082 00:37:35,840 --> 00:37:37,000 STATISTICALLY IT'S NOT 1083 00:37:37,000 --> 00:37:39,600 DIFFERENT, FOLIC ACID IS REALLY 1084 00:37:39,600 --> 00:37:40,440 RECOMMENDED PERICONCEPTUALLY OR 1085 00:37:40,440 --> 00:37:42,160 IN THE FIRST 6 WEEKS OF 1086 00:37:42,160 --> 00:37:44,400 PREGNANCY AND THAT'S WHEN FOLIC 1087 00:37:44,400 --> 00:37:45,120 ACID CONTAINING SUPPLEMENT USE 1088 00:37:45,120 --> 00:37:49,040 TENDS TO BE THE LOWEST. 1089 00:37:49,040 --> 00:37:49,840 ANOTHER INTERESTING POINT HERE 1090 00:37:49,840 --> 00:37:53,680 IS THAT THE USE OF EYE O DINE 1091 00:37:53,680 --> 00:37:55,400 CONTAINING DIETARY SUPPLEMENTS 1092 00:37:55,400 --> 00:37:56,920 IS QUITE LOW. 1093 00:37:56,920 --> 00:37:59,080 SO LESS--OR AROUND 1 IN 4 1094 00:37:59,080 --> 00:38:00,280 PREGNANT WOMEN REGARDLESS OF 1095 00:38:00,280 --> 00:38:03,040 TRIMESTER ARE USING A PRODUCT 1096 00:38:03,040 --> 00:38:04,600 THAT CONTAINS IODINE. 1097 00:38:04,600 --> 00:38:07,880 AND IODINE NEEDS DURING 1098 00:38:07,880 --> 00:38:09,240 PREGNANCY ARE INCREASED. 1099 00:38:09,240 --> 00:38:13,360 THE PREVALENCE BY CERTAIN 1100 00:38:13,360 --> 00:38:14,000 POPULATION CHARACTERISTICS, SO 1101 00:38:14,000 --> 00:38:16,600 WE WILL START WITH AGE HERE, 1102 00:38:16,600 --> 00:38:19,160 OLDER PREGNANT WOMEN, SO 35-44 1103 00:38:19,160 --> 00:38:20,600 YEARS SIGNIFICANTLY USE MORE OF 1104 00:38:20,600 --> 00:38:23,920 ANY TYPE OF DIETARY SUPPLEMENT 1105 00:38:23,920 --> 00:38:24,360 THAN YOUNGER WOMEN. 1106 00:38:24,360 --> 00:38:26,640 AND YOU WILL SEE THE PREVALENCE 1107 00:38:26,640 --> 00:38:30,000 DIFFERENCES HERE FOR PRENATALS 1108 00:38:30,000 --> 00:38:33,240 EXCLUSIVELY, BUT THOSE WERE NOT 1109 00:38:33,240 --> 00:38:33,720 STATISTICALLY DIFFERENT. 1110 00:38:33,720 --> 00:38:39,120 IN THIS SLIDE, WE ARE LOOKING AT 1111 00:38:39,120 --> 00:38:40,680 POVERTY TO INCOME RATIO, SO THIS 1112 00:38:40,680 --> 00:38:42,880 IS A MEASURE THAT REPRESENT 1113 00:38:42,880 --> 00:38:44,880 HOUSEHOLD INCOME TO THE POVERTY 1114 00:38:44,880 --> 00:38:46,400 THRESHOLD AFTER ADJUSTING TO 1115 00:38:46,400 --> 00:38:47,080 FAMILY SIZE. 1116 00:38:47,080 --> 00:38:49,160 SO THE RATIO IS USED TO QUALIFY 1117 00:38:49,160 --> 00:38:51,520 FOR THINGS LIKE FEDERAL FOOD 1118 00:38:51,520 --> 00:38:52,360 ASITTANCE PROGRAMS AMONG OTHER 1119 00:38:52,360 --> 00:38:55,600 THINGS SO A HIGHER PIR IS 1120 00:38:55,600 --> 00:38:57,120 INDICATIVE OF A HIGHER FAMILY 1121 00:38:57,120 --> 00:38:59,840 INCOME AND WE SEE SIGNIFICANT 1122 00:38:59,840 --> 00:39:02,600 LYNNIAN TRENDS IN ANY SUPPLEMENT 1123 00:39:02,600 --> 00:39:07,120 USE AND PRENATAL SUPPLEMENT USE 1124 00:39:07,120 --> 00:39:08,000 SPECIFICALLY BY INCOME. 1125 00:39:08,000 --> 00:39:10,240 IN THIS SLIDE, WE'RE LOOKING AT 1126 00:39:10,240 --> 00:39:13,240 PREVALENCE OF ANY USE AND 1127 00:39:13,240 --> 00:39:16,280 PRENATAL USE BY RACE AND 1128 00:39:16,280 --> 00:39:16,880 ETHNICITY. 1129 00:39:16,880 --> 00:39:20,680 AND SO NONHISPANIC WHITE WOMEN 1130 00:39:20,680 --> 00:39:21,480 HAVE SIGNIFICANTLY DIFFERENT 1131 00:39:21,480 --> 00:39:23,560 PREVALENCE OF ANY USE WHEN 1132 00:39:23,560 --> 00:39:25,200 COMPARED WITH NONHISPANIC BLACK 1133 00:39:25,200 --> 00:39:28,400 AND HISPANIC AND MEXICAN 1134 00:39:28,400 --> 00:39:30,120 AMERICAN WOMEN WHEREAS PRENATALS 1135 00:39:30,120 --> 00:39:31,760 DO NOT DIFFER BETWEEN 1136 00:39:31,760 --> 00:39:33,400 NONHISPANIC BLACK AND HISPANIC 1137 00:39:33,400 --> 00:39:35,360 AND MEXICAN AMERICAN WOMEN. 1138 00:39:35,360 --> 00:39:37,920 SO, THERE ARE DATA AVAILABLE ON 1139 00:39:37,920 --> 00:39:39,560 ASIAN AMERICAN WOMEN BUT THEY 1140 00:39:39,560 --> 00:39:41,080 WERE NOT AACROSS ALL THESE 1141 00:39:41,080 --> 00:39:43,760 SURVEY YEARS, AND OF COURSE, 1142 00:39:43,760 --> 00:39:44,880 THIS DOESN'T REPRESENT OTHER 1143 00:39:44,880 --> 00:39:48,440 RACE AND ETHNIC GROUPS. 1144 00:39:48,440 --> 00:39:51,040 HERE WE'RE LOOKING AT 1145 00:39:51,040 --> 00:39:52,880 MOTIVATIONS OR REASONS WHY 1146 00:39:52,880 --> 00:39:56,560 PREGNANT AND LACTATING WOMEN ARE 1147 00:39:56,560 --> 00:39:57,800 USING THESE PRODUCTS. 1148 00:39:57,800 --> 00:40:01,120 AND THE MAJORITY OF BOTH 1149 00:40:01,120 --> 00:40:03,360 PREGNANT AND LACTATING WOMEN ARE 1150 00:40:03,360 --> 00:40:05,280 USING ANY TYPE OF PRENATAL 1151 00:40:05,280 --> 00:40:06,680 SUPPLEMENTS BASED ON THE 1152 00:40:06,680 --> 00:40:08,560 RECOMMENDATION OF A HEALTHCARE 1153 00:40:08,560 --> 00:40:08,800 PROVIDER. 1154 00:40:08,800 --> 00:40:13,240 SO YOU WILL SEE THAT'S IN THE 1155 00:40:13,240 --> 00:40:14,520 LIGHTER ORANGE BOXES, SO MOVING 1156 00:40:14,520 --> 00:40:21,400 ON NOW TO DATA ON INFANT ANDS 1157 00:40:21,400 --> 00:40:22,680 TODDLERS. 1158 00:40:22,680 --> 00:40:23,960 THIS IS ANOTHER COLLABORATIVE 1159 00:40:23,960 --> 00:40:26,080 PROJECT BETWEEN MY TEAM AND 1160 00:40:26,080 --> 00:40:31,440 RESEARCHERS AT ODS BED BY 1161 00:40:31,440 --> 00:40:33,280 DR. GAHCHE, AND 1162 00:40:33,280 --> 00:40:34,680 DRS. [INDISCERNIBLE] AND 1163 00:40:34,680 --> 00:40:36,320 [INDISCERNIBLE] PICTURES HIRE 1164 00:40:36,320 --> 00:40:39,840 HERE, SO ABOUT 18% OF INFANTS 1165 00:40:39,840 --> 00:40:41,200 AND TODDLERS USE DIETARY SUPLEMS 1166 00:40:41,200 --> 00:40:43,040 BUT THE TYPE AND FORMS CHANGE 1167 00:40:43,040 --> 00:40:44,000 BASED ON LIFE STAGE. 1168 00:40:44,000 --> 00:40:47,840 SO THIS SLIDE WE'RE LOOKING MORE 1169 00:40:47,840 --> 00:40:48,680 GRANULARLY ACROSS AGE GROUPS AND 1170 00:40:48,680 --> 00:40:49,680 YOU SLEEP APNEA AND OBESITYY 1171 00:40:49,680 --> 00:40:51,280 WHAT I DISCUSSION ON THE PRIOR 1172 00:40:51,280 --> 00:40:54,080 SLIDE THAT VITAMIN D AND 1173 00:40:54,080 --> 00:40:56,280 MULTIVITAMIN DROPS ARE HIGHER IN 1174 00:40:56,280 --> 00:40:58,120 YOUNGER ENFANTS AND REALLY A 1175 00:40:58,120 --> 00:41:00,040 TRANSITION TO JEWABLE AND GUMY 1176 00:41:00,040 --> 00:41:06,200 PRODUCTS STARTS AT ABOUT 1 YEAR 1177 00:41:06,200 --> 00:41:06,760 OF AGE. 1178 00:41:06,760 --> 00:41:08,920 LOOKING AT TRENDS OVER TIME, 1179 00:41:08,920 --> 00:41:10,880 THERE'S A SIGNIFICANT INCREASE 1180 00:41:10,880 --> 00:41:13,720 IN DIETARY SUPPLEMENT USE AMONG 1181 00:41:13,720 --> 00:41:16,280 OUR NATION'S YOUNGEST INFANTS SO 1182 00:41:16,280 --> 00:41:18,720 0-6 MONTHS AND THIS IS LARGELY 1183 00:41:18,720 --> 00:41:21,480 BEING DRIVEN BY AN INCREASE IN 1184 00:41:21,480 --> 00:41:24,600 VITAMIN D DROPS AND SUPPLEMENTS. 1185 00:41:24,600 --> 00:41:26,880 MOVING ON NOW TO LOOK AT 1186 00:41:26,880 --> 00:41:28,840 SUPPLEMENT USE AMONG U.S. 1187 00:41:28,840 --> 00:41:31,040 CHILDREN, WE KNOW ACROSS VARIOUS 1188 00:41:31,040 --> 00:41:33,000 NHANES CYCLES AT ABOUT ONE-THIRD 1189 00:41:33,000 --> 00:41:35,000 OF CHILDREN USE DIETARY 1190 00:41:35,000 --> 00:41:36,280 SUPPLEMENTS DOES NOT TEND TO 1191 00:41:36,280 --> 00:41:38,520 VARY BY SEX OR GENDER AS WE 1192 00:41:38,520 --> 00:41:43,840 PREVIOUSLY DESCRIBED FOR ADULTS. 1193 00:41:43,840 --> 00:41:45,560 MOST CHILDREN TAKE 1 PRODUCT 1194 00:41:45,560 --> 00:41:56,040 MOST COMMONLY A MULTIVITAMIN 1195 00:42:00,360 --> 00:42:00,960 MULTIMINERAL. 1196 00:42:00,960 --> 00:42:06,080 ON THIS SLIDE, WE SEE THE 1197 00:42:06,080 --> 00:42:07,120 GENERAL DIFFERENCE, THAT 1198 00:42:07,120 --> 00:42:09,320 CHILDREN OF HIGHER AGE HAVE A 1199 00:42:09,320 --> 00:42:10,640 HIGHER USE OF SUPPLEMENT USE 1200 00:42:10,640 --> 00:42:13,400 COMPARED TO OTHER AGE GROUPS. 1201 00:42:13,400 --> 00:42:16,560 AS I MENTIONED MOST COMMON 1202 00:42:16,560 --> 00:42:17,240 PRODUCTS MULTIVITAMIN, 1203 00:42:17,240 --> 00:42:18,200 MULTIMINERAL AND WHILE MOST 1204 00:42:18,200 --> 00:42:19,800 CHILDREN TAKE ON 1, 5% OF 1205 00:42:19,800 --> 00:42:25,720 CHILDREN TAKE 3 OR MORE DIETARY 1206 00:42:25,720 --> 00:42:26,840 SUPPLEMENTS PER DAY. 1207 00:42:26,840 --> 00:42:27,800 IN THESE SURVEY YEARS WE HAVE 1208 00:42:27,800 --> 00:42:31,200 DATA AVAILABLE TO US ON 1209 00:42:31,200 --> 00:42:32,120 NONHISPANIC ASIAN CHILDREN WHO 1210 00:42:32,120 --> 00:42:33,880 HAVE A SIMILAR USE OF 1211 00:42:33,880 --> 00:42:35,080 NONHISPANIC WHITE CHILDREN AND 1212 00:42:35,080 --> 00:42:37,720 THAT'S JUST HIGHER AND THAT 1213 00:42:37,720 --> 00:42:39,920 NONHISPANIC BLACK AND HISPANIC 1214 00:42:39,920 --> 00:42:42,440 AND MEXICAN-AMERICAN CHILDREN DO 1215 00:42:42,440 --> 00:42:43,400 NOT DIFFER STATISTICALLY IN 1216 00:42:43,400 --> 00:42:47,680 THEIR PREVALENCE OF USE. 1217 00:42:47,680 --> 00:42:49,360 THIS IS LOOKING AT WEIGHT STATUS 1218 00:42:49,360 --> 00:42:51,280 BY SUPPLEMENT USE AND WE 1219 00:42:51,280 --> 00:42:52,960 OBSERVED A SIGNIFICANT LINEAR 1220 00:42:52,960 --> 00:42:54,680 TREND SUCH THAT CHILDREN WHO ARE 1221 00:42:54,680 --> 00:42:56,120 UNDERWEIGHT TEND TO REPORT THE 1222 00:42:56,120 --> 00:42:57,920 HIGHEST PREVALENCE OF USE AND 1223 00:42:57,920 --> 00:43:01,360 THOSE CHILDREN WHO ARE OBESE 1224 00:43:01,360 --> 00:43:05,440 REPORT THE LOWEST PREVALENCE OF 1225 00:43:05,440 --> 00:43:05,880 USE. 1226 00:43:05,880 --> 00:43:07,520 THIS IS LOOKING AT SCREEN TIME 1227 00:43:07,520 --> 00:43:10,400 SO THE AMERICAN ACADEMY OF 1228 00:43:10,400 --> 00:43:12,040 PEDIATRICS RECOMMENDS 2 OR FEWER 1229 00:43:12,040 --> 00:43:14,240 HOURS OF SCREEN TIME PER DAY AND 1230 00:43:14,240 --> 00:43:18,600 CHILDREN WHO HAVE 4 OR MORE 1231 00:43:18,600 --> 00:43:20,200 HOURS OF SCREEN TIME TEND TO 1232 00:43:20,200 --> 00:43:22,920 HAVE LESS PREVALENCE OF DIETARY 1233 00:43:22,920 --> 00:43:23,360 SUPPLEMENT USE. 1234 00:43:23,360 --> 00:43:25,440 LOOKING AT HEALTH INSURANCE, SO 1235 00:43:25,440 --> 00:43:27,120 CHILDREN WHO HAVE PRIVATE HEALTH 1236 00:43:27,120 --> 00:43:29,200 INSURANCE, ARE MORE LIKELY TO 1237 00:43:29,200 --> 00:43:30,160 REPORT DIETARY SUPPLEMENT USE 1238 00:43:30,160 --> 00:43:32,480 THAN EITHER CHILDREN WHO HAVE NO 1239 00:43:32,480 --> 00:43:36,680 INSURANCE, OR USE PUBLIC HEALTH 1240 00:43:36,680 --> 00:43:37,160 INSURANCE. 1241 00:43:37,160 --> 00:43:39,880 SIMILAR TO TRENDS THAT WE SAW 1242 00:43:39,880 --> 00:43:41,440 WITH PREGNANCY, INCOME AS 1243 00:43:41,440 --> 00:43:43,960 MEASURED BY THE POVERTY INCOME 1244 00:43:43,960 --> 00:43:45,160 RATIO IS ASSOCIATED WITH 1245 00:43:45,160 --> 00:43:49,680 SUPPLEMENT USE, AND THE SIMILAR 1246 00:43:49,680 --> 00:43:49,920 TREND. 1247 00:43:49,920 --> 00:43:52,120 AGAIN THE PIR IS USED TO QUALIFY 1248 00:43:52,120 --> 00:43:56,320 PER MOST MAJOR FEDERAL FOOD 1249 00:43:56,320 --> 00:43:57,920 ASSISTANCE PROGRAMS LIKE SNAP 1250 00:43:57,920 --> 00:43:58,640 AND WIC. 1251 00:43:58,640 --> 00:44:01,400 IN THIS SLIDE, WE ARE LOOKING AT 1252 00:44:01,400 --> 00:44:02,480 THE PREVALENCE OF USE AMONG 1253 00:44:02,480 --> 00:44:04,360 CHILDREN WHO ARE ELIGIBLE FOR 1254 00:44:04,360 --> 00:44:08,080 THESE PROGRAMS BY INCOME. 1255 00:44:08,080 --> 00:44:09,240 THOSE ARE PARTICIPANTS. 1256 00:44:09,240 --> 00:44:11,680 THEY COULD BE ELIGIBLE BUT NOT 1257 00:44:11,680 --> 00:44:14,160 PARTICIPANTS OR THEY'RE NOT 1258 00:44:14,160 --> 00:44:16,000 ELIGIBLE AND NONPARTICIPANTS SO 1259 00:44:16,000 --> 00:44:18,680 FOR SNAP PARTICIPATION, THERE'S 1260 00:44:18,680 --> 00:44:20,280 A SIGNIFICANTLY DIFFERENT 1261 00:44:20,280 --> 00:44:21,840 PREVALENCE OF USE WHEREAS FOR 1262 00:44:21,840 --> 00:44:24,760 CHILDREN IN THE WIC PROGRAM 1263 00:44:24,760 --> 00:44:26,640 WHICH IS LIMITED TO CHILDREN 1264 00:44:26,640 --> 00:44:30,560 BIRTH-5 YEARS OF AGE, ONLY 1265 00:44:30,560 --> 00:44:31,200 NONPARTICIPANT INCOME ELIGIBLE 1266 00:44:31,200 --> 00:44:32,360 CHILDREN HAD A HIGHER PREVALENCE 1267 00:44:32,360 --> 00:44:35,320 OF USE THAT DID NOT DIFFER FROM 1268 00:44:35,320 --> 00:44:37,400 INCOME ELIGIBLE PARTICIPANTS OR 1269 00:44:37,400 --> 00:44:38,600 NONPARTICIPANTS AND SO INCOME 1270 00:44:38,600 --> 00:44:40,360 DIDN'T TELL THE ONLY STORY. 1271 00:44:40,360 --> 00:44:43,240 WE ALSO HAVE LOOKED AT DATA BY 1272 00:44:43,240 --> 00:44:47,400 FOOD SECURITY STATUS, SO FOOD 1273 00:44:47,400 --> 00:44:49,680 INSECURITY IS DEFINED AS LIMITED 1274 00:44:49,680 --> 00:44:52,160 OR UNCERTAIN AVAILABILITY OF 1275 00:44:52,160 --> 00:44:53,000 NUTRITIONALLY ADEQUATE AND SAFE 1276 00:44:53,000 --> 00:44:55,520 FOODS AND THE ABILITY TO ACQUIRE 1277 00:44:55,520 --> 00:44:57,160 THESE FOODS IN SOCIALLY 1278 00:44:57,160 --> 00:44:57,680 ACCEPTABLE WAYS. 1279 00:44:57,680 --> 00:45:00,960 SO THERE ARE 4 LEVELS OF FOOD 1280 00:45:00,960 --> 00:45:01,440 SECURITY. 1281 00:45:01,440 --> 00:45:03,680 AND THIS IS A VALIDATED MODULE 1282 00:45:03,680 --> 00:45:07,800 THAT WAS DEVELOPED BY THE USDA 1283 00:45:07,800 --> 00:45:09,400 TO CATEGORIZE PEOPLE INTO FOOD 1284 00:45:09,400 --> 00:45:10,400 SECURITY GROUPS. 1285 00:45:10,400 --> 00:45:12,280 SO WHILE WE HAVE THESE 4 1286 00:45:12,280 --> 00:45:14,040 SECURITY GROUPS WE TEND TO 1287 00:45:14,040 --> 00:45:20,880 COMBINE HIGH AND MARGINAL INTO 1288 00:45:20,880 --> 00:45:23,840 HIGH AND MARGINAL AND THEN LOW 1289 00:45:23,840 --> 00:45:26,280 AND VERY LOW INTO INSECURE SO WE 1290 00:45:26,280 --> 00:45:28,840 SAW DIFFERENT SUPPLEMENT USE BY 1291 00:45:28,840 --> 00:45:29,520 FOOD SECURITY CATEGORIES. 1292 00:45:29,520 --> 00:45:31,520 SO MOVING ON NOW TO LOOK AT 1293 00:45:31,520 --> 00:45:35,640 TRENDS OVER TIME AND NONVITAMIN, 1294 00:45:35,640 --> 00:45:36,280 NONMINERAL DIETARY SUPPLEMENTS, 1295 00:45:36,280 --> 00:45:40,200 SO THESE ARE THINGS LIKE 1296 00:45:40,200 --> 00:45:44,880 HERBALS, BOTANICALS, OMEGA 3s, 1297 00:45:44,880 --> 00:45:47,480 FIBER, MELATONIN AND THE BAR ON 1298 00:45:47,480 --> 00:45:50,080 THE BOTTOM IN ORANGE IS THE 1299 00:45:50,080 --> 00:45:51,120 PREVALENCE OF NONVITAMIN, 1300 00:45:51,120 --> 00:45:54,520 NONMINERAL SUPPLEMENT USE OVER 1301 00:45:54,520 --> 00:45:57,960 TIME WHICH HAS STATISTICALLY 1302 00:45:57,960 --> 00:45:59,920 INCREASED WHERE I MENTIONED WITH 1303 00:45:59,920 --> 00:46:01,480 ALL OTHER SUPPLEMENTS HAVE BEEN 1304 00:46:01,480 --> 00:46:03,120 PRETTY STABLE ACROSS TIME IN 1305 00:46:03,120 --> 00:46:09,280 ABOUT ONE-THIRD OF CHILDREN 1306 00:46:09,280 --> 00:46:10,200 REPORTING USE. 1307 00:46:10,200 --> 00:46:11,840 IN THIS SLIDE WE'RE LOOKING AT 1308 00:46:11,840 --> 00:46:15,040 TRENDS OVER TIME IN NONVITAMIN, 1309 00:46:15,040 --> 00:46:16,600 NONMINERAL IN CHILDREN WHO USE 1310 00:46:16,600 --> 00:46:17,200 THESE PRODUCTS. 1311 00:46:17,200 --> 00:46:19,200 SO IN PANEL A, WE CAN SEE 1312 00:46:19,200 --> 00:46:21,920 DIFFERENCES BY SEX AND GENDER 1313 00:46:21,920 --> 00:46:25,040 WHICH DID NOT DIFFER UNTIL ABOUT 1314 00:46:25,040 --> 00:46:26,680 2015-2016 AND THIS IS WHEN BOYS 1315 00:46:26,680 --> 00:46:28,920 HAD A HIGHER PREVALENCE OF 1316 00:46:28,920 --> 00:46:30,080 NONVITAMIN MINERALS WHEN 1317 00:46:30,080 --> 00:46:30,880 COMPARED WITH GIRLS. 1318 00:46:30,880 --> 00:46:34,120 SO IN PANEL B, WE CAN SEE THAT 1319 00:46:34,120 --> 00:46:36,880 OLDER CHILDREN CONSISTENTLY USE 1320 00:46:36,880 --> 00:46:38,920 MORE NONVITAMIN, NONMINERAL 1321 00:46:38,920 --> 00:46:40,120 PRODUCTS IN YOUNGER CHILDREN, 1322 00:46:40,120 --> 00:46:42,960 WHICH IS DIFFERENT FROM WHAT WE 1323 00:46:42,960 --> 00:46:45,560 WE VAW WITH THE NUCLEOTIDES TRI 1324 00:46:45,560 --> 00:46:46,840 EPT CONTAINING SUPPLEMENTS. 1325 00:46:46,840 --> 00:46:47,960 NONHISPANIC WHITE CHILDREN HAD 1326 00:46:47,960 --> 00:46:51,040 THE HIGHEST PREVALENCE EVER 1327 00:46:51,040 --> 00:46:52,200 NONVITAMIN NONMINERAL 1328 00:46:52,200 --> 00:46:55,080 SUPPLEMENTS WHEN COMPARE WIDE 1329 00:46:55,080 --> 00:46:56,320 HISPANIC AND NONHISPANIC 1330 00:46:56,320 --> 00:46:57,440 CHILDREN, THAT'S VISUALIZED IN 1331 00:46:57,440 --> 00:46:58,320 PANEL C. 1332 00:46:58,320 --> 00:47:00,440 AND FINALLY LOOKING AT INCOME 1333 00:47:00,440 --> 00:47:03,280 CATEGORIES IN PANEL D, CHILDREN 1334 00:47:03,280 --> 00:47:06,480 LIVING IN HIGH INCOME HOUSEHOLDS 1335 00:47:06,480 --> 00:47:08,680 TENDED TO HAVE NONVITAMIN, 1336 00:47:08,680 --> 00:47:10,520 NONMINERAL USE THAN THOSE IN THE 1337 00:47:10,520 --> 00:47:17,200 LOW OR MIDDLE INCOME CATEGORIES 1338 00:47:17,200 --> 00:47:18,440 AMONG SPECIFIC NONVITAMIN 1339 00:47:18,440 --> 00:47:21,000 NONMINERAL PRODUCTS, THE 1340 00:47:21,000 --> 00:47:22,840 PRESENCE OF PROBIATIC OR 1341 00:47:22,840 --> 00:47:23,960 MECHANICAL USE, APPEARS TO BE 1342 00:47:23,960 --> 00:47:25,480 RELATED TO THE CHILD AND THESE 1343 00:47:25,480 --> 00:47:28,400 ARE THE MOTIVATIONS FOR THESE 1344 00:47:28,400 --> 00:47:29,680 PRODUCTS SO NONVITAMIN, 1345 00:47:29,680 --> 00:47:30,840 NONMINERAL USERS ARE MORE LIKELY 1346 00:47:30,840 --> 00:47:32,880 TO REPORT USE OF SUPPLEMENTS FOR 1347 00:47:32,880 --> 00:47:34,960 RELAXATION, FOR STRESS AND 1348 00:47:34,960 --> 00:47:36,720 SLEEP, FOR MENTAL HEALTH, FOR 1349 00:47:36,720 --> 00:47:38,880 THINGS LIKE COLON AND BOWEL 1350 00:47:38,880 --> 00:47:42,880 HEALTH AS OPPOSE TO THE MORE 1351 00:47:42,880 --> 00:47:44,760 TRADITIONAL MOTIVATIONS FOR USE 1352 00:47:44,760 --> 00:47:46,400 FOR VITAMIN MINERAL CONTAINING 1353 00:47:46,400 --> 00:47:48,120 SUPPLEMENTS WHICH ARE MAINLY FOR 1354 00:47:48,120 --> 00:47:51,000 HEALTH RELATED REASONS OR TO 1355 00:47:51,000 --> 00:47:51,760 SUPPLEMENT THE DIET. 1356 00:47:51,760 --> 00:47:54,160 SO IN THIS LAST SECTION, WE WILL 1357 00:47:54,160 --> 00:47:56,480 LOOK AT ADULTS AND OLDER ASULTS. 1358 00:47:56,480 --> 00:47:59,840 FIRST WE WILL LOOK AT ALL 1359 00:47:59,840 --> 00:48:02,080 ADULTDS COMBINED SO YOUNGER 1360 00:48:02,080 --> 00:48:04,960 ADULTS AND OLDER ADULTS FROM 1361 00:48:04,960 --> 00:48:05,920 DATA FROM 2011-2014. 1362 00:48:05,920 --> 00:48:07,680 AS WE ALREADY DISCUSSED IN THE 1363 00:48:07,680 --> 00:48:09,080 PREBEGINNING OF THIS 1364 00:48:09,080 --> 00:48:10,080 PRESENTATION, WE KNOW THAT HALF 1365 00:48:10,080 --> 00:48:14,920 OF U.S. REDULTS REPORT ANY 1366 00:48:14,920 --> 00:48:16,120 DIETARY SUPPLEMENT, WE KNOW 1367 00:48:16,120 --> 00:48:17,880 THERE ARE TRENDS BY SEX AND AGE, 1368 00:48:17,880 --> 00:48:20,120 AND THOSE ARE THE PREVALENCE 1369 00:48:20,120 --> 00:48:21,600 ESTIMATES PRESENTED HERE, 1370 00:48:21,600 --> 00:48:23,920 SIMILAR TO CHILDREN, NONHISPANIC 1371 00:48:23,920 --> 00:48:27,240 WHITE AND ASIAN ADULTS HAVE 1372 00:48:27,240 --> 00:48:29,200 SIMILAR PREVALENCE OF USE, 1373 00:48:29,200 --> 00:48:30,640 WHEREAS NONHISPANIC BLACK AND 1374 00:48:30,640 --> 00:48:37,280 MEXICAN AMERICANS, HAVE LOWER 1375 00:48:37,280 --> 00:48:37,840 USE. 1376 00:48:37,840 --> 00:48:40,440 SUPPLEMENT USE IS TIED TO 1377 00:48:40,440 --> 00:48:40,920 EDUCATIONAL ATTAINMENT. 1378 00:48:40,920 --> 00:48:41,880 SO OVERALL SIGNIFICANT 1379 00:48:41,880 --> 00:48:43,360 DIFFERENCES BY ASULT WHO IS HAVE 1380 00:48:43,360 --> 00:48:44,760 LESS THAN A HIGH SCHOOL 1381 00:48:44,760 --> 00:48:46,520 EDUCATION, A HOOL SCHOOL DIPLOMA 1382 00:48:46,520 --> 00:48:49,720 OR EQUIVALENT OR GREATER THAN A 1383 00:48:49,720 --> 00:48:51,000 HIGH SCHOOL EDUCATION AND YOU 1384 00:48:51,000 --> 00:48:54,880 WILL SEE THAT THAT SAME TREND IS 1385 00:48:54,880 --> 00:48:57,520 TRUE FOR MEN WHEREAS AMONG WOMEN 1386 00:48:57,520 --> 00:48:58,480 PREVALENCE IS SIMILAR FOR THOSE 1387 00:48:58,480 --> 00:49:05,040 WHO HAVE A HIGH SCHOOL OR MORE 1388 00:49:05,040 --> 00:49:05,480 EDUCATION. 1389 00:49:05,480 --> 00:49:07,240 WHAT'S DIFFERENT IN ADULTS THAN 1390 00:49:07,240 --> 00:49:08,880 CHILDREN IS THAT MOST ADULTS 1391 00:49:08,880 --> 00:49:10,520 TEND TO TAKE MORE THAN 1 1392 00:49:10,520 --> 00:49:11,920 PRODUCT. 1393 00:49:11,920 --> 00:49:15,520 SO AMONG USERS, 43% TAKE 1 1394 00:49:15,520 --> 00:49:17,120 PRODUCT REGULARLY BUT MORE THAN 1395 00:49:17,120 --> 00:49:21,280 10% TAKE 5 OR MORE PRODUCTS. 1396 00:49:21,280 --> 00:49:25,200 AGAIN VERY SIMILAR THEME, 1397 00:49:25,200 --> 00:49:25,760 MULTIVITAMIN, MULTIVITAMIN 1398 00:49:25,760 --> 00:49:27,640 MINERAL IS THE MOST COMMONLY 1399 00:49:27,640 --> 00:49:32,480 USED PRODUCT ACROSS ALL AGE 1400 00:49:32,480 --> 00:49:32,760 GROUPS. 1401 00:49:32,760 --> 00:49:33,840 LOOKING AT ASSOCIATIONS WITH 1402 00:49:33,840 --> 00:49:35,920 SUPPLEMENT USE AND WEIGHT STATUS 1403 00:49:35,920 --> 00:49:39,200 IN U.S. ADULTS, WE SEE THAT 1404 00:49:39,200 --> 00:49:41,440 UNDERWEIGHT AND OBESE TEND TO 1405 00:49:41,440 --> 00:49:43,240 HAVE LESS PREVALENCE OF USE THAN 1406 00:49:43,240 --> 00:49:46,000 ADULTS WHO ARE CATEGORIZED AS 1407 00:49:46,000 --> 00:49:48,640 NORMAL OR OVERWEIGHT BY BODY 1408 00:49:48,640 --> 00:49:51,280 MASS INDEX CATEGORIES. 1409 00:49:51,280 --> 00:49:53,480 WE INTRODUCED THE CONCEPT OF 1410 00:49:53,480 --> 00:49:57,840 FOOD SECURITY AND SECTION ON 1411 00:49:57,840 --> 00:50:01,760 CHILDREN AND THE TRANSFER WERE 1412 00:50:01,760 --> 00:50:03,800 SEEN IN ADULTS REGARDLESS OF SEX 1413 00:50:03,800 --> 00:50:06,400 OR GENDER SUCH THAT INDIVIDUALS 1414 00:50:06,400 --> 00:50:08,400 WITH FOOD INSECURITY ARE MORE 1415 00:50:08,400 --> 00:50:09,600 LIKELY TO USE DIETARY SUM 1416 00:50:09,600 --> 00:50:09,880 ELEMENTS. 1417 00:50:09,880 --> 00:50:12,280 SO AS WE LOOK AT DATA AND OTHER 1418 00:50:12,280 --> 00:50:14,400 LIFE STAGES BY POVERTY INCOME 1419 00:50:14,400 --> 00:50:16,120 RATIO, WE SEE THE EXACT SAME 1420 00:50:16,120 --> 00:50:20,080 TRENDS HERE IN U.S. ADULTS. 1421 00:50:20,080 --> 00:50:21,520 AND WHAT'S INTERESTING IS NOT 1422 00:50:21,520 --> 00:50:24,280 ONLY PREVALENCE BUT THE NUMBER 1423 00:50:24,280 --> 00:50:29,920 OF SUPPLEMENTS, VARY ACCORDING 1424 00:50:29,920 --> 00:50:31,280 TO POVERTY TO INCOME RATIO AND 1425 00:50:31,280 --> 00:50:32,800 YOU CAN SEE THOSE NUMBERS 1426 00:50:32,800 --> 00:50:34,200 PRESENTED HERE AND THEY'RE 1427 00:50:34,200 --> 00:50:38,400 EXPLAINED IN FULL DETAIL IN THIS 1428 00:50:38,400 --> 00:50:39,360 PUBLICATION. 1429 00:50:39,360 --> 00:50:41,360 IN TERMS OF PARTICIPATE NOTHING 1430 00:50:41,360 --> 00:50:43,400 SNAP, REMEMBER WE TALKED ABOUT 1431 00:50:43,400 --> 00:50:46,280 SNAP BEFORE, THE SUPPLEMENTAL 1432 00:50:46,280 --> 00:50:48,240 NUTRITION ASSISTANCE PRESENTLY, 1433 00:50:48,240 --> 00:50:51,120 OVER ALL AND BY SEX THERE ARE 1434 00:50:51,120 --> 00:50:52,280 SIGNIFICANT DIFFERENCES BY THOSE 1435 00:50:52,280 --> 00:50:53,880 WHO PARTICIPATE IN THE PROGRAM, 1436 00:50:53,880 --> 00:50:55,880 THOSE WHO ARE INCOME ELIGIBLE 1437 00:50:55,880 --> 00:50:57,480 BUT CHOOSE NOT TO PARTICIPATE 1438 00:50:57,480 --> 00:51:00,280 AND THOSE WHO ARE NOT ELIGIBLE 1439 00:51:00,280 --> 00:51:03,120 BASED ON THEIR INCOME. 1440 00:51:03,120 --> 00:51:04,200 SO VERY SIMILAR TRENDS IN,A 1441 00:51:04,200 --> 00:51:08,760 DULTS THAT WE SAW IN OTHER LIFE 1442 00:51:08,760 --> 00:51:09,960 STAGE GROUPS. 1443 00:51:09,960 --> 00:51:11,760 AND THEN FINALLY WE'LL TALK MORE 1444 00:51:11,760 --> 00:51:14,880 SPECIFICALLY ABOUT OLDER ADULTS 1445 00:51:14,880 --> 00:51:16,760 AND DR. GAHCHE LED THIS ANALYSIS 1446 00:51:16,760 --> 00:51:21,640 AS WELL, AND OLDER ASULTS USE 1447 00:51:21,640 --> 00:51:23,360 AROUND--70% OF THE U.S. OLDER 1448 00:51:23,360 --> 00:51:25,920 ADULTS ROUTINELY TAKE A DIETARY 1449 00:51:25,920 --> 00:51:27,760 SUPPLEMENT. 1450 00:51:27,760 --> 00:51:30,960 I WILL NOT SHOW YOU THE INTER 1451 00:51:30,960 --> 00:51:33,280 DATA, BUT IT MIRRORS WHAT WE SAW 1452 00:51:33,280 --> 00:51:34,440 ON THE ENTIRE ADULT POPULATION. 1453 00:51:34,440 --> 00:51:36,760 WHAT I WILL COMMENT ON IS NEARLY 1454 00:51:36,760 --> 00:51:39,640 ONE-THIRD OF OLDER ADULTS TAKE 4 1455 00:51:39,640 --> 00:51:42,120 OR MORE PRODUCTS DAY SO THIS IS 1456 00:51:42,120 --> 00:51:43,160 SLIGHTLY HIGHER THAN ADULTS IN 1457 00:51:43,160 --> 00:51:44,600 GENERAL AND WE KNOW THAT OLDER 1458 00:51:44,600 --> 00:51:46,480 ADULTS ALSO TEND TO USE MORE 1459 00:51:46,480 --> 00:51:49,960 PRESCRIPTION MEDICATIONS SO THIS 1460 00:51:49,960 --> 00:51:51,960 IS SOMETHING WE ALWAYS ASK 1461 00:51:51,960 --> 00:51:54,480 ADULTS TO DISCLOSE TO THEIR 1462 00:51:54,480 --> 00:51:55,240 HEALTHCARE PRACTICE 1463 00:51:55,240 --> 00:51:58,120 RESEARCHITION BECAUSE THERE CAN 1464 00:51:58,120 --> 00:51:59,880 BE NUTRIENT-NUCLEOTIDES 1465 00:51:59,880 --> 00:52:00,760 T-REGENT, AND NUTRIENT-DRUG 1466 00:52:00,760 --> 00:52:01,280 ACTIONS. 1467 00:52:01,280 --> 00:52:07,520 LOOKING AT THE U.S. OLDER ADULT 1468 00:52:07,520 --> 00:52:09,240 POPULATION BY SPECIFIC AGE 1469 00:52:09,240 --> 00:52:10,600 CATEGORIES AND THOSE SAME TRENDS 1470 00:52:10,600 --> 00:52:12,080 WE TALKED ABOUT CONTINUE TO 1471 00:52:12,080 --> 00:52:14,840 PERSIST WITH MORE THAN 80% OF 80 1472 00:52:14,840 --> 00:52:20,320 YEAR-OLDS REPORTING THE USE OF A 1473 00:52:20,320 --> 00:52:21,240 DIETARY SUPPLEMENT. 1474 00:52:21,240 --> 00:52:23,960 PRIMARILY AS WE'VE SEEN IN OTHER 1475 00:52:23,960 --> 00:52:26,600 AGE GROUPS, MULTIVITAMIN OR 1476 00:52:26,600 --> 00:52:27,560 MINERAL VITAMIN D SUPPLEMENT SO 1477 00:52:27,560 --> 00:52:30,320 WE ARE LOOKINGA THE USERS AND 1478 00:52:30,320 --> 00:52:31,800 NONUSERS COMBINED WHEN WE GIVE 1479 00:52:31,800 --> 00:52:33,520 YOU AN ESTIMATE LIKE 39%. 1480 00:52:33,520 --> 00:52:37,080 SO 39% OF THE ENTIRE U.S. ADULT 1481 00:52:37,080 --> 00:52:40,080 POPULATION OVER THE AGE OF 60 IS 1482 00:52:40,080 --> 00:52:42,320 USING A MULTIVITAMIN 1483 00:52:42,320 --> 00:52:43,120 MULTIMINERAL. 1484 00:52:43,120 --> 00:52:44,880 AS WE'VE TALKED ABOUT AD 1485 00:52:44,880 --> 00:52:49,720 NAUSEUM, WOMEN USE MORE THAN MEN 1486 00:52:49,720 --> 00:52:56,200 ACROSS MOST LIFE STAGES, 1487 00:52:56,200 --> 00:52:57,400 PARTICULARLY IN ADULTHOOD. 1488 00:52:57,400 --> 00:52:59,400 THIS IS LOOKING AT AGAIN, THE 1489 00:52:59,400 --> 00:53:02,040 POPULATION OF OLDER ADULTS AND 1490 00:53:02,040 --> 00:53:05,600 THESE SAME THEMES EXIST IN OLDER 1491 00:53:05,600 --> 00:53:07,880 ADULTINGS AND THE ENTIRE ADULT 1492 00:53:07,880 --> 00:53:09,080 POPULATION SO WE WON'T SPEND 1493 00:53:09,080 --> 00:53:10,680 VERY MUCH TIME GOING THROUGH 1494 00:53:10,680 --> 00:53:13,760 EACH OF THESE ESTIMATES HERE. 1495 00:53:13,760 --> 00:53:16,120 I'D LIKE TO DO A REALLY QUICK 1496 00:53:16,120 --> 00:53:20,040 CONCLUSION AND SUMMARY AND SOME 1497 00:53:20,040 --> 00:53:20,280 CAVEATS. 1498 00:53:20,280 --> 00:53:23,320 SO I HOPE I'VE CONVINCE YOU THAT 1499 00:53:23,320 --> 00:53:24,360 DIETARY SUPPLEMENT USE AND WIDE 1500 00:53:24,360 --> 00:53:25,400 SPREAD IN THE U.S. WITH MORE 1501 00:53:25,400 --> 00:53:27,520 THAN A THIRD OF CHILDREN, AND 1502 00:53:27,520 --> 00:53:30,400 MORE THAN HALF OF ADULTS 1503 00:53:30,400 --> 00:53:30,960 ROUTINELY REPORTING USE. 1504 00:53:30,960 --> 00:53:34,040 WE KNOW THIS FROM THE AT-HOME 1505 00:53:34,040 --> 00:53:37,440 PRODUCT INVENTORY FROM THE 1506 00:53:37,440 --> 00:53:38,520 NHANES SURVEY. 1507 00:53:38,520 --> 00:53:40,120 THERE ARE SOME POPULATION 1508 00:53:40,120 --> 00:53:43,080 SUBGROUPS THAT TEND TO USE MORE. 1509 00:53:43,080 --> 00:53:45,200 WE TALKED ABOUT PREGNANT AND 1510 00:53:45,200 --> 00:53:46,640 LACTATING WOMEN AND WE ALSO 1511 00:53:46,640 --> 00:53:47,720 TALKED ABOUT OLDER ADULTS BUT 1512 00:53:47,720 --> 00:53:49,320 THERE ARE SPECIFIC POPULATIONS 1513 00:53:49,320 --> 00:53:51,960 THAT ARE IN THE U.S. THAT ARE 1514 00:53:51,960 --> 00:53:54,760 ALSO HIGH USE GROUPS THAT ARE 1515 00:53:54,760 --> 00:53:56,360 NOT CAPTURED IN NHANES. 1516 00:53:56,360 --> 00:53:59,360 SO WE KNOW THAT ACTIVE MILITARY 1517 00:53:59,360 --> 00:54:02,120 FOR EXAMPLE HAVE A VERY HIGH 1518 00:54:02,120 --> 00:54:03,640 PREVALENCE OF USE, CANCER 1519 00:54:03,640 --> 00:54:06,000 SURVIVORS HAVE A VERY HIGH 1520 00:54:06,000 --> 00:54:06,640 PREVALENCE OF USE. 1521 00:54:06,640 --> 00:54:09,040 WHEY WANTED TO DO TODAY WAS GIVE 1522 00:54:09,040 --> 00:54:11,040 YOU VERY BROAD BRUSH STROKES OF 1523 00:54:11,040 --> 00:54:13,520 THE U.S. LANDSCAPE BUT THERE ARE 1524 00:54:13,520 --> 00:54:14,960 OTHER GROUPS THAT ARE HIGH USERS 1525 00:54:14,960 --> 00:54:17,480 THAT NEED TO BE CONSIDERED. 1526 00:54:17,480 --> 00:54:20,080 WE TALKED ABOUT THE VARIOUS 1527 00:54:20,080 --> 00:54:21,000 DEMOGRAPHIC AND LIFESTYLE 1528 00:54:21,000 --> 00:54:23,000 FACTORS, THAT ARE ASSOCIATED 1529 00:54:23,000 --> 00:54:24,720 WITH DIETARY SUPPLEMENT USE. 1530 00:54:24,720 --> 00:54:26,160 WE TALKED ABOUT HOW MOST OF 1531 00:54:26,160 --> 00:54:28,960 THOSE ARE SIMILAR IN ADULTS AND 1532 00:54:28,960 --> 00:54:31,480 CHILDREN, BUT THERE ARE SOME 1533 00:54:31,480 --> 00:54:32,560 DIFFERENCES PARTICULARLY WITH 1534 00:54:32,560 --> 00:54:35,280 REGARD TO SEX AND GENDER 1535 00:54:35,280 --> 00:54:36,680 DIFFERENCES, AND MULTIVITAMIN 1536 00:54:36,680 --> 00:54:40,600 MINERAL USE IN CHILDREN, VERSUS 1537 00:54:40,600 --> 00:54:41,240 ADULTS. 1538 00:54:41,240 --> 00:54:43,800 BY AND LARGE, WE HAVE SAID IN AT 1539 00:54:43,800 --> 00:54:45,480 LEAST 3 TIMES, MULTIVITAMIN 1540 00:54:45,480 --> 00:54:48,280 MINERALS ARE THE MOST COMMONLY 1541 00:54:48,280 --> 00:54:50,000 USED REGARDLESS OF WHAT STAGE OF 1542 00:54:50,000 --> 00:54:52,280 THE LIFE COURSE WE LOOKED AT. 1543 00:54:52,280 --> 00:54:54,840 AND IT'S IMPORTANT THAT WE 1544 00:54:54,840 --> 00:54:56,840 MEASURE ACCURATELY THE NUTRIENT 1545 00:54:56,840 --> 00:54:58,320 CONTRIBUTIONS FROM DIETARY 1546 00:54:58,320 --> 00:54:59,720 SUPPLEMENTS BECAUSE OTHERWISE, 1547 00:54:59,720 --> 00:55:03,160 WE ARE UNDER ESTIMATING NUTRIENT 1548 00:55:03,160 --> 00:55:03,640 EXPOSURES. 1549 00:55:03,640 --> 00:55:07,400 SO THERE'S ALWAYS LIMITATIONS 1550 00:55:07,400 --> 00:55:12,200 AND CAVEATS TO CONSIDER WITH ANY 1551 00:55:12,200 --> 00:55:15,640 TYPE OF ANALYSIS AND OURS IS NO 1552 00:55:15,640 --> 00:55:16,200 DIFFERENT. 1553 00:55:16,200 --> 00:55:17,440 SO SELF-REPORTED DIETARY DATA 1554 00:55:17,440 --> 00:55:19,280 ARE PRONE TO SYSTEMATIC ERRORS, 1555 00:55:19,280 --> 00:55:20,840 IN SOME WAYS WE CAN GET AROUND 1556 00:55:20,840 --> 00:55:23,160 THAT WITH THE AT-HOME PRODUCT 1557 00:55:23,160 --> 00:55:24,280 INVENTORY BUT THERE'S ALWAYS 1558 00:55:24,280 --> 00:55:25,440 MEASUREMENT ERROR AND WE KNOW 1559 00:55:25,440 --> 00:55:27,120 VERY LITTLE ABOUT THE 1560 00:55:27,120 --> 00:55:28,840 MEASUREMENT ERROR STRUCTURE OF 1561 00:55:28,840 --> 00:55:30,120 REPORTING OF DIETARY SUPPLEMENTS 1562 00:55:30,120 --> 00:55:32,440 WHICH IS LIKELY TO DIFFER VERY 1563 00:55:32,440 --> 00:55:37,040 MUCH FROM THAT OF FOODS AND 1564 00:55:37,040 --> 00:55:37,320 BEVERAGES. 1565 00:55:37,320 --> 00:55:39,360 SO WITH THAT I WILL CLOSE AND I 1566 00:55:39,360 --> 00:55:42,720 WILL SAY AGAIN, HAPPY BOTHER 1567 00:55:42,720 --> 00:55:44,400 DAY, HAPPY ANNIVERSARY OFFICE OF 1568 00:55:44,400 --> 00:55:46,240 DIETARY SUPPLEMENTS, I HAD A 1569 00:55:46,240 --> 00:55:47,680 WONDERFUL TIME WHEN I WORKED 1570 00:55:47,680 --> 00:55:50,040 THERE, NOT ONLY PROFESSIONAL BUT 1571 00:55:50,040 --> 00:55:51,360 PERSONALLY, WITH SO MANY PEOPLE. 1572 00:55:51,360 --> 00:55:53,040 AND THESE ARE JUST A FEW PHOTOS 1573 00:55:53,040 --> 00:55:55,440 THAT I HAD ON MY COMPUTER OF 1574 00:55:55,440 --> 00:55:57,480 REALLY HAPPY MOMENTS WITH PEOPLE 1575 00:55:57,480 --> 00:55:58,760 IN THE OFFICE AND IT'S A GREAT 1576 00:55:58,760 --> 00:56:00,520 PLACE TO WORK AND I HOPE THAT 1577 00:56:00,520 --> 00:56:06,360 YOU CONTINUE TO DRIVE IN THE 1578 00:56:06,360 --> 00:56:06,720 NEXT 25 YEARS. 1579 00:56:06,720 --> 00:56:08,120 SO THANK YOU IF ARE YOUR TIME 1580 00:56:08,120 --> 00:56:09,640 AND ATTENTION, THANK YOU TO ALL 1581 00:56:09,640 --> 00:56:10,760 THE WONDERFUL COLLEAGUES AND 1582 00:56:10,760 --> 00:56:14,400 COLLABORATORS THAT I HAVE BOTH 1583 00:56:14,400 --> 00:56:16,160 AT ODS AND TO PURDUE UNIVERSITY 1584 00:56:16,160 --> 00:56:18,400 AND HERE'S MY E-MAIL ADDRESS IF 1585 00:56:18,400 --> 00:56:19,560 YOU WOULD LOAMACYIC TO CONTACT 1586 00:56:19,560 --> 00:56:21,360 ME, IF HAVE YOU ANY QUESTIONS 1587 00:56:21,360 --> 00:56:22,640 REGARDING ANY OF THE DATA I 1588 00:56:22,640 --> 00:56:23,400 PRESENTED. 1589 00:56:23,400 --> 00:56:24,440 THANKS AGAIN. 1590 00:56:24,440 --> 00:56:25,320 >>THANK YOU 1591 00:56:25,320 --> 00:56:26,600 DR. BAILEY WILL BE TAKING 1592 00:56:26,600 --> 00:56:28,320 QUESTIONS RIGHT AFTER OUR NEXT 1593 00:56:28,320 --> 00:56:30,640 SPEAKER, WE WILL DO A PANEL 1594 00:56:30,640 --> 00:56:31,240 DISCUSSION. 1595 00:56:31,240 --> 00:56:36,440 BUT NOW WE HAVE DR. JOHANNA, 1596 00:56:36,440 --> 00:56:38,080 DWYER, SHE IS A SENIOR NUTRITION 1597 00:56:38,080 --> 00:56:40,320 SCIENTIST IN THE OFFICE OF 1598 00:56:40,320 --> 00:56:44,120 DIETARY SUPPLEMENTS SHE IS ALSO 1599 00:56:44,120 --> 00:56:46,560 DIRECTOR OF THE FRANCIS TUSTS 1600 00:56:46,560 --> 00:56:48,400 CENTER, AS WELL AS A SENIOR 1601 00:56:48,400 --> 00:56:50,600 SCIENTIST AT THE GENE MIER FREED 1602 00:56:50,600 --> 00:56:53,720 MAN SCHOOL OF NUTRITION SCIENCE 1603 00:56:53,720 --> 00:56:54,280 AND POLICY [INDISCERNIBLE]. 1604 00:56:54,280 --> 00:56:57,080 I'M SORRY AT THE UNITED STATES 1605 00:56:57,080 --> 00:56:58,920 DEPARTMENT OF AGRICULTURE HUMAN 1606 00:56:58,920 --> 00:57:02,280 NUTRITION RESEARCH CENTER ON 1607 00:57:02,280 --> 00:57:03,560 AGING AT TUFSs, SO PLEASE TELL 1608 00:57:03,560 --> 00:57:05,600 US ABOUT WHY AMERICANS ARE USING 1609 00:57:05,600 --> 00:57:06,440 DIETARY SUPPLEMENTS AND WE THEN 1610 00:57:06,440 --> 00:57:09,000 WE WILL HAVE A PANEL DISCUSSION 1611 00:57:09,000 --> 00:57:17,240 AFTERWARDS. 1612 00:57:17,240 --> 00:57:21,080 THANK YOU. 1613 00:57:21,080 --> 00:57:25,560 >> DR. JOHANNA DWYER, SHE IS 1614 00:57:25,560 --> 00:57:27,640 PROFESSOR AT THE COMMUNITY OF 1615 00:57:27,640 --> 00:57:29,000 HEALTH AT TUSTS UNIVERSITY 1616 00:57:29,000 --> 00:57:30,760 SCHOOL OF MEDICINE AND ALSOA 1617 00:57:30,760 --> 00:57:33,200 FREED MAN SCIENCE AND POLICY AT 1618 00:57:33,200 --> 00:57:37,160 TUFTs AND AS WELL AS A 1619 00:57:37,160 --> 00:57:38,600 SCIENTIST WITH HUMAN NUTRITION 1620 00:57:38,600 --> 00:57:41,240 RESEARCH CENTER ON AGING AT 1621 00:57:41,240 --> 00:57:43,520 TUFTs, SO PLEASE WELCOME 1622 00:57:43,520 --> 00:57:45,520 DR. DWYER AND SHE WILL TELL US 1623 00:57:45,520 --> 00:57:48,120 ALL ABOUT WHY AMERICANS ARE 1624 00:57:48,120 --> 00:57:48,680 USING DIETARY SUPPLEMENTS. 1625 00:57:48,680 --> 00:57:51,200 >> I'LL TELL YOU A LITTLE BIT 1626 00:57:51,200 --> 00:57:51,480 ABOUT IT. 1627 00:57:51,480 --> 00:57:51,840 >> [LAUGHTER] 1628 00:57:51,840 --> 00:57:53,160 >> LET ME GO THROUGH 5 1629 00:57:53,160 --> 00:57:55,360 QUESTIONS, FIRST OF ALL WHY DO 1630 00:57:55,360 --> 00:57:59,360 MOTIVATIONS MATTER, HOW WE FIND 1631 00:57:59,360 --> 00:58:00,160 OUT ABOUT MOTIVATIONS. 1632 00:58:00,160 --> 00:58:01,280 >> WHAT REASONS PEOPLE ARE 1633 00:58:01,280 --> 00:58:02,480 GIVING FOR USING SUPPLEMENTS. 1634 00:58:02,480 --> 00:58:04,880 HOW THE REASONS DIFFER FROM 1635 00:58:04,880 --> 00:58:07,440 GROUP TO GROUP. 1636 00:58:07,440 --> 00:58:10,360 AND THEN FINALLY FOR THOSE THAT 1637 00:58:10,360 --> 00:58:11,840 ARE PRACTITIONERS ARE SOME 1638 00:58:11,840 --> 00:58:13,040 PRACTICE IMPLICATIONS. 1639 00:58:13,040 --> 00:58:16,680 SO LET'S FIRST OF ALL THINK 1640 00:58:16,680 --> 00:58:18,680 ABOUT WHY WE REALLY CARE ABOUT 1641 00:58:18,680 --> 00:58:18,960 MOTIVATIONS. 1642 00:58:18,960 --> 00:58:22,480 IT SEEMS TO ME THERE ARE 3 BIG 1643 00:58:22,480 --> 00:58:22,720 REASONS. 1644 00:58:22,720 --> 00:58:24,560 ONE IS WE WANT TO KNOW WHY 1645 00:58:24,560 --> 00:58:25,640 PEOPLE USE SUPPLEMENTS FOR 1646 00:58:25,640 --> 00:58:28,080 DEALING WITH HEALTH PROBLEMS AND 1647 00:58:28,080 --> 00:58:32,960 THERE ARE MANY REASONS. 1648 00:58:32,960 --> 00:58:34,680 THE SECOND IS SOMETIMES KNOWING 1649 00:58:34,680 --> 00:58:36,640 MOTIVATIONS CAN GIVE US WARNING 1650 00:58:36,640 --> 00:58:39,080 SIGNS OF INAPPROPRIATE USE AND 1651 00:58:39,080 --> 00:58:42,080 THIRD, IT CAN GIVE US STRATEGIES 1652 00:58:42,080 --> 00:58:43,160 FOR ENCOURAGING OR DISCOURAGING 1653 00:58:43,160 --> 00:58:45,880 USE AND LET ME JUST GIVE YOU 1 1654 00:58:45,880 --> 00:58:47,760 LITTLE EXAMPLE OF THAT. 1655 00:58:47,760 --> 00:58:51,520 I THINK REGAN WAS THE 1 WHO 1656 00:58:51,520 --> 00:58:52,720 TALKED ABOUT VITAMIN D AND SO 1657 00:58:52,720 --> 00:58:56,280 LET'S TAKE A CASE IN POINT. 1658 00:58:56,280 --> 00:58:58,640 VITAMIN D STATUS IN EXCLUSIVELY 1659 00:58:58,640 --> 00:59:01,520 BREAST FED INFANTS, THESE ARE 1660 00:59:01,520 --> 00:59:02,840 INFANTS EXCLUSIVELY BREAST FED 1661 00:59:02,840 --> 00:59:06,000 FOR LIKE 6 MONTHS OR SO AND 1662 00:59:06,000 --> 00:59:09,320 ABOUT 45% OF WOMEN WHO 1663 00:59:09,320 --> 00:59:11,800 EXCLUSIVELY BREAST FEED THEIR 1664 00:59:11,800 --> 00:59:13,600 INFANTS DIDN'T SUPPLEMENT WITH 1665 00:59:13,600 --> 00:59:14,160 VITAMIN D. 1666 00:59:14,160 --> 00:59:16,840 THIS WAS IN A LITTLE STUDY. 1667 00:59:16,840 --> 00:59:18,440 AND WHEN THEY WENT IN 1668 00:59:18,440 --> 00:59:19,840 INVESTIGATED WHY, IT TURNED OUT 1669 00:59:19,840 --> 00:59:24,760 SOME OF THEM ASSUME THAD BREAST 1670 00:59:24,760 --> 00:59:25,680 MILK HAD ENOUGH. 1671 00:59:25,680 --> 00:59:27,200 OTHERS WERE FEEDING A LITTLE BIT 1672 00:59:27,200 --> 00:59:31,600 OF FORMULA NOW AND THEN AND 1673 00:59:31,600 --> 00:59:33,400 BECAUSE THEY--THE FORMULAS ARE 1674 00:59:33,400 --> 00:59:35,040 ADVERTISED AS BEING COMPLETE 1675 00:59:35,040 --> 00:59:36,440 WITH ALL NUTRIENTS AND OF COURSE 1676 00:59:36,440 --> 00:59:38,480 THEY ARE, THEY FELT LIKE FEEDING 1677 00:59:38,480 --> 00:59:39,920 A LITTLE BIT OF FORMULA WAS 1678 00:59:39,920 --> 00:59:42,800 ENOUGH AND THEY WOULD BE FINE. 1679 00:59:42,800 --> 00:59:44,080 SOMETIMES THE MOTHERS SAID THE 1680 00:59:44,080 --> 00:59:46,520 BABY DIDN'T LIKE IT OR MAYBE THE 1681 00:59:46,520 --> 00:59:48,360 MOTHER DIDN'T LIKE IT WHEN SHE 1682 00:59:48,360 --> 00:59:50,240 TASTED THE SUPPLEMENT AND 1683 00:59:50,240 --> 00:59:52,480 FINALLY THERE WAS A LACK OF 1684 00:59:52,480 --> 00:59:52,840 KNOWLEDGE. 1685 00:59:52,840 --> 00:59:54,920 SO BASIC POINT HERE IS THAT 1686 00:59:54,920 --> 00:59:56,880 KNOWING THE REASONS WHY WOMEN 1687 00:59:56,880 --> 00:59:58,280 WERE NOT USING SUPPLEMENTS 1688 00:59:58,280 --> 01:00:00,000 REALLY HELPED A LOT IN TERMS OF 1689 01:00:00,000 --> 01:00:02,720 COMING UP WITH SOLUTIONS THAT 1690 01:00:02,720 --> 01:00:05,120 WOULD FOCUS ON DEALING WITH 1691 01:00:05,120 --> 01:00:06,120 THOSE REASONS ONCE IT BECAME 1692 01:00:06,120 --> 01:00:08,800 CLEAR WHAT WAS GOING ON. 1693 01:00:08,800 --> 01:00:13,600 SO IT IS IMPORTANT TO KNOW ABOUT 1694 01:00:13,600 --> 01:00:14,040 MOTIVATION. 1695 01:00:14,040 --> 01:00:16,200 LET'S JUST SPEND A LITTLE BIT OF 1696 01:00:16,200 --> 01:00:18,640 TIME FINDING OUT ABOUT 1697 01:00:18,640 --> 01:00:20,160 MOTIVATIONS FOR SUPPLEMENT USE. 1698 01:00:20,160 --> 01:00:22,000 AND REGAN POINTED OUT THE MANY 1699 01:00:22,000 --> 01:00:24,640 DIFFERENCES BETWEEN PEOPLE IN 1700 01:00:24,640 --> 01:00:27,600 TERMS OF DIETARY SUPPLEMENT USE 1701 01:00:27,600 --> 01:00:28,560 THAT REALLY DIFFERENT PEOPLE 1702 01:00:28,560 --> 01:00:30,080 FROM THOSE WHO DON'T USE 1703 01:00:30,080 --> 01:00:31,280 SUPPLEMENTS WILL SEE THAT AS WE 1704 01:00:31,280 --> 01:00:34,880 GO THROUGH THE TALK. 1705 01:00:34,880 --> 01:00:36,320 LET'S JUST THINK OF 4 DIFFERENT 1706 01:00:36,320 --> 01:00:37,720 WAYS THAT CAN YOU FIND OUT A 1707 01:00:37,720 --> 01:00:40,080 LITTLE BIT ABOUT MOTIVATIONS, 1 1708 01:00:40,080 --> 01:00:42,200 IS SALES, 1 IS SURVEYS, 1 IS 1709 01:00:42,200 --> 01:00:44,160 FOCUS GROUPS, AND THEN THE LAST 1710 01:00:44,160 --> 01:00:48,360 1 I LIKE TO TALK ABOUT IS WEB 1711 01:00:48,360 --> 01:00:48,600 RELATED. 1712 01:00:48,600 --> 01:00:50,120 AND THIS IS NEW THIS YEAR 1713 01:00:50,120 --> 01:00:54,160 BECAUSE WE'VE JUST DONE SOME 1714 01:00:54,160 --> 01:00:55,480 STUDIES ON THIS. 1715 01:00:55,480 --> 01:00:55,680 OKAY. 1716 01:00:55,680 --> 01:00:59,360 STARTING OFF WITH SALES, JAMIE 1717 01:00:59,360 --> 01:01:01,960 MENTIONED THIS IN HER TALK AND 1718 01:01:01,960 --> 01:01:04,880 IT IS A USEFUL THING TO LOOK AT 1719 01:01:04,880 --> 01:01:06,360 NATIONAL BUSINESS JOURNAL OR 1720 01:01:06,360 --> 01:01:07,520 NUTRITION BUSINESS JOURNAL OR 1721 01:01:07,520 --> 01:01:10,840 OTHER SOURCES OF SALES DATA BUT 1722 01:01:10,840 --> 01:01:12,920 YOU CAN ONLY INFER THE 1723 01:01:12,920 --> 01:01:14,720 MOTIVATIONS FROM THESE DATA, 1724 01:01:14,720 --> 01:01:15,760 NEVERTHELESS, THEY DO GIVE YOU 1725 01:01:15,760 --> 01:01:17,200 PRETTY GOOD IDEA OF WHAT PEOPLE 1726 01:01:17,200 --> 01:01:23,240 ARE WILLING TO PAY FOR. 1727 01:01:23,240 --> 01:01:25,200 THE THEMES ARE THAT SALES 1728 01:01:25,200 --> 01:01:26,600 REFLECT PRICE AND NOT PREVALENCE 1729 01:01:26,600 --> 01:01:27,480 OF USE. 1730 01:01:27,480 --> 01:01:31,480 SO, FOR INSTANCE, A MULTIVIETA 1731 01:01:31,480 --> 01:01:34,440 VITAMIN SUPPLEMENT YOU GET AT 1732 01:01:34,440 --> 01:01:36,960 CVS OR REXALL, IS A FAIRLY CHEAP 1733 01:01:36,960 --> 01:01:38,080 PRODUCT, NOT VERY EXPENSIVE AND 1734 01:01:38,080 --> 01:01:39,880 SOME OF THE CONDITION SPECIFIC 1735 01:01:39,880 --> 01:01:41,080 SUPPLEMENTS I'LL SHOW YOU IN A 1736 01:01:41,080 --> 01:01:43,080 MINUTE ARE VERY EXPENSIVE. 1737 01:01:43,080 --> 01:01:45,160 SO SALES DON'T REFLECT 1738 01:01:45,160 --> 01:01:46,120 PREVALENCE OF USE AND THEN THE 1739 01:01:46,120 --> 01:01:47,320 OTHER THING IS YOU CAN'T REALLY 1740 01:01:47,320 --> 01:01:48,720 TELL WHICH IS THE CHICKEN AND 1741 01:01:48,720 --> 01:01:50,840 WHICH IS THE EGG, WHETHER THE 1742 01:01:50,840 --> 01:01:54,760 MOTIVATIONS THAT ARE INFERRED 1743 01:01:54,760 --> 01:01:56,560 FROM SUPPLEMENTS MARKETING 1744 01:01:56,560 --> 01:01:59,960 PITCHES OR ACTUALLY THE 1745 01:01:59,960 --> 01:02:01,720 BEGINNING, FOR INSTANCE, A 1746 01:02:01,720 --> 01:02:03,520 PERFORMANCE ENHANCER, PEOPLE WHO 1747 01:02:03,520 --> 01:02:04,320 TAKE PERFORMANCE ENHANCERS DO IT 1748 01:02:04,320 --> 01:02:06,000 BECAUSE THEY WANT TO ENHANCE 1749 01:02:06,000 --> 01:02:08,640 THEIR PERFORMANCE OR IS IT THAT 1750 01:02:08,640 --> 01:02:10,080 THEY'RE CONVINCED FROM THE END? 1751 01:02:10,080 --> 01:02:12,120 I'LL COME BACK TO THAT LATER. 1752 01:02:12,120 --> 01:02:13,960 REGAN DID A GREAT JOB TALKING 1753 01:02:13,960 --> 01:02:16,200 ABOUT SOME OF THE FEDERAL 1754 01:02:16,200 --> 01:02:17,320 POPULATION BASED SURVEYS AND I 1755 01:02:17,320 --> 01:02:20,680 WILL GO THROUGH THEM RATHER 1756 01:02:20,680 --> 01:02:21,320 QUICKLY. 1757 01:02:21,320 --> 01:02:24,080 BUT THEY'RE EXTREMELY VALUABLE 1758 01:02:24,080 --> 01:02:25,200 INCLUDING FOR MOTIVATION. 1759 01:02:25,200 --> 01:02:26,960 THE COMMERCIAL SURVEYS AND SMALL 1760 01:02:26,960 --> 01:02:29,800 SURVEYS ALSO HAVE A PLACE 1761 01:02:29,800 --> 01:02:32,760 THOUGH, BECAUSE THE FEDERAL 1762 01:02:32,760 --> 01:02:34,200 SURVEYS ARE COMMINATED BY THE 1763 01:02:34,200 --> 01:02:38,840 PREVALENCE OF USE OF 1764 01:02:38,840 --> 01:02:39,320 MULTIVITAMIN VALENTINED 1765 01:02:39,320 --> 01:02:41,480 SUPPLEMENTS SO IT'S HARD TO GET 1766 01:02:41,480 --> 01:02:43,080 AT THESE OTHER SUPPLEMENTS THAT 1767 01:02:43,080 --> 01:02:44,320 MAY BE OF INTEREST PARTICULARLY 1768 01:02:44,320 --> 01:02:48,080 FOR CLIN IPGZS AND FOR CONCERNS 1769 01:02:48,080 --> 01:02:49,840 ABOUT DRUG NUTRIENT IRCHT 1770 01:02:49,840 --> 01:02:50,080 ACTIONS. 1771 01:02:50,080 --> 01:02:52,320 OKAY, LET'S START WITH THE 1772 01:02:52,320 --> 01:02:53,920 NATIONAL HEALTH AND YOU HAD 1773 01:02:53,920 --> 01:02:55,000 TRICIAN EXAM NATION SURVEY. 1774 01:02:55,000 --> 01:02:58,040 CAN YOU GET TOTAL DIETARY 1775 01:02:58,040 --> 01:03:00,720 EXPOSURE FROM ALL FOOD 1776 01:03:00,720 --> 01:03:04,000 SUPLEAPTS, DRUGS, YOU CAN GET 1777 01:03:04,000 --> 01:03:05,640 ASSOCIATIONS OF MOTIVATIONS WITH 1778 01:03:05,640 --> 01:03:07,400 DEMOGRAPHICS AND WITH LAB 1779 01:03:07,400 --> 01:03:12,840 VALUES, YOU CAN GET TIME TRENDS, 1780 01:03:12,840 --> 01:03:14,920 THEY'RE REPRESENTATIVE OF THE 1781 01:03:14,920 --> 01:03:15,800 U.S. AMBULATORY POPULATION AND 1782 01:03:15,800 --> 01:03:16,480 THEY'RE FREE. 1783 01:03:16,480 --> 01:03:19,480 SO THERE'S EVERY REASON TO USE 1784 01:03:19,480 --> 01:03:20,640 THIS RESOURCE. 1785 01:03:20,640 --> 01:03:21,200 THE PROBLEMS THOUGH, 1786 01:03:21,200 --> 01:03:23,360 PARTICULARLY TODAY BECAUSE OF 1787 01:03:23,360 --> 01:03:26,680 THE COVID YEAR, ARE THAT 1788 01:03:26,680 --> 01:03:28,400 RESPONSE RATES ARE LOW AND THE 1789 01:03:28,400 --> 01:03:30,720 OTHER POINT IS THAT THE DATA ARE 1790 01:03:30,720 --> 01:03:32,360 IECIALLY A COUPLE YEAR AND HALF 1791 01:03:32,360 --> 01:03:35,920 OR SO AFTER THEY WERE COLLECTED 1792 01:03:35,920 --> 01:03:37,680 AND CROSS SECTIONAL AND A COMMON 1793 01:03:37,680 --> 01:03:39,520 MISTAKE IS ASSUMING THAT YOU CAN 1794 01:03:39,520 --> 01:03:41,200 INFER CAUSATION FROM THAT, AND 1795 01:03:41,200 --> 01:03:43,360 YOU REALLY CAN'T JUST BECAUSE 1796 01:03:43,360 --> 01:03:46,560 THERE'S A CORRELATION DOESN'T 1797 01:03:46,560 --> 01:03:47,080 MEAN CAUSATION. 1798 01:03:47,080 --> 01:03:49,440 AND THE AMOUNT OF NUCLEOTIDES 1799 01:03:49,440 --> 01:03:51,680 T-REGENT CONTAINING SUPPLEMENTS 1800 01:03:51,680 --> 01:03:54,080 ARE PROVIDED BUT FOR NONMUSEUM 1801 01:03:54,080 --> 01:03:56,240 TRIENT SUPPLEMENTINGS IT'S 1802 01:03:56,240 --> 01:04:00,880 DIFFICULT TO GET THEM OUT. 1803 01:04:00,880 --> 01:04:05,760 SECOND BIG NATIONAL SURVEY AND 1804 01:04:05,760 --> 01:04:07,880 THE NATIONAL HEALTH SURVEY, IT'S 1805 01:04:07,880 --> 01:04:08,280 POPULATION BASED. 1806 01:04:08,280 --> 01:04:10,120 WHAT I LIKED ABOUT IT, WE USED 1807 01:04:10,120 --> 01:04:12,880 IT FOR RESEARCH ON 1 PAPER, 1808 01:04:12,880 --> 01:04:13,720 THEY'RE VERY LARGE NUMBERS AND 1809 01:04:13,720 --> 01:04:18,040 YOU CAN GET AT SOME OF THESE 1810 01:04:18,040 --> 01:04:21,760 LESS COMMONLY USED SUPPLEMENTS 1811 01:04:21,760 --> 01:04:25,160 LIKE MELATONIN, COQ10 AND SO 1812 01:04:25,160 --> 01:04:26,280 FORTH, AND THE PROBLEM IS THAT 1813 01:04:26,280 --> 01:04:28,960 THE SOUP ELEMENTS ARE GROUPED IN 1814 01:04:28,960 --> 01:04:31,920 BIG CATEGORIES LIKE MULTIVITAMIN 1815 01:04:31,920 --> 01:04:34,560 MINERAL, SINGLE VITAMIN, 1816 01:04:34,560 --> 01:04:35,280 NONNUTRIENT, NONVITAMIN, 1817 01:04:35,280 --> 01:04:38,360 NONMINERAL BUT IT DOES GET AT 1818 01:04:38,360 --> 01:04:41,360 THESE LESS POPULAR PRODUCTS. 1819 01:04:41,360 --> 01:04:43,560 THE OTHER NICE THING ABOUT IT IS 1820 01:04:43,560 --> 01:04:48,160 ABOUT EVERY 5 YEARS BUT I DON'T 1821 01:04:48,160 --> 01:04:53,880 THINK LATELY, THE NATIONAL 1822 01:04:53,880 --> 01:04:57,200 INSTITUTION OF INTEGRATED AND 1823 01:04:57,200 --> 01:04:58,560 ALTERNATIVE MEDICINE DOES A 1824 01:04:58,560 --> 01:05:00,720 SUPPLEMENT WHICH GOES INTO GREAT 1825 01:05:00,720 --> 01:05:02,280 DEPTH IN TERMS OF COMPLEMENTAR 1826 01:05:02,280 --> 01:05:04,520 SKPE BAKUGAN ALTERNATIVE 1827 01:05:04,520 --> 01:05:08,040 MEDICINE AND ALSO A FAIR AMOUNT 1828 01:05:08,040 --> 01:05:08,840 OF DIETARY SUPPLEMENTS. 1829 01:05:08,840 --> 01:05:10,840 THE PROBLEM IS, THERE AREN'T ANY 1830 01:05:10,840 --> 01:05:13,120 MEASURES OF HEALTH OR OUTCOMES 1831 01:05:13,120 --> 01:05:15,880 LIKE THERE ARE FOR HANES WHERE 1832 01:05:15,880 --> 01:05:19,560 YOU CAN HITCH UP WITH THE 1833 01:05:19,560 --> 01:05:22,600 NATIONAL DEATH INDEX, THERE'S NO 1834 01:05:22,600 --> 01:05:24,600 NATIONAL DIETARY INDEX SO YOU 1835 01:05:24,600 --> 01:05:26,120 CAN'T CALCULATE NUCLEOTIDES TRI 1836 01:05:26,120 --> 01:05:27,840 INTAKE AND THE DATA IS QUITE 1837 01:05:27,840 --> 01:05:29,640 BIG, BECAUSE THE LAST BIG SURVEY 1838 01:05:29,640 --> 01:05:31,560 TOO INCLUDED A LOT ON 1839 01:05:31,560 --> 01:05:32,520 SIGNIFYETARY SUPPLEMENTS WAS 1840 01:05:32,520 --> 01:05:36,600 BACK IN 2012 SO THERE'S LITTLE 1841 01:05:36,600 --> 01:05:39,520 CURRENT DATA. 1842 01:05:39,520 --> 01:05:41,280 THE OTHER NATIONAL SURVEYS 1843 01:05:41,280 --> 01:05:43,720 INCLUDE THE NATIONAL MARKETING 1844 01:05:43,720 --> 01:05:45,680 INSTITUTE SURVEYS AND ALSO 1845 01:05:45,680 --> 01:05:48,000 SOMETIMES NEILSEN WILL DO A 1846 01:05:48,000 --> 01:05:49,040 NATIONAL SURVEY. 1847 01:05:49,040 --> 01:05:53,240 THE PRO HERE, IS THAT SOME 1848 01:05:53,240 --> 01:05:56,200 LIMITED TREND DATA ARE 1849 01:05:56,200 --> 01:05:56,480 AVAILABLE. 1850 01:05:56,480 --> 01:05:57,600 THE SURVEY, YOU PAY TO PLAY. 1851 01:05:57,600 --> 01:06:01,080 WHAT YOU DO IS YOU BUY A 1852 01:06:01,080 --> 01:06:02,360 QUESTION IF YOU'RE A COMPANY AND 1853 01:06:02,360 --> 01:06:04,040 THEY GET IT TO TEST IT FOR YOU 1854 01:06:04,040 --> 01:06:05,480 AND THEN THEY PUT IT ON THE 1855 01:06:05,480 --> 01:06:09,000 SURVEY AND YOU GET AN ANSWER 1856 01:06:09,000 --> 01:06:10,880 USUALLY IN A COUPLE MONTHS. 1857 01:06:10,880 --> 01:06:13,680 SO THE TURNOVER IS RAPID, AND 1858 01:06:13,680 --> 01:06:16,760 AGAIN, THE SURVEY TENDS TO GET 1859 01:06:16,760 --> 01:06:19,640 IT RARELY USED SUPPLEMENTS WHICH 1860 01:06:19,640 --> 01:06:22,360 IS OF INTEREST AND THERE ISN'T 1861 01:06:22,360 --> 01:06:24,920 MUCH NHANES ON SOME OF THEM. 1862 01:06:24,920 --> 01:06:27,920 THE CONS ARE, THIS ISN'T FOR 1863 01:06:27,920 --> 01:06:29,800 PUBLIC USE, YOU HAVE TO PAY THIS 1864 01:06:29,800 --> 01:06:31,120 GOET THIS SURVEY AND THE MORE 1865 01:06:31,120 --> 01:06:32,240 YOU PAY, THE MORE INFORMATION 1866 01:06:32,240 --> 01:06:32,560 YOU GET. 1867 01:06:32,560 --> 01:06:37,200 THE QUESTION HERE IS THERE ARE 1868 01:06:37,200 --> 01:06:38,840 PROBLEMS WITH WITH SOME OF THE 1869 01:06:38,840 --> 01:06:40,280 QUESTIONS AREN'T REALLY CONSUMER 1870 01:06:40,280 --> 01:06:42,120 CONTESTED SO IT CAN BE DIFFICULT 1871 01:06:42,120 --> 01:06:45,560 TO INTERPRET WHAT ACTUALLY IS 1872 01:06:45,560 --> 01:06:48,120 BEING GOTTEN AT. 1873 01:06:48,120 --> 01:06:49,880 THERE'S LIMITED DIETARY, ISICAL 1874 01:06:49,880 --> 01:06:52,440 AND OUTCOME DATA AND I THINK IN 1875 01:06:52,440 --> 01:06:55,600 SOME CASES, THE SURVEYS AREN'T 1876 01:06:55,600 --> 01:06:56,600 REPRESENTATIVE EVEN THOUGH 1877 01:06:56,600 --> 01:06:58,480 THEY'RE INNATE, IT SEEMS LIKE 1878 01:06:58,480 --> 01:06:59,640 THEY OVERSAMPLE USERS WHEN YOU 1879 01:06:59,640 --> 01:07:04,000 COMPARE IT TO SOMETHING LIKE 1880 01:07:04,000 --> 01:07:04,680 HANES FOR EXAMPLE. 1881 01:07:04,680 --> 01:07:06,640 AND THE FORMAT IS LARGELY WEB 1882 01:07:06,640 --> 01:07:09,560 BASED SO IF YOU'RE CONCERNED 1883 01:07:09,560 --> 01:07:11,400 ABOUT COMPUTER ILLITERATE PEOPLE 1884 01:07:11,400 --> 01:07:14,000 AS MANY ELTONJOHNERLY PEOPLE ARE 1885 01:07:14,000 --> 01:07:15,320 AND IMMIGRANTS WHO DON'T SPEAK 1886 01:07:15,320 --> 01:07:17,800 ENGLISH, YOU WILL NOT GET VERY 1887 01:07:17,800 --> 01:07:23,000 MUCH NECESSARILY FROM THESE 1888 01:07:23,000 --> 01:07:23,240 SURVEYS. 1889 01:07:23,240 --> 01:07:24,040 WHAT ABOUT SPECIAL GROUPS? 1890 01:07:24,040 --> 01:07:26,720 THERE ARE A LOT OF SPECIAL USE 1891 01:07:26,720 --> 01:07:29,360 THINGS HERE. 1892 01:07:29,360 --> 01:07:31,600 THERE WERE [INDISCERNIBLE] 1893 01:07:31,600 --> 01:07:34,560 SURVIVORS, CANCER SURVIVORS, HIV 1894 01:07:34,560 --> 01:07:39,960 PATIENTS AND SURVEY PROVIDERS 1895 01:07:39,960 --> 01:07:40,880 PHYSICIANS, DIETITIANS AND SO 1896 01:07:40,880 --> 01:07:42,400 FORTH, THE PURPOSE OF THESE 1897 01:07:42,400 --> 01:07:43,480 SURVEYS ARE THAT THEY EXPLAIN 1898 01:07:43,480 --> 01:07:45,360 THE BEHAVIOR AND MOTIVATION OF 1899 01:07:45,360 --> 01:07:47,280 SUBGROUPS OF SPECIAL INTEREST OR 1900 01:07:47,280 --> 01:07:49,680 SPECIAL RISK, THERE ARE U.S. 1901 01:07:49,680 --> 01:07:53,640 LEADERSHIP VERY USEFUL IN 1902 01:07:53,640 --> 01:07:58,240 GETTING INSIGHT ON USERS, 1 FOR 1903 01:07:58,240 --> 01:07:59,360 CRAFTING INTERVENTIONS, IN TERMS 1904 01:07:59,360 --> 01:08:04,160 OF SOME OF THE DISADVANTAGES 1905 01:08:04,160 --> 01:08:06,760 HERE, 1 IS THAT AGAIN THE ITEMS 1906 01:08:06,760 --> 01:08:08,080 MAY BE POORLY WORDED AND 1907 01:08:08,080 --> 01:08:09,480 UNTESTED SO THE MEANING IS 1908 01:08:09,480 --> 01:08:10,880 DIFFICULT TO GET FOR THE 1909 01:08:10,880 --> 01:08:11,960 RESPONDENT AND WHAT I WOULD 1910 01:08:11,960 --> 01:08:13,520 SUGGEST IF YOU'RE THINKING OF 1911 01:08:13,520 --> 01:08:15,920 DOING SUCH A SURVEY. 1912 01:08:15,920 --> 01:08:17,880 USE THE NATIONALLY TESTED 1S 1913 01:08:17,880 --> 01:08:20,240 THAT ARE ON HANES OR ON THE 1914 01:08:20,240 --> 01:08:21,000 NATIONAL HEALTH INTERVIEW 1915 01:08:21,000 --> 01:08:23,040 SURVEY, THEY'RE FREE AND YOU CAN 1916 01:08:23,040 --> 01:08:24,320 USE THEM WITHOUT ASKING, CAN YOU 1917 01:08:24,320 --> 01:08:27,080 JUST USE THEM AND THEY HAVE BEEN 1918 01:08:27,080 --> 01:08:27,760 TESTED. 1919 01:08:27,760 --> 01:08:31,360 THE OTHER PROBLEMS WITH THESE 1920 01:08:31,360 --> 01:08:33,360 SURVEYS, IS VERY OFTEN THEY'RE 1921 01:08:33,360 --> 01:08:35,400 REPRESENTED, IT'S JUST A GROUP I 1922 01:08:35,400 --> 01:08:37,600 DIETITIANS RATHER THAN ALL THE 1923 01:08:37,600 --> 01:08:38,880 DIETITIANS IN THE COUNTRY OR ALL 1924 01:08:38,880 --> 01:08:40,480 THE PHARMACISTS AND THE RESPONSE 1925 01:08:40,480 --> 01:08:43,200 RATES ARE OFTEN VERY LOW, 1926 01:08:43,200 --> 01:08:44,440 PARTICULARLY IF THEY'RE WEB 1927 01:08:44,440 --> 01:08:47,200 BASED, SOMETIMES THEY RUN, 1, 1928 01:08:47,200 --> 01:08:48,600 2,S 3,% WHICH PROBABLY ISN'T 1929 01:08:48,600 --> 01:08:54,400 ENOUGH TO BE REPRESENTATIVE. 1930 01:08:54,400 --> 01:08:55,480 NEVERTHELESS, THEY GIVE REALLY 1931 01:08:55,480 --> 01:08:56,600 USEFUL INFORMATION. 1932 01:08:56,600 --> 01:08:58,120 LET ME GIVE AN EXAMPLE AGAIN OF 1933 01:08:58,120 --> 01:08:59,160 WHY IT IS IMPORTANT TO STUDY 1934 01:08:59,160 --> 01:09:00,840 SOME OF THESE THINGS AND AGAIN, 1935 01:09:00,840 --> 01:09:03,360 IT GOES RIGHT BACK TO SOMETHING 1936 01:09:03,360 --> 01:09:09,560 I THINK REGAN TALKED ABOUT, 1937 01:09:09,560 --> 01:09:10,600 WHICH WAS PRENATALS. 1938 01:09:10,600 --> 01:09:12,680 AND I CHOSE AN IRISH EXAMPLE 1939 01:09:12,680 --> 01:09:14,880 BECAUSE I'M OF IRISH DESCENT BUT 1940 01:09:14,880 --> 01:09:18,720 IN IRELAND THE FOOD SUPPLY TENDS 1941 01:09:18,720 --> 01:09:21,840 TO BE UNFORTIFIED WITH FOLIC 1942 01:09:21,840 --> 01:09:23,880 ACID AND FOALATE INTAKES TEND TO 1943 01:09:23,880 --> 01:09:27,640 BE ON THE LOW SIDE, SO 1 OF THE 1944 01:09:27,640 --> 01:09:31,720 PROBLEMS IN IRELAND WAS A HIGH 1945 01:09:31,720 --> 01:09:32,800 PREVALENCE OF NARROW 2 DEFECTS 1946 01:09:32,800 --> 01:09:40,080 EVEN AS A THIS HAD A COMPAIN ON 1947 01:09:40,080 --> 01:09:41,360 FOA05 ON CONNECTIONS AND THE 1948 01:09:41,360 --> 01:09:45,960 NEED FOR INCREASING FOLIC ACID, 1949 01:09:45,960 --> 01:09:50,880 PRECONCEPT EALSZ AND IN FIFTH 1950 01:09:50,880 --> 01:09:53,720 AND 96% OF WOMEN TOOK FOLIC ACID 1951 01:09:53,720 --> 01:09:54,880 DURING PREGNANCY BECAUSE THEY 1952 01:09:54,880 --> 01:09:56,040 HAVE A NATIONAL HEALTH SERVICE 1953 01:09:56,040 --> 01:09:57,560 AND THEY GO TO THE DOCTOR AND 1954 01:09:57,560 --> 01:10:02,240 THE DOCTOR WILL GIVE THEM A 1955 01:10:02,240 --> 01:10:04,160 FOALATE IRON SUPPLEMENT, THE 1956 01:10:04,160 --> 01:10:08,520 PROBLEM WAS ONLY 25% TOOK FOLIC 1957 01:10:08,520 --> 01:10:11,280 ACID SUPPLEMENT CONTAINING 1958 01:10:11,280 --> 01:10:13,360 SUPPLEMENT PREINATE, 1959 01:10:13,360 --> 01:10:13,960 PRECONCEPTIONALLY, AND 1960 01:10:13,960 --> 01:10:15,760 PRECONCEPTUALLY, TOO, I GUESS AT 1961 01:10:15,760 --> 01:10:18,120 THE VERY TIME WHEN YOU REALLY 1962 01:10:18,120 --> 01:10:20,760 NEEDED IT IF YOU'RE GOING TO 1963 01:10:20,760 --> 01:10:22,520 LOWER THE PREVALENCE OF NEURAL 1964 01:10:22,520 --> 01:10:24,600 TUBE DEFECTS BECAUSE THE NEURAL 1965 01:10:24,600 --> 01:10:27,040 TUBE CLOSES IN THOSE FIRST FEW 1966 01:10:27,040 --> 01:10:32,120 WEEKS OF PREGNANCY, NOT LATER 1967 01:10:32,120 --> 01:10:32,880 ON. 1968 01:10:32,880 --> 01:10:34,400 WELL THEY DID SOME INVESTIGATION 1969 01:10:34,400 --> 01:10:36,080 OF WHAT WAS GOING ON HERE AND 1970 01:10:36,080 --> 01:10:37,680 WHAT THEY FOUND WAS THAT MANY 1971 01:10:37,680 --> 01:10:39,920 WOMEN DIDN'T EXPECT TO GET 1972 01:10:39,920 --> 01:10:43,760 PREGNANT SO THEY WEREN'T LOOKING 1973 01:10:43,760 --> 01:10:46,240 TO GET PREGNANT AND FIGURED THEY 1974 01:10:46,240 --> 01:10:48,000 WOULDN'T ALTHOUGH THEY DID AND 1975 01:10:48,000 --> 01:10:49,480 SO THEY WEREN'T PACIFIC 1976 01:10:49,480 --> 01:10:50,120 NORTHWESTING A SUPPLEMENT. 1977 01:10:50,120 --> 01:10:52,320 ARGTS WERE POOR OR THEY WERE 1978 01:10:52,320 --> 01:10:53,640 IMMIGRANTS WHO DIDN'T SPEAK 1979 01:10:53,640 --> 01:10:57,360 ENGLISH AND THEY WERE UNAWARE OF 1980 01:10:57,360 --> 01:11:00,560 THE NEURAL TUBE DEFECT RISK AND 1981 01:11:00,560 --> 01:11:02,160 THIS MEDIVATION LED TO BETTER 1982 01:11:02,160 --> 01:11:04,560 PUBLIC HEALTH PRESSURES TO 1983 01:11:04,560 --> 01:11:06,880 ADDRESS THE PROBLEM. 1984 01:11:06,880 --> 01:11:08,640 OKAY, FOCUS GROUPS, JUST TO 1985 01:11:08,640 --> 01:11:15,600 MENTION HERE, THEY DO PROVIDE 1986 01:11:15,600 --> 01:11:16,760 NUANCED INSIGHT INTO WHAT IS 1987 01:11:16,760 --> 01:11:18,200 BEHIND THE USE AND THIS IS DONE 1988 01:11:18,200 --> 01:11:23,160 BY TD NATIONAL CENTER FOR HEALTH 1989 01:11:23,160 --> 01:11:24,400 STATISTICS TO CLAWRIFY THEIR 1990 01:11:24,400 --> 01:11:25,560 QUESTIONS AND THAT'S WHY I SAY 1991 01:11:25,560 --> 01:11:27,400 USE THEM IF YOU CAN, THOSE 1992 01:11:27,400 --> 01:11:28,760 QUESTION SAYS. 1993 01:11:28,760 --> 01:11:32,280 THE PROBLEM IS IT'S VERY 1994 01:11:32,280 --> 01:11:33,280 EXPENSIVE, THE USERS, THE 1995 01:11:33,280 --> 01:11:35,440 INTERVIEWERS HAD TO BE VERY WELL 1996 01:11:35,440 --> 01:11:39,880 TRAINED AND YOU ALSO NEED 1997 01:11:39,880 --> 01:11:40,600 COGNITIVE PSYCHOLOGIST TO REALLY 1998 01:11:40,600 --> 01:11:45,600 UNDERSTAND WHAT'S GOING ON WHEN 1999 01:11:45,600 --> 01:11:47,800 YOU THE ANALYSIS OF REPLAY AND 2000 01:11:47,800 --> 01:11:50,120 REREADING WHAT THE PEOPLE HAVE 2001 01:11:50,120 --> 01:11:53,600 SAID AND IN INTERPRETATION TENDS 2002 01:11:53,600 --> 01:11:54,880 TO BE QUALITATIVE AND 2003 01:11:54,880 --> 01:11:55,760 SUBJECTIVE. 2004 01:11:55,760 --> 01:11:57,200 HERE AT ODS, WE FOUND THEM VERY 2005 01:11:57,200 --> 01:11:58,720 USEFUL FOR GETTING AT THE 2006 01:11:58,720 --> 01:12:02,720 DIFFERENCES BETWEEN USERS WHO 2007 01:12:02,720 --> 01:12:03,600 ARE BASICALLY MULTIVITAMINERAL 2008 01:12:03,600 --> 01:12:05,040 SUPPLEMENT USERS AND SOME OF THE 2009 01:12:05,040 --> 01:12:07,560 VERY HEAVY USERS THAT REGAN WAS 2010 01:12:07,560 --> 01:12:09,800 TALKING ABOUT HERBALS AND 2011 01:12:09,800 --> 01:12:11,240 BOTANICALS, IT'S A SMALL GROUP 2012 01:12:11,240 --> 01:12:12,680 OF SUPPLEMENT USERS BUT IT'S 2013 01:12:12,680 --> 01:12:13,880 VERY IMPORTANT AS YOU WILL SEE 2014 01:12:13,880 --> 01:12:21,840 IN A MINUTE WHEN WE TALK ABOUT 2015 01:12:21,840 --> 01:12:22,480 CONDITION SPECIFIC SUPPLEMENTS. 2016 01:12:22,480 --> 01:12:23,560 THE FINAL WAY OF STUDYING 2017 01:12:23,560 --> 01:12:24,680 MOTIVATIONS, I WOULD LIKE TO 2018 01:12:24,680 --> 01:12:26,120 TALK ABOUT IS A LITTLE FARTHER 2019 01:12:26,120 --> 01:12:29,440 UPFIELD AND THAT IS USING 2020 01:12:29,440 --> 01:12:31,600 DATABASES, OF THE DIETARY 2021 01:12:31,600 --> 01:12:32,440 SUPPLEMENT LABELED DATABASE THAT 2022 01:12:32,440 --> 01:12:33,600 JAMIE MENTIONED AND YOU WILL 2023 01:12:33,600 --> 01:12:40,040 HEAR MORE ABOUT LATER I THINK IS 2024 01:12:40,040 --> 01:12:41,280 USEFUL TO SEARCH SUPPLEMENT 2025 01:12:41,280 --> 01:12:42,520 DATABASES LIKE THIS FOR SLAIBL 2026 01:12:42,520 --> 01:12:43,880 CLAIMS AND SEE WHAT'S GOING ON 2027 01:12:43,880 --> 01:12:45,400 HERE, AND TRY TO ELABORATE ON 2028 01:12:45,400 --> 01:12:47,000 THIS IN THE NEXT IF YOU MINUTES. 2029 01:12:47,000 --> 01:12:51,840 THE PROS OF THIS ARE THE 2030 01:12:51,840 --> 01:12:55,600 DATABASE CONTAINS EVERYTHING ON 2031 01:12:55,600 --> 01:12:58,760 THE LABEL INCLUDING CLAIMS. 2032 01:12:58,760 --> 01:12:59,960 AND IT'S POSSIBLE TO AT LEAST 2033 01:12:59,960 --> 01:13:03,400 GET SOME IDEA OF MOTIVATIONS 2034 01:13:03,400 --> 01:13:04,960 FROM PURCHASES, PRODUCTS, WITH 2035 01:13:04,960 --> 01:13:08,200 CERTAIN MARKETING CLAIMS, AGAIN 2036 01:13:08,200 --> 01:13:10,240 IT'S ALL IN PRINT, IT'S NOT 2037 01:13:10,240 --> 01:13:12,080 REALLY THE MOTIVATION ITSELF, 2038 01:13:12,080 --> 01:13:14,960 THE PERSON ISN'T TELLING YOU. 2039 01:13:14,960 --> 01:13:16,680 THEY'RE JUST BUYING SOMETHING. 2040 01:13:16,680 --> 01:13:19,040 DURING THESE KINDS OF SEARCHES 2041 01:13:19,040 --> 01:13:21,000 OF DATABASES DOES REQUIRE SOME 2042 01:13:21,000 --> 01:13:21,960 TECHNICAL EXPERTISE AND IT TAKES 2043 01:13:21,960 --> 01:13:25,080 A LOT OF TIME. 2044 01:13:25,080 --> 01:13:29,560 AND IT'S LIMITED TO THE LABELS 2045 01:13:29,560 --> 01:13:31,000 THAT ARE INCLUDED IN THE 2046 01:13:31,000 --> 01:13:33,120 DATABASE BUT WE'RE UP TO 126,000 2047 01:13:33,120 --> 01:13:35,480 NOW, IN TERMS OF THE DIETARY 2048 01:13:35,480 --> 01:13:36,160 SUPPLEMENT LABELED DAILY BASIS 2049 01:13:36,160 --> 01:13:37,800 THEA BASE, IT'S A PUBLIC USE 2050 01:13:37,800 --> 01:13:42,360 DATABASE, CAN YOU GO ON WEB AND 2051 01:13:42,360 --> 01:13:43,040 GET IT. 2052 01:13:43,040 --> 01:13:44,800 AND YET THERE'S STILL SOME 2053 01:13:44,800 --> 01:13:47,600 SUPPLEMENTS THAT ARE STILL NOT 2054 01:13:47,600 --> 01:13:47,840 IN THERE. 2055 01:13:47,840 --> 01:13:48,640 NEVERTHELESS, LOOKING AT IT 2056 01:13:48,640 --> 01:13:51,440 TELLS A LOT AND I WILL TRY TO 2057 01:13:51,440 --> 01:13:56,080 TALK MORE ABOUT THAT IF YOU WANT 2058 01:13:56,080 --> 01:13:56,400 LATER. 2059 01:13:56,400 --> 01:13:59,800 LET ME JUST GO OVER AND MENTION 2060 01:13:59,800 --> 01:14:03,520 AGAIN, WHY PEOPLE USE 2061 01:14:03,520 --> 01:14:03,840 SUPPLEMENTS. 2062 01:14:03,840 --> 01:14:12,320 REGAN MENTIONED THE LAW AND I 2063 01:14:12,320 --> 01:14:14,400 THINK JAIME DID TOO WHICH IS TO 2064 01:14:14,400 --> 01:14:15,000 SUPPLEMENT THE DIET. 2065 01:14:15,000 --> 01:14:16,880 THERE ARE MANY OTHER REASONS AS 2066 01:14:16,880 --> 01:14:17,120 WELL. 2067 01:14:17,120 --> 01:14:19,200 WE KNOW THIS FROM EVERYTHING 2068 01:14:19,200 --> 01:14:20,360 WE'VE STUDIED HERE IS A PAPER 2069 01:14:20,360 --> 01:14:24,880 THAT REGAN DID AND JAIME WAS ON, 2070 01:14:24,880 --> 01:14:26,600 LOOKING AT SOME OF THE 2071 01:14:26,600 --> 01:14:27,960 MOTIVATIONS FOR USING 2072 01:14:27,960 --> 01:14:29,480 SUPPLEMENTS AND PEOPLE SAID, 2073 01:14:29,480 --> 01:14:30,880 SUPPLEMENT THE DIET BUT THEY 2074 01:14:30,880 --> 01:14:32,520 SAID IT ONLY ABOUT 20% OF THE 2075 01:14:32,520 --> 01:14:33,880 TIME. 2076 01:14:33,880 --> 01:14:35,960 THE MAIN REASONS WERE OTHER 2077 01:14:35,960 --> 01:14:40,760 THINGS LIKE IMPROVING HEALTH AND 2078 01:14:40,760 --> 01:14:42,160 MAINTAINING HEALTH, PREVENTING 2079 01:14:42,160 --> 01:14:43,320 HEALTH PROBLEMS. 2080 01:14:43,320 --> 01:14:44,800 SO HEALTH PROMOTION, MAINTENANCE 2081 01:14:44,800 --> 01:14:46,760 AND PREVENTION ARE COMMON 2082 01:14:46,760 --> 01:14:50,240 MOTIVATIONS FOR SUPPLEMENT USE. 2083 01:14:50,240 --> 01:14:51,560 AND THE MOTIVATIONS ALSO VARY AS 2084 01:14:51,560 --> 01:14:57,200 CAN YOU SEE IN THIS SLIDE, 2085 01:14:57,200 --> 01:14:58,360 DEPENDING ON WHICH SUPPLEMENT 2086 01:14:58,360 --> 01:14:59,040 YOU'RE TALKING ABOUT. 2087 01:14:59,040 --> 01:15:02,080 IF YOU ARE TALKING ABOUT A 2088 01:15:02,080 --> 01:15:02,720 MULTIVITAMIN MINERAL SUPPLEMENT 2089 01:15:02,720 --> 01:15:03,680 DOWN AT THE BOTTOM OF THIS 2090 01:15:03,680 --> 01:15:05,480 SLIDE, CAN YOU SEE THAT ABOUT 2091 01:15:05,480 --> 01:15:08,960 HALF OF ALL PEOPLE GAVE THAT AS 2092 01:15:08,960 --> 01:15:11,400 THEIR FIRST REASON FOR USING 2093 01:15:11,400 --> 01:15:12,520 SUPPLEMENTS, WHEREAS FOR 2094 01:15:12,520 --> 01:15:15,280 BOTANICALS IT WAS ONLY ABOUT 25% 2095 01:15:15,280 --> 01:15:17,720 AND IT VARIED WITH OTHER 2096 01:15:17,720 --> 01:15:20,120 VITAMINS AND MINERAL 2097 01:15:20,120 --> 01:15:21,840 COMBINATIONS WITH RESPECT TO HOW 2098 01:15:21,840 --> 01:15:25,360 COMMON THIS WAS AS A REASON. 2099 01:15:25,360 --> 01:15:28,720 WHEN WE GO TO NONVITAMIN, 2100 01:15:28,720 --> 01:15:32,080 NONMINERAL SUPPLEMENTS, THINGS 2101 01:15:32,080 --> 01:15:33,200 LIKE MELATONIN, COQ10, THINGS 2102 01:15:33,200 --> 01:15:37,240 LIKE THAT, WELLNESS REASONS 2103 01:15:37,240 --> 01:15:39,200 CONTINUE TO BE A MAIN REASON, 2104 01:15:39,200 --> 01:15:43,560 BUT THEN AGAIN THERE'S THIS 2105 01:15:43,560 --> 01:15:45,000 SMALL SUBGROUP BUT NEVERTHELESS 2106 01:15:45,000 --> 01:15:46,600 A BIG SUBGROUP WHICH IT COMES TO 2107 01:15:46,600 --> 01:15:47,960 THE NUMBER OF AMERICANS WHO ARE 2108 01:15:47,960 --> 01:15:49,800 USING IT TO TREAT A CONDITION 2109 01:15:49,800 --> 01:15:53,600 AND PARTICULARLY FOR THE 2110 01:15:53,600 --> 01:15:54,080 NONVITAMIN NONMINERAL 2111 01:15:54,080 --> 01:15:56,880 SUPPLEMENTS THIS SEEMS TO BE AN 2112 01:15:56,880 --> 01:15:57,240 ISSUE. 2113 01:15:57,240 --> 01:15:59,040 SO ALTHOUGH MOST SUPPLEMENTS ARE 2114 01:15:59,040 --> 01:16:00,880 BEING USED FOR WELLNESS, NOT 2115 01:16:00,880 --> 01:16:01,720 DISEASE TREATMENT, THERE IS A 2116 01:16:01,720 --> 01:16:04,400 GROUP THAT ARE USING THEM FOR 2117 01:16:04,400 --> 01:16:07,000 THIS PURPOSE. 2118 01:16:07,000 --> 01:16:08,200 SO THE MOTIVATIONS VARY ALL OVER 2119 01:16:08,200 --> 01:16:11,080 THE MAP AND I WOULD LIKE TO 2120 01:16:11,080 --> 01:16:14,480 SPEND A LITTLE MORE TIME ON THE 2121 01:16:14,480 --> 01:16:15,760 CONDITION SPECIFIC, THAT IS 2122 01:16:15,760 --> 01:16:17,760 THOSE THOSE THAT ARE USED OR 2123 01:16:17,760 --> 01:16:18,800 ASSOCIATED WITH ILLNESS OR 2124 01:16:18,800 --> 01:16:21,640 DISEASE BECAUSE I THINK THIS IS 2125 01:16:21,640 --> 01:16:23,800 VERY IMPORTANT TO RESEARCH 2126 01:16:23,800 --> 01:16:24,360 FURTHER. 2127 01:16:24,360 --> 01:16:27,200 NOW, WHAT WE CALL DISEASE OR 2128 01:16:27,200 --> 01:16:28,960 CONDITION SPECIFIC REASONS FOR 2129 01:16:28,960 --> 01:16:32,680 USE, HAVE TO DO WITH SOME 2130 01:16:32,680 --> 01:16:36,040 CONDITION, WHETHER IT'S OBESITY, 2131 01:16:36,040 --> 01:16:39,280 OR COPD, OR KIDNEY DISEASE, 2132 01:16:39,280 --> 01:16:41,520 WHATEVER IT MIGHT BE, SOME 2133 01:16:41,520 --> 01:16:43,680 DISEASE OR ILLNESS OR CONDITION. 2134 01:16:43,680 --> 01:16:45,240 WHY DO PEOPLE DO THIS, WELL, 2135 01:16:45,240 --> 01:16:47,680 PART OF IT, I THINK COMES 2136 01:16:47,680 --> 01:16:48,960 BECAUSE SUPPLEMENTS ARE VIEWED 2137 01:16:48,960 --> 01:16:50,680 BY MANY, MANY PEOPLE IN THE 2138 01:16:50,680 --> 01:16:54,160 UNITED STATES, IT'S HARMLESS AND 2139 01:16:54,160 --> 01:16:56,680 OVERLOOKED, AND POWERFUL 2140 01:16:56,680 --> 01:16:58,240 EFFECTIVE TREATMENTS, PEOPLE 2141 01:16:58,240 --> 01:17:01,000 TURN TO SUPPLEMENTS, IF OTHER 2142 01:17:01,000 --> 01:17:02,840 PEOPLE AREN'T CURED OR THEY'RE 2143 01:17:02,840 --> 01:17:06,080 INEFFECTIVE FOR EXAMPLE IN THE 2144 01:17:06,080 --> 01:17:07,240 EARLY--LATE 80S AND EARLY 90S, 2145 01:17:07,240 --> 01:17:12,400 WE DID A LOT OF STUDIES UP AT 2146 01:17:12,400 --> 01:17:13,680 TUFTs, AND TUFTs MEDICAL 2147 01:17:13,680 --> 01:17:17,160 CENTER ON HIV PATIENTS, HIV/AIDS 2148 01:17:17,160 --> 01:17:19,800 IN THOSE DAYS BEFORE PROTEASE 2149 01:17:19,800 --> 01:17:21,840 INHIBITORS, MANY, MANY OF THESE 2150 01:17:21,840 --> 01:17:25,360 PATIENTS WERE TAKING BOTANICALS, 2151 01:17:25,360 --> 01:17:27,040 PARTICULARLY ST. JOHNS WART FOR 2152 01:17:27,040 --> 01:17:32,200 DEPRESSION, THEY WERE VERY 2153 01:17:32,200 --> 01:17:33,160 MUCH--THEY WERE TAKING THEM 2154 01:17:33,160 --> 01:17:35,200 BECAUSE THERE WAS NO EFFECTIVE 2155 01:17:35,200 --> 01:17:39,240 TREATMENT AS THE AIDS ADVANCED. 2156 01:17:39,240 --> 01:17:41,920 ADVANCED CANCERS IS ANOTHER 2157 01:17:41,920 --> 01:17:43,320 COMMON CONDITION WHERE PEOPLE 2158 01:17:43,320 --> 01:17:44,480 AREN'T FINDING ANY TREATMENT 2159 01:17:44,480 --> 01:17:46,120 THAT'S HELPFUL AND THEY TURN TO 2160 01:17:46,120 --> 01:17:47,560 SUPPLEMENTS AS A LAST RESORT. 2161 01:17:47,560 --> 01:17:50,080 AND THEN THERE ARE PEOPLE WHO 2162 01:17:50,080 --> 01:17:53,200 FOR A VARIETY OF REASONS, REGAN 2163 01:17:53,200 --> 01:17:54,280 MENTIONED FINANCIAL, BUT THERE 2164 01:17:54,280 --> 01:17:56,560 ARE ALSO PERSONAL REASONS AND 2165 01:17:56,560 --> 01:17:59,760 OTHER REASONS BUT PEOPLE ARE 2166 01:17:59,760 --> 01:18:00,480 USING FOR SELF-TREATMENT. 2167 01:18:00,480 --> 01:18:02,200 SO FOR ALL THESE REASONS, THEY 2168 01:18:02,200 --> 01:18:04,800 MAY BE USING A CONDITION 2169 01:18:04,800 --> 01:18:06,800 SPECIFIC SUPPLEMENT. 2170 01:18:06,800 --> 01:18:09,000 AND REGAN AND JAMIE DID SOME 2171 01:18:09,000 --> 01:18:10,600 INTERESTING WORK ON MOTIVATIONS 2172 01:18:10,600 --> 01:18:14,040 FOR THESE CONDITION SPECIFIC 2173 01:18:14,040 --> 01:18:14,440 SUPPLEMENTS. 2174 01:18:14,440 --> 01:18:20,080 AGAIN, WITH HANES, THIS IS HANES 2175 01:18:20,080 --> 01:18:22,160 27 HPV 10 IN ADULTS, WHAT YOU 2176 01:18:22,160 --> 01:18:25,760 SEE HERE IS A NUMBER OF THE 2177 01:18:25,760 --> 01:18:27,280 SUPPLEMENTS FOR INSTANCE, IMMUNE 2178 01:18:27,280 --> 01:18:28,800 WHICH IS PURPLE, IT WAS VITAMIN 2179 01:18:28,800 --> 01:18:33,160 C THAT SEEMED TO BE THE 2180 01:18:33,160 --> 01:18:33,440 FAVORITE. 2181 01:18:33,440 --> 01:18:35,440 OR HEART HEALTH IT SEEMED TO BE 2182 01:18:35,440 --> 01:18:37,200 THE OMEGA 3s WHICH YOU 2183 01:18:37,200 --> 01:18:38,600 WOULDN'T BE SURPRISED ABOUT AND 2184 01:18:38,600 --> 01:18:40,360 THEN FOR CALCIUM AND VITAMIN D, 2185 01:18:40,360 --> 01:18:41,760 IT WAS BONE HEALTH. 2186 01:18:41,760 --> 01:18:45,560 IN A SENSE THESE SORT OF MARKETS 2187 01:18:45,560 --> 01:18:47,320 OR MOTIVATIONS ARE THE SAME AS 2188 01:18:47,320 --> 01:18:48,640 THE MARKETING CLAIMS AND SO THE 2189 01:18:48,640 --> 01:18:51,480 QUESTION IS WHICH COMES FIRST, 2190 01:18:51,480 --> 01:18:54,120 IS IT THE MARKETING CLAIM OR THE 2191 01:18:54,120 --> 01:18:54,480 MOTIVATION. 2192 01:18:54,480 --> 01:18:58,520 WELL, I THINK ALL OF THIS SHOWS 2193 01:18:58,520 --> 01:18:59,960 THAT CONSUMERS SEE SUPPLEMENTS 2194 01:18:59,960 --> 01:19:01,880 AS SAFE AND EFFECTIVE BECAUSE 2195 01:19:01,880 --> 01:19:03,040 THEY THINK THEY'RE APPROVED BY 2196 01:19:03,040 --> 01:19:06,000 THE GOVERNMENT BECAUSE THEY 2197 01:19:06,000 --> 01:19:07,520 THINK THEY'RE TESTED FOR SAFETY 2198 01:19:07,520 --> 01:19:08,920 AND EFFECTIVENESS AND THAT 2199 01:19:08,920 --> 01:19:10,800 THEY'RE ANALYZED FOR THEIR 2200 01:19:10,800 --> 01:19:11,920 CONTENTS BY SOMEBODY, PROBABLY 2201 01:19:11,920 --> 01:19:15,120 THE GOVERNMENT AND THEN, THE 2202 01:19:15,120 --> 01:19:17,320 PRODUCERS ARE REQUIRED TO 2203 01:19:17,320 --> 01:19:21,040 DISCLOSE KNOWN ADVERSE EFFECTS 2204 01:19:21,040 --> 01:19:22,680 TO CONSUMERS AND WHILE SOME OF 2205 01:19:22,680 --> 01:19:23,880 THIS IS TRUE, IT'S NOT 2206 01:19:23,880 --> 01:19:25,680 NECESSARILY TRUE THAT ALL OF 2207 01:19:25,680 --> 01:19:30,400 THOSE THINGS ARE PRESENT. 2208 01:19:30,400 --> 01:19:34,240 SO THOSE ARE THE MOTIVATING 2209 01:19:34,240 --> 01:19:35,200 INFLUENZS, REGAN MENTIONED THE 2210 01:19:35,200 --> 01:19:39,360 WHOLE ISSUE OF AUTHORITY WITH 2211 01:19:39,360 --> 01:19:41,680 RESPECT TO PRENATALS AND HOW 2212 01:19:41,680 --> 01:19:43,520 VERY OFTEN A DOCTOR WOULD 2213 01:19:43,520 --> 01:19:44,720 PRESCRIBE A PRENATAL BUT THERE 2214 01:19:44,720 --> 01:19:47,120 ARE ALSO TRUSTED SOURCES, 2215 01:19:47,120 --> 01:19:48,920 SOMETIMES IT'S A WIFE OR PARENT 2216 01:19:48,920 --> 01:19:50,240 OR FRIEND OR ROLE MODEL. 2217 01:19:50,240 --> 01:19:52,760 THERE ARE ALSO PEOPLE WHO ON 2218 01:19:52,760 --> 01:19:55,640 THEIR OWN WANT TO LOOK BETTER, 2219 01:19:55,640 --> 01:19:58,280 WEIGH LESS WHARKS HAVE YOU. 2220 01:19:58,280 --> 01:19:59,280 WELL THEY HAVE DIFFERENT WORLD 2221 01:19:59,280 --> 01:20:01,280 VIEW AND THAT'S WHAT WE FOUND 2222 01:20:01,280 --> 01:20:03,080 WITH SOME PEOPLE WHO WERE VERY 2223 01:20:03,080 --> 01:20:06,800 HIGH USERS OF HERBALS AND 2224 01:20:06,800 --> 01:20:08,280 BOTANICALS AND NONVITAMIN 2225 01:20:08,280 --> 01:20:10,600 NONMINERAL SUPPLEMENTS IT WAS 2226 01:20:10,600 --> 01:20:13,120 PART OF A WHOLE LIFESTYLE AND 2227 01:20:13,120 --> 01:20:13,960 THERE'S FINALLY ADVERTISING, LET 2228 01:20:13,960 --> 01:20:16,360 ME TOUCH ON A FEW OF THEM IN A 2229 01:20:16,360 --> 01:20:18,480 BIT MORE DEPTH BEFORE WE WIND UP 2230 01:20:18,480 --> 01:20:20,520 AND HAVE LUNCH. 2231 01:20:20,520 --> 01:20:23,800 FIRST OF ALL, IT'S USED BASED ON 2232 01:20:23,800 --> 01:20:24,840 AUTHORITATIVE ADVICE. 2233 01:20:24,840 --> 01:20:26,440 WE TALKED ABOUT PRENATALS ABOUT 2234 01:20:26,440 --> 01:20:28,640 YOU WHO PEOPLE REGARD AS 2235 01:20:28,640 --> 01:20:31,640 AUTHORITIES, AND WHAT THEY 2236 01:20:31,640 --> 01:20:32,840 CONSIDER EVIDENCE, VARIES A LOT. 2237 01:20:32,840 --> 01:20:35,040 SOMETIMES IT'S THE DOCTOR, BUT 2238 01:20:35,040 --> 01:20:37,440 SOMETIMES IT'S A COACH OR 2239 01:20:37,440 --> 01:20:40,840 TRAINER, AND THE QUESTION IS 2240 01:20:40,840 --> 01:20:42,200 WHETHER THE AMOUNT OF EVIDENCE 2241 01:20:42,200 --> 01:20:43,760 THEY'RE USE NOTHING ALL OF THOSE 2242 01:20:43,760 --> 01:20:48,200 CASES IS EXACTLY THE SAME. 2243 01:20:48,200 --> 01:20:50,920 NOW TONY FAUCI, DR. FAUCI AT 2244 01:20:50,920 --> 01:20:53,560 NIH, WE ARE VERY PROUD OF HIM, 2245 01:20:53,560 --> 01:20:54,840 SOME PEOPLE SAY HE'S THE BEST 2246 01:20:54,840 --> 01:20:56,040 KNOWN PHYSICIAN IN AMERICA, I'M 2247 01:20:56,040 --> 01:20:58,160 NOT SURE THAT'S RIGHT, I THINK 2248 01:20:58,160 --> 01:21:03,440 DR. GOOGLE IS EVEN MORE FAMOUS 2249 01:21:03,440 --> 01:21:05,480 THAN DR. FAUCI, AND THIS A PAPER 2250 01:21:05,480 --> 01:21:07,280 FROM A FEW YEARS AGO, SAYING 2251 01:21:07,280 --> 01:21:09,120 DR. GOOGLE WAS THE KEY 2252 01:21:09,120 --> 01:21:10,480 CONSULTANT FOR THE MAIORITY OF 2253 01:21:10,480 --> 01:21:13,240 CANCER PATIENTS AND I HAD A 2254 01:21:13,240 --> 01:21:15,920 COUPLE OF WONDERFUL STUDENTS UP 2255 01:21:15,920 --> 01:21:18,640 AT TUFTs MEDICAL CENTER AND WE 2256 01:21:18,640 --> 01:21:19,800 GOT INTEREST IN THIS. 2257 01:21:19,800 --> 01:21:21,760 SO WE DECIDE WE WOULD USE A WEB 2258 01:21:21,760 --> 01:21:23,360 BASEDDA, PROACH TO LOOKING AT 2259 01:21:23,360 --> 01:21:27,000 MOTIVATION TO ASK A QUESTION 2260 01:21:27,000 --> 01:21:28,800 LIKE SUPPLEMENTS AND CANCER, IF 2261 01:21:28,800 --> 01:21:30,280 YOU ARE DIAGNOSED WITH CANCER, 2262 01:21:30,280 --> 01:21:32,480 THE FIRST THING YOU TEND T DO 2263 01:21:32,480 --> 01:21:35,200 IS TO GO TO THE WEB AND TAKE A 2264 01:21:35,200 --> 01:21:37,640 LOOK ANDEE WHAT IT SAYS THERE. 2265 01:21:37,640 --> 01:21:40,280 AND SO, THE IDEA OF THIS WAS 2266 01:21:40,280 --> 01:21:42,840 THAT IT MORE OR LESS MIMICS SOME 2267 01:21:42,840 --> 01:21:44,120 PEOPLE'S BEHAVIOR WHEN THEY'RE 2268 01:21:44,120 --> 01:21:46,160 TRYING TO SEEK HELP AND GET 2269 01:21:46,160 --> 01:21:47,800 INFORMATION AND IT PROVIDES A 2270 01:21:47,800 --> 01:21:49,120 GLIMPSE OF WHAT'S OUT THERE. 2271 01:21:49,120 --> 01:21:51,880 IT'S NOT THE SAME AS WEBMD, 2272 01:21:51,880 --> 01:21:53,600 BECAUSE THAT'S NOT AVAILABLE TO 2273 01:21:53,600 --> 01:21:54,920 THE AVERAGE PERSON BUT A GOOGLE 2274 01:21:54,920 --> 01:21:58,400 SEARCH IS AVAILABLE TO MOST 2275 01:21:58,400 --> 01:22:02,400 EVERYBODY AND GOOGLE HAS A VAST 2276 01:22:02,400 --> 01:22:04,120 MAJORITY OF THE SEARCH ENGINE 2277 01:22:04,120 --> 01:22:07,080 USE IN THE COUNTRY AND PROBABLY 2278 01:22:07,080 --> 01:22:07,360 THE WORLD. 2279 01:22:07,360 --> 01:22:09,800 THE PROBLEM WITH THIS APPROACH 2280 01:22:09,800 --> 01:22:12,240 BEFORE GOING TO IT IS YOU CAN 2281 01:22:12,240 --> 01:22:13,280 ONLY MAKE INFERENCES AND WHAT 2282 01:22:13,280 --> 01:22:17,640 YOU GET IS A MIX OFADS AND 2283 01:22:17,640 --> 01:22:18,440 RESULTS PAGES WITH INFORMATION 2284 01:22:18,440 --> 01:22:21,760 ON THEM AND IT'S CALLITATIVE AND 2285 01:22:21,760 --> 01:22:23,520 SUBJECTIVE AND INTERPRETATION IS 2286 01:22:23,520 --> 01:22:24,920 HIGHY UBIQUITIN JECTIVE SO WITH 2287 01:22:24,920 --> 01:22:26,360 ALL THOSE CAVEATS, LET ME SHOW 2288 01:22:26,360 --> 01:22:27,560 WHAT YOU WE FOUND. 2289 01:22:27,560 --> 01:22:32,000 WE ASKED DR. GOOGLE, JUST TYPED 2290 01:22:32,000 --> 01:22:34,880 IN THE SEARCH TERM SUPPLEMENTS 2291 01:22:34,880 --> 01:22:36,840 AND CANCER AND WHAT 2292 01:22:36,840 --> 01:22:37,440 [INDISCERNIBLE] WHO WAS FIRST 2293 01:22:37,440 --> 01:22:40,760 AUTHOR ON THIS PROBLEM AND 2294 01:22:40,760 --> 01:22:43,360 [INDISCERNIBLE], WE CAME UP WITH 2295 01:22:43,360 --> 01:22:49,160 A TOTAL OF SOME 496 ADS AND 2296 01:22:49,160 --> 01:22:51,640 ABOUT 160 CONTENT PAGES SO THE 2297 01:22:51,640 --> 01:22:53,360 OVERWHELMING MAJORITY WERE THE 2298 01:22:53,360 --> 01:22:55,320 ADS, NOT THE CONTENT. 2299 01:22:55,320 --> 01:22:58,200 AND LET ME JUST BEFORE I SHOW 2300 01:22:58,200 --> 01:23:02,360 YOU THE RESULTS, MENTION THAT 2301 01:23:02,360 --> 01:23:03,720 THE DIETARY SUPPLEMENTS, ADS 2302 01:23:03,720 --> 01:23:07,040 THAT CAME UP DIDN'T REALLY HAVE 2303 01:23:07,040 --> 01:23:09,480 ILLEGAL CLAIMS ON THE LABEL, BUT 2304 01:23:09,480 --> 01:23:11,240 WHEN YOU TYPED IN SEARCH ENGINE 2305 01:23:11,240 --> 01:23:12,760 TERMS AND I WILL SHOW YOU THE 2306 01:23:12,760 --> 01:23:15,840 TERMS WEB CONNECTED TYPED IN, 2307 01:23:15,840 --> 01:23:20,800 YOU DID GET A DISPLAY OF ADS FOR 2308 01:23:20,800 --> 01:23:22,480 SPECIFIC SUPPLEMENTS SO IT WAS A 2309 01:23:22,480 --> 01:23:23,320 LITTLE SUBTLE. 2310 01:23:23,320 --> 01:23:25,400 NOW REMEMBER THAT A STRUCTURED 2311 01:23:25,400 --> 01:23:28,640 FUNCTION CLAIMS TO HELP MAINTAIN 2312 01:23:28,640 --> 01:23:30,480 OR SUPPORT THE BODY ARE LEGAL 2313 01:23:30,480 --> 01:23:32,160 AND SUPPLEMENTS, CAN YOU SAY 2314 01:23:32,160 --> 01:23:34,720 IMMUNE HEALTH, BUT YOU CAN'T SAY 2315 01:23:34,720 --> 01:23:36,440 IMMUNO DEFICIENCY AND YOU CAN'T 2316 01:23:36,440 --> 01:23:36,760 SAY CANCER. 2317 01:23:36,760 --> 01:23:43,680 BUT YOU CAN CLAIM TO DIAGNOSE, 2318 01:23:43,680 --> 01:23:45,080 TREAT OR PREVENT CANCER, YOU 2319 01:23:45,080 --> 01:23:46,640 CAN'T SAY TREATS OR PREVENTS 2320 01:23:46,640 --> 01:23:47,360 CANCER ON THE LABEL. 2321 01:23:47,360 --> 01:23:51,240 SO LET ME SHOW YOU WHAT THE 2322 01:23:51,240 --> 01:23:51,520 SEARCH DID. 2323 01:23:51,520 --> 01:23:53,000 PART OF THIS WAS THE PAPER AND 2324 01:23:53,000 --> 01:23:54,600 PART WAS THAT I DID LATER. 2325 01:23:54,600 --> 01:23:58,120 IF YOU SEARCH THE TERM 2326 01:23:58,120 --> 01:23:59,320 SUPPLEMENTS AND CANCER, WHAT YOU 2327 01:23:59,320 --> 01:24:01,440 COME UP WITH IS A LOT OF ADS, SO 2328 01:24:01,440 --> 01:24:06,920 LOOK AT THE PRICES ON SOME OF 2329 01:24:06,920 --> 01:24:09,600 THESE, 1 IS $650; IF YOU TYPE IN 2330 01:24:09,600 --> 01:24:11,880 SUPPLEMENTS TO PREVENT CANCER, 2331 01:24:11,880 --> 01:24:15,360 AGAIN, A WHOLE BUNCH OF THINGS 2332 01:24:15,360 --> 01:24:16,880 COME UP, IT'S NOT ON A LABEL BUT 2333 01:24:16,880 --> 01:24:18,200 IT COMES UP IN THE SEARCH. 2334 01:24:18,200 --> 01:24:21,440 IF YOU LOOK AT SUPPLEMENTS TO 2335 01:24:21,440 --> 01:24:23,120 TREAT CANCER, AGAIN, MANY 2336 01:24:23,120 --> 01:24:24,560 PRODUCTS COME UP. 2337 01:24:24,560 --> 01:24:26,520 AND SUPPLEMENTS TO SUPPORT 2338 01:24:26,520 --> 01:24:29,920 CANCER TREATMENT, AGAIN, A LOT 2339 01:24:29,920 --> 01:24:32,760 OF DIFFERENT SUPPLEMENTS COME UP 2340 01:24:32,760 --> 01:24:33,240 AGAIN. 2341 01:24:33,240 --> 01:24:35,520 IF YOU TYPE IN SUPPLEMENTS TO 2342 01:24:35,520 --> 01:24:37,320 CURE CANCER WHICH IS CLEARLY 2343 01:24:37,320 --> 01:24:38,640 ILLEGAL, NOTHING COMES UP SO 2344 01:24:38,640 --> 01:24:41,160 PEOPLE ARE A LITTLE HERE LEERY I 2345 01:24:41,160 --> 01:24:42,440 THINK OF ADVERTISING THAT 2346 01:24:42,440 --> 01:24:43,800 SOMETHING CURES CANCER BECAUSE 2347 01:24:43,800 --> 01:24:45,800 THEY KNOW THE FDA'S GOING TO 2348 01:24:45,800 --> 01:24:47,800 COME AFTER THEM OR FDC WILL COME 2349 01:24:47,800 --> 01:24:49,600 AFTER THAT. 2350 01:24:49,600 --> 01:24:52,280 OKAY, BACK TO THE STUDY THOUGH, 2351 01:24:52,280 --> 01:24:54,320 WHEN WE ASKED DR. GOOGLE IN 2352 01:24:54,320 --> 01:24:56,240 ADDITION TO THOSE HALF THOUSAND 2353 01:24:56,240 --> 01:24:58,880 ADS THAT WE FOUND, WE ALSO FOUND 2354 01:24:58,880 --> 01:25:00,960 ABOUT 160 CONTENT OR RESEARCH 2355 01:25:00,960 --> 01:25:06,360 RESULTS BEIGES AND WE--WE TRIED 2356 01:25:06,360 --> 01:25:09,920 TO RATE THEM IN TERMS OF THEIR 2357 01:25:09,920 --> 01:25:11,880 AUTHORITATIVENESS OR IN TERMS OF 2358 01:25:11,880 --> 01:25:13,480 THEIR HEALTH INFORMATION THAT 2359 01:25:13,480 --> 01:25:14,120 THEY CONTAIN. 2360 01:25:14,120 --> 01:25:16,160 AND WHAT WE FOUND IS THAT OHM 2361 01:25:16,160 --> 01:25:20,280 25% OF THEM, THAT ARE CIRCLED ON 2362 01:25:20,280 --> 01:25:22,240 THIS SLIDE REALLY SCORED HIGH IN 2363 01:25:22,240 --> 01:25:24,520 TERMS OF THE HEALTH INFORMATION 2364 01:25:24,520 --> 01:25:28,440 INDEX CRITERIA THAT WE USED. 2365 01:25:28,440 --> 01:25:30,040 TWENTY-FIVE% WERE HIGH QUALITY, 2366 01:25:30,040 --> 01:25:31,880 BUT EVEN THOSE WERE NOT EASY TO 2367 01:25:31,880 --> 01:25:34,760 COME UP WITH ON THE SEARCH, THEY 2368 01:25:34,760 --> 01:25:38,040 CAME UP LATER IN THE SEARCH 2369 01:25:38,040 --> 01:25:39,000 RATHER THAN EARLY AND OFTEN 2370 01:25:39,000 --> 01:25:40,320 THOSE THAT DID COME UP EVEN 2371 01:25:40,320 --> 01:25:42,160 THOUGH THEY WERE VERY HIGHLY 2372 01:25:42,160 --> 01:25:45,240 REPUTABLE GROUPS LIKE THE 2373 01:25:45,240 --> 01:25:46,760 NATIONAL CANCER INSTITUTE, VERY 2374 01:25:46,760 --> 01:25:49,240 OFTEN THEY WEREN'T EASILY 2375 01:25:49,240 --> 01:25:51,200 READABLE BY SOMEONE WITH AN 2376 01:25:51,200 --> 01:25:52,240 EIGHTH GRADE READING ABILITY. 2377 01:25:52,240 --> 01:25:55,160 SO THERE ARE STILL PROBLEMS IN 2378 01:25:55,160 --> 01:25:56,280 TERMS OF THE QUALITY. 2379 01:25:56,280 --> 01:25:58,760 AND THEN I SAW THIS IN A 2380 01:25:58,760 --> 01:26:00,440 DOCTOR'S OFFICE, PLEASE DON'T 2381 01:26:00,440 --> 01:26:04,480 CONFUSE YOUR GOOGLE SEARCH WITH 2382 01:26:04,480 --> 01:26:04,880 MY MANAGE DEGREE. 2383 01:26:04,880 --> 01:26:07,280 BACK TO SOME THEORIES THAT HAVE 2384 01:26:07,280 --> 01:26:08,840 BEEN ADVANCED BY SOCIAL STOF 2385 01:26:08,840 --> 01:26:12,640 THEDS TO EXPLAIN MOTIVATION, 2386 01:26:12,640 --> 01:26:15,480 THERE'S THE ADVERTISING AND 2387 01:26:15,480 --> 01:26:16,320 MARKETING, MEDICAL 2388 01:26:16,320 --> 01:26:17,000 SELF-TREATMENT, INSURANCE POLICY 2389 01:26:17,000 --> 01:26:18,960 SORT OF IDEAS AND LICENSING, LET 2390 01:26:18,960 --> 01:26:21,880 ME JUST RUN THROUGH THEM 2391 01:26:21,880 --> 01:26:22,120 QUICKLY. 2392 01:26:22,120 --> 01:26:23,960 AVERAGE, AS WE ALREADY TALKED 2393 01:26:23,960 --> 01:26:26,360 ABOUT IS COMMERCIAL SPEECH TO 2394 01:26:26,360 --> 01:26:28,200 SELL OR PERSUADE CONSUMERS, I 2395 01:26:28,200 --> 01:26:29,400 THINK IS SOMETHING WE NEED TO 2396 01:26:29,400 --> 01:26:31,880 STUDY A LOT MORE ABOUT. 2397 01:26:31,880 --> 01:26:34,560 THE IDEA HERE IS YOU NOTICE THE 2398 01:26:34,560 --> 01:26:36,440 AD, YOU UNDERSTAND WHAT IT'S 2399 01:26:36,440 --> 01:26:38,080 SAYING AS IN SOME OF THE ADS 2400 01:26:38,080 --> 01:26:39,920 I'VE JUST SHOWN YOU, YOU 2401 01:26:39,920 --> 01:26:43,840 CONCLUDE WELL THAT MAYBE THEY DO 2402 01:26:43,840 --> 01:26:44,920 SUPPORT CANCER TREATMENT, RETAIN 2403 01:26:44,920 --> 01:26:46,160 THAT BELIEF AND THEN YOU GO 2404 01:26:46,160 --> 01:26:48,280 AHEAD AND BUY THE SUPPLEMENT. 2405 01:26:48,280 --> 01:26:49,520 THIS IS ALL DETAILED FOR THOSE 2406 01:26:49,520 --> 01:26:53,200 WHO WANT TO DO FURTHER READING 2407 01:26:53,200 --> 01:26:59,600 ON IT IN THIS PARTICULAR BOOK. 2408 01:26:59,600 --> 01:27:01,720 LET ME ALSO MENTION A BIT MORE 2409 01:27:01,720 --> 01:27:02,200 ABOUT SELF-MEDICATION. 2410 01:27:02,200 --> 01:27:03,640 I THINK THERE ARE MANY REASONS 2411 01:27:03,640 --> 01:27:05,800 FOR THIS, THERE'S CERTAINLY A 2412 01:27:05,800 --> 01:27:06,600 PREFERENCE FOR SELF-MEDICATION, 2413 01:27:06,600 --> 01:27:09,360 I THINK WE ALL LIKE TO AVOID 2414 01:27:09,360 --> 01:27:10,560 GOING TO A HOSPITAL, 2415 01:27:10,560 --> 01:27:15,960 PARTICULARLY IN THESE DAYS OF 2416 01:27:15,960 --> 01:27:16,560 COVID. 2417 01:27:16,560 --> 01:27:17,280 OTHERS DISTRUST MEDICAL 2418 01:27:17,280 --> 01:27:19,240 CONVENTIONAL MEDICINE AND FEEL 2419 01:27:19,240 --> 01:27:22,840 THAT SELF-MEDICATION IS A BETTER 2420 01:27:22,840 --> 01:27:23,040 IDEA. 2421 01:27:23,040 --> 01:27:24,240 I'VE ALREADY TALKED ABOUT 2422 01:27:24,240 --> 01:27:25,800 DESPAIR DUE TO FAILED 2423 01:27:25,800 --> 01:27:26,960 CONVENTIONAL TREATMENTS, I KNOW 2424 01:27:26,960 --> 01:27:28,960 MY OWN BROTHER WHEN HE WAS DYING 2425 01:27:28,960 --> 01:27:33,960 OF COLON CANCER, HIS WIFE WAS 2426 01:27:33,960 --> 01:27:34,800 CONVINCED THAT SHARK CARTILAGE 2427 01:27:34,800 --> 01:27:36,760 WAS THE WAY TO GO AND HE DID NOT 2428 01:27:36,760 --> 01:27:38,400 TAKE IT BUT HE THROUGH IT DOWN 2429 01:27:38,400 --> 01:27:39,480 THE TOILET, BUT SHE WAS TRYING 2430 01:27:39,480 --> 01:27:43,040 TO GET HIM TO TAKE IT. 2431 01:27:43,040 --> 01:27:45,240 THERE'S A RELUCTANCE TO REVEAL A 2432 01:27:45,240 --> 01:27:46,280 HEALTH PROBLEM IN SOME CASES 2433 01:27:46,280 --> 01:27:49,280 THAT LEADS TO SELF-MEDICATION, 2434 01:27:49,280 --> 01:27:53,120 FOR EXAMPLE, USING GINGO-BILOBA, 2435 01:27:53,120 --> 01:27:54,880 IF YOU'RE AN OLDER PERSON WHO 2436 01:27:54,880 --> 01:27:56,720 BEGINS TO SEE THEIR MEMORY SLIP, 2437 01:27:56,720 --> 01:27:58,840 PEOPLE WITH PROBLEMS WITH SEXUAL 2438 01:27:58,840 --> 01:28:01,000 PERFORMANCE, PEOPLE WHO ARE 2439 01:28:01,000 --> 01:28:03,680 TRYING TO GET RID OF A HANG OVER 2440 01:28:03,680 --> 01:28:05,760 OR PEOPLE WHO ARE TRYING TO GET 2441 01:28:05,760 --> 01:28:06,840 RID OF AN ADDICTION. 2442 01:28:06,840 --> 01:28:08,520 AND THEN THERE'S THE WHOLE ISSUE 2443 01:28:08,520 --> 01:28:12,880 OF LACK OF MONEY FOR 2444 01:28:12,880 --> 01:28:13,720 CONVENTIONAL MEDICINE, THERAPIES 2445 01:28:13,720 --> 01:28:19,280 AND PARTICULARLY WITH PEOPLE WHO 2446 01:28:19,280 --> 01:28:21,080 LACK MONEY FOR ANTIPSYCHOTICS, 2447 01:28:21,080 --> 01:28:23,120 FOR EXAMPLE, THEY MAY GO TO 2448 01:28:23,120 --> 01:28:23,720 SUPPLEMENTS. 2449 01:28:23,720 --> 01:28:25,360 NOW LET ME JUST MENTION THE 2450 01:28:25,360 --> 01:28:27,200 BUSINESS AGAIN OF, I TALKED 2451 01:28:27,200 --> 01:28:29,120 ABOUT DESPAIR DUE TO FAILED 2452 01:28:29,120 --> 01:28:30,360 CONVENTIONAL TREATMENTS AND 2453 01:28:30,360 --> 01:28:32,920 JAMIE SHOWED THESE DATA BUT LOOK 2454 01:28:32,920 --> 01:28:37,000 AT THIS, THIS UPTICK DURING 2020 2455 01:28:37,000 --> 01:28:39,560 OF HERBAL AND BOTANICAL 2456 01:28:39,560 --> 01:28:39,960 SUPPLEMENT SALES. 2457 01:28:39,960 --> 01:28:41,320 IT WENT WAY UP AND I THINK PART 2458 01:28:41,320 --> 01:28:45,920 OF THAT MAY HAVE BEEN A COVID 2459 01:28:45,920 --> 01:28:46,160 EFFECT. 2460 01:28:46,160 --> 01:28:47,400 PEOPLE DIDN'T KNOW WHAT TO DO SO 2461 01:28:47,400 --> 01:28:50,160 THEY SAID I WILL TAKE SOME 2462 01:28:50,160 --> 01:28:51,680 HERBALS OR BOTANICALS OR MAYBE I 2463 01:28:51,680 --> 01:28:52,880 WILL TAKE VITA MINE D BECAUSE 2464 01:28:52,880 --> 01:28:55,120 MAYBE WILL BE GOOD FOR THAT 2465 01:28:55,120 --> 01:28:57,920 FUNNY PNEUMONIA THAT PEOPLE WERE 2466 01:28:57,920 --> 01:28:58,280 GETTING. 2467 01:28:58,280 --> 01:29:00,480 IN TERMS OF IDEAS TO COVER ALL 2468 01:29:00,480 --> 01:29:01,720 THE BASES JUST IN CASE AND I 2469 01:29:01,720 --> 01:29:03,520 THINK A LOT OF PEOPLE TOOK 2470 01:29:03,520 --> 01:29:05,040 VITAMIN D FOR THAT REASON, 2471 01:29:05,040 --> 01:29:07,960 DURING THE COVID TIME, AND THEN 2472 01:29:07,960 --> 01:29:09,720 THERE ARE THE PEOPLE WHO--AND 2473 01:29:09,720 --> 01:29:11,120 THERE ARE VERY FEW IN NUMBER BUT 2474 01:29:11,120 --> 01:29:14,360 THERE ARE PEOPLE WHO THINK THAT 2475 01:29:14,360 --> 01:29:16,360 SUPPLEMENTS CONFER A LICENSE TO 2476 01:29:16,360 --> 01:29:18,640 ENGAGE IN UNHEALTHY HEALTH 2477 01:29:18,640 --> 01:29:20,560 BEHAVIORS AS IT SORT OF BLOTS 2478 01:29:20,560 --> 01:29:22,480 OUT THE BAD THINGS THAT THEY'VE 2479 01:29:22,480 --> 01:29:25,040 DONE AND OF COURSE IT DOESN'T 2480 01:29:25,040 --> 01:29:26,760 WORK THAT WAY BUT NEVERTHELESS 2481 01:29:26,760 --> 01:29:29,200 THERE ARE SOME PEOPLE WHO THINK 2482 01:29:29,200 --> 01:29:29,560 IT. 2483 01:29:29,560 --> 01:29:31,200 SOMEBODY ELSE, I THINK REGAN, A 2484 01:29:31,200 --> 01:29:35,000 QUESTION ABOUT SOME OF THE 2485 01:29:35,000 --> 01:29:36,520 DIFFERENT GROUPS AND LET ME JUST 2486 01:29:36,520 --> 01:29:38,480 QUICKLY RUN THROUGH A COUPLE OF 2487 01:29:38,480 --> 01:29:44,400 THOSE DIFFERENT GROUPS AND THEN 2488 01:29:44,400 --> 01:29:44,680 CONCLUDE. 2489 01:29:44,680 --> 01:29:46,640 [INDISCERNIBLE] USE, I WANTED TO 2490 01:29:46,640 --> 01:29:47,600 SHOW THIS SLIDE WHICH I LIKE 2491 01:29:47,600 --> 01:29:51,000 FROM THE WORK OF PEOPLE AT 2492 01:29:51,000 --> 01:29:54,600 D.O.D. AND WHAT THEY DID WAS 2493 01:29:54,600 --> 01:29:56,200 THEY STUDIED SOLDIERS AND THEIR 2494 01:29:56,200 --> 01:29:57,280 USE OF VARIOUS DIETARY 2495 01:29:57,280 --> 01:29:58,720 SUPPLEMENTS AND WHAT YOU SEE 2496 01:29:58,720 --> 01:30:02,320 HERE IS 2 THINGS, 1 IS THE 2497 01:30:02,320 --> 01:30:04,680 SOLDIER WHO IS WERE DEPLOYED IN 2498 01:30:04,680 --> 01:30:08,080 PLACES LIKE AFGHAN TAN OR IRAQ, 2499 01:30:08,080 --> 01:30:10,840 AND THE OTHER WERE PEOPLE WHO 2500 01:30:10,840 --> 01:30:13,040 WERE IN GARRISON WHO WERE NOT 2501 01:30:13,040 --> 01:30:15,280 ACTIVELY FIGHTING BUT ACTIVE 2502 01:30:15,280 --> 01:30:16,760 SERVICE MEMBERS AND WHAT YOU SEE 2503 01:30:16,760 --> 01:30:18,800 IS FIRST OF ALL AN ENORMOUSLY 2504 01:30:18,800 --> 01:30:21,200 HIGH USE OF SUPPLEMENTS OVERALL, 2505 01:30:21,200 --> 01:30:23,400 ABOUT 80% AND THEN IF YOU LOOK 2506 01:30:23,400 --> 01:30:26,560 OVER TO THE PROTEIN AND AMINO 2507 01:30:26,560 --> 01:30:27,760 ACIDS AND COMBINATIONS, YOU SEE 2508 01:30:27,760 --> 01:30:31,200 A VERY HIGH PROPORTION OF THE 2509 01:30:31,200 --> 01:30:33,240 SOLDIERS IN BOTH CATEGORIES WERE 2510 01:30:33,240 --> 01:30:34,280 USING THOSE PRODUCTS AS WELL AND 2511 01:30:34,280 --> 01:30:36,360 I THINK YOU WILL HEAR A LOT MORE 2512 01:30:36,360 --> 01:30:38,800 ABOUT THAT FROM 1 OF OUR OTHER 2513 01:30:38,800 --> 01:30:40,480 SPEAKERS LATER BUT THE MILITARY 2514 01:30:40,480 --> 01:30:42,280 IS DOING SOME VERY INTERESTING 2515 01:30:42,280 --> 01:30:45,480 WORK ON DIETARY SUPPLEMENTS. 2516 01:30:45,480 --> 01:30:49,360 AND FOR YOUNG ADPULTS WHO ARE 2517 01:30:49,360 --> 01:30:50,520 INTERESTED IN PERFORMANCE, 2518 01:30:50,520 --> 01:30:51,600 PHYSICAL PERFORMANCE I WOULD 2519 01:30:51,600 --> 01:30:53,320 STRONGLY SUGGEST THIS IS AN 2520 01:30:53,320 --> 01:30:56,960 EXCELLENT SOURCE OF MATERIAL ON 2521 01:30:56,960 --> 01:30:58,480 THOSE PARTICULAR KINDS OF USERS. 2522 01:30:58,480 --> 01:31:01,200 LET ME JUST SHOW YOU 1 OTHER 2523 01:31:01,200 --> 01:31:05,080 SLIDE THAT JAIME AND REGAN DID 2524 01:31:05,080 --> 01:31:07,400 INVOLVING LOOKING AT PEOPLE WITH 2525 01:31:07,400 --> 01:31:09,080 VARIOUS ILLNESSES AND THEIR USE 2526 01:31:09,080 --> 01:31:09,920 OF CONDITION SPECIFIC 2527 01:31:09,920 --> 01:31:11,440 SUPPLEMENTS AND WHAT YOU SEE 2528 01:31:11,440 --> 01:31:16,680 HERE FOR ARTHRITIS ON YOUR LEFT 2529 01:31:16,680 --> 01:31:20,680 IS MUCH HIGHER USE OF 2530 01:31:20,680 --> 01:31:21,160 GLUCOSAMINE AND CHOND 2531 01:31:21,160 --> 01:31:21,840 REORGANIZATION OF THE 2532 01:31:21,840 --> 01:31:22,680 INSTITUTEIN SUPPLEMENTS IN THOSE 2533 01:31:22,680 --> 01:31:27,200 WHO HAD THIS TYPE OF ILLNESS AND 2534 01:31:27,200 --> 01:31:30,600 HERE ON YOUR RIGHT IS A HISTORY 2535 01:31:30,600 --> 01:31:32,440 OF OSTERPOROSEIS OR FRACTURE, 2536 01:31:32,440 --> 01:31:34,840 THERE'S A MUCH HIGHER USE OF 2537 01:31:34,840 --> 01:31:36,120 VITAMIN D AND CALCIUM IN PEOPLE 2538 01:31:36,120 --> 01:31:41,000 WITH THOSE PARTICULAR 2539 01:31:41,000 --> 01:31:41,280 CONDITIONS. 2540 01:31:41,280 --> 01:31:42,760 AND FOR CANCER HERE'S A NICE 2541 01:31:42,760 --> 01:31:44,440 STUDY THAT WAS PUBLISHED A 2542 01:31:44,440 --> 01:31:50,120 COUPLE YEARS AGO ON CANCER 2543 01:31:50,120 --> 01:31:51,680 PATIENTS OVER TIME IN THIS 2544 01:31:51,680 --> 01:31:54,720 NHANES, THESE WERE SURVIVORS AND 2545 01:31:54,720 --> 01:31:55,360 PEOPLE ACCOUNTIVELY UNDERGOING 2546 01:31:55,360 --> 01:31:56,280 TREATMENT WHO ARE LIVING AT HOME 2547 01:31:56,280 --> 01:31:57,720 AND WHAT YOU SEE AGAIN IS THAT 2548 01:31:57,720 --> 01:32:01,000 MUCH HIGHER USE OF CANCER AMONG 2549 01:32:01,000 --> 01:32:04,800 CANCER PATIENTS OVER THE YEARS. 2550 01:32:04,800 --> 01:32:06,520 SO LOTS OF IMPLICATIONS HERE 2551 01:32:06,520 --> 01:32:08,400 THAT WE NEED TO TAKE INTO 2552 01:32:08,400 --> 01:32:09,560 ACCOUNT AS WE'RE GOING THROUGH 2553 01:32:09,560 --> 01:32:14,760 THE REST OF THE COURSE, 1 WAS 2554 01:32:14,760 --> 01:32:15,880 THAT MOTIVATIONS MAY REVEAL 2555 01:32:15,880 --> 01:32:18,320 HEALTH NEEDS AND THAT'S WHY 2556 01:32:18,320 --> 01:32:19,720 THEY'RE SO IMPORTANT TO THOSE OF 2557 01:32:19,720 --> 01:32:22,440 US WHO WORK IN CLINICAL HEALTH 2558 01:32:22,440 --> 01:32:22,880 AND PUBLIC MEDICINE. 2559 01:32:22,880 --> 01:32:26,360 THE SECOND IS THAT METHODS ARE 2560 01:32:26,360 --> 01:32:28,560 FINDING MOTIVATIONS DO EXIST AND 2561 01:32:28,560 --> 01:32:32,480 WE CAN USE THEM. 2562 01:32:32,480 --> 01:32:33,200 THIRD, SUPPLEMENT USERS ARE 2563 01:32:33,200 --> 01:32:36,000 DIFFERENT AND WE KNOW THAT THE 2564 01:32:36,000 --> 01:32:39,640 REASONS FOR USE VARY AMONG USERS 2565 01:32:39,640 --> 01:32:42,440 AND FROM 1 SUPPLEMENT TO ANOTHER 2566 01:32:42,440 --> 01:32:44,920 AND FINALLY, WE NEED TO REMEMBER 2567 01:32:44,920 --> 01:32:46,840 TO ASK ABOUT USE TO BETTER HELP 2568 01:32:46,840 --> 01:32:51,120 OUR PATIENTS IF WE'RE IN 2569 01:32:51,120 --> 01:32:53,000 CLINICAL SITUATIONS IF YOU'RE 2570 01:32:53,000 --> 01:32:54,080 SEEING PATIENTS, TAKE A LITTLE 2571 01:32:54,080 --> 01:32:56,680 EXTRA TIME PARTICULARLY TO TALK 2572 01:32:56,680 --> 01:32:59,760 TO PATIENTS WHO HAVE MAIN 2573 01:32:59,760 --> 01:33:01,640 CHRONIC ILLNESSES, ESPECIALLY 2574 01:33:01,640 --> 01:33:04,080 THOSE WITH POOR PROGNOSIS OR 2575 01:33:04,080 --> 01:33:05,400 ADVANCE STAGES BUT MANY 2576 01:33:05,400 --> 01:33:07,280 MEDICATIONS WITH PAINFUL OR 2577 01:33:07,280 --> 01:33:08,360 COMPLICATED OR INEFFECTIVE 2578 01:33:08,360 --> 01:33:09,400 CONVENTIONAL THERAPIES AND THE 2579 01:33:09,400 --> 01:33:12,400 OTHER BIG GROUP IS THOSE WITH 2580 01:33:12,400 --> 01:33:13,800 POSSIBLY RISKY PATTERNS OF USE. 2581 01:33:13,800 --> 01:33:16,560 THAT IS PEOPLE WHO ARE TAKING 2582 01:33:16,560 --> 01:33:18,200 MANY, MANY MEDICATIONS AT THE 2583 01:33:18,200 --> 01:33:21,080 SAME TIME BECAUSE THERE'S A RISK 2584 01:33:21,080 --> 01:33:24,680 OF INTERREACTIONS WITH THE 2585 01:33:24,680 --> 01:33:26,320 SUPPLEMENT AND ALSO, 2586 01:33:26,320 --> 01:33:27,360 INTERACTIONS OR RISKY PATTERNS 2587 01:33:27,360 --> 01:33:30,760 WHERE PEOPLE ARE USING THE 2588 01:33:30,760 --> 01:33:34,800 SUPPLEMENTS TO DELAY OR REPLACE 2589 01:33:34,800 --> 01:33:35,400 EFFECTIVE MEDICAL TREATMENT. 2590 01:33:35,400 --> 01:33:37,520 AND REMEMBER THAT IF YOU DON'T 2591 01:33:37,520 --> 01:33:39,800 ASK, PEOPLE ARE NOT GOING TO 2592 01:33:39,800 --> 01:33:41,040 TELL YOU. 2593 01:33:41,040 --> 01:33:43,800 YOU HAVE TO ASK, IS THIS STUDY 2594 01:33:43,800 --> 01:33:47,720 DONE ALMOST 10 YEARS AGO NOW, 2595 01:33:47,720 --> 01:33:51,480 SHOWS, IN OVER 50% OF THE CASES 2596 01:33:51,480 --> 01:33:54,040 IN THIS PARTICULAR STUDY, 2597 01:33:54,040 --> 01:33:55,680 PATIENTS, THE REASON WHY THEY 2598 01:33:55,680 --> 01:33:58,440 DIDN'T TELL THE DOCTOR ABOUT THE 2599 01:33:58,440 --> 01:34:01,560 SUPPLEMENT USE WAS THAT THE 2600 01:34:01,560 --> 01:34:02,400 DOCTOR DIDN'T ASK. 2601 01:34:02,400 --> 01:34:03,840 OR THEY DIDN'T THINK THE DOCTOR 2602 01:34:03,840 --> 01:34:04,880 NEEDED TO KNOW BECAUSE THEY 2603 01:34:04,880 --> 01:34:08,080 DIDN'T ASK SO THE QUESTION HERE 2604 01:34:08,080 --> 01:34:10,520 IS TO SIMPLY GO AHEAD AND ASK IF 2605 01:34:10,520 --> 01:34:12,400 IF YOU ASK USUALLY PEOPLE WILL 2606 01:34:12,400 --> 01:34:12,680 TELL YOU. 2607 01:34:12,680 --> 01:34:14,120 THANK YOU VERY MUCH AND LOOK 2608 01:34:14,120 --> 01:34:15,240 FORWARD TO ANSWERING ANY 2609 01:34:15,240 --> 01:34:21,760 QUESTIONS I CAN. 2610 01:34:21,760 --> 01:34:24,160 >> THANK YOU DR. DWYER, I WOULD 2611 01:34:24,160 --> 01:34:27,880 LIKE TO ASK THAT DR. BAILEY AND 2612 01:34:27,880 --> 01:34:28,680 DR. DWYER JOIN US NOW. 2613 01:34:28,680 --> 01:34:31,080 WE WILL DO A DISCUSSION FOR OUR 2614 01:34:31,080 --> 01:34:31,520 ATTENDEES. 2615 01:34:31,520 --> 01:34:32,480 PLEASE SUBMIT QUESTIONS FOR ALL 2616 01:34:32,480 --> 01:34:36,480 OF US THROUGH THE Q&A PANEL. 2617 01:34:36,480 --> 01:34:38,280 AND DIRECT THOSE TO ALL 2618 01:34:38,280 --> 01:34:38,560 PANELISTS. 2619 01:34:38,560 --> 01:34:41,000 OKAY, SO WE HAVE A FEW QUESTIONS 2620 01:34:41,000 --> 01:34:42,800 THAT I DID RESPOND TO IN THE Q&A 2621 01:34:42,800 --> 01:34:45,000 BUT WE CAN JUST READ THEM OUT 2622 01:34:45,000 --> 01:34:48,000 FOR NOW SO EVERYBODY HEARS. 2623 01:34:48,000 --> 01:34:49,800 NANCY GOMEZ ASKED HOW OFTEN IS 2624 01:34:49,800 --> 01:34:52,320 THE RESEARCH HIGHLIGHTED IN THE 2625 01:34:52,320 --> 01:34:54,760 SUPPLEMENT FACT SHEETS REVIEWED 2626 01:34:54,760 --> 01:34:56,000 AND UPDATED? 2627 01:34:56,000 --> 01:34:59,440 AND BASICALLY WE UPDATE THE FACT 2628 01:34:59,440 --> 01:35:01,080 SHEETS AS NEEDED WITH NEW 2629 01:35:01,080 --> 01:35:02,240 IMPORTANT STUDIES AS THEY COME 2630 01:35:02,240 --> 01:35:02,680 IN. 2631 01:35:02,680 --> 01:35:05,800 WE TRY TO THOROUGHLY REVIEW EACH 2632 01:35:05,800 --> 01:35:07,320 FACT SHEET EVERY 1-3 YEARS AND 2633 01:35:07,320 --> 01:35:09,320 UPDATE THEM BUT IT'S THE END OF 2634 01:35:09,320 --> 01:35:10,920 EACH FACT SHEET WE ALSO WANT TO 2635 01:35:10,920 --> 01:35:12,480 POINT OUT THERE'S A LINK TO THE 2636 01:35:12,480 --> 01:35:13,880 HISTORY OF INFORMATION THAT 2637 01:35:13,880 --> 01:35:16,360 WE'VE CHANGED OR MODIFIED SO YOU 2638 01:35:16,360 --> 01:35:21,960 KNOW HOW RECENT EACH FACT SHEET 2639 01:35:21,960 --> 01:35:22,200 IS. 2640 01:35:22,200 --> 01:35:23,800 AND JOHANNA AND REGAN YOU CAN 2641 01:35:23,800 --> 01:35:26,040 JUMP IN FOR SOME OF THESE OTHER 2642 01:35:26,040 --> 01:35:27,560 QUESTIONS, THAT CAME IN IF YOU 2643 01:35:27,560 --> 01:35:28,240 HAVE SOMETHING ELSE. 2644 01:35:28,240 --> 01:35:30,120 WE DID HAVE SOMEONE WHO 2645 01:35:30,120 --> 01:35:33,520 MENTIONED THAT SOME OF THE DATA 2646 01:35:33,520 --> 01:35:35,680 THAT REGAN SHOWED, IT CAN BE OLD 2647 01:35:35,680 --> 01:35:39,160 DATA, YOU KNOW SOME OF IT'S 2648 01:35:39,160 --> 01:35:41,080 COMING FROM THE 2011-2014 NHANES 2649 01:35:41,080 --> 01:35:44,360 SURVEY AND YOU KNOW HOW 2650 01:35:44,360 --> 01:35:46,880 BASICALLY HAS THE CHANGE IN 2651 01:35:46,880 --> 01:35:50,000 CLIMATE RELATED TO DIETARY 2652 01:35:50,000 --> 01:35:50,520 SUPPLEMENT USAGE CHANGED 2653 01:35:50,520 --> 01:35:52,560 ESPECIALLY NOW THAT WE HAVE--WE 2654 01:35:52,560 --> 01:35:57,200 HAD COVID AND DO HAVE A CHANCE 2655 01:35:57,200 --> 01:35:57,720 IN SUPPLEMENT USE? 2656 01:35:57,720 --> 01:36:00,720 AND SO I WANTED TO START OFF BY 2657 01:36:00,720 --> 01:36:03,840 JUST SAYING THAT NHANES DOES 2658 01:36:03,840 --> 01:36:06,640 COLLECT DATA CONTINUOUSLY, SO 2659 01:36:06,640 --> 01:36:08,400 EVERY YEAR, THE MOST RECENT 2660 01:36:08,400 --> 01:36:12,720 ESTIMATES AVAILABLE THAT WE HAVE 2661 01:36:12,720 --> 01:36:16,360 ARE USAGE FROM 27-2018 NHANES 2662 01:36:16,360 --> 01:36:17,920 SURVEY SORE BASICALLY THEY GO 2663 01:36:17,920 --> 01:36:19,120 INTO THE FIELD, THEY COLLECT THE 2664 01:36:19,120 --> 01:36:21,400 DATA BUT THEN THERE'S STILL A 2665 01:36:21,400 --> 01:36:23,720 LAG PERIOD WHERE THEY HAVE TO 2666 01:36:23,720 --> 01:36:25,640 PROCESS THAT DATA AND IT COULD 2667 01:36:25,640 --> 01:36:27,800 BE ABOUT 2 YEARS BEFORE IT'S 2668 01:36:27,800 --> 01:36:30,680 POSTED ON THEIR WEBSITE FOR 2669 01:36:30,680 --> 01:36:31,120 RESEARCHERS TO USE. 2670 01:36:31,120 --> 01:36:34,040 BUT THEN ON TOP OF IT, COVID HIT 2671 01:36:34,040 --> 01:36:37,880 AND NHANES DID HAVE TO STOP 2672 01:36:37,880 --> 01:36:41,520 OPERATIONS IN EARLY 2020 SO 2673 01:36:41,520 --> 01:36:42,800 UNFORTUNATELY WE DON'T HAVE 2674 01:36:42,800 --> 01:36:45,920 INFORMATION ON SUPPLEMENT USE ON 2675 01:36:45,920 --> 01:36:49,480 THE POPULATION DURING THAT 2676 01:36:49,480 --> 01:36:50,000 PERIOD FROM NHANES. 2677 01:36:50,000 --> 01:36:53,360 THERE ARE A LOT OF IT WE CAN GET 2678 01:36:53,360 --> 01:36:57,200 FROM THE SALES DATA SO YES WE DO 2679 01:36:57,200 --> 01:36:59,440 KNOW THAT WE DO BASICALLY 2680 01:36:59,440 --> 01:37:00,400 HYPOTHESIZE THAT THERE ARE SOME 2681 01:37:00,400 --> 01:37:04,400 PROD UBTS THAT HAVE INCREASED, 2682 01:37:04,400 --> 01:37:06,520 PROBABLY VITAMIN D, VITAMIN C, 2683 01:37:06,520 --> 01:37:07,440 ZINC, SOME OF THE PROJECTION 2684 01:37:07,440 --> 01:37:08,920 NEURONS OR PIONS TANICALS DUE TO 2685 01:37:08,920 --> 01:37:11,280 COVID AND THEN THIS LEADS AND 2686 01:37:11,280 --> 01:37:14,040 JOHANNA, CAN YOU JUMP IN, TOO, 2687 01:37:14,040 --> 01:37:16,880 SOMEONE ELSE ASKED HAS THE 2688 01:37:16,880 --> 01:37:19,200 MOTIVATIONS CHANGED SINCE WE 2689 01:37:19,200 --> 01:37:20,720 LOOKED AT IT YEARS AGO? 2690 01:37:20,720 --> 01:37:22,480 AND PROBABLY FOR A LOT OF 2691 01:37:22,480 --> 01:37:25,160 PRODUCTS MAYBE THE MOTIVATION 2692 01:37:25,160 --> 01:37:26,960 HAVEN'T CHANGED ENORMOUSLY BUT 2693 01:37:26,960 --> 01:37:29,320 YES, FOR COVID-19,IME SURE FOR 2694 01:37:29,320 --> 01:37:30,080 CERTAIN PRODUCTS THAT'S GOING TO 2695 01:37:30,080 --> 01:37:33,320 BE SOME OF THE MOTIVATION AT 2696 01:37:33,320 --> 01:37:34,400 THIS POINT. 2697 01:37:34,400 --> 01:37:36,200 UNFORTUNATELY THOUGH, WE DON'T 2698 01:37:36,200 --> 01:37:40,840 HAVE THAT NATIONALLY 2699 01:37:40,840 --> 01:37:42,640 REPRESENTATIVE DATA. 2700 01:37:42,640 --> 01:37:44,240 >> GOOD POINT JAIME, YES ISSUES 2701 01:37:44,240 --> 01:37:44,640 IT'S A PITY. 2702 01:37:44,640 --> 01:37:48,000 YOU'RE RIGHT, IF WE LOOK AT THE 2703 01:37:48,000 --> 01:37:49,200 TRADE JOURNALS, WHICH WE GET IN 2704 01:37:49,200 --> 01:37:53,600 THE OFFICE, IT DOES LOOK AS 2705 01:37:53,600 --> 01:37:55,120 THOUGH THE MOTIVATIONS MAY HAVE 2706 01:37:55,120 --> 01:37:56,640 CHANGED BECAUSE PEOPLE WERE SO 2707 01:37:56,640 --> 01:37:59,720 DESPERATE AT THE BEGINNING OF 2708 01:37:59,720 --> 01:38:00,960 COVID, THEY DID ANYTHING 2709 01:38:00,960 --> 01:38:04,560 POSSIBLE TO TRY TO AVERT THIS 2710 01:38:04,560 --> 01:38:05,000 TERRIBLE PROBLEM. 2711 01:38:05,000 --> 01:38:07,520 SO I THINK PROBABLY WE WILL FIND 2712 01:38:07,520 --> 01:38:12,440 IN RETROSPECT THAT THERE WERE 2713 01:38:12,440 --> 01:38:15,760 SOME CHANGES. 2714 01:38:15,760 --> 01:38:16,040 >> YEAH. 2715 01:38:16,040 --> 01:38:17,240 AND THEN SOMETHING ELSE THAT 2716 01:38:17,240 --> 01:38:19,280 GOES BACK A LITTLE--SWITCHING 2717 01:38:19,280 --> 01:38:25,440 BACK TO MY PRESENTATION, WE HAD 2718 01:38:25,440 --> 01:38:27,080 SOMEONE MENTION THAT DEFINITELY, 2719 01:38:27,080 --> 01:38:28,520 THERE ARE SO MANY SUPPLEMENTS ON 2720 01:38:28,520 --> 01:38:30,360 THE MARKET AND WE NEED SO MUCH 2721 01:38:30,360 --> 01:38:33,400 MORE RESEARCH ON THE EFFICACY OF 2722 01:38:33,400 --> 01:38:34,760 DIETARY SUPPLEMENTS, AND YOU 2723 01:38:34,760 --> 01:38:37,960 KNOW WHAT IS NIH DOING ABOUT 2724 01:38:37,960 --> 01:38:38,320 THIS? 2725 01:38:38,320 --> 01:38:41,520 AND IS THE FUNDING ENOUGH? 2726 01:38:41,520 --> 01:38:44,320 AND YEAH, THIS IS ALWAYS GOING 2727 01:38:44,320 --> 01:38:46,680 TO BE--THIS IS A DILEMMA. 2728 01:38:46,680 --> 01:38:49,840 DEFINITELY, WE NEED TO BE ABLE 2729 01:38:49,840 --> 01:38:51,680 TO SUPPORT MORE RESEARCH ON 2730 01:38:51,680 --> 01:38:54,080 SUPPLEMENTS BUT YES THERE, IS 2731 01:38:54,080 --> 01:38:56,680 LIMITED FUNDING OVER WHAT WE 2732 01:38:56,680 --> 01:38:58,440 THINK OVER A HUNDRED THOUSAND 2733 01:38:58,440 --> 01:39:00,400 PROD UBT ON THE MARKET, YOU KNOW 2734 01:39:00,400 --> 01:39:04,920 HOW DO YOU REALLY TACKLE THAT 2735 01:39:04,920 --> 01:39:07,040 AND REALLY STUDY THIS AND IT'S 2736 01:39:07,040 --> 01:39:08,800 OF COURSE, IT'S A CHALLENGE, IT 2737 01:39:08,800 --> 01:39:10,960 CONTINUES TO BE A CHALLENGE. 2738 01:39:10,960 --> 01:39:14,480 , YEAH, I THINK 1 THING NEW 2739 01:39:14,480 --> 01:39:16,880 JAIME, IS WISELY, THE FOOD AND 2740 01:39:16,880 --> 01:39:20,400 DRUG ADMINISTRATION FOCUSES 2741 01:39:20,400 --> 01:39:21,240 FIRST ON SAFETY BECAUSE SAFETY 2742 01:39:21,240 --> 01:39:23,320 OF COURSE IS THE ULTIMATE THING 2743 01:39:23,320 --> 01:39:28,200 THAT WE WANT TO MAKE SURE THAT 2744 01:39:28,200 --> 01:39:29,800 IF PRODUCTS ARE TAINTED AND 2745 01:39:29,800 --> 01:39:33,080 GOING TO HURT PEOPLE THAT 2746 01:39:33,080 --> 01:39:34,280 THEY'RE TAKEN OFF THE MARKET BUT 2747 01:39:34,280 --> 01:39:37,240 EFKASP A R SEA BIG ISSUE. 2748 01:39:37,240 --> 01:39:39,160 YOU KNOW EFKASP A R SEA BIG 2749 01:39:39,160 --> 01:39:42,760 ISSUE FOR DIETARY SUPPLEMENTS 2750 01:39:42,760 --> 01:39:46,560 AND IT'S ALSO A BIG ISSUE FOR 2751 01:39:46,560 --> 01:39:46,800 COSMETICS. 2752 01:39:46,800 --> 01:39:49,280 I NOTICED, THAT CREAM I BOUGHT 2753 01:39:49,280 --> 01:39:50,800 DIDN'T DO ANY GOOD AND IT MAY BE 2754 01:39:50,800 --> 01:39:55,400 TRUE FOR SOME OF THE DIETARY 2755 01:39:55,400 --> 01:39:56,440 SUPPLEMENTS. 2756 01:39:56,440 --> 01:39:57,880 [LAUGHTER] 2757 01:39:57,880 --> 01:39:58,160 >> YES. 2758 01:39:58,160 --> 01:40:02,280 >> OKAY, NOW WE DO HAVE A 2759 01:40:02,280 --> 01:40:04,880 QUESTION FROM LINDA, HOW IS THE 2760 01:40:04,880 --> 01:40:06,400 MILITARY SOURCING SUPLEAPTS AND 2761 01:40:06,400 --> 01:40:07,840 WOULD THIS SOURCING BE A GUIDE 2762 01:40:07,840 --> 01:40:09,280 FOR PRODUCT QUALITY FOR PEOPLE 2763 01:40:09,280 --> 01:40:09,760 OUTSIDE THE MILITARY. 2764 01:40:09,760 --> 01:40:13,120 IF SO, HOW WOULD A CONSUMER 2765 01:40:13,120 --> 01:40:18,720 OBTAIN ACCESS TO THIS 2766 01:40:18,720 --> 01:40:20,400 INFORMATION? 2767 01:40:20,400 --> 01:40:21,600 >> WELL, THERE'S 1--I CAN'T GIVE 2768 01:40:21,600 --> 01:40:22,800 YOU AN EXAMPLE OF HOW THEY 2769 01:40:22,800 --> 01:40:26,880 SOURCE IT, BUT I CAN SAY THAT 2770 01:40:26,880 --> 01:40:28,640 THE INFORMATION ON DIETARY 2771 01:40:28,640 --> 01:40:29,920 SUPPLEMENTS IN THE MILITARY, I 2772 01:40:29,920 --> 01:40:31,120 THINK YOU WILL HEAR MORE ABOUT 2773 01:40:31,120 --> 01:40:34,920 LATER IN THE SYMPOSIUM, BUT THE. 2774 01:40:34,920 --> 01:40:35,480 >> YES ON WEDNESDAY. 2775 01:40:35,480 --> 01:40:40,440 >> BUT THE WORD TO KEEP IN MIND 2776 01:40:40,440 --> 01:40:45,720 IS OPPS. 2777 01:40:45,720 --> 01:40:47,720 OPERATION SUPPLEMENT SAFETY, 2778 01:40:47,720 --> 01:40:47,960 SO-- 2779 01:40:47,960 --> 01:40:49,160 >> I DON'T THINK THEY REGULATE 2780 01:40:49,160 --> 01:40:51,000 WHAT'S SOLD TO THE MILITARY BUT 2781 01:40:51,000 --> 01:40:53,560 THEY DO A REALLY GOOD GOB OF 2782 01:40:53,560 --> 01:40:54,280 RECORDING ADVERSE EVENTS AND 2783 01:40:54,280 --> 01:40:55,360 THING LIKE THAT AND YOU WILL 2784 01:40:55,360 --> 01:40:57,880 HEAR MORE ABOUT THAT THIS WEEK. 2785 01:40:57,880 --> 01:40:58,840 >> WEDNESDAY MORNING WE DO HAVE 2786 01:40:58,840 --> 01:41:00,480 SOME BOOKS FROM THE MILITARY 2787 01:41:00,480 --> 01:41:02,640 THAT WILL BE PROVIDING 2788 01:41:02,640 --> 01:41:03,680 INFORMATION ON SUPPLEMENT USE IN 2789 01:41:03,680 --> 01:41:05,280 THE MILITARY AND THIS WOULD BE A 2790 01:41:05,280 --> 01:41:09,240 GREAT QUESTION TO ASK THEM. 2791 01:41:09,240 --> 01:41:11,080 >> YEAH, THE THING--JUST AS A 2792 01:41:11,080 --> 01:41:12,720 PRELUDE TO THAT, YOU KNOW 2793 01:41:12,720 --> 01:41:15,440 SERVICE MEN AND WOMEN ARE 2794 01:41:15,440 --> 01:41:17,600 CITIZEN TOO SO THEY CAN--THEY 2795 01:41:17,600 --> 01:41:20,160 HAVE FREEDOM OF CHOICE, BUT THE 2796 01:41:20,160 --> 01:41:22,240 MILITARY HAS DONE A SUPERB JOB, 2797 01:41:22,240 --> 01:41:25,960 I THINK IN DEVELOPING 2798 01:41:25,960 --> 01:41:28,200 INFORMATION AND EDUCATION 2799 01:41:28,200 --> 01:41:30,200 PROGRAMS TO HELP HIDE WHAT THEY 2800 01:41:30,200 --> 01:41:32,280 WISH TO CHOOSE BECAUSE SOME OF 2801 01:41:32,280 --> 01:41:33,360 THESE FOLKS, IN FACT MOST OF 2802 01:41:33,360 --> 01:41:37,840 THEM ARE ON THE OTHER LIMITED 2803 01:41:37,840 --> 01:41:38,920 INCOMES, YOU KNOW, SERVICE MEN 2804 01:41:38,920 --> 01:41:41,080 DON'T MAKE A LOT OF MONEY. 2805 01:41:41,080 --> 01:41:44,080 AND YET IF THEY'RE TAKING A 2806 01:41:44,080 --> 01:41:45,040 PERFORMANCE SUPPLEMENT AND IT'S 2807 01:41:45,040 --> 01:41:47,400 GOING TO DO GOOD AND IT DOESN'T, 2808 01:41:47,400 --> 01:41:48,720 AND IT'S COSTING $300 A MONTH 2809 01:41:48,720 --> 01:41:49,960 MAYBE THEIR MONEY WOULD BE 2810 01:41:49,960 --> 01:41:52,120 BETTER SPENT SOME OTHER WAY. 2811 01:41:52,120 --> 01:41:54,760 SO I THINK YOU WILL ENJOY THOSE 2812 01:41:54,760 --> 01:41:55,680 PRESENTATIONS BY THE MILITARY 2813 01:41:55,680 --> 01:41:57,000 FOLK, THEY ARE JUST TERRIFIC 2814 01:41:57,000 --> 01:41:59,400 PEOPLE TO WORK WITH. 2815 01:41:59,400 --> 01:41:59,720 >> GREAT. 2816 01:41:59,720 --> 01:42:02,960 ALL RIGHT, WE HAVE A QUESTION BY 2817 01:42:02,960 --> 01:42:04,840 MARY LEE, ARE THERE ANY STUDIES 2818 01:42:04,840 --> 01:42:06,720 LOOKING AT SUPPLEMENT USE IN 2819 01:42:06,720 --> 01:42:07,640 CANCER PATIENTS USING SUPPLEMENT 2820 01:42:07,640 --> 01:42:12,120 THAT HAVE BEEN ASSOCIATED WITH 2821 01:42:12,120 --> 01:42:14,600 HIGHER INDENSE FOR EXAMPLE, BETA 2822 01:42:14,600 --> 01:42:15,840 CAR O TEEN. 2823 01:42:15,840 --> 01:42:17,400 >> THERE'S A LOT OF RESEARCH IN 2824 01:42:17,400 --> 01:42:20,160 CANCER SURVIVORS AND THEY'RE THE 2825 01:42:20,160 --> 01:42:21,120 HIGHEST POPULATION SUBGROUP FOR 2826 01:42:21,120 --> 01:42:24,800 THE USE OF DIETARY SUPPLEMENTS, 2827 01:42:24,800 --> 01:42:31,200 SO UPWARDS OF 80%. 2828 01:42:31,200 --> 01:42:33,080 THERE ARE INCIDENCES WHERE IT 2829 01:42:33,080 --> 01:42:35,240 WAS PREVENTATIVE TO CANCER, AND 2830 01:42:35,240 --> 01:42:37,120 THERE WAS STUDIES WITH A 2831 01:42:37,120 --> 01:42:38,160 SUGGESTED INCREASE RISK WITH 2832 01:42:38,160 --> 01:42:39,120 SUPPLEMENT USE SO IT'S REALLY 2833 01:42:39,120 --> 01:42:40,560 SOMETHING THAT NEEDS TO BE 2834 01:42:40,560 --> 01:42:41,880 CAREFULLY CONSIDER WIDE THE 2835 01:42:41,880 --> 01:42:46,440 CANCER SURVIVOR AND HIS OR HER 2836 01:42:46,440 --> 01:42:47,680 OR THEIR HEALTHCARE PRACTITIONER 2837 01:42:47,680 --> 01:42:49,840 ON AN INDIVIDUAL BASIS, I 2838 01:42:49,840 --> 01:42:51,560 WOULDN'T SAY ODS OR ANYONE HERE 2839 01:42:51,560 --> 01:42:52,320 WOULD MAKE ANY RECOMMENDATIONS 2840 01:42:52,320 --> 01:42:54,840 ABOUT YOU THERE'S A VERY 2841 01:42:54,840 --> 01:42:57,000 EQUIVOCAL LITERATURE BASED ON 2842 01:42:57,000 --> 01:42:58,320 WHAT NUTRIENT AND WHAT CANCER 2843 01:42:58,320 --> 01:42:58,600 TYPE. 2844 01:42:58,600 --> 01:43:05,600 SO I DON'T THINK--THE ISSUE IS 1 2845 01:43:05,600 --> 01:43:07,800 THAT DEFINITELY IS 1 WHERE 2846 01:43:07,800 --> 01:43:09,200 ANYBODY WHRO'S AFFLICTED WITH 2847 01:43:09,200 --> 01:43:11,360 ANY KIND OF CANCER SHOULD 2848 01:43:11,360 --> 01:43:11,960 DISCUSS THIS WITH THEIR 2849 01:43:11,960 --> 01:43:13,440 PHYSICIAN AND THEY SHOULD ALSO 2850 01:43:13,440 --> 01:43:15,440 GO TO THE NATIONAL CANCER 2851 01:43:15,440 --> 01:43:18,600 INSTITUTE SITE WHICH HAS GOOD 2852 01:43:18,600 --> 01:43:20,680 MATERIAL ON IT. 2853 01:43:20,680 --> 01:43:22,720 BUT, THE REASON FOR CONCERN IS 2854 01:43:22,720 --> 01:43:24,600 BECAUSE ON MANY THERAPIES, 2855 01:43:24,600 --> 01:43:26,320 YOU'RE TAKING MULTIPLE 2856 01:43:26,320 --> 01:43:29,120 MEDICATIONS AND SOME OF THOSE 2857 01:43:29,120 --> 01:43:31,640 MEDICATIONS MAY INFACT, INTERACT 2858 01:43:31,640 --> 01:43:33,360 WITH A SUPPLEMENT AND THAT WOULD 2859 01:43:33,360 --> 01:43:38,800 BE A TERRIBLE THING, YOU KNOW, 2860 01:43:38,800 --> 01:43:41,760 IT MIGHT NOT MAKE THE MEDICATION 2861 01:43:41,760 --> 01:43:44,360 WORK THE WAY IT SHOULD SO 2862 01:43:44,360 --> 01:43:49,200 CAUTION IS WARRANTED, I THINK. 2863 01:43:49,200 --> 01:43:52,320 >> OKAY. 2864 01:43:52,320 --> 01:43:52,960 THANK YOU. 2865 01:43:52,960 --> 01:43:54,760 THIS QUESTION IS FROM LEAH, I 2866 01:43:54,760 --> 01:43:57,800 DON'T HAVE THE ANSWER BUT MAYBE 2867 01:43:57,800 --> 01:43:59,000 JOHANNA AND REGAN DO, IS THERE 2868 01:43:59,000 --> 01:44:01,400 ANY SORT OF DATA THAT GOES 2869 01:44:01,400 --> 01:44:02,320 ALONGSIDE DIETARY SUPPLEMENTS 2870 01:44:02,320 --> 01:44:04,200 REGARDING THE EXTENT OF THESE 2871 01:44:04,200 --> 01:44:04,520 SUPPLEMENTS? 2872 01:44:04,520 --> 01:44:06,200 THIS WOULD SEEM TO BE CONCERNS 2873 01:44:06,200 --> 01:44:07,840 WHEN YOU SEE DIETARY SUPPLEMENT 2874 01:44:07,840 --> 01:44:10,520 USAGE AT HIGH LEVELS FOR THOSE 2875 01:44:10,520 --> 01:44:14,400 70% WHO ARE LIKELY ON A FIXED 2876 01:44:14,400 --> 01:44:15,000 INCOME? 2877 01:44:15,000 --> 01:44:17,000 >> THAT'S KIND OF WHY WE RESENT 2878 01:44:17,000 --> 01:44:19,040 THE USAGE DATA WITH THE SALES 2879 01:44:19,040 --> 01:44:20,560 DATA BECAUSE SOME SUPPLEMENTS 2880 01:44:20,560 --> 01:44:21,520 ARE MORE EXPENSE I REALLY THAN 2881 01:44:21,520 --> 01:44:23,480 OTHERS SO IF WE LOOK AT THEUSAGE 2882 01:44:23,480 --> 01:44:25,200 PATTERN AND THE SALES DATA WE 2883 01:44:25,200 --> 01:44:27,080 CAN GET SOME KIND OF PIECES TO 2884 01:44:27,080 --> 01:44:29,720 THE PUZZLE FROM EACH OF THOSE 2885 01:44:29,720 --> 01:44:31,920 BUT YOU'RE ABSOLUTELY CORRECT. 2886 01:44:31,920 --> 01:44:34,000 THOSE OLDER ADULTS ARE THE 2887 01:44:34,000 --> 01:44:34,720 HIGHEST USER GROUPS, THEY TEND 2888 01:44:34,720 --> 01:44:37,680 TO BE ON FIXED INCOMES AND HOW 2889 01:44:37,680 --> 01:44:39,000 THEY USE SUPPLEMENTS IS PART OF 2890 01:44:39,000 --> 01:44:40,200 THAT FIXED INCOME, THERE'S NOT A 2891 01:44:40,200 --> 01:44:44,400 LET OF RESEARCH THAT I KNOW OF, 2892 01:44:44,400 --> 01:44:46,960 JOHANNA, YOU MAY KNOW OF MORE? 2893 01:44:46,960 --> 01:44:48,000 >> NO, NO. 2894 01:44:48,000 --> 01:44:52,120 IN MY OTHER HAT BACK IN BOSTON, 2895 01:44:52,120 --> 01:44:54,440 WE TEND TO DO IS TO SUGGEST TO 2896 01:44:54,440 --> 01:44:57,760 OUR OLDER PATIENTS IF THEY NEED 2897 01:44:57,760 --> 01:45:00,120 A SUPPLEMENT LIKE A MULTIVITAMIN 2898 01:45:00,120 --> 01:45:02,760 MINERAL SUPPLEMENT THAT SOME OF 2899 01:45:02,760 --> 01:45:05,200 THE GENERIC 1S THAT YOU CAN BUY 2900 01:45:05,200 --> 01:45:06,840 IN DRUG STORES ESPECIALLY WHEN 2901 01:45:06,840 --> 01:45:08,920 THEY'RE ON SALE OR GOOD, FOR 2902 01:45:08,920 --> 01:45:11,800 INSTANCE A LOT OF OLDER WOMEN 2903 01:45:11,800 --> 01:45:13,640 ASK ABOUT CALCIUM VITAMIN D ASK 2904 01:45:13,640 --> 01:45:16,160 THAT'S WHAT I DO, I GO AND GET 2905 01:45:16,160 --> 01:45:18,840 IT AT 1 OF THE BIG DRUG STORES 2906 01:45:18,840 --> 01:45:21,520 RATHER THAN ON THE WEB. 2907 01:45:21,520 --> 01:45:23,600 THE WEB TENDS TO BE MORE 2908 01:45:23,600 --> 01:45:25,680 EXPENSIVE AT LEAST IN MY 2909 01:45:25,680 --> 01:45:26,520 IMPRESSION, THE PRODUCTSOT WEB 2910 01:45:26,520 --> 01:45:29,520 SEEM TO BE A LITTLE BIT MORE EBS 2911 01:45:29,520 --> 01:45:30,960 PENSIVE THAN THE BIG BOX STORES 2912 01:45:30,960 --> 01:45:37,840 OR THE DRUG STORES. 2913 01:45:37,840 --> 01:45:41,720 SPHRK HERE'S A QUESTION, HOW 2914 01:45:41,720 --> 01:45:43,440 OTHER INDUSTRIALIZED NATIONS 2915 01:45:43,440 --> 01:45:44,720 DEAL WITH SUPPLEMENTS, ARE 2916 01:45:44,720 --> 01:45:47,440 SUPPLEMENTS PART OF THEIR 2917 01:45:47,440 --> 01:45:48,000 MEDICAL PROTOCOL. 2918 01:45:48,000 --> 01:45:49,760 >> WELL I CAN ANSWER THAT A 2919 01:45:49,760 --> 01:45:53,120 LITTLE, BUT NOT A LOT. 2920 01:45:53,120 --> 01:46:00,640 >> IN MANY PARTS OF THE WORLD, 2921 01:46:00,640 --> 01:46:03,560 FOR EXAMPLE WE HAVE A CATEGORY, 2922 01:46:03,560 --> 01:46:04,960 DIETARY SUPPLEMENTS ARE UNIQUE 2923 01:46:04,960 --> 01:46:07,160 IN THIS COUNTRY BAIZE THEY 2924 01:46:07,160 --> 01:46:08,200 INCLUDE OTHER DIETARY 2925 01:46:08,200 --> 01:46:14,720 INGREDIENTS THAT AREN'T 2926 01:46:14,720 --> 01:46:20,040 NUTRIENTS AND IN THE EUROPEAN 2927 01:46:20,040 --> 01:46:21,760 UNION, MOST OF THE FOOD 2928 01:46:21,760 --> 01:46:23,720 SUPPLEMENTS ARE NUTRIENTS SO 2929 01:46:23,720 --> 01:46:25,040 THEY'RE RESTRICTED TO SPECIFIC 2930 01:46:25,040 --> 01:46:31,600 NUTRIENTS SO THE REGULATIONS ARE 2931 01:46:31,600 --> 01:46:34,080 ARE FOCUSED ON THE NUTRIENTS AND 2932 01:46:34,080 --> 01:46:36,480 IT'S QUITE DIFFERENT FROM OUR 2933 01:46:36,480 --> 01:46:41,920 LAW WHICH HAS A MUCH BROADER 2934 01:46:41,920 --> 01:46:42,200 CATEGORY. 2935 01:46:42,200 --> 01:46:44,880 IN TERMS OF THE ASIAN, SOME OF 2936 01:46:44,880 --> 01:46:45,920 THE ASIAN COUNTRIES AND 2937 01:46:45,920 --> 01:46:50,280 ELSEWHERE IN THE WORLD, SOME 2938 01:46:50,280 --> 01:46:52,120 THINGS THAT ARE CALLED DIETARY 2939 01:46:52,120 --> 01:46:54,280 SUPPLEMENTS WE WOULD CALL 2940 01:46:54,280 --> 01:46:54,960 TRADITIONAL AND COMPLIMENTARY 2941 01:46:54,960 --> 01:46:56,160 MEDICINES AND SO THAT 2942 01:46:56,160 --> 01:46:57,760 GERONTOLOGYSTSS INTO A WHOLE 2943 01:46:57,760 --> 01:47:04,800 OTHER CATEGOR THAT'S QUITE 2944 01:47:04,800 --> 01:47:05,080 DIFFERENT. 2945 01:47:05,080 --> 01:47:06,840 BUT WE HAVEN'T DONE ANY BIG 2946 01:47:06,840 --> 01:47:08,640 STUDIES, I THINK THE 1 PAPER 2947 01:47:08,640 --> 01:47:11,560 THAT'S QUITE GOOD ON THAT, WAS 2948 01:47:11,560 --> 01:47:13,320 DONE BY ANDREW CHOW AND I DON'T 2949 01:47:13,320 --> 01:47:14,920 HAVE THE REFERENCE I CAN GIVE 2950 01:47:14,920 --> 01:47:18,000 BUT ANDREW DID A NICE STUDY 2951 01:47:18,000 --> 01:47:19,200 ACROSS ALL THE DIFFERENT 2952 01:47:19,200 --> 01:47:22,160 COUNTRIES WITH RESPECT TO THE 2953 01:47:22,160 --> 01:47:23,240 REGULATIONS, OR NOT THE 2954 01:47:23,240 --> 01:47:25,520 REGGULESS BUT THE LEGISLATION 2955 01:47:25,520 --> 01:47:30,160 THAT GOVERNS THE SUPPLEMENTS AND 2956 01:47:30,160 --> 01:47:32,760 THE QUESTIONER MIGHT ENJOY READ 2957 01:47:32,760 --> 01:47:33,400 THAGOREAN STUDY. 2958 01:47:33,400 --> 01:47:35,280 >> AND JOE BETS WILL BE 2959 01:47:35,280 --> 01:47:39,000 PRESENTING TODAY OR FURTHERMORE 2960 01:47:39,000 --> 01:47:39,240 --TOMORROW 2961 01:47:39,240 --> 01:47:41,440 AND HE IS A GOOD PERSON TO ASK 2962 01:47:41,440 --> 01:47:43,520 QUESTIONS OF INTERNATIONAL 2963 01:47:43,520 --> 01:47:43,960 REGULATIONS AS WELL. 2964 01:47:43,960 --> 01:47:44,840 >> YEAH, BECAUSE HE DOES A LOT 2965 01:47:44,840 --> 01:47:47,280 OF WORK WITH PARTICULARLY IN 2966 01:47:47,280 --> 01:47:48,560 ASIA ON SOME OF THE SUPPLEMENTS 2967 01:47:48,560 --> 01:47:55,080 THERE SO HE KNOWS A LOT ABOUT 2968 01:47:55,080 --> 01:47:55,520 THEM. 2969 01:47:55,520 --> 01:47:56,920 HE WILL BE PRESENTING IN THE 2970 01:47:56,920 --> 01:47:57,960 NEXT SESSION. 2971 01:47:57,960 --> 01:47:59,400 >> GREAT. 2972 01:47:59,400 --> 01:48:00,280 >> THIS WAS INTERESTING, IT'S 2973 01:48:00,280 --> 01:48:02,560 HOW HAVE YOU CHANGED THE MIND 2974 01:48:02,560 --> 01:48:08,280 SET FOR INDIVIDUALS THAT NEED 2975 01:48:08,280 --> 01:48:10,880 IRON SUPPLEMENT. 2976 01:48:10,880 --> 01:48:11,960 THERE'S SUFFERING WITH ANEMIA 2977 01:48:11,960 --> 01:48:13,520 BUT THERE'S A LOT OF SIDE 2978 01:48:13,520 --> 01:48:14,840 EFFECTS WITH TAKING IRON SO HOW 2979 01:48:14,840 --> 01:48:18,640 DO WE OVERCOME THAT BASICALLY? 2980 01:48:18,640 --> 01:48:20,600 >> IT'S A GOOD QUESTION. 2981 01:48:20,600 --> 01:48:21,840 >> I KNOW. 2982 01:48:21,840 --> 01:48:24,880 >> WELL, THE FIRST THING THAT'S 2983 01:48:24,880 --> 01:48:25,920 INTERESTING AND REGAN YOU CAN 2984 01:48:25,920 --> 01:48:27,480 SPEAK TO THE PRENATALS BETTER 2985 01:48:27,480 --> 01:48:33,120 THAN I CAN, BUT I KNOW THAT 2986 01:48:33,120 --> 01:48:35,560 [INDISCERNIBLE] AND DR. SALD ANO 2987 01:48:35,560 --> 01:48:36,760 IS TALKING LATER TOO, SHE WILL 2988 01:48:36,760 --> 01:48:43,000 BE GOOD TO LOOK AT THESE AND THE 2989 01:48:43,000 --> 01:48:44,960 IRON THEY CONTAIN, SO MUCH IRON 2990 01:48:44,960 --> 01:48:48,360 IN THEM THAT THEY ALSO CONTAIN A 2991 01:48:48,360 --> 01:48:49,440 STOOL SOFTENER WHICH JOE BETS 2992 01:48:49,440 --> 01:48:51,920 WILL TELL YOU IS ILLEGAL OR IT 2993 01:48:51,920 --> 01:48:54,240 WAS ON THE LABEL SO IT WAS 2994 01:48:54,240 --> 01:48:55,120 ILLEGAL, SO THE FIRST TECHNOLOGY 2995 01:48:55,120 --> 01:48:59,240 TRANSFER I THINK WOULD BE TO 2996 01:48:59,240 --> 01:49:01,640 TALK WITH WHOEVER THE HEALTHCARE 2997 01:49:01,640 --> 01:49:08,040 PROVIDER IS, TO FIND OUT IF THE 2998 01:49:08,040 --> 01:49:10,160 DOSE IS REALLY THE DOSE THAT IS 2999 01:49:10,160 --> 01:49:10,960 NEEDED BECAUSE SOMETIMES A 3000 01:49:10,960 --> 01:49:13,200 PHYSICIAN WILL JUST SAY, OH TAKE 3001 01:49:13,200 --> 01:49:14,600 AN IRON SUPPLEMENT AND THEY 3002 01:49:14,600 --> 01:49:15,560 DON'T REALLY HELP TO YOU PICK 3003 01:49:15,560 --> 01:49:18,400 WHICH 1 AND YOU MAY PICK THE 1 3004 01:49:18,400 --> 01:49:20,000 THAT NEEDS A STOOL SOFTENER AS 3005 01:49:20,000 --> 01:49:22,240 WELL, BUT REGAN YOU DID SAY-- 3006 01:49:22,240 --> 01:49:25,320 >> YEAH, SO A LOT OF WHAT ODS 3007 01:49:25,320 --> 01:49:35,760 DOES, ESPECIALLY FROM THE 3008 01:49:36,080 --> 01:49:36,720 POPULATION--TREND ONE-ON-ONE 3009 01:49:36,720 --> 01:49:39,200 PATIENT PERCEPTIONS AND 3010 01:49:39,200 --> 01:49:40,960 MOTIVATIONS, IS MORE POPULATION 3011 01:49:40,960 --> 01:49:43,120 LEVEL AND SO, IT'S HARD TO KIND 3012 01:49:43,120 --> 01:49:45,360 OF COMMENT ON THAT, I CAN SAY, 3013 01:49:45,360 --> 01:49:48,200 YOU KNOW HAVING 3 CHILDREN, TAKE 3014 01:49:48,200 --> 01:49:50,400 AN IRON SUPPLEMENT IS VERY HARD 3015 01:49:50,400 --> 01:49:55,280 ON YOUR GI SYSTEM AND CAN BE 3016 01:49:55,280 --> 01:49:56,240 DISCOURAGING AT TIMES. 3017 01:49:56,240 --> 01:49:58,360 BUT IN TERMS OF HOW I WOULD 3018 01:49:58,360 --> 01:50:00,600 RESPOND TO YOUR QUESTION, I JUST 3019 01:50:00,600 --> 01:50:01,960 DON'T THINK I'M THE QUALIFIED 3020 01:50:01,960 --> 01:50:07,280 PERSON TO ANSWER THAT DIRECTLY. 3021 01:50:07,280 --> 01:50:10,520 >> WELL, SHEILA 1 OF OUR 3022 01:50:10,520 --> 01:50:12,600 ATTENDEES DID SUGGEST SOMETHING, 3023 01:50:12,600 --> 01:50:14,240 A GOOD SUGGESTION SHE'S A 3024 01:50:14,240 --> 01:50:16,920 PRACTITIONER AND SHE TYPICALLY 3025 01:50:16,920 --> 01:50:17,880 SUGGESTS STARTINGA AN IRON 3026 01:50:17,880 --> 01:50:19,000 SUPPLEMENT EVERY OTHER DAY 3027 01:50:19,000 --> 01:50:21,320 BECAUSE AT LEAST THEY'RE GETTING 3028 01:50:21,320 --> 01:50:22,720 SOME, MIGHT NOT BE SO 3029 01:50:22,720 --> 01:50:24,360 OVERWHELMING TO THEIR SYSTEM, 3030 01:50:24,360 --> 01:50:27,000 AND THEN WE ALSO HAVE THE ISSUE 3031 01:50:27,000 --> 01:50:30,640 OF THE FORM OF IRON OF COURSE 3032 01:50:30,640 --> 01:50:32,360 BECAUSE IT'S NOT JUST DOSE, IT 3033 01:50:32,360 --> 01:50:36,720 CAN ALSO BE THE FORM THAT THE 3034 01:50:36,720 --> 01:50:37,280 IRON'S COMING IN. 3035 01:50:37,280 --> 01:50:40,120 >> AS WELL AS THE BACKGROUND 3036 01:50:40,120 --> 01:50:41,520 DIET, SO VEGETARIANS HAVE 3037 01:50:41,520 --> 01:50:44,360 DIFFERENT COMPOUNDS IN THEIR 3038 01:50:44,360 --> 01:50:49,960 DIETARY PATTERNS THAT MAY 3039 01:50:49,960 --> 01:50:51,720 INHIBIT IRON CONSON AND THERE'S 3040 01:50:51,720 --> 01:50:53,640 BEEN ARE DISCUSSIONS ABOUT WHAT 3041 01:50:53,640 --> 01:50:55,600 SPACE, WHAT FORM, WHAT AMOUNT, 3042 01:50:55,600 --> 01:50:58,840 HOW OFTEN TO PRODUCE THE RISK OF 3043 01:50:58,840 --> 01:51:02,320 PRENATAL IRON INSUFFICIENCY FOR 3044 01:51:02,320 --> 01:51:02,840 SURE. 3045 01:51:02,840 --> 01:51:05,440 >> OKAY, THANK YOU DR. BAILEY 3046 01:51:05,440 --> 01:51:06,880 AND DR. DWYER, WE ARE COMING TO 3047 01:51:06,880 --> 01:51:10,280 THE END OF OUR SESSION 1. 3048 01:51:10,280 --> 01:51:11,800 WE WILL TAKE A 10 MINUTE BREAK, 3049 01:51:11,800 --> 01:51:12,920 WELL, 9 MINUTES AT THIS POINT 3050 01:51:12,920 --> 01:51:15,280 AND COME BACK AT 1 AND THEN 3051 01:51:15,280 --> 01:51:17,080 WE'RE GOING TO HAVE A SESSION ON 3052 01:51:17,080 --> 01:51:19,960 RULES AND REGULATIONS, WE WILL 3053 01:51:19,960 --> 01:51:21,920 HEAR FROM SPEAKER--A SPEAKER 3054 01:51:21,920 --> 01:51:24,680 FROM FDA, FTC AND ALSO OUR 3055 01:51:24,680 --> 01:51:26,720 ACTING DIRECTOR AT ODS. 3056 01:51:26,720 --> 01:51:29,080 SO I WILL SEE EVERYONE BACK AT 3057 01:51:29,080 --> 01:51:29,200 1. 3058 01:51:29,200 --> 01:51:37,600 THANK YOU. 3059 01:51:37,600 --> 01:51:42,200 THIS IS SESSION 2, RULES AND 3060 01:51:42,200 --> 01:51:44,440 REGULATION, DR. THOMAS WILL BE 3061 01:51:44,440 --> 01:51:46,720 MODERATING, HAS BEEN WITH THE 3062 01:51:46,720 --> 01:51:47,880 OFFICE OF DIETARY SUPPLEMENTS 3063 01:51:47,880 --> 01:51:49,280 SINCE 2005. 3064 01:51:49,280 --> 01:51:50,640 THANK YOU, DR. THOMAS. 3065 01:51:50,640 --> 01:51:52,000 >> THANK YOU. 3066 01:51:52,000 --> 01:51:56,240 I'LL BE MODERATING THE SECOND 3067 01:51:56,240 --> 01:51:57,680 SESSION, RULES AND REGULATIONS, 3068 01:51:57,680 --> 01:51:59,440 WE'LL GIVE A SOLID GROUNDING IN 3069 01:51:59,440 --> 01:52:01,160 THE OVERSIGHT AND REGULATION OF 3070 01:52:01,160 --> 01:52:04,120 DIETARY SUPPLEMENTS WITHIN THE 3071 01:52:04,120 --> 01:52:05,800 FEDERAL GOVERNMENT. 3072 01:52:05,800 --> 01:52:08,840 YOU'LL GET AN OVERVIEW OF THE 3073 01:52:08,840 --> 01:52:10,480 FOOD, DRUG, DIETARY SUPPLEMENTS 3074 01:52:10,480 --> 01:52:11,560 SIMILARITIES AND DIFFERENCES 3075 01:52:11,560 --> 01:52:13,440 FOLLOWED BY PERSPECTIVES OF THE 3076 01:52:13,440 --> 01:52:15,400 FOOD AND DRUG ADMINISTRATION AND 3077 01:52:15,400 --> 01:52:17,920 FEDERAL TRADE COMMISSION. 3078 01:52:17,920 --> 01:52:19,480 THREE SPEAKERS, AFTER THEIR 3079 01:52:19,480 --> 01:52:22,840 PRESENTATIONS WE'LL HAVE TIME 3080 01:52:22,840 --> 01:52:25,200 FOR YOUR QUESTIONS TO THE PANEL. 3081 01:52:25,200 --> 01:52:27,000 PLEASE SUBMIT QUESTIONS FOR THE 3082 01:52:27,000 --> 01:52:29,040 PRESENTERS IN THE Q&A PANEL OF 3083 01:52:29,040 --> 01:52:31,760 YOUR WEBEX, AND DIRECT THEM TO 3084 01:52:31,760 --> 01:52:32,480 ALL PANELISTS. 3085 01:52:32,480 --> 01:52:35,280 PLEASE ONLY USE THE CHAT BOX 3086 01:52:35,280 --> 01:52:39,120 FUNCTION FOR TECHNICAL QUESTIONS 3087 01:52:39,120 --> 01:52:40,960 OR ISSUES WITH WEBEX. 3088 01:52:40,960 --> 01:52:45,360 I'M GOING TO BRIEFLY INTRODUCE 3089 01:52:45,360 --> 01:52:54,080 EACH SPEAKER, GO TO TO THE 3090 01:52:54,080 --> 01:53:00,000 WEBSITE FOR BIOS. 3091 01:53:00,000 --> 01:53:03,120 FIRST IS JOSEPH BETZ, DIRECTED 3092 01:53:03,120 --> 01:53:07,560 ANALYTICAL METHODS AND REFERENCE 3093 01:53:07,560 --> 01:53:10,640 MATERIALS PROGRAM AS PHARMA 3094 01:53:10,640 --> 01:53:12,720 COGNICIST BY TRAINING, BEFORE 3095 01:53:12,720 --> 01:53:15,920 THAT RESEARCH CHEMIST AT THE 3096 01:53:15,920 --> 01:53:16,360 FDA. 3097 01:53:16,360 --> 01:53:19,280 DR. BETZ WILL EXPLAIN HOW FOOD, 3098 01:53:19,280 --> 01:53:21,800 DRUGS, DIETARY SUPPLEMENTS ARE 3099 01:53:21,800 --> 01:53:22,600 REGULATED. 3100 01:53:22,600 --> 01:53:23,160 WELCOME, DR. BETZ. 3101 01:53:23,160 --> 01:53:29,360 >> THANK YOU FOR THE KIND 3102 01:53:29,360 --> 01:53:30,440 INTRODUCTION. 3103 01:53:30,440 --> 01:53:39,880 LET ME LEAP RIGHT IN. 3104 01:53:39,880 --> 01:53:43,040 3105 01:53:43,040 --> 01:53:44,120 THAT SHOULD WORK. 3106 01:53:44,120 --> 01:53:46,720 CAN EVERYBODY SEE MY SLIDES? 3107 01:53:46,720 --> 01:53:51,200 LOOKS GREAT. 3108 01:53:51,200 --> 01:53:51,600 >> OKAY. 3109 01:53:51,600 --> 01:53:52,680 GOOD MORNING OR GOOD AFTERNOON, 3110 01:53:52,680 --> 01:53:55,200 DEPENDING WHAT PART OF THE WORLD 3111 01:53:55,200 --> 01:53:56,120 YOU'RE IN. 3112 01:53:56,120 --> 01:54:02,680 THIS IS GOING TO PROVIDE JUST A 3113 01:54:02,680 --> 01:54:04,280 BRIEF OVERVIEWS OF CONTROVERSIAL 3114 01:54:04,280 --> 01:54:06,160 ISSUES. 3115 01:54:06,160 --> 01:54:16,720 YOU HEARD FROM DR. DWYER AND DR. 3116 01:54:21,840 --> 01:54:25,160 GAHCE THIS MORNING, LET'S GO TO 3117 01:54:25,160 --> 01:54:26,920 THE ACT. 3118 01:54:26,920 --> 01:54:34,160 IN 2006, PASSED BY CONGRESS, 3119 01:54:34,160 --> 01:54:35,920 AMENDED IN 1938, THE PRODUCTS 3120 01:54:35,920 --> 01:54:41,080 ARE REGULATED BY FDA BASED ON 3121 01:54:41,080 --> 01:54:45,520 INTENDED USE. 3122 01:54:45,520 --> 01:54:49,920 THE CATEGORIES ARE FOODS, DRUGS, 3123 01:54:49,920 --> 01:54:53,680 COSMETICS, MEDICAL DEVICES. 3124 01:54:53,680 --> 01:54:57,560 FOODS INCLUDES VETERINARY FOODS, 3125 01:54:57,560 --> 01:55:05,120 ANIMAL FEEDS, CHOWS, VETERINARY 3126 01:55:05,120 --> 01:55:06,600 DRUGS AND DRUG CATEGORY. 3127 01:55:06,600 --> 01:55:08,560 INTENDED USE, THEY LOOK AT THE 3128 01:55:08,560 --> 01:55:10,240 LABEL, LOOK AT THE ADVERTISING, 3129 01:55:10,240 --> 01:55:12,520 LOOK AT ANY ORAL OR WRITTEN 3130 01:55:12,520 --> 01:55:18,440 STATEMENTS MADE BY THE COMPANY 3131 01:55:18,440 --> 01:55:19,840 ABOUT THE PRODUCT. 3132 01:55:19,840 --> 01:55:22,800 IN SOME CASES THERE'S GUESS WORK 3133 01:55:22,800 --> 01:55:25,120 BUT FOR THE MOST PART FDA CAN 3134 01:55:25,120 --> 01:55:26,160 FIGURE OUT INTENDED USE BASED ON 3135 01:55:26,160 --> 01:55:28,040 THOSE THINGS. 3136 01:55:28,040 --> 01:55:32,040 WHATEVER FDA CONCLUDES AND 3137 01:55:32,040 --> 01:55:34,280 WHATEVER THE COMPANY INTENDED TO 3138 01:55:34,280 --> 01:55:35,800 SELL, THE REGULATIONS FOR THAT 3139 01:55:35,800 --> 01:55:36,600 CATEGORY APPLY. 3140 01:55:36,600 --> 01:55:37,720 WE'LL FIND OUT THERE'S A LITTLE 3141 01:55:37,720 --> 01:55:42,640 BIT OF DIFFERENCE BETWEEN THE 3142 01:55:42,640 --> 01:55:43,720 VARIOUS REGULATORY CATEGORIES. 3143 01:55:43,720 --> 01:55:47,720 I WILL NOTE BECAUSE I'VE BEEN 3144 01:55:47,720 --> 01:55:51,160 ASKED TO DO A TALK IN JUNE IN 3145 01:55:51,160 --> 01:55:54,120 CANADA THERE'S TO REGULATORY 3146 01:55:54,120 --> 01:55:54,760 CATEGORY FOR FUNCTIONAL FOOD IN 3147 01:55:54,760 --> 01:55:55,440 THE U.S. 3148 01:55:55,440 --> 01:55:57,840 THERE WAS A WORKSHOP BY FDA 3149 01:55:57,840 --> 01:56:00,080 SEVERAL YEARS BACK, THEY 3150 01:56:00,080 --> 01:56:01,840 CONCLUDED THE CURRENT REGULATORY 3151 01:56:01,840 --> 01:56:03,280 STRATEGY FOR CONVENTIONAL FOODS 3152 01:56:03,280 --> 01:56:05,280 THAT ALLOW HEALTH CLAIMS IS GOOD 3153 01:56:05,280 --> 01:56:06,760 ENOUGH FOR FUNCTIONAL FOODS. 3154 01:56:06,760 --> 01:56:08,520 THEREFORE NO SPECIAL CATEGORY 3155 01:56:08,520 --> 01:56:09,280 WAS NEEDED. 3156 01:56:09,280 --> 01:56:12,800 I ALSO POINT OUT FDA REGULATES 3157 01:56:12,800 --> 01:56:14,280 PRODUCTS AND INTERSTATE 3158 01:56:14,280 --> 01:56:15,720 COMMERCE, FINISHED PRODUCTS THAT 3159 01:56:15,720 --> 01:56:21,520 MOVE, END UP ON THE WEB AND 3160 01:56:21,520 --> 01:56:24,160 RETAIL STORES, DOES NOT REGULATE 3161 01:56:24,160 --> 01:56:25,600 PRACTICE OF MEDICINE, REGULATED 3162 01:56:25,600 --> 01:56:27,120 ON A STATE-BY-STATE BASIS, BY 3163 01:56:27,120 --> 01:56:28,040 THE STATES THEMSELVES. 3164 01:56:28,040 --> 01:56:30,440 WE'LL LEAP STRAIGHT INTO THE ONE 3165 01:56:30,440 --> 01:56:33,920 WE'RE GOING TO TALK THE LEAST 3166 01:56:33,920 --> 01:56:37,160 ABOUT THIS MORNING, OR THIS 3167 01:56:37,160 --> 01:56:39,600 AFTERNOON, THAT IS DRUGS. 3168 01:56:39,600 --> 01:56:42,600 A DRUG AN ARTICLE INTENDED TO 3169 01:56:42,600 --> 01:56:43,440 DIAGNOSE, CURE, MITIGATE, TREAT, 3170 01:56:43,440 --> 01:56:47,280 PREVENT A DISEASE IN MAN OR 3171 01:56:47,280 --> 01:56:47,520 ANIMALS. 3172 01:56:47,520 --> 01:56:48,240 OR TO AFFECT STRUCTURE OR 3173 01:56:48,240 --> 01:56:49,800 FUNCTION OF THE BODY. 3174 01:56:49,800 --> 01:56:53,480 WE'LL GET INTO CONFUSION FROM 3175 01:56:53,480 --> 01:56:57,040 THAT LATER IN THE TALK. 3176 01:56:57,040 --> 01:56:58,480 A DRUG MULTIPLE GENERALLY 3177 01:56:58,480 --> 01:57:02,200 RECOGNIZED AS SAFE AND 3178 01:57:02,200 --> 01:57:03,240 EFFECTIVE. 3179 01:57:03,240 --> 01:57:04,720 THE ACRONYM IS GRASE. 3180 01:57:04,720 --> 01:57:06,120 YOU MAY HAVE HEARD IT IN 3181 01:57:06,120 --> 01:57:07,360 CONJUNCTION WITH FOODS, WE'LL 3182 01:57:07,360 --> 01:57:11,880 TALK ABOUT THAT LATER. 3183 01:57:11,880 --> 01:57:17,800 FREE MARKET APPROVAL IS REQUIRED 3184 01:57:17,800 --> 01:57:22,440 FOR DRUGS, INVESTIGATIONAL AND 3185 01:57:22,440 --> 01:57:29,720 NEW DRUG APPLICATION ROUTE. 3186 01:57:29,720 --> 01:57:32,040 THE SPONSOR FUNDS, FDA REVIEWS 3187 01:57:32,040 --> 01:57:34,240 RESULTS AND MAKES CONCLUSION OF 3188 01:57:34,240 --> 01:57:35,400 SAFETY AND EFFICACY BEFORE THE 3189 01:57:35,400 --> 01:57:37,440 PRODUCT IS ALLOWED ON THE 3190 01:57:37,440 --> 01:57:37,680 MARKET. 3191 01:57:37,680 --> 01:57:41,560 ALL THIS HAPPENS BEFORE THE 3192 01:57:41,560 --> 01:57:43,880 PRODUCT HITS THE MARKET. 3193 01:57:43,880 --> 01:57:44,520 PRE-MARKET APPROVAL. 3194 01:57:44,520 --> 01:57:48,360 A FOOD, THIS IS THE DEFINITION 3195 01:57:48,360 --> 01:57:53,640 COPIED FROM THE ACT, DON'T 3196 01:57:53,640 --> 01:57:57,480 ACCUSE ME OF PARAPHRASING, USE 3197 01:57:57,480 --> 01:58:00,840 FOR MAN OR OTHER ANIMALS, 3198 01:58:00,840 --> 01:58:02,680 CHEWING GUM, ARTICLES FOR 3199 01:58:02,680 --> 01:58:04,520 COMPONENTS, CONSUMED FOR TASTE, 3200 01:58:04,520 --> 01:58:08,120 AROMA, NUTRITIVE VALUE. 3201 01:58:08,120 --> 01:58:12,120 THERE'S A CATEGORY CALLED 3202 01:58:12,120 --> 01:58:15,480 MEDICAL FOODS, IF YOU WANT TO 3203 01:58:15,480 --> 01:58:17,440 REPLY TO THE URL AND CITATION, 3204 01:58:17,440 --> 01:58:19,400 I'M NOT GOING TO TALK ABOUT IT 3205 01:58:19,400 --> 01:58:21,160 VERY MUCH TODAY. 3206 01:58:21,160 --> 01:58:31,640 FOODS ARE SAFE BY DEFINITION, 3207 01:58:32,320 --> 01:58:36,640 GENERALLY RECOGNIZED BY SAFE, 3208 01:58:36,640 --> 01:58:40,120 THE ACRONYM, UNLESS A SUBSTANCE 3209 01:58:40,120 --> 01:58:41,320 ADDED TO FOODS, SUBSTANCE USED 3210 01:58:41,320 --> 01:58:44,120 IN OR AS FOOD PRIOR TO JANUARY 3211 01:58:44,120 --> 01:58:46,160 1, 1958, IS CONSIDERED TO HAVE A 3212 01:58:46,160 --> 01:58:48,360 HISTORY OF SAFE USE AND 3213 01:58:48,360 --> 01:58:49,000 GRANDFATHERED. 3214 01:58:49,000 --> 01:58:52,600 FDA CAN DO A POST-1958 REVIEW OF 3215 01:58:52,600 --> 01:58:59,640 SAFETY AND IN FACT HAS REVIEWED 3216 01:58:59,640 --> 01:59:06,480 A NUMBER OF MATERIALS, 3217 01:59:06,480 --> 01:59:08,080 CYCLAMATES, BEING ONCE. 3218 01:59:08,080 --> 01:59:13,000 FOODS MUST BE GRAS, GENERALLY 3219 01:59:13,000 --> 01:59:14,520 RECOGNIZED AS SAFE, 3220 01:59:14,520 --> 01:59:16,760 DETERMINATION MADE BY QUALIFIED 3221 01:59:16,760 --> 01:59:19,240 EXPERTS USING SCIENTIFIC 3222 01:59:19,240 --> 01:59:20,120 PROCEDURES. 3223 01:59:20,120 --> 01:59:23,280 THERE ARE SPECIAL RULES FOR 3224 01:59:23,280 --> 01:59:25,760 PESTICIDES, COLORS, FOOD CONTACT 3225 01:59:25,760 --> 01:59:30,200 SURFACES, ALL ARE FOOD ADDITIVE, 3226 01:59:30,200 --> 01:59:31,520 DIRECT OR INDIRECT, I WON'T TALK 3227 01:59:31,520 --> 01:59:32,480 ABOUT THOSE EITHER. 3228 01:59:32,480 --> 01:59:34,120 IF YOU'RE INTERESTED, WE CAN 3229 01:59:34,120 --> 01:59:35,240 HAVE AN OFFLINE CONVERSATION, 3230 01:59:35,240 --> 01:59:36,760 SEND ME AN E-MAIL AND I WILL 3231 01:59:36,760 --> 01:59:42,120 SEND YOU TO THE APPROPRIATE 3232 01:59:42,120 --> 01:59:44,000 PERSON AT FDA TO SPEAK. 3233 01:59:44,000 --> 01:59:49,880 THERE HAVE BEEN A NUMBER OF 3234 01:59:49,880 --> 01:59:51,720 AMENDMENTS TO THE FOOD DRUG 3235 01:59:51,720 --> 01:59:54,360 COSMETIC ACT SINCE IT WAS 3236 01:59:54,360 --> 01:59:55,040 PASSED. 3237 01:59:55,040 --> 01:59:56,000 FOR THE PURPOSE OF OUR 3238 01:59:56,000 --> 01:59:57,560 DISCUSSION TODAY THE TWO MOST 3239 01:59:57,560 --> 02:00:02,760 SIGNIFICANT ARE THE ONE THAT DR. 3240 02:00:02,760 --> 02:00:04,400 GHACHE MENTIONED, BUT PRECEDING 3241 02:00:04,400 --> 02:00:07,160 WAS THIS ONE, NUTRITION LABELING 3242 02:00:07,160 --> 02:00:12,160 AND EDUCATION ACT OF 1990. 3243 02:00:12,160 --> 02:00:20,800 IT PROVIDED FOR -- REQUIRED 3244 02:00:20,800 --> 02:00:21,920 NUTRITION LABELS BY 1994, THE 3245 02:00:21,920 --> 02:00:24,520 PURPOSE WAS TO MAKE IT EASIER 3246 02:00:24,520 --> 02:00:26,160 FOR CONSUMERS TO PLAN HEALTHY 3247 02:00:26,160 --> 02:00:26,600 DIETS. 3248 02:00:26,600 --> 02:00:28,600 YOU'LL NOTICE THIS IS SOMETHING 3249 02:00:28,600 --> 02:00:33,960 THAT'S SELDOM MENTIONED WHEN WE 3250 02:00:33,960 --> 02:00:37,360 TALK ABOUT BOTH, THE WORD 3251 02:00:37,360 --> 02:00:39,360 "EDUCATION" IS IN BOTH, INTENT 3252 02:00:39,360 --> 02:00:40,760 TO PROVIDE ACCURATE INFORMATION 3253 02:00:40,760 --> 02:00:41,840 TO CONSUMERS TO MAKE INFORMED 3254 02:00:41,840 --> 02:00:46,360 DECISIONS ABOUT WHAT THEY PUT IN 3255 02:00:46,360 --> 02:00:47,320 THEIR MOUTHS. 3256 02:00:47,320 --> 02:00:48,960 THERE HAVE BEEN SEVERAL RULES 3257 02:00:48,960 --> 02:00:49,640 SINCE THEN. 3258 02:00:49,640 --> 02:00:54,000 THERE WAS AN FDA RULE ON 3259 02:00:54,000 --> 02:00:55,880 TRANSFATS, 2003 AND THEN 3260 02:00:55,880 --> 02:00:57,640 REVISION IN 2006. 3261 02:00:57,640 --> 02:01:04,680 FDA RULE ON FOOD ALLERGENS, IN 3262 02:01:04,680 --> 02:01:06,600 DECEMBER OF 2018 NEW LABELING 3263 02:01:06,600 --> 02:01:06,880 REGULATIONS. 3264 02:01:06,880 --> 02:01:09,000 WE'LL A BIT ABOUT THOSE. 3265 02:01:09,000 --> 02:01:09,960 I PROVIDED INFORMATION, URLs 3266 02:01:09,960 --> 02:01:11,640 FOR THOSE FOR YOU. 3267 02:01:11,640 --> 02:01:13,320 THEY WILL BE AVAILABLE WHEN YOU 3268 02:01:13,320 --> 02:01:16,480 ASK FOR THE SLIDE DECK. 3269 02:01:16,480 --> 02:01:17,920 THERE'S A NEW SECTION, WHAT'S 3270 02:01:17,920 --> 02:01:20,880 NEW SECTION, IN THE FDA WEBSITE 3271 02:01:20,880 --> 02:01:21,480 AS WELL. 3272 02:01:21,480 --> 02:01:24,760 WHEN YOU GO TO THE LABELING AND 3273 02:01:24,760 --> 02:01:25,600 NUTRITION GUIDANCE DOCUMENTS, 3274 02:01:25,600 --> 02:01:27,320 THIS IS THE LANDING PAGE. 3275 02:01:27,320 --> 02:01:28,960 AGAIN, THE URL AT THE TOP. 3276 02:01:28,960 --> 02:01:30,720 I DON'T PLAN ON SPENDING TOO 3277 02:01:30,720 --> 02:01:32,320 MUCH TIME GOING THROUGH ALL THIS 3278 02:01:32,320 --> 02:01:32,680 STUFF. 3279 02:01:32,680 --> 02:01:38,520 THIS IS A VERY BRIEF OVERVIEW. 3280 02:01:38,520 --> 02:01:42,840 SO, IN ADDITION TO THE 3281 02:01:42,840 --> 02:01:45,000 PROVISIONS ABOUT HEALTH CLAIMS, 3282 02:01:45,000 --> 02:01:46,440 THE NLEA ESTABLISHED RULES FOR 3283 02:01:46,440 --> 02:01:48,960 WHAT THE FOOD LABEL SHOULD LOOK 3284 02:01:48,960 --> 02:01:49,320 LIKE. 3285 02:01:49,320 --> 02:01:54,880 SO, IT LAYS OUT SIMPLE STUFF, ON 3286 02:01:54,880 --> 02:01:55,680 THE PRINCIPAL DISPLACE PANEL FOR 3287 02:01:55,680 --> 02:01:59,400 A CEREAL BOX WOULD BE THE BIG 3288 02:01:59,400 --> 02:02:00,360 FRONT OF THE BOX. 3289 02:02:00,360 --> 02:02:02,120 YOU NEED TO LIST STATEMENT OF 3290 02:02:02,120 --> 02:02:06,680 IDENTITY, NAME OF THE FOOD, NET 3291 02:02:06,680 --> 02:02:09,760 QUANTITY OF THE PRODUCT IN THE 3292 02:02:09,760 --> 02:02:12,040 PACKAGE, AMOUNT OF PRODUCT, ALL 3293 02:02:12,040 --> 02:02:18,960 OF THOSE GO ON A DISPLAY PANEL. 3294 02:02:18,960 --> 02:02:20,040 STANDARDIZED FOOD IS ANOTHER CAN 3295 02:02:20,040 --> 02:02:23,320 OF WORMS THAT I WON'T OPEN 3296 02:02:23,320 --> 02:02:23,520 TODAY. 3297 02:02:23,520 --> 02:02:24,840 JUST BE AWARE THERE ARE SOME 3298 02:02:24,840 --> 02:02:31,000 FOODS DIVINED IN THE 3299 02:02:31,000 --> 02:02:34,840 REGULATION, ICE CREAM AND TOMATO 3300 02:02:34,840 --> 02:02:36,760 JUICE, ALL QUITE OFTEN MANDATORY 3301 02:02:36,760 --> 02:02:38,560 TESTS ONE HAS TO DO TO DETERMINE 3302 02:02:38,560 --> 02:02:40,520 WHETHER OR NOT THEY COMPLY WITH 3303 02:02:40,520 --> 02:02:51,040 THE RULES FOR STANDARDIZED FOOD. 3304 02:02:51,760 --> 02:02:53,800 IN ADDITION TO PDP, THERE'S AN 3305 02:02:53,800 --> 02:02:54,400 INFORMATION PANEL, AND THAT'S 3306 02:02:54,400 --> 02:02:59,320 WHERE YOU PUT ALL THE OTHER 3307 02:02:59,320 --> 02:03:00,440 STUFF. 3308 02:03:00,440 --> 02:03:02,240 THIS IS ACTUALLY CODIFIED, THE 3309 02:03:02,240 --> 02:03:03,240 INFORMATION PANEL IS IMMEDIATELY 3310 02:03:03,240 --> 02:03:05,160 TO THE RIGHT OF THE PRINCIPAL 3311 02:03:05,160 --> 02:03:06,480 DISPLAY PANEL. 3312 02:03:06,480 --> 02:03:08,320 IT MUST CONTAIN NAME, ADDRESS, 3313 02:03:08,320 --> 02:03:11,080 PLACE OF BUSINESS OF THE 3314 02:03:11,080 --> 02:03:11,840 MANUFACTURER. 3315 02:03:11,840 --> 02:03:13,760 IT HAS TO HAVE AN INGREDIENT 3316 02:03:13,760 --> 02:03:15,680 LIST THAT INCLUDES NUTRITION 3317 02:03:15,680 --> 02:03:18,760 LABELING, IT HAS TO HAVE ANY 3318 02:03:18,760 --> 02:03:20,960 REQUIRED ALLERGY LABELING YOU 3319 02:03:20,960 --> 02:03:23,480 MAY HAVE SEEN LABELS LIKE THIS 3320 02:03:23,480 --> 02:03:27,120 PRODUCT WAS MANUFACTURED IN A 3321 02:03:27,120 --> 02:03:30,600 FACILITY THAT ALSO PROCESSES 3322 02:03:30,600 --> 02:03:31,240 PEANUTS, SO BEWARE. 3323 02:03:31,240 --> 02:03:34,640 IT HAS TO HAVE A LABEL 3324 02:03:34,640 --> 02:03:38,960 IDENTIFICATION OF ARTIFICIAL 3325 02:03:38,960 --> 02:03:41,320 FLAVORING, COLORING, CHEMICAL 3326 02:03:41,320 --> 02:03:41,680 PRESERVATIVES. 3327 02:03:41,680 --> 02:03:42,720 THE NUTRITION LABELING, CONTENT 3328 02:03:42,720 --> 02:03:49,760 OF THE NUTRIENTS, IS LISTED IN A 3329 02:03:49,760 --> 02:03:51,400 NUTRIENT FACT PANEL. 3330 02:03:51,400 --> 02:03:53,600 THERE WERE NEW REGULATIONS 3331 02:03:53,600 --> 02:03:57,320 PUBLISHED IN 2018, AGAIN THERE'S 3332 02:03:57,320 --> 02:04:00,920 THE CFR REFERENCE IF YOU'RE 3333 02:04:00,920 --> 02:04:01,360 INTERESTED. 3334 02:04:01,360 --> 02:04:04,880 IT REQUIRES ONE TO ADD NUTRIENT 3335 02:04:04,880 --> 02:04:06,880 CONTENT CLAIMS TO THE LABEL, IF 3336 02:04:06,880 --> 02:04:10,880 THERE'S A PERCENT DAILY VALUE. 3337 02:04:10,880 --> 02:04:14,080 SO, THERE'S A SIDE-BY-SIDE 3338 02:04:14,080 --> 02:04:16,400 COMPARISON OF THE OLD ORIGINAL 3339 02:04:16,400 --> 02:04:17,680 NUTRITION FACTS LABEL, AND THE 3340 02:04:17,680 --> 02:04:18,680 NEW LABEL. 3341 02:04:18,680 --> 02:04:20,520 I KNOW YOU CAN'T READ A LOT OF 3342 02:04:20,520 --> 02:04:23,360 THAT PROBABLY UNLESS YOU HAVE A 3343 02:04:23,360 --> 02:04:27,320 PRETTY GOOD MONITOR, BUT I WILL 3344 02:04:27,320 --> 02:04:32,320 HIGHLIGHT SOME THINGS. 3345 02:04:32,320 --> 02:04:34,520 SERVING SIZE, THE FONT HAD TO BE 3346 02:04:34,520 --> 02:04:39,240 PUT INTO A LARGER FONT FOR THE 3347 02:04:39,240 --> 02:04:40,680 SERVING SIZE. 3348 02:04:40,680 --> 02:04:42,120 NUMBER OF CALORIES, OLD LABEL 3349 02:04:42,120 --> 02:04:44,680 HAD A VERY SMALL FONT SIZE, 3350 02:04:44,680 --> 02:04:45,840 NUMBER OF CALORIES AND PRODUCT 3351 02:04:45,840 --> 02:04:49,480 PER SERVING HAD TO BE PUT IN 3352 02:04:49,480 --> 02:04:50,520 LARGER FONT AND BOLDED. 3353 02:04:50,520 --> 02:04:53,400 ADDED SUGARS HAVE TO BE DECLARED 3354 02:04:53,400 --> 02:04:54,920 IN THE NEW LABEL. 3355 02:04:54,920 --> 02:04:58,560 THERE'S A CHANGE IN REQUIRED 3356 02:04:58,560 --> 02:04:59,080 NUTRIENTS. 3357 02:04:59,080 --> 02:04:59,720 UPDATED DAILY VALUE. 3358 02:04:59,720 --> 02:05:06,600 ACTUAL AMOUNTS HAVE TO BE 3359 02:05:06,600 --> 02:05:08,640 DECLARED INSTEAD OF 3360 02:05:08,640 --> 02:05:09,320 INTERNATIONAL UNITS, MICROGRAMS, 3361 02:05:09,320 --> 02:05:13,160 MILIGRAMS HAVE TO BE DECLARED 3362 02:05:13,160 --> 02:05:15,480 FOR CERTAIN VITAMINS. 3363 02:05:15,480 --> 02:05:19,520 A NEW FOOTNOTE WAS ADDED. 3364 02:05:19,520 --> 02:05:22,800 THE NUTRIENT CONTENT CLAIM IS 3365 02:05:22,800 --> 02:05:24,520 THERE, SO YOU'LL SEE FATS, FOR 3366 02:05:24,520 --> 02:05:26,640 INSTANCE, THERE WILL BE A 3367 02:05:26,640 --> 02:05:28,560 LISTING OF THE ACTUAL AMOUNT OF 3368 02:05:28,560 --> 02:05:30,240 FAT IN THE PRODUCT. 3369 02:05:30,240 --> 02:05:32,920 ALONG WITH THE PERCENT DAILY 3370 02:05:32,920 --> 02:05:35,520 VALUE FOR A CERTAIN SIZE CALORIE 3371 02:05:35,520 --> 02:05:36,600 INTAKE. 3372 02:05:36,600 --> 02:05:41,680 SO THAT'S THE NUTRIENT CONTENT 3373 02:05:41,680 --> 02:05:44,480 CLAIM AND DAILY VALUE. 3374 02:05:44,480 --> 02:05:45,240 OKAY. 3375 02:05:45,240 --> 02:05:46,400 CLAIMS, THIS IS PROBABLY THE 3376 02:05:46,400 --> 02:05:47,960 MOST CONTROVERSIAL PART, THE 3377 02:05:47,960 --> 02:05:50,000 PART I'LL SPEND THE MOST TIME O 3378 02:05:50,000 --> 02:05:51,400 HEALTH CLAIMS DESCRIBE THE 3379 02:05:51,400 --> 02:05:52,920 RELATIONSHIP BETWEEN A SUBSTANCE 3380 02:05:52,920 --> 02:05:55,120 AND DISEASE OR HEALTH-RELATED 3381 02:05:55,120 --> 02:05:55,560 CONDITION. 3382 02:05:55,560 --> 02:05:59,440 HEALTH CLAIMS FOR FOODS REQUIRE 3383 02:05:59,440 --> 02:06:01,160 PRIOR AUTHORIZATION BY FDA. 3384 02:06:01,160 --> 02:06:03,920 THERE'S ALSO A CATEGORY OF 3385 02:06:03,920 --> 02:06:05,440 HEALTH CLAIMS THAT DO NOT 3386 02:06:05,440 --> 02:06:09,040 REQUIRE -- THEY SORT OF REQUIRE 3387 02:06:09,040 --> 02:06:10,520 PRIOR AUTHORIZATION BUT I'LL 3388 02:06:10,520 --> 02:06:11,880 TALK MORE ABOUT THAT IN DETAIL. 3389 02:06:11,880 --> 02:06:12,920 SO, THERE ARE TWO TYPES OF 3390 02:06:12,920 --> 02:06:13,640 HEALTH CLAIMS. 3391 02:06:13,640 --> 02:06:15,680 THERE ARE QUALIFIED HEALTH 3392 02:06:15,680 --> 02:06:17,480 CLAIMS AND UNQUALIFIED HEALTH 3393 02:06:17,480 --> 02:06:17,720 CLAIMS. 3394 02:06:17,720 --> 02:06:19,600 THE FIRST HEALTH CLAIMS THAT 3395 02:06:19,600 --> 02:06:21,760 WERE PERMITTED BY THE NLEA ARE 3396 02:06:21,760 --> 02:06:23,720 WHAT WE CALL UNQUALIFIED HEALTH 3397 02:06:23,720 --> 02:06:23,960 CLAIMS. 3398 02:06:23,960 --> 02:06:26,680 THE STANDARD FOR THAT AS I 3399 02:06:26,680 --> 02:06:29,120 MENTIONED EARLIER IS SIGNIFICANT 3400 02:06:29,120 --> 02:06:31,960 SCIENTIFIC AGREEMENT WHICH IN 3401 02:06:31,960 --> 02:06:34,920 THE PROCESS INVOLVES RULEMAKING, 3402 02:06:34,920 --> 02:06:41,800 ONE SUBMITS ONE'S DATA TO FDA. 3403 02:06:41,800 --> 02:06:44,000 FDA REVIEWS AND IF THEY AGREE 3404 02:06:44,000 --> 02:06:46,200 DATA ARE SUPPORTED THEY WILL 3405 02:06:46,200 --> 02:06:47,840 ISSUE A REGULATION, A RULE THAT 3406 02:06:47,840 --> 02:06:50,560 SAYS YOU CAN MAKE THIS CLAIM AND 3407 02:06:50,560 --> 02:06:53,080 THERE'S CAVEATS AND ALL SORTS OF 3408 02:06:53,080 --> 02:06:53,640 THINGS. 3409 02:06:53,640 --> 02:06:56,480 THE CLAIM HAS TO BE WORDED A 3410 02:06:56,480 --> 02:07:01,520 CERTAIN WAY. 3411 02:07:01,520 --> 02:07:03,320 IT HAS TO BE PRESENTED USING 3412 02:07:03,320 --> 02:07:07,640 CERTAIN WORDS IN TERMS OF -- 3413 02:07:07,640 --> 02:07:09,840 CLAIM, THE INTENDED USE MUST BE 3414 02:07:09,840 --> 02:07:15,280 THE SAME AS PRESENTED IN THE 3415 02:07:15,280 --> 02:07:16,040 EVIDENCE. 3416 02:07:16,040 --> 02:07:21,200 SO, THERE ARE STILL -- THERE ARE 3417 02:07:21,200 --> 02:07:25,120 SOME RULES ASSOCIATED WITH THE 3418 02:07:25,120 --> 02:07:26,040 HEALTH CLAIM. 3419 02:07:26,040 --> 02:07:27,760 QUALIFIED HEALTH CLAIMS IS 3420 02:07:27,760 --> 02:07:28,240 DIFFERENT. 3421 02:07:28,240 --> 02:07:32,120 A FIRST AMENDMENT CASE WAS 3422 02:07:32,120 --> 02:07:36,880 BROUGHT AGAINST -- SOMETIME IN 3423 02:07:36,880 --> 02:07:38,760 THE LATE '90s, AND IT SAID 3424 02:07:38,760 --> 02:07:39,920 BASICALLY THAT COMPANIES ARE 3425 02:07:39,920 --> 02:07:42,120 ALLOWED TO SAY THINGS THAT ARE 3426 02:07:42,120 --> 02:07:43,760 TRUE ON A LABEL. 3427 02:07:43,760 --> 02:07:48,360 AND SO THERE WAS SOME BACK AND 3428 02:07:48,360 --> 02:07:50,920 FORTH IN THE COURTS, FDA, 3429 02:07:50,920 --> 02:07:51,400 RULE-MAKING PROCESS. 3430 02:07:51,400 --> 02:07:53,680 9 3431 02:07:53,680 --> 02:07:55,000 THE END WAS COMPANIES ARE 3432 02:07:55,000 --> 02:07:57,280 ALLOWED TO MAKE QUALIFIED HEALTH 3433 02:07:57,280 --> 02:07:59,480 CLAIMS MEANING YOU CAN SAY THAT 3434 02:07:59,480 --> 02:08:01,960 AN INGREDIENT DOES GOOD THINGS 3435 02:08:01,960 --> 02:08:03,960 FOR YOU, AS LONG AS YOU PROVIDE 3436 02:08:03,960 --> 02:08:10,040 ALL OF THE CAVEATS AND 3437 02:08:10,040 --> 02:08:12,400 DISCLAIMERS THAT ARE IN THE 3438 02:08:12,400 --> 02:08:12,800 EVIDENCE. 3439 02:08:12,800 --> 02:08:14,120 IF, SAY, FOR AN UNQUALIFIED 3440 02:08:14,120 --> 02:08:15,600 CLAIM YOU MAY HAVE TEN STUDIES 3441 02:08:15,600 --> 02:08:19,120 ALL OF WHICH SAY AN INGREDIENT 3442 02:08:19,120 --> 02:08:22,320 OR NUTRIENT IS GOOD FOR REDUCING 3443 02:08:22,320 --> 02:08:22,600 CHOLESTEROL. 3444 02:08:22,600 --> 02:08:24,640 THAT WOULD BE A GOOD BASIS FOR 3445 02:08:24,640 --> 02:08:27,360 AN UNQUALIFIED HEALTH CLAIM. 3446 02:08:27,360 --> 02:08:32,920 IF THREE OF SEVEN STUDIES SAID 3447 02:08:32,920 --> 02:08:34,800 THIS MATERIAL MAY LOWER 3448 02:08:34,800 --> 02:08:36,320 CHOLESTEROL, TWO STUDIES WERE 3449 02:08:36,320 --> 02:08:39,080 EQUIVOCAL IN RESULTS, ONE STUDY 3450 02:08:39,080 --> 02:08:41,160 SAID THERE WAS NO, YOU KNOW, 3451 02:08:41,160 --> 02:08:44,320 THERE WAS NO REDUCTION, THEN YOU 3452 02:08:44,320 --> 02:08:47,960 COULD MAKE THE CLAIM THAT THIS 3453 02:08:47,960 --> 02:08:48,480 INGREDIENT MAY LOWER 3454 02:08:48,480 --> 02:08:51,320 CHOLESTEROL, BUT YOU WOULD ALSO 3455 02:08:51,320 --> 02:08:54,840 HAVE TO INCLUDE ALL OF THOSE 3456 02:08:54,840 --> 02:08:56,480 CAVEATS AND DISCLAIMERS AS PART 3457 02:08:56,480 --> 02:09:03,240 OF THE CLAIM, ON THE LABEL. 3458 02:09:03,240 --> 02:09:06,440 WHICH OF COURSE LEADS TO TINY 3459 02:09:06,440 --> 02:09:08,000 FONT AND LARGE LABELS, NOT 3460 02:09:08,000 --> 02:09:10,560 PRACTICAL ON A SMALL PACKAGE 3461 02:09:10,560 --> 02:09:10,800 SIZE. 3462 02:09:10,800 --> 02:09:12,440 QUALIFIED HEALTH CLAIMS DON'T 3463 02:09:12,440 --> 02:09:14,880 UNDERGROW RULEMAKING. 3464 02:09:14,880 --> 02:09:19,120 FDA DRAFTS A LETTER OF 3465 02:09:19,120 --> 02:09:19,600 REGULATORY ENFORCEMENT 3466 02:09:19,600 --> 02:09:20,800 DISCRETION, WHEREBY THEY JUST 3467 02:09:20,800 --> 02:09:22,760 SAY, WELL, WE'RE NOT GOING TO GO 3468 02:09:22,760 --> 02:09:24,760 AFTER THESE GUYS THAT MAKE THESE 3469 02:09:24,760 --> 02:09:27,240 CLAIMS AS LONG AS THOSE CAVEATS 3470 02:09:27,240 --> 02:09:30,000 ON THE LABELING IS APPROPRIATE. 3471 02:09:30,000 --> 02:09:30,600 NO RULEMAKING. 3472 02:09:30,600 --> 02:09:32,720 YOU GET TO MAKE YOUR CLAIM. 3473 02:09:32,720 --> 02:09:39,040 AND IF YOU MESS UP SOMEHOW, THEN 3474 02:09:39,040 --> 02:09:45,880 FDA CAN REVOKE THAT ENFORCEMENT 3475 02:09:45,880 --> 02:09:46,400 DISCRETION LETTER. 3476 02:09:46,400 --> 02:09:49,240 HEALTH CLAIMS COULD BE MADE FOR 3477 02:09:49,240 --> 02:09:55,160 CONVENTIONAL FOODS AND DIETARY 3478 02:09:55,160 --> 02:09:55,680 SUPPLEMENTS. 3479 02:09:55,680 --> 02:09:57,240 THERE WAS A FIGHT FOR A WHILE 3480 02:09:57,240 --> 02:09:58,440 ABOUT WHETHER OR NOT FIBER 3481 02:09:58,440 --> 02:10:02,240 SHOULD OR SHOULD NOT BE 3482 02:10:02,240 --> 02:10:03,520 CONSIDERED A NUTRIENT. 3483 02:10:03,520 --> 02:10:05,200 AND THESE CLAIMS MUST IDENTIFY 3484 02:10:05,200 --> 02:10:06,560 THE NEW OF NUTRIENT LABEL TO 3485 02:10:06,560 --> 02:10:11,040 WHICH THE CLAIM REFERS. 3486 02:10:11,040 --> 02:10:13,120 SO, X AMOUNT OF THIS INGREDIENT 3487 02:10:13,120 --> 02:10:15,400 HAS SHOWN THAT THE CAN REDUCE 3488 02:10:15,400 --> 02:10:16,280 CHOLESTEROL LEVELS, FOR 3489 02:10:16,280 --> 02:10:19,040 INSTANCE, AS AN EXAMPLE. 3490 02:10:19,040 --> 02:10:21,960 SO, WHY IS ALL THIS IMPORTANT? 3491 02:10:21,960 --> 02:10:25,000 WELL, BACK JUST IN THE LEAD UP 3492 02:10:25,000 --> 02:10:30,040 TO NLEA THERE WAS SOME RESEARCH 3493 02:10:30,040 --> 02:10:38,280 THAT SHOWED THINGS LIKE FIBER 3494 02:10:38,280 --> 02:10:41,680 MAY HELP PREVENT -- LOWER 3495 02:10:41,680 --> 02:10:42,640 CREDITS WHICH MIGHT PREVENT 3496 02:10:42,640 --> 02:10:45,720 CARDIOVASCULAR DISEASE. 3497 02:10:45,720 --> 02:10:48,680 YOU STARTED SEEING HEART SYMBOLS 3498 02:10:48,680 --> 02:10:55,960 ON CEREAL BOXES, BY THE 3499 02:10:55,960 --> 02:10:58,280 INTERPRETATION OF LAW, THAT 3500 02:10:58,280 --> 02:10:59,680 CLASSIFIED AS DRUG. 3501 02:10:59,680 --> 02:11:01,640 THE ONLY REASON YOU'RE LOWERING 3502 02:11:01,640 --> 02:11:04,400 CHOLESTEROL IS PREVENT HEART 3503 02:11:04,400 --> 02:11:05,720 DISEASE, THEREFORE PUTTING THAT 3504 02:11:05,720 --> 02:11:11,840 HEART SYMBOL ON YOUR CHEERIOS 3505 02:11:11,840 --> 02:11:14,160 BOX COULD ACCIDENTLY RECLASSIFY 3506 02:11:14,160 --> 02:11:16,880 YOUR CHEERIOS AS A DRUG. 3507 02:11:16,880 --> 02:11:18,640 AND OF COURSE IF YOUR CHEERIOS 3508 02:11:18,640 --> 02:11:21,320 HAD NOT GONE THROUGH PRE-MARKET 3509 02:11:21,320 --> 02:11:23,480 REVIEW PROCESS WITH FDA, THEN IT 3510 02:11:23,480 --> 02:11:25,280 WAS AN ADULTERATED DRUG, HAD NOT 3511 02:11:25,280 --> 02:11:27,040 BEEN APPROVED, HAD NOT GONE 3512 02:11:27,040 --> 02:11:28,280 THROUGH THE APPROVAL PROCESS. 3513 02:11:28,280 --> 02:11:29,920 THEREFORE IT WAS ILLEGAL. 3514 02:11:29,920 --> 02:11:32,120 SO, THE CONGRESS WANTED TO MAKE 3515 02:11:32,120 --> 02:11:34,240 A COMMON SENSE REMEDY TO THAT. 3516 02:11:34,240 --> 02:11:39,720 SO, WHAT THEY DID IS PERMITTED 3517 02:11:39,720 --> 02:11:41,600 HEALTH CLAIMS. 3518 02:11:41,600 --> 02:11:42,920 SO, CURE, TREAT, PREVENT, 3519 02:11:42,920 --> 02:11:44,840 MITIGATE IS NOW PERMITTED. 3520 02:11:44,840 --> 02:11:48,160 YOU CAN SEE NOW SEE A CHEERIOS 3521 02:11:48,160 --> 02:11:51,520 BOX WITH THAT HEART OR LOWER 3522 02:11:51,520 --> 02:11:53,640 CHOLESTEROL SYMBOL THANKS TO 3523 02:11:53,640 --> 02:11:54,360 NLEA. 3524 02:11:54,360 --> 02:11:58,600 THERE IS A FAIRLY SHORT LIST, 3525 02:11:58,600 --> 02:12:04,720 KIND OF STABLE FOR A NUMBER OF 3526 02:12:04,720 --> 02:12:06,920 YEARS, SO THERE'S A RELATIVELY 3527 02:12:06,920 --> 02:12:08,240 SHORT LIST OF AUTHORIZED HEALTH 3528 02:12:08,240 --> 02:12:10,240 CLAIMS THAT MEET THAT 3529 02:12:10,240 --> 02:12:10,960 SIGNIFICANT SCIENTIFIC AGREEMENT 3530 02:12:10,960 --> 02:12:11,600 STANDARD. 3531 02:12:11,600 --> 02:12:15,040 THESE ARE THE AUTHORIZED HEALTH 3532 02:12:15,040 --> 02:12:15,800 CLAIMS. 3533 02:12:15,800 --> 02:12:19,800 CALCIUM, VITAMIN D AND 3534 02:12:19,800 --> 02:12:30,360 OSTEOPOROSIS LIPIDS AND CANCER, 3535 02:12:31,480 --> 02:12:32,200 SATURATED FAD AND CHOLESTEROL, 3536 02:12:32,200 --> 02:12:33,080 DENTAL CARIES. 3537 02:12:33,080 --> 02:12:34,600 ALL HAVE BEEN AROUND FOR A 3538 02:12:34,600 --> 02:12:34,800 WHILE. 3539 02:12:34,800 --> 02:12:36,680 THE MAIN CHANGE IN THE LAST 3540 02:12:36,680 --> 02:12:39,440 NUMBER OF YEARS IS THAT FDA 3541 02:12:39,440 --> 02:12:45,000 PROPOSED TO REVOKE THE SOY 3542 02:12:45,000 --> 02:12:46,080 PROTEIN AND CARDIOVASCULAR 3543 02:12:46,080 --> 02:12:47,040 DISEASE AUTHORIZED HEALTH CLAIM, 3544 02:12:47,040 --> 02:12:48,400 THAT PROPOSAL WAS MADE IN 2017, 3545 02:12:48,400 --> 02:12:54,440 AS FAR AS I KNOW THAT HAS NOT 3546 02:12:54,440 --> 02:12:57,160 GONE ANYWHERE SINCE. 3547 02:12:57,160 --> 02:12:58,640 A RELATIVELY SHORT LIST OF 3548 02:12:58,640 --> 02:12:59,480 AUTHORIZED HEALTH CLAIMS. 3549 02:12:59,480 --> 02:13:01,080 THE SLIDES ARE AVAILABLE. 3550 02:13:01,080 --> 02:13:03,040 I GOT THIS DIRECTLY FROM FDA'S 3551 02:13:03,040 --> 02:13:05,560 WEBSITE, YOU SEE THE URL DOWN 3552 02:13:05,560 --> 02:13:05,760 THERE. 3553 02:13:05,760 --> 02:13:07,400 THEN THERE ARE THE QUALIFIED 3554 02:13:07,400 --> 02:13:08,200 HEALTH CLAIMS. 3555 02:13:08,200 --> 02:13:12,040 AS MENTIONED THEY ARE SUPPORTED 3556 02:13:12,040 --> 02:13:14,360 BY SCIENTIFIC EVIDENCE BUT DON'T 3557 02:13:14,360 --> 02:13:15,480 MEET RIGOROUS SCIENTIFIC 3558 02:13:15,480 --> 02:13:16,800 AGREEMENT STANDARD. 3559 02:13:16,800 --> 02:13:19,080 THE DISCLAIMER OR OTHER 3560 02:13:19,080 --> 02:13:23,000 QUALIFYING LANGUAGE TO 3561 02:13:23,000 --> 02:13:24,120 ACCURATELY COMMUNICATE LEVEL OF 3562 02:13:24,120 --> 02:13:25,080 EVIDENCE HAS TO BE ON THE LABEL 3563 02:13:25,080 --> 02:13:27,440 AS PART OF THE CLAIM. 3564 02:13:27,440 --> 02:13:29,240 FDA DOESN'T APPROVE THESE 3565 02:13:29,240 --> 02:13:31,160 QUALIFIED HEALTH CLAIMS. 3566 02:13:31,160 --> 02:13:33,520 FOOD MANUFACTURERS PETITION THE 3567 02:13:33,520 --> 02:13:39,120 AGENCY TO CONSIDER EXERCISING 3568 02:13:39,120 --> 02:13:40,080 INENFORCEMENT DISCRETION AND FDA 3569 02:13:40,080 --> 02:13:44,480 CAN ISSUE A LETTER OF 3570 02:13:44,480 --> 02:13:45,920 ENFORCEMENT DISCRETION, THE 3571 02:13:45,920 --> 02:13:47,200 PROCESS DOES NOT INVOLVE 3572 02:13:47,200 --> 02:13:50,520 RULEMAKING SO THAT'S KIND OF 3573 02:13:50,520 --> 02:13:50,800 COMPLICATED. 3574 02:13:50,800 --> 02:13:54,120 THEN WE COME TO DIETARY 3575 02:13:54,120 --> 02:13:54,400 SUPPLEMENTS. 3576 02:13:54,400 --> 02:13:56,080 THE DEFINITION, THIS IS THE KEY, 3577 02:13:56,080 --> 02:13:58,240 THE FIRST SENTENCE, FIRST 3578 02:13:58,240 --> 02:14:00,640 BULLET, ANY PRODUCT OTHER THAN 3579 02:14:00,640 --> 02:14:04,400 TOBACCO THAT CONTAINS A VITAMIN, 3580 02:14:04,400 --> 02:14:05,440 MINERAL, HERB OR BOTANICAL OR 3581 02:14:05,440 --> 02:14:09,080 AMINO ACID INTENDED AS A 3582 02:14:09,080 --> 02:14:13,080 SUPPLEMENT TO THE DIET, INTENDED 3583 02:14:13,080 --> 02:14:14,560 USE, DEFINES A DIETARY 3584 02:14:14,560 --> 02:14:14,920 SUPPLEMENT. 3585 02:14:14,920 --> 02:14:16,320 CONGRESS ADDED SOME OTHER 3586 02:14:16,320 --> 02:14:19,400 THINGS, WHAT CAN BE INCLUDED IN 3587 02:14:19,400 --> 02:14:23,440 THAT SUPPLEMENT, THE DIET, 3588 02:14:23,440 --> 02:14:23,920 CATEGORY. 3589 02:14:23,920 --> 02:14:24,640 CONCENTRATE METABOLITE 3590 02:14:24,640 --> 02:14:28,440 CONSTITUENT OR COMBINATION OF 3591 02:14:28,440 --> 02:14:29,880 VITAMIN, MINERAL, HERB, 3592 02:14:29,880 --> 02:14:32,000 BOTANICAL, ET CETERA CAN ALSO BE 3593 02:14:32,000 --> 02:14:32,840 DIETARY INGREDIENT. 3594 02:14:32,840 --> 02:14:34,840 AS FOR FOODS FDA BE ON CONGRESS 3595 02:14:34,840 --> 02:14:36,360 SET OUT A GRANDFATHER DATE, 3596 02:14:36,360 --> 02:14:37,600 DIETARY INGREDIENTS THAT HAVE 3597 02:14:37,600 --> 02:14:40,720 BEEN PRESENT IN THE FOOD SUPPLY 3598 02:14:40,720 --> 02:14:42,480 PRIOR TO 1994, AS ARTICLES USED 3599 02:14:42,480 --> 02:14:44,120 FOR FOOD IN A FORM IN WHICH THE 3600 02:14:44,120 --> 02:14:47,920 FOOD HAS NOT BEEN CHEMICALLY 3601 02:14:47,920 --> 02:14:48,720 ALTERED ARE GRANDFATHERED. 3602 02:14:48,720 --> 02:14:49,720 IF YOU CAN SHOW YOUR INGREDIENT 3603 02:14:49,720 --> 02:14:53,120 WAS ON THE MARKET PRIOR TO 1994, 3604 02:14:53,120 --> 02:14:54,760 THEN YOU'RE GRANDFATHERED AND DO 3605 02:14:54,760 --> 02:14:57,600 NOT NEED TO FILE A NEW DIETARY 3606 02:14:57,600 --> 02:14:59,120 INGREDIENT NOTIFICATION. 3607 02:14:59,120 --> 02:15:00,560 IF IT'S NOT GRANDFATHERED YOU 3608 02:15:00,560 --> 02:15:06,360 NEED TO FILE A NEW DIETARY 3609 02:15:06,360 --> 02:15:07,320 INGREDIENT NOTIFICATION. 3610 02:15:07,320 --> 02:15:10,840 IT SHOULD BE A 75-DAY NOVEMBER, 3611 02:15:10,840 --> 02:15:11,360 SORRY. 3612 02:15:11,360 --> 02:15:14,120 NOBODY REQUIRES A 74-DAY 3613 02:15:14,120 --> 02:15:14,680 NOTIFICATION. 3614 02:15:14,680 --> 02:15:20,600 SO, I'M NOT GOING TO COVER THAT. 3615 02:15:20,600 --> 02:15:22,120 ACCORDING TO FDA AND INDUSTRY 3616 02:15:22,120 --> 02:15:24,000 SOURCES THE INDUSTRY HAS BEEN 3617 02:15:24,000 --> 02:15:26,920 WOEFULLY INADEQUATE IN FILING 3618 02:15:26,920 --> 02:15:28,600 DIETARY INGREDIENT 3619 02:15:28,600 --> 02:15:29,160 NOTIFICATIONS. 3620 02:15:29,160 --> 02:15:32,560 IT WON'T COMMENT ON ACCURACY OF 3621 02:15:32,560 --> 02:15:35,160 THAT, OF THAT CLAIM. 3622 02:15:35,160 --> 02:15:36,440 I WOULD JUST SAY THAT THERE 3623 02:15:36,440 --> 02:15:41,200 SEEMS TO BE MORE INGREDIENTS ON 3624 02:15:41,200 --> 02:15:48,720 THE MARKET THAN NEW DIETARY 3625 02:15:48,720 --> 02:15:50,000 INGREDIENT NOTIFICATIONS. 3626 02:15:50,000 --> 02:15:55,240 TWO THINGS WE'LL COVER TODAY 3627 02:15:55,240 --> 02:15:56,200 INGREDIENT CANNOT BE PRE-1994 3628 02:15:56,200 --> 02:15:56,960 APPROVED DRUG. 3629 02:15:56,960 --> 02:16:04,160 WE'LL TALK ABOUT THIS LATER BUT 3630 02:16:04,160 --> 02:16:10,440 THE MAIN EXAMPLE WAS APPROVED IN 3631 02:16:10,440 --> 02:16:12,960 1963 AS A DRUG, CANNOT BE THE 3632 02:16:12,960 --> 02:16:16,160 SUBJECT OF PUBLICLY AVAILABLE 3633 02:16:16,160 --> 02:16:16,880 PRE-94 INVESTIGATIONAL DRUG 3634 02:16:16,880 --> 02:16:17,440 APPLICATION. 3635 02:16:17,440 --> 02:16:21,800 THAT COMES UP IN A VERY 3636 02:16:21,800 --> 02:16:25,960 CONTROVERSIAL INGREDIENT, CBD, 3637 02:16:25,960 --> 02:16:28,360 SUBJECT OF A PRE-1994 3638 02:16:28,360 --> 02:16:28,920 INVESTIGATIONAL NEW DRUG 3639 02:16:28,920 --> 02:16:34,760 APPLICATION FOR CERTAIN FORMS OF 3640 02:16:34,760 --> 02:16:37,360 EPILEPSY, CHILDHOOD EPILEPSY. 3641 02:16:37,360 --> 02:16:38,160 DIETARY SUPPLEMENTS ARE 3642 02:16:38,160 --> 02:16:39,360 CONSIDERED A SPECIAL CATEGORY OF 3643 02:16:39,360 --> 02:16:40,600 FOOD AND CANNOT BE REPRESENTED 3644 02:16:40,600 --> 02:16:44,960 AS A FOOD OR MEAL REPLACEMENT. 3645 02:16:44,960 --> 02:16:46,160 THESE ARE SUPPLEMENTARY, YOU'RE 3646 02:16:46,160 --> 02:16:50,320 NOT ALLOWED TO CLAIM IF YOU TAKE 3647 02:16:50,320 --> 02:16:51,840 THIS PILL IT'S LIKE HAVING A 3648 02:16:51,840 --> 02:16:52,480 STEAK DINNER. 3649 02:16:52,480 --> 02:17:00,360 IT DOESN'T WORK THAT WAY. 3650 02:17:00,360 --> 02:17:03,240 DR. GHACHE NOTED ABOUT THE 3651 02:17:03,240 --> 02:17:04,120 VITAMIN SUPPLEMENTS AND THEIR 3652 02:17:04,120 --> 02:17:06,920 HISTORY ALMOST FROM THE FIRST 3653 02:17:06,920 --> 02:17:10,880 DAYS OF THE DISCOVERY OF 3654 02:17:10,880 --> 02:17:12,960 VITAMINS, ENTREPRENEURS AND 3655 02:17:12,960 --> 02:17:13,680 SCIENTISTS, MEDICAL DOCTORS, 3656 02:17:13,680 --> 02:17:15,480 THOUGHT IT WOULD BE A GOOD IDEA 3657 02:17:15,480 --> 02:17:18,360 TO MAKE SURE EVERYBODY GETS 3658 02:17:18,360 --> 02:17:26,440 ENOUGH OF THESE NEWLY DISCOVERED 3659 02:17:26,440 --> 02:17:31,160 VITOMERS AS ORIGINAL COMPOUNDS 3660 02:17:31,160 --> 02:17:35,720 WERE CALLED, PEOPLE SOLD THEM. 3661 02:17:35,720 --> 02:17:37,040 REGULATIONS GOVERNING FOR FOR 3662 02:17:37,040 --> 02:17:42,320 SPECIAL DIETARY USE BEGINNING IN 3663 02:17:42,320 --> 02:17:42,760 1941. 3664 02:17:42,760 --> 02:17:44,360 NOW, THE STRICTURES FOR WHEN 3665 02:17:44,360 --> 02:17:45,920 SOMETHING MIGHT BE CONSIDER FOR 3666 02:17:45,920 --> 02:17:50,720 SPECIAL DIETARY USE WERE FAIRLY 3667 02:17:50,720 --> 02:17:51,800 CONTAINED, FAIRLY STRICT, AND 3668 02:17:51,800 --> 02:17:56,000 THEREFORE KIND OF RESTRICTIVE IN 3669 02:17:56,000 --> 02:17:56,960 THE MARKETPLACE. 3670 02:17:56,960 --> 02:17:59,160 BUT FDA HAD SOME HIGH PROFILE 3671 02:17:59,160 --> 02:18:00,840 CASES WHERE THEY STARTED GOING 3672 02:18:00,840 --> 02:18:05,200 AFTER A COUPLE COMPANIES SELLING 3673 02:18:05,200 --> 02:18:08,680 VITAMIN AND MINERAL SUPPLEMENTS. 3674 02:18:08,680 --> 02:18:11,360 MEAN 1962 AND 1973 FDA ATTEMPTED 3675 02:18:11,360 --> 02:18:12,720 TO PASS MORE RESTRICTIVE 3676 02:18:12,720 --> 02:18:14,080 REVELATIONS WHEN DIETARY USE 3677 02:18:14,080 --> 02:18:17,800 INDICATIONS SEEMED TO BE GETTING 3678 02:18:17,800 --> 02:18:19,000 OUT OF HAND. 3679 02:18:19,000 --> 02:18:22,520 AND IN RESPONSE TO THAT, 3680 02:18:22,520 --> 02:18:25,120 CONGRESS PASSED A VITAMIN AND 3681 02:18:25,120 --> 02:18:30,000 MINERAL LEGISLATION IN 1976, THE 3682 02:18:30,000 --> 02:18:31,040 ROGERS/PROXMIRE AMENDMENT, THAT 3683 02:18:31,040 --> 02:18:33,240 SPECIFICALLY PROHIBITED FDA FROM 3684 02:18:33,240 --> 02:18:35,240 CLASSIFYING VITAMIN AND MINERAL 3685 02:18:35,240 --> 02:18:36,680 SUPPLEMENTS AS DRUGS BASED 3686 02:18:36,680 --> 02:18:41,000 SOLELY ON THEIR COMBINATIONS OR 3687 02:18:41,000 --> 02:18:42,200 POTENCY UNLESS AN ACTUAL DRUG 3688 02:18:42,200 --> 02:18:43,680 CLAIM WAS MADE FOR THE PRODUCT. 3689 02:18:43,680 --> 02:18:48,240 SO THAT'S A LITTLE BIT OF THE 3690 02:18:48,240 --> 02:18:50,160 HISTORY OF DIETARY SUPPLEMENT 3691 02:18:50,160 --> 02:18:50,480 REGULATION. 3692 02:18:50,480 --> 02:18:53,160 THERE'S AN AWFUL LOT OF 3693 02:18:53,160 --> 02:18:54,920 LITERATURE PRIOR TO THAT TIME 3694 02:18:54,920 --> 02:18:56,880 THAT REFERRED TO NUTRITIONAL 3695 02:18:56,880 --> 02:19:01,920 SUPPLEMENTS RATHER THAN DIETARY 3696 02:19:01,920 --> 02:19:03,360 SUPPLEMENTS. 3697 02:19:03,360 --> 02:19:05,960 I SPECULATE THE REASON THE WORD 3698 02:19:05,960 --> 02:19:08,560 DIETARY SUM ELEMENT WAS THERE TO 3699 02:19:08,560 --> 02:19:10,520 INCLUDE THINGS NOT NUTRIENTS, SO 3700 02:19:10,520 --> 02:19:12,240 IT WOULD BE INAPPROPRIATE TO 3701 02:19:12,240 --> 02:19:14,480 CALL ST. JOHN'S WORT A 3702 02:19:14,480 --> 02:19:15,720 NUTRITIONAL SUPPLEMENT, SO 3703 02:19:15,720 --> 02:19:17,960 CONGRESS CAME UP WITH THE WORD 3704 02:19:17,960 --> 02:19:19,960 DIETARY SUPPLEMENT INSTEAD. 3705 02:19:19,960 --> 02:19:22,160 ANYBODY THAT KNOWS WHETHER 3706 02:19:22,160 --> 02:19:27,160 THAT'S SPECULATION IS TRUE, 3707 02:19:27,160 --> 02:19:28,080 PLEASE PIPE UP. 3708 02:19:28,080 --> 02:19:34,480 THIS IS PROBABLY A PRE-1970 3709 02:19:34,480 --> 02:19:36,040 PRODUCT BECAUSE CYCLAMATES WERE 3710 02:19:36,040 --> 02:19:38,480 BANNED IN 1970 BUT THERE WAS 3711 02:19:38,480 --> 02:19:39,280 CONTROVERSY WHETHER OR NOT THEY 3712 02:19:39,280 --> 02:19:41,400 WERE BAD FOR YOU BEFORE 1970. 3713 02:19:41,400 --> 02:19:45,240 THIS WAS AN IMAGE BY SEARCHING 3714 02:19:45,240 --> 02:19:47,680 E-BAY FOR IMAGES OF OLD DIETARY 3715 02:19:47,680 --> 02:19:49,240 SUPPLEMENT LABELS. 3716 02:19:49,240 --> 02:19:51,160 THIS IS CHOCKS VITAMINS. 3717 02:19:51,160 --> 02:20:00,200 I PROBABLY TOOK THESE AS A KID 3718 02:20:00,200 --> 02:20:02,520 MYSELF, SOMETHING SIMILAR. 3719 02:20:02,520 --> 02:20:04,040 MULTI-VITAMINS, IT WAS A BUCK 3720 02:20:04,040 --> 02:20:08,640 FOR 25 CAPSULES, THAT SHOWS HOW 3721 02:20:08,640 --> 02:20:09,960 OLD IT IS. 3722 02:20:09,960 --> 02:20:13,960 BACK IN THE DAY IF YOU WALKED IN 3723 02:20:13,960 --> 02:20:16,280 A HEALTH FOOD STORE, I ADMIT TO 3724 02:20:16,280 --> 02:20:18,240 CHEATING, THIS IS A CONTEMPORARY 3725 02:20:18,240 --> 02:20:20,680 PACKAGE BUT TYPICAL OF A HEALTH 3726 02:20:20,680 --> 02:20:22,360 FOOD STORE PRIOR TO 1994. 3727 02:20:22,360 --> 02:20:24,040 TO AVOID INTENDED USE STUFF, 3728 02:20:24,040 --> 02:20:26,640 WHAT YOU WOULD DO IS WALK INTO A 3729 02:20:26,640 --> 02:20:29,280 HEALTH FOOD STORE AND THERE 3730 02:20:29,280 --> 02:20:34,840 WOULD BE THIS CELLOPHANE-WRAPPED 3731 02:20:34,840 --> 02:20:38,720 PACKAGE OF MISTLETOE, OR ST. 3732 02:20:38,720 --> 02:20:40,000 JOHN'S WORT, OR SOMETHING LIKE 3733 02:20:40,000 --> 02:20:45,320 THAT, ALL ON THE LABEL IS 3734 02:20:45,320 --> 02:20:47,440 AMOUNT IN THE BAG AND WORD 3735 02:20:47,440 --> 02:20:52,280 MISSILE TO TO AVOID HAVING FDA 3736 02:20:52,280 --> 02:20:53,320 COME AFTER YOU BECAUSE YOU WERE 3737 02:20:53,320 --> 02:20:54,040 MAKING A CLAIM. 3738 02:20:54,040 --> 02:20:55,760 YOU HAD TO KNOW WHAT YOU WERE 3739 02:20:55,760 --> 02:20:57,400 SUPPOSED TO USE MISTLETOE FOR OR 3740 02:20:57,400 --> 02:21:00,040 IN MANY CASES THE CLERK WAS MORE 3741 02:21:00,040 --> 02:21:01,440 THAN HELPFUL TO RECOMMEND 3742 02:21:01,440 --> 02:21:03,560 MISTLETOE FOR THIS OR THAT 3743 02:21:03,560 --> 02:21:03,760 AILMENT. 3744 02:21:03,760 --> 02:21:08,240 YOU GO TO TO THE STORE, SAY TO 3745 02:21:08,240 --> 02:21:10,200 THE CLERK, I NEED SOMETHING 3746 02:21:10,200 --> 02:21:13,200 BECAUSE I'M CONSTIPATED, THE 3747 02:21:13,200 --> 02:21:18,000 CLERK WOULD DIRECT YOU TO THE 3748 02:21:18,000 --> 02:21:20,840 CASCERA BARK OR SOMETHING LIKE 3749 02:21:20,840 --> 02:21:21,280 THAT. 3750 02:21:21,280 --> 02:21:28,640 HERBAL PRODUCTS BEFORE 1994 WERE 3751 02:21:28,640 --> 02:21:30,800 LESS WELL LABELED; THE CONSUMER, 3752 02:21:30,800 --> 02:21:32,120 UNLESS THEY WERE INFORMED OR 3753 02:21:32,120 --> 02:21:33,640 CONSUMER WILLING TO LISTEN TO A 3754 02:21:33,640 --> 02:21:36,520 CLERK WHO MAY OR MAY NOT HAVE 3755 02:21:36,520 --> 02:21:40,320 HAD SOME EDUCATION IN HERBS OR 3756 02:21:40,320 --> 02:21:41,480 MEDICINE, REALLY DIDN'T KNOW 3757 02:21:41,480 --> 02:21:45,520 WHAT TO DO WITH A LOT OF THESE 3758 02:21:45,520 --> 02:21:46,040 BOTANICALS. 3759 02:21:46,040 --> 02:21:47,360 THERE WAS NO INTERNET, ONE WOULD 3760 02:21:47,360 --> 02:21:51,040 HAVE TO GET ONE'S INFORMATION 3761 02:21:51,040 --> 02:21:55,080 ELSEWHERE. 3762 02:21:55,080 --> 02:21:57,120 FAST FORWARD TO 1994, DIETARY 3763 02:21:57,120 --> 02:21:58,320 SUPPLEMENT LABEL, FROM THAT KIND 3764 02:21:58,320 --> 02:22:01,000 OF PRIMITIVE LABEL I JUST SHOWED 3765 02:22:01,000 --> 02:22:01,880 YOU, THE DIETARY SUPPLEMENT 3766 02:22:01,880 --> 02:22:03,600 LABEL LOOKS LIKE THIS, SIMILAR 3767 02:22:03,600 --> 02:22:06,920 TO FOOD LABEL WITH PRINCIPAL 3768 02:22:06,920 --> 02:22:08,640 DISPLAY PANEL, INFORMATION 3769 02:22:08,640 --> 02:22:10,280 PANEL. 3770 02:22:10,280 --> 02:22:12,280 WORD DIETARY SUPPLEMENT HAD TO 3771 02:22:12,280 --> 02:22:14,880 APPEAR ON THE LABEL. 3772 02:22:14,880 --> 02:22:15,520 ACTUALLY NUTRITIONAL SUPPLEMENT, 3773 02:22:15,520 --> 02:22:18,280 I'VE SEEN THAT COUNT AS WELL BUT 3774 02:22:18,280 --> 02:22:20,480 I'M NOT QUITE SURE HOW GRAY THAT 3775 02:22:20,480 --> 02:22:21,240 AREA IS. 3776 02:22:21,240 --> 02:22:22,440 THE NAME AND ADDRESS OF THE 3777 02:22:22,440 --> 02:22:25,520 PLACE OF BUSINESS HAS TO APPEAR 3778 02:22:25,520 --> 02:22:27,160 ON THE LABEL. 3779 02:22:27,160 --> 02:22:28,520 NUTRITION LABELING. 3780 02:22:28,520 --> 02:22:30,480 AND AGAIN, IT'S THE SAME IN SOME 3781 02:22:30,480 --> 02:22:33,120 WAYS AS THE FOOD LABEL, 3782 02:22:33,120 --> 02:22:34,960 NUTRITION LABELING IS REQUIRED. 3783 02:22:34,960 --> 02:22:36,680 EXCEPT INSTEAD OF NUTRITION FACT 3784 02:22:36,680 --> 02:22:38,560 OR NUTRIENT FACT PANEL YOU HAVE 3785 02:22:38,560 --> 02:22:47,400 TO HAVE A SUPPLEMENT FACT PANEL, 3786 02:22:47,400 --> 02:22:48,840 REQUIRES INGREDIENT LIST, YOU'LL 3787 02:22:48,840 --> 02:22:51,040 SEE DIETARY SUPPLEMENTS THAT SAY 3788 02:22:51,040 --> 02:22:52,920 THIS PRODUCT WAS MANUFACTURED IN 3789 02:22:52,920 --> 02:22:55,120 IN A FACILITY THAT ALSO PROCESS 3790 02:22:55,120 --> 02:22:57,920 PEANUTS, ET CETERA, ET CETERA. 3791 02:22:57,920 --> 02:23:00,240 IT ALSO REQUIRES SAME LABEL 3792 02:23:00,240 --> 02:23:02,240 IDENTIFICATION OF ARTIFICIAL 3793 02:23:02,240 --> 02:23:03,720 FLAVORING, COLORING, CHEMICAL 3794 02:23:03,720 --> 02:23:08,120 PRESERVATIVES AS THE FOOD LABEL. 3795 02:23:08,120 --> 02:23:09,720 IT REQUIRES INGREDIENT AMOUNT 3796 02:23:09,720 --> 02:23:10,720 AND IDENTITY. 3797 02:23:10,720 --> 02:23:12,600 THE IDENTITY IS REASONABLY EASY 3798 02:23:12,600 --> 02:23:13,520 FOR NUTRIENTS. 3799 02:23:13,520 --> 02:23:15,720 WE ALL PRETTY MUCH KNOW WHAT 3800 02:23:15,720 --> 02:23:18,000 VITAMIN B 6 AND B-12 ARE AND 3801 02:23:18,000 --> 02:23:20,520 WHAT THEY ARE CALLED. 3802 02:23:20,520 --> 02:23:23,680 THEY ARE STANDARD NAMES. 3803 02:23:23,680 --> 02:23:25,800 BOTANICALS, NOT SO MUCH. 3804 02:23:25,800 --> 02:23:27,800 A TALK I USED TO GIVE ABOUT A 3805 02:23:27,800 --> 02:23:30,240 DOZEN DIFFERENT LOCAL NAMES FOR 3806 02:23:30,240 --> 02:23:32,040 THE HERB BLACK COHOSH. 3807 02:23:32,040 --> 02:23:33,280 AND SO THE AMERICAN HERBAL 3808 02:23:33,280 --> 02:23:34,840 PRODUCT ASSOCIATION WHICH IS THE 3809 02:23:34,840 --> 02:23:37,160 TRADE ASSOCIATION CAME UP WITH A 3810 02:23:37,160 --> 02:23:38,880 LIST OF STANDARDIZED NAMES. 3811 02:23:38,880 --> 02:23:39,960 SO YOU WOULDN'T HAVE 27 3812 02:23:39,960 --> 02:23:47,920 DIFFERENT COMMON NAMES FOR THE 3813 02:23:47,920 --> 02:23:48,680 SAME LATIN BINOMIAL NAME. 3814 02:23:48,680 --> 02:23:49,960 IF THE INGREDIENT IS NOT IN 3815 02:23:49,960 --> 02:23:50,840 HERBS OF COMMERCE YOU'RE 3816 02:23:50,840 --> 02:23:53,160 REQUIRED TO USE THE LATIN NAME 3817 02:23:53,160 --> 02:23:54,320 ON THE LABEL. 3818 02:23:54,320 --> 02:23:55,640 WHETHER IT'S IN HERBS OF 3819 02:23:55,640 --> 02:23:56,720 COMMERCE OR NOT YOU'RE ALSO 3820 02:23:56,720 --> 02:23:58,280 REQUIRED TO LIST THE PLANT PART 3821 02:23:58,280 --> 02:23:59,720 THAT WAS USED IN THE 3822 02:23:59,720 --> 02:24:01,920 MANUFACTURER, WHETHER IT'S A 3823 02:24:01,920 --> 02:24:05,200 ROOT, LEAF, OR WHATEVER. 3824 02:24:05,200 --> 02:24:07,920 THERE'S ALSO PROPRIETARY BLEND 3825 02:24:07,920 --> 02:24:09,480 CONCEPT WHICH I'LL COVER IN A 3826 02:24:09,480 --> 02:24:09,880 BIT. 3827 02:24:09,880 --> 02:24:13,640 IT HAS TO BE -- LABEL HAS TO BE 3828 02:24:13,640 --> 02:24:16,320 21 CFR PART 101 COMPLIANT WHICH 3829 02:24:16,320 --> 02:24:18,640 IS LABELING REGULATIONS DEALING 3830 02:24:18,640 --> 02:24:20,600 WITH SUPPLEMENT FACTS, NUTRIENT 3831 02:24:20,600 --> 02:24:21,040 FACTS. 3832 02:24:21,040 --> 02:24:23,640 SO, HERE WE ARE, DIETARY 3833 02:24:23,640 --> 02:24:25,760 SUPPLEMENT LABELS, STATEMENT OF 3834 02:24:25,760 --> 02:24:26,480 IDENTITY, GINSENG, DIETARY 3835 02:24:26,480 --> 02:24:28,400 SUPPLEMENT, NET QUANTITY DOWN AT 3836 02:24:28,400 --> 02:24:32,760 THE BOTTOM, 60 CAPSULES INSTEAD 3837 02:24:32,760 --> 02:24:39,120 OF 9 OUNCES, NUTRITION LABEL, 3838 02:24:39,120 --> 02:24:43,280 INGREDIENT LIST, NAME AND PLACE 3839 02:24:43,280 --> 02:24:45,480 OF BUSINESS. 3840 02:24:45,480 --> 02:24:47,520 SO, THIS SUPPLEMENT FACTS PANEL 3841 02:24:47,520 --> 02:24:49,960 SHOWS ALL THE NUTRIENTS THAT ARE 3842 02:24:49,960 --> 02:24:52,880 IN THIS PARTICULAR PRODUCT. 3843 02:24:52,880 --> 02:24:56,080 VITAMIN A THROUGH POTASSIUM, 3844 02:24:56,080 --> 02:24:58,160 IT'S NOT ALPHABETICAL, HERE IS 3845 02:24:58,160 --> 02:24:59,960 ZINC TOWARDS THE MIDDLE. 3846 02:24:59,960 --> 02:25:02,200 IF THERE'S A DAILY VALUE 3847 02:25:02,200 --> 02:25:03,480 ESTABLISHED, THAT NOT ONLY THE 3848 02:25:03,480 --> 02:25:06,400 AMOUNT BUT DAILY VALUE HAS TO BE 3849 02:25:06,400 --> 02:25:09,080 GIVEN ON THE LABEL. 3850 02:25:09,080 --> 02:25:13,640 FOR DIETARY -- FOR DIETARY 3851 02:25:13,640 --> 02:25:14,880 SUPPLEMENTS, YOU ARE ALLOWED TO 3852 02:25:14,880 --> 02:25:18,520 LIST INGREDIENTS THAT HAVE NO 3853 02:25:18,520 --> 02:25:19,520 ESTABLISHED DIETARY VALUE. 3854 02:25:19,520 --> 02:25:29,560 OR DAILY VALUE. 3855 02:25:29,560 --> 02:25:29,960 SO, BORON, NICKEL 3856 02:25:29,960 --> 02:25:31,880 THEY ARE LISTED BUT YOU'RE 3857 02:25:31,880 --> 02:25:35,760 ALLOWED TO PUT AN ASTERISK FOR 3858 02:25:35,760 --> 02:25:36,440 DAILY VALUE. 3859 02:25:36,440 --> 02:25:39,640 I TOLD YOU I WOULD TALK ABOUT 3860 02:25:39,640 --> 02:25:40,320 PROPRIETARY BLEND CONCEPT. 3861 02:25:40,320 --> 02:25:41,720 TALK TO THE SUPPLEMENT FOLK, 3862 02:25:41,720 --> 02:25:48,480 THEY WILL TELL YOU THIS IS THE 3863 02:25:48,480 --> 02:25:50,080 SAME CONCEPT IN CONVENTIONAL 3864 02:25:50,080 --> 02:25:50,720 PACKAGED FOODS. 3865 02:25:50,720 --> 02:25:51,760 CAMPBELL'S SOUP COMPANY IS NOT 3866 02:25:51,760 --> 02:25:53,720 GOING TO TELL YOU THE EXACT 3867 02:25:53,720 --> 02:25:56,360 AMOUNT OF THE HERBS, SPICES, AND 3868 02:25:56,360 --> 02:25:58,120 TOMATOES THEY PUT INTO THEIR 3869 02:25:58,120 --> 02:25:59,720 CAMPBELL'S SOUP BECAUSE THAT'S A 3870 02:25:59,720 --> 02:26:01,720 TRADE SECRET AND THEY DON'T WANT 3871 02:26:01,720 --> 02:26:02,800 PEOPLE REVERSE ENGINEERING 3872 02:26:02,800 --> 02:26:04,960 THINGS FROM THE LABEL. 3873 02:26:04,960 --> 02:26:07,360 SO, IT'S A PROPRIETARY BLEND. 3874 02:26:07,360 --> 02:26:09,640 SO YOU'RE REQUIRED TO LIST THE 3875 02:26:09,640 --> 02:26:11,600 TOTAL AMOUNT OF THE PROPRIETARY 3876 02:26:11,600 --> 02:26:15,480 BLEND, IN THIS CASE 1,000 3877 02:26:15,480 --> 02:26:17,440 MILLIGRAMS OF THE BLEND. 3878 02:26:17,440 --> 02:26:20,160 YOU CAN CALL SOME FANCY NAME 3879 02:26:20,160 --> 02:26:23,680 LIKE, YOU KNOW, THE X FACTOR 3880 02:26:23,680 --> 02:26:26,160 PROPRIETARY BLEND, AND YOU HAVE 3881 02:26:26,160 --> 02:26:29,040 TO LIST THE AMOUNT OF X FACTOR 3882 02:26:29,040 --> 02:26:29,800 ON THE LABEL. 3883 02:26:29,800 --> 02:26:34,240 BUT THEN YOU ALSO HAVE TO LIST 3884 02:26:34,240 --> 02:26:38,560 WHAT IS ACTUALLY IN THE 3885 02:26:38,560 --> 02:26:39,760 PROPRIETARY BLEND, AND YOU HAVE 3886 02:26:39,760 --> 02:26:45,560 TO LIST IT IN TERMS OF THE 3887 02:26:45,560 --> 02:26:47,320 AMOUNT OF ITS PRESENCE IN THE 3888 02:26:47,320 --> 02:26:49,480 BLEND FROM THE HIGHEST AMOUNT TO 3889 02:26:49,480 --> 02:26:52,120 THE LOWEST AMOUNT. 3890 02:26:52,120 --> 02:27:02,640 SO IN THIS CASE IT'S EXTRACTS, 3891 02:27:03,840 --> 02:27:08,960 THE HIGHEST CONCENTRATION AT 3892 02:27:08,960 --> 02:27:12,960 THE TOP, CAYENNE WOULD BE THE 3893 02:27:12,960 --> 02:27:13,160 LOWEST. 3894 02:27:13,160 --> 02:27:15,320 THE PERCENT DAILY VALUE IN THIS 3895 02:27:15,320 --> 02:27:19,240 CASE THEY USE A SWORD INSTEAD OF 3896 02:27:19,240 --> 02:27:26,320 ASTERISK TO INDICATE NO DAILY 3897 02:27:26,320 --> 02:27:27,600 VALUE HAS BEEN ESTABLISHED. 3898 02:27:27,600 --> 02:27:31,920 HEALTH CLAIMS FOR DIETARY 3899 02:27:31,920 --> 02:27:33,920 SUPPLEMENTS ARE PERMISSIBLE, CAN 3900 02:27:33,920 --> 02:27:34,920 BE QUALIFIED OR UNQUALIFIED, BUT 3901 02:27:34,920 --> 02:27:36,040 HEALTH CLAIMS ARE ONLY ALLOWED 3902 02:27:36,040 --> 02:27:37,880 TO BE MADE FOR NUTRIENTS. 3903 02:27:37,880 --> 02:27:40,320 YOU CAN'T MAKE A HEALTH CLAIM 3904 02:27:40,320 --> 02:27:41,400 FOR THE ST. JOHN'S WART IN THE 3905 02:27:41,400 --> 02:27:45,480 PRODUCT BECAUSE IT'S NOT A 3906 02:27:45,480 --> 02:27:45,800 NUTRIENT. 3907 02:27:45,800 --> 02:27:47,080 STATEMENTS OF NUTRITIONAL 3908 02:27:47,080 --> 02:27:49,520 SUPPORT ARE PERMITTED ON DIETARY 3909 02:27:49,520 --> 02:27:51,920 SUPPLEMENTS, ALSO ON FOODS BUT 3910 02:27:51,920 --> 02:27:52,720 SELDOM USED. 3911 02:27:52,720 --> 02:27:55,880 THESE ARE ALSO KNOWN AS 3912 02:27:55,880 --> 02:27:57,960 STRUCTURE FUNCTION CLAIMS, 3913 02:27:57,960 --> 02:28:00,040 REQUIRE 30-DAY NOTIFICATION TO 3914 02:28:00,040 --> 02:28:01,320 FDA, MAINLY SO FDA CAN TELL YOU 3915 02:28:01,320 --> 02:28:04,120 WHETHER OR NOT IT'S A LEGITIMATE 3916 02:28:04,120 --> 02:28:06,400 STRUCTURE/FUNCTION CLAIM, IF YOU 3917 02:28:06,400 --> 02:28:10,000 CROSS THE LINE INTO A DRUG CLAIM 3918 02:28:10,000 --> 02:28:12,200 IT'S IN YOUR BEST INTEREST IF 3919 02:28:12,200 --> 02:28:13,920 YOU PROVIDE THE 30-DAY 3920 02:28:13,920 --> 02:28:14,760 PRE-MARKET NOTIFICATION TO FDA 3921 02:28:14,760 --> 02:28:15,560 BECAUSE THEY CAN TELL YOU 3922 02:28:15,560 --> 02:28:16,680 WHETHER OR NOT YOU NEED TO PRINT 3923 02:28:16,680 --> 02:28:18,160 UP A NEW BATCH OF LABELS BEFORE 3924 02:28:18,160 --> 02:28:25,560 YOU HAVE TO PRINT UP A NEW BATCH 3925 02:28:25,560 --> 02:28:27,880 OF LABELS. 3926 02:28:27,880 --> 02:28:31,840 THEY MAY CLAIM WHILE DISCLOSING 3927 02:28:31,840 --> 02:28:38,400 PREVALENCE OF IN THE U.S., 3928 02:28:38,400 --> 02:28:39,040 SCURVY, USUAL STUFF. 3929 02:28:39,040 --> 02:28:42,320 DESCRIBE THE ROLE OF NUTRIENT OR 3930 02:28:42,320 --> 02:28:43,440 DIETARY INGREDIENT INTENDED TO 3931 02:28:43,440 --> 02:28:50,840 AFFECT STRUCTURE OR FUNCTION OF 3932 02:28:50,840 --> 02:28:52,160 HUMANS. 3933 02:28:52,160 --> 02:28:52,960 CHARACTERIZE MECHANISM TO 3934 02:28:52,960 --> 02:28:54,360 MAINTAIN STRUCTURE OR FUNCTION, 3935 02:28:54,360 --> 02:28:56,360 DESCRIBE GENERAL WELL-BEING FROM 3936 02:28:56,360 --> 02:28:58,680 CONSUMPTION OF NUTRIENT OR 3937 02:28:58,680 --> 02:28:59,640 DIETARY AGREEMENT. 3938 02:28:59,640 --> 02:29:03,360 THEY MUST NOT CLAIM TO DIAGNOSE, 3939 02:29:03,360 --> 02:29:05,240 MITIGATE, CURE, OR PREVENT 3940 02:29:05,240 --> 02:29:05,640 DISEASE. 3941 02:29:05,640 --> 02:29:10,800 JAMIE TOLD US ABOUT THAT 3942 02:29:10,800 --> 02:29:11,040 EARLIER. 3943 02:29:11,040 --> 02:29:13,640 NOW, PEOPLE MAKE THE ASSERTION 3944 02:29:13,640 --> 02:29:15,240 THAT DIETARY SUPPLEMENTS WITH 3945 02:29:15,240 --> 02:29:16,080 NOT REGULATED. 3946 02:29:16,080 --> 02:29:16,720 THAT'S NOT TRUE. 3947 02:29:16,720 --> 02:29:17,800 THEY ARE IN FACT REGULATED. 3948 02:29:17,800 --> 02:29:19,360 THEY HAVE ALL SORTS OF 3949 02:29:19,360 --> 02:29:19,800 REGULATIONS. 3950 02:29:19,800 --> 02:29:21,080 THEY JUST ARE NOT REGULATED THE 3951 02:29:21,080 --> 02:29:23,160 SAME WAY AS DRUGS ARE. 3952 02:29:23,160 --> 02:29:25,160 SO, MANUFACTURERS ARE REQUIRED 3953 02:29:25,160 --> 02:29:27,440 TO HAVE SUBSTANTIATION THAT 3954 02:29:27,440 --> 02:29:29,080 CLAIMS ARE TRUTHFUL AND NOT 3955 02:29:29,080 --> 02:29:32,800 MISLEADING, JUST NOT REQUIRED TO 3956 02:29:32,800 --> 02:29:34,440 SHOW IT TO ANYBODY. 3957 02:29:34,440 --> 02:29:38,640 IF FDA IS ABLE TO DETERMINE THAT 3958 02:29:38,640 --> 02:29:39,920 THERE'S NO SUBSTANTIATION AND 3959 02:29:39,920 --> 02:29:43,280 THE PRODUCT AND CLAIM IS MADE, 3960 02:29:43,280 --> 02:29:46,480 THE PRODUCT IS MISBRANDED. 3961 02:29:46,480 --> 02:29:48,400 THERE IS NO PRE OR POST MARKET 3962 02:29:48,400 --> 02:29:49,480 FOR FDA SUBSTANTIATION REVIEW. 3963 02:29:49,480 --> 02:29:52,400 IF THERE'S REVIEW IT'S A 3964 02:29:52,400 --> 02:29:54,360 REVIEW -- AT ALL IT'S BY THE 3965 02:29:54,360 --> 02:29:58,680 FEDERAL TRADE COMMISSION, NOT 3966 02:29:58,680 --> 02:30:00,400 THE FDA. 3967 02:30:00,400 --> 02:30:02,360 MANDATORY LABELING, AND IF 3968 02:30:02,360 --> 02:30:04,480 CLAIMS ARE MADE NOTICE ON THE 3969 02:30:04,480 --> 02:30:06,600 LABEL CLAIMS HAVE NOT BEEN 3970 02:30:06,600 --> 02:30:08,840 EVALUATED BY THE FDA. 3971 02:30:08,840 --> 02:30:10,640 SO REGULATORY SUMMARY IS THIS. 3972 02:30:10,640 --> 02:30:13,400 DRUG IS INTENDED TO CURE, TREAT, 3973 02:30:13,400 --> 02:30:15,480 MITIGATE A DISEASE, UNSAFE BY 3974 02:30:15,480 --> 02:30:19,480 DEFINITION, UNTIL THE SPONSOR 3975 02:30:19,480 --> 02:30:20,960 APPROVES OTHERWISE. 3976 02:30:20,960 --> 02:30:22,920 PRE-MARKET APPROVAL FOR EFFICACY 3977 02:30:22,920 --> 02:30:24,480 AND SAFETY, MANDATORY 3978 02:30:24,480 --> 02:30:25,240 FORMULATION STANDARDS AND 3979 02:30:25,240 --> 02:30:26,680 PRODUCT REGISTRATION ALL OF 3980 02:30:26,680 --> 02:30:29,560 WHICH ARE ESTABLISHED DURING THE 3981 02:30:29,560 --> 02:30:31,960 NEW DRUG APPLICATION PROCESS. 3982 02:30:31,960 --> 02:30:34,800 THERE ARE LABELING RULES, 3983 02:30:34,800 --> 02:30:36,000 MANDATORY ADVERSE EVENT 3984 02:30:36,000 --> 02:30:36,240 REPORTING. 3985 02:30:36,240 --> 02:30:38,480 THERE ARE CURRENT GOOD 3986 02:30:38,480 --> 02:30:39,080 MANUFACTURING PRACTICE 3987 02:30:39,080 --> 02:30:41,440 REQUIREMENTS FOR DRUGS AS WELL. 3988 02:30:41,440 --> 02:30:43,200 SUPPLEMENTS ARE INTENDED TO 3989 02:30:43,200 --> 02:30:45,160 SUPPLEMENT THE DIET. 3990 02:30:45,160 --> 02:30:46,400 SUPPLEMENTS ARE FOOD, THEREFORE 3991 02:30:46,400 --> 02:30:49,920 THEY HAVE TO BE GRAS, THEY HAVE 3992 02:30:49,920 --> 02:30:54,160 SAFE BY DEFINITION UNLESS A NEW 3993 02:30:54,160 --> 02:30:55,000 DIETARY INGREDIENT OR NOT 3994 02:30:55,000 --> 02:30:57,000 ELIGIBLE TO BE A DIETARY 3995 02:30:57,000 --> 02:30:57,640 INGREDIENT. 3996 02:30:57,640 --> 02:31:00,920 ONCE YOU FILE NOTIFICATION AND 3997 02:31:00,920 --> 02:31:04,680 FDA FILES A LETTER OF NO 3998 02:31:04,680 --> 02:31:05,880 OPPOSITION, THEN YOU'RE ALLOWED 3999 02:31:05,880 --> 02:31:09,320 TO MARKET YOUR NEW INGREDIENT. 4000 02:31:09,320 --> 02:31:10,840 LIMITED PRE-MARKET REVIEW, THAT 4001 02:31:10,840 --> 02:31:12,800 REVIEW IS NEW DIETARY AGREEMENT 4002 02:31:12,800 --> 02:31:14,800 NOTIFICATION PROCESS, THERE'S NO 4003 02:31:14,800 --> 02:31:16,280 PRE-MARKET APPROVAL. 4004 02:31:16,280 --> 02:31:18,040 NO MANDATORY FORMULATION 4005 02:31:18,040 --> 02:31:21,480 STANDARDS AND NO PRODUCT 4006 02:31:21,480 --> 02:31:22,520 REGISTRATION FOR DIETARY 4007 02:31:22,520 --> 02:31:23,080 SUPPLEMENTS. 4008 02:31:23,080 --> 02:31:25,440 THERE ARE LABELING RULES, AS WE 4009 02:31:25,440 --> 02:31:26,360 WENT THROUGH. 4010 02:31:26,360 --> 02:31:30,120 THERE IS MANDATORY SERIOUS 4011 02:31:30,120 --> 02:31:31,400 ADVERSE EVENT REPORTING. 4012 02:31:31,400 --> 02:31:35,240 AND THERE ARE REQUIRED MANDATORY 4013 02:31:35,240 --> 02:31:36,760 CURRENT GOOD MANUFACTURING GOOD 4014 02:31:36,760 --> 02:31:38,120 PRACTICE REGULATIONS. 4015 02:31:38,120 --> 02:31:39,960 SUPPLEMENTS ARE IN FACT 4016 02:31:39,960 --> 02:31:41,240 REGULATED. 4017 02:31:41,240 --> 02:31:43,000 SO, I THINK I'M PRETTY MUCH AT 4018 02:31:43,000 --> 02:31:46,520 THE END OF MY TIME. 4019 02:31:46,520 --> 02:31:48,840 SO I DO HAVE A LITTLE BIT OF 4020 02:31:48,840 --> 02:31:52,840 CASE STUDY, I WILL ASK THE CHAIR 4021 02:31:52,840 --> 02:31:54,840 IF HE WANTS ME TO COVER THE CASE 4022 02:31:54,840 --> 02:31:56,400 STUDY OR WHETHER I SHOULD JUST 4023 02:31:56,400 --> 02:31:58,880 STOP HERE AROUND WAIT FOR 4024 02:31:58,880 --> 02:31:59,160 QUESTIONS. 4025 02:31:59,160 --> 02:32:01,240 >> YOU HAVE FIVE MORE MINUTES. 4026 02:32:01,240 --> 02:32:01,680 >> EXCELLENT. 4027 02:32:01,680 --> 02:32:01,880 OKAY. 4028 02:32:01,880 --> 02:32:03,920 I SHOULD BE ABLE TO GO THROUGH 4029 02:32:03,920 --> 02:32:05,000 THIS FAIRLY QUICKLY. 4030 02:32:05,000 --> 02:32:08,800 SO I REMEMBER COMING BACK FROM A 4031 02:32:08,800 --> 02:32:14,480 MEETING ON THE WEST COAST, I 4032 02:32:14,480 --> 02:32:18,400 THINK SOMETIME IN EARLY 2000s, 4033 02:32:18,400 --> 02:32:23,080 BEING PRESENTED WITH A PLETHORA 4034 02:32:23,080 --> 02:32:25,320 OF BEVERAGES AT A BREAK AT THIS 4035 02:32:25,320 --> 02:32:25,560 MEETING. 4036 02:32:25,560 --> 02:32:28,280 AND THERE WERE ALL THESE ENERGY 4037 02:32:28,280 --> 02:32:31,320 DRINKS AND STRANGE COLAS AND 4038 02:32:31,320 --> 02:32:34,440 THINGS LIKE THAT THAT WERE 4039 02:32:34,440 --> 02:32:36,120 LABELED AS DIETARY SUPPLEMENTS. 4040 02:32:36,120 --> 02:32:38,320 AND A COUPLE YEARS LATER THOSE 4041 02:32:38,320 --> 02:32:40,520 PRODUCTS WERE SUDDENLY NOT 4042 02:32:40,520 --> 02:32:41,560 DIETARY SUPPLEMENTS ANYMORE BUT 4043 02:32:41,560 --> 02:32:42,720 THEY WERE CONVENTIONAL FOODS. 4044 02:32:42,720 --> 02:32:44,240 THERE'S A COUPLE REASONS FOR 4045 02:32:44,240 --> 02:32:44,560 THAT. 4046 02:32:44,560 --> 02:32:48,080 ONE IS COMPANIES STARTED 4047 02:32:48,080 --> 02:32:49,800 LABELING, MARKETING THESE 4048 02:32:49,800 --> 02:32:51,680 PRODUCTS DECLARING THEM DIETARY 4049 02:32:51,680 --> 02:32:52,880 SUPPLEMENTS BECAUSE THEY WANTED 4050 02:32:52,880 --> 02:32:55,920 TO PUT THINGS IN THEM THAT WERE 4051 02:32:55,920 --> 02:32:57,160 NOT GRAS, NOT GENERALLY 4052 02:32:57,160 --> 02:32:58,240 RECOGNIZED AS SAFE. 4053 02:32:58,240 --> 02:33:01,640 THE WAY TO DO THAT WAS TO USE A 4054 02:33:01,640 --> 02:33:03,400 DIETARY INGREDIENT AND PUT THOSE 4055 02:33:03,400 --> 02:33:04,280 IN THE PRODUCT. 4056 02:33:04,280 --> 02:33:06,600 WELL, A COUPLE YEARS LATER FDA 4057 02:33:06,600 --> 02:33:09,720 STARTED SAYING, NO, NO, NO, 4058 02:33:09,720 --> 02:33:10,600 DON'T DO THAT. 4059 02:33:10,600 --> 02:33:14,200 AND THEN YOU SAW SOME OF THESE 4060 02:33:14,200 --> 02:33:15,600 PRODUCTS REFORMULATED. 4061 02:33:15,600 --> 02:33:18,840 YOU SAW SOME INGREDIENTS HAVE 4062 02:33:18,840 --> 02:33:19,760 SELF-AFFIRMED GRAS 4063 02:33:19,760 --> 02:33:20,760 APPLICATIONS -- OR NOTIFICATIONS 4064 02:33:20,760 --> 02:33:21,320 TO FDA. 4065 02:33:21,320 --> 02:33:23,400 AND SO YOU ENDED UP WITH HAVING 4066 02:33:23,400 --> 02:33:25,920 THESE THINGS THAT HAD BEEN 4067 02:33:25,920 --> 02:33:29,000 CALLING THEMSELVES DIETARY 4068 02:33:29,000 --> 02:33:29,760 SUPPLEMENTS SUDDENLY WITH 4069 02:33:29,760 --> 02:33:31,280 NUTRITION FACT PANELS INSTEAD OF 4070 02:33:31,280 --> 02:33:32,160 SUPPLEMENT FACT PANELS. 4071 02:33:32,160 --> 02:33:35,640 AND THEN AT THE SAME TIME 4072 02:33:35,640 --> 02:33:39,120 THERE'S THESE LITTLE TINY 4073 02:33:39,120 --> 02:33:40,800 THINGS, FIVE-HOUR ENERGY AND 4074 02:33:40,800 --> 02:33:42,520 PRODUCTS SIMILAR TO THOSE, THAT 4075 02:33:42,520 --> 02:33:44,440 STILL HAVE A SUPPLEMENT FACTS 4076 02:33:44,440 --> 02:33:46,120 PANEL THAT CALL THEMSELVES 4077 02:33:46,120 --> 02:33:47,680 SUPPLEMENTS RATHER THAN 4078 02:33:47,680 --> 02:33:48,800 CONVENTIONAL FOODS. 4079 02:33:48,800 --> 02:33:54,240 SO, WHY IS THAT? 4080 02:33:54,240 --> 02:33:55,680 WELL, FDA EVENTUALLY STEPPED IN 4081 02:33:55,680 --> 02:33:56,440 AND CLARIFIED. 4082 02:33:56,440 --> 02:34:00,160 IN ADDITION TO THE WHOLE, YOU 4083 02:34:00,160 --> 02:34:02,120 KNOW, YOU CAN'T PUT ST. JOHN'S 4084 02:34:02,120 --> 02:34:03,560 WORT IN A CONVENTIONAL FOOD 4085 02:34:03,560 --> 02:34:05,320 BECAUSE IT'S NOT GENERALLY 4086 02:34:05,320 --> 02:34:07,480 RECOGNIZED AS SAFE, YOU KNOW, IT 4087 02:34:07,480 --> 02:34:09,480 BECOMES A FOOD ADDITIVE, IT'S 4088 02:34:09,480 --> 02:34:10,800 NOT GENERALLY RECOGNIZED AS SAFE 4089 02:34:10,800 --> 02:34:13,160 FOR USE IN FOODS THEREFORE YOU 4090 02:34:13,160 --> 02:34:14,160 CAN'T PUT THAT INTO YOUR 4091 02:34:14,160 --> 02:34:15,040 PRODUCT. 4092 02:34:15,040 --> 02:34:19,440 SO FDA SAID YEAH, DON'T DO THAT. 4093 02:34:19,440 --> 02:34:21,840 SO, FDA PROMULGATED GUIDANCE ON 4094 02:34:21,840 --> 02:34:25,360 DISTINGUISHING LIQUID DIETARY 4095 02:34:25,360 --> 02:34:26,280 SUPPLEMENTS FROM BEVERAGES. 4096 02:34:26,280 --> 02:34:27,760 THE URL IS THERE. 4097 02:34:27,760 --> 02:34:28,840 THE RULES, THE GUIDANCE IS 4098 02:34:28,840 --> 02:34:29,080 THERE. 4099 02:34:29,080 --> 02:34:35,000 WHAT IT BOILS DOWN TO IF THE 4100 02:34:35,000 --> 02:34:37,200 PRODUCT PROVIDES A SIGNIFICANT 4101 02:34:37,200 --> 02:34:39,440 AMOUNT OF WATER FOR HYDRATION 4102 02:34:39,440 --> 02:34:40,560 PURPOSES, THEN YOU SHOULDN'T 4103 02:34:40,560 --> 02:34:42,520 CALL IT A DIETARY SUPPLEMENT, 4104 02:34:42,520 --> 02:34:46,200 BUT CALL IT A BEVERAGE WHICH IS 4105 02:34:46,200 --> 02:34:47,600 CONVENTIONAL FOOD. 4106 02:34:47,600 --> 02:34:50,200 SO, A BIG BOTTLE OR BIG CAN LIKE 4107 02:34:50,200 --> 02:34:54,840 THIS WHICH IS 12 OR 16 OUNCES 4108 02:34:54,840 --> 02:34:55,720 PROVIDES SIGNIFICANT AMOUNT OF 4109 02:34:55,720 --> 02:34:57,360 WATER TO MEET YOUR DAILY 4110 02:34:57,360 --> 02:34:59,000 HYDRATION NEEDS. 4111 02:34:59,000 --> 02:35:02,280 PRODUCT LIKE THIS I THINK IT'S 1 4112 02:35:02,280 --> 02:35:08,000 OTHER ORE -- 1 OR 2 OUNCES DOES 4113 02:35:08,000 --> 02:35:08,520 NOT PROVIDE SIGNIFICANT 4114 02:35:08,520 --> 02:35:12,880 HYDRATION NEEDS SO THAT CANNOT 4115 02:35:12,880 --> 02:35:16,440 BE CALLED A DIETARY SUPPLEMENT. 4116 02:35:16,440 --> 02:35:16,960 PROBLEM SOLVED. 4117 02:35:16,960 --> 02:35:20,440 VERY OLD PRODUCTS THAT OCCURRED 4118 02:35:20,440 --> 02:35:24,120 AROUND THE TIME THAT ABOUT FIVE 4119 02:35:24,120 --> 02:35:26,320 YEARS AFTER WHERE SOME PEOPLE 4120 02:35:26,320 --> 02:35:28,680 TRIED TO GET CREATIVE. 4121 02:35:28,680 --> 02:35:33,720 THERE WAS A LINE BY HAIN'S 4122 02:35:33,720 --> 02:35:38,000 COMPANY THAT OWNS CELESTIAL 4123 02:35:38,000 --> 02:35:40,400 SEASONINGS, MARKETING SOME 4124 02:35:40,400 --> 02:35:42,680 PRODUCTS THEY CALLED HAIN'S 4125 02:35:42,680 --> 02:35:43,720 KITCHEN PRESCRIPTION. 4126 02:35:43,720 --> 02:35:45,000 ONE PRODUCT WAS CHICKEN BROTH 4127 02:35:45,000 --> 02:35:49,160 AND NEWED ALSO WITH ECHINACEA, 4128 02:35:49,160 --> 02:35:50,440 ANOTHER WAS TOMATO BASIL SOUP 4129 02:35:50,440 --> 02:35:51,920 WITH ST. JOHN'S WORT. 4130 02:35:51,920 --> 02:35:53,320 COMPANY SUBMITTED NOTICE OF 4131 02:35:53,320 --> 02:35:55,720 CLAIMS WITH LABELED TO FDA 4132 02:35:55,720 --> 02:35:57,160 ASSERTING THESE PRODUCTS WERE 4133 02:35:57,160 --> 02:35:57,840 DIETARY SUPPLEMENTS. 4134 02:35:57,840 --> 02:36:01,720 THESE WERE CANS OF SOUP. 4135 02:36:01,720 --> 02:36:03,360 LABELS HAD PICTURE OF SOUP, USE 4136 02:36:03,360 --> 02:36:06,640 OF THE WORD SOUP, USE OF THE 4137 02:36:06,640 --> 02:36:09,200 PHRASE HEAT AND SERVE, MADE 4138 02:36:09,200 --> 02:36:10,280 REFERENCE TO POTATOES, SPLIT 4139 02:36:10,280 --> 02:36:15,000 PEA, CHICKEN BROTH AND NOODLES, 4140 02:36:15,000 --> 02:36:15,720 INGREDIENTS INCLUDED ECHINACEA 4141 02:36:15,720 --> 02:36:20,040 AND ST. ST. JOHN'S WORT, STILL 4142 02:36:20,040 --> 02:36:23,320 NOT GENERALLY RECOGNIZED AS SAFE 4143 02:36:23,320 --> 02:36:26,880 FOOD ADDITIVES. 4144 02:36:26,880 --> 02:36:27,920 THEY MADE STRUCTURE-FUNCTION 4145 02:36:27,920 --> 02:36:28,800 CLAIMS. 4146 02:36:28,800 --> 02:36:31,680 THEY WANTED TO INCLUDE THOSE 4147 02:36:31,680 --> 02:36:33,760 INGREDIENTS, AND WENT DIETARY 4148 02:36:33,760 --> 02:36:35,600 SUPPLEMENT ROUTE AND THOUGHT THE 4149 02:36:35,600 --> 02:36:38,200 ACT GAVE THEM SAFE HAVEN TO DO 4150 02:36:38,200 --> 02:36:38,720 THAT. 4151 02:36:38,720 --> 02:36:41,560 AND THEY ALSO WANTED TO MAKE 4152 02:36:41,560 --> 02:36:42,200 STRUCTURE-FUNCTION CLAIM. 4153 02:36:42,200 --> 02:36:43,600 HERE'S A WAY TO GET THIS INTO 4154 02:36:43,600 --> 02:36:47,000 THE MARKETPLACE, WE'LL CAUGHT IT 4155 02:36:47,000 --> 02:36:48,880 A DIETARY SUPPLEMENT, WE'LL BE 4156 02:36:48,880 --> 02:36:51,480 ABLE TO GIVE PEOPLE THESE NEW 4157 02:36:51,480 --> 02:36:52,840 INGREDIENTS WITHOUT HAVING TO 4158 02:36:52,840 --> 02:36:57,520 FILE FOOD ADDITIVE POSITION OR 4159 02:36:57,520 --> 02:37:02,120 GO THROUGH GRAS AFFIRMATION 4160 02:37:02,120 --> 02:37:02,560 PROCESS. 4161 02:37:02,560 --> 02:37:04,720 SO, THE COMPANIES CALL THESE 4162 02:37:04,720 --> 02:37:06,720 PRODUCTS HERBAL SUPPLEMENTS BUT 4163 02:37:06,720 --> 02:37:09,720 AFTER REVIEW, FDA CONCLUDED THE 4164 02:37:09,720 --> 02:37:11,800 LABEL STATEMENTS REPRESENT THE 4165 02:37:11,800 --> 02:37:14,960 PRODUCT AS A CONVENTIONAL FOOD 4166 02:37:14,960 --> 02:37:15,760 INTENDED USE. 4167 02:37:15,760 --> 02:37:20,520 THEREFORE, CANNOT BE A DIETARY 4168 02:37:20,520 --> 02:37:20,960 SUPPLEMENT. 4169 02:37:20,960 --> 02:37:26,040 SO, AS I ALREADY SAID, UNDER THE 4170 02:37:26,040 --> 02:37:29,320 ANT, MUST BE USED IN ACCORDANCE 4171 02:37:29,320 --> 02:37:30,320 WITH FOOD ADDITIVE REGULATIONS 4172 02:37:30,320 --> 02:37:32,520 AND THE AGENCY WAS NOT AWARE OF 4173 02:37:32,520 --> 02:37:34,360 THE BASIS FOR CONCLUDED THESE 4174 02:37:34,360 --> 02:37:35,800 INGREDIENTS WERE GENERALLY 4175 02:37:35,800 --> 02:37:39,320 RECOGNIZED AS SAFE FOR USE IN 4176 02:37:39,320 --> 02:37:44,000 CONVENTIONAL FOODS. 4177 02:37:44,000 --> 02:37:46,160 SO, THE STATEMENTS, THE 4178 02:37:46,160 --> 02:37:47,520 STRUCTURE FUNCTION CLAIMS, 4179 02:37:47,520 --> 02:37:50,800 AGENCY SAID WERE NOT HEALTH 4180 02:37:50,800 --> 02:37:52,200 CLAIMS, STRUCTURE-FUNCTION 4181 02:37:52,200 --> 02:37:53,640 CLAIMS, THEY WEREN'T NUTRIENT 4182 02:37:53,640 --> 02:37:58,280 RELATED, THEREFORE THEY WERE NOT 4183 02:37:58,280 --> 02:37:59,040 APPROPRIATE TO CONVENTIONAL 4184 02:37:59,040 --> 02:38:00,560 FOOD. 4185 02:38:00,560 --> 02:38:03,200 THE NAME OF THE PRODUCT, KITCHEN 4186 02:38:03,200 --> 02:38:04,280 PRESCRIPTION, SUGGESTED THE 4187 02:38:04,280 --> 02:38:06,240 PRODUCT MAY BE INTENDED TO 4188 02:38:06,240 --> 02:38:07,440 DIAGNOSE, CURE, MITIGATE OR 4189 02:38:07,440 --> 02:38:09,840 TREAT A DISEASE. 4190 02:38:09,840 --> 02:38:12,120 THEREFORE, IT WAS AN UNAPPROVED 4191 02:38:12,120 --> 02:38:12,920 NEW DRUG. 4192 02:38:12,920 --> 02:38:14,680 THIS COMPANY KIND OF SCREWED UP 4193 02:38:14,680 --> 02:38:16,400 IN EVERY POSSIBLE WAY THEY COULD 4194 02:38:16,400 --> 02:38:18,560 SCREW UP IN TERMS OF THE 4195 02:38:18,560 --> 02:38:18,920 PRODUCT. 4196 02:38:18,920 --> 02:38:21,040 SO, THE CLAIMS THEY MADE ON THE 4197 02:38:21,040 --> 02:38:26,680 LABEL MADE THEIR PRODUCT BOTH A 4198 02:38:26,680 --> 02:38:31,200 DRUG BUT ALSO ADULTERATED FOOD. 4199 02:38:31,200 --> 02:38:38,440 THE INGREDIENT ST. JOHN'S WORT, 4200 02:38:38,440 --> 02:38:39,480 ECHINACEA, WERE NOT GRAS. 4201 02:38:39,480 --> 02:38:42,760 FDA SAID YOU CAN CONTINUE TO 4202 02:38:42,760 --> 02:38:45,520 SELL THIS STUFF IF YOU'LL SHOW 4203 02:38:45,520 --> 02:38:47,840 FDA THAT THOSE SUBSTANCES ARE 4204 02:38:47,840 --> 02:38:48,040 SAFE. 4205 02:38:48,040 --> 02:38:50,560 >> I NEED YOU TO WRAP UP. 4206 02:38:50,560 --> 02:38:51,360 >> OKAY. 4207 02:38:51,360 --> 02:38:52,760 PRODUCTS ARE PROPERTY LABELED 4208 02:38:52,760 --> 02:38:58,040 WITH NUTRITION FACTS RATHER THAN 4209 02:38:58,040 --> 02:38:59,080 SUPPLEMENT FACTS PANEL. 4210 02:38:59,080 --> 02:39:04,040 LABEL DOES NOT SUGGEST EFFECT ON 4211 02:39:04,040 --> 02:39:06,640 DISEASE, STRUCTURE-FUNCTION 4212 02:39:06,640 --> 02:39:08,640 EFFECTS CLAIMS ON LABEL ACHIEVED 4213 02:39:08,640 --> 02:39:10,280 VIA NUTRITIVE VALUE. 4214 02:39:10,280 --> 02:39:13,080 AND THE PICTURES OF TOMATOES, 4215 02:39:13,080 --> 02:39:18,760 USE OF THE WORD DELICIOUS, FDA 4216 02:39:18,760 --> 02:39:20,320 DECIDED THOSE TERMS, THOSE 4217 02:39:20,320 --> 02:39:21,880 CLAIMS, CLASSIFIED THE PRODUCT 4218 02:39:21,880 --> 02:39:23,640 AS CONVENTIONAL FOOD BASED ON 4219 02:39:23,640 --> 02:39:24,760 INTENDED USE. 4220 02:39:24,760 --> 02:39:27,440 REMEMBER THE ORIGINAL DEFINITION 4221 02:39:27,440 --> 02:39:31,040 OF A FOOD, YOU KNOW, TASTE, 4222 02:39:31,040 --> 02:39:33,600 ODOR, NUTRITIVE VALUE. 4223 02:39:33,600 --> 02:39:36,240 SO, CONCLUSION IS THAT PRODUCTS 4224 02:39:36,240 --> 02:39:38,480 ARE CLASSIFIED BY THE 4225 02:39:38,480 --> 02:39:42,040 MANUFACTURER AS FOODS, DIETARY 4226 02:39:42,040 --> 02:39:45,280 SUPPLEMENTS OR DRUGS IF THEY DO 4227 02:39:45,280 --> 02:39:48,920 IT RIGHT, RANGING FROM BASIC 4228 02:39:48,920 --> 02:39:50,000 NUTRITION, HEALTH PROMOTION, 4229 02:39:50,000 --> 02:39:51,960 CURE, TREAT, MITIGATE. 4230 02:39:51,960 --> 02:39:53,000 RULES CHANGE DEPENDING WHICH BOX 4231 02:39:53,000 --> 02:39:53,760 YOU DECIDE YOUR PRODUCT IS 4232 02:39:53,760 --> 02:39:55,760 SUPPOSED TO BE IN. 4233 02:39:55,760 --> 02:39:57,360 AGAIN, YOU'RE IN CONTROL. 4234 02:39:57,360 --> 02:39:59,240 THE MANUFACTURER DECIDES ON THE 4235 02:39:59,240 --> 02:40:00,840 BOX THROUGH INTENDED USE. 4236 02:40:00,840 --> 02:40:01,600 LABELING CLAIMS, ALL THAT KIND 4237 02:40:01,600 --> 02:40:02,600 OF STUFF. 4238 02:40:02,600 --> 02:40:05,360 IF THE COMPANY MESSES UP AS HAIN 4239 02:40:05,360 --> 02:40:09,640 COMPANY DID, FDA IS LEFT TO 4240 02:40:09,640 --> 02:40:11,360 FIGURE OUT WHICH BOX IS INTEND 4241 02:40:11,360 --> 02:40:12,280 AND WILL USE APPROPRIATE RULES 4242 02:40:12,280 --> 02:40:13,240 FOR THAT BOX. 4243 02:40:13,240 --> 02:40:15,120 IF YOU END UP PUTTING YOUR THING 4244 02:40:15,120 --> 02:40:17,000 IN A BOX YOU DID NOT INTEND IT 4245 02:40:17,000 --> 02:40:18,880 TO YOU COULD END UP REGULATED AS 4246 02:40:18,880 --> 02:40:20,480 A DRUG RATHER THAN WHAT YOU 4247 02:40:20,480 --> 02:40:23,120 INTENDED AS A FOOD OR AS A 4248 02:40:23,120 --> 02:40:24,480 DIETARY SUPPLEMENT. 4249 02:40:24,480 --> 02:40:28,800 I WILL END THERE AND, PAUL, 4250 02:40:28,800 --> 02:40:30,160 THANKS FOR YOUR PATIENCE. 4251 02:40:30,160 --> 02:40:32,360 >> OKAY. 4252 02:40:32,360 --> 02:40:34,920 THANKS VERY MUCH, JOE. 4253 02:40:34,920 --> 02:40:39,400 4254 02:40:39,400 --> 02:40:42,000 NEXT SPEAKER IS GERIE VOSS WHO 4255 02:40:42,000 --> 02:40:45,520 WILL JANE WHAT THE U.S. FOOD AND 4256 02:40:45,520 --> 02:40:46,400 DRUG ADMINISTRATION DOES, 4257 02:40:46,400 --> 02:40:49,120 DIRECTS DIVISION OF POLICY AND 4258 02:40:49,120 --> 02:40:52,600 REGULATION IMPLEMENTATION AT 4259 02:40:52,600 --> 02:40:56,360 FDA OFFICE OF DIETARY 4260 02:40:56,360 --> 02:40:57,720 SUPPLEMENTS, AN ATTORNEY WITH 4261 02:40:57,720 --> 02:40:59,160 THE FDA SINCE 2009. 4262 02:40:59,160 --> 02:41:04,360 WE 4263 02:41:04,360 --> 02:41:05,720 WE WELCOME YOU. 4264 02:41:05,720 --> 02:41:06,760 TAKE IT AWAY. 4265 02:41:06,760 --> 02:41:09,080 >> I'M GOING TO SHARE MY SCREEN. 4266 02:41:09,080 --> 02:41:09,560 GREAT. 4267 02:41:09,560 --> 02:41:16,040 LET ME GRAB THAT. 4268 02:41:16,040 --> 02:41:16,600 POWERPOINT. 4269 02:41:16,600 --> 02:41:16,800 SHARE. 4270 02:41:16,800 --> 02:41:18,960 OKAY. 4271 02:41:18,960 --> 02:41:21,240 4272 02:41:21,240 --> 02:41:23,880 THERE WE GO. 4273 02:41:23,880 --> 02:41:26,280 HI, EVERYONE. 4274 02:41:26,280 --> 02:41:33,160 YES, I'M GERIE VOSS, DIRECTORY 4275 02:41:33,160 --> 02:41:34,520 DIVISION OF POLICY AND 4276 02:41:34,520 --> 02:41:36,240 REGULATION, FOR FDA CENTER FOR 4277 02:41:36,240 --> 02:41:37,360 FOOD SAFETY AND APPLIED 4278 02:41:37,360 --> 02:41:39,200 NUTRITION OFFICE OF DIETARY 4279 02:41:39,200 --> 02:41:39,960 SUPPLEMENT PROGRAMS. 4280 02:41:39,960 --> 02:41:41,120 IN THE GOVERNMENT AWHILE, YOU 4281 02:41:41,120 --> 02:41:44,440 KNOW WE USE A LOT OF ACRONYMS, 4282 02:41:44,440 --> 02:41:50,160 WE REFER TO DPRI AS PART OF 4283 02:41:50,160 --> 02:41:50,360 ODSP. 4284 02:41:50,360 --> 02:41:53,320 TODAY I'M SPEAKING HOW THE FDA 4285 02:41:53,320 --> 02:41:56,960 REGULATES DIETARY SUPPLEMENTS. 4286 02:41:56,960 --> 02:41:58,480 MY WORK AT FDA INVOLVES ALL OF 4287 02:41:58,480 --> 02:41:59,920 THE AREAS WE'RE GOING TO TALK 4288 02:41:59,920 --> 02:42:02,000 ABOUT TODAY. 4289 02:42:02,000 --> 02:42:05,760 AND THAT INCLUDES NEW DIETARY 4290 02:42:05,760 --> 02:42:07,600 INGREDIENT NOTIFICATION 4291 02:42:07,600 --> 02:42:09,560 REQUIREMENTS, CURRENT GOOD 4292 02:42:09,560 --> 02:42:10,920 MANUFACTURING PRACTICE 4293 02:42:10,920 --> 02:42:12,320 REGULATIONS, SUPPLEMENT LABELS, 4294 02:42:12,320 --> 02:42:14,960 ADVERSE EVENT REPORTING, DIETARY 4295 02:42:14,960 --> 02:42:16,720 SUPPLEMENT POLICY DEVELOPMENT, 4296 02:42:16,720 --> 02:42:17,960 ENFORCEMENT OF DIETARY 4297 02:42:17,960 --> 02:42:19,320 SUPPLEMENT LAWS AND REGULATIONS. 4298 02:42:19,320 --> 02:42:22,680 SOME OF THIS IS PART OF WHAT DR. 4299 02:42:22,680 --> 02:42:24,320 BETZ TOUCHED ON ALREADY SO I MAY 4300 02:42:24,320 --> 02:42:29,400 MOVED QUICKLY IN SOME OF THOSE 4301 02:42:29,400 --> 02:42:31,480 AREAS HE'S TOUCHED ON AND FOR 4302 02:42:31,480 --> 02:42:33,800 SOME AREAS IT'S HELPFUL REVIEW. 4303 02:42:33,800 --> 02:42:37,080 AS THIS SLIDE SHOWS, THE PRIMARY 4304 02:42:37,080 --> 02:42:38,720 AUTHORITY FOR DIETARY SUPPLEMENT 4305 02:42:38,720 --> 02:42:39,760 REGULATION COMES FROM THE 4306 02:42:39,760 --> 02:42:41,440 FEDERAL FOOD DRUG AND COSMETIC 4307 02:42:41,440 --> 02:42:44,680 ACT, THAT'S THE LAW THAT GOVERNS 4308 02:42:44,680 --> 02:42:46,920 ALL FDA REGULATED COMMODITIES. 4309 02:42:46,920 --> 02:42:49,560 THE FIRST LAW THAT DEFINES 4310 02:42:49,560 --> 02:43:00,080 REGULATION OF DIETARY IS DSHEA, 4311 02:43:02,000 --> 02:43:03,440 PASSED IN 1994, LAYING OUT 4312 02:43:03,440 --> 02:43:04,960 FRAMEWORK AND PROVIDING MOST OF 4313 02:43:04,960 --> 02:43:06,280 THE REQUIREMENTS WE'LL TALK 4314 02:43:06,280 --> 02:43:13,880 ABOUT FOR THE REMAINDER OF THE 4315 02:43:13,880 --> 02:43:14,200 PRESENTATION. 4316 02:43:14,200 --> 02:43:16,160 IT ESTABLISHED REQUIREMENTS FOR 4317 02:43:16,160 --> 02:43:18,000 NEW DIETARY INGREDIENT 4318 02:43:18,000 --> 02:43:19,480 PRE-MARKET REVIEW, AS DR. BETZ 4319 02:43:19,480 --> 02:43:22,200 MENTIONED THIS IS THE ONLY TIME 4320 02:43:22,200 --> 02:43:24,720 THAT FDA HAS THE ABILITY TO DO 4321 02:43:24,720 --> 02:43:28,080 ANY SORT OF PRE-MARKET REVIEW 4322 02:43:28,080 --> 02:43:29,560 REGARDING A DIETARY SUPPLEMENT. 4323 02:43:29,560 --> 02:43:32,960 IT MADE IT A REQUIREMENT ALL 4324 02:43:32,960 --> 02:43:34,680 DIETARY SUPPLEMENTS BE PRODUCED 4325 02:43:34,680 --> 02:43:42,520 IN ACCORDANCE WITH CURRENT GOOD 4326 02:43:42,520 --> 02:43:43,720 MANUFACTURING PRACTICES, 4327 02:43:43,720 --> 02:43:44,480 INCLUDING SUPPLEMENTS UNDER 4328 02:43:44,480 --> 02:43:46,320 ADULTERATED PROVISIONS OF THE 4329 02:43:46,320 --> 02:43:48,600 ACT BASICALLY GIVING FDA ABILITY 4330 02:43:48,600 --> 02:43:52,960 TO ENFORCE DENSE ADULTERATED 4331 02:43:52,960 --> 02:43:54,440 DIETARY SUPPLEMENTED. 4332 02:43:54,440 --> 02:43:57,600 IN ORDER TO DISCUSS HOW THE FDA 4333 02:43:57,600 --> 02:43:58,760 REGULATES DIETARY SUPPLEMENTS 4334 02:43:58,760 --> 02:44:00,640 LET'S REVIEW THE DEFINITION OF 4335 02:44:00,640 --> 02:44:03,840 WHAT WE DO REGULATE AND DON'T 4336 02:44:03,840 --> 02:44:04,400 REGULATE. 4337 02:44:04,400 --> 02:44:06,240 DIETARY SUPPLEMENT IS DEFINED AS 4338 02:44:06,240 --> 02:44:09,040 PRODUCT OTHER THAN TOBACCO, 4339 02:44:09,040 --> 02:44:10,480 OBVIOUSLY, THAT PORTION WAS PUT 4340 02:44:10,480 --> 02:44:18,360 IN LATER INTO THE ACT, AFTER FDA 4341 02:44:18,360 --> 02:44:20,560 RECEIVED AUTHORITY TO ALSO 4342 02:44:20,560 --> 02:44:21,720 REGULATE TOBACCO PRODUCTS. 4343 02:44:21,720 --> 02:44:23,120 IT'S A PRODUCT OTHER THAN 4344 02:44:23,120 --> 02:44:24,840 TOBACCO INTENDED TO SUPPLEMENT 4345 02:44:24,840 --> 02:44:25,800 THE DIET. 4346 02:44:25,800 --> 02:44:27,800 SUPPLEMENTING THE DIET MEANS 4347 02:44:27,800 --> 02:44:32,600 AUGMENTING THE DIET TO PROMOTE 4348 02:44:32,600 --> 02:44:34,800 HEALTH, A PRODUCT INTENDED FOR 4349 02:44:34,800 --> 02:44:35,320 INGESTION, REFERRING TO 4350 02:44:35,320 --> 02:44:39,920 INTERNALLY INTO THE STOMACH OR 4351 02:44:39,920 --> 02:44:40,520 G.I. TRACT, THEREFORE DIETARY 4352 02:44:40,520 --> 02:44:44,440 SUPPLEMENT COULDN'T BE A NASAL 4353 02:44:44,440 --> 02:44:49,480 SPRAY OR INHALED OR SUBLINGUALS, 4354 02:44:49,480 --> 02:44:49,840 INJECTABLES. 4355 02:44:49,840 --> 02:45:00,320 WE SEE THESE WHERE WE LEARN THAT 4356 02:45:00,320 --> 02:45:03,160 PRODUCTS ARE NOT INTENDED FOR 4357 02:45:03,160 --> 02:45:04,040 INGESTION. 4358 02:45:04,040 --> 02:45:05,640 DR. BETZ MENTIONED IT CAN'T BE A 4359 02:45:05,640 --> 02:45:08,800 SOLE ITEM OF A MEAL OR DIET AND 4360 02:45:08,800 --> 02:45:10,400 MAY NOT BE REPRESENTED AS 4361 02:45:10,400 --> 02:45:12,240 CONVENTIONAL FOOD AND MUST BE 4362 02:45:12,240 --> 02:45:14,840 LABELED AS A DIETARY SUPPLEMENT, 4363 02:45:14,840 --> 02:45:15,640 THAT'S KEY. 4364 02:45:15,640 --> 02:45:17,680 DIETARY SUPPLEMENT NEEDS TO 4365 02:45:17,680 --> 02:45:20,320 CONTAIN ONE OR MORE OF DIETARY 4366 02:45:20,320 --> 02:45:22,520 INGREDIENTS, THOSE ARE LISTED 4367 02:45:22,520 --> 02:45:26,920 HERE, VITAMIN, MINERAL, HERB OR 4368 02:45:26,920 --> 02:45:28,600 BOTANICAL, AMINO ACID, SOME 4369 02:45:28,600 --> 02:45:29,560 EXAMPLES OF DIETARY SUPPLEMENTS 4370 02:45:29,560 --> 02:45:37,880 THAT YOU MAY HAVE HEARD OF, FOR 4371 02:45:37,880 --> 02:45:38,360 EXAMPLE, LACTOBACILLUS 4372 02:45:38,360 --> 02:45:40,400 ACIDOPHILUS, I'M NOT GOOD AT 4373 02:45:40,400 --> 02:45:41,960 PRESENTING LATIN TERMS BUT 4374 02:45:41,960 --> 02:45:48,080 HOPEFULLY I SAID THAT CORRECTLY. 4375 02:45:48,080 --> 02:45:48,640 CHONDROITIN SULFATE, 4376 02:45:48,640 --> 02:45:49,400 CONCENTRATIONS, METABOLITES, 4377 02:45:49,400 --> 02:45:50,920 GREEN TEA EXACTS, THOSE SORTS OF 4378 02:45:50,920 --> 02:45:56,440 THINGS WILL BE CONSIDERED 4379 02:45:56,440 --> 02:45:57,760 DIETARY SUPPLEMENTS. 4380 02:45:57,760 --> 02:45:59,600 THE LAW SPECIFICALLY 4381 02:45:59,600 --> 02:46:00,080 DISTINGUISHES DIETARY 4382 02:46:00,080 --> 02:46:02,760 SUPPLEMENTS FROM DRUGS IN 4383 02:46:02,760 --> 02:46:04,960 SEVERAL WAYS. 4384 02:46:04,960 --> 02:46:07,720 IT STATES THAT THE DIETARY 4385 02:46:07,720 --> 02:46:09,560 SUPPLEMENT CAN'T BE AN ARTICLE, 4386 02:46:09,560 --> 02:46:16,800 THERE'S A LOT OF CASE LAW TO 4387 02:46:16,800 --> 02:46:19,400 EXPLAIN APPROVED AS NEW DRUG, 4388 02:46:19,400 --> 02:46:23,160 ANTIBIOTIC OR BIOLOGIC, OR 4389 02:46:23,160 --> 02:46:26,840 AUTHORIZED BY INVESTIGATION AS A 4390 02:46:26,840 --> 02:46:28,800 NEW DRUG FOR WHICH SUBSTANTIAL 4391 02:46:28,800 --> 02:46:29,720 CLINICAL INVESTIGATIONS HAVE 4392 02:46:29,720 --> 02:46:31,680 BEEN INSTITUTED AND FOR WHICH 4393 02:46:31,680 --> 02:46:34,080 THE EXISTENCE OF SUCH 4394 02:46:34,080 --> 02:46:36,160 INVESTIGATIONS HAS BEEN MADE 4395 02:46:36,160 --> 02:46:38,240 PUBLIC, UNLESS THE ARTICLE WAS 4396 02:46:38,240 --> 02:46:40,200 MARKETED AS DIETARY SUPPLEMENT 4397 02:46:40,200 --> 02:46:42,400 OR FOOD BEFORE SUCH APPROVAL OR 4398 02:46:42,400 --> 02:46:42,760 AUTHORIZATION. 4399 02:46:42,760 --> 02:46:44,920 YOU CAN IMAGINE THAT WHEN WE ARE 4400 02:46:44,920 --> 02:46:47,360 TRYING TO FIGURE OUT WHETHER OR 4401 02:46:47,360 --> 02:46:49,520 NOT A PRODUCT IS IN FACT A 4402 02:46:49,520 --> 02:46:51,200 DIETARY SUPPLEMENT VERSUS A DRUG 4403 02:46:51,200 --> 02:46:53,240 THERE IS A LOT OF INFORMATION 4404 02:46:53,240 --> 02:46:56,080 THAT WE HAVE TO CONSIDER, ALL OF 4405 02:46:56,080 --> 02:46:58,160 THESE FACTORS, AND MANY TIMES 4406 02:46:58,160 --> 02:46:59,600 THE OFFICE OF DIETARY SUPPLEMENT 4407 02:46:59,600 --> 02:47:02,320 PROGRAMS WILL HAVE TO REACH OUT 4408 02:47:02,320 --> 02:47:04,720 TO OUR CENTER FOR DRUGS TO HAVE 4409 02:47:04,720 --> 02:47:07,280 THEM TELL US WHETHER OR NOT, FOR 4410 02:47:07,280 --> 02:47:10,560 EXAMPLE, A PRODUCT HAS BEEN 4411 02:47:10,560 --> 02:47:14,480 AUTHORIZED BY INVESTIGATION, 4412 02:47:14,480 --> 02:47:15,280 HAVE CLINICAL INVESTIGATIONS 4413 02:47:15,280 --> 02:47:17,400 BEEN MADE PUBLIC, THERE'S CASE 4414 02:47:17,400 --> 02:47:18,760 LAW THAT PROVIDES MORE 4415 02:47:18,760 --> 02:47:19,800 EXPLANATION AS TO WHAT EXACTLY 4416 02:47:19,800 --> 02:47:23,920 ALL OF THOSE TERMS MEAN. 4417 02:47:23,920 --> 02:47:27,720 SO MORE ON DIETARY SUPPLEMENTS 4418 02:47:27,720 --> 02:47:28,200 VERSUS DRUGS, DIETARY 4419 02:47:28,200 --> 02:47:28,840 SUPPLEMENTS ARE DISTINGUISHED 4420 02:47:28,840 --> 02:47:32,240 FROM DRUGS BECAUSE A DRUG IS AN 4421 02:47:32,240 --> 02:47:34,920 ARTICLE INTENDED TO DIAGNOSE, 4422 02:47:34,920 --> 02:47:35,800 CURE, MITIGATE, TREAT, OR 4423 02:47:35,800 --> 02:47:41,400 PREVENT DISEASE. 4424 02:47:41,400 --> 02:47:42,400 SUPPLEMENTS CAN'T MAKE THOSE 4425 02:47:42,400 --> 02:47:44,040 CLAIMS HOWEVER BOTH CAN BE 4426 02:47:44,040 --> 02:47:45,120 INTENDED TO AFFECT STRUCTURE OR 4427 02:47:45,120 --> 02:47:48,160 FUNCTION OF HUMAN BODY AND THEN 4428 02:47:48,160 --> 02:47:48,840 REQUIREMENTS FOR MANUFACTURERS 4429 02:47:48,840 --> 02:47:53,440 TO FOLLOW IF THEY WISH TO MAKE 4430 02:47:53,440 --> 02:47:54,840 THOSE STRUCTURE-FUNCTION CLAIMS 4431 02:47:54,840 --> 02:47:57,400 IN PRODUCTS THAT ARE DIETARY 4432 02:47:57,400 --> 02:47:57,720 SUPPLEMENTS. 4433 02:47:57,720 --> 02:47:59,800 AGAIN, AS HAS BEEN MENTIONED 4434 02:47:59,800 --> 02:48:01,640 PREVIOUSLY DRUGS MUST UNDERGO 4435 02:48:01,640 --> 02:48:04,080 FDA APPROVAL AFTER CLINICAL 4436 02:48:04,080 --> 02:48:04,600 STUDIES TO DETERMINE 4437 02:48:04,600 --> 02:48:05,920 EFFECTIVENESS AND SAFETY. 4438 02:48:05,920 --> 02:48:08,680 THERE ARE NO SIMILAR PRE-MARKET 4439 02:48:08,680 --> 02:48:10,120 APPROVAL REQUIREMENTS FOR 4440 02:48:10,120 --> 02:48:11,840 DIETARY SUPPLEMENTS, THE ONLY 4441 02:48:11,840 --> 02:48:14,040 TYPE OF PRE-MARKET APPROVAL WE 4442 02:48:14,040 --> 02:48:17,600 GET IS IN THE NDI CONTEXT, NEW 4443 02:48:17,600 --> 02:48:19,520 DIETARY INGREDIENT CONTEXT, I'LL 4444 02:48:19,520 --> 02:48:24,200 SPEAK ABOUT THAT IN A FEW 4445 02:48:24,200 --> 02:48:24,680 MINUTES. 4446 02:48:24,680 --> 02:48:28,320 SO NOW DIETARY SUPPLEMENTS AND 4447 02:48:28,320 --> 02:48:31,080 DRUG APPLICATIONS, THIS IS A BIT 4448 02:48:31,080 --> 02:48:32,640 OF A COMPLICATED EVOLVING AREA, 4449 02:48:32,640 --> 02:48:34,600 SO THE BEST THING TO DO IS IF 4450 02:48:34,600 --> 02:48:37,560 YOU HAVE A QUESTION WITH RESPECT 4451 02:48:37,560 --> 02:48:40,040 TO THIS AREA, IT'S BEST TO 4452 02:48:40,040 --> 02:48:40,720 CONTACT FDA. 4453 02:48:40,720 --> 02:48:42,800 YOU CAN EITHER CONTACT THE 4454 02:48:42,800 --> 02:48:45,000 OFFICE OF DIETARY SUPPLEMENT 4455 02:48:45,000 --> 02:48:47,160 PROGRAMS AND WE CAN PUT YOU IN 4456 02:48:47,160 --> 02:48:51,440 TOUCH WITH PROPER FOLKS AT CDER, 4457 02:48:51,440 --> 02:48:53,760 CENTER FOR DRUGS, OR REACH OUT 4458 02:48:53,760 --> 02:48:54,640 TO CDER DIRECTLY. 4459 02:48:54,640 --> 02:48:56,840 THERE ARE SEVERAL CONSIDERATIONS 4460 02:48:56,840 --> 02:48:59,800 THOUGH FOR WHETHER AN IND IS 4461 02:48:59,800 --> 02:49:01,600 REQUIRED FOR YOUR PRODUCT 4462 02:49:01,600 --> 02:49:03,920 INCLUDING WHETHER THE INTENDED 4463 02:49:03,920 --> 02:49:06,240 POPULATION IS QUOTE/UNQUOTE 4464 02:49:06,240 --> 02:49:07,200 VULNERABLE. 4465 02:49:07,200 --> 02:49:09,160 BASICALLY IF THE CLINICAL 4466 02:49:09,160 --> 02:49:12,040 INVESTIGATION IS INTENDED ONLY 4467 02:49:12,040 --> 02:49:13,880 TO EVALUATE THE DIETARY 4468 02:49:13,880 --> 02:49:14,760 SUPPLEMENT'S EFFECT ON STRUCTURE 4469 02:49:14,760 --> 02:49:17,280 OR FUNCTION OF THE BODY, THEN AN 4470 02:49:17,280 --> 02:49:19,040 IND WOULD NOT BE REQUIRED. 4471 02:49:19,040 --> 02:49:21,880 THAT'S SORT OF THE GENERAL 4472 02:49:21,880 --> 02:49:23,400 PRINCIPLE HELPFUL TO WORK WITH 4473 02:49:23,400 --> 02:49:23,840 HERE. 4474 02:49:23,840 --> 02:49:25,920 HOWEVER, IF THE CLINICAL 4475 02:49:25,920 --> 02:49:28,200 INVESTIGATION IS INTENDED TO 4476 02:49:28,200 --> 02:49:29,640 EVALUATE THE DIETARY 4477 02:49:29,640 --> 02:49:31,280 SUPPLEMENT'S ABILITY TO EITHER 4478 02:49:31,280 --> 02:49:33,120 DIAGNOSE, CURE, MITIGATE, TREAT 4479 02:49:33,120 --> 02:49:35,200 OR PREVENT DISEASE, THEN AN IND 4480 02:49:35,200 --> 02:49:36,320 IS REQUIRED. 4481 02:49:36,320 --> 02:49:39,040 THAT'S THE CATCH PHRASE YOU'VE 4482 02:49:39,040 --> 02:49:41,000 HEARD FOR DISTINGUISHING BETWEEN 4483 02:49:41,000 --> 02:49:43,000 DRUGS AND DIETARY SUPPLEMENTS, 4484 02:49:43,000 --> 02:49:44,880 IT'S ALSO THE INFORMATION WE 4485 02:49:44,880 --> 02:49:48,800 LOOK CLOSELY AT WHEN WE'RE 4486 02:49:48,800 --> 02:49:51,080 CONSIDERING LABELING CLAIMS. 4487 02:49:51,080 --> 02:49:52,920 SO, FURTHER DISTINGUISHING 4488 02:49:52,920 --> 02:49:56,000 DIETARY SUPPLEMENTS FROM 4489 02:49:56,000 --> 02:49:57,320 CONVENTIONAL FOODS, CONVENTIONAL 4490 02:49:57,320 --> 02:49:59,640 FOOD IS DEFINED UNDER THE ACT AS 4491 02:49:59,640 --> 02:50:02,560 AN ARTICLE USED FOR FOOD OR 4492 02:50:02,560 --> 02:50:05,480 DRINK FOR MAN OR OTHER ANIMALS, 4493 02:50:05,480 --> 02:50:06,960 CHEWING GUM, INTERESTING THAT 4494 02:50:06,960 --> 02:50:17,400 GETS A SEPARATE CATEGORY. 4495 02:50:20,480 --> 02:50:29,080 SOUPS, CANDY, CONVENTIONAL 4496 02:50:29,080 --> 02:50:29,280 FOODS. 4497 02:50:29,280 --> 02:50:30,960 DIETARY SUPPLEMENTS MAY NOT BE 4498 02:50:30,960 --> 02:50:33,000 REPRESENTED FOR USE AS 4499 02:50:33,000 --> 02:50:34,040 CONVENTIONAL FOOD, CAN'T BE 4500 02:50:34,040 --> 02:50:36,320 REPRESENTED AS THE SOLE ITEM OF 4501 02:50:36,320 --> 02:50:38,280 A MEAL OR THE DIET SO IT'S 4502 02:50:38,280 --> 02:50:44,320 HELPFUL TO LOOK OBVIOUSLY AT ALL 4503 02:50:44,320 --> 02:50:46,080 OF THEIR LABELING, INSERTS, 4504 02:50:46,080 --> 02:50:47,840 ADVERTISING TO KNOW WHETHER OR 4505 02:50:47,840 --> 02:50:49,360 NOT THEY ARE HOLDING THEIR 4506 02:50:49,360 --> 02:50:51,560 PRODUCT OUT THAT WAY. 4507 02:50:51,560 --> 02:50:53,080 DIETARY SUPPLEMENTS ALSO HAVE 4508 02:50:53,080 --> 02:50:54,280 DIFFERENT LABELING THAN 4509 02:50:54,280 --> 02:50:55,360 CONVENTIONAL FOODS. 4510 02:50:55,360 --> 02:50:57,520 CONVENTIONAL FOODS AS DISCUSSED 4511 02:50:57,520 --> 02:51:00,840 USED THE NUTRITION FACTS PANEL, 4512 02:51:00,840 --> 02:51:02,240 SUPPLEMENTS USE THE SUPPLEMENT 4513 02:51:02,240 --> 02:51:05,760 FACT PANEL, THERE'S A BUNCH OF 4514 02:51:05,760 --> 02:51:06,480 OTHER REQUIREMENTS SUPPLEMENTS 4515 02:51:06,480 --> 02:51:10,800 NEED TO USE IN TERMS OF 4516 02:51:10,800 --> 02:51:11,200 LABELING. 4517 02:51:11,200 --> 02:51:13,000 NOW THAT WE'VE DISCUSSED 4518 02:51:13,000 --> 02:51:14,080 SUPPLEMENTS, WHAT THEY ARE AND 4519 02:51:14,080 --> 02:51:17,720 ARE NOT, WHAT ARE FDA'S 4520 02:51:17,720 --> 02:51:20,840 AUTHORITIES RELATED TO THEIR 4521 02:51:20,840 --> 02:51:21,480 REGULATION? 4522 02:51:21,480 --> 02:51:23,360 SO REGULATORY RESPONSIBILITIES, 4523 02:51:23,360 --> 02:51:25,480 DIETARY SUPPLEMENT REGULATION 4524 02:51:25,480 --> 02:51:28,080 GENERALLY COVERS THESE MAIN 4525 02:51:28,080 --> 02:51:28,640 POINTS. 4526 02:51:28,640 --> 02:51:30,080 FACILITY REGISTRATION, THAT'S 4527 02:51:30,080 --> 02:51:32,680 THE REGISTRATION OF THE 4528 02:51:32,680 --> 02:51:34,120 MANUFACTURER. 4529 02:51:34,120 --> 02:51:36,160 NEW DIETARY INGREDIENT 4530 02:51:36,160 --> 02:51:37,200 NOTIFICATION. 4531 02:51:37,200 --> 02:51:41,960 THAT'S NDI OR NDIN PROCESS. 4532 02:51:41,960 --> 02:51:45,800 CURRENT GOOD MANUFACTURING 4533 02:51:45,800 --> 02:51:46,480 PRACTICES. 4534 02:51:46,480 --> 02:51:49,200 LABELINGPROVISIONS INCLUDING 4535 02:51:49,200 --> 02:51:51,400 STRUCTURE/FUNCTION CLAIM 4536 02:51:51,400 --> 02:51:51,960 NOTIFICATIONS, ADVERSE EVENT 4537 02:51:51,960 --> 02:51:52,480 REPORTING. 4538 02:51:52,480 --> 02:51:57,280 LET ME TALK FIRST ABOUT THE 4539 02:51:57,280 --> 02:51:58,600 FACILITY REGISTRATION. 4540 02:51:58,600 --> 02:51:59,960 WE'RE TALKING ABOUT FACILITY 4541 02:51:59,960 --> 02:52:02,040 REGISTRATION AND NOT INDIVIDUAL 4542 02:52:02,040 --> 02:52:03,400 PRODUCT REGISTRATION. 4543 02:52:03,400 --> 02:52:05,200 ALL FOOD FACILITIES MUST 4544 02:52:05,200 --> 02:52:06,800 REGISTER WITH FDA. 4545 02:52:06,800 --> 02:52:09,760 THAT MEANS IF THEY ARE DOMESTIC 4546 02:52:09,760 --> 02:52:11,760 OR FOREIGN THEY HAVE TO PROVIDE 4547 02:52:11,760 --> 02:52:13,520 BASIC INFORMATION, NAME, 4548 02:52:13,520 --> 02:52:14,600 ADDRESS, TYPE OF FACILITY, 4549 02:52:14,600 --> 02:52:16,800 RESPONSIBLE PARTY, AND THEY NEED 4550 02:52:16,800 --> 02:52:19,440 TO RENEW THAT INFORMATION EVERY 4551 02:52:19,440 --> 02:52:20,840 EVEN-NUMBERED CALENDAR YEAR. 4552 02:52:20,840 --> 02:52:23,440 WE USE THAT INFORMATION TO HELP 4553 02:52:23,440 --> 02:52:25,640 US DETERMINE WHICH FACILITIES 4554 02:52:25,640 --> 02:52:34,200 WE'RE GOING TO BE INSPECTING. 4555 02:52:34,200 --> 02:52:34,400 OKAY. 4556 02:52:34,400 --> 02:52:37,040 ONE MORE THING I WANTED TO 4557 02:52:37,040 --> 02:52:39,120 MENTION REGARDING REGISTRATION. 4558 02:52:39,120 --> 02:52:40,520 REGISTRATION IS SOMETHING THAT 4559 02:52:40,520 --> 02:52:44,360 WAS ADDED AS PART OF THE 4560 02:52:44,360 --> 02:52:45,360 BIOTERRORISM ACT OF 2002 AS AS A 4561 02:52:45,360 --> 02:52:47,480 RESULT OF 9/11, FOR THAT REASON 4562 02:52:47,480 --> 02:52:49,960 THIS INFORMATION CAN'T BE 4563 02:52:49,960 --> 02:52:50,200 DISCLOSED. 4564 02:52:50,200 --> 02:52:55,120 SO, IF YOU'RE TRYING TO FIND OUT 4565 02:52:55,120 --> 02:52:56,000 MORE INFORMATION ABOUT A 4566 02:52:56,000 --> 02:52:57,200 MANUFACTURER, YOU WON'T BE ABLE 4567 02:52:57,200 --> 02:52:58,840 TO FIND OUT THROUGH THAT 4568 02:52:58,840 --> 02:52:59,640 REGISTRATION PROCESS. 4569 02:52:59,640 --> 02:53:02,560 NOW I'M GOING TO MOVE TO THE 4570 02:53:02,560 --> 02:53:08,280 SLIDE 10, NEW DIETARY INGREDIENT 4571 02:53:08,280 --> 02:53:08,600 NOTIFICATION. 4572 02:53:08,600 --> 02:53:13,600 SECTION 413A 2 OF THE ACT 4573 02:53:13,600 --> 02:53:15,240 ESTABLISHED REQUIREMENT THAT 4574 02:53:15,240 --> 02:53:17,120 MANUFACTURERS OR DISTRIBUTORS OF 4575 02:53:17,120 --> 02:53:19,760 DIETARY SUPPLEMENT MUST SUBMIT 4576 02:53:19,760 --> 02:53:22,480 NOTIFICATION TO FDA 75 DAYS 4577 02:53:22,480 --> 02:53:24,720 BEFORE THAT NEW DIETARY 4578 02:53:24,720 --> 02:53:26,200 INGREDIENT IS MARKETED. 4579 02:53:26,200 --> 02:53:28,240 AND AS HAS BEEN MENTIONED BEFORE 4580 02:53:28,240 --> 02:53:30,720 BUT IT'S SO IMPORTANT, IT'S 4581 02:53:30,720 --> 02:53:32,360 CRITICAL TO KEEP REFERENCING 4582 02:53:32,360 --> 02:53:33,880 THIS IS FDA'S ONLY OPPORTUNITY 4583 02:53:33,880 --> 02:53:36,000 FOR SOME LEVEL OF PRE-MARKET 4584 02:53:36,000 --> 02:53:39,280 REVIEW, SO IT'S CRITICAL THAT 4585 02:53:39,280 --> 02:53:43,120 FDA GET THAT SAFETY INFORMATION 4586 02:53:43,120 --> 02:53:46,040 TO HELPFUL FILL ITS 4587 02:53:46,040 --> 02:53:46,440 RESPONSIBILITIES. 4588 02:53:46,440 --> 02:53:48,240 THE NOTIFICATION HAS TO INCLUDE 4589 02:53:48,240 --> 02:53:50,960 A BUNCH OF INFORMATION THAT IS 4590 02:53:50,960 --> 02:53:55,560 INCLUDED IN THE CODE OF FEDERAL 4591 02:53:55,560 --> 02:53:58,280 REGULATIONS, 21 CFR 190.6, THAT 4592 02:53:58,280 --> 02:54:00,480 INCLUDES NAME AND ADDRESS, 4593 02:54:00,480 --> 02:54:02,000 SIGNATURE OF RESPONSIBLE PARTY, 4594 02:54:02,000 --> 02:54:03,240 NAME OF THE INGREDIENT, 4595 02:54:03,240 --> 02:54:05,880 DESCRIPTION OF THE PRODUCT OR 4596 02:54:05,880 --> 02:54:07,280 PRODUCTS CONTAINING THE NDI, 4597 02:54:07,280 --> 02:54:11,160 AMOUNT OF NDI IN THE PRODUCT, 4598 02:54:11,160 --> 02:54:12,680 CONDITIONS OF USE, AND HISTORY 4599 02:54:12,680 --> 02:54:16,720 OF USE FOR ANY OTHER EVIDENCE OF 4600 02:54:16,720 --> 02:54:18,920 SAFETY ESTABLISHING THE NDI WILL 4601 02:54:18,920 --> 02:54:20,360 REASONABLY BE ACCEPTED TO BE 4602 02:54:20,360 --> 02:54:21,480 SAFE. 4603 02:54:21,480 --> 02:54:22,480 THAT IS THE STATUTORY 4604 02:54:22,480 --> 02:54:25,200 REQUIREMENT IN THE ACT, SO WE 4605 02:54:25,200 --> 02:54:26,560 NEED EVIDENCE ESTABLISHING THAT 4606 02:54:26,560 --> 02:54:29,480 THE NDI WILL BE EXPECTED TO BE 4607 02:54:29,480 --> 02:54:30,720 SAFE. 4608 02:54:30,720 --> 02:54:32,240 SO, IT'S IMPORTANT TO ALSO NOTE 4609 02:54:32,240 --> 02:54:34,320 THAT THIS IS ACTUALLY A 4610 02:54:34,320 --> 02:54:36,840 NOTIFICATION AND REVIEW PROCESS 4611 02:54:36,840 --> 02:54:39,760 BY FDA, SO FDA IS NOT APPROVING 4612 02:54:39,760 --> 02:54:41,840 THE INGREDIENT TO BE USED IN A 4613 02:54:41,840 --> 02:54:43,960 DIETARY SUPPLEMENT, IT'S 4614 02:54:43,960 --> 02:54:46,480 ACTUALLY JUST REVIEWING AND 4615 02:54:46,480 --> 02:54:50,240 EITHER ACCEPTING OR REJECTING 4616 02:54:50,240 --> 02:54:50,880 THAT DIETARY INGREDIENT 4617 02:54:50,880 --> 02:54:53,080 NOTIFICATION. 4618 02:54:53,080 --> 02:54:54,240 4619 02:54:54,240 --> 02:54:56,040 SO, THE NEW DIETARY INGREDIENT 4620 02:54:56,040 --> 02:54:57,200 NOTIFICATION REQUIREMENT IS FOR 4621 02:54:57,200 --> 02:54:58,880 THOSE PRODUCTS THAT CONTAIN AN 4622 02:54:58,880 --> 02:55:01,920 NDI AND SO AN NDI IS A DIETARY 4623 02:55:01,920 --> 02:55:05,520 INGREDIENT THAT WAS NOT MARKETED 4624 02:55:05,520 --> 02:55:07,600 IN A DIETARY SUPPLEMENT BEFORE 4625 02:55:07,600 --> 02:55:10,800 OCTOBER 15, 1994, THAT'S 4626 02:55:10,800 --> 02:55:12,000 ACTUALLY THE DATE DSHEA WAS 4627 02:55:12,000 --> 02:55:15,040 SIGNED INTO LAW. 4628 02:55:15,040 --> 02:55:16,480 DURING THAT REVIEW PERIOD WHERE 4629 02:55:16,480 --> 02:55:17,800 FDA HAS THIS INFORMATION, FDA 4630 02:55:17,800 --> 02:55:20,000 REVIEWS NOW HAVE INDICATION AND 4631 02:55:20,000 --> 02:55:20,960 PROVIDES THE RESPONSE, 4632 02:55:20,960 --> 02:55:22,760 ESSENTIALLY FDA'S RESPONSE IS 4633 02:55:22,760 --> 02:55:25,920 GOING TO CONSIST OF TWO 4634 02:55:25,920 --> 02:55:26,240 CATEGORIES. 4635 02:55:26,240 --> 02:55:28,960 IT'S EITHER ACKNOWLEDGMENT OF 4636 02:55:28,960 --> 02:55:30,160 THE NOTIFICATION WITHOUT 4637 02:55:30,160 --> 02:55:32,560 OBJECTION TO IT OR 4638 02:55:32,560 --> 02:55:34,440 ACKNOWLEDGMENT WITH OBJECTION. 4639 02:55:34,440 --> 02:55:37,400 OBJECTION IS BASED ON EITHER THE 4640 02:55:37,400 --> 02:55:38,840 APPLICANT NOT BEING ABLE TO 4641 02:55:38,840 --> 02:55:41,120 PROPERLY IDENTIFY THE INGREDIENT 4642 02:55:41,120 --> 02:55:45,720 THAT IS THE NDI OR BASED ON THE 4643 02:55:45,720 --> 02:55:46,800 MANUFACTURER'S SAFETY 4644 02:55:46,800 --> 02:55:47,080 INFORMATION. 4645 02:55:47,080 --> 02:55:49,760 THERE ARE ALSO TIMES WHERE FDA 4646 02:55:49,760 --> 02:55:52,360 WILL RESPOND WITH A LETTER THE 4647 02:55:52,360 --> 02:55:53,840 INGREDIENT IS NOT A DIETARY 4648 02:55:53,840 --> 02:55:56,760 INGREDIENT AND THEREFORE IF IT 4649 02:55:56,760 --> 02:55:58,520 DOESN'T FIT THE DEFINITION OF 4650 02:55:58,520 --> 02:56:00,120 DIETARY INGREDIENT WHICH I 4651 02:56:00,120 --> 02:56:01,840 TALKED ABOUT EARLIER, CAN'T BE 4652 02:56:01,840 --> 02:56:03,720 NDI, THEREFORE THAT'S NOT THE 4653 02:56:03,720 --> 02:56:05,560 PROPER MECHANISM FOR THE PRODUCT 4654 02:56:05,560 --> 02:56:08,560 TO BE USING FOR PRE-MARKET 4655 02:56:08,560 --> 02:56:08,960 NOTIFICATION. 4656 02:56:08,960 --> 02:56:11,600 IN THAT CASE IT'S MORE LIKELY IT 4657 02:56:11,600 --> 02:56:12,800 COULD BE A -- MUCH MORE LIKELY 4658 02:56:12,800 --> 02:56:14,240 THAT THE PRODUCT WILL END UP 4659 02:56:14,240 --> 02:56:16,640 BEING A DRUG OR FOOD OR 4660 02:56:16,640 --> 02:56:17,640 SOMETHING ELSE. 4661 02:56:17,640 --> 02:56:19,040 FDA THEN MAKES SAFETY 4662 02:56:19,040 --> 02:56:21,120 CONCLUSIONS THAT ARE BASED UPON 4663 02:56:21,120 --> 02:56:22,840 THE CHEMICAL IDENTITY AND 4664 02:56:22,840 --> 02:56:23,760 MANUFACTURING PROCESS. 4665 02:56:23,760 --> 02:56:26,280 THEY LOOK AT SPECS FOR EACH 4666 02:56:26,280 --> 02:56:28,080 COMPONENT, ANALYTICAL METHODS, 4667 02:56:28,080 --> 02:56:32,400 THAT SORT OF THING. 4668 02:56:32,400 --> 02:56:34,240 FDA'S INFORMATION THAT WE 4669 02:56:34,240 --> 02:56:38,960 RECEIVE, IT'S REDACTED BUT ALSO 4670 02:56:38,960 --> 02:56:40,920 PUT ON REGS.GOV AND FDA'S 4671 02:56:40,920 --> 02:56:43,800 RESPONSE LETTER SO FOLKS CAN SEE 4672 02:56:43,800 --> 02:56:44,000 THAT. 4673 02:56:44,000 --> 02:56:45,520 REVIEWERS WILL DETERMINE IF 4674 02:56:45,520 --> 02:56:47,600 THERE'S A HISTORY OF SAFE USE IN 4675 02:56:47,600 --> 02:56:49,760 FOOD OR IF THERE'S ANY OTHER 4676 02:56:49,760 --> 02:56:52,640 EVIDENCE OF SAFETY BASED ON 4677 02:56:52,640 --> 02:56:53,560 INFORMATION PROVIDED. 4678 02:56:53,560 --> 02:56:57,360 THAT WOULD BE PUBLISHED 4679 02:56:57,360 --> 02:56:58,240 LITERATURE, TOXOLOGICAL, ANY 4680 02:56:58,240 --> 02:56:59,880 OTHER INFORMATION AND, AGAIN, 4681 02:56:59,880 --> 02:57:02,960 THAT WOULD BE INCLUDED AS PART 4682 02:57:02,960 --> 02:57:06,000 OF THE SUBMISSION THAT WOULD BE 4683 02:57:06,000 --> 02:57:09,960 ADDED TO THE REGULATION'S.GOV 4684 02:57:09,960 --> 02:57:13,000 WEBSITE, WITH THE CONFIDENTIAL 4685 02:57:13,000 --> 02:57:13,560 INFORMATION REDACTED. 4686 02:57:13,560 --> 02:57:15,400 SO THIS IS JUST A CHART THAT 4687 02:57:15,400 --> 02:57:17,160 EXPLAINS A LITTLE BIT MORE ABOUT 4688 02:57:17,160 --> 02:57:19,600 WHETHER OR NOT IT IS A NEW 4689 02:57:19,600 --> 02:57:20,120 DIETARY INGREDIENT. 4690 02:57:20,120 --> 02:57:24,200 AS YOU CAN SEE, THAT IS ON FDA'S 4691 02:57:24,200 --> 02:57:24,960 WEBSITE. 4692 02:57:24,960 --> 02:57:26,840 THESE QUESTIONS ARE INSTRUCTIVE 4693 02:57:26,840 --> 02:57:29,440 IN HELPING A POTENTIAL NOTIFIER 4694 02:57:29,440 --> 02:57:32,960 DETERMINE IF THEY NEED TO -- IF 4695 02:57:32,960 --> 02:57:35,360 THEIR PRODUCT CONTAINS AN NDI. 4696 02:57:35,360 --> 02:57:37,680 WAS THE PRODUCT MARKETED AFTER 4697 02:57:37,680 --> 02:57:39,400 OCTOBER 15, 1994? 4698 02:57:39,400 --> 02:57:40,920 WAS THE PRODUCT PRESENT IN THE 4699 02:57:40,920 --> 02:57:43,120 FOOD SUPPLY AS AN ARTICLE USED 4700 02:57:43,120 --> 02:57:44,280 FOR FOOD? 4701 02:57:44,280 --> 02:57:45,760 WAS IT CHEMICALLY ALTERED? 4702 02:57:45,760 --> 02:57:50,360 THIS CHART PROVIDES SOME 4703 02:57:50,360 --> 02:57:51,600 ADDITIONAL INFORMATION. 4704 02:57:51,600 --> 02:57:54,400 SO, CONTINUING ALONG WITH THE 4705 02:57:54,400 --> 02:57:55,160 NEW DIETARY INGREDIENT 4706 02:57:55,160 --> 02:57:56,000 NOTIFICATIONS, AND SOMETHING 4707 02:57:56,000 --> 02:57:58,640 ELSE THAT I THINK IS CRITICAL TO 4708 02:57:58,640 --> 02:58:00,440 REFERENCE HERE, DR. BETZ 4709 02:58:00,440 --> 02:58:02,600 MENTIONED THAT FDA HAS MADE 4710 02:58:02,600 --> 02:58:07,480 STATEMENTS ABOUT THE LACK OF NDI 4711 02:58:07,480 --> 02:58:08,280 AND FROM MANUFACTURERS. 4712 02:58:08,280 --> 02:58:11,280 NOW, LAST WEEK IN ORDER TO 4713 02:58:11,280 --> 02:58:14,200 ADDRESS THIS, FDA PUBLISHED A 4714 02:58:14,200 --> 02:58:15,520 DRAFT GUIDANCE SEEKING COMMENT 4715 02:58:15,520 --> 02:58:18,040 ON WHAT'S REFERRED TO AS A 4716 02:58:18,040 --> 02:58:18,720 TEMPORARY ENFORCEMENT DISCRETION 4717 02:58:18,720 --> 02:58:20,640 POLICY, AND THAT'S AIMED AT 4718 02:58:20,640 --> 02:58:21,880 INCREASING AMOUNT OF SAFETY 4719 02:58:21,880 --> 02:58:24,320 INFORMATION THE AGENCY HAS ABOUT 4720 02:58:24,320 --> 02:58:25,680 THE DIETARY SUPPLEMENT 4721 02:58:25,680 --> 02:58:27,760 MARKETPLACE FOR PROVIDING THE 4722 02:58:27,760 --> 02:58:29,520 INDUSTRY AN OPPORTUNITY TO 4723 02:58:29,520 --> 02:58:32,800 SUBMIT LATE NEW DIETARY 4724 02:58:32,800 --> 02:58:35,040 INGREDIENT NOTIFICATION IS. 4725 02:58:35,040 --> 02:58:37,160 IF FINALIZED THEY WILL HAVE SIX 4726 02:58:37,160 --> 02:58:38,840 MONTHS TO PROVIDE LATENT DIETARY 4727 02:58:38,840 --> 02:58:39,920 INGREDIENT NOTIFICATIONS AND 4728 02:58:39,920 --> 02:58:44,160 WON'T BE PENALIZED FOR PROVIDING 4729 02:58:44,160 --> 02:58:48,760 THEM TO FDA AFTER THAT 75-DAY 4730 02:58:48,760 --> 02:58:49,360 NOTIFICATION PERIOD WHEN THEY 4731 02:58:49,360 --> 02:58:50,160 WERE SUPPOSED TO DO IT. 4732 02:58:50,160 --> 02:58:53,480 NOW I'M GOING TO MOVE TO CURRENT 4733 02:58:53,480 --> 02:58:54,240 GOOD MANUFACTURING PRACTICES. 4734 02:58:54,240 --> 02:58:57,120 THIS AREA IS A LARGE PART OF 4735 02:58:57,120 --> 02:58:59,480 FDA'S POST-MARKET REGULATION OF 4736 02:58:59,480 --> 02:59:00,240 DIETARY SUPPLEMENTS. 4737 02:59:00,240 --> 02:59:04,960 APPLIES TO DOMESTIC AND FOREIGN 4738 02:59:04,960 --> 02:59:06,080 MANUFACTURERS. 4739 02:59:06,080 --> 02:59:08,360 FDA PUBLISHED THEIR FINAL RULE 4740 02:59:08,360 --> 02:59:09,840 ABOUT CURRENT GOOD MANUFACTURING 4741 02:59:09,840 --> 02:59:13,120 PRODUCTS, THIS IS IN 2007, AND 4742 02:59:13,120 --> 02:59:15,800 IT'S CODIFIED AT 21 CFR 111. 4743 02:59:15,800 --> 02:59:19,080 THIS IS AN EXTENSIVE REGULATION 4744 02:59:19,080 --> 02:59:21,680 THAT ESTABLISHES MINIMUM 4745 02:59:21,680 --> 02:59:22,800 cGMPs NECESSARY FOR 4746 02:59:22,800 --> 02:59:23,760 MANUFACTURING, PACKAGING, 4747 02:59:23,760 --> 02:59:26,640 LABELING AND HOLDING OF 4748 02:59:26,640 --> 02:59:28,160 SUPPLEMENTS, 16 SUBPARTS, 4749 02:59:28,160 --> 02:59:30,720 REGULATION HAS AN EMPHASIS ON A 4750 02:59:30,720 --> 02:59:33,200 PRODUCTION AND PROCESS CONTROLS, 4751 02:59:33,200 --> 02:59:36,400 BASICALLY BUILDING QUALITY INTO 4752 02:59:36,400 --> 02:59:38,360 THE PRODUCT, REQUIREMENT FOR 4753 02:59:38,360 --> 02:59:41,200 TESTING OF RAW MATERIAL AND 4754 02:59:41,200 --> 02:59:43,600 FINISHED PRODUCT STAGE. 4755 02:59:43,600 --> 02:59:44,920 INVESTIGATORS WILL CONFIRM 4756 02:59:44,920 --> 02:59:48,080 COMPLIANCE DURING INSPECTION. 4757 02:59:48,080 --> 02:59:52,720 FAILURE COULD TO COME BY MAY 4758 02:59:52,720 --> 02:59:54,920 RESULT IN FURTHER ENFORCEMENT 4759 02:59:54,920 --> 02:59:55,800 ACTION. 4760 02:59:55,800 --> 02:59:56,160 OKAY. 4761 02:59:56,160 --> 02:59:59,520 SO, THIS NEXT SLIDE IS ABOUT 4762 02:59:59,520 --> 03:00:00,160 DIETARY SUPPLEMENT LABELING, 4763 03:00:00,160 --> 03:00:01,560 AGAIN SOMETHING I KNOW THAT'S 4764 03:00:01,560 --> 03:00:03,360 BEEN TOUCHED ON PREVIOUSLY SO 4765 03:00:03,360 --> 03:00:05,840 I'M GOING TO MOVE QUICKER 4766 03:00:05,840 --> 03:00:10,440 THROUGH THESE SLIDES. 4767 03:00:10,440 --> 03:00:11,800 BASICALLY DIETARY SUPPLEMENTS 4768 03:00:11,800 --> 03:00:13,840 HAVE A REQUIREMENT SPECIFIC TO 4769 03:00:13,840 --> 03:00:14,680 SUPPLEMENTS EVEN THOUGH 4770 03:00:14,680 --> 03:00:16,880 CONSIDERED A CATEGORY OF FOOD. 4771 03:00:16,880 --> 03:00:18,560 FOR EXAMPLE, LABELED PROPERLY, 4772 03:00:18,560 --> 03:00:21,400 LIST ALL INGREDIENTS PROPERLY 4773 03:00:21,400 --> 03:00:24,480 FORMATTED SUPPLEMENT FACTS 4774 03:00:24,480 --> 03:00:25,920 LABEL, ET CETERA. 4775 03:00:25,920 --> 03:00:28,400 AS SHOWN PREVIOUSLY, THIS IS 4776 03:00:28,400 --> 03:00:29,360 WHAT A SUPPLEMENT FACTS PANEL 4777 03:00:29,360 --> 03:00:31,040 LOOKS LIKE. 4778 03:00:31,040 --> 03:00:34,960 WE'VE GOT THE SERVINGS, 4779 03:00:34,960 --> 03:00:37,000 DIFFERENT NUTRIENTS, WITH THEIR 4780 03:00:37,000 --> 03:00:39,240 AMOUNT PER SERVING, PERCENT OF 4781 03:00:39,240 --> 03:00:41,120 DAILY VALUE, AND OTHER 4782 03:00:41,120 --> 03:00:42,640 INGREDIENTS THAT MIGHT BE 4783 03:00:42,640 --> 03:00:43,800 INCLUDED IN THE DIETARY 4784 03:00:43,800 --> 03:00:48,680 SUPPLEMENT THAT MIGHT BE 4785 03:00:48,680 --> 03:00:49,200 FILLERS, PRESERVATIVES, 4786 03:00:49,200 --> 03:00:52,080 SWEETENERS, FLAVORINGS, OR OTHER 4787 03:00:52,080 --> 03:00:52,480 COLORS. 4788 03:00:52,480 --> 03:00:55,280 THIS IS JUST AN EXAMPLE OF WHAT 4789 03:00:55,280 --> 03:00:57,800 WE LOOK AT ON THE DIETARY 4790 03:00:57,800 --> 03:00:59,720 SUPPLEMENT LABELING, FRONT AND 4791 03:00:59,720 --> 03:01:03,360 BACK, YOU CAN SEE ON ONE SIDE 4792 03:01:03,360 --> 03:01:05,760 YOU SEE THE DIETARY SUPPLEMENT 4793 03:01:05,760 --> 03:01:06,240 DISCLAIMER. 4794 03:01:06,240 --> 03:01:10,040 YOU SEE IT'S MARKETED WITH A 4795 03:01:10,040 --> 03:01:14,000 WORDS THIS IS A SUPPLEMENT, FACT 4796 03:01:14,000 --> 03:01:15,080 PANEL ON THE BACK, BLACKED OUT 4797 03:01:15,080 --> 03:01:18,600 BUT DOES HAVE THE ADDRESS AND 4798 03:01:18,600 --> 03:01:22,040 PHONE NUMBER TO CONTACT FOR 4799 03:01:22,040 --> 03:01:25,640 ADVERSE EVENTS. 4800 03:01:25,640 --> 03:01:32,840 SO NOW MORE STRUCTURE/FUNCTION 4801 03:01:32,840 --> 03:01:34,680 CLAIM NOTIFICATIONS, BEAR CLAIMS 4802 03:01:34,680 --> 03:01:37,200 AND NUTRIENT DEFICIENCY CLAIMS 4803 03:01:37,200 --> 03:01:39,600 AND WELL-BEING CLAIMS. 4804 03:01:39,600 --> 03:01:41,720 NUTRIENT DEFICIENT CLAIMS MIGHT 4805 03:01:41,720 --> 03:01:45,320 BE VITAMIN D DEFICIENCY CAN 4806 03:01:45,320 --> 03:01:46,240 CAUSE RICKETS IN CHILDREN, 4807 03:01:46,240 --> 03:01:46,800 OBVIOUSLY VERY RARE IN THE 4808 03:01:46,800 --> 03:01:47,720 UNITED STATES. 4809 03:01:47,720 --> 03:01:55,680 GENERAL WELL-BEING CLAIM HELPS 4810 03:01:55,680 --> 03:01:59,880 MAINTAIN VITALITY OR INVIGORATE 4811 03:01:59,880 --> 03:02:04,560 YOUR BODY. 4812 03:02:04,560 --> 03:02:06,000 REQUIRED TO MAINTAIN 4813 03:02:06,000 --> 03:02:07,880 SUBSTANTIATION, MIGHT BE TESTS, 4814 03:02:07,880 --> 03:02:11,240 ANALYSES, RESEARCH STUDIES, ET 4815 03:02:11,240 --> 03:02:11,760 CETERA. 4816 03:02:11,760 --> 03:02:12,760 REQUIREMENTS ASSOCIATED WITH 4817 03:02:12,760 --> 03:02:13,760 STRUCTURE/FUNCTION CLAIMS, THIS 4818 03:02:13,760 --> 03:02:14,960 HAS BEEN DISCUSSED A LITTLE BIT 4819 03:02:14,960 --> 03:02:19,880 BUT HAS TO HAVE THAT DISCLAIMER. 4820 03:02:19,880 --> 03:02:21,200 MANUFACTURERS SELLING THE 4821 03:02:21,200 --> 03:02:22,960 PRODUCT WITH STRUCTURE/FUNCTION 4822 03:02:22,960 --> 03:02:25,680 CLAIM HAVE TO NOTIFY FDA WITHIN 4823 03:02:25,680 --> 03:02:27,880 30 DAYS OF MARKETING THE PRODUCT 4824 03:02:27,880 --> 03:02:29,760 CONTAINING THE CLAIM. 4825 03:02:29,760 --> 03:02:31,080 THAT NOTIFICATION WILL INCLUDE 4826 03:02:31,080 --> 03:02:33,480 TEXT OF THE CLAIM, AND FDA WILL 4827 03:02:33,480 --> 03:02:35,760 REVIEW AND PROVIDE A RESPONSE IF 4828 03:02:35,760 --> 03:02:37,200 THERE'S ANY CONCERNS WITH 4829 03:02:37,200 --> 03:02:47,560 RESPECT TO THAT CLAIM. 4830 03:02:50,920 --> 03:02:52,320 THIS IS MORE ON 4831 03:02:52,320 --> 03:02:52,960 STRUCTURE/FUNCTION CLAIMS, I'LL 4832 03:02:52,960 --> 03:02:54,320 SKIP THIS BECAUSE WE'RE RUNNING 4833 03:02:54,320 --> 03:02:56,600 SHORT ON TIME. 4834 03:02:56,600 --> 03:02:58,680 SLIDE 20, THIS IS INTERESTING 4835 03:02:58,680 --> 03:03:00,440 FOR FOLKS THROUGHOUT THE 4836 03:03:00,440 --> 03:03:02,160 PANDEMIC, FDA HAS SENT WARNING 4837 03:03:02,160 --> 03:03:04,720 LETTERS TO COMPANIES MARKETING 4838 03:03:04,720 --> 03:03:06,880 DIETARY SUPPLEMENTS WITH 4839 03:03:06,880 --> 03:03:08,120 UNLAWFUL DISEASE CLAIMS. 4840 03:03:08,120 --> 03:03:10,880 MAKING THESE PRODUCTS CONSIDERED 4841 03:03:10,880 --> 03:03:11,840 UNAPPROVED DRUGS IN VIOLATION OF 4842 03:03:11,840 --> 03:03:13,560 THE ACT BUT I'M HAPPY TO REPORT 4843 03:03:13,560 --> 03:03:15,120 MOST FIRMS DO MAKE CORRECTIONS 4844 03:03:15,120 --> 03:03:17,400 TO THEIR CLAIMS AFTER THEY 4845 03:03:17,400 --> 03:03:19,800 RECEIVE A WARNING LETTER IN THIS 4846 03:03:19,800 --> 03:03:20,120 INSTANCE. 4847 03:03:20,120 --> 03:03:24,000 HERE'S AN EXAMPLE OF A PACKAGE 4848 03:03:24,000 --> 03:03:25,720 OF ZINC CHARGE PRODUCTS, 4849 03:03:25,720 --> 03:03:27,920 MISLEADING PROBLEMATIC CLAIMS 4850 03:03:27,920 --> 03:03:31,080 WITH RESPECT TO CORONAVIRUS 4851 03:03:31,080 --> 03:03:32,720 GIVEN HOW SERIOUS THIS PANDEMIC 4852 03:03:32,720 --> 03:03:34,840 IS IT'S GREAT TO SEE FIRMS ARE 4853 03:03:34,840 --> 03:03:37,280 MAKING -- MANY FIRMS ARE MAKING 4854 03:03:37,280 --> 03:03:40,040 CHANGES WHEN THEY RECEIVE AN FDA 4855 03:03:40,040 --> 03:03:41,080 WARNING LETTER. 4856 03:03:41,080 --> 03:03:44,000 THE WARNING LETTER ALSO INCLUDES 4857 03:03:44,000 --> 03:03:45,320 LANGUAGE STATING FDA'S ADVISING 4858 03:03:45,320 --> 03:03:47,920 CONSUMERS NOT TO PURCHASE OR USE 4859 03:03:47,920 --> 03:03:51,800 THESE PRODUCTS. 4860 03:03:51,800 --> 03:03:55,120 SO SLIDE 21, ADVERSE EVENT 4861 03:03:55,120 --> 03:03:56,400 REPORTING, IF A MANUFACTURER 4862 03:03:56,400 --> 03:03:59,160 RECEIVES A REPORT AND DETERMINE, 4863 03:03:59,160 --> 03:04:00,240 IT'S SERIOUS THEY HAVE 15 4864 03:04:00,240 --> 03:04:02,240 BUSINESS DAYS TO FORWARD TO FDA. 4865 03:04:02,240 --> 03:04:04,320 A YEAR LATER THE MANUFACTURER 4866 03:04:04,320 --> 03:04:05,520 SHOULD ALSO PROVIDE AN UPDATE 4867 03:04:05,520 --> 03:04:07,960 WITH ANY NEW OR RELEVANT 4868 03:04:07,960 --> 03:04:09,840 INFORMATION PERTAINING TO THAT 4869 03:04:09,840 --> 03:04:11,360 ADVERSE EVENT REPORT. 4870 03:04:11,360 --> 03:04:13,400 REPORTING SYSTEM WORKS THROUGH 4871 03:04:13,400 --> 03:04:15,680 FDA'S ADVERSE EVENT REPORTING 4872 03:04:15,680 --> 03:04:18,000 PROGRAM AND SUBMISSIONS RECEIVED 4873 03:04:18,000 --> 03:04:19,680 THROUGH ELECTRONIC PORTAL, ALSO 4874 03:04:19,680 --> 03:04:21,160 RECEIVED THROUGH E-MAIL, PHONE 4875 03:04:21,160 --> 03:04:23,800 CALLS, OR LETTERS. 4876 03:04:23,800 --> 03:04:26,560 AND ONCE THAT'S IN OUR SYSTEM 4877 03:04:26,560 --> 03:04:28,720 BOTH ESP REVIEWERS WILL EVALUATE 4878 03:04:28,720 --> 03:04:32,640 CASES AND DETERMINE IF ANY 4879 03:04:32,640 --> 03:04:33,760 FOLLOW-UP IS NEEDED, ODSP 4880 03:04:33,760 --> 03:04:35,720 MEDICAL OFFICERS ARE RESPONSIBLE 4881 03:04:35,720 --> 03:04:36,920 FOR RECOGNIZING ANY TRIGGERS 4882 03:04:36,920 --> 03:04:39,440 THAT MAY BE EVIDENCE WITH 4883 03:04:39,440 --> 03:04:42,640 RESPECT TO SPECIFIC FIRMS, 4884 03:04:42,640 --> 03:04:43,680 PRODUCTS, OR INGREDIENTS. 4885 03:04:43,680 --> 03:04:47,280 SO IN ADDITION TO SENDING OUT 4886 03:04:47,280 --> 03:04:49,640 WARNING LETTERS FOR cGMP AND 4887 03:04:49,640 --> 03:04:51,920 LABELING VIOLATIONS, THAT'S 4888 03:04:51,920 --> 03:04:54,560 PROBABLY WHAT IS -- WHAT MOST 4889 03:04:54,560 --> 03:04:56,120 PEOPLE KNOW THE FDA IS DOING 4890 03:04:56,120 --> 03:04:57,840 WITH RESPECT TO THESE 4891 03:04:57,840 --> 03:04:58,920 VIOLATIONS, THERE ARE OTHER 4892 03:04:58,920 --> 03:05:02,440 STEPS THAT FDA IS TAKING, FDA IS 4893 03:05:02,440 --> 03:05:04,040 RESPONSIBLE FOR TAKING ACTION 4894 03:05:04,040 --> 03:05:05,400 AGAINST UNSAFE PRODUCTS AFTER 4895 03:05:05,400 --> 03:05:08,160 THEY ARE MARKETED. 4896 03:05:08,160 --> 03:05:10,120 WE PUT OUT FOR EXAMPLE GUIDANCE 4897 03:05:10,120 --> 03:05:12,040 FOR INDUSTRY ON HIGHLY 4898 03:05:12,040 --> 03:05:14,800 CONCENTRATED CAFFEINE IN DIETARY 4899 03:05:14,800 --> 03:05:15,880 SUPPLEMENTS, THIS PRESENTS A 4900 03:05:15,880 --> 03:05:18,080 SIGNIFICANT PUBLIC HEALTH THREAT 4901 03:05:18,080 --> 03:05:19,640 AND IS CONTRIBUTED TO TWO DEATHS 4902 03:05:19,640 --> 03:05:23,560 IN THE U.S. SO WE DID ISSUE MANY 4903 03:05:23,560 --> 03:05:24,520 WARNING LETTERS AND GUIDANCE ON 4904 03:05:24,520 --> 03:05:29,680 THIS TO MAKE SURE PEOPLE WHO 4905 03:05:29,680 --> 03:05:33,080 INTENT TO USE POWDERED CAFFEINE 4906 03:05:33,080 --> 03:05:34,320 USE IT PROPER. 4907 03:05:34,320 --> 03:05:35,600 THERE'S EXAMPLES OF WARNING 4908 03:05:35,600 --> 03:05:38,160 LETTERS WE SENT OUT IN RECENT 4909 03:05:38,160 --> 03:05:38,440 YEARS. 4910 03:05:38,440 --> 03:05:40,200 ALSO I WANT TO HIGHLIGHT WHAT WE 4911 03:05:40,200 --> 03:05:42,480 REFER TO AS CLAIMS INITIATIVES, 4912 03:05:42,480 --> 03:05:44,360 THESE ARE SOME ACTIONS THAT FDA 4913 03:05:44,360 --> 03:05:46,560 HAS TAKEN OVER THE LAST COUPLE 4914 03:05:46,560 --> 03:05:47,120 YEARS. 4915 03:05:47,120 --> 03:05:49,520 SOME IN COMBINATION WITH THE 4916 03:05:49,520 --> 03:05:51,280 FEDERAL TRADE COMMISSION, AND 4917 03:05:51,280 --> 03:05:53,240 THESE JUST HELP TO HIGHLIGHT 4918 03:05:53,240 --> 03:05:55,560 ACTIONS THAT FDA'S TAKING WITH 4919 03:05:55,560 --> 03:05:57,200 RESPECT TO CERTAIN TYPES OF 4920 03:05:57,200 --> 03:05:59,720 PRODUCTS, AND ALSO HELPS TO 4921 03:05:59,720 --> 03:06:01,680 HIGHLIGHT THE DANGERS OF 4922 03:06:01,680 --> 03:06:03,800 PRODUCTS AND OF USING PRODUCTS 4923 03:06:03,800 --> 03:06:06,080 THAT ARE NOT CONSIDERED SAFE AND 4924 03:06:06,080 --> 03:06:09,760 EFFECTIVE TREATMENTS FOR CERTAIN 4925 03:06:09,760 --> 03:06:10,160 DISEASES. 4926 03:06:10,160 --> 03:06:13,720 SO, FINALLY I'LL CLOSE WITH SOME 4927 03:06:13,720 --> 03:06:15,440 INFORMATION ON INSPECTION. 4928 03:06:15,440 --> 03:06:16,600 IN MARCH 2020 FDA DID ANNOUNCE 4929 03:06:16,600 --> 03:06:20,280 THAT DUE TO THE PANDEMIC IT WAS 4930 03:06:20,280 --> 03:06:22,160 TEMPORARILY POSTPONING ALL 4931 03:06:22,160 --> 03:06:24,320 DOMESTIC AND FOREIGN ROUTINE 4932 03:06:24,320 --> 03:06:26,840 SURVEILLANCE ACTIVITY. 4933 03:06:26,840 --> 03:06:30,320 BUT WE DID CONTINUE TO MISSION 4934 03:06:30,320 --> 03:06:31,440 CRITICAL INSPECTIONS WHEN 4935 03:06:31,440 --> 03:06:32,440 POSSIBLE, ENGAGED IN ALTERNATIVE 4936 03:06:32,440 --> 03:06:34,160 FORMS OF REVIEW WHEN POSSIBLE, 4937 03:06:34,160 --> 03:06:35,720 AS WELL. 4938 03:06:35,720 --> 03:06:39,640 AND DURING THE PAUSE IN 4939 03:06:39,640 --> 03:06:41,720 INSPECTIONS INITIATED OTHER 4940 03:06:41,720 --> 03:06:43,160 PROGRAMS THAT MANUFACTURERS 4941 03:06:43,160 --> 03:06:46,520 COULD PARTICIPATE IN LIKE, FOR 4942 03:06:46,520 --> 03:06:47,080 EXAMPLE, VOLUNTARY REMOTE 4943 03:06:47,080 --> 03:06:49,720 REGULATORY ASSESSMENTS, THAT 4944 03:06:49,720 --> 03:06:54,440 WOULD ALLOW FDA TO REMOTE INTO A 4945 03:06:54,440 --> 03:06:55,960 MANUFACTURER'S FACILITY 4946 03:06:55,960 --> 03:06:56,840 BASICALLY TO EVALUATE 4947 03:06:56,840 --> 03:06:58,080 DOCUMENTATION, MAYBE CLEAR UP 4948 03:06:58,080 --> 03:07:00,040 CERTAIN THINGS THAT MIGHT NEED 4949 03:07:00,040 --> 03:07:01,360 TO BE HANDLED LATER IN AN -- 4950 03:07:01,360 --> 03:07:03,200 THAT WOULD HAVE BEEN NEEDED TO 4951 03:07:03,200 --> 03:07:04,720 HAVE BEEN HANDLED LATER IN 4952 03:07:04,720 --> 03:07:07,320 INSPECTION BUT THAT'S A WIN FOR 4953 03:07:07,320 --> 03:07:08,920 FDA, A WIN FOR CONSUMERS AND THE 4954 03:07:08,920 --> 03:07:11,600 MANUFACTURER IF THEY ARE ABLE TO 4955 03:07:11,600 --> 03:07:15,240 HANDLE THAT ALL BEFORE THE 4956 03:07:15,240 --> 03:07:17,120 LARGER INSPECTION DOES IN FACT 4957 03:07:17,120 --> 03:07:17,600 HAPPEN. 4958 03:07:17,600 --> 03:07:18,840 SO, I KNOW I RUSHED AT THE END 4959 03:07:18,840 --> 03:07:22,400 BUT I WAS TRYING TO MAKE SURE WE 4960 03:07:22,400 --> 03:07:24,440 STAY WITHIN OUR TIMING. 4961 03:07:24,440 --> 03:07:26,280 THIS CONCLUDES MY PRESENTATION 4962 03:07:26,280 --> 03:07:27,960 ON HOW FDA REGULATES DIETARY 4963 03:07:27,960 --> 03:07:29,680 SUPPLEMENTS AND I'M HAPPY TO 4964 03:07:29,680 --> 03:07:31,440 ANSWER ANY QUESTIONS YOU MAY 4965 03:07:31,440 --> 03:07:32,280 HAVE DURING OUR PANEL 4966 03:07:32,280 --> 03:07:33,200 DISCUSSION. 4967 03:07:33,200 --> 03:07:37,320 THANK YOU SO MUCH. 4968 03:07:37,320 --> 03:07:38,680 >> THANK YOU SO MUCH. 4969 03:07:38,680 --> 03:07:41,720 FINAL SPEAKER FOR THIS SESSION 4970 03:07:41,720 --> 03:07:43,360 IS MISS TAWANA DAVIS, EXPLAINING 4971 03:07:43,360 --> 03:07:45,280 WHAT THE FEDERAL TRADE 4972 03:07:45,280 --> 03:07:47,560 COMMISSION DOES WITH SPECIAL 4973 03:07:47,560 --> 03:07:50,480 FOCUS ON ITS SUPPLEMENT RELATED 4974 03:07:50,480 --> 03:07:51,000 RESPONSIBILITIES. 4975 03:07:51,000 --> 03:07:55,080 SHE IS ASSISTANT DIRECTOR IN THE 4976 03:07:55,080 --> 03:07:56,520 DIVISION OF ADVERTISING 4977 03:07:56,520 --> 03:07:59,520 PRACTICES, BUREAU OF CONSUMER 4978 03:07:59,520 --> 03:08:01,000 PROTECTION AT THE FTC. 4979 03:08:01,000 --> 03:08:04,400 AN ATTORNEY, HAS BEEN WITH THE 4980 03:08:04,400 --> 03:08:06,720 FTC SINCE 2002. 4981 03:08:06,720 --> 03:08:12,080 SO WELCOME, MS. DAVIS. 4982 03:08:12,080 --> 03:08:14,760 I'M VERY GLAD TO BE HERE WITH 4983 03:08:14,760 --> 03:08:15,440 YOU TODAY. 4984 03:08:15,440 --> 03:08:17,400 WE IN THE DIVISION OF 4985 03:08:17,400 --> 03:08:18,040 ADVERTISING PRACTICES CONSIDER 4986 03:08:18,040 --> 03:08:23,520 THIS TO BE ONE OF THE FTC'S MOST 4987 03:08:23,520 --> 03:08:28,440 IMPORTANT OUTREACH OPPORTUNITIES 4988 03:08:28,440 --> 03:08:29,680 ON DIETARY SUPPLEMENTS. 4989 03:08:29,680 --> 03:08:31,400 THERE'S PRODUCTS THAT OFFER 4990 03:08:31,400 --> 03:08:32,800 PROVEN HEALTH BENEFITS, AND 4991 03:08:32,800 --> 03:08:35,320 OTHER THAT SHOW PROMISE. 4992 03:08:35,320 --> 03:08:37,040 BUT NEED NUTRITIONAL STUDY. 4993 03:08:37,040 --> 03:08:38,320 UNFORTUNATELY, THERE ARE ALSO 4994 03:08:38,320 --> 03:08:39,400 PRODUCTS ON THE MARKET THAT 4995 03:08:39,400 --> 03:08:42,480 AREN'T BACKED BY ANY SCIENCE 4996 03:08:42,480 --> 03:08:43,760 THAT THEY WILL PROVIDE BENEFIT 4997 03:08:43,760 --> 03:08:46,160 CLAIM OR WORSE MAY EVEN BE 4998 03:08:46,160 --> 03:08:47,400 HARMFUL. 4999 03:08:47,400 --> 03:08:51,720 THOSE ARE THE PRODUCTS FTC 5000 03:08:51,720 --> 03:08:52,400 FOCUSES ON. 5001 03:08:52,400 --> 03:08:53,760 TODAY I'LL TALK ABOUT THE FTC 5002 03:08:53,760 --> 03:08:56,040 ROLE IN POLICING HOW SUPPLEMENTS 5003 03:08:56,040 --> 03:08:57,240 ARE ADVERTISED AND HOW WE'RE 5004 03:08:57,240 --> 03:08:59,320 WORKING TO MAKE SURE CLAIMS FOR 5005 03:08:59,320 --> 03:09:00,840 SUPPLEMENTS ARE BACKED BY SOLID 5006 03:09:00,840 --> 03:09:03,040 SCIENCE, NOT JUST MARKETING 5007 03:09:03,040 --> 03:09:03,240 HYPE. 5008 03:09:03,240 --> 03:09:05,160 AND WHAT WE'VE BEEN DOING TO 5009 03:09:05,160 --> 03:09:11,480 PROTECT CONSUMERS DURING THE 5010 03:09:11,480 --> 03:09:12,080 PANDEMIC. 5011 03:09:12,080 --> 03:09:15,120 BEFORE WE BEGIN, LET ME START 5012 03:09:15,120 --> 03:09:16,520 WITH THE DISCLAIMER MY COMMENTS 5013 03:09:16,520 --> 03:09:18,600 REFLECT MY OWN VIEWS AND DO NOT 5014 03:09:18,600 --> 03:09:19,840 NECESSARILY REFLECT THE VIEWS OF 5015 03:09:19,840 --> 03:09:22,800 THE COMMISSION OR ANY INDIVIDUAL 5016 03:09:22,800 --> 03:09:24,320 COMMISSIONER. 5017 03:09:24,320 --> 03:09:26,960 TODAY I'M GOING TO SPEND A 5018 03:09:26,960 --> 03:09:27,840 LITTLE TIME EXPLAINING THE 5019 03:09:27,840 --> 03:09:38,000 JURISDICTION OVER SUPPLEMENTS, 5020 03:09:38,000 --> 03:09:38,840 AUTHORITY AND HOW THEY 5021 03:09:38,840 --> 03:09:40,600 COORDINATE AND HOW WE APPROACH A 5022 03:09:40,600 --> 03:09:41,640 LAW ENFORCEMENT CASE AGAINST 5023 03:09:41,640 --> 03:09:43,840 FALSE OR MISLEADING CLAIMS ABOUT 5024 03:09:43,840 --> 03:09:45,880 THE ADVOCACY AND SAFETY OF 5025 03:09:45,880 --> 03:09:46,280 SUPPLEMENTS. 5026 03:09:46,280 --> 03:09:48,280 I HAVE SOME BRIEF EXAMPLES OF 5027 03:09:48,280 --> 03:09:50,120 HEALTH FRAUDS IN THIS INDUSTRY 5028 03:09:50,120 --> 03:09:59,680 WHERE THE FTC HAS TAKEN ACTION. 5029 03:09:59,680 --> 03:10:02,760 IT'S ALL PART OF THE FTC CHARGE 5030 03:10:02,760 --> 03:10:04,360 TO PROTECT CONSUMERS. 5031 03:10:04,360 --> 03:10:07,200 WE'RE A SMALL INDEPENDENT LAW 5032 03:10:07,200 --> 03:10:11,800 ENFORCEMENT AGENCY, WITH A BROAD 5033 03:10:11,800 --> 03:10:22,280 MANDATE, TO STOP DECEPTIVE 5034 03:10:25,080 --> 03:10:30,120 CLAIMS AND UNFAIR PRACTICES IN 5035 03:10:30,120 --> 03:10:30,400 COMMERCE. 5036 03:10:30,400 --> 03:10:34,280 WE LOOK AT ALL FORMS OF 5037 03:10:34,280 --> 03:10:35,160 MARKETING, ANYTHING DESIGNED TO 5038 03:10:35,160 --> 03:10:37,240 INDUCE SOMEONE TO PURCHASE A 5039 03:10:37,240 --> 03:10:39,800 PRODUCT, LOOK AT MARKETING IN TV 5040 03:10:39,800 --> 03:10:42,400 AND RADIO COMMERCIALS, PRINT ADS 5041 03:10:42,400 --> 03:10:44,520 IN NEWSPAPERS AND MAGAZINES, 5042 03:10:44,520 --> 03:10:45,920 DIRECT MAIL, MUCH OF TODAY'S 5043 03:10:45,920 --> 03:10:47,120 MARKETING IS ALSO IN THE 5044 03:10:47,120 --> 03:10:51,960 INTERNET SO WE LOOK AT WEBSITES, 5045 03:10:51,960 --> 03:10:53,080 FACEBOOK, TWITTER, YouTube, 5046 03:10:53,080 --> 03:10:56,760 INSTAGRAM, BLOG POSTS, MARKETING 5047 03:10:56,760 --> 03:10:57,880 E-MAILS, TEXTS. 5048 03:10:57,880 --> 03:10:59,720 ALTHOUGH WE DEFER TO FDA ON 5049 03:10:59,720 --> 03:11:01,240 LABELING, WE DO LOOK AT THE 5050 03:11:01,240 --> 03:11:06,240 PACKAGING AND INSERTS THAT ARE 5051 03:11:06,240 --> 03:11:10,000 INCLUDED WITH THE PRODUCT. 5052 03:11:10,000 --> 03:11:14,080 HERE ARE THE THINGS OVER THE 5053 03:11:14,080 --> 03:11:16,240 YEARS, ILLEGAL ROBO CALLS, SHAM 5054 03:11:16,240 --> 03:11:22,040 CHARITIES, GET RICH QUICK 5055 03:11:22,040 --> 03:11:25,480 SCHEMES, IDENTITY THEFT, COLD 5056 03:11:25,480 --> 03:11:26,760 AND FLU REMEDIES, FLUSHABLE 5057 03:11:26,760 --> 03:11:28,640 WIPES THAT AREN'T AS 5058 03:11:28,640 --> 03:11:31,160 ENVIRONMENTALLY FRIENDLY AS THEY 5059 03:11:31,160 --> 03:11:33,120 CLAIM AND LOOK AT FOOD PRODUCTS 5060 03:11:33,120 --> 03:11:34,920 LIKE POM WONDERFUL AND CASES 5061 03:11:34,920 --> 03:11:43,760 AGAINST KELLOGG FOR CLAIMING 5062 03:11:43,760 --> 03:11:46,400 FROSTED MINI WHEATS 5063 03:11:46,400 --> 03:11:47,000 (INDISCERNIBLE) AND PROBIOTIC 5064 03:11:47,000 --> 03:11:48,040 PRODUCTS AFFECTS COLD AND FLU. 5065 03:11:48,040 --> 03:11:50,120 WE'VE LOOKED AT A NUMBER OF 5066 03:11:50,120 --> 03:11:52,120 PRODUCTS CLAIMING TO IMPROVE 5067 03:11:52,120 --> 03:11:54,000 COGNITIVE FUNCTION OR PREVENT 5068 03:11:54,000 --> 03:11:56,520 ELEMENT OF ALZHEIMER'S AND 5069 03:11:56,520 --> 03:11:57,000 DEMENTIA. 5070 03:11:57,000 --> 03:11:58,440 AS MORE PEOPLE ARE DIAGNOSED 5071 03:11:58,440 --> 03:11:59,880 WITH THESE CONDITIONS, MARKETERS 5072 03:11:59,880 --> 03:12:01,960 ARE DEVELOPING PRODUCTS THAT 5073 03:12:01,960 --> 03:12:03,480 CAPITALIZE ON CONSUMERS' 5074 03:12:03,480 --> 03:12:05,240 ANXIETIES AND DESIRE TO PREVENT 5075 03:12:05,240 --> 03:12:05,520 THEM. 5076 03:12:05,520 --> 03:12:08,160 MANY OF YOU MAY BE FAMILIAR WITH 5077 03:12:08,160 --> 03:12:13,440 THE BRAIN TRAINING GAME LUMOSITY 5078 03:12:13,440 --> 03:12:15,600 CLAIMING IT PROVIDES COGNITIVE 5079 03:12:15,600 --> 03:12:18,880 BENEFITS BUT RESEARCH SHOWS 5080 03:12:18,880 --> 03:12:20,280 IMPROVEMENT ON GAINS BUT NO 5081 03:12:20,280 --> 03:12:24,400 EVIDENCE OF A REAL WORLD 5082 03:12:24,400 --> 03:12:24,880 BENEFIT. 5083 03:12:24,880 --> 03:12:29,000 THIS IS ONE OF MY CASES, YOU MAY 5084 03:12:29,000 --> 03:12:30,840 HAVE HEARD OF TOMMY COPPER. 5085 03:12:30,840 --> 03:12:33,840 WE SAW TONS OF TV ADS TOUTING 5086 03:12:33,840 --> 03:12:35,880 COP YOU ARE INFUSED COMPRESSION 5087 03:12:35,880 --> 03:12:36,920 SLEEVES FOR JOINTS, BACK, 5088 03:12:36,920 --> 03:12:39,840 SHOULDER, YOU NAME IT. 5089 03:12:39,840 --> 03:12:41,120 TOMMIE COPPER WAS A LEADER IN 5090 03:12:41,120 --> 03:12:42,360 THIS INDUSTRY, THE COMPANY 5091 03:12:42,360 --> 03:12:45,440 CLAIMED THE COPPER IN ITS 5092 03:12:45,440 --> 03:12:47,360 GARMENTS PENETRATED SKIN AND 5093 03:12:47,360 --> 03:12:49,120 TRANSDETERMINEALLY TREATED OR 5094 03:12:49,120 --> 03:12:52,320 CURED DISEASE SUCH AS ARTHRITIS, 5095 03:12:52,320 --> 03:12:53,200 MULTIPLE SCLEROSIS, 5096 03:12:53,200 --> 03:12:53,600 FIBROMYALGIA. 5097 03:12:53,600 --> 03:12:54,880 THEY EVEN CLAIMED CONSUMERS 5098 03:12:54,880 --> 03:12:57,200 COULD WEAR THESE SLEEVES INSTEAD 5099 03:12:57,200 --> 03:12:58,640 OF GETTING SURGERY. 5100 03:12:58,640 --> 03:12:59,320 UNFORTUNATELY THE COMPANY DID 5101 03:12:59,320 --> 03:13:02,160 NOT HAVE SCIENCE TO SUPPORT 5102 03:13:02,160 --> 03:13:02,960 THESE CLAIMS. 5103 03:13:02,960 --> 03:13:04,640 TOMMIE COPPER AGREED TO ENTER 5104 03:13:04,640 --> 03:13:06,520 INTO AN FTC SETTLEMENT THAT 5105 03:13:06,520 --> 03:13:08,080 PROHIBITED THE COMPANY FROM 5106 03:13:08,080 --> 03:13:13,640 MAKING CLAIMS WITHOUT COMPETENT 5107 03:13:13,640 --> 03:13:14,400 RELIABLE SCIENTIFIC EVIDENCE 5108 03:13:14,400 --> 03:13:16,120 INCLUDED $87 MILLION JUDGMENT, 5109 03:13:16,120 --> 03:13:20,400 MOST SUSPENDED BASED ON 5110 03:13:20,400 --> 03:13:21,960 INABILITY TO PAY. 5111 03:13:21,960 --> 03:13:25,000 THE FCC'S AUTHORITY OVER DIETARY 5112 03:13:25,000 --> 03:13:27,080 SUPPLEMENT MARKETING OVERLAPS 5113 03:13:27,080 --> 03:13:28,960 WITH FDA. 5114 03:13:28,960 --> 03:13:30,720 OUR AGENCY HAS LIAISON AGREEMENT 5115 03:13:30,720 --> 03:13:32,800 UNDER WHICH FDA HAS PRIMARY 5116 03:13:32,800 --> 03:13:36,720 AUTHORITY OVER CLAIMS MADE IN 5117 03:13:36,720 --> 03:13:38,880 LABELING, FTC HAS PRIMARY 5118 03:13:38,880 --> 03:13:40,480 AUTHORITY OVER ADVERTISING. 5119 03:13:40,480 --> 03:13:44,720 GIVEN OUR SHARED AUTHORITY WE 5120 03:13:44,720 --> 03:13:49,680 STRIVE TO HAVE CONSISTENCY IN 5121 03:13:49,680 --> 03:13:55,200 POLICIES AND ENFORCEMENT 5122 03:13:55,200 --> 03:13:56,240 EFFORTS. 5123 03:13:56,240 --> 03:13:58,280 AS I INDICATED BEFORE, THE FTC 5124 03:13:58,280 --> 03:14:01,440 IS PRIMARILY A LAW ENFORCEMENT 5125 03:14:01,440 --> 03:14:03,200 AGENCY RATHER THAN REGULATORY 5126 03:14:03,200 --> 03:14:03,440 AGENCY. 5127 03:14:03,440 --> 03:14:07,240 THAT MEANS WE DO NOT ENGAGE IN 5128 03:14:07,240 --> 03:14:09,440 ANY KINDS OF PRE-MARKET 5129 03:14:09,440 --> 03:14:10,760 REGULATORY APPROVAL PROCESS. 5130 03:14:10,760 --> 03:14:13,920 FTC LAW REQUIRES CLAIMS IN 5131 03:14:13,920 --> 03:14:15,160 ADVERTISING BE SUBSTANTIATED 5132 03:14:15,160 --> 03:14:17,120 BEFORE THEY ARE MADE BUT WE DO 5133 03:14:17,120 --> 03:14:19,000 NOT REQUIRE COMPANIES TO SUBMIT 5134 03:14:19,000 --> 03:14:22,720 ADS IN ADVANCE AND WE DO NOT 5135 03:14:22,720 --> 03:14:25,000 EVALUATE OR PRE-APPROVE CLAIMS, 5136 03:14:25,000 --> 03:14:27,400 EVEN HEALTH CLAIMS. 5137 03:14:27,400 --> 03:14:29,360 ALSO UNLIKE FDA OUR REGULATORY 5138 03:14:29,360 --> 03:14:31,520 FRAMEWORK DOES NOT MAKE 5139 03:14:31,520 --> 03:14:32,880 DISTINCTION BETWEEN PRODUCT 5140 03:14:32,880 --> 03:14:33,360 CATEGORIES. 5141 03:14:33,360 --> 03:14:34,280 OUR APPROACH TO EVALUATING AN AD 5142 03:14:34,280 --> 03:14:36,360 WILL BE THE SAME WHETHER THE 5143 03:14:36,360 --> 03:14:39,880 PRODUCT IS POSITIONED AS A FOOD 5144 03:14:39,880 --> 03:14:42,280 OR DIETARY SUPPLEMENT, DRUG OR 5145 03:14:42,280 --> 03:14:42,640 DEVICE. 5146 03:14:42,640 --> 03:14:44,920 DSHEA DOES NOT APPLY TO 5147 03:14:44,920 --> 03:14:45,360 ADVERTISING. 5148 03:14:45,360 --> 03:14:46,760 THERE'S NO BRIGHT LINE 5149 03:14:46,760 --> 03:14:48,080 DISTINCTION UNDER FTC LAW 5150 03:14:48,080 --> 03:14:50,480 BETWEEN HEALTH CLAIMS OR 5151 03:14:50,480 --> 03:14:52,200 STRUCTURE/FUNCTION CLAIMS OR 5152 03:14:52,200 --> 03:14:54,560 DISEASE CLAIMS. 5153 03:14:54,560 --> 03:14:56,600 ALL CLAIMS THE FTC IS ASKING 5154 03:14:56,600 --> 03:14:59,800 ARE THEY BACKED BY GOOD SCIENCE. 5155 03:14:59,800 --> 03:15:02,440 BECAUSE THE FTC AND FDA BOTH 5156 03:15:02,440 --> 03:15:05,080 HAVE ACTIVE ENFORCEMENT PROGRAMS 5157 03:15:05,080 --> 03:15:07,920 INVOLVING THE MARKETING OF 5158 03:15:07,920 --> 03:15:11,440 SUPPLEMENTS, WE INTERACT 5159 03:15:11,440 --> 03:15:14,960 REGULARLY TO ENSURE CONSISTENCY. 5160 03:15:14,960 --> 03:15:16,360 MOST OF OUR ENFORCEMENT CASES, 5161 03:15:16,360 --> 03:15:18,000 WE'RE NOT BOTH PURSUING ONE 5162 03:15:18,000 --> 03:15:18,360 COMPANY. 5163 03:15:18,360 --> 03:15:20,920 WE TRY TO COMMUNICATE TO MAKE 5164 03:15:20,920 --> 03:15:22,560 SURE EFFORTS ARE COMPLEMENTARY 5165 03:15:22,560 --> 03:15:24,840 AND THAT WE'RE CONSISTENT ON THE 5166 03:15:24,840 --> 03:15:27,160 SCIENCE, AND WE GENERALLY AVOID 5167 03:15:27,160 --> 03:15:29,240 DUPLICATION OF EFFORTS. 5168 03:15:29,240 --> 03:15:31,480 BOTH AGENCIES TRY TO ALLOCATE 5169 03:15:31,480 --> 03:15:34,280 LIMITED RESOURCES IN THE MOST 5170 03:15:34,280 --> 03:15:35,800 EFFICIENT WAY. 5171 03:15:35,800 --> 03:15:37,480 SOME CASES BOTH AGENCIES MAY 5172 03:15:37,480 --> 03:15:39,560 DECIDE TO INVESTIGATE AND PURSUE 5173 03:15:39,560 --> 03:15:41,160 A JOINT ENFORCEMENT ACTION. 5174 03:15:41,160 --> 03:15:44,000 THOSE CASES WE WILL FORMALLY 5175 03:15:44,000 --> 03:15:45,160 SHARE INFORMATION ABOUT 5176 03:15:45,160 --> 03:15:48,480 COMPANIES, TRY TO PUT THE BEST 5177 03:15:48,480 --> 03:15:50,360 USE, UNIQUE ENFORCEMENT TOOLS 5178 03:15:50,360 --> 03:15:52,920 AVAILABLE TO EACH AGENCY. 5179 03:15:52,920 --> 03:15:54,440 FOR EXAMPLE, THE FTC HAS POWER 5180 03:15:54,440 --> 03:15:59,400 TO SUBPOENA DOCUMENTS FROM 5181 03:15:59,400 --> 03:16:00,880 SUPPLEMENT MARKETERS, FDA CAN 5182 03:16:00,880 --> 03:16:02,200 HAVE INSPECTION OF FACILITY AND 5183 03:16:02,200 --> 03:16:04,080 ORDER PRODUCT SEIZURE. 5184 03:16:04,080 --> 03:16:04,800 INTERACTION IS ESPECIALLY 5185 03:16:04,800 --> 03:16:06,880 IMPORTANT BECAUSE AS I SAID THE 5186 03:16:06,880 --> 03:16:09,400 FTC IS PRIMARILY A LAW 5187 03:16:09,400 --> 03:16:10,640 ENFORCEMENT AGENCY. 5188 03:16:10,640 --> 03:16:12,600 WE'RE LAWYERS AND ECONOMISTS, 5189 03:16:12,600 --> 03:16:13,720 NOT SCIENTISTS. 5190 03:16:13,720 --> 03:16:18,400 WE NEED TO RELY ON FDA WEALTH OF 5191 03:16:18,400 --> 03:16:21,000 NUTRITION AND HEALTH EXPERTISE. 5192 03:16:21,000 --> 03:16:22,560 WE FREQUENTLY TURN TO OTHER 5193 03:16:22,560 --> 03:16:24,840 AGENCIES FOR ASSISTANCE FOR 5194 03:16:24,840 --> 03:16:27,920 OVERVIEW OF SCIENCE OR HELP US 5195 03:16:27,920 --> 03:16:28,320 IDENTIFY EXPERTS. 5196 03:16:28,320 --> 03:16:29,720 THE SAME REASON, WE GENERALLY 5197 03:16:29,720 --> 03:16:32,200 DEFER TO FDA ON MATTERS RELATED 5198 03:16:32,200 --> 03:16:34,840 TO CONTENT, PURITY, OR SAFETY OF 5199 03:16:34,840 --> 03:16:36,000 DIETARY SUPPLEMENTS. 5200 03:16:36,000 --> 03:16:37,720 THEY HAVE THE AUTHORITY AND ARE 5201 03:16:37,720 --> 03:16:39,080 BETTER EQUIPPED TO DEAL WITH 5202 03:16:39,080 --> 03:16:39,960 THESE ISSUES. 5203 03:16:39,960 --> 03:16:42,480 WE WILL GENERALLY LIMIT OUR 5204 03:16:42,480 --> 03:16:43,840 ACTIONS ON SAFETY TO INSTANCES 5205 03:16:43,840 --> 03:16:45,920 WHERE A COMPANY MADE UNFOUNDED 5206 03:16:45,920 --> 03:16:49,280 CLAIMS IN ADVERTISING ABOUT THE 5207 03:16:49,280 --> 03:16:51,920 SAFETY OF A PRODUCT. 5208 03:16:51,920 --> 03:16:55,880 5209 03:16:55,880 --> 03:16:59,400 I'D LIKE TO GIVE YOU THE SHORT 5210 03:16:59,400 --> 03:17:01,320 VERSION TUTORIAL ON FTC 5211 03:17:01,320 --> 03:17:02,200 ADVERTISING LAW. 5212 03:17:02,200 --> 03:17:03,280 ILLUSTRATING HOW WE APPROACH OUR 5213 03:17:03,280 --> 03:17:13,720 CASES WITH A FEW EXAMPLES. 5214 03:17:14,080 --> 03:17:19,320 THE FTC AUTHORITY IN SECTION 5 5215 03:17:19,320 --> 03:17:21,920 AND SECTION 12, 5 PROHIBITS 5216 03:17:21,920 --> 03:17:23,560 UNFAIR OR DECEPTIVE ACT OR 5217 03:17:23,560 --> 03:17:25,520 PRACTICES IN COMMERCE INCLUDING 5218 03:17:25,520 --> 03:17:27,160 ADVERTISING. 5219 03:17:27,160 --> 03:17:28,360 SECTION 12 SPECIFICALLY 5220 03:17:28,360 --> 03:17:29,960 PROHIBITS DISSEMINATION OF FALSE 5221 03:17:29,960 --> 03:17:33,000 ADS DEFINED AS ADS THAT SHALL 5222 03:17:33,000 --> 03:17:36,280 MISLEADING IN MATERIALS THAT 5223 03:17:36,280 --> 03:17:37,640 SPECIFICALLY WITH RESPECT TO 5224 03:17:37,640 --> 03:17:40,040 FOODS INCLUDING SUPPLEMENTS, 5225 03:17:40,040 --> 03:17:42,000 DRUGS, AND DEVICES. 5226 03:17:42,000 --> 03:17:43,400 TWO STRAIGHTFORWARD AND SIMPLE 5227 03:17:43,400 --> 03:17:45,080 PROVISIONS, NOT A LOT OF 5228 03:17:45,080 --> 03:17:45,800 DETAILED REGULATIONS YOU NEED TO 5229 03:17:45,800 --> 03:17:47,640 BE FAMILIAR WITH TO UNDERSTAND 5230 03:17:47,640 --> 03:17:48,880 FTC LAWS. 5231 03:17:48,880 --> 03:17:54,920 ALL CAN BE DISTILLED DOWN TO TWO 5232 03:17:54,920 --> 03:17:56,760 PRINCIPLES. 5233 03:17:56,760 --> 03:17:59,960 CLAIMS ARE CONVEYED, ARE CLAIMS 5234 03:17:59,960 --> 03:18:00,320 SUBSTANTIATED? 5235 03:18:00,320 --> 03:18:01,480 THE FIRST QUESTION WE ASK 5236 03:18:01,480 --> 03:18:03,000 OURSELVES WHEN LOOKING AT AD FOR 5237 03:18:03,000 --> 03:18:06,200 A PRODUCT WHAT CLAIMS ARE BEING 5238 03:18:06,200 --> 03:18:06,640 CONVEYED? 5239 03:18:06,640 --> 03:18:08,040 CLAIMS ARE CONSUMER DRIVEN. 5240 03:18:08,040 --> 03:18:10,360 WE CONSIDER ANY CLAIM THAT A 5241 03:18:10,360 --> 03:18:11,760 REASONABLE CONSUMER WOULD TAKE 5242 03:18:11,760 --> 03:18:16,360 AWAY FROM AN IDEA, LOOK AT 5243 03:18:16,360 --> 03:18:18,560 EXPRESS CLAIMS, ABC SUPPLEMENT 5244 03:18:18,560 --> 03:18:20,680 CURES CANCER, AN EXPRESS CLAIM 5245 03:18:20,680 --> 03:18:22,480 AND LOOK AT IMPLIED CLAIMS, I'LL 5246 03:18:22,480 --> 03:18:24,160 SHOW YOU AN EXAMPLE LATER. 5247 03:18:24,160 --> 03:18:26,560 WE LOOK AT NET IMPRESSION OF AN 5248 03:18:26,560 --> 03:18:29,600 AD, CONSIDER ALL THE ELEMENTS. 5249 03:18:29,600 --> 03:18:31,240 WRITTEN TEXT, IMAGES, EVERYTHING 5250 03:18:31,240 --> 03:18:34,640 ABOUT THE AD AND IMPRESSION MADE 5251 03:18:34,640 --> 03:18:36,280 ON CONSUMER. 5252 03:18:36,280 --> 03:18:37,680 OFTEN ADS INCLUDE TESTIMONIALS 5253 03:18:37,680 --> 03:18:38,920 FROM CONSUMER SAYING THE PRODUCT 5254 03:18:38,920 --> 03:18:41,840 WORKED FOR THEM WHICH CONVEYS 5255 03:18:41,840 --> 03:18:43,040 THE PRODUCT WILL WORK FOR THEM 5256 03:18:43,040 --> 03:18:43,800 AS WELL. 5257 03:18:43,800 --> 03:18:46,240 WE LOOK TO SEE IF THE AD 5258 03:18:46,240 --> 03:18:48,040 DISCLOSES MATERIAL INFORMATION 5259 03:18:48,040 --> 03:18:49,760 AND HOW IT'S DISCLOSED. 5260 03:18:49,760 --> 03:18:51,600 TINY PRINT THAT CANNOT BE READ 5261 03:18:51,600 --> 03:18:56,200 IS NOT AN EFFECTIVE DISCLOSURE. 5262 03:18:56,200 --> 03:19:00,720 HERE IS A GOOD EXAMPLE OF HOW AN 5263 03:19:00,720 --> 03:19:06,160 IMAGE CAN CONVEY A CLAIM. 5264 03:19:06,160 --> 03:19:07,560 THE PROBIOTICS WERE EMBEDDED IN 5265 03:19:07,560 --> 03:19:11,480 LINING OF THE STRAW WITH THE 5266 03:19:11,480 --> 03:19:12,520 DRINK, STRAW JUMPING OUT OF THE 5267 03:19:12,520 --> 03:19:15,560 DRINK BOX AND FORMS A PROTECTIVE 5268 03:19:15,560 --> 03:19:22,600 BARRIER AROUND A GIRL, AS A BOY 5269 03:19:22,600 --> 03:19:22,840 SNEEZES. 5270 03:19:22,840 --> 03:19:24,840 THIS AD IS TELLING PARENTS IF 5271 03:19:24,840 --> 03:19:26,760 YOUR KIDS BRING BOOST IT WILL 5272 03:19:26,760 --> 03:19:29,120 KEEP THEM FROM CATCHING A NASTY 5273 03:19:29,120 --> 03:19:35,360 GERM FROM THE SICK KID NEXT TO 5274 03:19:35,360 --> 03:19:36,600 THEM IN CLASS. 5275 03:19:36,600 --> 03:19:38,560 AFTER THE CLAIMS WE GO TO THE 5276 03:19:38,560 --> 03:19:39,560 SECOND STEP. 5277 03:19:39,560 --> 03:19:41,400 IS THERE A SOLID SCIENCE TO BACK 5278 03:19:41,400 --> 03:19:45,520 THOSE CLAIMS? 5279 03:19:45,520 --> 03:19:52,480 ARE THEY SUBSTANTIATED? 5280 03:19:52,480 --> 03:19:59,280 OUR POLICIES ARE RIGOROUS 5281 03:19:59,280 --> 03:19:59,920 SCIENTIFIC STANDARDS BASED ON 5282 03:19:59,920 --> 03:20:03,000 ACCEPTED NORMS OF EXPERTS IN THE 5283 03:20:03,000 --> 03:20:03,200 FIELD. 5284 03:20:03,200 --> 03:20:04,760 WE'RE LOOKING FOR THE STUDIES, 5285 03:20:04,760 --> 03:20:06,400 QUALITY IS AS IMPORTANT AS 5286 03:20:06,400 --> 03:20:06,680 QUANTITY. 5287 03:20:06,680 --> 03:20:09,360 NO FIXED FORMULA OR NUMBER OR 5288 03:20:09,360 --> 03:20:11,360 LENGTH OR SIZE OF STUDIES. 5289 03:20:11,360 --> 03:20:13,960 WITH RARE EXCEPTIONS WE'RE 5290 03:20:13,960 --> 03:20:17,320 LOOKING FOR HIGH QUALITY HUMAN 5291 03:20:17,320 --> 03:20:21,760 CLINICAL TRIALS. 5292 03:20:21,760 --> 03:20:23,480 MARKETERS CAN'T RELY UPON ANY 5293 03:20:23,480 --> 03:20:26,320 STUDIES, STUDIES MUST BE SOUND, 5294 03:20:26,320 --> 03:20:27,040 SHOULD BE RANDOMIZED, 5295 03:20:27,040 --> 03:20:28,720 CONTROLLED, DOUBLE BLINDED. 5296 03:20:28,720 --> 03:20:30,640 SHOULD USE APPROPRIATE OUTCOME 5297 03:20:30,640 --> 03:20:30,880 MEASURES. 5298 03:20:30,880 --> 03:20:32,680 THEY SHOULD BE PEER REVIEWED. 5299 03:20:32,680 --> 03:20:36,080 PUBLISHED IN A REPUTABLE 5300 03:20:36,080 --> 03:20:36,440 JOURNAL. 5301 03:20:36,440 --> 03:20:37,160 INDEPENDENT, STUDIES CONDUCTED 5302 03:20:37,160 --> 03:20:38,360 BY MANUFACTURERS ON THEIR OWN 5303 03:20:38,360 --> 03:20:42,640 PRODUCTS MAY BE VIEWED AS 5304 03:20:42,640 --> 03:20:43,640 SUSPECT. 5305 03:20:43,640 --> 03:20:45,600 RESULTS SHOULD BE STATISTICALLY 5306 03:20:45,600 --> 03:20:47,600 SIGNIFICANT, CLINICALLY 5307 03:20:47,600 --> 03:20:47,920 MEANINGFUL. 5308 03:20:47,920 --> 03:20:51,400 WHAT DOES IT MATTER IF THERE'S 5309 03:20:51,400 --> 03:21:02,040 NO REAL GENUINE BENEFIT FOR CON. 5310 03:21:10,280 --> 03:21:11,320 NO P-HACKING. 5311 03:21:11,320 --> 03:21:13,280 THIS IS AN EXAMPLE HOW PHONE 5312 03:21:13,280 --> 03:21:15,120 COMPANIES RUN AFOUL OF THE LAW 5313 03:21:15,120 --> 03:21:22,800 LETTING MARKETERS GET AHEAD OF 5314 03:21:22,800 --> 03:21:24,320 THEIR RESEARCH DEPARTMENT. 5315 03:21:24,320 --> 03:21:26,960 WHEN LOOKING AT A COMPANY'S 5316 03:21:26,960 --> 03:21:28,360 SUBSTANTIATION WE DON'T EVALUATE 5317 03:21:28,360 --> 03:21:29,680 STUDIES IN ISOLATION. 5318 03:21:29,680 --> 03:21:33,440 WE CONSIDER ALL RELEVANT 5319 03:21:33,440 --> 03:21:35,240 EVIDENCE, TRY TO RECONCILE 5320 03:21:35,240 --> 03:21:35,920 INCONSISTENT AND CONFLICTING 5321 03:21:35,920 --> 03:21:37,920 RESULTS, SOMETIMES CLAIM MAY 5322 03:21:37,920 --> 03:21:39,120 NEED TO BE QUALIFIED. 5323 03:21:39,120 --> 03:21:40,760 OUR VIEW IS DON'T MAKE THE CLAIM 5324 03:21:40,760 --> 03:21:48,560 IF THE WEIGHT OF THE EVIDENCE 5325 03:21:48,560 --> 03:21:49,960 CONTRADICTS THAT CLAIM. 5326 03:21:49,960 --> 03:21:52,160 THE POM WONDERFUL INVOLVED 5327 03:21:52,160 --> 03:21:53,760 CLAIMS FOR POMAGRANATE JUICE AND 5328 03:21:53,760 --> 03:21:55,120 DIETARY SUPPLEMENT IN PILL AND 5329 03:21:55,120 --> 03:21:56,320 LIQUID FORM. 5330 03:21:56,320 --> 03:21:58,400 I BELIEVE THIS IS AN AD, A 5331 03:21:58,400 --> 03:22:04,840 BANNER, A BANNER AD THAT 5332 03:22:04,840 --> 03:22:05,560 APPEARED ON THE INTERNET. 5333 03:22:05,560 --> 03:22:08,680 IT WAS OUR VIEW THE ONLY THING 5334 03:22:08,680 --> 03:22:10,880 THAT YOU'RE SAVING PROSTATES 5335 03:22:10,880 --> 03:22:12,760 FROM IS CANCER, AND WHEN 5336 03:22:12,760 --> 03:22:14,080 CONSUMERS CLICKED ON THE LEARN 5337 03:22:14,080 --> 03:22:15,920 MORE LINK THROUGH TO THE WEBSITE 5338 03:22:15,920 --> 03:22:18,120 THEY WERE ABLE TO READ ABOUT 5339 03:22:18,120 --> 03:22:19,880 STUDIES THAT POM WONDERFUL 5340 03:22:19,880 --> 03:22:20,960 CONDUCTED THAT ALLEGEDLY SHOWED 5341 03:22:20,960 --> 03:22:25,960 A VARIETY OF BENEFITS SUCH AS 5342 03:22:25,960 --> 03:22:27,960 DECREASE IN ARTERIAL PLAQUE, 5343 03:22:27,960 --> 03:22:31,080 SLOWING OF PSA DOUBLING TIME, 5344 03:22:31,080 --> 03:22:36,080 AND A PRODUCT THAT WAS 40% AS 5345 03:22:36,080 --> 03:22:38,680 EFFECTIVE AS VIAGRA. 5346 03:22:38,680 --> 03:22:39,800 UNFORTUNATELY FOR POM WONDERFUL, 5347 03:22:39,800 --> 03:22:42,440 THE SCIENCE DID NOT WATCH THEIR 5348 03:22:42,440 --> 03:22:42,760 CLAIMS. 5349 03:22:42,760 --> 03:22:45,080 RESULTS OF THE HEART DISEASE 5350 03:22:45,080 --> 03:22:46,560 STUDIES WERE CONFLICTING. 5351 03:22:46,560 --> 03:22:52,280 ONE SMALL STUDY SUGGESTED 5352 03:22:52,280 --> 03:22:54,520 BENEFIT FOR ARTERIAL PLAQUE, A 5353 03:22:54,520 --> 03:22:57,760 SECOND FOUND NO BENEFIT. 5354 03:22:57,760 --> 03:23:02,440 PROSTATE CANCER STUDY WAS NOT 5355 03:23:02,440 --> 03:23:02,680 BLINDED. 5356 03:23:02,680 --> 03:23:04,000 ERECTILE DYSFUNCTION LACKED 5357 03:23:04,000 --> 03:23:05,480 STATISTICAL SIGNIFICANCE, 5358 03:23:05,480 --> 03:23:09,640 REPORTING ON FAVORABLE RESULTS, 5359 03:23:09,640 --> 03:23:13,480 IGNORED NOT SO FAVORABLE 5360 03:23:13,480 --> 03:23:13,880 RESULTS. 5361 03:23:13,880 --> 03:23:15,560 OUR MAN THAT IS PRODUCT AND 5362 03:23:15,560 --> 03:23:19,760 CLAIMS SHOULD MATCH THE SCIENCE. 5363 03:23:19,760 --> 03:23:21,160 THE AMOUNT OF INGREDIENT TESTED 5364 03:23:21,160 --> 03:23:24,160 IN A STUDY SHOULD MATCH WHAT IS 5365 03:23:24,160 --> 03:23:26,360 ACTUALLY IN THE PRODUCT. 5366 03:23:26,360 --> 03:23:30,520 RESEARCH SHOWS 10 GRAMS OF AN 5367 03:23:30,520 --> 03:23:31,120 INGREDIENT INTRAVENOUSLY 5368 03:23:31,120 --> 03:23:33,760 PROVIDES A BENEFIT YOU SHOULDN'T 5369 03:23:33,760 --> 03:23:36,960 CLAIM THE PRODUCT IS 1 GRAM IN 5370 03:23:36,960 --> 03:23:38,560 CAPSULE FORM PROVIDING THE SAME 5371 03:23:38,560 --> 03:23:40,640 BENEFIT OR STUDIED IN HEALTHY 5372 03:23:40,640 --> 03:23:43,000 30-YEAR-OLDS WILL WORK FOR AN 5373 03:23:43,000 --> 03:23:44,800 ELDERLY POPULATION WITH CHRONIC 5374 03:23:44,800 --> 03:23:45,040 DISEASES. 5375 03:23:45,040 --> 03:23:49,720 AND DEGREE AND NATURE OF EFFECT 5376 03:23:49,720 --> 03:23:52,040 CLAIMS SHOULD MATCH THE 5377 03:23:52,040 --> 03:23:52,480 RESEARCH. 5378 03:23:52,480 --> 03:23:54,000 THIS IS AN EXAMPLE OF A CASE 5379 03:23:54,000 --> 03:23:57,000 WHERE THE CLAIMS DID NOT MATCH 5380 03:23:57,000 --> 03:23:58,280 THE SCIENCE. 5381 03:23:58,280 --> 03:24:01,960 IF YOU LOOK CAREFULLY AT THE BOX 5382 03:24:01,960 --> 03:24:03,840 IT SAYS THAT 100 MILLIGRAMS OF 5383 03:24:03,840 --> 03:24:05,960 DHA PROMOTES HEALTHY BRAIN AND 5384 03:24:05,960 --> 03:24:07,360 EYE DEVELOPMENT. 5385 03:24:07,360 --> 03:24:10,680 BUT THERE'S ONLY ONE SERVING OF 5386 03:24:10,680 --> 03:24:17,960 THE PRODUCT PROVIDES 100 5387 03:24:17,960 --> 03:24:20,120 MICROGRAMS OF DHA. 5388 03:24:20,120 --> 03:24:21,320 THE FTC ENFORCEMENT PRIORITIES 5389 03:24:21,320 --> 03:24:24,840 ARE HEALTH AND SAFETY RISK, 5390 03:24:24,840 --> 03:24:27,120 SERIOUS DISEASES AND CONDITIONS, 5391 03:24:27,120 --> 03:24:30,200 CHILDREN, WIDESPREAD OR 5392 03:24:30,200 --> 03:24:32,720 SUBSTANTIAL INJURY. 5393 03:24:32,720 --> 03:24:33,520 OBVIOUSLY BOGUS COVID-19 5394 03:24:33,520 --> 03:24:37,960 PRODUCTS ARE HIGH PRIORITY AT 5395 03:24:37,960 --> 03:24:38,760 THE MOMENT. 5396 03:24:38,760 --> 03:24:41,480 IN 2021 CONGRESS ENACTED COVID 5397 03:24:41,480 --> 03:24:43,760 CONSUMER PROTECTION ACT, 5398 03:24:43,760 --> 03:24:46,000 UNLAWFUL UNDER SECTION 5 FOR ANY 5399 03:24:46,000 --> 03:24:48,240 PERSON OR ENTITY TO MAKE 5400 03:24:48,240 --> 03:24:51,640 DECEPTIVE CLAIMS THAT A PRODUCT 5401 03:24:51,640 --> 03:24:54,560 TREATS, CURES, PREVENTS, 5402 03:24:54,560 --> 03:24:55,920 MITIGATES, OR DIAGNOSES 5403 03:24:55,920 --> 03:24:56,200 COVID-19. 5404 03:24:56,200 --> 03:25:03,920 THE ACT ALLOWS THE FTC TO OBTAIN 5405 03:25:03,920 --> 03:25:05,240 CIVIL PENALTIES UP TO $47,000 5406 03:25:05,240 --> 03:25:06,760 PER VIOLATION, AND CHARGED 5407 03:25:06,760 --> 03:25:09,320 MARKETERS UNDER THIS NEW 5408 03:25:09,320 --> 03:25:09,720 STATUTE. 5409 03:25:09,720 --> 03:25:11,160 DOJ FILED COMPLAINTS ON BEHALF 5410 03:25:11,160 --> 03:25:13,160 OF THE COMMISSION AGAINST 5411 03:25:13,160 --> 03:25:14,680 MARKETERS WHO CLAIM THEIR 5412 03:25:14,680 --> 03:25:19,520 VITAMIN D PRODUCT, NASAL SPRAYS, 5413 03:25:19,520 --> 03:25:21,000 HERBAL TEAS TREAT COVID-19. 5414 03:25:21,000 --> 03:25:22,640 I ANTICIPATE THERE WILL LIKELY 5415 03:25:22,640 --> 03:25:28,480 BE MORE ACTION UNDER THE CCPA IN 5416 03:25:28,480 --> 03:25:33,600 THE FUTURE. 5417 03:25:33,600 --> 03:25:34,360 5418 03:25:34,360 --> 03:25:39,080 LET'S LOOK AT SOME RECENT FTC 5419 03:25:39,080 --> 03:25:41,040 DIETARY SUPPLEMENT CASES. 5420 03:25:41,040 --> 03:25:42,960 A MULTI-NATIONAL CORPORATION IS 5421 03:25:42,960 --> 03:25:46,280 BASED IN GERMANY, IT IS THE 5422 03:25:46,280 --> 03:25:48,560 PUBLICLY TRADED PARENT COMPANY 5423 03:25:48,560 --> 03:25:51,200 OF BASF GROUP WHICH HAS 5424 03:25:51,200 --> 03:25:52,800 SUBSIDIARIES AND JOINT VENTURES 5425 03:25:52,800 --> 03:25:55,040 IN 90 COUNTRIES INCLUDING THE 5426 03:25:55,040 --> 03:25:55,920 UNITED STATES. 5427 03:25:55,920 --> 03:25:59,960 THROUGH NUTRITION AND HEALTH 5428 03:25:59,960 --> 03:26:00,640 DIVISION PRODUCES SUPPLEMENTS 5429 03:26:00,640 --> 03:26:03,360 AND MEDICAL FOODS IN EUROPE, 5430 03:26:03,360 --> 03:26:07,520 NORTH AMERICA, SOUTH AMERICA, 5431 03:26:07,520 --> 03:26:12,440 AND IN THE ASIA PACIFIC REGION 5432 03:26:12,440 --> 03:26:13,280 AND DEVELOPED FISH OIL 5433 03:26:13,280 --> 03:26:14,720 SUPPLEMENTS FOR THE NORTH 5434 03:26:14,720 --> 03:26:18,680 AMERICAN MARKET TO TREAT 5435 03:26:18,680 --> 03:26:21,400 NON-ALCOHOLIC FATTY LIVER 5436 03:26:21,400 --> 03:26:23,080 DISEASE, OR NAFLD. 5437 03:26:23,080 --> 03:26:28,760 NAFLD IS BUILDUP FAT IN THE 5438 03:26:28,760 --> 03:26:34,440 LIVER FROM OBESITY, DIABETES, 5439 03:26:34,440 --> 03:26:34,920 HIGH CHOLESTEROL. 5440 03:26:34,920 --> 03:26:40,600 THE CLINICAL TRIAL WAS A 5441 03:26:40,600 --> 03:26:41,400 RANDOMIZED DOUBLE BLIND HUMAN 5442 03:26:41,400 --> 03:26:46,360 CLINICAL TRIAL DESIGNED TO 5443 03:26:46,360 --> 03:26:47,480 EVALUATE WHETHER HEPAXA REDUCES 5444 03:26:47,480 --> 03:26:49,560 LIVER FAT IN ADULTS WITH NAFLD. 5445 03:26:49,560 --> 03:26:52,760 AT THE END OF SIX MONTHS STUDY, 5446 03:26:52,760 --> 03:26:54,800 MRI DATA SHOWED NO STATISTICALLY 5447 03:26:54,800 --> 03:26:57,320 SIGNIFICANT REDUCTION OF LIVER 5448 03:26:57,320 --> 03:26:59,560 FAT IN THE HEPAXA PATIENTS AS 5449 03:26:59,560 --> 03:27:00,680 COMPARED TO PLACEBO PATIENTS. 5450 03:27:00,680 --> 03:27:04,280 WHEN THE STUDY FAILED TO SHOW 5451 03:27:04,280 --> 03:27:05,000 EFFECT RESEARCHERS SUBJECTED 5452 03:27:05,000 --> 03:27:07,280 DATA TO POST HOC ANALYSIS OF 5453 03:27:07,280 --> 03:27:11,440 DIFFERENT SUBGROUPS OF TEST 5454 03:27:11,440 --> 03:27:13,440 SUBJECTS TO FIND A POSITIVE 5455 03:27:13,440 --> 03:27:15,040 MESSAGE. 5456 03:27:15,040 --> 03:27:16,680 THAT ANALYSIS FOUND THAT SMALL 5457 03:27:16,680 --> 03:27:18,920 SUBGROUP OF PATIENTS WITH 5458 03:27:18,920 --> 03:27:21,760 BASELINE FATTY LIVER INDEX OVER 5459 03:27:21,760 --> 03:27:23,600 40 EXPERIENCED STATISTICALLY 5460 03:27:23,600 --> 03:27:25,280 SIGNIFICANT REDUCTION IN LIVER 5461 03:27:25,280 --> 03:27:27,480 FAT AFTER USING HEPAXA WHEN 5462 03:27:27,480 --> 03:27:30,640 COMPARED WITH PLACEBO. 5463 03:27:30,640 --> 03:27:37,000 THIS SUBGROUP INCLUDED FIVE 5464 03:27:37,000 --> 03:27:38,040 HEPAXA PATIENTS, 12 PLACEBO. 5465 03:27:38,040 --> 03:27:41,040 THEY DID NOT TEST THE PRODUCT IN 5466 03:27:41,040 --> 03:27:42,000 CHILDREN AT ALL. 5467 03:27:42,000 --> 03:27:45,600 THE COMPANY AGREED TO SETTLE 5468 03:27:45,600 --> 03:27:47,120 WITH FTC, ORDER PROHIBITS 5469 03:27:47,120 --> 03:27:48,760 COMPANIES FROM CLAIMING PRODUCTS 5470 03:27:48,760 --> 03:27:51,320 REDUCE LIVER FAT OR TREATS ANY 5471 03:27:51,320 --> 03:27:55,720 DISEASE UNLESS CLAIM IS TRUE AND 5472 03:27:55,720 --> 03:27:56,920 SUPPORTED BY COMPETENT RELIABLE 5473 03:27:56,920 --> 03:27:59,000 SCIENTIFIC EVIDENCE, IN THE 5474 03:27:59,000 --> 03:28:00,400 ORDER AS RANDOMIZED CLINICAL 5475 03:28:00,400 --> 03:28:02,040 TRIAL. 5476 03:28:02,040 --> 03:28:06,120 THE COUPLES AGREED TO PAY 5477 03:28:06,120 --> 03:28:07,560 $416,000 IN REDRESS TO 5478 03:28:07,560 --> 03:28:10,040 CONSUMERS. 5479 03:28:10,040 --> 03:28:12,440 BASF WAS AN EXAMPLE OF AN 5480 03:28:12,440 --> 03:28:14,840 ENFORCEMENT ACTION THE FTC TOOK. 5481 03:28:14,840 --> 03:28:16,840 ANOTHER MATTER, WE MAY WORK 5482 03:28:16,840 --> 03:28:20,240 JOINTLY WITH FDA TO TAKE ACTION 5483 03:28:20,240 --> 03:28:20,800 AGAINST ADVERTISERS MAKING 5484 03:28:20,800 --> 03:28:22,920 DECEPTIVE HEALTH CLAIMS. 5485 03:28:22,920 --> 03:28:24,480 LAST SEPTEMBER THE FTC SEND 5486 03:28:24,480 --> 03:28:26,760 CEASE AND DESIST LETTERS TO TEN 5487 03:28:26,760 --> 03:28:28,640 COMPANIES SUSPECTED OF 5488 03:28:28,640 --> 03:28:30,440 ADVERTISING UNPROVEN TREATMENTS 5489 03:28:30,440 --> 03:28:33,480 OR CURES FOR DIABETES. 5490 03:28:33,480 --> 03:28:36,120 AND ORDERs COMPANIES TO STOP 5491 03:28:36,120 --> 03:28:36,960 MAKING UNSUBSTANTIATED CLAIMS 5492 03:28:36,960 --> 03:28:38,800 WITHIN 15 DAYS OR FACE POTENTIAL 5493 03:28:38,800 --> 03:28:40,040 LEGAL ACTION. 5494 03:28:40,040 --> 03:28:41,920 THE DEMANDS WERE ISSUED JOINTLY 5495 03:28:41,920 --> 03:28:43,680 WITH FDA WARNING LETTERS, WHICH 5496 03:28:43,680 --> 03:28:46,120 THE FDA WARNED THE COMPANIES 5497 03:28:46,120 --> 03:28:48,480 THEIR DIABETES PRODUCTS WERE 5498 03:28:48,480 --> 03:28:49,680 BOTH UNAPPROVED AND MISBRANDED, 5499 03:28:49,680 --> 03:28:52,680 IN VIOLATION OF THE FEDERAL FOOD 5500 03:28:52,680 --> 03:28:55,400 DRUG AND COSMETIC ACT. 5501 03:28:55,400 --> 03:28:57,920 THESE TEN COMPANIES SOLD DIETARY 5502 03:28:57,920 --> 03:28:59,360 SUPPLEMENTS, SHAKES, DRINKS, AND 5503 03:28:59,360 --> 03:29:00,120 PRODUCTS ONLINE. 5504 03:29:00,120 --> 03:29:06,440 THE PRODUCTS HAD NAMES LIKE 5505 03:29:06,440 --> 03:29:08,640 SUGAR BALANCE, BERRY SUGAR 5506 03:29:08,640 --> 03:29:10,040 CONTROL, BALANCE DIABETES 5507 03:29:10,040 --> 03:29:11,320 SUPPLEMENT. 5508 03:29:11,320 --> 03:29:13,680 ONCE CEASE AND DESIST DEMANDS 5509 03:29:13,680 --> 03:29:17,520 WERE ISSUED, THE COMPANIES WERE 5510 03:29:17,520 --> 03:29:19,720 MONITORED TO TAKE DOWN DECEPTIVE 5511 03:29:19,720 --> 03:29:19,960 CLAIMS. 5512 03:29:19,960 --> 03:29:21,640 THROUGHOUT THE PANDEMIC, WARNING 5513 03:29:21,640 --> 03:29:22,760 LETTERS HAVE BEEN ONE OF THE 5514 03:29:22,760 --> 03:29:27,360 MOST IMPORTANT TOOLS THE FTC HAS 5515 03:29:27,360 --> 03:29:28,240 USED TO COMBAT UNSUBSTANTIATED 5516 03:29:28,240 --> 03:29:29,120 AND FALSE CLAIMS. 5517 03:29:29,120 --> 03:29:31,760 THEY ALLOW THE AGENCY TO ACT 5518 03:29:31,760 --> 03:29:34,400 QUICKLY AGAINST A NUMBER OF 5519 03:29:34,400 --> 03:29:35,800 MARKETERS ALL AT ONCE. 5520 03:29:35,800 --> 03:29:37,560 SINCE THE PANDEMIC BEGAN THE FTC 5521 03:29:37,560 --> 03:29:40,240 HAS ISSUED LETTERS TO MORE THAN 5522 03:29:40,240 --> 03:29:42,960 400 COMPANIES AND INDIVIDUALS. 5523 03:29:42,960 --> 03:29:46,320 IN JANUARY, WITH THE OMICRON 5524 03:29:46,320 --> 03:29:53,080 VARIANT ON THE RISE, 24 LETTERS 5525 03:29:53,080 --> 03:29:55,920 WERE ISSUED DEMANDING THEY STOP 5526 03:29:55,920 --> 03:29:57,800 MAKING CLAIMS. 5527 03:29:57,800 --> 03:30:00,440 THEY MARKETERS WERE HOCKING 5528 03:30:00,440 --> 03:30:01,520 SUPPLEMENTS, FILTERED WATER, 5529 03:30:01,520 --> 03:30:02,480 I.V. THERAPY TREATMENTS. 5530 03:30:02,480 --> 03:30:05,360 MOST OF THE DEMANDS WERE SENT TO 5531 03:30:05,360 --> 03:30:06,760 COMPANIES USING SOCIAL MEDIA 5532 03:30:06,760 --> 03:30:08,640 PLATFORMS TO SELL PRODUCTS AND 5533 03:30:08,640 --> 03:30:10,920 IN THOSE INSTANCES THE AGENCY 5534 03:30:10,920 --> 03:30:13,760 ALSO NOTIFIED THE PLATFORMS AS 5535 03:30:13,760 --> 03:30:13,960 WELL. 5536 03:30:13,960 --> 03:30:15,760 WARNING LETTERS HAVE PROVED 5537 03:30:15,760 --> 03:30:17,040 EXTREMELY EFFECTIVE DURING THE 5538 03:30:17,040 --> 03:30:18,640 PANDEMIC WITH MOST MARKETERS 5539 03:30:18,640 --> 03:30:22,560 REMOVING THEIR CLAIMS RATHER 5540 03:30:22,560 --> 03:30:24,800 THAN FACE A LAWSUIT. 5541 03:30:24,800 --> 03:30:27,040 IF YOU'RE INTERESTED IN LEARNING 5542 03:30:27,040 --> 03:30:28,600 MORE ABOUT THE COMMISSION'S 5543 03:30:28,600 --> 03:30:32,680 WORK, AND PARTICULARLY WORK ON 5544 03:30:32,680 --> 03:30:36,800 CORONAVIRUS, GO TO 5545 03:30:36,800 --> 03:30:37,680 WWW.CONSUMER.FTC.GOV, THE WEB 5546 03:30:37,680 --> 03:30:39,400 SIDE GOOD INFORMATION FOR 5547 03:30:39,400 --> 03:30:40,160 CONSUMERS AND SHOWS CONSUMERS 5548 03:30:40,160 --> 03:30:42,960 HOW TO PROTECT THEMSELVES FROM A 5549 03:30:42,960 --> 03:30:46,640 WIDE VARIETY OF SCAMS. 5550 03:30:46,640 --> 03:30:50,960 YOU WILL ALSO FIND CONSUMER 5551 03:30:50,960 --> 03:30:53,640 ALERTS ABOUT VARIOUS SCAMS. 5552 03:30:53,640 --> 03:30:56,760 AND WE INVITE THE PUBLIC TO 5553 03:30:56,760 --> 03:31:01,120 REPORT ANY SUSPECTED FRAUD THEY 5554 03:31:01,120 --> 03:31:02,360 ENCOUNTER AT 5555 03:31:02,360 --> 03:31:06,120 REPORTFRAUD.FTC.GOV. 5556 03:31:06,120 --> 03:31:07,480 THANK YOU FOR LISTENING TODAY. 5557 03:31:07,480 --> 03:31:11,520 IF YOU HAVE ANY QUESTIONS, FEEL 5558 03:31:11,520 --> 03:31:13,000 FREE TO ASK ME, DURING THE 5559 03:31:13,000 --> 03:31:15,480 PANEL, OR IF YOU WANT TO CONTACT 5560 03:31:15,480 --> 03:31:16,800 ME OFFLINE MY INFORMATION IS 5561 03:31:16,800 --> 03:31:19,360 LISTED ON THE SCREEN. 5562 03:31:19,360 --> 03:31:21,480 THANK YOU. 5563 03:31:21,480 --> 03:31:22,160 >> THANK YOU. 5564 03:31:22,160 --> 03:31:26,400 GLAD WE GOT TO HEAR THAT ENTIRE 5565 03:31:26,400 --> 03:31:26,760 PRESENTATION. 5566 03:31:26,760 --> 03:31:29,240 WE HAVE ABOUT 20 MINUTES SORE SO 5567 03:31:29,240 --> 03:31:31,200 FOR QUESTIONS AND ANSWERS, SO 5568 03:31:31,200 --> 03:31:33,040 LET'S BEGIN. 5569 03:31:33,040 --> 03:31:37,920 IT'S JUST YOU, DR. BETZ, AND 5570 03:31:37,920 --> 03:31:38,480 MS. VOSS. 5571 03:31:38,480 --> 03:31:40,120 FIRST QUESTION, COMPANIES USE 5572 03:31:40,120 --> 03:31:42,760 RESEARCH ON INGREDIENTS TO 5573 03:31:42,760 --> 03:31:43,960 SUBSTANTIATE THEIR CLAIMS THAT 5574 03:31:43,960 --> 03:31:46,280 IS IN THE SAME SPACE AS THEIRS 5575 03:31:46,280 --> 03:31:48,640 BUT IS NOT NECESSARILY THE SAME 5576 03:31:48,640 --> 03:31:48,920 INGREDIENT. 5577 03:31:48,920 --> 03:31:50,720 FOR EXAMPLE, RESEARCH ON 5578 03:31:50,720 --> 03:31:54,000 CREATINE MONO HYDRATE IS USED TO 5579 03:31:54,000 --> 03:31:55,960 SUBSTANTIATE CLAIMS ON PRIMITIVE 5580 03:31:55,960 --> 03:31:57,040 FORMS OF CREATINE. 5581 03:31:57,040 --> 03:31:58,800 IS THIS OKAY? 5582 03:31:58,800 --> 03:32:00,480 OR IS IT INAPPROPRIATE AND/OR 5583 03:32:00,480 --> 03:32:08,640 ILLEGAL? 5584 03:32:08,640 --> 03:32:11,040 >> DR. BETZ, I'M HAPPY TO LET 5585 03:32:11,040 --> 03:32:12,080 YOU START IF YOU'D LIKE. 5586 03:32:12,080 --> 03:32:15,440 >> I'M NOT GOING TO COMMENT ON 5587 03:32:15,440 --> 03:32:19,240 ANY REGULATORY OR LEGAL 5588 03:32:19,240 --> 03:32:22,760 QUESTIONS. 5589 03:32:22,760 --> 03:32:23,800 I WILL SAY THAT THE PRECEDENT 5590 03:32:23,800 --> 03:32:26,920 SEEMS TO BE IF IT'S NOT THE 5591 03:32:26,920 --> 03:32:29,160 EXACT SAME INGREDIENT, FOR THE 5592 03:32:29,160 --> 03:32:35,400 EXACT SAME CONDITION OF USE, AND 5593 03:32:35,400 --> 03:32:37,920 THE EXACT SAME POPULATION, THEN 5594 03:32:37,920 --> 03:32:38,880 THE CONCEPT THAT YOU'RE 5595 03:32:38,880 --> 03:32:42,360 REFERRING TO IS CALLED BORROWED 5596 03:32:42,360 --> 03:32:43,800 SCIENCE IN THE DIETARY 5597 03:32:43,800 --> 03:32:45,320 SUPPLEMENT INDUSTRY AND IT'S 5598 03:32:45,320 --> 03:32:46,200 FAIRLY COMMON. 5599 03:32:46,200 --> 03:32:49,160 THE SPECIFIC CASE I CAN'T 5600 03:32:49,160 --> 03:32:51,400 COMMENT ON BECAUSE I DON'T KNOW 5601 03:32:51,400 --> 03:32:52,640 THE FACTS OF THE CLAIMS OR 5602 03:32:52,640 --> 03:32:53,320 ANYTHING LIKE THAT. 5603 03:32:53,320 --> 03:32:57,400 SO I'LL LEAVE IT TO THE 5604 03:32:57,400 --> 03:33:00,760 REGULATORY AND TO THE FEDERAL 5605 03:33:00,760 --> 03:33:02,320 TRADE COMMISSION FOLK. 5606 03:33:02,320 --> 03:33:03,920 >> YEAH, I GUESS I WOULD SAY 5607 03:33:03,920 --> 03:33:06,840 WITH RESPECT TO THAT QUESTION, 5608 03:33:06,840 --> 03:33:09,760 IF THERE'S ISSUES WITH RESPECT 5609 03:33:09,760 --> 03:33:13,240 TO -- IF THIS IS COVERING 5610 03:33:13,240 --> 03:33:13,840 CONCEPT NEW DIETARY INGREDIENT 5611 03:33:13,840 --> 03:33:19,120 NOVEMBER INDICATION -- 5612 03:33:19,120 --> 03:33:20,320 NOTIFICATION, WE ENCOURAGE THEM 5613 03:33:20,320 --> 03:33:22,640 TO COME TO OUR OFFICE TO HAVE A 5614 03:33:22,640 --> 03:33:24,680 PRE-MEETING TO DISCUSS IN THE 5615 03:33:24,680 --> 03:33:27,320 CONTEXT OF STRUCTURE/FUNCTION 5616 03:33:27,320 --> 03:33:30,280 CLAIM NOTIFICATIONS, THERE'S AN 5617 03:33:30,280 --> 03:33:33,000 SFCN MAILBOX REACHED THROUGH OUR 5618 03:33:33,000 --> 03:33:33,960 WEBSITE, SPECIFIC CLAIMS, 5619 03:33:33,960 --> 03:33:37,360 QUESTIONS, CAN BE DIRECTED 5620 03:33:37,360 --> 03:33:38,920 THERE. 5621 03:33:38,920 --> 03:33:40,560 >> OKAY. 5622 03:33:40,560 --> 03:33:40,880 THANKS. 5623 03:33:40,880 --> 03:33:42,520 IT SEEMS WE HAVE MS. DAVIS WITH 5624 03:33:42,520 --> 03:33:48,120 US FOR THE Q&A, SO FEEL FREE, 5625 03:33:48,120 --> 03:33:49,520 MS. DAVIS, TO OFFER YOUR POINTS 5626 03:33:49,520 --> 03:33:52,480 OF VIEW TO ANY OF THESE 5627 03:33:52,480 --> 03:33:52,840 QUESTIONS. 5628 03:33:52,840 --> 03:33:53,760 ANOTHER QUESTION, IT SEEMS LIKE 5629 03:33:53,760 --> 03:33:55,560 THERE ARE A LOT OF PRODUCTS THAT 5630 03:33:55,560 --> 03:33:58,080 ARE MARKETS IN A MANNER THAT IS 5631 03:33:58,080 --> 03:34:00,560 ILLEGAL, AND/OR PROMOTED IN AN 5632 03:34:00,560 --> 03:34:02,640 APPROPRIATE MANNER, WHAT CAN BE 5633 03:34:02,640 --> 03:34:04,080 DONE ABOUT IT? 5634 03:34:04,080 --> 03:34:08,360 REGULATION AGAIN. 5635 03:34:08,360 --> 03:34:10,760 >> YES, UNFORTUNATELY, I WOULD 5636 03:34:10,760 --> 03:34:12,280 AGREE WITH THAT. 5637 03:34:12,280 --> 03:34:13,920 FDA CERTAINLY IS UTILIZING ITS 5638 03:34:13,920 --> 03:34:17,840 RESOURCES TO THE BEST OF ITS 5639 03:34:17,840 --> 03:34:18,880 ABILITY TO GET SOWTH PRODUCTS 5640 03:34:18,880 --> 03:34:24,440 OFF THE MARKET. 5641 03:34:24,440 --> 03:34:28,160 WE ENCOURAGE CONSUMERS TO CON 5642 03:34:28,160 --> 03:34:30,320 CONTACT FDA TO FIND OUT IF 5643 03:34:30,320 --> 03:34:31,680 FURTHER ACTION NEEDS TO BE 5644 03:34:31,680 --> 03:34:31,880 TAKEN. 5645 03:34:31,880 --> 03:34:33,240 IF YOU WORK FOR A MANUFACTURER 5646 03:34:33,240 --> 03:34:35,040 AND YOU'RE AWARE EVER VIOLATIONS 5647 03:34:35,040 --> 03:34:37,600 OCCURRING, YOU CAN CONTACT THE 5648 03:34:37,600 --> 03:34:39,560 AGENCY AND WE CAN DETERMINE 5649 03:34:39,560 --> 03:34:42,280 WHETHER OR NOT AND HOW 5650 03:34:42,280 --> 03:34:43,360 APPROPRIATE FOLLOW-UP WOULD BE 5651 03:34:43,360 --> 03:34:43,640 NECESSARY. 5652 03:34:43,640 --> 03:34:46,800 WE CONTINUE TO SEND OUT WARNING 5653 03:34:46,800 --> 03:34:48,120 LETTERS, AND PERFORM OTHER 5654 03:34:48,120 --> 03:34:49,520 ENFORCEMENT ACTIONS AS THEY COME 5655 03:34:49,520 --> 03:34:50,320 UP. 5656 03:34:50,320 --> 03:34:51,920 SOME OF THESE ENFORCEMENT 5657 03:34:51,920 --> 03:34:55,000 ACTIONS HAVE LED TO CASES THAT 5658 03:34:55,000 --> 03:34:56,840 MORE RECENTLY HAVE RESULTED IN 5659 03:34:56,840 --> 03:34:59,480 LARGE FINES AND JAIL TIME, SO WE 5660 03:34:59,480 --> 03:35:01,480 CONTINUE TO WORK WITHIN THE 5661 03:35:01,480 --> 03:35:02,320 RESOURCES AND STATUTORY 5662 03:35:02,320 --> 03:35:04,400 AUTHORITY WE HAVE TO DO WHAT WE 5663 03:35:04,400 --> 03:35:07,280 CAN TO GET THOSE PRODUCTS OFF 5664 03:35:07,280 --> 03:35:08,240 THE MARKET. 5665 03:35:08,240 --> 03:35:08,680 >> OKAY. 5666 03:35:08,680 --> 03:35:12,080 AND WHAT ARE THE DIFFERENCES, IF 5667 03:35:12,080 --> 03:35:13,240 ANY, BETWEEN STRUCTURE/FUNCTION 5668 03:35:13,240 --> 03:35:16,560 CLAIMS ON FOODS AND ON DIETARY 5669 03:35:16,560 --> 03:35:17,080 SUPPLEMENTS? 5670 03:35:17,080 --> 03:35:18,760 WHY DO -- ALSO RELATED, WHY DO 5671 03:35:18,760 --> 03:35:20,800 SELLERS HAVE TO HAVE PROOF FOR 5672 03:35:20,800 --> 03:35:22,800 THESE TYPES OF CLAIMS BUT NOT 5673 03:35:22,800 --> 03:35:26,520 SHARE THIS PROOF WITH FDA OR 5674 03:35:26,520 --> 03:35:26,840 FTC? 5675 03:35:26,840 --> 03:35:29,000 HOW CAN WE BE SURE THEY ARE 5676 03:35:29,000 --> 03:35:31,880 BEING HONEST? 5677 03:35:31,880 --> 03:35:34,280 >> WELL, WITH REGARDS TO HAVING 5678 03:35:34,280 --> 03:35:38,120 THE PROOF OF INFORMATION WE CAN 5679 03:35:38,120 --> 03:35:39,480 OKAY WORK WITHIN LEGISLATIVE 5680 03:35:39,480 --> 03:35:40,680 AUTHORITY WE HAVE, THE 5681 03:35:40,680 --> 03:35:42,840 LEGISLATIVE AUTHORITY WE HAVE 5682 03:35:42,840 --> 03:35:44,280 DOESN'T REQUIRE -- DOESN'T ALLOW 5683 03:35:44,280 --> 03:35:47,240 FDA AS AUTHORIZED AGENCY TO 5684 03:35:47,240 --> 03:35:50,840 OBTAIN THIS INFORMATION FROM 5685 03:35:50,840 --> 03:35:53,240 MANUFACTURERS, SO WE HAVE TO AT 5686 03:35:53,240 --> 03:35:55,040 THAT RATE TRUST THAT THEY ARE 5687 03:35:55,040 --> 03:35:56,800 HOLDING ONTO THIS INFORMATION. 5688 03:35:56,800 --> 03:36:01,280 WE CAN OF COURSE CONDUCT 5689 03:36:01,280 --> 03:36:03,360 INSPECTION AND ASK FOR 5690 03:36:03,360 --> 03:36:05,120 INFORMATION AS WE SEE FIT BUT 5691 03:36:05,120 --> 03:36:07,760 CAN'T REQUIRE THEM TO PROVIDE 5692 03:36:07,760 --> 03:36:08,840 THE INFORMATION, THAT'S SOME OF 5693 03:36:08,840 --> 03:36:13,120 THE LIMITS ON OUR AUTHORITY. 5694 03:36:13,120 --> 03:36:16,160 >> ANOTHER QUESTION HERE, HOW DO 5695 03:36:16,160 --> 03:36:17,160 OTHER INDUSTRIALIZED NATIONS 5696 03:36:17,160 --> 03:36:18,360 DEAL WITH SUPPLEMENTS ARE 5697 03:36:18,360 --> 03:36:20,160 SUPPLEMENTS PART OF THEIR 5698 03:36:20,160 --> 03:36:20,920 MEDICAL PROTOCOL? 5699 03:36:20,920 --> 03:36:23,280 OBVIOUSLY THAT DEPENDS ON THE 5700 03:36:23,280 --> 03:36:25,280 COUNTRY OF COURSE. 5701 03:36:25,280 --> 03:36:26,360 >> YES, DEPENDS ON THE COUNTRY. 5702 03:36:26,360 --> 03:36:28,000 SOME REFER TO THEM AS MEDICAL 5703 03:36:28,000 --> 03:36:30,640 PRODUCTS, SOME REFER TO THEM AS 5704 03:36:30,640 --> 03:36:31,960 DIETARY SUPPLEMENTS, NUTRITIONAL 5705 03:36:31,960 --> 03:36:32,240 PRODUCTS. 5706 03:36:32,240 --> 03:36:36,640 IT REALLY DEPENDS ON THE 5707 03:36:36,640 --> 03:36:36,880 COUNTRY. 5708 03:36:36,880 --> 03:36:40,280 >> YEAH, CANADA FOR INSTANCE HAS 5709 03:36:40,280 --> 03:36:42,480 A PRODUCT CALLED NATURAL HEALTH 5710 03:36:42,480 --> 03:36:43,800 PRODUCTS THAT INCORPORATE A LOT 5711 03:36:43,800 --> 03:36:46,720 OF THE SORTS OF THINGS THAT ARE 5712 03:36:46,720 --> 03:36:48,600 AVAILABLE HERE AS DIETARY 5713 03:36:48,600 --> 03:36:50,040 SUPPLEMENTS, BUT IN CANADA THEY 5714 03:36:50,040 --> 03:36:52,640 ARE REGULATED AS A SPECIAL 5715 03:36:52,640 --> 03:36:54,080 CATEGORY OF OTC DRUGS RATHER 5716 03:36:54,080 --> 03:36:59,880 THAN SPECIAL CATEGORY OF FOOD. 5717 03:36:59,880 --> 03:37:01,800 AND THERE IS PRE-MARKET 5718 03:37:01,800 --> 03:37:03,400 APPROVAL, AND THINGS LIKE THAT. 5719 03:37:03,400 --> 03:37:04,680 THAT'S CANADIAN CASE. 5720 03:37:04,680 --> 03:37:06,040 I KNOW CERTAIN COUNTRIES IN 5721 03:37:06,040 --> 03:37:08,840 EUROPE, I'M NOT GOING TO TRY AND 5722 03:37:08,840 --> 03:37:10,240 PARSE A DIFFERENT COUNTRY IN 5723 03:37:10,240 --> 03:37:11,560 EUROPE OR ADDRESS THE E.U. 5724 03:37:11,560 --> 03:37:14,680 I DO KNOW THERE ARE CERTAIN 5725 03:37:14,680 --> 03:37:19,320 COUNTRIES THAT REGULATE DIETARY 5726 03:37:19,320 --> 03:37:21,640 SUPPLEMENTS, ESSENTIALLY 5727 03:37:21,640 --> 03:37:23,640 NUTRITIONAL SUPPLEMENTS, HERBS 5728 03:37:23,640 --> 03:37:25,040 ARE NOT CONSIDERED, ONLY 5729 03:37:25,040 --> 03:37:25,800 CONVENTIONAL NUTRIENTS ARE. 5730 03:37:25,800 --> 03:37:31,880 A NUMBER OF THESE PLACES 5731 03:37:31,880 --> 03:37:34,440 NUTRITIONAL VALUE CANNOT EXCEED 5732 03:37:34,440 --> 03:37:38,200 THE DAILY VALUE OR THE RDI FOR 5733 03:37:38,200 --> 03:37:40,920 THE NUTRIENT OF CONCERN. 5734 03:37:40,920 --> 03:37:42,680 AND AGAIN IT VARIES FROM COUNTRY 5735 03:37:42,680 --> 03:37:44,440 TO COUNTRY. 5736 03:37:44,440 --> 03:37:45,640 THERE ARE COUNTRIES THAT 5737 03:37:45,640 --> 03:37:49,480 REGULATE ESPECIALLY THE HERBS AS 5738 03:37:49,480 --> 03:37:51,280 TRADITIONAL MEDICINES. 5739 03:37:51,280 --> 03:37:53,520 SOME COUNTRIES HOLD THEM TO A 5740 03:37:53,520 --> 03:37:56,560 FAIRLY HIGH STANDARD PRE-MARKET 5741 03:37:56,560 --> 03:37:59,360 APPROVAL, OTHER ONES LESS HIGH 5742 03:37:59,360 --> 03:38:00,120 STANDARD. 5743 03:38:00,120 --> 03:38:01,680 YOU KNOW, MATERIAL TIME AND 5744 03:38:01,680 --> 03:38:04,840 EXTENT, YOU KNOW, HISTORY OF 5745 03:38:04,840 --> 03:38:09,640 USE, AS THEIR APPROVAL PROCESS. 5746 03:38:09,640 --> 03:38:12,840 IT REALLY IS -- IT REALLY VARIES 5747 03:38:12,840 --> 03:38:15,200 FROM COUNTRY TO COUNTRY AROUND 5748 03:38:15,200 --> 03:38:16,600 THE WORLD. 5749 03:38:16,600 --> 03:38:17,120 >> OKAY. 5750 03:38:17,120 --> 03:38:20,200 FDA OFFICIAL ABOUT THREE YEARS 5751 03:38:20,200 --> 03:38:21,920 AGO ESTIMATED THERE WERE 4600 5752 03:38:21,920 --> 03:38:24,040 NEW DIETARY INGREDIENTS IN THE 5753 03:38:24,040 --> 03:38:26,720 SUPPLEMENT MARKET BUT FDA HAS 5754 03:38:26,720 --> 03:38:28,960 ONLY RECEIVED AROUND 1200 TOTAL 5755 03:38:28,960 --> 03:38:29,880 NOTIFICATIONS. 5756 03:38:29,880 --> 03:38:32,480 AND THAT'S QUITE A DISCONNECT. 5757 03:38:32,480 --> 03:38:36,520 YOU SAID LAST WEEK FDA RELEASED 5758 03:38:36,520 --> 03:38:39,960 A DRAFT GUIDANCE TO GET MORE 5759 03:38:39,960 --> 03:38:42,600 NDIs SUBMITTED FOR THESE NOT 5760 03:38:42,600 --> 03:38:43,360 IMPROVED INGREDIENTS. 5761 03:38:43,360 --> 03:38:46,560 WHAT IS NEEDED TO MAKE THIS 5762 03:38:46,560 --> 03:38:47,320 FINAL? 5763 03:38:47,320 --> 03:38:49,760 >> SO THAT'S A GREAT QUESTION. 5764 03:38:49,760 --> 03:38:52,000 THIS GUIDANCE AS I MENTIONED WAS 5765 03:38:52,000 --> 03:38:54,240 ISSUED LAST WEEK. 5766 03:38:54,240 --> 03:38:56,480 WE WILL HAVE -- WHEN FDA PUTS 5767 03:38:56,480 --> 03:38:57,800 OUT GUIDANCE YOU CAN COMMENT AT 5768 03:38:57,800 --> 03:39:00,520 ANY TIME BUT WE'VE ASKED YOU 5769 03:39:00,520 --> 03:39:02,720 SUBMIT COMMENTS WITHIN 60 DAYS. 5770 03:39:02,720 --> 03:39:04,920 ONCE WE RECEIVE AND REVIEW THOSE 5771 03:39:04,920 --> 03:39:06,160 COMMENTS, WE'LL EVALUATE AND 5772 03:39:06,160 --> 03:39:09,320 DETERMINE WHETHER OR NOT THAT 5773 03:39:09,320 --> 03:39:11,960 POLICY NEEDS TO BE RESTRUCTURED 5774 03:39:11,960 --> 03:39:13,680 OR CHANGED IN ANY WAY, AFTER 5775 03:39:13,680 --> 03:39:16,200 THAT 60 DAYS AFTER WE'VE 5776 03:39:16,200 --> 03:39:17,600 EVALUATED ALL OF THE COMMENTS 5777 03:39:17,600 --> 03:39:20,400 WE'LL WRITE UP THE FINAL POLICY. 5778 03:39:20,400 --> 03:39:23,320 IT WILL GO THROUGH ALL OF THE 5779 03:39:23,320 --> 03:39:25,200 REQUIRED CLEARANCES AND THEN BE 5780 03:39:25,200 --> 03:39:27,080 ISSUED, BUT FDA WILL WORK 5781 03:39:27,080 --> 03:39:28,280 EXPEDITIOUSLY TO REVIEW THOSE 5782 03:39:28,280 --> 03:39:30,680 COMMENTS AND GET THIS FINAL 5783 03:39:30,680 --> 03:39:31,880 GUIDANCE OUT AS SOON AS 5784 03:39:31,880 --> 03:39:34,000 POSSIBLE, WE DO THINK IT'S 5785 03:39:34,000 --> 03:39:36,120 IMPORTANT TO ENCOURAGE MORE NDI 5786 03:39:36,120 --> 03:39:37,120 NOTIFICATIONS, MORE SAFETY 5787 03:39:37,120 --> 03:39:40,920 INFORMATION, TO MAKE IT INTO THE 5788 03:39:40,920 --> 03:39:41,960 HANDS OF THE AGENCY. 5789 03:39:41,960 --> 03:39:49,320 >> IF THERE WERE DIETARY 5790 03:39:49,320 --> 03:39:52,440 SUPPLEMENTS SHOWN TO HELP, SAY, 5791 03:39:52,440 --> 03:39:53,880 CANCER PATIENTS, MORE EFFECTIVE 5792 03:39:53,880 --> 03:39:55,840 IN THAT POPULATION THAN HEALTHY 5793 03:39:55,840 --> 03:39:56,640 INDIVIDUALS WOULD THAT 5794 03:39:56,640 --> 03:40:00,880 CATEGORIZE THE SUPPLEMENT AS A 5795 03:40:00,880 --> 03:40:05,520 DRUG OR COULD IT STILL STAY AS 5796 03:40:05,520 --> 03:40:06,040 SUPPLEMENT? 5797 03:40:06,040 --> 03:40:08,520 >> I WOULDN'T BE ABLE TO COMMENT 5798 03:40:08,520 --> 03:40:13,080 ON A SPECIFIC PRODUCT. 5799 03:40:13,080 --> 03:40:15,000 DR. BETZ MAY WANT TO ANSWER. 5800 03:40:15,000 --> 03:40:18,640 >> WHAT DO YOU MEAN BY HELP 5801 03:40:18,640 --> 03:40:19,280 SOMEBODY BE HEALTHIER? 5802 03:40:19,280 --> 03:40:23,000 YOU CAN BE A HEALTHY CANCER 5803 03:40:23,000 --> 03:40:27,040 PATIENT, YOU KNOW, MAYBE 5804 03:40:27,040 --> 03:40:28,400 SLIGHTLY LESS WASTING OR 5805 03:40:28,400 --> 03:40:30,280 SOMETHING LIKE THAT. 5806 03:40:30,280 --> 03:40:32,480 AND IT'S VERY DIFFERENT THAN 5807 03:40:32,480 --> 03:40:35,080 TREATS OR CURES THE CANCER. 5808 03:40:35,080 --> 03:40:36,720 YOU KNOW, IF YOU'RE CLAIMING TO 5809 03:40:36,720 --> 03:40:39,160 TREAT OR CURE THE CANCER, THEN 5810 03:40:39,160 --> 03:40:42,720 YOU'RE A DRUG, PERIOD. 5811 03:40:42,720 --> 03:40:44,320 MAINTAINING THE HEALTH OF A 5812 03:40:44,320 --> 03:40:46,480 VULNERABLE INDIVIDUAL WHO HAS A 5813 03:40:46,480 --> 03:40:51,120 CERTAIN DISEASE, I'M NOT SURE 5814 03:40:51,120 --> 03:40:52,840 WHERE THAT WOULD FIT. 5815 03:40:52,840 --> 03:40:57,000 YOU KNOW, IT WOULD BE VERY 5816 03:40:57,000 --> 03:40:58,520 NARROW TIGHTROPE TO BE WALKING 5817 03:40:58,520 --> 03:41:01,720 ON IF I WERE TO TRY TO MAKE THAT 5818 03:41:01,720 --> 03:41:02,920 CLAIM I THINK. 5819 03:41:02,920 --> 03:41:04,880 >> HOW ARE COMPANIES GETTING 5820 03:41:04,880 --> 03:41:06,000 AWAY WITH FORMULATING 5821 03:41:06,000 --> 03:41:10,360 SUPPLEMENTS AS GUMMIES IF, 5822 03:41:10,360 --> 03:41:13,320 QUOTE, CANDY IS CONSIDERED A 5823 03:41:13,320 --> 03:41:14,120 FOOD? 5824 03:41:14,120 --> 03:41:17,320 >> THAT'S A GREAT QUESTION. 5825 03:41:17,320 --> 03:41:18,800 IT WOULD WOULD MEET THE 5826 03:41:18,800 --> 03:41:20,160 DEFINITION OF DIETARY SUPPLEMENT 5827 03:41:20,160 --> 03:41:22,840 IF BEING MARKETED IN THE WAY 5828 03:41:22,840 --> 03:41:27,560 THAT WE HAVE EXPRESS EXPRESSED 5829 03:41:27,560 --> 03:41:28,320 EARLIER, CONTAINS REQUIRED 5830 03:41:28,320 --> 03:41:33,360 CLAIMS OF A DIETARY SUPPLEMENT, 5831 03:41:33,360 --> 03:41:34,560 A LIKELY A SUPPLEMENT BUT THERE 5832 03:41:34,560 --> 03:41:37,680 ARE PRODUCTS THAT WALK THAT LINE 5833 03:41:37,680 --> 03:41:40,360 A LITTLE BIT IN A MORE DIFFICULT 5834 03:41:40,360 --> 03:41:42,680 WAY IN THAT CASE ODPS WILL REACH 5835 03:41:42,680 --> 03:41:47,560 OUT TO -- WE HAVE AN OFFICE OF 5836 03:41:47,560 --> 03:41:48,520 NUTRITION AND FOOD LABELING, AND 5837 03:41:48,520 --> 03:41:50,040 THEY WILL HELP US EVALUATE AND 5838 03:41:50,040 --> 03:41:52,280 DETERMINE WHETHER OR NOT IT IS 5839 03:41:52,280 --> 03:41:56,120 IN FACT A DIETARY SUPPLEMENT. 5840 03:41:56,120 --> 03:41:58,760 >> YEAH, IT'S INTERESTING THAT 5841 03:41:58,760 --> 03:42:02,760 CASE STUDY, THE HAIN'S PRODUCT, 5842 03:42:02,760 --> 03:42:05,560 FDA SPECIFICALLY IN THE WARNING 5843 03:42:05,560 --> 03:42:06,440 LETTERS SPECIFICALLY CALLED OUT 5844 03:42:06,440 --> 03:42:09,800 THE FACT THAT THE COMPANY HAD 5845 03:42:09,800 --> 03:42:12,840 PROMOTED THEIR STUFF AS 5846 03:42:12,840 --> 03:42:13,120 DELICIOUS. 5847 03:42:13,120 --> 03:42:15,240 AS PROOF THEY WERE TRYING TO 5848 03:42:15,240 --> 03:42:21,360 SELL A CONVENTIONAL FOOD RATHER 5849 03:42:21,360 --> 03:42:22,280 THAN DIETARY SUPPLEMENT. 5850 03:42:22,280 --> 03:42:24,720 IF YOU REPRESENT YOUR GUMMY AS 5851 03:42:24,720 --> 03:42:25,880 GOOD TASTING, TASTES GOOD, YOU 5852 03:42:25,880 --> 03:42:28,640 MIGHT BE WALKING CLOSER TO THE 5853 03:42:28,640 --> 03:42:30,360 CONVENTIONAL CANDY LINE, YOU 5854 03:42:30,360 --> 03:42:31,480 KNOW. 5855 03:42:31,480 --> 03:42:38,440 SO IT COMES DOWN TO, YOU KNOW, 5856 03:42:38,440 --> 03:42:39,000 USING YOUR WORDS CAREFULLY. 5857 03:42:39,000 --> 03:42:41,440 >> AS A LAWYER WE SAY 5858 03:42:41,440 --> 03:42:41,840 CASE-BY-CASE BASIS, 5859 03:42:41,840 --> 03:42:43,240 UNFORTUNATELY IT'S THE SAME 5860 03:42:43,240 --> 03:42:44,720 THING HERE. 5861 03:42:44,720 --> 03:42:45,120 >> RIGHT. 5862 03:42:45,120 --> 03:42:46,800 >> ANOTHER QUESTION, I'M UNDER 5863 03:42:46,800 --> 03:42:48,520 THE IMPRESSION THAT GRAS STATUS 5864 03:42:48,520 --> 03:42:51,480 FOR FOOD IS APPLIED TO SPECIFIC 5865 03:42:51,480 --> 03:42:53,120 FOOD CONSTITUENTS AT SPECIFIC 5866 03:42:53,120 --> 03:42:53,720 LEVELS. 5867 03:42:53,720 --> 03:42:57,960 IF THIS IS SO, HOW CAN DIETARY 5868 03:42:57,960 --> 03:43:01,000 SUPPLEMENTS STATE THEIR PRODUCT 5869 03:43:01,000 --> 03:43:02,880 MEETS GRAS WHEN MAY CONTAIN TEN 5870 03:43:02,880 --> 03:43:06,200 TIMES OR SO THE LEVEL OF THE 5871 03:43:06,200 --> 03:43:07,800 NUTRIENT? 5872 03:43:07,800 --> 03:43:11,000 >> I'M NOT AS FAMILIAR WITH THE 5873 03:43:11,000 --> 03:43:13,640 SPECIFICS OF THE GRAS 5874 03:43:13,640 --> 03:43:15,040 NOTIFICATION PROCESS, AND WHAT 5875 03:43:15,040 --> 03:43:17,640 IS REQUIRED OF THEM. 5876 03:43:17,640 --> 03:43:22,880 I DO KNOW, AND I CAN STATE THAT 5877 03:43:22,880 --> 03:43:24,000 WE'RE AWARE UNFORTUNATELY 5878 03:43:24,000 --> 03:43:25,200 COMPANIES ARE USING SELF-GRAS 5879 03:43:25,200 --> 03:43:27,720 STATUS TO GET OUT OF THE NDI 5880 03:43:27,720 --> 03:43:30,040 NOTIFICATION PROCESS, BUT I'M 5881 03:43:30,040 --> 03:43:32,560 NOT AWARE OF SPECIFICALLY WHAT 5882 03:43:32,560 --> 03:43:37,160 THEY ARE CLAIMING IS GRAS IN 5883 03:43:37,160 --> 03:43:38,360 THEIR PRODUCTS. 5884 03:43:38,360 --> 03:43:39,800 >> AGAIN, THAT WOULD BE CASE BY 5885 03:43:39,800 --> 03:43:44,160 CASE I THINK. 5886 03:43:44,160 --> 03:43:45,360 SO THEIR GRAS SELF-AFFIRMATION 5887 03:43:45,360 --> 03:43:46,680 WOULD REQUIRE INFORMATION NOT 5888 03:43:46,680 --> 03:43:48,320 ONLY ABOUT THE SUBSTANCE BUT 5889 03:43:48,320 --> 03:43:52,040 ABOUT ALSO ITS INTENDED USE, HOW 5890 03:43:52,040 --> 03:43:55,520 WILL IT BE USED, AT WHAT LEVELS, 5891 03:43:55,520 --> 03:44:00,480 AND WHAT ARE THE RECOMMENDATIONS 5892 03:44:00,480 --> 03:44:01,760 FOR USE. 5893 03:44:01,760 --> 03:44:03,200 AND EACH GRAS SELF-AFFIRMATION 5894 03:44:03,200 --> 03:44:05,960 WOULD HAVE TO UNDERGO, YOU KNOW, 5895 03:44:05,960 --> 03:44:10,320 SOME KIND OF SCIENTIFIC REVIEW, 5896 03:44:10,320 --> 03:44:13,600 WHETHER IT'S A SELF-AFFIRMATION 5897 03:44:13,600 --> 03:44:15,360 OR FORMAL GRAS NOTIFICATION TO 5898 03:44:15,360 --> 03:44:17,600 FDA STILL HAS TO UNDERGO A 5899 03:44:17,600 --> 03:44:21,160 REVIEW BY QUALIFIED EXPERTS. 5900 03:44:21,160 --> 03:44:27,000 AND SO, YOU KNOW, YOU COULD MAKE 5901 03:44:27,000 --> 03:44:28,720 A GRAS SELF-AFFIRMATION FOR A 5902 03:44:28,720 --> 03:44:32,000 CERTAIN SUBSTANCE FOR A CERTAIN 5903 03:44:32,000 --> 03:44:37,000 USE, AND IT DOESN'T HAVE TO MEET 5904 03:44:37,000 --> 03:44:38,880 THE SAME GRAS-INTENDED USE 5905 03:44:38,880 --> 03:44:39,760 DEFINITION AS THE SAME 5906 03:44:39,760 --> 03:44:41,720 SUBSTANCE, FOR INSTANCE, IN A 5907 03:44:41,720 --> 03:44:43,360 CONVENTIONAL FOOD WHICH WOULD 5908 03:44:43,360 --> 03:44:47,560 BE -- MIGHT BE FOR A DIFFERENT 5909 03:44:47,560 --> 03:44:48,920 TECHNICAL EFFECT. 5910 03:44:48,920 --> 03:44:53,000 SO, AGAIN, CASE BY CASE I THINK. 5911 03:44:53,000 --> 03:44:55,440 AS LONG AS THE SCIENTIFIC 5912 03:44:55,440 --> 03:44:57,200 REVIEWERS HAVE DONE THEIR DUE 5913 03:44:57,200 --> 03:44:58,240 DILIGENCE AND ACTUALLY REVIEWED 5914 03:44:58,240 --> 03:45:04,120 IT AS THE COMPANY WILL USE IT, 5915 03:45:04,120 --> 03:45:08,400 THEN I THINK -- I THINK THAT 5916 03:45:08,400 --> 03:45:09,320 IT'S PROBABLY OKAY ALTHOUGH, 5917 03:45:09,320 --> 03:45:10,840 AGAIN, LIKE YOU I'M NOT AN 5918 03:45:10,840 --> 03:45:16,320 EXPERT ON THE GRAS PROCESS. 5919 03:45:16,320 --> 03:45:18,160 >> HAS THERE BEEN RESEARCHERS ON 5920 03:45:18,160 --> 03:45:19,000 CONSUMERS UNDERSTANDING OF 5921 03:45:19,000 --> 03:45:20,120 DISCLAIMER LANGUAGE ON LABELS 5922 03:45:20,120 --> 03:45:21,440 AND IN ADVERTISING, YOU KNOW, 5923 03:45:21,440 --> 03:45:25,160 THAT HAS NOT BEEN EVALUATED BY 5924 03:45:25,160 --> 03:45:26,200 THE FDA? 5925 03:45:26,200 --> 03:45:27,800 WHAT DO CONSUMERS THINK THAT 5926 03:45:27,800 --> 03:45:28,520 MEANS? 5927 03:45:28,520 --> 03:45:32,200 IS THE DISCLAIMER ITSELF 5928 03:45:32,200 --> 03:45:34,680 POTENTIALLY MISLEADING? 5929 03:45:34,680 --> 03:45:37,600 >> WELL, I THINK THAT OUR SOCIAL 5930 03:45:37,600 --> 03:45:40,240 SCIENTISTS HAVE PROBABLY DONE 5931 03:45:40,240 --> 03:45:41,120 SOME MORE EXTENSIVE RESEARCH. 5932 03:45:41,120 --> 03:45:43,760 I HAVE NOT SEEN ANY RESEARCH TO 5933 03:45:43,760 --> 03:45:47,360 SAY THAT THAT DISCLAIMER 5934 03:45:47,360 --> 03:45:48,000 LANGUAGE IS MISLEADING. 5935 03:45:48,000 --> 03:45:50,720 IT HAS BEEN IN PRACTICE FOR A 5936 03:45:50,720 --> 03:45:52,160 LONG TIME NOW. 5937 03:45:52,160 --> 03:45:53,520 I WOULD BE CERTAINLY INTERESTED 5938 03:45:53,520 --> 03:45:54,880 IF YOU'RE REFERRING TO RESEARCH 5939 03:45:54,880 --> 03:45:57,320 THAT YOU HAVE, YOU CAN CERTAINLY 5940 03:45:57,320 --> 03:46:03,120 REACH OUT TO FDA TO PRESENT THAT 5941 03:46:03,120 --> 03:46:04,240 RESEARCH. 5942 03:46:04,240 --> 03:46:12,080 >> A TECHNICAL QUESTION HERE, 5943 03:46:12,080 --> 03:46:13,080 DIETARY SUPPLEMENTS MAY NOT 5944 03:46:13,080 --> 03:46:14,800 INCLUDE ARTICLE AUTHORIZED FOR 5945 03:46:14,800 --> 03:46:16,480 INVESTIGATION AS NEW DRUG, 5946 03:46:16,480 --> 03:46:18,880 ANTIBIOTIC OR BIOLOGICAL FOR 5947 03:46:18,880 --> 03:46:19,760 WHICH SUBSTANTIAL CLINICAL 5948 03:46:19,760 --> 03:46:20,320 INVESTIGATIONS HAVE BEEN 5949 03:46:20,320 --> 03:46:23,160 INSTITUTE AND FOR WHICH THE 5950 03:46:23,160 --> 03:46:24,560 EXISTENCE OF SUCH INVESTIGATION 5951 03:46:24,560 --> 03:46:28,480 HAS BEEN MADE PUBLIC, UNQUOTE. 5952 03:46:28,480 --> 03:46:30,640 WHAT CONSTITUTES THE 5953 03:46:30,640 --> 03:46:31,440 INVESTIGATIONS BEING MADE 5954 03:46:31,440 --> 03:46:33,200 PUBLIC? 5955 03:46:33,200 --> 03:46:34,720 >> THERE'S CASE LAW THAT REALLY 5956 03:46:34,720 --> 03:46:36,920 GETS INTO THE NITTY-GRITTY OF 5957 03:46:36,920 --> 03:46:37,120 THAT. 5958 03:46:37,120 --> 03:46:38,440 THAT'S NOT SOMETHING THAT WE 5959 03:46:38,440 --> 03:46:39,960 COULD PROBABLY GET INTO IN A 5960 03:46:39,960 --> 03:46:43,040 LIMITED TIME WE HAVE HERE. 5961 03:46:43,040 --> 03:46:48,720 BUT AS SOON AS WE HAVE SEEN 5962 03:46:48,720 --> 03:46:49,840 GENERALLY IT'S SOMETHING THAT A 5963 03:46:49,840 --> 03:46:52,280 COMPANY PUTS IN THE MARKETPLACE, 5964 03:46:52,280 --> 03:46:54,320 A P.R. NEWS WIRE THEY PUT OUT, 5965 03:46:54,320 --> 03:46:55,400 SOMETHING LIKE THAT COULD BE 5966 03:46:55,400 --> 03:46:59,160 USED AS AN EXAMPLE OF THEM 5967 03:46:59,160 --> 03:47:00,120 MAKING IT PUBLIC. 5968 03:47:00,120 --> 03:47:03,200 BUT THAT ALSO COULD BE A 5969 03:47:03,200 --> 03:47:05,520 CASE-BY-CASE ANALYSIS. 5970 03:47:05,520 --> 03:47:06,880 I'D HAVE TO LOOK BACK AT CASE 5971 03:47:06,880 --> 03:47:09,760 LAW TO PROVIDE MORE INFORMATION. 5972 03:47:09,760 --> 03:47:11,040 >> HOW IS IT SUPPLEMENTS ARE 5973 03:47:11,040 --> 03:47:14,680 ABLE TO BE DISTRIBUTED IN, 5974 03:47:14,680 --> 03:47:15,760 QUOTE, THERAPEUTIC DOSES? 5975 03:47:15,760 --> 03:47:18,760 FOR EXAMPLE 5,000 IUs FOR 5976 03:47:18,760 --> 03:47:20,720 VITAMIN D 3 BEYOND THE UPPER 5977 03:47:20,720 --> 03:47:23,120 LEVEL WHEN OTHER MEDICAL SOURCES 5978 03:47:23,120 --> 03:47:24,520 STATE ANYONE TAKING THIS AMOUNT 5979 03:47:24,520 --> 03:47:26,480 SHOULD HAVE THEIR VITAMIN D 5980 03:47:26,480 --> 03:47:29,800 LEVELS REGULARLY CHECKED TO 5981 03:47:29,800 --> 03:47:31,640 AVOID RISK OF TOXICITY? 5982 03:47:31,640 --> 03:47:39,480 THAT PART ISN'T EXACTLY TRUE. 5983 03:47:39,480 --> 03:47:39,800 OKAY. 5984 03:47:39,800 --> 03:47:43,000 >> WELL, YOU KNOW, MY ANSWER TO 5985 03:47:43,000 --> 03:47:44,840 THAT IS THE PROXMIRE AMENDMENT. 5986 03:47:44,840 --> 03:47:50,320 YOU KNOW, THAT'S WHY WE HAVE 5987 03:47:50,320 --> 03:47:52,160 MEGADOSES OF VITAMINS WHETHER OR 5988 03:47:52,160 --> 03:47:53,600 NOT THAT'S SMART IS A DIFFERENT 5989 03:47:53,600 --> 03:48:01,360 ISSUE THAT I WON'T TALK ABOUT. 5990 03:48:01,360 --> 03:48:02,920 5991 03:48:02,920 --> 03:48:06,800 >> ARE PRESS RELEASES THAT SHARE 5992 03:48:06,800 --> 03:48:10,000 FINDINGS PUBLISHED IN A PER 5993 03:48:10,000 --> 03:48:11,000 REVIEW ARTICLE CONSIDERED 5994 03:48:11,000 --> 03:48:11,360 CLAIMS? 5995 03:48:11,360 --> 03:48:13,520 >> IT WOULD DEPENDS ON WHAT THE 5996 03:48:13,520 --> 03:48:16,280 PRESS RELEASES SAY, IF THEY MAKE 5997 03:48:16,280 --> 03:48:17,240 STATEMENTS ABOUT INTENDED USE OF 5998 03:48:17,240 --> 03:48:20,400 THE PRODUCT COULD BE CONSIDERED 5999 03:48:20,400 --> 03:48:24,480 CLAIMS THAT FDA WOULD EVALUATE. 6000 03:48:24,480 --> 03:48:25,480 >> YEAH, THERE'S INTERESTING 6001 03:48:25,480 --> 03:48:27,320 PART OF DSHEA THAT ALMOST NOBODY 6002 03:48:27,320 --> 03:48:28,960 EVER TALKS ABOUT, AND THAT IS 6003 03:48:28,960 --> 03:48:31,040 YOU USED TO WALK INTO A HEALTH 6004 03:48:31,040 --> 03:48:35,960 FOOD STORE AND FIND PAMPHLETS 6005 03:48:35,960 --> 03:48:39,200 THAT WERE FREE, THAT GAVE 6006 03:48:39,200 --> 03:48:40,200 CONSUMERS INFORMATION ABOUT, YOU 6007 03:48:40,200 --> 03:48:42,720 KNOW, WHAT TO USE YOUR ST. 6008 03:48:42,720 --> 03:48:47,920 JOHN'S WORT FOR, FOR INSTANCE. 6009 03:48:47,920 --> 03:48:49,560 FDA WAS TAKING ACTION AGAINST 6010 03:48:49,560 --> 03:48:51,960 PRODUCTS BASED ON THAT 6011 03:48:51,960 --> 03:48:54,400 LITERATURE, THAT THIRD PARTY 6012 03:48:54,400 --> 03:48:55,640 LITERATURE, THAT WAS PRESENT IN 6013 03:48:55,640 --> 03:48:56,800 THE HEALTH FOOD STORE. 6014 03:48:56,800 --> 03:48:59,320 SO THEY WERE CLAIMING THAT THIRD 6015 03:48:59,320 --> 03:49:01,600 PARTY LITERATURE IS HOW YOU KNEW 6016 03:49:01,600 --> 03:49:02,720 THAT THE ST. JOHN'S WORT WAS 6017 03:49:02,720 --> 03:49:04,680 INTENDED TO BE USED AS A DRUG. 6018 03:49:04,680 --> 03:49:06,800 IT COMES BACK TO INTENDED USE, 6019 03:49:06,800 --> 03:49:08,400 ALL SORTS OF THINGS. 6020 03:49:08,400 --> 03:49:10,040 CONGRESS SPECIFICALLY IN THE 6021 03:49:10,040 --> 03:49:12,040 DSHEA SAID THAT THAT LITERATURE 6022 03:49:12,040 --> 03:49:13,800 IS ALLOWED TO BE THERE, AS LONG 6023 03:49:13,800 --> 03:49:15,640 AS IT'S TRUTHFUL AND NOT 6024 03:49:15,640 --> 03:49:17,720 MISLEADING, AS LONG AS IT 6025 03:49:17,720 --> 03:49:19,440 DOESN'T MENTION A SPECIFIC 6026 03:49:19,440 --> 03:49:20,440 PRODUCT, SPECIFIC BRAND. 6027 03:49:20,440 --> 03:49:23,840 SO, YOU COULD HAVE A LITERATURE 6028 03:49:23,840 --> 03:49:25,680 ABOUT ST. JOHN'S WORT, AS LONG 6029 03:49:25,680 --> 03:49:28,680 AS IT WASN'T BRAND X ST. JOHN'S 6030 03:49:28,680 --> 03:49:29,080 WORT. 6031 03:49:29,080 --> 03:49:29,960 AND CONGRESS AUTHORIZED THAT AND 6032 03:49:29,960 --> 03:49:37,520 SAID IT'S PART OF DSHEA. 6033 03:49:37,520 --> 03:49:38,800 IT'S NOT EXACTLY THE SAME AS 6034 03:49:38,800 --> 03:49:41,960 PRESS RELEASE BUT THE THIRD 6035 03:49:41,960 --> 03:49:45,400 PARTY LITERATURE IS STILL LEGAL. 6036 03:49:45,400 --> 03:49:46,600 >> BOY, IN THOSE DAYS I USED TO 6037 03:49:46,600 --> 03:49:48,880 WORK IN HEALTH FOOD STORES, 6038 03:49:48,880 --> 03:49:51,200 PARTLY RESPONSIBLE FOR 6039 03:49:51,200 --> 03:49:51,920 DISTRIBUTING THAT LITERATURE. 6040 03:49:51,920 --> 03:49:54,360 AND FOR THAT I GUESS I APOLOGIZE 6041 03:49:54,360 --> 03:49:54,640 NOW. 6042 03:49:54,640 --> 03:49:58,080 WE HAVE A FINAL QUESTION, AND IF 6043 03:49:58,080 --> 03:50:00,680 MS. DAVIS IS HERE, HOW AND WHEN 6044 03:50:00,680 --> 03:50:03,800 DO FDA AND FTC WORK TOGETHER TO 6045 03:50:03,800 --> 03:50:04,840 ADDRESS DIETARY SUPPLEMENT 6046 03:50:04,840 --> 03:50:05,960 PRODUCTS IN THE MARKETPLACE? 6047 03:50:05,960 --> 03:50:08,720 CAN YOU GIVE SOME EXAMPLES AND 6048 03:50:08,720 --> 03:50:17,360 DO YOU ACTUALLY GET ALONG? 6049 03:50:17,360 --> 03:50:20,400 >> I'M HAPPY TO LET MS. DAVIS 6050 03:50:20,400 --> 03:50:20,600 START. 6051 03:50:20,600 --> 03:50:25,040 >> HELLO, CAN YOU HEAR ME? 6052 03:50:25,040 --> 03:50:25,600 >> YES. 6053 03:50:25,600 --> 03:50:27,160 >> OKAY, GREAT. 6054 03:50:27,160 --> 03:50:30,760 WELL, YOU KNOW, WE GET ALONG 6055 03:50:30,760 --> 03:50:31,200 FINE. 6056 03:50:31,200 --> 03:50:34,920 WE HAVE GREAT RESPECT FOR FDA 6057 03:50:34,920 --> 03:50:36,360 AND THEIR EXPERTISE. 6058 03:50:36,360 --> 03:50:38,640 YOU KNOW, THERE ARE REGULAR 6059 03:50:38,640 --> 03:50:39,720 INTERACTIONS, REGULAR MEETINGS, 6060 03:50:39,720 --> 03:50:41,080 BETWEEN OUR AGENCIES, WHERE 6061 03:50:41,080 --> 03:50:44,520 WE'RE ABLE TO DISCUSS PARTICULAR 6062 03:50:44,520 --> 03:50:45,200 PRODUCTS, PARTICULAR CASES THAT 6063 03:50:45,200 --> 03:50:47,960 WE MIGHT BE INTERESTED IN 6064 03:50:47,960 --> 03:50:49,000 BRINGING. 6065 03:50:49,000 --> 03:50:52,800 YOU KNOW, SOMETIMES WE HAVE A 6066 03:50:52,800 --> 03:50:55,080 CASE OR PRODUCT ABOUT WHICH WE 6067 03:50:55,080 --> 03:50:56,960 WANT TO, YOU KNOW, ISSUE A 6068 03:50:56,960 --> 03:50:58,960 WARNING LETTER, MAYBE FDA WANTS 6069 03:50:58,960 --> 03:51:01,840 TO DO SOMETHING SIMILAR. 6070 03:51:01,840 --> 03:51:02,520 SO WE COORDINATE. 6071 03:51:02,520 --> 03:51:04,480 SO WE'VE BEEN ABLE TO WORK 6072 03:51:04,480 --> 03:51:05,400 TOGETHER QUITE FREQUENTLY. 6073 03:51:05,400 --> 03:51:07,000 I THINK I POINTED TO THE 6074 03:51:07,000 --> 03:51:08,280 DIABETES WARNING LETTER IN MY 6075 03:51:08,280 --> 03:51:11,520 PRESENTATION SO THAT WOULD BE AN 6076 03:51:11,520 --> 03:51:12,240 EXAMPLE. 6077 03:51:12,240 --> 03:51:14,920 I KNOW FDA HAS DONE SOME WARNING 6078 03:51:14,920 --> 03:51:17,560 LETTERS WITH RESPECT TO COVID. 6079 03:51:17,560 --> 03:51:19,960 WE'VE DONE SOMETHING SIMILAR. 6080 03:51:19,960 --> 03:51:21,560 SO, YES, BOTH AGENCIES, I THINK 6081 03:51:21,560 --> 03:51:22,520 OUR RELATIONSHIP IS GOOD AND WE 6082 03:51:22,520 --> 03:51:28,680 TRY TO STAY ON THE SAME PAGE 6083 03:51:28,680 --> 03:51:29,400 WITH DIETARY SUPPLEMENTS WITH 6084 03:51:29,400 --> 03:51:32,080 THE SAME GOAL TRYING TO PROTECT 6085 03:51:32,080 --> 03:51:32,360 CONSUMERS. 6086 03:51:32,360 --> 03:51:33,840 >> I WOULD ECHO THAT WE HAVE AN 6087 03:51:33,840 --> 03:51:35,600 EXCELLENT RELATIONSHIP AND HAVE 6088 03:51:35,600 --> 03:51:37,760 BEEN WORKING CLOSELY TO TRY TO 6089 03:51:37,760 --> 03:51:40,520 DO THESE JOINT HEALTH CLAIM 6090 03:51:40,520 --> 03:51:42,400 INITIATIVES TO BRING MORE 6091 03:51:42,400 --> 03:51:44,760 ATTENTION, SOMETIMES WHEN FDA 6092 03:51:44,760 --> 03:51:47,120 AND FTC ARE TOGETHER TALKING 6093 03:51:47,120 --> 03:51:48,400 ABOUT AN ISSUE, MAYBE IT DRAWS 6094 03:51:48,400 --> 03:51:49,800 MORE ATTENTION FROM CONSUMERS 6095 03:51:49,800 --> 03:51:50,800 FROM THE MEDIA. 6096 03:51:50,800 --> 03:51:53,120 THESE TYPES OF CLAIMS 6097 03:51:53,120 --> 03:51:55,320 INITIATIVES ARE HELPFUL IN 6098 03:51:55,320 --> 03:51:57,280 ALERTING FOLKS TO POTENTIALLY 6099 03:51:57,280 --> 03:51:58,520 PROBLEMATIC PRODUCTS AND GETTING 6100 03:51:58,520 --> 03:52:00,640 THEM OFF THE MARKET. 6101 03:52:00,640 --> 03:52:01,000 >> OKAY. 6102 03:52:01,000 --> 03:52:03,200 THANKS VERY MUCH TO OUR THREE 6103 03:52:03,200 --> 03:52:03,960 SPEAKERS. 6104 03:52:03,960 --> 03:52:06,440 THIS WAS A TERRIFIC SESSION. 6105 03:52:06,440 --> 03:52:08,120 THAT'S IT FOR SESSION NUMBER 2. 6106 03:52:08,120 --> 03:52:10,000 I BELIEVE WE'RE GOING TO TAKE A 6107 03:52:10,000 --> 03:52:11,480 SHORT BREAK AND BE BACK IN A 6108 03:52:11,480 --> 03:52:12,360 LITTLE BIT. 6109 03:52:12,360 --> 03:52:13,480 THERE'S JAIME TO SAY EXACTLY 6110 03:52:13,480 --> 03:52:14,240 WHAT IT IS. 6111 03:52:14,240 --> 03:52:15,200 >> WE'RE NOT GOING TO TAKE A 6112 03:52:15,200 --> 03:52:19,360 BREAK BECAUSE WE GOT THE BREAK 6113 03:52:19,360 --> 03:52:19,600 BEFORE. 6114 03:52:19,600 --> 03:52:21,320 BUT FOR TIME WE'RE GOING TO HAVE 6115 03:52:21,320 --> 03:52:24,080 TO JUMP RIGHT IN TO SESSION 3, 6116 03:52:24,080 --> 03:52:25,360 WHICH IS DATABASES AND 6117 03:52:25,360 --> 03:52:28,880 RESOURCES, OUR LAST SESSION FOR 6118 03:52:28,880 --> 03:52:29,960 TODAY. 6119 03:52:29,960 --> 03:52:31,760 WE HAVE KAREN REGAN, OFFICE OF 6120 03:52:31,760 --> 03:52:33,800 DIETARY SUPPLEMENTS, SHE WILL BE 6121 03:52:33,800 --> 03:52:37,280 MODERATING THIS SESSION. 6122 03:52:37,280 --> 03:52:42,480 THANK YOU, KAREN. 6123 03:52:42,480 --> 03:52:47,400 >> GOOD AFTERNOON, EVERYONE. 6124 03:52:47,400 --> 03:52:54,160 THE SESSION IS 3, DATABASES AND 6125 03:52:54,160 --> 03:52:58,200 RESOURCES, MS. MERKEL WILL TALK 6126 03:52:58,200 --> 03:52:59,040 ABOUT DATABASES MAINTAINED BY 6127 03:52:59,040 --> 03:53:02,760 ODS THAT JAIME GAVE A GREAT 6128 03:53:02,760 --> 03:53:11,920 OVERVIEW OF THIS MORNING. 6129 03:53:11,920 --> 03:53:14,120 MS.MERKEL IS SCIENCE AND HEALTH 6130 03:53:14,120 --> 03:53:15,640 COMMUNICATIONS CONSULTANT, 6131 03:53:15,640 --> 03:53:17,840 OFFICE OF DIETARY SUPPLEMENTS, 6132 03:53:17,840 --> 03:53:20,200 PRIMARILY WORKS ON DIETARY 6133 03:53:20,200 --> 03:53:21,600 SUPPLEMENT AND LITERATURE 6134 03:53:21,600 --> 03:53:22,040 DATABASES. 6135 03:53:22,040 --> 03:53:23,920 AND SHE ALSO WORKS IN 6136 03:53:23,920 --> 03:53:25,280 COMMUNICATION AND PROMOTION 6137 03:53:25,280 --> 03:53:28,440 ACTIVITIES FOR THE OFFICE. 6138 03:53:28,440 --> 03:53:32,240 THERE'S A MORE DETAILED BIO OF 6139 03:53:32,240 --> 03:53:35,520 MS. MERKEL ON THE WEBSITE, THE 6140 03:53:35,520 --> 03:53:39,720 PRACTICUM WEBSITE. 6141 03:53:39,720 --> 03:53:40,000 MS.MERKEL? 6142 03:53:40,000 --> 03:53:47,000 YOU'RE ON MUTE. 6143 03:53:47,000 --> 03:53:48,920 >> AUDIO IS YET TO BE CONNECTED 6144 03:53:48,920 --> 03:53:49,120 MAYBE. 6145 03:53:49,120 --> 03:53:51,520 JOYCE, IF YOU GO TO THE BOTTOM 6146 03:53:51,520 --> 03:53:52,720 OF THE WEBEX WINDOW. 6147 03:53:52,720 --> 03:53:55,560 OH, I CAN UNMUTE YOU. 6148 03:53:55,560 --> 03:53:56,000 YOU'RE UNMUTED NOW. 6149 03:53:56,000 --> 03:53:59,120 >> CAN YOU HEAR ME NOW? 6150 03:53:59,120 --> 03:54:01,360 >> YEP. 6151 03:54:01,360 --> 03:54:04,120 >> OKAY. 6152 03:54:04,120 --> 03:54:14,640 I NEED THE SHARE ABILITY, SORRY. 6153 03:54:25,680 --> 03:54:27,480 >> LOOKING GOOD. 6154 03:54:27,480 --> 03:54:29,240 >> LOOKS GREAT. 6155 03:54:29,240 --> 03:54:29,640 >> OKAY, GREAT. 6156 03:54:29,640 --> 03:54:30,480 GOOD AFTERNOON, EVERYONE. 6157 03:54:30,480 --> 03:54:33,040 I'M HAPPY TO BE HERE TO TALK 6158 03:54:33,040 --> 03:54:34,880 ABOUT SOMETHING I ABSOLUTELY 6159 03:54:34,880 --> 03:54:39,040 LOVE, I'VE BEEN ABLE TO BLEND 6160 03:54:39,040 --> 03:54:40,360 BACKGROUND IN NUTRITION ALONG 6161 03:54:40,360 --> 03:54:41,360 WITH LIBRARY SCIENCE HAVING 6162 03:54:41,360 --> 03:54:42,960 WORKED IN A FEW LIBRARIES OVER 6163 03:54:42,960 --> 03:54:45,680 THE COURSE OF MY CAREER AS WELL 6164 03:54:45,680 --> 03:54:46,600 AS TECHNOLOGY. 6165 03:54:46,600 --> 03:54:48,360 SOME OF THESE YOU PROBABLY WILL 6166 03:54:48,360 --> 03:54:49,800 KNOW A LOT ABOUT, OTHERS I'M 6167 03:54:49,800 --> 03:54:52,600 HOPING I WILL BE ABLE TO GIVE 6168 03:54:52,600 --> 03:54:54,920 YOU ONE PIECE OF NEW INFORMATION 6169 03:54:54,920 --> 03:54:58,400 TO LOOK FOR ANSWERS OR TRY TO 6170 03:54:58,400 --> 03:55:01,400 FURTHER FIND RESEARCH ON DIETARY 6171 03:55:01,400 --> 03:55:03,080 SUPPLEMENTS. 6172 03:55:03,080 --> 03:55:04,320 SO, WHERE WE'RE GOING TODAY. 6173 03:55:04,320 --> 03:55:10,200 WE'RE GOING TO LOOK AT WHERE TO 6174 03:55:10,200 --> 03:55:13,040 FIND BIBLIOGRAPHIC LITERATURE, 6175 03:55:13,040 --> 03:55:13,600 PUBLISHED RESEARCH, THINGS 6176 03:55:13,600 --> 03:55:16,160 ONGOING, ALSO A VARIETY OF 6177 03:55:16,160 --> 03:55:18,960 DATABASES THAT HAVE INGREDIENTS, 6178 03:55:18,960 --> 03:55:21,080 METHODS, LABELS, NUTRIENTS, SO 6179 03:55:21,080 --> 03:55:22,800 MUCH OUT THERE WHICH YOU ALREADY 6180 03:55:22,800 --> 03:55:24,080 HAVE MAYBE SEEN. 6181 03:55:24,080 --> 03:55:27,400 AND THEN A VARIETY OF RESOURCES 6182 03:55:27,400 --> 03:55:29,040 AND MONOGRAPHS AND FACTSHEETS 6183 03:55:29,040 --> 03:55:30,120 AND EVIDENCE REPORTS. 6184 03:55:30,120 --> 03:55:32,000 SO IF YOU'RE LOOKING FOR 6185 03:55:32,000 --> 03:55:32,640 SOMEBODY THAT'S ALREADY DONE THE 6186 03:55:32,640 --> 03:55:34,480 WORK FOR YOU AND LOOKED AT 6187 03:55:34,480 --> 03:55:35,400 EVERYTHING, THIS IS A GREAT 6188 03:55:35,400 --> 03:55:38,080 PLACE THAT YOU DON'T HAVE TO 6189 03:55:38,080 --> 03:55:39,640 RECREATE THE WHEEL. 6190 03:55:39,640 --> 03:55:41,400 ALSO A LITTLE BIT ABOUT A COUPLE 6191 03:55:41,400 --> 03:55:43,320 PLACES YOU CAN GET ALERTS, 6192 03:55:43,320 --> 03:55:44,920 THINGS PUSHED TO YOUR E-MAIL 6193 03:55:44,920 --> 03:55:51,840 ABOUT NEW STUFF COMING OUT. 6194 03:55:51,840 --> 03:55:53,560 SO, FIRST OF ALL, I WOULD ASSUME 6195 03:55:53,560 --> 03:55:56,160 AND HOPE MOST OF YOU HAVE HEARD 6196 03:55:56,160 --> 03:55:58,920 OF PubMed AND MEDLINE 6197 03:55:58,920 --> 03:56:01,200 THROUGH THE NATIONAL LIBRARY OF 6198 03:56:01,200 --> 03:56:02,840 MEDICINE AT THE INSTITUTES OF 6199 03:56:02,840 --> 03:56:03,040 HEALTH. 6200 03:56:03,040 --> 03:56:09,880 BUT WE'RE ALSO GOING TO LOOK AT 6201 03:56:09,880 --> 03:56:18,400 ACRI COLA, AND AGRIS, THERE'S 6202 03:56:18,400 --> 03:56:24,080 DATABASES OR COLLABORATORS OR 6203 03:56:24,080 --> 03:56:30,480 COORDINATORS, WAYS ARTICLES ARE 6204 03:56:30,480 --> 03:56:34,120 INDEXED AND MADE AVAILABLE. 6205 03:56:34,120 --> 03:56:34,920 BIBLIOGRAPHIC SEARCHING, LOOKING 6206 03:56:34,920 --> 03:56:37,440 FOR ARTICLES, FOR THE PIECE OF 6207 03:56:37,440 --> 03:56:39,400 RESEARCH TO BACK UP IS AN ART. 6208 03:56:39,400 --> 03:56:42,520 THERE'S NO ONE WAY TO DO IT. 6209 03:56:42,520 --> 03:56:45,080 YOU CAN GET A BUNCH OF STUFF, 6210 03:56:45,080 --> 03:56:47,000 SOME MIGHT NOT BE VERY RELEVANT, 6211 03:56:47,000 --> 03:56:49,000 IF YOU WANT TO SEE EVERYTHING, 6212 03:56:49,000 --> 03:56:54,160 SENSITIVITY, OR IF YOU WANT TO 6213 03:56:54,160 --> 03:56:57,760 JUST LOOK FOR SOMETHING THAT'S 6214 03:56:57,760 --> 03:56:58,760 SPECIFIC, TINY PIECE, YOU HAVE 6215 03:56:58,760 --> 03:57:01,080 THE RISK OF MISSING SOMETHING. 6216 03:57:01,080 --> 03:57:02,440 MULTIPLE DATABASES, MULTIPLE 6217 03:57:02,440 --> 03:57:05,400 WAYS OF LOOKING AT THINGS, 6218 03:57:05,400 --> 03:57:10,960 MULTIPLE SEARCH STRINGS, A WAY I 6219 03:57:10,960 --> 03:57:15,320 APPROACH LITERATURE SEARCHING. 6220 03:57:15,320 --> 03:57:20,760 THESE ARE ALL PARTS OF THE NLM, 6221 03:57:20,760 --> 03:57:23,040 NATIONAL LIBRARY OF MEDICINE. 6222 03:57:23,040 --> 03:57:25,880 PubMed AND MEDLINE ARE 6223 03:57:25,880 --> 03:57:26,120 SIMILAR. 6224 03:57:26,120 --> 03:57:27,760 A KEY DIFFERENCE, MEDLINE 6225 03:57:27,760 --> 03:57:28,600 ARTICLES ARE INDEXED. 6226 03:57:28,600 --> 03:57:30,480 THAT EITHER A HUMAN OR MACHINE 6227 03:57:30,480 --> 03:57:33,120 HAS GONE THROUGH AND ASSIGNED 6228 03:57:33,120 --> 03:57:34,640 TOPIC AND INDEX WORDS SO IT'S 6229 03:57:34,640 --> 03:57:37,160 EASIER TO FIND THEM WHEN YOU'RE 6230 03:57:37,160 --> 03:57:37,760 SEARCHING. 6231 03:57:37,760 --> 03:57:41,000 A FEW MORE MILLION CITATIONS 6232 03:57:41,000 --> 03:57:42,840 THAN PubMed THAN IN MEDLINE, 6233 03:57:42,840 --> 03:57:47,320 33 MILLION CITATIONS RIGHT NOW 6234 03:57:47,320 --> 03:57:48,520 IN PubMed. 6235 03:57:48,520 --> 03:57:52,240 WE'LL LOOK MORE AT MEDLINE AND 6236 03:57:52,240 --> 03:57:54,520 PubMed COMING UP BUT 6237 03:57:54,520 --> 03:57:56,320 PubMed CENTRAL, PMC, YOU CAN 6238 03:57:56,320 --> 03:57:57,400 GET FULL TEXT. 6239 03:57:57,400 --> 03:57:59,800 YOU MAYBE HAD THE EXPERIENCE TO 6240 03:57:59,800 --> 03:58:01,880 CLICK ON FULL TEXT BUT GO TO THE 6241 03:58:01,880 --> 03:58:03,960 ARTICLE AND FIND YOU DON'T HAVE 6242 03:58:03,960 --> 03:58:06,280 ACCESS BECAUSE YOU NEED A 6243 03:58:06,280 --> 03:58:07,280 SUBSCRIPTION OR THROUGH YOUR 6244 03:58:07,280 --> 03:58:08,920 LIBRARY OR YOU HAVE TO PAY A FEE 6245 03:58:08,920 --> 03:58:11,520 TO GET THE ARTICLE. 6246 03:58:11,520 --> 03:58:12,920 HOWEVER, PUBMED CENTRAL IS FULL 6247 03:58:12,920 --> 03:58:13,720 TEXT. 6248 03:58:13,720 --> 03:58:15,880 A LOT OF THAT IS REQUIRED FOR 6249 03:58:15,880 --> 03:58:19,040 ARTICLES THAT HAVE SOME FUNDING 6250 03:58:19,040 --> 03:58:20,560 FROM NIH OR FROM GOVERNMENT 6251 03:58:20,560 --> 03:58:21,080 ENTITIES. 6252 03:58:21,080 --> 03:58:22,760 OTHER ARTICLES CAN BE IN THERE 6253 03:58:22,760 --> 03:58:23,440 AS WELL. 6254 03:58:23,440 --> 03:58:24,960 AUTHORS CAN SUBMIT THEM TO 6255 03:58:24,960 --> 03:58:27,360 PUBLIC METH CENTRAL. 6256 03:58:27,360 --> 03:58:29,000 SO THERE YOU CAN GET FREE TEXT, 6257 03:58:29,000 --> 03:58:30,880 WHICH IS GREAT. 6258 03:58:30,880 --> 03:58:32,960 THERE'S ALSO A BOOKSHELF WHERE 6259 03:58:32,960 --> 03:58:35,160 THINGS LIKE THE DIETARY 6260 03:58:35,160 --> 03:58:36,640 REFERENCE INTAKE DOCUMENTS ARE 6261 03:58:36,640 --> 03:58:37,040 PUT. 6262 03:58:37,040 --> 03:58:38,600 I'LL SHOW YOU ANOTHER BOOK A 6263 03:58:38,600 --> 03:58:40,000 LITTLE BIT LATER THAT'S USEFUL, 6264 03:58:40,000 --> 03:58:41,800 THAT'S IN THE BOOKSHELF. 6265 03:58:41,800 --> 03:58:44,360 THERE'S LOTS OF PIECES TO THE 6266 03:58:44,360 --> 03:58:46,040 NATIONAL LIBRARY OF MEDICINE, 6267 03:58:46,040 --> 03:58:52,000 ALL UNDER AUSPICES OF 6268 03:58:52,000 --> 03:58:52,720 PubMed, MEDLINE GROUP. 6269 03:58:52,720 --> 03:58:54,680 WE USED TO HAVE SOMETHING VERY 6270 03:58:54,680 --> 03:58:54,920 USEFUL. 6271 03:58:54,920 --> 03:58:56,680 I WANT TO POINT THIS OUT, THIS 6272 03:58:56,680 --> 03:58:57,880 CHANGED THIS YEAR. 6273 03:58:57,880 --> 03:58:58,880 THERE'S SOMETHING CALLED FILTERS 6274 03:58:58,880 --> 03:59:00,400 WHERE YOU CAN FILTER WHAT YOU'RE 6275 03:59:00,400 --> 03:59:02,280 SEARCHING FOR BY THINGS LIKE 6276 03:59:02,280 --> 03:59:04,760 DATE AND LANGUAGE, AND HUMAN OR 6277 03:59:04,760 --> 03:59:06,960 NON-HUMAN, HUMAN OR MONKEY, OR 6278 03:59:06,960 --> 03:59:07,240 SOMETHING. 6279 03:59:07,240 --> 03:59:07,600 OR RAT. 6280 03:59:07,600 --> 03:59:09,480 BUT WE USED TO HAVE SOMETHING 6281 03:59:09,480 --> 03:59:12,200 CALLED FILTERS WHERE WE ACTUALLY 6282 03:59:12,200 --> 03:59:14,840 HAD A DIETARY SUPPLEMENT FILTER, 6283 03:59:14,840 --> 03:59:17,200 CREATED IN COORDINATION WITH THE 6284 03:59:17,200 --> 03:59:18,640 OFFICE OF DIETARY SUPPLEMENTS. 6285 03:59:18,640 --> 03:59:22,000 THERE WAS ALSO A COMPLEMENTARY 6286 03:59:22,000 --> 03:59:23,280 MEDICINE SUBJECT, CAM, DONE WITH 6287 03:59:23,280 --> 03:59:25,680 THE NATIONAL CENTER FOR 6288 03:59:25,680 --> 03:59:27,040 COMPLEMENTARY AROUND INTEGRATIVE 6289 03:59:27,040 --> 03:59:27,760 HEALTH, NCCIH. 6290 03:59:27,760 --> 03:59:29,840 BOTH OF THOSE HAVE GONE AWAY, 6291 03:59:29,840 --> 03:59:31,560 WHICH IS KIND OF SAD. 6292 03:59:31,560 --> 03:59:33,440 I WILL ALSO SHOW YOU THOUGH 6293 03:59:33,440 --> 03:59:36,720 HOWEVER IF YOU WANT THE SEARCH 6294 03:59:36,720 --> 03:59:38,120 STRATEGY OR STRING OR WAY TO 6295 03:59:38,120 --> 03:59:44,000 SEARCH WHAT WE USED T USE WITH 6296 03:59:44,000 --> 03:59:45,400 DIETARY SUPPLEMENTS THERE'S A 6297 03:59:45,400 --> 03:59:46,920 LINK STILL ON THE PAGE. 6298 03:59:46,920 --> 03:59:49,560 YOU COULD ACTUALLY TAKE THIS 6299 03:59:49,560 --> 03:59:51,120 SEARCH STRATEGY, HUGE ASS, IT 6300 03:59:51,120 --> 03:59:52,600 YOU COULD SPEAK IT FOR WHAT YOU 6301 03:59:52,600 --> 03:59:55,240 NEED AND THROW IT INTO 6302 03:59:55,240 --> 03:59:56,360 PubMed. 6303 03:59:56,360 --> 03:59:57,240 IT'S NO LONGER UPDATED, LAST 6304 03:59:57,240 --> 03:59:59,640 TIME IT WAS UPDATED WAS IN MARCH 6305 03:59:59,640 --> 04:00:01,440 BUT SO THIS ACTUAL STRATEGY IS 6306 04:00:01,440 --> 04:00:02,040 STILL THERE. 6307 04:00:02,040 --> 04:00:04,800 HOWEVER, YOU'RE NOT ABLE TO 6308 04:00:04,800 --> 04:00:10,240 APPLY IT FROM THE MAIN 6309 04:00:10,240 --> 04:00:11,760 PubMed PAGE ANYMORE. 6310 04:00:11,760 --> 04:00:14,920 WHAT YOU USED TO FIND UNDER 6311 04:00:14,920 --> 04:00:15,720 SUBJECT IS GONE. 6312 04:00:15,720 --> 04:00:21,000 WHICH WAS A NEW FEATURE THIS 6313 04:00:21,000 --> 04:00:21,680 YEAR, UNFORTUNATELY. 6314 04:00:21,680 --> 04:00:26,560 BUT I'LL SHOW YOU SOMETHING THAT 6315 04:00:26,560 --> 04:00:29,200 NCCIH HAS DONE TO MAKE IT 6316 04:00:29,200 --> 04:00:29,440 REPLACED. 6317 04:00:29,440 --> 04:00:30,840 WITH SEARCHING, IF YOU DON'T 6318 04:00:30,840 --> 04:00:34,560 HAVE OUR FILTER YOU CAN USE THE 6319 04:00:34,560 --> 04:00:37,080 MeSH HEADING, MEDICAL SUBJECT 6320 04:00:37,080 --> 04:00:37,320 HEADING. 6321 04:00:37,320 --> 04:00:38,920 THERE'S ONE FOR DIETARY 6322 04:00:38,920 --> 04:00:42,960 SUPPLEMENTS WHICH BASED ON 6323 04:00:42,960 --> 04:00:44,320 INDEXING OF THE MEDLINE RECORD 6324 04:00:44,320 --> 04:00:47,240 PULLS OUT RECORDS WITH THAT 6325 04:00:47,240 --> 04:00:48,120 PARTICULAR TOPIC. 6326 04:00:48,120 --> 04:00:52,920 AND IT'S VERY EASY TO DO. 6327 04:00:52,920 --> 04:00:56,240 THIS GIVES YOU THE DETAILS OF 6328 04:00:56,240 --> 04:00:57,640 WHAT THE MeSH ENCOMPASSES, SO 6329 04:00:57,640 --> 04:01:00,280 IF YOU WERE TO PUT ANY TERMS 6330 04:01:00,280 --> 04:01:03,240 INTO YOUR SEARCH BOX IN 6331 04:01:03,240 --> 04:01:05,640 PubMed, IT WOULD DEFER TO 6332 04:01:05,640 --> 04:01:06,960 THIS PARTICULAR SUBJECT HEADING. 6333 04:01:06,960 --> 04:01:09,480 IT'S VERY EASY JUST TO ADD IT UP 6334 04:01:09,480 --> 04:01:11,520 INTO HERE, YOU ADD IT TO YOUR 6335 04:01:11,520 --> 04:01:13,040 SEARCH BUILDER, IT THROWS IT IN, 6336 04:01:13,040 --> 04:01:18,120 OR YOU CAN USE THE CODING 6337 04:01:18,120 --> 04:01:18,760 YOURSELF. 6338 04:01:18,760 --> 04:01:26,040 AND TAKE IT TO PubMed. 6339 04:01:26,040 --> 04:01:28,720 LET'S THROW THAT IN. 6340 04:01:28,720 --> 04:01:32,880 IT WILL APPLY THAT PARTICULAR 6341 04:01:32,880 --> 04:01:34,640 MeSH HEADING AND BINGO, GIVE 6342 04:01:34,640 --> 04:01:37,040 YOU A LIST OF ARTICLES YOU CAN 6343 04:01:37,040 --> 04:01:39,760 GO THROUGH OR FURTHER REFINE BY 6344 04:01:39,760 --> 04:01:44,680 DATE OR IF YOU WANT SYSTEMATIC 6345 04:01:44,680 --> 04:01:47,120 REVIEW OR A RANDOMIZED 6346 04:01:47,120 --> 04:01:48,640 CONTROLLED TRIAL, BUT MeSH 6347 04:01:48,640 --> 04:01:49,600 HEADINGS ARE THE THINGS TO BE 6348 04:01:49,600 --> 04:01:51,720 USING NOW SINCE WE DON'T HAVE 6349 04:01:51,720 --> 04:01:52,680 OUR FILTER ANYMORE. 6350 04:01:52,680 --> 04:01:55,320 THERE ARE ALSO MeSH HEADINGS 6351 04:01:55,320 --> 04:01:57,400 FOR CHINESE HERBAL DRUGS, HERBAL 6352 04:01:57,400 --> 04:01:58,280 MEDICINE, PROBIOTICS. 6353 04:01:58,280 --> 04:02:01,280 YOU CAN ALSO PUT IN ALL THE 6354 04:02:01,280 --> 04:02:04,040 INDIVIDUAL NUTRIENTS, SAY 6355 04:02:04,040 --> 04:02:06,280 VITAMIN D OR IRON OR ZINC AND GO 6356 04:02:06,280 --> 04:02:07,440 FROM THERE BECAUSE THERE ARE 6357 04:02:07,440 --> 04:02:08,440 MeSH HEADINGS FOR EACH OF 6358 04:02:08,440 --> 04:02:09,640 THOSE AS WELL. 6359 04:02:09,640 --> 04:02:16,880 IT HELPS AND MAKES THE SEARCHING 6360 04:02:16,880 --> 04:02:17,440 MUCH EASIER. 6361 04:02:17,440 --> 04:02:20,360 THIS IS A NEWER FEATURE IN 6362 04:02:20,360 --> 04:02:21,000 PubMed CALLED CLINICAL 6363 04:02:21,000 --> 04:02:24,080 QUERIES, WHERE THEY HAVE PUT 6364 04:02:24,080 --> 04:02:26,720 FILTERS IN FOR YOU, AND THEY MAY 6365 04:02:26,720 --> 04:02:28,000 NOT NECESSARILY BE SPECIFIC TO 6366 04:02:28,000 --> 04:02:29,960 DIETARY SUPPLEMENTS BUT MAY BE 6367 04:02:29,960 --> 04:02:32,440 OF INTEREST. 6368 04:02:32,440 --> 04:02:34,360 IT'S CALLED CLINICAL QUERIES. 6369 04:02:34,360 --> 04:02:38,520 AND YOU CAN DO IT BY CLINICAL 6370 04:02:38,520 --> 04:02:39,760 STUDIES OR COVID-19 BEING THAT'S 6371 04:02:39,760 --> 04:02:41,400 OF GREAT INTEREST THESE DAYS. 6372 04:02:41,400 --> 04:02:46,440 YOU CAN ALSO DO IT BY DIAGNOSES, 6373 04:02:46,440 --> 04:02:47,720 ETIOLOGY, PROGNOSIS, A BROAD 6374 04:02:47,720 --> 04:02:55,360 VERSUS NARROW, AGAIN YOU CAN PUT 6375 04:02:55,360 --> 04:03:00,080 IN -- I'M RANDOMLY PICKING 6376 04:03:00,080 --> 04:03:02,960 GINGKO, I HAVE NO PARTICULAR 6377 04:03:02,960 --> 04:03:03,560 INTEREST, A CAVEAT. 6378 04:03:03,560 --> 04:03:06,560 IT WILL GIVE A SET OF STUDIES 6379 04:03:06,560 --> 04:03:10,040 AND TAKE YOU THEN, RIGHT BACK 6380 04:03:10,040 --> 04:03:11,400 INTO PubMed AND DO MORE 6381 04:03:11,400 --> 04:03:13,120 REFINING IF YOU WANT. 6382 04:03:13,120 --> 04:03:14,840 IT'S ANOTHER WAY TO START 6383 04:03:14,840 --> 04:03:17,520 NARROWING OR GETTING AT WHAT 6384 04:03:17,520 --> 04:03:23,960 YOU'RE LOOKING FOR. 6385 04:03:23,960 --> 04:03:26,280 OH THE BOOKSHELF, LOTS OF BOOKS. 6386 04:03:26,280 --> 04:03:27,560 AS I SAID DIETARY REFERENCE 6387 04:03:27,560 --> 04:03:29,720 INTAKE BOOKS AS WELL AS LOTS OF 6388 04:03:29,720 --> 04:03:30,200 OTHERS. 6389 04:03:30,200 --> 04:03:33,680 BUT I FOUND THIS ONE OF 6390 04:03:33,680 --> 04:03:35,960 PARTICULAR USE. 6391 04:03:35,960 --> 04:03:37,280 IT'S SPECIFICALLY TO LACTATION 6392 04:03:37,280 --> 04:03:37,960 AND DRUGS. 6393 04:03:37,960 --> 04:03:40,000 HOWEVER, IF YOU LOOK AS I DID 6394 04:03:40,000 --> 04:03:41,680 THROUGH THIS LIST OF WHAT THEY 6395 04:03:41,680 --> 04:03:42,760 CALL DRUGS, YOU'RE GOING TO FIND 6396 04:03:42,760 --> 04:03:47,600 A LOT OF THINGS THAT MIGHT BE 6397 04:03:47,600 --> 04:03:49,520 CONSIDERED A DIETARY SUPPLEMENT 6398 04:03:49,520 --> 04:03:51,960 OR HERBAL. 6399 04:03:51,960 --> 04:03:55,040 LET'S SEE. 6400 04:03:55,040 --> 04:03:57,360 I'LL PICK ONE. 6401 04:03:57,360 --> 04:03:59,680 I'LL GO TO GINGKO. 6402 04:03:59,680 --> 04:04:05,160 THERE'S GINGKO. 6403 04:04:05,160 --> 04:04:07,840 WHAT IT DOES, SUMMARIZES USE 6404 04:04:07,840 --> 04:04:09,880 DURING LACTATION, AND TALKS 6405 04:04:09,880 --> 04:04:11,640 ABOUT -- GIVE REFERENCES, IT'S A 6406 04:04:11,640 --> 04:04:13,160 PLACE TO LOOK FOR MORE 6407 04:04:13,160 --> 04:04:16,440 INFORMATION THAT'S BEEN WRITTEN 6408 04:04:16,440 --> 04:04:22,440 UP ABOUT A SPECIFIC INGREDIENT. 6409 04:04:22,440 --> 04:04:25,040 THAT'S AVAILABLE THROUGH THE 6410 04:04:25,040 --> 04:04:27,640 BOOKSHELF AT PubMed OR -- 6411 04:04:27,640 --> 04:04:31,360 YEAH. 6412 04:04:31,360 --> 04:04:34,360 THE OTHER THING I FOUND REALLY 6413 04:04:34,360 --> 04:04:37,160 USEFUL, AND THIS KIND OF 6414 04:04:37,160 --> 04:04:40,160 REPLACES THE CAM OR 6415 04:04:40,160 --> 04:04:42,360 COMPLEMENTARY MEDICINE FILTER, 6416 04:04:42,360 --> 04:04:48,960 THESE ARE PRE-FORMATTED FILTERS 6417 04:04:48,960 --> 04:04:52,560 FROM NCCIH THAT PULLS TOGETHER 6418 04:04:52,560 --> 04:04:56,640 SPECIFIC INGREDIENTS IN 6419 04:04:56,640 --> 04:04:57,240 SYSTEMATIC REVIEW SEARCH, RCT, 6420 04:04:57,240 --> 04:05:01,640 RANDOMIZED CONTROLLED TRIAL OR 6421 04:05:01,640 --> 04:05:04,160 HERB-DRUG INTERACTION SEARCH, 6422 04:05:04,160 --> 04:05:06,360 YOU CAN CHANGE THAT AS YOU'RE 6423 04:05:06,360 --> 04:05:16,880 SEARCHING, LET ME GO TO THAT. 6424 04:05:17,800 --> 04:05:18,760 EVIDENCE-BASED LITERATURE 6425 04:05:18,760 --> 04:05:21,560 REVIEW, YOU CAN SEE ACAI, YOU 6426 04:05:21,560 --> 04:05:23,400 CAN SEE WHAT IT GIVES YOU. 6427 04:05:23,400 --> 04:05:26,040 IT TAKES YOU TO PubMed, 6428 04:05:26,040 --> 04:05:29,000 WHICH IS GREAT. 6429 04:05:29,000 --> 04:05:31,880 YOU CAN ALSO SEARCH FURTHER OR 6430 04:05:31,880 --> 04:05:34,040 BREAK IT DOWN, 13 RESULTS ARE 6431 04:05:34,040 --> 04:05:36,880 NOT HARD TO TAKE A LOOK AT. 6432 04:05:36,880 --> 04:05:38,200 AGAIN, REMEMBER IT DOESN'T OF 6433 04:05:38,200 --> 04:05:39,000 GOES BACK FIVE YEARS. 6434 04:05:39,000 --> 04:05:40,680 IF YOU WANT TO GO FURTHER BACK 6435 04:05:40,680 --> 04:05:42,200 YOU HAVE TO DO ADJUSTING. 6436 04:05:42,200 --> 04:05:46,960 THIS IS A REALLY NICE FEATURE 6437 04:05:46,960 --> 04:05:50,680 THAT USES PubMed THANKS TO 6438 04:05:50,680 --> 04:05:52,320 NCCIH. 6439 04:05:52,320 --> 04:06:00,640 6440 04:06:00,640 --> 04:06:03,120 AGRICOLA, SIMILAR TO PubMed, 6441 04:06:03,120 --> 04:06:04,800 ARTICLES, REFERENCES, RESOURCES, 6442 04:06:04,800 --> 04:06:06,840 THE THING IS YOU MIGHT GET MORE 6443 04:06:06,840 --> 04:06:08,280 OF THE PLANT SCIENCE, MORE OF 6444 04:06:08,280 --> 04:06:10,800 THE GROWING OF THE HERBS, BUT 6445 04:06:10,800 --> 04:06:12,520 USDA DOES DEAL WITH FOOD AND 6446 04:06:12,520 --> 04:06:12,800 NUTRITION. 6447 04:06:12,800 --> 04:06:16,520 SO YOU'RE GOING TO FIND A LOT OF 6448 04:06:16,520 --> 04:06:19,480 OVERLAP BETWEEN PubMed AND 6449 04:06:19,480 --> 04:06:21,360 ACRICOLA BUT MAY FIND MORE OF 6450 04:06:21,360 --> 04:06:23,400 THE GROWING, AND THAT TYPE OF 6451 04:06:23,400 --> 04:06:25,480 USEFUL INFORMATION IN THIS 6452 04:06:25,480 --> 04:06:26,560 PARTICULAR DATABASE. 6453 04:06:26,560 --> 04:06:35,160 AGAIN, FREE AND OPEN, AT THE 6454 04:06:35,160 --> 04:06:36,240 USDA NATIONAL AGRICULTURAL 6455 04:06:36,240 --> 04:06:36,440 LIBRARY. 6456 04:06:36,440 --> 04:06:38,200 IT HAS PRINTED WORK TO THE 6457 04:06:38,200 --> 04:06:39,120 15th CENTURY, A BEAUTIFUL 6458 04:06:39,120 --> 04:06:40,840 COLLECTION OF SOME OF THE 6459 04:06:40,840 --> 04:06:44,560 ORIGINAL TURN OF THE CENTURY 6460 04:06:44,560 --> 04:06:53,120 1900s DRAWINGS OF THE PLANTS, 6461 04:06:53,120 --> 04:06:55,360 VERY, VERY INTERESTING CONTENT. 6462 04:06:55,360 --> 04:06:56,480 EASY TO USE INTERFACE. 6463 04:06:56,480 --> 04:06:58,040 I WON'T SHOW THAT BUT IT'S EASY 6464 04:06:58,040 --> 04:06:59,360 TO USE. 6465 04:06:59,360 --> 04:07:01,280 YOU CAN ALWAYS CONTACT THE 6466 04:07:01,280 --> 04:07:03,120 LIBRARIANS AT THE NATIONAL 6467 04:07:03,120 --> 04:07:04,800 AGRICULTURAL LIBRARY AS WELL, AS 6468 04:07:04,800 --> 04:07:07,000 WELL AS CONTACT LIBRARIANS AT 6469 04:07:07,000 --> 04:07:08,320 THE NATIONAL LIBRARY OF MEDICINE 6470 04:07:08,320 --> 04:07:10,000 IF YOU'RE HAVING ISSUES OR HAVE 6471 04:07:10,000 --> 04:07:18,160 SPECIFIC QUESTIONS. 6472 04:07:18,160 --> 04:07:18,280 6473 04:07:18,280 --> 04:07:21,440 AGRIS IS INTERNATIONAL THROUGH 6474 04:07:21,440 --> 04:07:24,440 FAO PART OF THE UNITED NATIONS, 6475 04:07:24,440 --> 04:07:28,000 NOT AS BIG OR ROBUST BUT HAS 6476 04:07:28,000 --> 04:07:29,200 MORE THAN 13 MILLION RECORDS, 6477 04:07:29,200 --> 04:07:31,720 THE NICE THING ABOUT AGRIS THAT 6478 04:07:31,720 --> 04:07:32,960 SOME OTHER DATABASES DON'T 6479 04:07:32,960 --> 04:07:34,760 CAPTURE IS THAT IT GETS 6480 04:07:34,760 --> 04:07:36,440 SOMETHING CALLED GRAY 6481 04:07:36,440 --> 04:07:37,400 LITERATURE. 6482 04:07:37,400 --> 04:07:43,400 YOU MIGHT FIND DISSERTATIONS, 6483 04:07:43,400 --> 04:07:45,000 OTHER DATASETS THERE. 6484 04:07:45,000 --> 04:07:48,080 EASY TO USE INTERFACE FOR 6485 04:07:48,080 --> 04:07:48,640 SEARCHING. 6486 04:07:48,640 --> 04:07:49,800 INTERESTING AND USEFUL, I WOULD 6487 04:07:49,800 --> 04:07:51,960 FIND A THESIS SOMEBODY HAD DONE 6488 04:07:51,960 --> 04:07:54,120 LOADED INTO THIS DATABASE. 6489 04:07:54,120 --> 04:07:56,760 THAT MAYBE HADN'T MADE IT TO 6490 04:07:56,760 --> 04:08:00,040 PUBLICATION YET. 6491 04:08:00,040 --> 04:08:03,760 I WILL PUT IN JUST ONE LITTLE 6492 04:08:03,760 --> 04:08:05,280 PLUG FOR DR. GOOGLE BECAUSE 6493 04:08:05,280 --> 04:08:08,200 GOOGLE SCHOLAR ALSO IS A WAY TO 6494 04:08:08,200 --> 04:08:11,400 START AS A VERY BROAD SEARCH OF 6495 04:08:11,400 --> 04:08:13,040 A TOPIC THAT THEN OFTEN TAKES 6496 04:08:13,040 --> 04:08:14,880 YOU RIGHT TO PubMed OR 6497 04:08:14,880 --> 04:08:18,720 DIRECTLY TO THE JOURNAL FOR THE 6498 04:08:18,720 --> 04:08:19,960 ARTICLE, SO, AGAIN, SEARCHING IS 6499 04:08:19,960 --> 04:08:20,680 AN ART. 6500 04:08:20,680 --> 04:08:24,680 YOU WANT TO USE MULTIPLE WAYS TO 6501 04:08:24,680 --> 04:08:26,320 TRY TO FIND JUST THE RIGHT 6502 04:08:26,320 --> 04:08:30,920 ARTICLES. 6503 04:08:30,920 --> 04:08:32,760 6504 04:08:32,760 --> 04:08:35,360 GOING ON, THIS IS -- THIS 6505 04:08:35,360 --> 04:08:36,600 CATEGORY IS MORE DATABASES THAT 6506 04:08:36,600 --> 04:08:37,160 ARE ONGOING, AND THERE'S A 6507 04:08:37,160 --> 04:08:38,680 NUMBER OF THEM THAT HAVE A 6508 04:08:38,680 --> 04:08:40,400 RECORD OF WHAT'S BEING DONE SO 6509 04:08:40,400 --> 04:08:41,840 IT'S NOT NECESSARILY BEEN 6510 04:08:41,840 --> 04:08:42,560 PUBLISHED YET. 6511 04:08:42,560 --> 04:08:43,680 YOU WON'T FIND IT. 6512 04:08:43,680 --> 04:08:45,920 IT DOES HAVE ACCESS TO SOME 6513 04:08:45,920 --> 04:08:47,240 PUBLICATIONS THAT HAVE RESULTED 6514 04:08:47,240 --> 04:08:48,240 IN SOME OF THESE. 6515 04:08:48,240 --> 04:08:49,800 WHO IS DOING IT? 6516 04:08:49,800 --> 04:08:52,040 WHO IS FUNDING IT? 6517 04:08:52,040 --> 04:08:53,120 WHAT'S IT ENTAIL? 6518 04:08:53,120 --> 04:08:54,200 WHAT'S THE TIME FRAME? 6519 04:08:54,200 --> 04:08:58,480 THESE ARE ALSO ONLINE AND 6520 04:08:58,480 --> 04:08:59,960 ACCESSIBLE TO THE PUBLIC. 6521 04:08:59,960 --> 04:09:02,040 NIH REPORTER IS THE MAIN PLACE 6522 04:09:02,040 --> 04:09:04,240 WHERE ALL NIH ACTIVITIES FOR 6523 04:09:04,240 --> 04:09:05,480 RESEARCH ARE REPORTED. 6524 04:09:05,480 --> 04:09:08,520 AND IT ALSO INCLUDES SOME OTHER 6525 04:09:08,520 --> 04:09:11,560 ENTITIES BESIDES NIH INCLUDING 6526 04:09:11,560 --> 04:09:15,840 CDC, V.A., A COUPLE OTHERS BACK 6527 04:09:15,840 --> 04:09:17,280 TO 1972 BUT IT'S EVERYTHING THAT 6528 04:09:17,280 --> 04:09:22,320 NIH DOES FROM AIDS TO COVID TO 6529 04:09:22,320 --> 04:09:23,840 MATERNITY TO CHILDREN TO DRUGS 6530 04:09:23,840 --> 04:09:27,120 AND ALCOHOL, AS WELL AS 6531 04:09:27,120 --> 04:09:30,640 NUTRITION SUPPLEMENTS. 6532 04:09:30,640 --> 04:09:34,160 IT'S HUGE. 6533 04:09:34,160 --> 04:09:35,320 EASY INTERFACE, NICE LOOKING. 6534 04:09:35,320 --> 04:09:38,440 BUT WHAT MIGHT BE MORE USEFUL IS 6535 04:09:38,440 --> 04:09:42,240 THAT WE HAVE CREATED THROUGH OUR 6536 04:09:42,240 --> 04:09:43,440 OFFICE SOMETHING CALLED CARDS, 6537 04:09:43,440 --> 04:09:46,160 COMPUTER ACCESS TO RESEARCH ON 6538 04:09:46,160 --> 04:09:48,800 DIETARY SUPPLEMENTS, AND THIS IS 6539 04:09:48,800 --> 04:09:52,200 A DATABASE OF DIETARY SUPPLEMENT 6540 04:09:52,200 --> 04:09:53,720 RESEARCH, SO IT HAS PULLED IN 6541 04:09:53,720 --> 04:09:55,800 FROM NIH REPORTERS AS WELL AS 6542 04:09:55,800 --> 04:09:58,240 OTHER SOURCES JUST THOSE THAT 6543 04:09:58,240 --> 04:09:59,720 ARE RELATED TO DIETARY 6544 04:09:59,720 --> 04:10:00,680 SUPPLEMENTS. 6545 04:10:00,680 --> 04:10:03,120 ALL THE INFORMATION THAT YOU 6546 04:10:03,120 --> 04:10:07,400 NEED, PROJECT, P.I., PRIMARY 6547 04:10:07,400 --> 04:10:08,640 INVESTIGATOR, INGREDIENT, 6548 04:10:08,640 --> 04:10:09,320 OUTCOMES, RESEARCH METHODOLOGY, 6549 04:10:09,320 --> 04:10:12,440 ALL THE WAY BACK FROM 1999. 6550 04:10:12,440 --> 04:10:16,160 THIS IS A GREAT RESOURCE. 6551 04:10:16,160 --> 04:10:18,240 EASY TO USE. 6552 04:10:18,240 --> 04:10:19,640 GOOD LOOKING INTERFACE. 6553 04:10:19,640 --> 04:10:21,840 AND ACTUALLY, OUR MODERATOR OF 6554 04:10:21,840 --> 04:10:24,000 THE SESSION, KAREN REGAN, IS 6555 04:10:24,000 --> 04:10:26,120 DIRECTOR OF CARDS, IF YOU HAVE 6556 04:10:26,120 --> 04:10:27,080 QUESTIONS ABOUT IT SHE WILL BE 6557 04:10:27,080 --> 04:10:31,800 THE RIGHT ONE TO ASK. 6558 04:10:31,800 --> 04:10:34,320 6559 04:10:34,320 --> 04:10:36,520 clinicaltrials.gov, THIS IS A 6560 04:10:36,520 --> 04:10:38,160 GREAT PLACE TO SEE WHAT'S BEING 6561 04:10:38,160 --> 04:10:41,120 DONE WITH CLINICAL TRIALS 6562 04:10:41,120 --> 04:10:41,360 OBVIOUSLY. 6563 04:10:41,360 --> 04:10:43,880 IT IS BOTH INTERNATIONAL AND 6564 04:10:43,880 --> 04:10:46,800 WORLDWIDE, RIGHT NOW THERE'S 6565 04:10:46,800 --> 04:10:49,120 OVER 400,000 TRIALS WITHIN THE 6566 04:10:49,120 --> 04:10:50,000 DATABASE. 6567 04:10:50,000 --> 04:10:52,600 AND THERE ARE QUITE A FEW THAT 6568 04:10:52,600 --> 04:10:54,400 ARE RECRUITING. 6569 04:10:54,400 --> 04:10:56,360 SO, AGAIN, IT'S VERY BROAD, ALL 6570 04:10:56,360 --> 04:10:57,400 DIFFERENT HEALTH CONDITIONS. 6571 04:10:57,400 --> 04:11:00,120 BUT THERE'S A NICE DIETARY 6572 04:11:00,120 --> 04:11:01,480 SUPPLEMENT FEATURE TO IT. 6573 04:11:01,480 --> 04:11:05,440 ON THE SEARCH PAGE, IF YOU GO 6574 04:11:05,440 --> 04:11:08,600 DOWN TO STUDIES BY TOPIC, 6575 04:11:08,600 --> 04:11:11,080 THERE'S ACTUALLY A DIETARY 6576 04:11:11,080 --> 04:11:12,200 SUPPLEMENT TOPIC, A FEW YEARS 6577 04:11:12,200 --> 04:11:14,400 AGO WE PROVIDED THEM A LIST OF 6578 04:11:14,400 --> 04:11:15,360 DIETARY SUPPLEMENTS AND 6579 04:11:15,360 --> 04:11:18,320 INGREDIENTS WHICH THEY THEN 6580 04:11:18,320 --> 04:11:19,280 INCORPORATED INTO THIS. 6581 04:11:19,280 --> 04:11:28,280 LET ME SHOW YOU THAT. 6582 04:11:28,280 --> 04:11:33,120 SO STUDY BY TOPIC DOWN AT THE 6583 04:11:33,120 --> 04:11:33,520 BOTTOM. 6584 04:11:33,520 --> 04:11:34,000 DIETARY SUPPLEMENTS, 6585 04:11:34,000 --> 04:11:34,320 ALPHABETICAL. 6586 04:11:34,320 --> 04:11:36,040 AND WE'LL GO TO MY FAVORITE, 6587 04:11:36,040 --> 04:11:39,240 LET'S SEE IF I CAN -- I WON'T 6588 04:11:39,240 --> 04:11:40,320 JUMP DOWN TO GINGKO. 6589 04:11:40,320 --> 04:11:48,000 BUT HOW ABOUT LET'S GO TO, YEAH, 6590 04:11:48,000 --> 04:11:49,600 ASCORBIC ACID. 6591 04:11:49,600 --> 04:11:53,480 IT GIVES ALL THE STUDIES 6592 04:11:53,480 --> 04:11:54,120 COMPLETED, RECRUITING, STATUS, A 6593 04:11:54,120 --> 04:11:54,680 LOT OF INFORMATION. 6594 04:11:54,680 --> 04:11:57,280 THIS IS A PLACE TO LOOK AT 6595 04:11:57,280 --> 04:11:59,560 WHAT'S CURRENTLY GOING ON, MOST 6596 04:11:59,560 --> 04:12:00,000 RECENTLY COMPLETED. 6597 04:12:00,000 --> 04:12:01,360 IF COMPLETED MORE THAN LIKELY 6598 04:12:01,360 --> 04:12:03,640 YOU'LL FIND ARTICLES THAT HAVE 6599 04:12:03,640 --> 04:12:05,280 BEEN PUBLISHED RELATED TO THAT 6600 04:12:05,280 --> 04:12:15,840 PROJECT, ALSO IN THIS DATABASE. 6601 04:12:21,520 --> 04:12:23,760 ANOTHER CLINICAL TRIAL DATABASE, 6602 04:12:23,760 --> 04:12:25,560 IN NEUROPATHY, PARTNERED WITH 6603 04:12:25,560 --> 04:12:32,160 HRA AND U.K., USED BY W.H.O. AND 6604 04:12:32,160 --> 04:12:33,280 MEDICAL JOURNAL EDITORS. 6605 04:12:33,280 --> 04:12:36,680 IT'S FREE TO USE, SEARCHABLE, 6606 04:12:36,680 --> 04:12:39,000 THERE'S A COST FOR THE 6607 04:12:39,000 --> 04:12:40,640 INVESTIGATORS TO INCLUDE THEIR 6608 04:12:40,640 --> 04:12:43,760 STUDY, AND RIGHT NOW HAS 21,000, 6609 04:12:43,760 --> 04:12:45,360 ALMOST 22,000 RECORDS IN IT. 6610 04:12:45,360 --> 04:12:46,520 ANOTHER PLACE TO LOOK. 6611 04:12:46,520 --> 04:12:49,160 A LOT OF IT IS DUPLICATED WITH 6612 04:12:49,160 --> 04:12:50,040 clinicaltrials.gov BUT YOU 6613 04:12:50,040 --> 04:12:52,320 NEVER KNOW WHAT MIGHT BE 6614 04:12:52,320 --> 04:12:53,920 DIFFERENT. 6615 04:12:53,920 --> 04:13:03,280 IT'S WORTH TAKING A LOOK AT. 6616 04:13:03,280 --> 04:13:05,360 AND USDA CURRENT DATABASE, NOT 6617 04:13:05,360 --> 04:13:09,520 JUST PLANTS AND ANIMALS, ALSO 6618 04:13:09,520 --> 04:13:13,200 HUMAN NUTRITION, CRIS. 6619 04:13:13,200 --> 04:13:14,480 STUDIES IN HUMAN NUTRITION 6620 04:13:14,480 --> 04:13:17,600 RESEARCH AND PLANT GROWING YOU 6621 04:13:17,600 --> 04:13:18,840 WILL FIND IN THEIR DATABASE, 6622 04:13:18,840 --> 04:13:21,800 ANOTHER PLACE TO SEE WHAT'S 6623 04:13:21,800 --> 04:13:23,200 GOING ON. 6624 04:13:23,200 --> 04:13:23,400 OKAY. 6625 04:13:23,400 --> 04:13:25,360 SORRY, A QUICK TOUR OF WHERE 6626 04:13:25,360 --> 04:13:27,880 CURRENT RESEARCH WAS BEING 6627 04:13:27,880 --> 04:13:28,120 REPORTED. 6628 04:13:28,120 --> 04:13:29,640 ALSO A LOOK AT DATABASES THAT 6629 04:13:29,640 --> 04:13:31,920 MIGHT BE AVAILABLE FOR 6630 04:13:31,920 --> 04:13:35,000 NUTRIENTS, INGREDIENTS, METHODS, 6631 04:13:35,000 --> 04:13:35,880 AND LABELS. 6632 04:13:35,880 --> 04:13:42,000 SOME YOU'VE ALREADY HEARD ABOUT. 6633 04:13:42,000 --> 04:13:44,640 JAIME TALKED ABOUT THE AMRM 6634 04:13:44,640 --> 04:13:49,680 PROGRAM, WE DO HAVE A DATABASE 6635 04:13:49,680 --> 04:13:50,640 SEARCHABLE. 6636 04:13:50,640 --> 04:13:52,960 IT'S ON THE AMRM HOME PAGE. 6637 04:13:52,960 --> 04:13:55,240 YOU JUST PUT IN YOUR TOPIC AND 6638 04:13:55,240 --> 04:13:56,560 SEARCH IT. 6639 04:13:56,560 --> 04:13:59,840 I WANT TO SHOW YOU PUBLICATION 6640 04:13:59,840 --> 04:14:00,160 CATEGORIES. 6641 04:14:00,160 --> 04:14:08,800 THERE ARE ARTICLES LISTED UNDER 6642 04:14:08,800 --> 04:14:10,240 METHOD DEVELOPMENT REPORTS, 6643 04:14:10,240 --> 04:14:11,880 VALIDATION REPORTS, YOU'LL FIND 6644 04:14:11,880 --> 04:14:13,080 SOME ARTICLES RELATED TO THOSE. 6645 04:14:13,080 --> 04:14:15,040 SOME OF THESE ARE IN PubMed 6646 04:14:15,040 --> 04:14:15,480 AS WELL. 6647 04:14:15,480 --> 04:14:16,800 SO, AGAIN, THIS IS ANOTHER PLACE 6648 04:14:16,800 --> 04:14:21,760 TO LOOK JUST IN CASE YOU'RE NOT 6649 04:14:21,760 --> 04:14:24,360 THINKING YOU'RE FINDING 6650 04:14:24,360 --> 04:14:30,920 EVERYTHING. 6651 04:14:30,920 --> 04:14:33,040 SO DATA CENTRAL THROUGH USDA 6652 04:14:33,040 --> 04:14:35,320 WHAT WE'RE FAMILIAR WITH WITH 6653 04:14:35,320 --> 04:14:36,720 FOOD COMPOSITION DATA, THEY HAVE 6654 04:14:36,720 --> 04:14:39,360 EXPANDED AND NOW HAVE MORE FOODS 6655 04:14:39,360 --> 04:14:40,920 AND MORE DATABASES INCORPORATED 6656 04:14:40,920 --> 04:14:42,000 INTO IT. 6657 04:14:42,000 --> 04:14:46,040 DOES IT SPECIFICALLY HAVE 6658 04:14:46,040 --> 04:14:47,000 DIETARY SUPPLEMENTS? 6659 04:14:47,000 --> 04:14:48,880 NO, BUT IF YOU'RE LOOKING FOR 6660 04:14:48,880 --> 04:14:50,000 ZINC OR SPECIFIC INGREDIENTS, 6661 04:14:50,000 --> 04:14:52,080 IT'S A GOOD PLACE TO SEARCH. 6662 04:14:52,080 --> 04:14:53,240 I WON'T DEMONSTRATE THAT. 6663 04:14:53,240 --> 04:14:56,640 MY TIME IS GOING REALLY FAST. 6664 04:14:56,640 --> 04:14:59,400 SO I'M GOING TO GIVE A SHAMELESS 6665 04:14:59,400 --> 04:15:05,160 PLUG FOR NEW FEATURE THAT USDA, 6666 04:15:05,160 --> 04:15:06,720 FDA AND ODS HAVE BEEN WORKING 6667 04:15:06,720 --> 04:15:07,520 ON. 6668 04:15:07,520 --> 04:15:08,800 THERE WASN'T INFORMATION ABOUT 6669 04:15:08,800 --> 04:15:10,320 IODINE CONTENT OF FOODS SO WHAT 6670 04:15:10,320 --> 04:15:11,960 WE'VE DONE, WHAT THEY HAVE DONE, 6671 04:15:11,960 --> 04:15:16,120 THEY HAVE DONE SOME BENCH WORK, 6672 04:15:16,120 --> 04:15:17,760 SOME INVESTIGATING, CREATED A 6673 04:15:17,760 --> 04:15:19,320 DATABASE OF IODINE CONTENT IN 6674 04:15:19,320 --> 04:15:20,040 FOODS. 6675 04:15:20,040 --> 04:15:25,000 YOU CAN ACCESS THROUGH FOOD DATA 6676 04:15:25,000 --> 04:15:28,560 CENTRAL OR ACCESS DIRECTLY -- 6677 04:15:28,560 --> 04:15:29,520 OH. 6678 04:15:29,520 --> 04:15:36,680 THERE WE GO. 6679 04:15:36,680 --> 04:15:38,240 IT'S AN EXCEL SHEET SO I'M NOT 6680 04:15:38,240 --> 04:15:40,080 GOING TO DOWNLOAD IT FOR YOU. 6681 04:15:40,080 --> 04:15:44,240 BUT IT'S NICE THAT IT GIVES IT 6682 04:15:44,240 --> 04:15:52,160 IN 100-GRAM AMOUNTS AND COMMON 6683 04:15:52,160 --> 04:15:53,440 HOUSEHOLD AMOUNTS. 6684 04:15:53,440 --> 04:15:53,760 OKAY. 6685 04:15:53,760 --> 04:15:56,400 SO, CHECK OUT THIS NEW IODINE 6686 04:15:56,400 --> 04:15:57,600 CONTENT DATABASE. 6687 04:15:57,600 --> 04:15:59,240 THERE'S ALSO A PUBLICATION ON 6688 04:15:59,240 --> 04:16:01,400 THE DEVELOPMENT OF IT, IF YOU'RE 6689 04:16:01,400 --> 04:16:02,440 INTERESTED IN THAT. 6690 04:16:02,440 --> 04:16:04,120 NOW, ALL THESE THINGS THAT I'M 6691 04:16:04,120 --> 04:16:05,680 SHOWING YOU, YES, THEY ARE ON MY 6692 04:16:05,680 --> 04:16:09,640 SLIDES BUT ON THE AGENDA ON OUR 6693 04:16:09,640 --> 04:16:10,880 PRACTICAL OF PRACTICUM HOME PAGE 6694 04:16:10,880 --> 04:16:13,600 I HAVE A LEADING LIST OF LINKS 6695 04:16:13,600 --> 04:16:15,440 AND MORE ANNOTATED, SO YOU CAN 6696 04:16:15,440 --> 04:16:21,920 FIND THEM AND EASILY LINK USING 6697 04:16:21,920 --> 04:16:22,120 THAT. 6698 04:16:22,120 --> 04:16:22,760 DIETARY SUPPLEMENT INGREDIENT 6699 04:16:22,760 --> 04:16:24,960 DATABASE IS A PARTNERSHIP WITH 6700 04:16:24,960 --> 04:16:27,160 USDA AND ODS BUT WHAT THEY HAVE 6701 04:16:27,160 --> 04:16:28,800 DONE IS BENCH WORK, THEY HAVE 6702 04:16:28,800 --> 04:16:33,000 ACTUALLY TAKEN PRODUCTS OFF THE 6703 04:16:33,000 --> 04:16:38,440 SHELVES, ANALYZED. 6704 04:16:38,440 --> 04:16:40,320 YOU CAN'T LOOK AND SEE HOW MUCH 6705 04:16:40,320 --> 04:16:42,280 IS IN MY CENTRUM OR GENERIC 6706 04:16:42,280 --> 04:16:43,600 VITAMIN AT THE GROCERY STORE BUT 6707 04:16:43,600 --> 04:16:46,240 WHAT IT DOES IS GIVES AN 6708 04:16:46,240 --> 04:16:48,200 ESTIMATE OF THE CONTENT WHICH IS 6709 04:16:48,200 --> 04:16:50,600 THEN USEFUL IN THE SURVEYS THAT 6710 04:16:50,600 --> 04:16:53,440 ARE BEING DONE OF THE POPULATION 6711 04:16:53,440 --> 04:16:53,680 INTAKE. 6712 04:16:53,680 --> 04:16:57,160 THAT'S THE MAIN REASON FOR THAT. 6713 04:16:57,160 --> 04:16:58,600 THEN IT'S PUBLIC DOMAIN, 6714 04:16:58,600 --> 04:16:59,800 COPYRIGHT FREE, YOU CAN TAKE A 6715 04:16:59,800 --> 04:17:00,360 LOOK. 6716 04:17:00,360 --> 04:17:02,200 YOU WON'T BE ABLE TO 6717 04:17:02,200 --> 04:17:05,880 SPECIFICALLY LOOK AT CONTENT FOR 6718 04:17:05,880 --> 04:17:08,560 SPECIFIC BRAND OF VITAMIN. 6719 04:17:08,560 --> 04:17:11,280 MAINLY NOW IT'S MULTI-VITAMIN, 6720 04:17:11,280 --> 04:17:12,840 PRENATAL MULTI-VITAMIN, OMEGA 3, 6721 04:17:12,840 --> 04:17:19,280 STARTING IN GREEN TEA. 6722 04:17:19,280 --> 04:17:23,320 ZINC, IRON, COPPER, SELENIUM, 6723 04:17:23,320 --> 04:17:24,800 PHOSPHORUS, POTASSIUM, 6724 04:17:24,800 --> 04:17:27,040 MAGNESIUM, CRYPTONIGHT -- UH-OH. 6725 04:17:27,040 --> 04:17:37,560 YEP, DIETARY SUPPLEMENT LABELS 6726 04:17:42,520 --> 04:17:43,160 ARE CRITICAL. 6727 04:17:43,160 --> 04:17:46,240 WE HAVE 140,000 LABELS, I'M NOT 6728 04:17:46,240 --> 04:17:49,080 GOING TO TALK OTHER THAN TO SAY 6729 04:17:49,080 --> 04:17:55,160 A PRESENTATION FROM DR. SALDANHA 6730 04:17:55,160 --> 04:17:56,520 WILL GIVE YOU MORE INFORMATION. 6731 04:17:56,520 --> 04:18:05,320 TAKE A LOOK, VERY USEFUL. 6732 04:18:05,320 --> 04:18:06,120 WE DON'T MAKE RECOMMENDATIONS 6733 04:18:06,120 --> 04:18:07,600 BUT EVERYTHING ON THE LABEL OF 6734 04:18:07,600 --> 04:18:08,600 THE PARTICULAR PRODUCT. 6735 04:18:08,600 --> 04:18:10,360 YOU CAN SEE AN IMAGE OF THE 6736 04:18:10,360 --> 04:18:13,600 PRODUCT AND YOU CAN SEE HOW TO 6737 04:18:13,600 --> 04:18:15,680 CONTACT THE MANUFACTURER, YOU 6738 04:18:15,680 --> 04:18:18,560 CAN SORT AND SEARCH BY 6739 04:18:18,560 --> 04:18:19,800 INGREDIENT OR BY PRODUCER, OR 6740 04:18:19,800 --> 04:18:21,080 DIFFERENT THINGS LIKE THAT. 6741 04:18:21,080 --> 04:18:25,000 VERY USEFUL, IF YOU'RE LOOKING 6742 04:18:25,000 --> 04:18:26,320 FOR A SPECIFIC PRODUCT THAT YOU 6743 04:18:26,320 --> 04:18:27,840 WANT TO SEE WHAT'S ACTUALLY IN 6744 04:18:27,840 --> 04:18:31,320 IT, WHAT DOES THE LABEL ACTUALLY 6745 04:18:31,320 --> 04:18:34,400 SAY. 6746 04:18:34,400 --> 04:18:37,600 IT HAS ON MARKET AND OFF MARKET, 6747 04:18:37,600 --> 04:18:39,720 IN NO LONGER BEING SOLD IT 6748 04:18:39,720 --> 04:18:44,160 INDICATES THAT AS WELL. 6749 04:18:44,160 --> 04:18:46,200 THERE'S ALSO ANOTHER DIETARY 6750 04:18:46,200 --> 04:18:48,000 LABEL DATABASE, SUPPORTED BY 6751 04:18:48,000 --> 04:18:50,440 COUNCIL FOR RESPONSIBLE 6752 04:18:50,440 --> 04:18:51,720 NUTRITION, CRN, SUPPLEMENT OWL. 6753 04:18:51,720 --> 04:18:55,280 IT HAS FEWER PRODUCTS, INDUSTRY 6754 04:18:55,280 --> 04:18:56,560 BASED, ALSO A PLACE WHERE YOU 6755 04:18:56,560 --> 04:19:00,200 CAN LOOK THROUGH A VARIETY OF 6756 04:19:00,200 --> 04:19:02,600 LABELS. 6757 04:19:02,600 --> 04:19:05,200 6758 04:19:05,200 --> 04:19:06,120 SO, THE DIETARY SUPPLEMENT 6759 04:19:06,120 --> 04:19:09,560 DATABASE IS NOT THE ONLY GAME IN 6760 04:19:09,560 --> 04:19:10,640 TOWN. 6761 04:19:10,640 --> 04:19:12,520 I WILL GIVE TWO REFERENCES AND 6762 04:19:12,520 --> 04:19:16,680 THESE ARE ON MY READING LIST IF 6763 04:19:16,680 --> 04:19:18,240 YOU DOWNLOAD THAT, REVIEW ON 6764 04:19:18,240 --> 04:19:19,280 NATURAL PRODUCT DATABASES DONE A 6765 04:19:19,280 --> 04:19:20,960 COUPLE YEARS AGO WHICH IS AN 6766 04:19:20,960 --> 04:19:23,280 EXCELLENT ARTICLE. 6767 04:19:23,280 --> 04:19:25,760 AND THIS PARTICULAR ARTICLE 6768 04:19:25,760 --> 04:19:31,360 WHILE THE ARTICLE DEALS WITH 6769 04:19:31,360 --> 04:19:31,920 ETHNOBOTANICAL DATABASE FOR 6770 04:19:31,920 --> 04:19:33,440 BRAZILIAN FOODS THEY HAVE A 6771 04:19:33,440 --> 04:19:34,640 LOVELY SUPPLEMENTAL TABLE WITH 6772 04:19:34,640 --> 04:19:37,360 OF WHERE THEY COMPILED TONS OF 6773 04:19:37,360 --> 04:19:38,560 BOTANICAL DATABASES, LET'S SEE 6774 04:19:38,560 --> 04:19:43,160 IF I CAN SHOW YOU THAT. 6775 04:19:43,160 --> 04:19:47,800 IT IS ACTUALLY THE SUPPLEMENTARY 6776 04:19:47,800 --> 04:19:49,240 MATERIAL FOR THIS ARTICLE. 6777 04:19:49,240 --> 04:19:58,600 LET'S SEE, WHERE IS IT? 6778 04:19:58,600 --> 04:20:01,080 6779 04:20:01,080 --> 04:20:01,440 OKAY. 6780 04:20:01,440 --> 04:20:04,840 HERE IT IS. 6781 04:20:04,840 --> 04:20:06,600 WHAT'S NICE ABOUT IT, IT GIVES 6782 04:20:06,600 --> 04:20:10,320 THE NAME, HOW IT'S CLASSIFIED, 6783 04:20:10,320 --> 04:20:11,760 DESCRIBES WHERE IT'S LOCATED BUT 6784 04:20:11,760 --> 04:20:15,600 SAYS IF IT'S WORLDWIDE, 6785 04:20:15,600 --> 04:20:16,280 AUSTRALIA, CHINA, INDIA, AFRICA, 6786 04:20:16,280 --> 04:20:21,000 AND IT IS ONE OF THE BEST LISTS 6787 04:20:21,000 --> 04:20:23,400 OF BOTANICAL OR ETHNOBOTANICAL 6788 04:20:23,400 --> 04:20:25,000 OR PLANT INGREDIENT DATABASES, 6789 04:20:25,000 --> 04:20:26,400 LISTINGS, THAT I CAME ACROSS. 6790 04:20:26,400 --> 04:20:29,160 YES, ALL OF THESE ARE IN 6791 04:20:29,160 --> 04:20:30,920 INDIVIDUAL RESEARCH STUDIES AND 6792 04:20:30,920 --> 04:20:33,240 PRINTED ARTICLES, BUT THIS TABLE 6793 04:20:33,240 --> 04:20:36,720 IS EXCELLENT FOR GETTING A START 6794 04:20:36,720 --> 04:20:39,120 ON IF YOU'RE INTERESTED IN THE 6795 04:20:39,120 --> 04:20:49,320 PLANT DATABASE INGREDIENTS TYPE 6796 04:20:49,320 --> 04:20:50,720 THING. 6797 04:20:50,720 --> 04:20:52,160 IT'S EXCITING WHEN YOU COME 6798 04:20:52,160 --> 04:20:55,600 ACROSS A REALLY GOOD RESOURCE. 6799 04:20:55,600 --> 04:20:56,320 ALL RIGHT. 6800 04:20:56,320 --> 04:20:58,720 LAST THING I WANT TO HIT FAIRLY 6801 04:20:58,720 --> 04:20:59,520 QUICKLY IS ALL THE RESOURCES 6802 04:20:59,520 --> 04:21:05,080 THAT ARE ARE OUT THERE THAT HAVE 6803 04:21:05,080 --> 04:21:06,520 ALREADY DONE THE COMBINING AND 6804 04:21:06,520 --> 04:21:10,760 COORDINATING OF ALL THE 6805 04:21:10,760 --> 04:21:11,040 ARTICLES. 6806 04:21:11,040 --> 04:21:12,240 MONOGRAPHS, EVIDENCE REPORTS, 6807 04:21:12,240 --> 04:21:13,120 FACTSHEETS. 6808 04:21:13,120 --> 04:21:15,360 FIRST OFF, I DO HAVE TO PROMOTE 6809 04:21:15,360 --> 04:21:20,360 OUR ODS DIETARY SUPPLEMENT FACT 6810 04:21:20,360 --> 04:21:21,800 SHEET, EVIDENCE-BASED, REGULATED 6811 04:21:21,800 --> 04:21:22,680 REGULARLY, VITAMINS, MINERALS, 6812 04:21:22,680 --> 04:21:25,440 NUMBER OF HERBS AND BOTANICALS 6813 04:21:25,440 --> 04:21:26,720 AND SPECIAL INGREDIENTS. 6814 04:21:26,720 --> 04:21:28,360 WE HAVE PUT TOGETHER SEVERAL 6815 04:21:28,360 --> 04:21:29,000 COMBINATIONS AS WELL. 6816 04:21:29,000 --> 04:21:33,520 WE HAVE ONE ON WEIGHT LOSS, 6817 04:21:33,520 --> 04:21:35,480 EXERCISE, ATHLETIC PERFORMANCE, 6818 04:21:35,480 --> 04:21:37,440 MOST RECENT ONE COVID-19, 6819 04:21:37,440 --> 04:21:39,200 UPDATED REGULARLY AS THERE'S SO 6820 04:21:39,200 --> 04:21:40,760 MUCH RESEARCH COMING OUT ALL THE 6821 04:21:40,760 --> 04:21:41,080 TIME. 6822 04:21:41,080 --> 04:21:47,480 YOU'LL HEAR MORE ABOUT THAT FROM 6823 04:21:47,480 --> 04:21:48,320 CAREFUL HIGGINS MOMENT OR 6824 04:21:48,320 --> 04:21:52,520 WEDNESDAY. WE HAVE A THEM IN 6825 04:21:52,520 --> 04:21:56,240 HEALTH PROFESSIONAL, CONSUMER 6826 04:21:56,240 --> 04:21:57,880 VERSION, SPANISH VERSION, LINKED 6827 04:21:57,880 --> 04:21:58,440 TO PubMed. 6828 04:21:58,440 --> 04:22:04,600 I'LL SHOW YOU THAT QUICKLY. 6829 04:22:04,600 --> 04:22:06,200 A LONG LIST. 6830 04:22:06,200 --> 04:22:09,960 CLICK ON ONE, AND YOU CAN CHOOSE 6831 04:22:09,960 --> 04:22:10,760 THE CONSUMER, HEALTH 6832 04:22:10,760 --> 04:22:12,680 PROFESSIONAL, GO TO THAT. 6833 04:22:12,680 --> 04:22:14,760 YOU DON'T LIKE THAT, JUMP ACROSS 6834 04:22:14,760 --> 04:22:18,080 THE TOP AND GO TO HEALTH 6835 04:22:18,080 --> 04:22:20,160 PROFESSIONAL. 6836 04:22:20,160 --> 04:22:20,680 HEALTH PROFESSIONAL IS 6837 04:22:20,680 --> 04:22:22,560 REFERENCED, CONSUMER IS NOT. 6838 04:22:22,560 --> 04:22:25,280 HOPEFULLY IN AN EASIER TO READ 6839 04:22:25,280 --> 04:22:27,240 YET NOT TAKING THE SCIENCE DOWN 6840 04:22:27,240 --> 04:22:28,320 TOO MUCH IN THE CONSUMER 6841 04:22:28,320 --> 04:22:30,520 VERSION. 6842 04:22:30,520 --> 04:22:36,040 EXCELLENT RESOURCES. 6843 04:22:36,040 --> 04:22:38,880 YOU MAY BE AWARE OF NATURAL 6844 04:22:38,880 --> 04:22:40,000 MEDICINES DATABASE, SUBSCRIPTION 6845 04:22:40,000 --> 04:22:41,640 BASE WHICH ALSO HAS FACTSHEETS 6846 04:22:41,640 --> 04:22:45,720 AND A LOT OF MONOGRAPHS ON MANY, 6847 04:22:45,720 --> 04:22:48,120 MANY DIFFERENT PRODUCTS. 6848 04:22:48,120 --> 04:22:52,840 THEY TALK ABOUT ADVERSE 6849 04:22:52,840 --> 04:22:55,480 REACTION, SOME GRADING, IT'S A 6850 04:22:55,480 --> 04:22:57,800 USEFUL RESOURCE IF YOU HAVE 6851 04:22:57,800 --> 04:23:00,160 ACCESS TO THAT SUBSCRIPTION. 6852 04:23:00,160 --> 04:23:01,840 HEALTH CANADA, CANADA HAS A 6853 04:23:01,840 --> 04:23:04,280 DIFFERENT SYSTEM WHERE THEY DO 6854 04:23:04,280 --> 04:23:05,360 REQUIRE A DOCUMENTATION AND 6855 04:23:05,360 --> 04:23:06,840 MONOGRAPH FOR A NUMBER OF 6856 04:23:06,840 --> 04:23:10,320 PRODUCTS, IN FACT DR. BETZ 6857 04:23:10,320 --> 04:23:13,920 MENTIONED THE LICENSE NATURAL 6858 04:23:13,920 --> 04:23:14,560 HEALTH PRODUCTS DATABASE, THEY 6859 04:23:14,560 --> 04:23:17,200 HAVE A DATABASE FOR ALL THESE 6860 04:23:17,200 --> 04:23:18,160 MONOGRAPHS LISTED AND INCLUDED 6861 04:23:18,160 --> 04:23:19,920 SO YOU CAN GO AND READ THROUGH 6862 04:23:19,920 --> 04:23:21,120 AND GET ALL THE DATA. 6863 04:23:21,120 --> 04:23:24,720 IT'S LIKE A FACT SHEET WHICH IS 6864 04:23:24,720 --> 04:23:28,560 ALL REFERENCED, PROVIDED BY 6865 04:23:28,560 --> 04:23:29,200 HEALTH CANADA. 6866 04:23:29,200 --> 04:23:35,680 THE FDA HAS A LISTING OF TAINTED 6867 04:23:35,680 --> 04:23:37,560 PRODUCTS, NOT NECESSARILY A FACT 6868 04:23:37,560 --> 04:23:39,960 SHEET OR MONOGRAPH, IT'S A GOOD 6869 04:23:39,960 --> 04:23:41,360 RESOURCE THAT ANYBODY WORKING IN 6870 04:23:41,360 --> 04:23:44,320 SUPPLEMENTS SHOULD TAKE A LOOK 6871 04:23:44,320 --> 04:23:47,600 AT. 6872 04:23:47,600 --> 04:23:51,200 AS I SAID, BEFORE I GO ON TOO 6873 04:23:51,200 --> 04:23:53,080 FAR, I'LL SHOW YOU A REFERENCE 6874 04:23:53,080 --> 04:23:53,640 LIST. 6875 04:23:53,640 --> 04:23:57,680 THERE ARE SO MANY MORE. 6876 04:23:57,680 --> 04:24:00,920 YOU'LL HEAR LATER IN THE 6877 04:24:00,920 --> 04:24:04,520 PRACTICUM FROM THE MILITARY, THE 6878 04:24:04,520 --> 04:24:05,760 OPERATION SUPPLEMENT SAFETY 6879 04:24:05,760 --> 04:24:06,320 GROUP. 6880 04:24:06,320 --> 04:24:08,520 THEY HAVE GREAT FACTSHEETS AND 6881 04:24:08,520 --> 04:24:09,360 INFORMATION. 6882 04:24:09,360 --> 04:24:10,960 THE LINUS PAULING MICRONUTRIENT 6883 04:24:10,960 --> 04:24:12,120 INFORMATION CENTER HAS. 6884 04:24:12,120 --> 04:24:13,760 SO ALL OF THESE OTHER ENTITIES 6885 04:24:13,760 --> 04:24:15,160 ARE LISTED ON THE REFERENCE LIST 6886 04:24:15,160 --> 04:24:18,000 THAT I'M GOING TO SHOW YOU. 6887 04:24:18,000 --> 04:24:20,200 LAST COUPLE THINGS, MY TIME IS 6888 04:24:20,200 --> 04:24:21,400 GETTING SHORT, ALERTS. 6889 04:24:21,400 --> 04:24:22,560 SO, YOU DON'T HAVE TO LOOK FOR 6890 04:24:22,560 --> 04:24:23,640 SOME OF THESE THINGS. 6891 04:24:23,640 --> 04:24:25,560 YOU CAN HAVE THEM PUSHED TO YOUR 6892 04:24:25,560 --> 04:24:26,120 E-MAIL. 6893 04:24:26,120 --> 04:24:29,880 I USE A GOOGLE ALERT FOR DIETARY 6894 04:24:29,880 --> 04:24:32,800 SUPPLEMENTS AND SPECIFIC TOPIC. 6895 04:24:32,800 --> 04:24:34,880 AS OFTEN AAS I SET IT, ONCE A 6896 04:24:34,880 --> 04:24:36,520 DAY, ONCE A WEEK, THINGS THAT 6897 04:24:36,520 --> 04:24:38,720 ARE BEING FOUND ON THE INTERNET. 6898 04:24:38,720 --> 04:24:40,800 YOU CAN ALSO DO THE SAME THING 6899 04:24:40,800 --> 04:24:43,360 AT PubMed OR MEDLINE, AND 6900 04:24:43,360 --> 04:24:45,600 GET -- IF YOU HAVE A SPECIFIC 6901 04:24:45,600 --> 04:24:47,480 SEARCH YOU WANT RUN EVERY WEEK, 6902 04:24:47,480 --> 04:24:49,320 AND THEN SEND THAT INFORMATION 6903 04:24:49,320 --> 04:24:53,920 TO YOU, IN AN E-MAIL. 6904 04:24:53,920 --> 04:24:55,680 SO GOOGLE ALERTS. 6905 04:24:55,680 --> 04:24:57,520 AND THEN I'M SORRY, THIS IS VERY 6906 04:24:57,520 --> 04:24:59,280 SMALL, THIS IS A SEARCH STRATEGY 6907 04:24:59,280 --> 04:25:02,640 I HAVE SET UP FOR ARGININE, AND 6908 04:25:02,640 --> 04:25:03,400 WAR FIGHTERS. 6909 04:25:03,400 --> 04:25:05,200 WE WERE INTERESTED IN THE 6910 04:25:05,200 --> 04:25:07,160 MILITARY AND USE OF ARGININE. 6911 04:25:07,160 --> 04:25:09,800 I SET UP A SEARCH STRING SO NOW 6912 04:25:09,800 --> 04:25:11,760 EVERY WEEK THIS RUNS AND SENDS 6913 04:25:11,760 --> 04:25:13,720 ME AN E-MAIL OF ANY ARTICLES 6914 04:25:13,720 --> 04:25:15,960 THAT HAVE APPEARED IN PubMed 6915 04:25:15,960 --> 04:25:19,680 OR MEDLINE THAT ARE ON THIS THAT 6916 04:25:19,680 --> 04:25:23,800 FIT THE SEARCH STRING. 6917 04:25:23,800 --> 04:25:28,320 FREE AND EASY TO DO AT 6918 04:25:28,320 --> 04:25:29,000 PubMed. 6919 04:25:29,000 --> 04:25:30,760 WE HAVE A WEBSITE, OUR E-MAIL. 6920 04:25:30,760 --> 04:25:32,840 IF YOU HAVE SPECIFIC QUESTIONS 6921 04:25:32,840 --> 04:25:33,600 ABOUT SEARCHING LITERATURE I'M 6922 04:25:33,600 --> 04:25:37,400 HAPPY TO HELP. 6923 04:25:37,400 --> 04:25:39,600 YOU CAN E-MAIL ME. 6924 04:25:39,600 --> 04:25:42,560 I HAVE A -- ON THE PRACTICUM WEB 6925 04:25:42,560 --> 04:25:44,520 PAGE ON THE AGENDA UNDER MY 6926 04:25:44,520 --> 04:25:46,080 PARTICULAR NAME AND TIME, YOU 6927 04:25:46,080 --> 04:25:47,680 WILL FIND REFERENCES AND READING 6928 04:25:47,680 --> 04:25:51,840 LIST, ALL THE ARTICLES I'VE 6929 04:25:51,840 --> 04:25:53,800 TALKED ABOUT, DATABASES, THE 6930 04:25:53,800 --> 04:25:56,400 RESEARCH DATABASES, AND A WHOLE 6931 04:25:56,400 --> 04:25:58,520 LIST OF MONOGRAPHS AND 6932 04:25:58,520 --> 04:26:01,920 FACTSHEETS, WAY MORE THAN I 6933 04:26:01,920 --> 04:26:03,040 COULD HAVE POSSIBLY GONE 6934 04:26:03,040 --> 04:26:06,600 THROUGH, SO MUCH GREAT 6935 04:26:06,600 --> 04:26:07,160 INFORMATION. 6936 04:26:07,160 --> 04:26:08,600 HOPEFULLY, THIS IS GIVING YOU AT 6937 04:26:08,600 --> 04:26:10,000 LEAST ONE NEW PIECE OF 6938 04:26:10,000 --> 04:26:13,160 INFORMATION THAT YOU CAN USE. 6939 04:26:13,160 --> 04:26:15,480 AGAIN, USE THE QR CODE, STAY 6940 04:26:15,480 --> 04:26:15,800 CONNECTED. 6941 04:26:15,800 --> 04:26:18,200 WE DO REGULAR ODS UPDATES, 6942 04:26:18,200 --> 04:26:19,200 SCHOOLS FOR CONSUMERS. 6943 04:26:19,200 --> 04:26:21,360 ONCE A WEEK WE SEND OUT A TWEET 6944 04:26:21,360 --> 04:26:24,880 OF THE WEEK SO YOU CAN SEE 6945 04:26:24,880 --> 04:26:28,600 EVERYTHING WE TWEETED FOR THE 6946 04:26:28,600 --> 04:26:29,400 WEEK, FACEBOOK PAGE, TWITTER, 6947 04:26:29,400 --> 04:26:30,240 FOLLOW US. 6948 04:26:30,240 --> 04:26:32,520 GET MORE INFORMATION THAT WAY. 6949 04:26:32,520 --> 04:26:35,200 I THINK I'M DONE. 6950 04:26:35,200 --> 04:26:38,880 6951 04:26:38,880 --> 04:26:39,440 >> THANK YOU, JOYCE. 6952 04:26:39,440 --> 04:26:42,960 THAT WAS GREAT. 6953 04:26:42,960 --> 04:26:45,480 YOU HAVE SEVERAL KUDOS IN THE 6954 04:26:45,480 --> 04:26:47,040 Q&A AND WELL. 6955 04:26:47,040 --> 04:26:50,520 I HAVE A QUESTION, FIRST 6956 04:26:50,520 --> 04:26:51,760 QUESTION FROM YASMIN. 6957 04:26:51,760 --> 04:26:53,920 AND SHE SAYS THERE'S BEEN A 6958 04:26:53,920 --> 04:26:54,600 LONGSTANDING INTEREST IN 6959 04:26:54,600 --> 04:26:56,600 UNDERSTANDING THE ROLE OF 6960 04:26:56,600 --> 04:27:04,560 NUTRIENTS AND DIETARY . 6961 04:27:04,560 --> 04:27:06,400 ARE THERE DATABASES COLLECTING 6962 04:27:06,400 --> 04:27:07,600 DATA AND EVIDENCE OF BIOMARKERS 6963 04:27:07,600 --> 04:27:09,920 AND TOOLS FOR HOW TO EVALUATE 6964 04:27:09,920 --> 04:27:13,840 DIETARY SUPPLEMENTS TO SUPPORT 6965 04:27:13,840 --> 04:27:14,640 RESILIENCE AND HEALTH 6966 04:27:14,640 --> 04:27:15,200 OPTIMIZATION? 6967 04:27:15,200 --> 04:27:18,080 >> I DON'T KNOW OF A SPECIFIC 6968 04:27:18,080 --> 04:27:21,000 DATABASE RELATED TO BIOMARKERS. 6969 04:27:21,000 --> 04:27:24,400 I KNOW THAT ENTITIES SUCH AS 6970 04:27:24,400 --> 04:27:25,120 NATIONAL ACADEMIES OF SCIENCES, 6971 04:27:25,120 --> 04:27:27,240 THEY WERE STARTING TO LOOK AT 6972 04:27:27,240 --> 04:27:27,760 DIFFERENT NUTRIENTS, ARE 6973 04:27:27,760 --> 04:27:28,560 INTERESTED IN BIOMARKERS AND 6974 04:27:28,560 --> 04:27:31,840 THINGS LIKE THAT BUT I BELIEVE 6975 04:27:31,840 --> 04:27:33,560 THAT PubMed, MEDLINE, IS 6976 04:27:33,560 --> 04:27:35,000 PROBABLY THE BEST LIST OF WHERE 6977 04:27:35,000 --> 04:27:36,400 YOU'LL FIND THAT. 6978 04:27:36,400 --> 04:27:36,920 IT'S SO COMPREHENSIVE. 6979 04:27:36,920 --> 04:27:41,200 BUT I DON'T KNOW OF ANY SPECIFIC 6980 04:27:41,200 --> 04:27:41,880 BIOMARKER-TYPE DATABASE. 6981 04:27:41,880 --> 04:27:45,040 IF YOU DO, PLEAS LET US KNOW AND 6982 04:27:45,040 --> 04:27:47,680 WE CAN INCLUDE THAT INFORMATION. 6983 04:27:47,680 --> 04:27:49,200 IT'S NOTHING THAT'S COME ACROSS 6984 04:27:49,200 --> 04:27:50,800 MY RADAR. 6985 04:27:50,800 --> 04:27:52,080 SORRY. 6986 04:27:52,080 --> 04:27:53,200 >> THANKS, JOYCE. 6987 04:27:53,200 --> 04:27:56,480 THERE IS A TALK ON DIETARY 6988 04:27:56,480 --> 04:27:58,960 SUPPLEMENTS AND RESILIENCE 6989 04:27:58,960 --> 04:28:01,800 TOMORROW AFTERNOON. 6990 04:28:01,800 --> 04:28:04,240 >> YEP. 6991 04:28:04,240 --> 04:28:05,760 TALK TO LAVERNE ABOUT THAT. 6992 04:28:05,760 --> 04:28:07,160 >> NEXT QUESTION FOR ME, WHEN 6993 04:28:07,160 --> 04:28:10,280 WOULD ONE USE NIH REPORTER 6994 04:28:10,280 --> 04:28:12,560 VERSUS CARDS DATABASE TO SEARCH 6995 04:28:12,560 --> 04:28:15,440 UNFUNDED RESEARCH IN DIETARY 6996 04:28:15,440 --> 04:28:16,480 SUPPLEMENTS. 6997 04:28:16,480 --> 04:28:22,400 SO, CARDS IS LARGELY A SUBSET OF 6998 04:28:22,400 --> 04:28:24,160 NIH REPORTER. 6999 04:28:24,160 --> 04:28:26,480 WE DON'T HAVE EXACTLY THE SAME 7000 04:28:26,480 --> 04:28:30,960 PROJECTS BECAUSE CARDS DATA IS 7001 04:28:30,960 --> 04:28:31,520 MANUALLY CURATED. 7002 04:28:31,520 --> 04:28:33,120 AND SO SOMETIMES THINGS THAT 7003 04:28:33,120 --> 04:28:34,960 COME IN AS DIETARY SUPPLEMENTS 7004 04:28:34,960 --> 04:28:36,440 IN FACT AREN'T, WHEN LOOKED AT 7005 04:28:36,440 --> 04:28:37,400 MORE CLOSELY. 7006 04:28:37,400 --> 04:28:40,160 SO THOSE ARE REMOVED FROM CARDS. 7007 04:28:40,160 --> 04:28:43,640 AND THEN THERE ARE PROJECTS THAT 7008 04:28:43,640 --> 04:28:46,280 AREN'T PICKED UP BY THE DIETARY 7009 04:28:46,280 --> 04:28:48,360 SUPPLEMENT FINGERPRINT THAT PUTS 7010 04:28:48,360 --> 04:28:52,200 THEM INTO REPORTER, THAT WILL BE 7011 04:28:52,200 --> 04:28:57,080 PICKED UP BECAUSE WE -- 7012 04:28:57,080 --> 04:28:57,760 [AUDIO DISTORTION] 7013 04:28:57,760 --> 04:28:59,920 WE CAN ADD PROJECTS WE'RE AWARE 7014 04:28:59,920 --> 04:29:00,680 OF. 7015 04:29:00,680 --> 04:29:03,480 AGAIN CARDS IS MANUALLY CURATED 7016 04:29:03,480 --> 04:29:05,640 SO YOU SEARCH SPECIFICALLY BY 7017 04:29:05,640 --> 04:29:12,400 DISEASE OR BY STUDY TYPE, OR BY 7018 04:29:12,400 --> 04:29:13,520 POPULATION. 7019 04:29:13,520 --> 04:29:14,560 AND HEALTH OUTCOME. 7020 04:29:14,560 --> 04:29:17,600 IT'S A LITTLE MORE TARGETED 7021 04:29:17,600 --> 04:29:19,880 THAN JUST A KEY WORD SEARCH AND 7022 04:29:19,880 --> 04:29:20,400 REPORTER. 7023 04:29:20,400 --> 04:29:24,400 I MEAN, I WOULD SUGGEST USING 7024 04:29:24,400 --> 04:29:24,840 BOTH. 7025 04:29:24,840 --> 04:29:26,440 BECAUSE CORE IS THE SAME BUT 7026 04:29:26,440 --> 04:29:27,440 THEY HAVE DIFFERENT PROJECTS AND 7027 04:29:27,440 --> 04:29:29,160 CARDS MAY BE A LITTLE EASIER TO 7028 04:29:29,160 --> 04:29:31,840 FOCUS YOUR SEARCH. 7029 04:29:31,840 --> 04:29:33,680 7030 04:29:33,680 --> 04:29:35,800 >> OKAY. 7031 04:29:35,800 --> 04:29:41,360 AND THEN ANOTHER QUESTION IS IS 7032 04:29:41,360 --> 04:29:42,240 ACRICOLA AND PubMed NETWORK 7033 04:29:42,240 --> 04:29:44,560 CONNECTED SO YOU CAN DO ONE 7034 04:29:44,560 --> 04:29:46,600 SEARCH ACROSS BOTH OF THEM OR 7035 04:29:46,600 --> 04:29:49,800 DOES A PERSON SEARCHING HAVE TO 7036 04:29:49,800 --> 04:29:52,680 KNOW ABOUT BOTH OF THEM IF THEY 7037 04:29:52,680 --> 04:29:55,120 WANT TO DO A SEARCH? 7038 04:29:55,120 --> 04:29:57,440 IF THEY HAVEN'T TAKEN BEEN HERE 7039 04:29:57,440 --> 04:29:59,200 FOR YOUR TALK. 7040 04:29:59,200 --> 04:30:00,560 >> SO, THEY ARE GOING TO BE 7041 04:30:00,560 --> 04:30:02,840 RECORDS THAT ARE THE SAME IN 7042 04:30:02,840 --> 04:30:04,840 BOTH BUT AT THIS POINT I DON'T 7043 04:30:04,840 --> 04:30:07,520 KNOW THAT THEY ARE MESHED OR 7044 04:30:07,520 --> 04:30:07,880 CONNECTED. 7045 04:30:07,880 --> 04:30:11,680 THERE HAVE BEEN TALKS IN THE 7046 04:30:11,680 --> 04:30:13,240 PAST BUT RIGHT NOW THEY ARE 7047 04:30:13,240 --> 04:30:13,520 SEPARATE. 7048 04:30:13,520 --> 04:30:15,560 YOU'LL FIND SOME SAME JOURNALS 7049 04:30:15,560 --> 04:30:17,760 INCLUDED IN BOTH, INDEXED IN 7050 04:30:17,760 --> 04:30:17,960 BOTH. 7051 04:30:17,960 --> 04:30:20,160 ESPECIALLY IN PubMed, IF 7052 04:30:20,160 --> 04:30:22,920 IT'S A PLANT SCIENCE JOURNAL BUT 7053 04:30:22,920 --> 04:30:24,000 TALKS ABOUT HERBAL TYPE OF THING 7054 04:30:24,000 --> 04:30:33,440 YOU MIGHT FIND THAT IN PUBLIC 7055 04:30:33,440 --> 04:30:34,080 -- PubMed. 7056 04:30:34,080 --> 04:30:36,080 AT THIS POINT I DON'T BELIEVE 7057 04:30:36,080 --> 04:30:39,120 THEY ARE MESHED. 7058 04:30:39,120 --> 04:30:41,200 UNLESS YOU HAVE ACCESS TO A 7059 04:30:41,200 --> 04:30:45,120 LIBRARY THAT HAS SOME TYPE OF 7060 04:30:45,120 --> 04:30:46,120 CONSOLIDATOR, AND I'M NOT SURE 7061 04:30:46,120 --> 04:30:48,800 IF ANY OF THEM DO THAT YET WHERE 7062 04:30:48,800 --> 04:30:50,760 THEY SEARCH BOTH AND PROVIDE YOU 7063 04:30:50,760 --> 04:30:51,520 ALL THE RESULTS. 7064 04:30:51,520 --> 04:30:55,920 THERE MAY BE SOME PLATFORM THAT 7065 04:30:55,920 --> 04:30:56,520 LIBRARY -- SOME PROPRIETARY 7066 04:30:56,520 --> 04:30:59,280 PLATFORM THAT DOES THAT BUT 7067 04:30:59,280 --> 04:31:04,280 RIGHT NOW I SEARCH BOTH 7068 04:31:04,280 --> 04:31:05,840 SEPARATELY. 7069 04:31:05,840 --> 04:31:06,160 >> THANKS. 7070 04:31:06,160 --> 04:31:07,160 THANK YOU. 7071 04:31:07,160 --> 04:31:08,560 ANOTHER QUESTION, DO DATABASES 7072 04:31:08,560 --> 04:31:11,000 HAVE AN API AVAILABLE TO GET 7073 04:31:11,000 --> 04:31:13,840 DATA OUT FOR FURTHER RESEARCH? 7074 04:31:13,840 --> 04:31:15,600 >> SOME OF THEM DO, YES. 7075 04:31:15,600 --> 04:31:18,880 IN FACT, I BELIEVE LIKE THE DSLD 7076 04:31:18,880 --> 04:31:21,040 ACTUALLY DOES. 7077 04:31:21,040 --> 04:31:26,760 I BELIEVE THAT -- I'M NOT SURE 7078 04:31:26,760 --> 04:31:30,320 WITH AGRIS. 7079 04:31:30,320 --> 04:31:32,360 THE API IS ABOVE MY PAY GRADE. 7080 04:31:32,360 --> 04:31:36,280 I'LL REFER BACK TO SAY I'M A 7081 04:31:36,280 --> 04:31:37,280 DIETITIAN WITH LIBRARY KNOWLEDGE 7082 04:31:37,280 --> 04:31:38,600 BUT I DON'T HAVE ALL THAT 7083 04:31:38,600 --> 04:31:40,120 TECHNICAL SO I'M NOT SURE ABOUT 7084 04:31:40,120 --> 04:31:40,760 THE API. 7085 04:31:40,760 --> 04:31:43,960 >> OKAY, GREAT. 7086 04:31:43,960 --> 04:31:47,800 THANK YOU. 7087 04:31:47,800 --> 04:31:49,160 MAYBE LEILA WOULD KNOW. 7088 04:31:49,160 --> 04:31:49,960 NEXT TALK. 7089 04:31:49,960 --> 04:31:52,080 I THINK THAT'S A GOOD SEGUE, IF 7090 04:31:52,080 --> 04:31:53,720 WE MOVE TO THE NEXT TALK. 7091 04:31:53,720 --> 04:31:55,440 THANK YOU SO MUCH. 7092 04:31:55,440 --> 04:31:56,440 >> HAPPY SEARCHING, EVERYBODY. 7093 04:31:56,440 --> 04:32:02,680 >> A WONDERFUL TALK. 7094 04:32:02,680 --> 04:32:04,320 THANK YOU. 7095 04:32:04,320 --> 04:32:06,280 >> NEXT IS LEILA SALDANHA, 7096 04:32:06,280 --> 04:32:11,240 CURRENTLY SERVES AS PART-TIME 7097 04:32:11,240 --> 04:32:12,120 SCIENTIFIC CONSULTANT AT ODS, 7098 04:32:12,120 --> 04:32:15,760 PLAYED A LEADERSHIP ROLE IN 7099 04:32:15,760 --> 04:32:18,040 CREATING AND SUBJECT MATTER 7100 04:32:18,040 --> 04:32:23,960 EXPERT FOR PRODUCT LABEL 7101 04:32:23,960 --> 04:32:30,560 DATABASE ABOUT WHAT THESE SHE'S 7102 04:32:30,560 --> 04:32:32,360 GOING TO TALK ABOUT. 7103 04:32:32,360 --> 04:32:33,000 >> THANK YOU. 7104 04:32:33,000 --> 04:32:43,440 LET ME ATTEMPT TO SHARE MY 7105 04:32:51,760 --> 04:32:53,680 SLIDES. 7106 04:32:53,680 --> 04:32:54,560 7107 04:32:54,560 --> 04:32:55,080 >> LOOKS GOOD. 7108 04:32:55,080 --> 04:32:57,200 >> OKAY. 7109 04:32:57,200 --> 04:32:58,920 7110 04:32:58,920 --> 04:33:01,120 YOU CAN SEE MY SCREEN PROPERLY? 7111 04:33:01,120 --> 04:33:01,720 >> YES. 7112 04:33:01,720 --> 04:33:02,200 >> EXCELLENT. 7113 04:33:02,200 --> 04:33:08,400 YOU CAN HEAR ME PROPERLY TOO? 7114 04:33:08,400 --> 04:33:09,600 >> YES. 7115 04:33:09,600 --> 04:33:09,880 >> OKAY. 7116 04:33:09,880 --> 04:33:10,600 GOOD AFTERNOON. 7117 04:33:10,600 --> 04:33:19,120 I'M LEILA LEILA SALDANHA. 7118 04:33:19,120 --> 04:33:20,480 FINDING INFORMATION ON DIETARY 7119 04:33:20,480 --> 04:33:22,720 SUPPLEMENT PRODUCTS. 7120 04:33:22,720 --> 04:33:29,920 7121 04:33:29,920 --> 04:33:39,240 7122 04:33:39,240 --> 04:33:40,400 THIS PRESENTATION REFLECTED MY 7123 04:33:40,400 --> 04:33:42,000 VIEWPOINTS AND KNOWLEDGE ABOUT 7124 04:33:42,000 --> 04:33:45,200 THE TOPIC, ANY USE OF PRODUCT 7125 04:33:45,200 --> 04:33:46,800 NAMES AND PRODUCT LABELS IN THIS 7126 04:33:46,800 --> 04:33:48,440 PRESENTATION IS FOR DESCRIPTIVE 7127 04:33:48,440 --> 04:33:49,440 PURPOSES ONLY. 7128 04:33:49,440 --> 04:33:51,640 AND DOES NOT IMPLY AND 7129 04:33:51,640 --> 04:33:55,480 ENDORSEMENT OR RECOMMENDATION OF 7130 04:33:55,480 --> 04:33:56,160 THESE PRODUCTS. 7131 04:33:56,160 --> 04:33:59,960 MY TALK AS WAS MENTIONED EARLIER 7132 04:33:59,960 --> 04:34:02,080 WILL FOCUS ON DIETARY SUPPLEMENT 7133 04:34:02,080 --> 04:34:05,320 LABEL DATABASE AND HOW THE 7134 04:34:05,320 --> 04:34:06,520 LABELING REGULATION AFFECTS 7135 04:34:06,520 --> 04:34:15,520 INFORMATION LISTED IN THE DSLD, 7136 04:34:15,520 --> 04:34:19,800 AND AND FEATURES OF DSLS. 7137 04:34:19,800 --> 04:34:22,880 IN 2004 CONGRESS ASKED THE 7138 04:34:22,880 --> 04:34:25,880 OFFICE TO DEVELOP, CREATE, 7139 04:34:25,880 --> 04:34:36,440 REGULARLY UPDATE, MAINTAIN, AND 7140 04:34:42,120 --> 04:34:44,640 MAKE AVAILABLE A DATABASE, IT 7141 04:34:44,640 --> 04:34:50,160 HAS GONE THROUGH FUNCTIONAL 7142 04:34:50,160 --> 04:34:50,400 UPGRADES. 7143 04:34:50,400 --> 04:34:52,640 IN 2017 WE DEVELOPED AND 7144 04:34:52,640 --> 04:34:56,480 LAUNCHED MOBILE FRIENDLY VERSION 7145 04:34:56,480 --> 04:34:58,880 OF THE DSLD. 7146 04:34:58,880 --> 04:35:03,480 IN 2021, LAST YEAR, THE DSLD WAS 7147 04:35:03,480 --> 04:35:05,800 REDESIGNED AND LAUNCHED AFTER 18 7148 04:35:05,800 --> 04:35:09,320 MONTHS OF DEVELOPMENT WORK. 7149 04:35:09,320 --> 04:35:10,120 CURRENTLY, THERE ARE OVER 7150 04:35:10,120 --> 04:35:11,720 140,000 PRODUCT LABELS IN THE 7151 04:35:11,720 --> 04:35:13,240 DATABASE WHICH JOYCE HAS 7152 04:35:13,240 --> 04:35:17,080 MENTIONED TO YOU. 7153 04:35:17,080 --> 04:35:19,280 SINCE THE LABELS ARE KEPT IN THE 7154 04:35:19,280 --> 04:35:22,240 DATABASE THIS NUMBER INCLUDES 7155 04:35:22,240 --> 04:35:24,760 LABELS OF PRODUCTS ENTERED ON 7156 04:35:24,760 --> 04:35:29,840 MARKET AND HISTORIC LABELS THOSE 7157 04:35:29,840 --> 04:35:30,880 ENTERED ON AND AFTER 2011. 7158 04:35:30,880 --> 04:35:34,720 YOUR GOAL IS TO MAKE THE DSLD A 7159 04:35:34,720 --> 04:35:36,600 SOURCE OF SUPPLEMENT LABEL 7160 04:35:36,600 --> 04:35:38,440 INFORMATION FOR RESEARCHERS AND 7161 04:35:38,440 --> 04:35:42,840 USERS INTERESTED IN WANTING 7162 04:35:42,840 --> 04:35:43,720 INFORMATION ABOUT THESE 7163 04:35:43,720 --> 04:35:45,880 PRODUCTS, WHICH IS WHY KEY KEEP 7164 04:35:45,880 --> 04:35:47,720 LABELS AFTER PRODUCTS ARE 7165 04:35:47,720 --> 04:35:49,960 DISCONTINUED OR REFORMULATED OR 7166 04:35:49,960 --> 04:35:52,720 LABELS ARE REVISED TO FOLLOW NEW 7167 04:35:52,720 --> 04:35:54,120 LABELING REGULATIONS. 7168 04:35:54,120 --> 04:35:56,080 WE MOVE THESE LABELS TO THE OFF 7169 04:35:56,080 --> 04:36:01,760 MARKET CATEGORY IN THE DATABASE. 7170 04:36:01,760 --> 04:36:04,680 SO THESE ARE SECTIONS OF MY 7171 04:36:04,680 --> 04:36:11,960 TALK, SINCE DIETARY SUPPLEMENTS 7172 04:36:11,960 --> 04:36:15,040 ARE REGULATED AS FOODS, HOW THIS 7173 04:36:15,040 --> 04:36:17,560 OF THEY DIFFER AND AFFECT 7174 04:36:17,560 --> 04:36:18,760 INFORMATION IN DSLD, A FEW 7175 04:36:18,760 --> 04:36:20,920 SLIDES HOW TO NAVIGATE AND WHAT 7176 04:36:20,920 --> 04:36:24,160 TO EXPECT IN THE DSLD. 7177 04:36:24,160 --> 04:36:26,360 AND FINALLY USE OF CONVERSION 7178 04:36:26,360 --> 04:36:29,440 FACTORS AS RELATES TO LABELING. 7179 04:36:29,440 --> 04:36:32,800 YOU HAVE HEARD ABOUT THE 7180 04:36:32,800 --> 04:36:34,080 REGULATIONS GOVERNING DIETARY 7181 04:36:34,080 --> 04:36:36,040 SUPPLEMENTS, BUT I WILL BE 7182 04:36:36,040 --> 04:36:38,360 TALKING ABOUT THEM IN THE 7183 04:36:38,360 --> 04:36:40,040 CONTEXT OF TRYING TO APPRECIATE 7184 04:36:40,040 --> 04:36:43,640 THE INFORMATION IN THE DSLD 7185 04:36:43,640 --> 04:36:46,360 SINCE THE LABEL INFORMATION IN 7186 04:36:46,360 --> 04:36:50,000 DSLD IS DERIVED FROM PRODUCT 7187 04:36:50,000 --> 04:36:50,720 LABELS. 7188 04:36:50,720 --> 04:36:54,440 WHAT INFORMATION CAN YOU EXPECT 7189 04:36:54,440 --> 04:36:56,760 IN THE DSLD? 7190 04:36:56,760 --> 04:37:00,480 ITS INCLUDES LABELS AS DIETARY 7191 04:37:00,480 --> 04:37:01,440 SUPPLEMENTS, CAPTURES ALL THE 7192 04:37:01,440 --> 04:37:04,400 INFORMATION PRINTED ON THE 7193 04:37:04,400 --> 04:37:05,800 LABELS, ALL INGREDIENT 7194 04:37:05,800 --> 04:37:10,960 INFORMATION, AS LISTED WITHIN 7195 04:37:10,960 --> 04:37:12,520 THE SUPPLEMENT FACTS. 7196 04:37:12,520 --> 04:37:14,200 PANELS, CLAIMS, INFORMATION ON 7197 04:37:14,200 --> 04:37:16,760 THE GRAND, IMAGE OF THE PRODUCT 7198 04:37:16,760 --> 04:37:19,160 LABEL, YOU CAN SEARCH FOR ANY OF 7199 04:37:19,160 --> 04:37:21,440 THE INFORMATION IN THE DSLD. 7200 04:37:21,440 --> 04:37:24,760 IT IS IMPORTANT TO KEEP IN MIND 7201 04:37:24,760 --> 04:37:28,640 THAT THE NIH AND ODS ARE NOT 7202 04:37:28,640 --> 04:37:31,520 REGULATORY AGENCIES, SO WE DO 7203 04:37:31,520 --> 04:37:33,400 NOT VERIFY THIS INFORMATION. 7204 04:37:33,400 --> 04:37:35,720 SORRY, OR CHECK FOR CONFORMANCE 7205 04:37:35,720 --> 04:37:37,960 WITH REGULATION BEFORE IT IS 7206 04:37:37,960 --> 04:37:40,000 ENTERED IN THE DATABASE. 7207 04:37:40,000 --> 04:37:44,640 SO THOSE OF YOU FAMILIAR WITH 7208 04:37:44,640 --> 04:37:45,800 FOOD LABELING WILL RECOGNIZE 7209 04:37:45,800 --> 04:37:48,840 THIS IS NOT CURRENT LABEL FOR 7210 04:37:48,840 --> 04:37:49,200 CALTRATE. 7211 04:37:49,200 --> 04:37:50,160 RATHER THAN REPLACE WITH CURRENT 7212 04:37:50,160 --> 04:37:52,800 LABEL I THOUGHT I WOULD USE THIS 7213 04:37:52,800 --> 04:37:55,480 LABEL AS A TEACHING MOMENT. 7214 04:37:55,480 --> 04:37:58,480 ONE QUICK WAY, IF YOU GO TO THE 7215 04:37:58,480 --> 04:38:01,120 GROCERY STORE AND LOOK AT 7216 04:38:01,120 --> 04:38:03,840 LABELS, TO TELL WHETHER THIS IS 7217 04:38:03,840 --> 04:38:07,680 AN OLD OR REVISED LABEL, TO LOOK 7218 04:38:07,680 --> 04:38:13,240 AT THE UNITS USED TO EXPRESS 7219 04:38:13,240 --> 04:38:14,600 AMOUNT OF FAT SOLUBLE VITAMIN IF 7220 04:38:14,600 --> 04:38:15,440 IT'S LISTED. 7221 04:38:15,440 --> 04:38:18,520 ON THIS LABEL THE AMOUNTS ARE IN 7222 04:38:18,520 --> 04:38:18,960 IUs. 7223 04:38:18,960 --> 04:38:22,880 NEW UNITS ARE IN MICROGRAMS. 7224 04:38:22,880 --> 04:38:26,720 THE FOOD LABELING REGULATIONS 7225 04:38:26,720 --> 04:38:28,280 WHICH BECAME FINAL IN 2016 7226 04:38:28,280 --> 04:38:30,040 REQUIRE THE AMOUNT OF FAT 7227 04:38:30,040 --> 04:38:32,200 SOLUBLE VITAMINS BE LISTED IN 7228 04:38:32,200 --> 04:38:34,520 MICROGRAMS, I WILL ADDRESS 7229 04:38:34,520 --> 04:38:35,200 CONVERSION FACTORS IN LABELING 7230 04:38:35,200 --> 04:38:39,000 AT THE END OF MY TALK. 7231 04:38:39,000 --> 04:38:42,920 SO WHAT ARE THE SIMILARITIES AND 7232 04:38:42,920 --> 04:38:44,600 DIFFERENCES IN LABELING FROM 7233 04:38:44,600 --> 04:38:45,680 CONVENTIONAL FOODS? 7234 04:38:45,680 --> 04:38:50,040 LIKE FOODS, THERE IS NO 7235 04:38:50,040 --> 04:38:55,000 MANDATORY PRODUCT REGISTRATION 7236 04:38:55,000 --> 04:38:57,960 REQUIREMENT, OR REQUIREMENT TO 7237 04:38:57,960 --> 04:39:00,080 PROVIDE PRODUCT INFORMATION TO 7238 04:39:00,080 --> 04:39:03,600 FDA, MANDATORY PRODUCT LISTING. 7239 04:39:03,600 --> 04:39:06,200 THERE'S NO OFFICIAL RECORD OF 7240 04:39:06,200 --> 04:39:06,760 DIETARY SUPPLEMENT PRODUCTS 7241 04:39:06,760 --> 04:39:09,800 MARKETS IN THE U.S. 7242 04:39:09,800 --> 04:39:12,480 HOWEVER, THERE ARE MANY 7243 04:39:12,480 --> 04:39:13,360 DIFFERENCES, THESE DIFFERENCES 7244 04:39:13,360 --> 04:39:16,200 ARE OUTLINED IN THE DIETARY 7245 04:39:16,200 --> 04:39:20,800 SUPPLEMENT HEALTH EDUCATION ACT 7246 04:39:20,800 --> 04:39:21,440 OF 1994. 7247 04:39:21,440 --> 04:39:25,480 SO, SOME OF THE KEY FEATURES OF 7248 04:39:25,480 --> 04:39:29,440 DIETARY SUPPLEMENTS RESULTS FROM 7249 04:39:29,440 --> 04:39:32,480 THE DSHEA, FOCUSING ON TWO, 7250 04:39:32,480 --> 04:39:33,280 DSHEA CREATED A REGULATORY 7251 04:39:33,280 --> 04:39:36,120 CATEGORY OF PRODUCTS CALLED 7252 04:39:36,120 --> 04:39:37,400 DIETARY SUPPLEMENTS. 7253 04:39:37,400 --> 04:39:39,920 AND MORE IMPORTANTLY, AND TO 7254 04:39:39,920 --> 04:39:41,520 APPRECIATE THE DIFFERENCE 7255 04:39:41,520 --> 04:39:43,680 BETWEEN FOOD AND DIETARY 7256 04:39:43,680 --> 04:39:45,840 SUPPLEMENT PRODUCT LABELS, AND 7257 04:39:45,840 --> 04:39:48,680 TO APPRECIATE THE INFORMATION IN 7258 04:39:48,680 --> 04:39:52,640 THE DSLD, DSHEA ALSO CREATED A 7259 04:39:52,640 --> 04:39:54,920 NEW CATEGORY OF INGREDIENTS 7260 04:39:54,920 --> 04:39:55,840 CALLED DIETARY INGREDIENTS, AND 7261 04:39:55,840 --> 04:39:58,440 IT'S REALLY VERY IMPORTANT TO 7262 04:39:58,440 --> 04:40:00,640 UNDERSTAND THIS CONCEPT OF 7263 04:40:00,640 --> 04:40:02,520 DIETARY INGREDIENTS, IF YOU DO, 7264 04:40:02,520 --> 04:40:04,080 YOU REALLY HAVE, IN MY OPINION, 7265 04:40:04,080 --> 04:40:05,960 KNOW THE DIFFERENCE BETWEEN 7266 04:40:05,960 --> 04:40:08,320 FOODS AND DIETARY SUPPLEMENTS. 7267 04:40:08,320 --> 04:40:10,920 AND WITHIN THIS CATEGORY SIX 7268 04:40:10,920 --> 04:40:13,120 CLASSES OF DIETARY INGREDIENTS, 7269 04:40:13,120 --> 04:40:19,800 WHICH CAN BE LISTED WITHIN THE 7270 04:40:19,800 --> 04:40:21,360 SUPPLEMENT FACT BOX. 7271 04:40:21,360 --> 04:40:25,200 THESE DIETARY INGREDIENTS CAN 7272 04:40:25,200 --> 04:40:28,680 BE GROUPED INTO THOSE WITH DAILY 7273 04:40:28,680 --> 04:40:31,320 VALUES, AS THOSE WITHOUT DAILY 7274 04:40:31,320 --> 04:40:32,440 VALUES. 7275 04:40:32,440 --> 04:40:35,160 SO FOR LABELING PURPOSES, DAILY 7276 04:40:35,160 --> 04:40:38,000 VALUES ARE REFERENCED AMOUNTS OF 7277 04:40:38,000 --> 04:40:42,400 NUTRIENTS TO CONSUME OR NOT TO 7278 04:40:42,400 --> 04:40:44,040 EXCEED EACH SOMEDAY. 7279 04:40:44,040 --> 04:40:46,440 SO, THERE ARE SIX CATEGORIES OF 7280 04:40:46,440 --> 04:40:48,160 DIETARY INGREDIENTS, YOU'VE 7281 04:40:48,160 --> 04:40:50,160 HEARD ABOUT THE LIST MANY TIMES 7282 04:40:50,160 --> 04:40:53,320 TODAY, LISTED WITHIN THE 7283 04:40:53,320 --> 04:40:54,360 SUPPLEMENT FACT BOX BUT I DON'T 7284 04:40:54,360 --> 04:40:56,840 KNOW IF THIS ONE POINT REALLY 7285 04:40:56,840 --> 04:40:58,480 REGISTERED WITH YOU. 7286 04:40:58,480 --> 04:41:01,480 BUT THERE ARE ONLY 35 OF THESE 7287 04:41:01,480 --> 04:41:05,960 DIETARY INGREDIENTS THAT HAVE 7288 04:41:05,960 --> 04:41:08,760 DAILY VALUES. 7289 04:41:08,760 --> 04:41:11,080 VITAMINS AND MINERALS IN GREEN 7290 04:41:11,080 --> 04:41:12,680 HAVE DAILY VALUES. 7291 04:41:12,680 --> 04:41:15,280 THE THIRD AND FOURTH CLASS 7292 04:41:15,280 --> 04:41:17,240 HIGHLIGHTED IN THE SLIDE IN 7293 04:41:17,240 --> 04:41:20,720 YELLOW, SOME HAVE DAILY VALUES, 7294 04:41:20,720 --> 04:41:25,280 AND THE DSLD WILL BE CLASSIFIED 7295 04:41:25,280 --> 04:41:26,960 LABELS BY THE PRODUCT TYPE, WE 7296 04:41:26,960 --> 04:41:28,400 INCLUDED PRODUCT WITH AMINO ACID 7297 04:41:28,400 --> 04:41:30,480 IN ORIGINAL DEFINITION OF A 7298 04:41:30,480 --> 04:41:32,760 DIETARY SUPPLEMENT, PROTEIN WAS 7299 04:41:32,760 --> 04:41:35,760 NOT INCLUDED WITH AMINO ACIDS. 7300 04:41:35,760 --> 04:41:38,640 AND WE INCLUDED IN THE FOURTH 7301 04:41:38,640 --> 04:41:41,840 CLASS ALL OTHER NUTRIENTS SUCH 7302 04:41:41,840 --> 04:41:43,880 AS FIBER, FAT, CARBOHYDRATES, 7303 04:41:43,880 --> 04:41:45,360 THAT ARE NOT LISTED IN THE FIRST 7304 04:41:45,360 --> 04:41:47,240 THREE CLASSES. 7305 04:41:47,240 --> 04:41:49,560 THAT'S THE WAY WE CLASSIFY 7306 04:41:49,560 --> 04:41:51,160 INGREDIENTS IN THE DSLD. 7307 04:41:51,160 --> 04:41:54,640 SO, SOME OF THESE NUTRIENTS HAVE 7308 04:41:54,640 --> 04:41:55,760 DAILIES, BUT NOT ALL. 7309 04:41:55,760 --> 04:41:58,400 THIS IS IMPORTANT TO KNOW. 7310 04:41:58,400 --> 04:42:02,000 AND THERE ARE -- THERE'S A DAILY 7311 04:42:02,000 --> 04:42:04,800 PROTEIN BUT THERE ARE NO DVs 7312 04:42:04,800 --> 04:42:06,520 FOR INDIVIDUAL AMINO ACIDS, 7313 04:42:06,520 --> 04:42:10,800 THERE ARE DVs FOR FATS BUT NOT 7314 04:42:10,800 --> 04:42:13,440 ALL FATTY ACIDS. 7315 04:42:13,440 --> 04:42:17,040 THE FIFTH AND SIXTH CLASS WHICH 7316 04:42:17,040 --> 04:42:20,400 HAVE HERBS AND BOTANICALS, AND 7317 04:42:20,400 --> 04:42:22,520 THEN CONCENTRATE METABOLITE 7318 04:42:22,520 --> 04:42:23,520 CONSTITUENT EXTRACT OR ISOLATES 7319 04:42:23,520 --> 04:42:31,600 DO NOT HAVE DAILY VALUES. 7320 04:42:31,600 --> 04:42:33,680 TO SIMPLIFY CLASSIFICATION WE 7321 04:42:33,680 --> 04:42:35,160 INCLUDED ALL INGREDIENTS THAT 7322 04:42:35,160 --> 04:42:37,080 CANNOT BE CLASSIFIED IN THE 7323 04:42:37,080 --> 04:42:38,840 FIRST FIVE CLASSES, IN THE 7324 04:42:38,840 --> 04:42:41,800 SIXTHS CLASS, IN SHORT WE CALL 7325 04:42:41,800 --> 04:42:43,640 THIS THE NON-BOTANICALS AND 7326 04:42:43,640 --> 04:42:46,040 NON-NUTRIENTS, SO KEEP IN MIND 7327 04:42:46,040 --> 04:42:48,120 THE FIRST FOUR CATEGORIES LISTED 7328 04:42:48,120 --> 04:42:50,800 IN THE SLIDE ARE ALL NUTRIENTS, 7329 04:42:50,800 --> 04:42:52,600 AND THEN WE HAVE BOTANICALS, THE 7330 04:42:52,600 --> 04:42:54,880 FIFTH, AND THEN THE SIXTH IS 7331 04:42:54,880 --> 04:43:00,200 ANYTHING THAT'S NOT A BOTANICAL 7332 04:43:00,200 --> 04:43:01,400 AND NOT A NUTRIENT. 7333 04:43:01,400 --> 04:43:02,560 IF A DIETARY INGREDIENT HAS A 7334 04:43:02,560 --> 04:43:05,400 DAILY VALUE IT CAN BE LISTED 7335 04:43:05,400 --> 04:43:09,160 WITHIN THE SUPPLEMENT FACTS BUT 7336 04:43:09,160 --> 04:43:13,200 NOT WITHIN THE NUTRITION FACT 7337 04:43:13,200 --> 04:43:13,720 BOX. 7338 04:43:13,720 --> 04:43:14,720 HOWEVER, IF A DIETARY INGREDIENT 7339 04:43:14,720 --> 04:43:20,840 DOES NOT HAVE A DAILY VALUE, IT 7340 04:43:20,840 --> 04:43:22,840 CANNOT BE LISTED WITHIN THE 7341 04:43:22,840 --> 04:43:25,120 NUTRITION FACT BOX. 7342 04:43:25,120 --> 04:43:28,320 A GOOD EXAMPLE IS DHA AS SHOWN 7343 04:43:28,320 --> 04:43:29,960 IN THE SLIDE. 7344 04:43:29,960 --> 04:43:32,560 DHA CURRENTLY CANNOT BE LISTED 7345 04:43:32,560 --> 04:43:34,280 WITHIN THE NUTRITION FACT BOX 7346 04:43:34,280 --> 04:43:38,800 BECAUSE IT DOES NOT HAVE A DAILY 7347 04:43:38,800 --> 04:43:41,160 VALUE. 7348 04:43:41,160 --> 04:43:42,600 ANOTHER EXAMPLE IS CAFFEINE. 7349 04:43:42,600 --> 04:43:44,720 A THIRD POINT I WANTED TO MAKE 7350 04:43:44,720 --> 04:43:47,360 WHICH IS THE DISTINCTION BETWEEN 7351 04:43:47,360 --> 04:43:51,640 DIETARY INGREDIENTS WITH AND 7352 04:43:51,640 --> 04:43:54,640 WITHOUT DAILY VALUES IS THAT YOU 7353 04:43:54,640 --> 04:43:56,440 CAN MAKE STRUCTURAL FUNCTION 7354 04:43:56,440 --> 04:43:58,200 CLAIMS FOR ANY DIETARY 7355 04:43:58,200 --> 04:44:00,280 INGREDIENT THAT IS LISTED WITHIN 7356 04:44:00,280 --> 04:44:03,920 THE SUPPLEMENT FACT BOX, AND 7357 04:44:03,920 --> 04:44:08,440 SINCE YOU SEE IN THE LABELS, NOT 7358 04:44:08,440 --> 04:44:10,040 FOUND ON FOOD LABELS, AS YOU CAN 7359 04:44:10,040 --> 04:44:13,960 SEE ON THE SLIDE YOU WITH MAKE A 7360 04:44:13,960 --> 04:44:15,240 STRUCTURE/FUNCTION CLAIM FOR DHA 7361 04:44:15,240 --> 04:44:17,600 BUT CANNOT MAKE THIS ON A FOOD 7362 04:44:17,600 --> 04:44:17,840 LABEL. 7363 04:44:17,840 --> 04:44:20,800 AS IT DOES NOT HAVE A DAILY 7364 04:44:20,800 --> 04:44:21,000 VALUE. 7365 04:44:21,000 --> 04:44:23,680 NOW, I THINK IT WAS MENTIONED IN 7366 04:44:23,680 --> 04:44:26,520 A PRESENTATION YOU CAN MAKE 7367 04:44:26,520 --> 04:44:28,480 NUTRIENT CLAIMS STATING WELL 7368 04:44:28,480 --> 04:44:30,680 ACCEPTED FUNCTION FOR NUTRIENTS 7369 04:44:30,680 --> 04:44:33,520 ON FOOD LABELS, YOU KNOW, THINGS 7370 04:44:33,520 --> 04:44:39,880 THAT EVERYBODY EVERYBODY IS 7371 04:44:39,880 --> 04:44:41,320 TAUGHT, DRINK MILK FOR YOUR 7372 04:44:41,320 --> 04:44:47,120 BONES, AND A DISCLAIMER IS NOT 7373 04:44:47,120 --> 04:44:49,640 NEED FOR LIKE THE DISCLAIMER ON 7374 04:44:49,640 --> 04:44:50,920 THE SLIDE HERE. 7375 04:44:50,920 --> 04:44:53,440 SORRY, MY POINTER IS NOT WORKING 7376 04:44:53,440 --> 04:44:53,720 TOO WELL. 7377 04:44:53,720 --> 04:44:55,640 YOU'VE READ MANY OF THESE 7378 04:44:55,640 --> 04:44:59,040 NUTRIENT FUNCTION CLAIMS ON 7379 04:44:59,040 --> 04:44:59,720 CEREAL BOXES. 7380 04:44:59,720 --> 04:45:04,480 I WORKED FOR THE KELLOGG COMPANY 7381 04:45:04,480 --> 04:45:06,720 FOR TEN YEARS AND HELPED WRITE 7382 04:45:06,720 --> 04:45:08,800 AND SUBSTANTIATE THESE. 7383 04:45:08,800 --> 04:45:09,760 THE THESE ARE CAPTURED, AND WE 7384 04:45:09,760 --> 04:45:11,200 GET THE QUESTION. 7385 04:45:11,200 --> 04:45:13,080 THEY ARE NOT CATEGORIZED AS 7386 04:45:13,080 --> 04:45:16,040 THERE IS NO OFFICIAL 7387 04:45:16,040 --> 04:45:18,440 CATEGORIZATION FOR THESE TYPES 7388 04:45:18,440 --> 04:45:20,600 OF CLAIMS. 7389 04:45:20,600 --> 04:45:21,520 ANOTHER IMPORTANT DIFFERENCE 7390 04:45:21,520 --> 04:45:24,920 BETWEEN INGREDIENTS WITH AND 7391 04:45:24,920 --> 04:45:26,560 WITHOUT DAILY VALUES, THIS WAS 7392 04:45:26,560 --> 04:45:29,520 MENTIONED IN A PRESENTATION, YOU 7393 04:45:29,520 --> 04:45:31,600 CAN LIST DIETARY INGREDIENTS 7394 04:45:31,600 --> 04:45:33,880 WITHOUT DAILY VALUES AND 7395 04:45:33,880 --> 04:45:35,640 PROPRIETARY BLENDS, BUT YOU 7396 04:45:35,640 --> 04:45:38,400 CANNOT LIST INGREDIENTS WITH 7397 04:45:38,400 --> 04:45:40,400 DAILY VALUES IN PROPRIETARY 7398 04:45:40,400 --> 04:45:40,640 BLENDS. 7399 04:45:40,640 --> 04:45:43,680 SO FOR THOSE OF YOU WHO ARE 7400 04:45:43,680 --> 04:45:47,960 FAMILIAR WITH THE REGULATIONS, 7401 04:45:47,960 --> 04:45:49,560 THESE ARE THE B2 INGREDIENTS 7402 04:45:49,560 --> 04:45:52,560 DESCRIBED IN THE B2 SECTION OF 7403 04:45:52,560 --> 04:45:53,840 THE REGULATIONS. 7404 04:45:53,840 --> 04:45:56,920 THOSE WITHOUT DAILY VALUES ARE 7405 04:45:56,920 --> 04:45:58,800 THE B 3 INGREDIENTS, AS THEY ARE 7406 04:45:58,800 --> 04:46:01,520 DESCRIBED IN THE B3 SECTION OF 7407 04:46:01,520 --> 04:46:02,280 THE REGULATIONS. 7408 04:46:02,280 --> 04:46:04,800 SO, WHAT IS THE DIFFERENCE 7409 04:46:04,800 --> 04:46:08,640 BETWEEN A BLEND AND A 7410 04:46:08,640 --> 04:46:10,200 PROPRIETARY BLEND? 7411 04:46:10,200 --> 04:46:11,600 WITH PROPRIETARY BLEND, THE 7412 04:46:11,600 --> 04:46:14,520 MANUFACTURER DOES NOT HAVE TO 7413 04:46:14,520 --> 04:46:17,320 DECLARE THE AMOUNT OF EACH 7414 04:46:17,320 --> 04:46:20,120 COMPONENT WITHIN THE BLEND. 7415 04:46:20,120 --> 04:46:21,960 THE LABELS TO YOUR RIGHT, ONLY 7416 04:46:21,960 --> 04:46:25,400 THE AMOUNT OF THE BLEND MUST BE 7417 04:46:25,400 --> 04:46:25,680 DECLARED. 7418 04:46:25,680 --> 04:46:27,760 THIS CONTRASTS WITH THE LABEL TO 7419 04:46:27,760 --> 04:46:31,280 YOUR LEFT, WHERE THE AMOUNT OF 7420 04:46:31,280 --> 04:46:33,960 THE BLEND AND EACH INDIVIDUAL 7421 04:46:33,960 --> 04:46:35,800 INGREDIENT IS DECLARED. 7422 04:46:35,800 --> 04:46:38,880 WITH PROPRIETARY BLENDS, THE 7423 04:46:38,880 --> 04:46:39,840 AMOUNT OF EACH DIETARY 7424 04:46:39,840 --> 04:46:42,240 INGREDIENT WITHIN THE BLEND MUST 7425 04:46:42,240 --> 04:46:49,520 BE LISTED IN THE THE DESCENDING 7426 04:46:49,520 --> 04:46:50,800 VALUE BY WEIGHT. 7427 04:46:50,800 --> 04:46:53,080 THIS IS THE EARLIER SLIDE TO THE 7428 04:46:53,080 --> 04:46:54,520 RIGHT OF THE PROPRIETARY BLEND, 7429 04:46:54,520 --> 04:46:56,800 WHERE YOU CAN SEE TOTAL AMOUNT 7430 04:46:56,800 --> 04:46:59,000 OF THE BLEND IS DECLARED, 7431 04:46:59,000 --> 04:47:01,760 THERE'S A LIST OF INGREDIENTS IN 7432 04:47:01,760 --> 04:47:02,960 DECLINING ORDER OF PREDOMINANCE 7433 04:47:02,960 --> 04:47:06,000 BUT THE WEIGHT OF EACH OF THOSE 7434 04:47:06,000 --> 04:47:07,640 INGREDIENTS IS NOT PROVIDED ON 7435 04:47:07,640 --> 04:47:10,480 THE LABEL OR DECLARED ON THE 7436 04:47:10,480 --> 04:47:10,840 LABEL. 7437 04:47:10,840 --> 04:47:12,680 SO, THIS IS IMPORTANT WHEN YOU 7438 04:47:12,680 --> 04:47:14,800 SEE THE DSLD. 7439 04:47:14,800 --> 04:47:16,880 THIS IS NOT BECAUSE NIH IS 7440 04:47:16,880 --> 04:47:18,680 SLOPPY AND THIS IS IMPORTANT TO 7441 04:47:18,680 --> 04:47:19,920 KEEP IN MIND. 7442 04:47:19,920 --> 04:47:24,720 IF YOU SEE THE VALUES ON THE 7443 04:47:24,720 --> 04:47:26,080 DSLD SHOWN FOR CAFFEINE IT'S 7444 04:47:26,080 --> 04:47:29,440 BECAUSE THE MANUFACTURER HAS 7445 04:47:29,440 --> 04:47:31,840 CHOSEN TO DECLARE CAFFEINE AS A 7446 04:47:31,840 --> 04:47:33,720 PROPRIETARY BLEND, AND NOT PRINT 7447 04:47:33,720 --> 04:47:37,520 THE AMOUNT OF CAFFEINE ON THE 7448 04:47:37,520 --> 04:47:38,960 LABEL. 7449 04:47:38,960 --> 04:47:40,720 REMEMBER, THE DSLD IS 7450 04:47:40,720 --> 04:47:41,800 INFORMATION DERIVED FROM 7451 04:47:41,800 --> 04:47:44,960 INFORMATION PRINTED ON THE 7452 04:47:44,960 --> 04:47:47,240 LABELS, SO FOR MAYBE BIOACTIVES 7453 04:47:47,240 --> 04:47:50,280 OF INTEREST TO RESEARCHERS, 7454 04:47:50,280 --> 04:47:51,480 DEPENDING ON THE BIOACTIVE 7455 04:47:51,480 --> 04:47:54,080 BETWEEN 20 TO 70% OF LABELS MAY 7456 04:47:54,080 --> 04:47:58,560 NOT LIST THE AMOUNT OF THESE 7457 04:47:58,560 --> 04:47:59,240 INGREDIENTS. 7458 04:47:59,240 --> 04:48:02,760 SO WHAT ARE THE IMPLICATIONS FOR 7459 04:48:02,760 --> 04:48:04,000 RESEARCHERS AND PRACTITIONERS? 7460 04:48:04,000 --> 04:48:06,920 A RESEARCHER MAY BE UNABLE TO 7461 04:48:06,920 --> 04:48:10,000 ESTIMATE POPULATION INTAKES AND 7462 04:48:10,000 --> 04:48:12,480 EXPOSURE AMOUNTS OR INGREDIENTS, 7463 04:48:12,480 --> 04:48:14,360 OR PUBLIC HEALTH INTERESTS, 7464 04:48:14,360 --> 04:48:16,440 EXAMPLE CATCH EVEN. 7465 04:48:16,440 --> 04:48:18,200 PRACTITIONERS MAY BE UNABLE TO 7466 04:48:18,200 --> 04:48:19,640 DETERMINE DOSAGE AND INTERACTION 7467 04:48:19,640 --> 04:48:22,440 WITH OTHER FOODS OR DRUGS IF 7468 04:48:22,440 --> 04:48:25,560 AMOUNTS OF INGREDIENTS ARE NOT 7469 04:48:25,560 --> 04:48:26,920 DECLARED ON THE LABEL. 7470 04:48:26,920 --> 04:48:29,280 SO IN MY NEXT SET OF SLIDES, 7471 04:48:29,280 --> 04:48:32,320 FINALLY, I WILL SHOW YOU THE 7472 04:48:32,320 --> 04:48:33,720 FEATURES OF THE DSLD. 7473 04:48:33,720 --> 04:48:36,560 ON THIS SLIDE IS A SNAPSHOT OF 7474 04:48:36,560 --> 04:48:37,920 THE HOME PAGE. 7475 04:48:37,920 --> 04:48:40,000 AS YOU CAN SEE ON THE SLIDE, THE 7476 04:48:40,000 --> 04:48:44,720 NUMBER OF LABELS IN THE DATABASE 7477 04:48:44,720 --> 04:48:47,280 IS PROMINENTLY DISPLAYED, IF YOU 7478 04:48:47,280 --> 04:48:48,480 WORKED WITH THE PREVIOUS SLIDE 7479 04:48:48,480 --> 04:48:51,560 THIS IS A NEW FEATURE OF THE 7480 04:48:51,560 --> 04:48:54,040 DATABASE THAT WAS LAUNCHED LAST 7481 04:48:54,040 --> 04:48:54,320 YEAR. 7482 04:48:54,320 --> 04:48:56,080 YOU CAN NAVIGATE DATABASE USING 7483 04:48:56,080 --> 04:48:59,280 THE TABS IN THE MENU BOX ABOVE. 7484 04:48:59,280 --> 04:49:01,320 IF YOU SCROLL DOWN, YOU WILL 7485 04:49:01,320 --> 04:49:04,280 FIND OTHER INFORMATION ABOUT THE 7486 04:49:04,280 --> 04:49:06,800 DATABASE, AND INFORMATION ON NEW 7487 04:49:06,800 --> 04:49:08,320 FEATURES AND UPDATES. 7488 04:49:08,320 --> 04:49:11,320 YOU CAN START YOUR SEARCH FROM 7489 04:49:11,320 --> 04:49:14,720 THIS STAGE, I PREFER TO GO TO 7490 04:49:14,720 --> 04:49:18,840 THE SEARCH PAGE. 7491 04:49:18,840 --> 04:49:20,160 ALL RIGHT. 7492 04:49:20,160 --> 04:49:23,000 ON THE SEARCH PAGE IS AN EXAMPLE 7493 04:49:23,000 --> 04:49:26,280 FOR A SEARCH FOR IRON. 7494 04:49:26,280 --> 04:49:28,440 SO WHEN YOU ENTER IRON IN THE 7495 04:49:28,440 --> 04:49:31,000 SEARCH BAR, IT WILL SEARCH FOR 7496 04:49:31,000 --> 04:49:35,480 IRON THAT IS PRINTED ANYWHERE ON 7497 04:49:35,480 --> 04:49:36,560 THE LABEL. 7498 04:49:36,560 --> 04:49:39,400 YOU CAN NARROW YOUR SEARCH USING 7499 04:49:39,400 --> 04:49:49,920 THE FILTERS IN THE LEFT-HAND 7500 04:49:49,920 --> 04:49:52,520 COLUMN, SIMILAR TO THE COLUMN 7501 04:49:52,520 --> 04:49:54,000 YOU WOULD SEE IN PubMed. 7502 04:49:54,000 --> 04:49:56,560 AS YOU CAN SEE HERE THE FIRST 7503 04:49:56,560 --> 04:49:59,880 THING I DID WAS I NARROWED THE 7504 04:49:59,880 --> 04:50:03,480 SEARCH TO PRODUCTS ON MARKET, I 7505 04:50:03,480 --> 04:50:07,600 FURTHER NARROWED THE SEARCH TO 7506 04:50:07,600 --> 04:50:09,840 PRODUCTS ENTERED BETWEEN 2018 7507 04:50:09,840 --> 04:50:13,920 AND 2020. 7508 04:50:13,920 --> 04:50:15,840 I FURTHER SELECTED THE TARGET 7509 04:50:15,840 --> 04:50:17,720 PREGNANT AND LACTATING WOMEN, I 7510 04:50:17,720 --> 04:50:20,200 WAS ONLY INTERESTED IN PRENATAL 7511 04:50:20,200 --> 04:50:22,840 SUPPLEMENTS, AND THEN I FURTHER 7512 04:50:22,840 --> 04:50:25,800 NARROWED THE SEARCH BY THE 7513 04:50:25,800 --> 04:50:28,320 PRODUCT TYPE AND DID NOT INCLUDE 7514 04:50:28,320 --> 04:50:32,840 ALL THE PRODUCT TYPES PRENATAL 7515 04:50:32,840 --> 04:50:34,240 SUPPLEMENTS COME IN. 7516 04:50:34,240 --> 04:50:38,480 AND THIS RESULTED IN 64 LABELS 7517 04:50:38,480 --> 04:50:40,680 IN THE DATABASE. 7518 04:50:40,680 --> 04:50:43,960 YOU CAN THEN DOWNLOAD THIS 7519 04:50:43,960 --> 04:50:46,520 SEARCH, AND THE DSLD GIVES YOU A 7520 04:50:46,520 --> 04:50:49,800 VARIETY OF OPTIONS FOR 7521 04:50:49,800 --> 04:50:51,120 DOWNLOADING YOUR SEARCH RESULT, 7522 04:50:51,120 --> 04:50:52,960 IF YOU'RE A RESEARCHER YOU CAN 7523 04:50:52,960 --> 04:50:59,120 GET IT IN XL FORMAT, A COMMA 7524 04:50:59,120 --> 04:51:00,840 SEPARATED FILE FORMAT OR JSON 7525 04:51:00,840 --> 04:51:01,320 FILE FORMAT. 7526 04:51:01,320 --> 04:51:03,240 ONCE YOU CLICK ON THIS BUTTON IT 7527 04:51:03,240 --> 04:51:04,680 WILL TAKE YOU TO ANOTHER PAGE, 7528 04:51:04,680 --> 04:51:07,760 WHERE IT WILL ALSO GIVE YOU 7529 04:51:07,760 --> 04:51:09,400 OPTIONS ON HOW MUCH INFORMATION 7530 04:51:09,400 --> 04:51:11,360 YOU REALLY WANT SO YOU CAN 7531 04:51:11,360 --> 04:51:17,360 CHOOSE WHAT INFORMATION YOU 7532 04:51:17,360 --> 04:51:20,760 WANT. 7533 04:51:20,760 --> 04:51:22,880 ON THIS PAGE IS THE INGREDIENTS 7534 04:51:22,880 --> 04:51:25,600 PAGE, CHANGED IN THE UPDATED 7535 04:51:25,600 --> 04:51:26,680 DATABASE. 7536 04:51:26,680 --> 04:51:30,760 SO, WHEN YOU GO TO THE BROWSER 7537 04:51:30,760 --> 04:51:34,560 INGREDIENT PAGE AND SEARCH FOR 7538 04:51:34,560 --> 04:51:35,880 AN INGREDIENT, UNLIKE THE OLD 7539 04:51:35,880 --> 04:51:37,400 SITE WHERE IT TOOK YOU AND GAVE 7540 04:51:37,400 --> 04:51:42,080 YOU A LIST OF PRODUCTS, HERE 7541 04:51:42,080 --> 04:51:44,080 I'LL SHOW YOU SHORTLY IT DOES 7542 04:51:44,080 --> 04:51:45,160 NOT DO THAT. 7543 04:51:45,160 --> 04:51:49,080 AND WHAT IT DOES IS WHEN YOU GO 7544 04:51:49,080 --> 04:51:50,600 TO THE NEXT WHAT IT TAKES YOU 7545 04:51:50,600 --> 04:51:53,280 TO, THIS IS SOME OF THE 7546 04:51:53,280 --> 04:51:54,480 INFORMATION THAT JOYCE JUST 7547 04:51:54,480 --> 04:51:58,320 SHARED WITH YOU, BUT A DIFFERENT 7548 04:51:58,320 --> 04:52:01,360 WAY OF FINDING IT THROUGH THE 7549 04:52:01,360 --> 04:52:02,160 DSLD SITE. 7550 04:52:02,160 --> 04:52:04,120 SO, STAYING WITH IRON, CLICKING 7551 04:52:04,120 --> 04:52:06,200 WITH IRON, THIS INFORMATION 7552 04:52:06,200 --> 04:52:07,960 ACTUALLY WORKS IN THE OLD 7553 04:52:07,960 --> 04:52:10,160 DATABASE BUT IT WAS BURIED IN 7554 04:52:10,160 --> 04:52:15,720 THE DATABASE AND WE THOUGHT THIS 7555 04:52:15,720 --> 04:52:16,720 WAS IMPORTANT INFORMATION PEOPLE 7556 04:52:16,720 --> 04:52:17,800 WOULD LIKE TO KNOW, A GOOD 7557 04:52:17,800 --> 04:52:19,480 STARTING POINT TO HELP YOU WITH 7558 04:52:19,480 --> 04:52:21,040 YOUR RESEARCH. 7559 04:52:21,040 --> 04:52:22,760 SO MANY THINGS JOYCE TALKED 7560 04:52:22,760 --> 04:52:26,200 ABOUT IN HER PRESENTATION, FACT 7561 04:52:26,200 --> 04:52:26,720 SHEET, PubMed SEARCHES, 7562 04:52:26,720 --> 04:52:30,360 HERE'S ANOTHER WAY TO GET TO IT 7563 04:52:30,360 --> 04:52:33,840 BY LOOKING, SEARCHING FOR THE 7564 04:52:33,840 --> 04:52:37,440 INGREDIENT. 7565 04:52:37,440 --> 04:52:40,400 SO, UNDER THE RESOURCES PAGE, 7566 04:52:40,400 --> 04:52:44,880 YOU FIND ALSO OTHER USEFUL 7567 04:52:44,880 --> 04:52:45,200 INFORMATION. 7568 04:52:45,200 --> 04:52:48,040 I DID WANT TO BRING YOUR 7569 04:52:48,040 --> 04:52:50,880 ATTENTION TO THE RELEASE HISTORY 7570 04:52:50,880 --> 04:52:51,280 BUTTON. 7571 04:52:51,280 --> 04:52:54,440 SO ON THE RELEASE HISTORY, YOU 7572 04:52:54,440 --> 04:52:58,320 WILL GET HISTORY OF WHEN THE 7573 04:52:58,320 --> 04:53:00,720 DATABASE WAS UPDATED, AND SO THE 7574 04:53:00,720 --> 04:53:02,320 NEWEST RELEASE WAS ACTUALLY JUST 7575 04:53:02,320 --> 04:53:06,120 TWO WEEKS AGO, PRIOR TO THAT IF 7576 04:53:06,120 --> 04:53:07,920 YOU SEARCHED YOU WOULD HAVE 7577 04:53:07,920 --> 04:53:09,560 GOTTEN 136,000 LABELS, SO THE 7578 04:53:09,560 --> 04:53:11,320 RELEASE WILL GIVE YOU A HISTORY 7579 04:53:11,320 --> 04:53:14,400 OF, YOU KNOW, WHAT THE UPDATES 7580 04:53:14,400 --> 04:53:18,400 HAVE BEEN -- UPDATES TO THE 7581 04:53:18,400 --> 04:53:22,480 DATABASE. 7582 04:53:22,480 --> 04:53:24,480 SO, MOVING TO MY LAST TWO SLIDES 7583 04:53:24,480 --> 04:53:27,880 ON THE USE OF CONVERSION 7584 04:53:27,880 --> 04:53:32,320 FACTORS, AS IT RELATES TO 7585 04:53:32,320 --> 04:53:34,160 DIETARY SUPPLEMENT LABEL 7586 04:53:34,160 --> 04:53:35,800 DATABASES, LABELS, SORRY, AS YOU 7587 04:53:35,800 --> 04:53:38,360 CAN SEE FROM THIS SLIDE THE 7588 04:53:38,360 --> 04:53:39,960 UNITS USED FOR EXPRESSING THE 7589 04:53:39,960 --> 04:53:43,520 AMOUNT OF NUTRIENTS ON LABELS 7590 04:53:43,520 --> 04:53:45,240 HAS CHANGED, AND ESPECIALLY FOR 7591 04:53:45,240 --> 04:53:51,360 THE FAT SOLUBLE VITAMINS, GONE 7592 04:53:51,360 --> 04:53:54,240 FROM IUs TO MICROGRAMS, AND 7593 04:53:54,240 --> 04:54:00,280 FOLATE HAS GONE TO MICROGRAMS TO 7594 04:54:00,280 --> 04:54:01,680 DIETARY FOLATE. 7595 04:54:01,680 --> 04:54:04,200 SO MY INTENT WITH THIS SLIDE IS 7596 04:54:04,200 --> 04:54:07,920 NOT TO TELL YOU WHAT CONVERSION 7597 04:54:07,920 --> 04:54:11,400 FACTORS TO USE BUT TO MAKE AN 7598 04:54:11,400 --> 04:54:15,040 IMPORTANT POINT ABOUT YOUR 7599 04:54:15,040 --> 04:54:17,360 CHOICE OF CONVERSION FACTORS. 7600 04:54:17,360 --> 04:54:21,080 USING FOLATE AS AN EXAMPLE, I 7601 04:54:21,080 --> 04:54:23,840 WANT TO SHOW YOU DEPENDING WHICH 7602 04:54:23,840 --> 04:54:28,480 CONVERSION FACTOR YOU USE, YOU 7603 04:54:28,480 --> 04:54:30,960 CAN GET DIFFERENT ANSWERS. 7604 04:54:30,960 --> 04:54:32,480 SO THE UNITS FOR EXPRESSING 7605 04:54:32,480 --> 04:54:35,960 FOLATE AS I SAID IS NOW DIETARY 7606 04:54:35,960 --> 04:54:37,080 FOLATE EQUIVALENCE. 7607 04:54:37,080 --> 04:54:39,600 AND THE FOOD AND NUTRITION BOARD 7608 04:54:39,600 --> 04:54:43,760 AND THEIR REFERENCE INTAKE 7609 04:54:43,760 --> 04:54:54,280 PUBLICATION FOR B VITAMINS GIVES 7610 04:54:55,200 --> 04:54:55,920 TWO FORMULAS, MULTIPLYING BY 1.7 7611 04:54:55,920 --> 04:54:58,320 OR IF THE PRODUCT IS CONSUMED 7612 04:54:58,320 --> 04:55:02,400 WITH FOOD YOU DIVIDE BY .6, IF 7613 04:55:02,400 --> 04:55:06,480 IT IS TAKEN ON EMPTY STOMACH YOU 7614 04:55:06,480 --> 04:55:07,880 DIVIDE BY .5. 7615 04:55:07,880 --> 04:55:11,160 SO, YOU CAN GET VERY DIFFERENT 7616 04:55:11,160 --> 04:55:13,720 ANSWERS, DEPENDING ON WHICH 7617 04:55:13,720 --> 04:55:16,640 FORMULA YOU USE TO CONVERT THE 7618 04:55:16,640 --> 04:55:18,520 800 MICROGRAMS OF FOLIC ACID 7619 04:55:18,520 --> 04:55:24,600 WHICH IS A TYPICAL AMOUNT FOUND 7620 04:55:24,600 --> 04:55:28,000 IN PRENATAL SUPPLEMENTS TO THE 7621 04:55:28,000 --> 04:55:31,200 NEW AMOUNT AS DIETARY FOLATE 7622 04:55:31,200 --> 04:55:33,800 EQUIVALENCE. 7623 04:55:33,800 --> 04:55:35,760 SO FOR LABELING PURPOSES, THE 7624 04:55:35,760 --> 04:55:37,720 FDA HAS A GUIDANCE DOCUMENT AND 7625 04:55:37,720 --> 04:55:43,120 IT'S A REALLY EXCELLENT GUIDANCE 7626 04:55:43,120 --> 04:55:44,120 DOCUMENT THAT I'M CURRENTLY 7627 04:55:44,120 --> 04:55:51,760 SEEING NOT ONLY GIVING YOU 7628 04:55:51,760 --> 04:55:52,360 CONVERGENCE FACTORS, FDA 7629 04:55:52,360 --> 04:55:54,680 SELECTED 1.7, BUT WALK YOU 7630 04:55:54,680 --> 04:55:56,800 THROUGH HOW TO DO THE 7631 04:55:56,800 --> 04:55:57,560 CALCULATION. 7632 04:55:57,560 --> 04:55:59,760 IF FOR LABELING PURPOSES, PLEASE 7633 04:55:59,760 --> 04:56:01,400 USE THE FDA GUIDANCE DOCUMENT. 7634 04:56:01,400 --> 04:56:07,280 IF IT'S FOR RESEARCH PURPOSES, 7635 04:56:07,280 --> 04:56:10,040 USE WHICH EVER CONVERSION FACTOR 7636 04:56:10,040 --> 04:56:12,800 IS COMMON FOR THAT PUBLICATION, 7637 04:56:12,800 --> 04:56:17,520 BUT FOR SITE FOR REFERENCE WHAT 7638 04:56:17,520 --> 04:56:20,880 YOU USED AND WHY. 7639 04:56:20,880 --> 04:56:25,480 MY TAKEAWAYS, ONE, DIETARY 7640 04:56:25,480 --> 04:56:26,800 SUPPLEMENTS ARE FOOD, DSHEA 7641 04:56:26,800 --> 04:56:31,680 CREATED A NEW CLASS OF 7642 04:56:31,680 --> 04:56:34,960 INGREDIENTS CALLED DIETARY 7643 04:56:34,960 --> 04:56:36,880 INGREDIENTS. 7644 04:56:36,880 --> 04:56:38,640 SINCE THE DSLD CONTAINS 7645 04:56:38,640 --> 04:56:39,760 INFORMATION PRINTED ON LABELS, 7646 04:56:39,760 --> 04:56:45,440 THIS AFFECT WHAT IS IS IN THE 7647 04:56:45,440 --> 04:56:45,880 DSLD. 7648 04:56:45,880 --> 04:56:46,720 REGARDING DIETARY INGREDIENTS, 7649 04:56:46,720 --> 04:56:50,360 MOST DO NOT HAVE DAILY VALUES. 7650 04:56:50,360 --> 04:56:52,800 YOU CAN MAKE STATEMENTS OF 7651 04:56:52,800 --> 04:56:55,240 NUTRITIONAL SUPPORT FOR ANY 7652 04:56:55,240 --> 04:56:56,080 DIETARY INGREDIENT DECLARED 7653 04:56:56,080 --> 04:56:59,480 WITHIN THE SUPPLEMENT FACT BOX. 7654 04:56:59,480 --> 04:57:01,920 AND YOU CAN DECLARE DIETARY 7655 04:57:01,920 --> 04:57:04,960 INGREDIENTS THAT DO NOT HAVE 7656 04:57:04,960 --> 04:57:08,560 DAILY VALUES AS PROPRIETARY 7657 04:57:08,560 --> 04:57:09,360 BLENDS. 7658 04:57:09,360 --> 04:57:12,280 HOW DOES THIS IMPACT THE DSLD? 7659 04:57:12,280 --> 04:57:15,360 IF AN INGREDIENT IS LISTED 7660 04:57:15,360 --> 04:57:18,640 WITHIN A PROPRIETARY BLEND, YOU 7661 04:57:18,640 --> 04:57:22,160 WILL FIND BLANK AMOUNT IN THE 7662 04:57:22,160 --> 04:57:23,000 DSLD. 7663 04:57:23,000 --> 04:57:26,520 AND WE DO NOT CATEGORIZE THE 7664 04:57:26,520 --> 04:57:30,360 CLAIMS BASED ON -- SORRY, DO NOT 7665 04:57:30,360 --> 04:57:31,160 CATEGORIZE PRODUCTS BASED ON 7666 04:57:31,160 --> 04:57:34,760 INTENDED USE BECAUSE THERE IS NO 7667 04:57:34,760 --> 04:57:35,600 CATEGORIZATION SCHEME FOR 7668 04:57:35,600 --> 04:57:36,080 CLAIMS. 7669 04:57:36,080 --> 04:57:38,120 AND THIS IS VERY IMPORTANT 7670 04:57:38,120 --> 04:57:40,120 BECAUSE WE KEEP GETTING ASKED, 7671 04:57:40,120 --> 04:57:42,200 YOU KNOW, IS THERE A SEARCH FOR 7672 04:57:42,200 --> 04:57:44,200 INTENDED USE AND THERE IS NOT OF 7673 04:57:44,200 --> 04:57:47,680 NO SEARCH FOR INTENDED USE. 7674 04:57:47,680 --> 04:57:50,000 THANK YOU FOR LISTENING. 7675 04:57:50,000 --> 04:57:52,600 ONE LAST SHAMELESS SLIDE. 7676 04:57:52,600 --> 04:57:54,040 I'M SORRY. 7677 04:57:54,040 --> 04:57:58,000 IF YOU'RE REGISTERED TO ATTEND 7678 04:57:58,000 --> 04:57:59,080 NUTRITION 2022, I ENCOURAGE YOU 7679 04:57:59,080 --> 04:58:02,240 TO LISTEN TO OUR SESSION ON 7680 04:58:02,240 --> 04:58:03,680 PROPRIETARY BLENDS. 7681 04:58:03,680 --> 04:58:05,960 WE HAVE TWO EXCELLENT PANELISTS 7682 04:58:05,960 --> 04:58:08,920 AT THE SESSION, THAT WILL 7683 04:58:08,920 --> 04:58:10,600 PROVIDE YOU WITH REGULATORY AND 7684 04:58:10,600 --> 04:58:11,480 INDUSTRY PERSPECTIVE ON BLENDS. 7685 04:58:11,480 --> 04:58:15,480 THANK YOU VERY MUCH. 7686 04:58:15,480 --> 04:58:18,760 I'M GOING TO SHOP SHARING. 7687 04:58:18,760 --> 04:58:21,680 7688 04:58:21,680 --> 04:58:22,880 7689 04:58:22,880 --> 04:58:27,880 AND ARE WE BACK TO -- I STOPPED 7690 04:58:27,880 --> 04:58:28,120 SHARING. 7691 04:58:28,120 --> 04:58:29,320 ARE WE BACK? 7692 04:58:29,320 --> 04:58:32,000 OKAY, GREAT. 7693 04:58:32,000 --> 04:58:33,040 >> YES. 7694 04:58:33,040 --> 04:58:33,400 OKAY. 7695 04:58:33,400 --> 04:58:34,920 SO, I THINK THIS QUESTION MIGHT 7696 04:58:34,920 --> 04:58:38,120 BE A LITTLE OUT OF SCOPE BUT I 7697 04:58:38,120 --> 04:58:39,360 WILL ASK. 7698 04:58:39,360 --> 04:58:43,480 IT SAID, OF THE NINE AMINO ACIDS 7699 04:58:43,480 --> 04:58:46,120 NOT SYNTHESIZED AND ARE 7700 04:58:46,120 --> 04:58:47,560 THEREFORE ESSENTIAL, OR 7701 04:58:47,560 --> 04:58:48,560 INDISPENSABLE NUTRIENTS, WHY 7702 04:58:48,560 --> 04:58:53,920 DON'T THEY HAVE A DV? 7703 04:58:53,920 --> 04:58:56,400 >> WELL, THE DAILY -- SO, THE 7704 04:58:56,400 --> 04:59:01,040 WAY FDA ARRIVES AT THE DAILY 7705 04:59:01,040 --> 04:59:03,560 VALUES, THE BOARD ARRIVED AT THE 7706 04:59:03,560 --> 04:59:05,400 DIETARY REFERENCE INTAKE. 7707 04:59:05,400 --> 04:59:07,520 THE FDA DOESN'T REALLY ARRIVE AT 7708 04:59:07,520 --> 04:59:10,560 DV IF IT HAS NOT BEEN ARRIVED AT 7709 04:59:10,560 --> 04:59:12,360 BY THE FOOD AND NUTRITION BOARD, 7710 04:59:12,360 --> 04:59:14,160 AND IF THE FOOD AND NUTRITION 7711 04:59:14,160 --> 04:59:16,800 BOARD DOES NOT HAVE A DIETARY 7712 04:59:16,800 --> 04:59:18,600 REFERENCE INTAKE OR ANY 7713 04:59:18,600 --> 04:59:21,760 NUTRIENTS, THERE IS NO DV. 7714 04:59:21,760 --> 04:59:27,920 SO THE CONCEPT OF DV IS DERIVED 7715 04:59:27,920 --> 04:59:32,320 FROM THE DRIs THAT THE FOOD 7716 04:59:32,320 --> 04:59:35,240 AND NUTRITION BOARD PUBLISHES. 7717 04:59:35,240 --> 04:59:36,280 DOES THAT HELP? 7718 04:59:36,280 --> 04:59:39,240 >> YES, I THINK SO. 7719 04:59:39,240 --> 04:59:44,920 IT SAYS THAT I THINK YOU 7720 04:59:44,920 --> 04:59:46,880 ANSWERED DIFFERENCE BETWEEN RDI 7721 04:59:46,880 --> 04:59:49,320 AND DV. 7722 04:59:49,320 --> 04:59:52,600 >> THE DV IS THE -- THE WAY THE 7723 04:59:52,600 --> 04:59:55,880 DV IS DERIVED IS IT'S ONLY -- 7724 04:59:55,880 --> 04:59:58,920 THERE ARE ONLY FOUR DVs, FOR 7725 04:59:58,920 --> 05:00:03,640 OF AGES 4 AND ABOVE, FOR 7726 05:00:03,640 --> 05:00:05,440 INFANTS, PREGNANT AND LACTATING 7727 05:00:05,440 --> 05:00:06,320 WOMEN, FOR CHILDREN 1-4. 7728 05:00:06,320 --> 05:00:08,840 IF YOU GO TO THE DRI TABLES 7729 05:00:08,840 --> 05:00:11,920 YOU'LL SEE THAT THERE ARE A LOT 7730 05:00:11,920 --> 05:00:15,320 MORE AGE, GENDER GROUPS, IN THE 7731 05:00:15,320 --> 05:00:15,960 DRI TABLES. 7732 05:00:15,960 --> 05:00:18,400 WHAT THE FDA DOES IS SELECT, THE 7733 05:00:18,400 --> 05:00:20,920 HIGHEST AMOUNT WITHIN EACH OF 7734 05:00:20,920 --> 05:00:22,360 THOSE GROUPS, TO ARRIVE AT THE 7735 05:00:22,360 --> 05:00:27,440 DV. 7736 05:00:27,440 --> 05:00:28,200 >> GREAT. 7737 05:00:28,200 --> 05:00:29,560 THANK YOU. 7738 05:00:29,560 --> 05:00:32,160 AND THE QUESTIONER HAS ANOTHER 7739 05:00:32,160 --> 05:00:33,160 QUESTION RELATED, HE SEEMS TO BE 7740 05:00:33,160 --> 05:00:34,640 UNDER THE IMPRESSION YOU SAID 7741 05:00:34,640 --> 05:00:38,560 THAT ONE OF THE AMINO ACIDS DOES 7742 05:00:38,560 --> 05:00:39,160 HAVE A DV? 7743 05:00:39,160 --> 05:00:44,320 >> ONE OF THE AMINO ACIDS DOES 7744 05:00:44,320 --> 05:00:45,800 HAVE A DV? 7745 05:00:45,800 --> 05:00:48,520 NO AMINO ACID, TO THE BEST OF MY 7746 05:00:48,520 --> 05:00:50,760 KNOWLEDGE HAS A DRI. 7747 05:00:50,760 --> 05:00:53,760 AND THEREFORE IT CANNOT HAVE A 7748 05:00:53,760 --> 05:00:54,000 DV. 7749 05:00:54,000 --> 05:00:55,640 >> RIGHT, YEAH, I THINK THAT WAS 7750 05:00:55,640 --> 05:00:56,640 THE MISUNDERSTANDING. 7751 05:00:56,640 --> 05:00:56,840 OKAY. 7752 05:00:56,840 --> 05:01:01,920 I HAVE A QUESTION ABOUT THE 7753 05:01:01,920 --> 05:01:02,360 DSLD. 7754 05:01:02,360 --> 05:01:04,360 WHEN YOU'RE DOING A SEARCH, AND 7755 05:01:04,360 --> 05:01:08,480 YOU LIMIT IT BY YEARS, AS YOU 7756 05:01:08,480 --> 05:01:11,320 DID, SAY 2018 TO 2020, AND THEN 7757 05:01:11,320 --> 05:01:17,480 YOU SAY, ON MARKET, DOES THAT 7758 05:01:17,480 --> 05:01:20,320 MEAN YOU ONLY WANT SEARCH 7759 05:01:20,320 --> 05:01:22,640 RESULTS THAT THE PRODUCT WAS ON 7760 05:01:22,640 --> 05:01:23,520 MARKET DURING THOSE YEARS? 7761 05:01:23,520 --> 05:01:25,760 OR DOES IT HAVE TO BE ON MARKET 7762 05:01:25,760 --> 05:01:27,120 AT THE TIME OF THE SEARCH? 7763 05:01:27,120 --> 05:01:28,320 IT MAY HAVE BEEN ON MARKET AT 7764 05:01:28,320 --> 05:01:31,400 THE TIME BUT NOW IT'S NOT ON 7765 05:01:31,400 --> 05:01:31,640 MARKET. 7766 05:01:31,640 --> 05:01:33,000 >> SO, IT'S IMPORTANT TO 7767 05:01:33,000 --> 05:01:36,520 UNDERSTAND THE CONCEPT OF ON 7768 05:01:36,520 --> 05:01:42,760 MARKET AND OFF MARKET IN THE 7769 05:01:42,760 --> 05:01:43,520 DSLD. 7770 05:01:43,520 --> 05:01:46,080 SO, WHEN -- SO THERAPEUTIC 7771 05:01:46,080 --> 05:01:47,280 RESEARCH CENTER, AN ORGANIZATION 7772 05:01:47,280 --> 05:01:50,640 THAT JOYCE MENTIONED IN HER 7773 05:01:50,640 --> 05:01:54,360 PRESENTATION, HAS THE ODS 7774 05:01:54,360 --> 05:01:56,200 CONTRACT FOR SECURING LABELS, 7775 05:01:56,200 --> 05:02:00,280 CODING LABELS THAT ARE ENTERED 7776 05:02:00,280 --> 05:02:01,560 IN THE DATABASE. 7777 05:02:01,560 --> 05:02:02,920 ASSOCIATES HAS A CONTRACT FOR 7778 05:02:02,920 --> 05:02:05,000 DESIGN AND SEARCH AND FEATURES 7779 05:02:05,000 --> 05:02:06,960 OF THE DSLD. 7780 05:02:06,960 --> 05:02:08,040 WHEN THEY RECEIVE THE LABELS, 7781 05:02:08,040 --> 05:02:11,320 THEY ENTER IT IN THE DATABASE, 7782 05:02:11,320 --> 05:02:12,760 AND WHEN THEY RECEIVE 7783 05:02:12,760 --> 05:02:17,240 INFORMATION THAT THESE LABELS 7784 05:02:17,240 --> 05:02:18,800 ARE NO LONGER BEING -- NO LONGER 7785 05:02:18,800 --> 05:02:21,480 IN THE MARKETPLACE THEY TAKE 7786 05:02:21,480 --> 05:02:23,400 THEM OFF MARKET. 7787 05:02:23,400 --> 05:02:25,240 SO THIS ON MARKET/OFF MARKET IS 7788 05:02:25,240 --> 05:02:28,520 BASED ON THE CODING OF WHEN THE 7789 05:02:28,520 --> 05:02:30,440 LABELS WERE ENTERED AND ENTERED 7790 05:02:30,440 --> 05:02:31,880 INTO THE DATABASE, AND WHEN THEY 7791 05:02:31,880 --> 05:02:34,000 WERE TAKEN OUT. 7792 05:02:34,000 --> 05:02:38,520 SO WHEN I CHOSE LIKE 2018 TO 7793 05:02:38,520 --> 05:02:41,480 2020, AS MY SEARCH FOR IRON, FOR 7794 05:02:41,480 --> 05:02:44,640 EXAMPLE, AND I SEARCHED FOR 7795 05:02:44,640 --> 05:02:46,760 LABELS ON MARKET, DURING THOSE 7796 05:02:46,760 --> 05:02:50,320 YEARS THOSE LABELS WERE ON 7797 05:02:50,320 --> 05:02:51,560 MARKET. 7798 05:02:51,560 --> 05:02:56,120 >> OKAY. 7799 05:02:56,120 --> 05:02:57,920 >> IN 2021 SOME COULD HAVE BEEN 7800 05:02:57,920 --> 05:02:59,520 TAKEN OFF MARKET. 7801 05:02:59,520 --> 05:02:59,840 >> RIGHT. 7802 05:02:59,840 --> 05:03:03,560 BUT THEY WOULD STILL COME UP IN 7803 05:03:03,560 --> 05:03:04,480 SEARCH RESULTS. 7804 05:03:04,480 --> 05:03:06,320 >> IN 2021, NO, BECAUSE I WROTE 7805 05:03:06,320 --> 05:03:07,880 MY SEARCH FOR 2018 AND 2020, 7806 05:03:07,880 --> 05:03:11,840 WHICH MEANS I DID NOT INCLUDE 7807 05:03:11,840 --> 05:03:14,600 ANY LABELS BEFORE 2018 AND AFTER 7808 05:03:14,600 --> 05:03:17,280 2020. 7809 05:03:17,280 --> 05:03:18,440 >> RIGHT. 7810 05:03:18,440 --> 05:03:19,240 OKAY. 7811 05:03:19,240 --> 05:03:20,520 GREAT. 7812 05:03:20,520 --> 05:03:24,280 AND ANOTHER QUESTION COMING IN. 7813 05:03:24,280 --> 05:03:26,240 SAYS THE DSLD ALSO HAS 7814 05:03:26,240 --> 05:03:28,200 CONVERSION FACTORS FOR THE 7815 05:03:28,200 --> 05:03:30,720 NUTRIENT AMOUNTS IN THEIR 7816 05:03:30,720 --> 05:03:32,840 SEGREGATED LABELS? 7817 05:03:32,840 --> 05:03:34,520 I'M NOT SURE I -- 7818 05:03:34,520 --> 05:03:35,920 >> I DON'T KNOW WHAT -- 7819 05:03:35,920 --> 05:03:38,600 >> I'M NOT SURE I UNDERSTAND 7820 05:03:38,600 --> 05:03:43,000 THAT QUESTION. 7821 05:03:43,000 --> 05:03:46,400 JAMES, CAN WE UNMUTE SABA, OR HE 7822 05:03:46,400 --> 05:03:49,560 OR SHE CAN ASK THE QUESTION? 7823 05:03:49,560 --> 05:03:52,000 7824 05:03:52,000 --> 05:03:53,800 I THINK IT APPEARS IN THE CHAT. 7825 05:03:53,800 --> 05:04:02,080 YEAH. 7826 05:04:02,080 --> 05:04:04,160 ALSO HAVE CONVERSION FACTORS FOR 7827 05:04:04,160 --> 05:04:08,000 THE NUTRIENT AMOUNTS? 7828 05:04:08,000 --> 05:04:11,920 IN THEIR SEGREGATED LABELS. 7829 05:04:11,920 --> 05:04:16,320 >> OH, YOU MEAN IF IT'S IN 7830 05:04:16,320 --> 05:04:18,040 GRAMS, CAN YOU CONVERT TO 7831 05:04:18,040 --> 05:04:19,880 MICROGRAMS, ARE THEY TALKING 7832 05:04:19,880 --> 05:04:21,560 ABOUT CONVERTING THE WEIGHTS? 7833 05:04:21,560 --> 05:04:22,440 >> YES. 7834 05:04:22,440 --> 05:04:26,920 >> WE DID HAVE ONE FEATURE THAT 7835 05:04:26,920 --> 05:04:30,120 WE DISABLED, BECAUSE IT STARTED 7836 05:04:30,120 --> 05:04:33,200 TO GET VERY COMPLICATED, WHICH 7837 05:04:33,200 --> 05:04:35,280 WAS CONVERTING FROM THE OLD 7838 05:04:35,280 --> 05:04:37,680 UNITS OF DECLARATION TO NEW 7839 05:04:37,680 --> 05:04:38,320 UNITS. 7840 05:04:38,320 --> 05:04:40,280 AND IT BECAME VERY COMPLICATED 7841 05:04:40,280 --> 05:04:41,360 THAT VITAMIN A, WHICH IS WHY I 7842 05:04:41,360 --> 05:04:46,080 DIDN'T GO INTO ALL THE 7843 05:04:46,080 --> 05:04:48,080 CONVERSION FACTORS, BECAUSE 7844 05:04:48,080 --> 05:04:48,840 THE -- WITH CONVERSION FACTORS 7845 05:04:48,840 --> 05:04:51,120 IT ISN'T LIKE I SHOWED WITH 7846 05:04:51,120 --> 05:04:54,320 FOLATE OF COURSE, WITH FOLATE 7847 05:04:54,320 --> 05:04:56,160 THERE'S ONLY ONE 1.7, WITH 7848 05:04:56,160 --> 05:04:58,640 VITAMIN A THERE ARE A NUMBER OF 7849 05:04:58,640 --> 05:04:59,840 CONVERSION FACTORS, DEPENDING ON 7850 05:04:59,840 --> 05:05:02,080 THE FORM OF THE VITAMIN A. 7851 05:05:02,080 --> 05:05:07,440 AND IF THE FORM IS NOT REALLY 7852 05:05:07,440 --> 05:05:08,680 PROVIDED ON THE LABEL, IT 7853 05:05:08,680 --> 05:05:12,680 BECOMES DIFFICULT TO CONVERT AND 7854 05:05:12,680 --> 05:05:16,840 WE WERE SPENDING A LOT OF TIME 7855 05:05:16,840 --> 05:05:18,960 TRYING TO MAKE SURE WE WERE 7856 05:05:18,960 --> 05:05:20,480 ACCURATELY CONVERT WE GO DECIDED 7857 05:05:20,480 --> 05:05:21,800 WE WEREN'T GOING TO DO THAT AND 7858 05:05:21,800 --> 05:05:25,840 STOPPED DOING IT FOR ALL THE 7859 05:05:25,840 --> 05:05:26,360 NUTRIENTS. 7860 05:05:26,360 --> 05:05:28,960 AND BY NEXT YEAR, ACTUALLY BY 7861 05:05:28,960 --> 05:05:30,560 THIS YEAR, HOPEFULLY ALL THE 7862 05:05:30,560 --> 05:05:31,880 LABELS ON THE MARKET SHOULD 7863 05:05:31,880 --> 05:05:36,280 ACTUALLY BE HAVING THE NEW UNITS 7864 05:05:36,280 --> 05:05:39,040 BECAUSE ALL COMPANIES HAD TO BE 7865 05:05:39,040 --> 05:05:42,960 IN COMPLIANCE BY JANUARY OF LAST 7866 05:05:42,960 --> 05:05:45,400 YEAR, WHICH IS 2021. 7867 05:05:45,400 --> 05:05:47,760 AND WE'RE WELL INTO 2022 NOW. 7868 05:05:47,760 --> 05:05:50,520 SO, HOPEFULLY MOST OF THE LABELS 7869 05:05:50,520 --> 05:05:52,960 ON THE MARKETPLACE HAVE THE NEW 7870 05:05:52,960 --> 05:05:56,800 UNITS. 7871 05:05:56,800 --> 05:05:57,000 7872 05:05:57,000 --> 05:05:57,320 >> GREAT. 7873 05:05:57,320 --> 05:05:58,080 THANK YOU. 7874 05:05:58,080 --> 05:06:01,360 >> JAMES IS ASKING WHO HE SHOULD 7875 05:06:01,360 --> 05:06:01,600 UNMUTE. 7876 05:06:01,600 --> 05:06:04,080 >> YEAH, I ANSWERED HIM AND SAID 7877 05:06:04,080 --> 05:06:05,320 NEVER MIND, I THINK WE'VE GOT 7878 05:06:05,320 --> 05:06:07,720 IT. 7879 05:06:07,720 --> 05:06:09,800 7880 05:06:09,800 --> 05:06:13,600 SHE CLARIFIED IN THE CHAT. 7881 05:06:13,600 --> 05:06:18,200 >> OKAY. 7882 05:06:18,200 --> 05:06:18,400 OKAY. 7883 05:06:18,400 --> 05:06:23,920 >> I CAN ASK IF HER -- OR HE. 7884 05:06:23,920 --> 05:06:28,480 SABA, WOULD YOU LIKE TO ASK DR. 7885 05:06:28,480 --> 05:06:29,440 SALDANHA ANY QUESTIONS? 7886 05:06:29,440 --> 05:06:31,400 IF SO, WOULD YOU LIKE TO BE 7887 05:06:31,400 --> 05:06:33,520 UNMUTED? 7888 05:06:33,520 --> 05:06:37,680 7889 05:06:37,680 --> 05:06:37,880 SHE. 7890 05:06:37,880 --> 05:06:39,680 OKAY, SABA, WOULD YOU LIKE TO BE 7891 05:06:39,680 --> 05:06:44,240 UNMUTED? 7892 05:06:44,240 --> 05:06:45,680 7893 05:06:45,680 --> 05:06:45,840 NO? 7894 05:06:45,840 --> 05:06:48,320 IT'S CLEAR. 7895 05:06:48,320 --> 05:06:49,600 THANK YOU VERY MUCH. 7896 05:06:49,600 --> 05:06:53,640 YOU ANSWERED QUESTION. 7897 05:06:53,640 --> 05:06:55,240 DO WE HAVE ANY MORE QUESTIONS? 7898 05:06:55,240 --> 05:06:57,720 PLEASE PUT THEM IN THE Q&A, IF 7899 05:06:57,720 --> 05:07:06,160 SO. 7900 05:07:06,160 --> 05:07:08,440 GOING ONCE ... 7901 05:07:08,440 --> 05:07:15,000 GOING TWICE ... 7902 05:07:15,000 --> 05:07:15,760 OKAY. 7903 05:07:15,760 --> 05:07:19,560 WELL, THEN I GUESS THANK YOU 7904 05:07:19,560 --> 05:07:20,880 VERY MUCH, LEILA, A GREAT 7905 05:07:20,880 --> 05:07:21,240 PRESENTATION. 7906 05:07:21,240 --> 05:07:21,760 >> THANK YOU. 7907 05:07:21,760 --> 05:07:23,280 >> DO I TURN IT BACK OVER TO 7908 05:07:23,280 --> 05:07:24,440 YOU, JAIME? 7909 05:07:24,440 --> 05:07:25,880 >> YES. 7910 05:07:25,880 --> 05:07:27,040 THANK YOU, KAREN. 7911 05:07:27,040 --> 05:07:28,320 THANK YOU LEILA AND JOYCE. 7912 05:07:28,320 --> 05:07:30,640 THIS CONCLUDES THE FIRST DAY OF 7913 05:07:30,640 --> 05:07:31,240 THE PRACTICUM. 7914 05:07:31,240 --> 05:07:34,120 A BIG THANKS TO ALL THE SPEAKERS 7915 05:07:34,120 --> 05:07:34,760 AND MODERATORS. 7916 05:07:34,760 --> 05:07:36,760 AND JAMES TOO FOR RUNNING THE 7917 05:07:36,760 --> 05:07:37,400 WEBEX TODAY. 7918 05:07:37,400 --> 05:07:39,080 WE HAVE SOME GREAT SESSIONS 7919 05:07:39,080 --> 05:07:40,680 LINED UP FOR TOMORROW. 7920 05:07:40,680 --> 05:07:43,400 A SESSION ON RIGOR AND 7921 05:07:43,400 --> 05:07:43,760 REPRODUCIBILITY. 7922 05:07:43,760 --> 05:07:45,200 EFFICACY AND SAFETY. 7923 05:07:45,200 --> 05:07:48,240 AND THEN A FEW PRESENTATIONS, 7924 05:07:48,240 --> 05:07:49,560 ONE IS ON NUTRITION, GRANT 7925 05:07:49,560 --> 05:07:51,880 FUNDING AT NIH, THAT MAY BE OF 7926 05:07:51,880 --> 05:07:53,600 INTEREST TO MANY OF YOU. 7927 05:07:53,600 --> 05:07:57,120 WE START TOMORROW AT 11:00 A.M., 7928 05:07:57,120 --> 05:07:58,360 EASTERN TIME. 7929 05:07:58,360 --> 05:08:00,200 PLEASE HAVE A GREAT EVENING. 7930 05:08:00,200 --> 05:08:02,440 THANK YOU AGAIN. 7931 05:08:02,440 --> 00:00:00,000 THANK YOU.