WELCOME BACK TO DAY 3 OF THE
DIETARY SUPPLEMENT RESEARCH
PRACTICUM, OUR LAST DAY.
THANK YOU TO ALL THE ATTENDEES
YESTERDAY FOR SUBMITTING SO MANY
GREAT QUESTIONS.
PLEASE KEEP THEM COMING.
JUST A REMINDER PLEASE SUBMIT
TECHNICAL QUESTIONS TO THE CHAT
BOX, AND QUESTIONS FOR THE
PRESENTERS IN THE Q&A PANEL AND
DIRECT THOSE TO ALL PANELISTS.
TODAY WE'LL BE CONTINUING WITH
SESSION 6, SPECIAL TOPICS.
WE HAVE TWO PRESENTATIONS LEFT,
AND WE'LL MOVE OVER TO SESSION
7, MEETING THE STAKEHOLDERS AND
HEAR FROM THOSE THAT STUDY,
ADVOCATE, AND EDUCATE ON DIETARY
SUPPLEMENTS.
THIS WILL INCLUDE A PANELS,
SESSION 7, SO PLENTY OF TIME FOR
QUESTIONS.
LET'S GET STARTED.
I WANT TO WELCOME BACK OUR
MODERATOR, DR. BECKY COSTELLO.
>> THANK YOU, DR. GAHCHE.
WELCOME, GOOD MORNING.
OUR FIRST PANEL IS DIETS AND THE
U.S. DEPARTMENT OF DEFENSE.
AND WE'RE GOING TO HEAR FROM DR.
SCOTT AND MS. LINDSEY.
DR. SCOTT'S Ph.D. IS IN HEALTH
REHABILITATION SCIENCES, AND
HE'S A BOARD CERTIFIED
SPECIALIST IN SPORTS DIETETICS.
MS.LINDSEY IS ALSO FROM THE
UNIFORM SERVICE, SOMETIMES WE
CALL IT USO, SERVES AS DIRECTOR
OF OPERATIONS SAFETY, SENIOR
NUTRITION SCIENTIST WITH
CONSORTIUM FOR HEALTH AND
MILITARY PERFORMANCE.
WE'LL GO AHEAD AND START WITH
DR. SCOTT.
>> THANK YOU FOR THE
INTRODUCTION AND TO THE
ORGANIZING COMMITTEE FOR
INVITING US TO BE PART OF THE
SYMPOSIUM AGAIN THIS YEAR.
ANDREA AND I ARE HAPPY TO KICK
OFF DAY 3 WITH THE TALK ABOUT
DIETARY SUPPLEMENTS AND
DEPARTMENT OF DEFENSE.
THERE'S BEEN SOME GREAT
DISCUSSION OVER THE PAST COUPLE
DAYS ON THIS TOPIC, AND HOPE
WE'LL ANSWER YOUR QUESTIONS AS
WE MOVE THROUGHOUT OUR
PRESENTATION, BUT IF WE DON'T
PLEASE INCLUDE THOSE IN THE Q&A
AND WE'LL MAKE SURE WE GET TO
THEM AFTERWARDS.
WE'RE REQUIRED TO INCLUDE OUR
DISCLOSURE INFORMATION.
IT'S IMPORTANT TO KNOW THAT THE
OPINIONS AND ASSERTIONS
EXPRESSED ARE THOSE OF ANDREA
AND MYSELF AND DO NOT REFLECT
OFFICIAL POLICY OR POSITION OF
THE UNIFORMED SERVICES
UNIVERSITY, DEPARTMENT OF
DEFENSE, OR HENRY M JACKSON
FOUNDATION AND FURTHER MENTION
OF TRADE NAMES DOES NOT IMPLY
ENDORSEMENT BY THE U.S.
GOVERNMENT, NEITHER ANDREA NOR
MYSELF HAVE ANY FINANCIAL
CONFLICTS OF INTEREST TO
DISCLOSE.
WE WANT TO BRIEFLY MENTION
UNIFORMED SERVICES UNIVERSITY,
USU, WAS CHARTERED BY AN ACT OF
CONGRESS IN 1972, THE NATION'S
ONLY FEDERAL HEALTH SCIENCES
UNIVERSITY.
IT WAS ORIGINALLY FOUNDED TO BE
THE WEST POINT OF MEDICINE BUT
OVER THE YEARS OUR MISSION HAS
REALLY CONTINUED TO EVOLVE.
AS DR. COSTELLO MENTIONED OUR
MAIN CAMPUS IS ACROSS THE STREET
FROM THE NATIONAL INSTITUTES OF
HEALTH, ALSO HOME TO WALTER
REED, AND OUR CAMPUS AND MEDICAL
SCHOOL WE ALSO HAVE VARIOUS
GRADUATE DEGREE PROGRAMS WE
OFFER, AS WELL AS GRADUATE
SCHOOL OF NURSING.
ALL OF OUR STUDENTS IN THE
MEDICAL SCHOOL AND GRADUATE
SCHOOL OF NURSING ARE IN ONE OF
FOUR UNIFORMED PROFESSIONS,
INCLUDING THE U.S. ARMY, AIR
FORCE, NAVY, AND PUBLIC HEALTH
SERVICE.
IF YOU'RE INTERESTED IN LEARNING
MORE WE'VE INCLUDED OUR URL
THERE.
OUR OBJECTIVES TODAY ARE
FOUR-FOLD.
FIRST WE WANT TO DESCRIBE THE
PREVALENCE OF DIETARY SUPPLEMENT
USE IN THE DoD.
SECOND, WE WILL TAKE A LOOK AT
SELECT DIETARY SUPPLEMENT
RESEARCH INITIATIVES THAT WE
HAVE GOING ON AT THE UNIVERSITY.
I'LL PASS IT OVER TO ANDREA TO
BRIEFLY IDENTIFY SOME ISSUES
ASSOCIATED WITH DIETARY
SUPPLEMENTS AND LAST SHE WILL
INTRODUCE AND WALK US THROUGH
OPERATION SUPPLEMENT SAVES,
OPSS.
LET'S TALK ABOUT USE BY SERVICE
MEMBERS.
BEFORE WE LOOK AT THAT DATA I
THINK IT'S IMPORTANT TO
UNDERSTAND REALLY WHERE THESE
DATA COME FROM.
THERE ARE THREE MAIN SOURCES WE
DERIVE OUR PREVALENCE DATA FROM.
FIRST IS THE SURVEY OF HEALTH
RELATED BEHAVIORS, WHICH
ADMINISTERED THROUGH THE DEFENSE
HEALTH AGENCY, DHA.
THE SURVEY HAPPENS EVERY THREE
OR FOUR YEARS MOST RECENTLY
COMPLETED IN 2018 BY THE RAND
CORPORATION.
THE NEXT SET OF DATA WE HAVE ARE
DERIVED FROM MILLENIUM COHORT
STUDY OUT OF OF THE NAVAL HEALTH
RESEARCH CENTER IN SAN DIEGO.
AND THIS IS REALLY THE LARGEST
AND LONGEST RUNNING HEALTH STUDY
OF MILITARY SERVICE MEMBERS.
SO THEY DO FROM TIME TO TIME ASK
QUESTIONS ABOUT DIETARY
SUPPLEMENTS.
AND LAST IS THE U.S. MILITARY
DIETARY SUPPLEMENT USE STUDY
WHICH WAS CONDUCTED BETWEEN
DECEMBER OF 2018 AND AUGUST OF
2019.
DIETARY SUPPLEMENTS ARE
GENERALLY GROUPED INTO DIFFERENT
CATEGORIES, BASED ON THEIR
INGREDIENTS THROUGHOUT THESE
DIFFERENT SURVEYS, AND THOSE
CATEGORIES INCLUDE INDIVIDUAL
VITAMINS OR MINERALS,
MULTI-VITAMIN, MULTI-MINERAL
PRODUCTS, PROTEINS OR AMINO
ACID, HERBAL PRODUCTS, PURPORTED
PRO HORMONES, JOINT PRODUCTS,
COMBINATION PRODUCTS WHICH
INCLUDES MULTITUDE OF DIFFERENT
PRODUCTS, THOSE THAT CONTAIN ONE
OR MORE CATEGORIES OF THE
AFOREMENTIONED DIETARY
SUPPLEMENT INGREDIENTS, MOSTLY
IN DEPARTMENT OF DEFENSE THIS
INCLUDES WEIGHT LOSS PRODUCTS OR
PRE-WORKOUT PRODUCTS, AND THEN
OF COURSE THERE'S AN OTHER
CATEGORY.
GENERALLY SPEAKING ACROSS OUR
SURVEYS A USER IS ANY INDIVIDUAL
WHO SELF-REPORTS USING AT LEAST
ONE OR MORE CATEGORIES OF
DIETARY SUPPLEMENTS AT LEAST ONE
OR MORE TIME PER WEEK.
SO HERE WE SEE THE PREVALENCE
DATA OF DIETARY SUPPLEMENT USE
BY SERVICE BRANCH, USING DATA
DERIVED FROM U.S. MILITARY
DIETARY SUPPLEMENT USES STUDY.
AGAIN, WITH THAT USER DEFINED AS
ANYONE USING ONE OR MORE
CATEGORIES, ONE OR MORE TIMES
PER WEEK.
WHAT YOU SEE IS NEARLY 3 IN 4,
75% OF SERVICE MEMBERS REPORT
USING AT LEAST ONE OR MORE
CATEGORIES OF DIETARY
SUPPLEMENTS AT LEAST ON A WEEKLY
BASIS.
THIS PREVALENCE IS CONSIDERABLY
HIGHER THAN WHAT WE SEE IN THE
GENERAL U.S. ADULT POPULATION
BASED ON THE NHANES DATA THAT
DR. BAILEY AND OTHERS HAVE
ALREADY PRESENTED ON.
SIMILAR TO NHANES THE MOST
COMMON CATEGORY USE OF DIETARY
SUPPLEMENT USE BY SERVICE
MEMBERS IS MULTI-VITAMIN,
MULTI-MINERAL PRODUCTS.
HOWEVER, WHERE WE SEE THE
DIFFERENCE THE REMAIN TOP THREE
INCLUDE COMBINATION PRODUCTS,
SPECIFICALLY WEIGHT LOSS
PRODUCTS, PRE-WORKOUT TYPE
PRODUCTS, PROTEINS AND AMINO
ACIDS.
SO AT PRESENT, WHAT YOU'LL
NOTICE UP HERE IS WE DO NOT HAVE
ANY DATA ON THE USE OF DIETARY
SUPPLEMENTS AMONGST OUR NEWEST
BRANCH, THE SPACE FORCE.
WE HOPE IN THE COMING YEARS TO
BE ABLE TO PROVIDE PREVALENCE
DATA IN THAT AREA AS WELL.
SO GIVE THAN NEARLY 3 IN 4
MILITARY SERVICE MEMBERS REPORT
USING DIETARY SUPPLEMENTS, I
WANT TO NOW DISCUSS SELECT
RESEARCH INITIATIVES WE HAVE
GOING ON HERE AT THE UNIFORMED
SERVICES UNIVERSITY.
FIRST WE HAVE AN ONGOING PROJECT
THAT'S FOCUSED ON PRODUCT
TESTING, SPECIFICALLY WE'RE
INTERESTED IN TESTING FOR
ADULTERATION, PURITY AND QUALITY
IN COLLABORATION WITH OLE MISS,
WE HEARD FROM DR. GURLEY
YESTERDAY.
WE COMPLETED A PROJECT TO
EXPLORE DIETARY SUPPLEMENTS
MARKETED FOR BRAIN HEALTH AND
COGNITIVE ENHANCEMENT AND HAVE
AN ONGOING PROJECTS LOOKING AT
SUPPLEMENTED FOR IMMUNE HEALTH
AND LAST OMEGA 3 STATUS OF
MILITARY SERVICE MEMBERS, WE'RE
REGULARLY GETTING REQUESTS FROM
CONGRESS ASKING US WHAT WE'RE
DOING TO IMPROVE THE OMEGA 3
STATUS OF OUR SERVICE MEMBERS,
AND THIS PROJECT IS JUST ONE
EXAMPLE.
SO OVER THE LAST TWO TO TWO AND
A HALF YEARS WE SEEN INCREASE IN
NUMBER OF QUESTIONS WE'VE
RECEIVED FROM MILITARY SERVICE
MEMBERS ASKED ABOUT PRODUCTS
MARKETED FOR BRAIN HEALTH AND
COGNITIVE PERFORMANCE.
SO WE REALLY TOOK THIS AS AN
OPPORTUNITY TO TAKE A DEEP DIVE
INTO THE MARKETPLACE TO BETTER
UNDERSTAND WHAT'S CURRENTLY
BEING SOLD, INGREDIENTS THAT
MAKE UP THESE PRODUCTS AND TO
REALLY DIVE INTO THE PEER
REVIEWED LITERATURE TO HELP US
BETTER UNDERSTAND THE SAFETY AND
EFFICACY OF THESE INGREDIENTS AS
WELL AS TO HELP US ADDRESS ANY
GAPS IN KNOWLEDGE.
THE FOCUS OF THIS PROJECT IS
REALLY TO IMPROVE THE ABILITY TO
RESPOND TO SUCH INQUIRIES WHEN
WE RECEIVE THEM.
ANDREA WILL DISCUSS LATER HOW
OPERATION SUPPLEMENT SAFETY TOOK
THIS INFORMATION AND REALLY USES
IT TO EDUCATE OUR END USER.
SO FOR THIS SPECIFIC PROJECT, A
TOTAL OF 22 PRODUCTS WERE
TESTED.
ALL OF THESE PRODUCTS HAD BEEN
ASKED ABOUT IN AN ASK THE EXERT
QUERY SUBMITTED THROUGH
OPERATION SUPPLEMENT SAFETY BY
MILITARY SERVICE MEMBERS.
EACH PRODUCT WAS PURCHASED AND
SENT TO THE NATIONAL CENTER FOR
NATURAL PRODUCTS RESEARCH AT THE
UNIVERSITY OF MISSISSIPPI FOR
ANALYSIS TO VERIFY WHETHER THE
INGREDIENTS LISTED ON THE LABELS
WERE ACCURATE.
AND WHAT YOU SEE IS NEARLY 75%
OF THE PRODUCTS HAVE AT LEAST
ONE INGREDIENT CLAIMED ON THE
LABEL THAT WAS NOT DETECTED.
ALSO, MORE THAN 40% OF THE
PRODUCTS CONTAINED AN INGREDIENT
THAT BASED ON REGULATORY
GUIDANCE WE'VE HEARD ABOUT OVER
THE LAST COUPLE OF DAYS WOULD
NOT MEET THE DEFINITION OF A
DIETARY SUPPLEMENT.
OR WOULD REQUIRE A NEW DIETARY
INGREDIENT NOTIFICATION, NDIN,
PRIOR TO BEING SOLD, OF WHICH
THERE WAS NOT ONE AT THE TIME.
THIS PROJECT HAS YIELDED FIVE
PEER-REVIEWED PUBLICATIONS
INCLUDING A SYSTEMATIC REVIEW
ANNUAL EXPERTS PANEL
RECOMMENDATION IN ADDITION TO
EDUCATION PRODUCTS WHICH ANDREA
WILL MENTION LATER.
SIMILAR PROJECT IS CURRENTLY
UNDERWAY TO EVALUATE DIETARY
SUPPLEMENTS MARKETED FOR IMMUNE
HEALTH, AS YOU CAN IMAGINE THE
NUMBER OF QUESTIONS THAT WE
FIELDED IN THIS AREA HAS
INCREASED EXPONENTIALLY SINCE
THE START OF THE COVID-19 GLOBAL
PANDEMIC.
WHAT THIS IS SHOWING US, OVERALL
THE MAJORITY OF THE 30 PRODUCTS
THAT WE TESTED REALLY HAD
INACCURATE LABELS AND CLAIMS
MADE ON ANY OF THESE PRODUCTS
FOR SUPPORTING IMMUNE HEALTH ARE
REALLY NOT CONSISTENT WITH WHAT
FDA ALLOWS ON DIETARY
SUPPLEMENTS.
QUALITY CONTROL MEASURES REALLY
SEEM TO BE INSUFFICIENT FOR THE
MAJORITY OF THESE SELECT
PRODUCTS, YET CLAIMS ON THE
LABEL ARE LIKELY CONVINCING
CONSUMERS TO PURCHASE THE
PRODUCTS.
AND THIS IS CONCERNING GIVEN
THAT THERE'S LITTLE INFORMATION
AS TO WHETHER OR NOT THERE'S
ACTUAL BENEFITS FOR THESE.
WE'LL HEAR IN THE NEXT
PRESENTATION ABOUT DIETARY
SUPPLEMENTS FOR IMMUNE FUNCTION
OR IMMUNITY.
THE LAST PROJECT FOCUSES ON
IMPROVING OMEGA 3 INDEX LEVELS.
DATA FROM OUR LAB AND OTHERS HAS
CONSISTENTLY FOUND THAT MILITARY
SERVICE MEMBERS HAVE LOW LEVELS
OF OMEGA 3s, AS QUANTIFIED BY
THE OMEGA 3 INDEX.
IN GENERAL VALUES ABOVE 8% ARE
CONSIDERED OPTIMAL.
VALUES BELOW 4% ARE CONSIDERED
HIGH RISK, BASED ON
CARDIOVASCULAR DISEASE ENDPOINTS
FROM HARRIS AND OTHERS.
SERVICE MEMBERS AS WE SEE
GENERALLY FALL RIGHT AROUND 4%,
THIS PARTICULAR STUDY IS A
COLLABORATION BETWEEN THE
UNIFORMED SERVICES UNIVERSITY
AND OUR THREE SERVICE ACADEMIES,
WHICH INCLUDE U.S. MILITARY
ACADEMY AT WEST POINT, U.S.
NAVAL ACADEMY, IN ANNAPOLIS, AS
WELL AS THE U.S. AIR FORCE
ACADEMY IN COLORADO SPRINGS.
THE INTERVENTIONS INVOLVE EITHER
PROVIDING A PERSONALIZED DOSE OF
OMEGA-3 FATTY ACIDS BASED ON
BASELINE OMEGA 3 VALUES IN FORM
OF A SUPPLEMENT, MODIFYING
CAFETERIA MENUS TO INCLUDE MORE
OMEGA 3 RICH PRODUCTS SUCH AS
EGGS, MEAT, SALAD DRESSINGS AND
PEANUT BUTT ER AND DECREASING
OMEGA 6 OR COMBINATION OF BOTH.
IT WILL WRAP UP BY THE END OF
THE CALENDAR YEAR AND WE HOPE TO
SHARE RESULTS NEXT YEAR AT THE
SYMPOSIUM.
I'LL TURN IT OVER TO MS. ANDREA
LINDSEY TO BEGIN OUR
CONVERSATION ABOUT ISSUES
ASSOCIATED WITH DIETARY
SUPPLEMENTS IN THE DoD.
>> THANK YOU, JONATHAN.
GOOD MORNING, EVERYONE.
THANK YOU FOR THE OPPORTUNITY TO
TALK WITH YOU ALL ABOUT OUR WORK
WITH DIETARY SUPPLEMENTS IN THE
MILITARY AND WE SO APPRECIATE
BEING ABLE TO PARTICIPATE IN
THIS YEAR'S PRACTICUM.
SO, I'M GOING TO START TALKING
ABOUT HOW WE KNOW FROM OUR WORK
AND ALSO IN THE DOCUMENTED
ARTICLES THAT SERVICE MEMBERS
ARE A POPULATION AT RISK FOR
ADVERSE EVENTS.
DUE TO THE POTENTIAL FOR THESE
ADVERSE EVENTS, DIETARY
SUPPLEMENTS CAN POSE A THREAT TO
MILITARY READINESS.
WE KNOW THAT THERE'S A LOT OF
MISINFORMATION ON THE INTERNET.
WE GET THAT INTEL A LOT FROM OUR
ASK THE EXPERT QUESTIONS.
THIS ALSO INCREASED WITH COVID
AND PURCHASE OF MORE SUPPLEMENTS
VIA THE INTERNET.
CERTAINLY IN THE MILITARY
THERE'S PEER PRESSURE TO TAKE
WHAT OTHERS ARE TAKING, AND WE
KNOW THAT THEY ALSO SHARE
INFORMATION.
WE GET QUESTIONS AGAIN THAT SAY,
OH, MY FRIEND TOLD ME TO TAKE
THIS, OR WE GET QUESTIONS FROM A
LEADER WHO WILL SAY THAT SOMEONE
APPROACHED THEM ABOUT A
PARTICULAR SUPPLEMENT.
THE OTHER THING IS WE TRACK
DIRECT MARKETING TO SERVICE
MEMBERS BY SOME DIETARY
SUPPLEMENT MANUFACTURERS.
SOME OFFER DISCOUNTS AND EVEN
FREE TRIALS TO OUR MILITARY
SERVICE MEMBERS.
SO, DUE TO POTENTIAL SAFETY
ISSUES AND QUALITY WITH SOME OF
THE HIGH RISK DIETARY
SUPPLEMENTS, DIRECT MARKETING TO
THE MILITARY IS A CONCERN AS
THESE PRODUCTS COULD PRESENT A
RISK TO THE HEALTH AND CAREERS
OF MILITARY SERVICE MEMBERS.
NEXT SLIDE PLEASE.
SO FDA HAS FOUND CONTAMINANTS
AND ADULTERANTS IN SOME DIETARY
SUPPLEMENT PRODUCTS AND OF
COURSE THEY ARE THEIR TAINTED
PRODUCTS MARKETED AS DIETARY
SUPPLEMENT LIST, AS JONATHAN
MENTIONED WE'VE ALSO TESTED
PRODUCTS AND PUBLISHED RESULTS
AND FOUND CONTAMINANTS AND
ADULTERANTS.
FDA AS WE ALL KNOW IS A
REGULATORY AGENCY ON THIS TOPIC.
AND SO WHEN WE ALSO HEAR FROM
THEM ABOUT HIDDEN DRUG
INGREDIENTS AND UNDISCLOSED
INGREDIENTS WE TRY TO PUSH THAT
TO THE AUDIENCE.
THEY HAVE SAID THE HIGH RISK
CATEGORIES OF DIETARY SUPPLEMENT
PRODUCTS ARE BODY BUILDING,
WEIGHT LOSS, SEXUAL ENHANCEMENT
PRODUCTS.
AS JONATHAN MENTIONED, WE HAVE
IDENTIFIED BRAIN HEALTH,
COGNITIVE ENHANCEMENT PRODUCTS
AS ANOTHER HIGH RISK CATEGORY.
ALSO, ANY SUPPLEMENT WITH AN
INGREDIENT ON THE OPERATION
SUPPLEMENT SAFETY LIST OF DoD
DIETARY SUPPLEMENT INGREDIENTS
ARE CONSIDERED HIGH RISK.
I'LL SHOW THAT LIST IN A FEW
MINUTES.
SO, AGAIN, I WANT TO EMPHASIZE
THE POTENTIAL FOR ADVERSE EVENTS
FROM SERVICE MEMBERS TAKING MANY
DIETARY SUPPLEMENTS THAT CONTAIN
INGREDIENTS THAT CAN BE
DANGEROUS.
THERE'S CONSIDERABLE COST ALSO
WITH THE LOSS OF A SERVICE
MEMBER DUE TO AN ADVERSE EVENT,
IF SOMEONE HAS TO BE MEDEVACED
OUT OF THEATER, CERTAINLY IF WE
HAVE SITUATIONS OF LIVER INJURY,
KIDNEY INJURY, OR DEATH,
THAT'S -- WE DON'T EVEN WANT TO
TALK ABOUT THE COST BECAUSE WE
DON'T EVER WANT TO SEE AN
ADVERSE EVENT HAPPEN.
BUT ALSO IF A SERVICE MEMBERS
POPS POSITIVE A DRUG TEST
POTENTIALLY IS OUT OF SERVICE,
ALL OF THIS IMPACTS THE FORCE.
WE ACKNOWLEDGE THAT IT'S
CHALLENGING FOR US TO MEASURE
THE BEHAVIOR CHANGE WITH REGARD
TO OUR EDUCATIONAL EFFORTS ON
THIS TOPIC IN THE MILITARY BUT
WE DO KNOW THAT EDUCATION DOES
BRING THE IMPORTANT AWARENESS
THAT IS NEEDED.
NEXT SLIDE.
SO I'M GOING TO GIVE YOU THIS
EXAMPLE, AND IT'S AN UNFORTUNATE
EXAMPLE THAT OCCURRED IN THE
SUMMER OF 2018 AND THAT SENIOR
OFFICER TESTED POSITIVE ON A
DRUG TEST, TESTED POSITIVE FOR
D-AMPHETAMINE.
HE WANTED TO LOSE WEIGHT FOR A
PHYSICAL FITNESS TEST, SOMETHING
WE HEAR ABOUT ALL THE TIME.
AFTER HE POPPED POSITIVE HE
CONTACTED US, AND ASKED FOR
HELP.
SO, WE SENT THE PRODUCT TO OLE
MISS FOR TESTING.
AS WE KNOW THE ONLY WAY TO KNOW
FOR SURE WHAT'S IN A DIETARY
SUPPLEMENT PRODUCT IS TO HAVE IT
TESTED IN AN APPROVED LAB.
NEXT SLIDE.
THANK YOU.
SO THIS IS THE LABEL OF THE
PRODUCT THAT HE WAS TAKING.
NOW, CERTAINLY WE COULD TALK
ABOUT WHAT IS LISTED IN THAT
BLEND, AND THERE'S A FEW
STIMULANTS THERE LISTED.
OF COURSE WE COULD TALK ABOUT
THAT.
HOWEVER, HE WOULD HAVE
ABSOLUTELY NO KNOWLEDGE THAT
UPON TESTING THIS PRODUCT
CONTAINED LYSINE D AMPHETAMINE,
HE ALMOST LOST HIS CAREER, WAS
SIDELINED FOR A CERTAIN AMOUNT
OF TIME WHERE HE WAS ABLE TO
PROVE IT WAS THE SUPPLEMENT THAT
CAUSED THE POSITIVE TEST.
NOW THAT TAKES US TO OPERATION
SUPPLEMENT SAFETY.
I'M GOING TO JUST GIVE YOU A
LITTLE BIT OF WINDOW INTO OUR
PROGRAM.
FOR THOSE WHO ARE NOT AWARE,
OPERATION SUPPLEMENT SAFETY,
OPSS, IS THE MILITARY'S
EVIDENCE-BASED GO-TO RESOURCE ON
EVERYTHING RELATED TO DIETARY
SUPPLEMENTS.
IN JANUARY 2012 THE ASSISTANT
SECRETARY OF DEFENSE FOR HEALTH
AFFAIRS REQUESTED A DoD-WIDE
EDUCATIONAL CAMPAIGN ON DIETARY
SUPPLEMENTS, AND THIS WAS BASED
ON ALL THE ADVERSE EVENTS AND
SOME DEATHS IN THE MILITARY THAT
WERE ASSOCIATED WITH A FEW
PRODUCTS THAT CONTAINED THE
SYNTHETIC INGREDIENT DMAA, WE
STILL FIND IT IN SOME PRODUCTS
TODAY ALTHOUGH ILLEGAL.
WE HAVE MANY APPROACHES ARE
DIETARY SUPPLEMENTS AND WE ARE
THE ONLY ENTITY IN THE MILITARY
EDUCATING ON THIS TOPIC.
SO WE'RE THE SINGLE
AUTHORITATIVE SOURCE FOR OUR
PROVIDERS, FOR EXAMPLE.
AND CERTAINLY OPSS.ORG IS A BIG
PIECE OF THIS EFFORT WITH OUR
EVIDENCE-BASED INFOGRAPHICS,
POSITION STATEMENTS, GRAPHICS
VIDEOS, AND OTHER INFORMATION.
NEXT SLIDE.
THANK YOU.
WELL, THIS WAS VERY EXCITING FOR
US ON MARCH 9 THE DEPARTMENT OF
DEFENSE INSTRUCTION WHICH WE
REFER TO AS THE DODI ON USE OF
DIETARY SUPPLEMENTS IN THE
MILITARY WAS ISSUED AND WE HAD
NO IDEA WHEN THIS WAS GOING TO
BE SIGNED.
THIS WAS IN THE WORKS FOR MANY,
MANY YEARS.
DUE TO THE FREQUENCY OF DIETARY
SUPPLEMENTS USE BY SERVICE
MEMBERS, OVERALL DoD POLICY
WAS NEEDED TO PROVIDE GUIDANCE
TO ENSURE SAFE DIETARY
SUPPLEMENT USE AND TO MINIMIZE
THE RISK TO THE FORCE OF
POTENTIAL LIFE-THREATENING
ADVERSE EVENTS RESULTING IN
DIETARY SUPPLEMENT USE.
ALSO, TO PREVENT SOME POTENTIAL
DISCIPLINARY ACTIONs WE NOW
HAVE THIS DODI.
AND ON THE NEXT SCREEN, WHAT
DOES THE DODI SAY?
IT FORMALIZED OPERATION
SUPPLEMENT SAFETY AS GO-TO DoD
PROGRAM FOR EVERYTHING ON
DIETARY SUPPLEMENTS.
SO THAT WAS SOMETHING WE WERE
WAITING FOR.
WE ALSO HAVE TO POINT OUT THAT
WHEN WE STARTED OPERATION
SUPPLEMENT SAFETY IN 2010, 2011,
WE WERE AN EDUCATIONAL CAMPAIGN.
AND NOW WE AN ESTABLISHED
PROGRAM.
IT ALSO REQUIRES DIETARY
SUPPLEMENT EDUCATION FOR SERVICE
MEMBERS.
WE'VE BEEN DOING THIS ALL ALONG,
AND WE WILL CONTINUE TO DO SO.
AND IT ALSO REQUIRES EDUCATION
FOR ANYONE WHO PROVIDES
HEALTH-RELATED SERVICES TO THE
SERVICE MEMBER.
SO THAT INCLUDES HEALTH
PROMOTION SPECIALISTS, FITNESS
LEADERS, ATHLETIC TRAINERS,
STRENGTH AND CONDITIONING
SPECIALISTS, OF COURSE OUR
HEALTH CARE PERSONNEL, CLINICAL
DIETITIANS, ET CETERA.
FOR THESE GROUPS WE'RE
DEVELOPING A HEALTH PROFESSIONAL
MODULE AND I'LL MENTION THAT IN
A FEW MINUTES.
IT ALSO MANDATES ADVERSE EVENT
REPORTING BY HEALTH CARE
PROVIDERS AND I QUOTE, THE
REPORTING ADVERSE EVENTS FIELD
ON THE OPSS WEBSITE AND IN THE
ELECTRONIC HEALTH RECORD.
THIS IS NOW A VERY BIG EFFORT
FOR US, AND THAT WILL BE AN
ONGOING CONVERSATION.
FINALLY, IT PROVIDES THE DoD
PROHIBITED DIETARY SUPPLEMENT
INGREDIENT LIST WHICH IS
AVAILABLE ON THE MAIN PAGE OF
OPSS, AND I'LL SHOW YOU THAT ON
THE NEXT SLIDE.
HERE YOU SEE OUR REVISED HOME
PAGE, THE WHITE RECTANGLE,
ANALYTICS SHOW MAJORITY OF USERS
ARE ON THE MOBILE DEVICE.
SO WE REDESIGNED THE WEBSITE TO
MAKE IT MOBILE FRIENDLY.
I MENTIONED DoD PROHIBITED
LIST.
YOU SEE THAT.
USERS CAN CLICK ON THAT, I'LL
SHOW AN EXAMPLE IN A MINUTE.
ONCE THE DODI WAS SIGNED WE HAD
TO CHANGE THE LAYOUT OF THIS
VERY QUICKLY AND YOU SEE THAT
ATTENTION NEW DODI, IT TAKES YOU
TO A LANDING PAGE WITH QUESTIONS
AND ANSWER WITH THE DODI AND A
PICTURE TO CLICK ON AND THE DODI
DOWN LOADS ON THEIR DESKTOP.
A-Z INDEX IS A QUICK WAY TO GO
TO EVIDENCE-BASED INFORMATION ON
CREATINE, CAFFEINE, ASHWAGANDHA,
MANY RESOURCES.
REPORT SIDE EFFECTS TAKES A USER
DIRECTLY TO THE HHS-FDA SAFETY
REPORTING PORTAL.
CHECK YOUR SUPPLEMENT, I'LL SHOW
YOU THAT'S OUR INTERACTIVE SCORE
CARD AND I'LL SHOW YOU THE
LANDING PAGE OF THE "ASK THE
EXPERT" PORTAL.
NEXT SLIDE PLEASE.
THIS IS DIFFICULT TO SEE BUT
IT'S JUST TO SHOW YOU AN EXAMPLE
OF THE LANDING PAGE FOR AN
INGREDIENT THAT WAS SEARCHED.
WE'RE SHOWING DMHA, A SYNTHETIC
INGREDIENT NOT ALLOWED IN
DIETARY SUPPLEMENTS.
WE SEE IT A LOT IN DIETARY
SUPPLEMENT PRODUCTS.
SO YOU SEE THE LIST OF SYNONYMS
THERE.
WE SEE SOME OF THE OTHER NAMES
ON DIETARY SUPPLEMENT PRODUCTS
LABELS.
YOU CAN ONLY IMAGINE HOW
CHALLENGING THIS IS FOR A
SERVICE MEMBER TO NAVIGATE THIS.
NOW THERE ARE OVER 800
SUBSTANCES ON OUR PROHIBITED
LIST.
AND ABOUT 1700 SYNONYMS.
THIS IS VERY DIFFICULT, WE KNOW.
WE'RE IMPROVING OUR SEARCH
FUNCTION AS WE SPEAK.
AND I'LL TALK TO YOU IN A MINUTE
ABOUT THE APP WE'RE DEVELOPING.
SO, A SERVICE MEMBER HAS TO TAKE
THEIR SUPPLEMENTS AND LOOK UP
INGREDIENTS NOW BECAUSE OF THE
DODI TO MAKE SURE THEY DON'T
CONSUME A PRODUCT WITH A
PROHIBITED INGREDIENT.
NEXT SLIDE PLEASE.
SO THIS IS OUR PDF LITTLE SCORE
CARD OF OUR ALGORITHM, AND WE'VE
HAD THIS FOR MANY YEARS.
SOME OF YOU HAVE SEEN THIS
BEFORE AND HOPEFULLY USED THIS.
THIS IS ANOTHER TOOL IN THE
TOOLBOX FOR -- TO EDUCATE ABOUT
RELATIVE RISK OF A PARTICULAR
PRODUCT.
WE KNOW THAT NAVIGATING
INGREDIENTS AND DIETARY
SUPPLEMENTS CAN BE VERY
CHALLENGING, ESPECIALLY WITH THE
PERFORMANCE ENHANCING DIETARY
SUPPLEMENTS.
THERE ARE MANY STEPS A HEALTH
CARE PROVIDER AND SERVICE MEMBER
NEED TO TAKE TO EVALUATE A
PRODUCT FOR SAFETY.
NOW SINCE THE DODI HAS BEEN
SIGNED, A SERVICE MEMBER FIRST
HAS TO CHECK DOES MY PRODUCT
HAVE AN INGREDIENT ON THAT
PROHIBITED LIST?
IF IT DOES NOT, THIS IS A GREAT
TOOL TO USE TO ASSESS THE
RELATIVE SAFETY.
SO IT'S SEVEN QUESTIONS, AN
ANSWER OF YES SCORES A 1, NO
SCORES A 0, PRODUCT SCORING LESS
THAN 4 ARE CONSIDERED RISKY.
PRODUCTS WITH A SCORE OF 4 OR
BETTER ARE CONSIDERED LESS
RISKY.
NEXT SLIDE.
HERE'S THE INTERACTIVE VERSION
FROM THAT WHITE RECTANGLE ON THE
MAIN PAGE, CHECK YOUR
SUPPLEMENT, IT WILL ADD IT FOR
USERS.
SO HERE IS WHAT YOU SEE WHEN YOU
CLICK ON RESOURCES.
YOU GET THE OPTION FOR OUTREACH
AND EDUCATIONAL RESOURCES, WHICH
HAS, AGAIN, VIDEOS,
EVIDENCE-BASED ARTICLES,
HANDOUTS, POSITION STATEMENTS,
ET CETERA.
WE'RE SHOWING YOU THESE TICKED
INDICATION MATERIALS BECAUSE IN
THE MILITARY RIGHT NOW THERE'S A
HUGE PUSH TO EDUCATE ON ENERGY
DRINKS.
WE KNOW MILITARY SERVICE MEMBERS
ARE USING ENERGY DRINKS, AND IN
FACT WHEN WE DO IN-PERSON
PRESENTATIONS WE ALWAYS HAVE
SOMEONE IN THE AUDIENCE WHO HAS
AN ENERGY DRINK, AND IT'S A
GREAT OPPORTUNITY TO SAY, SHOW
ME AND FIND THE AMOUNT OF
CAFFEINE IN THAT ENERGY DRINK.
SO WE UPDATED OUR PROMO ON
ENERGY DRINKS TO INCLUDE ENERGY
SHOTS, YOU'RE SEEING THAT ON THE
LEFT OF YOUR SCREEN.
AND IN THE MILITARY CBD AND HEMP
ARE NOT ALLOWED, THEY ARE
PROHIBITED INGREDIENTS.
THIS IS VERY CHALLENGING FOR US
RIGHT NOW BECAUSE THERE'S A LOT
OF PRODUCTS, A LOT OF FOOD
PRODUCTS, THERE'S A LOT OF
PRODUCTS IN GENERAL WITH HEMP AN
CBD BUT THESE ARE PROHIBITED
INGREDIENTS.
WE DEVELOPED THAT PROMO FOR OUR
AUDIENCE AND THAT'S AVAILABLE ON
OPERATION SUPPLEMENT SAFETY.
RECENTLY, WE POSTED THIS ON OUR
SOCIAL MEDIA AS THIS BECAME AN
ISSUE IN THE NAVY AND THEY
PUSHED OUT INFORMATION ABOUT
ROCK STAR UNPLUGGED BECAUSE IT
CONTAINS HEMP SEED OIL.
AND THERE'S CONCERN IT MIGHT
RESULT IN A POSITIVE DRUG TEST.
SO, VERY RARELY WILL WE EVER
PUSH OUT INFORMATION ABOUT A
BRAND NAME PRODUCT.
WE GOT THIS APPROVED ONLY
BECAUSE, AGAIN, THIS IS A
WARNING TO OUR SERVICE MEMBERS
TO NOT USE THIS PRODUCT OR ANY
OTHER PRODUCT THAT CONTAINS
HEMP, HEMP SEED OIL, OR CBD.
SO DR. SCOTT TALKED ABOUT THE
BRAIN HEALTH INITIATIVE.
WE PACKAGED UP ALL THOSE
EVIDENCE-BASED ARTICLES INTO THE
BRAIN HEALTH GUIDE WHICH IS WHAT
YOU'RE SEEING ON THE SCREEN AS
ANOTHER WAY TO PUSH OUT OUR
RESOURCES ON SOCIAL MEDIA.
YOU SEE THE REAL FOODS PROMO
THAT WE JUST UPDATED ON THE
RIGHT OF THE SCREEN.
AND THAT IS OF COURSE DUE TO
COVID-19, THERE'S A LOT OF
REQUESTS FOR INFORMATION ABOUT
THOSE TYPES OF PROMOS, AND AS HE
MENTIONED, WHEN THE IMMUNE
FUNCTION PROJECT FINISHES AND WE
HAVE THE INFORMATION FROM THAT
STUDY, WE WILL TAKE THAT
INFORMATION AND WRITE
EVIDENCE-BASED ARTICLES AND
PACKAGE IT AGAIN INTO AN IMMUNE
HEALTH GUIDE FOR OPERATION
SUPPLEMENT SAFETY.
HERE IS THE LANDING PAGE OF OUR
"ASK THE EXPERT" PORTAL, THEY
MAY BE A CIVILIAN OR SERVICE
MEMBER OR HEALTH PROVIDER.
THEY TELL US IF THEY ARE A
LEADER.
WE'RE VERY CAREFUL OF COURSE TO
KEEP THE INFORMATION PRIVATE.
SINCE THE DODI WAS SIGNED, WE
WENT FROM AN AVERAGE OF ABOUT 65
TO 80 ASK THE EXPERT QUESTIONS
TO OVER 200.
WE ANSWER ALL OF OUR QUESTIONS
WITHIN 7 BUSINESS DAYS.
THEY ARE ALL EVIDENCE-BASED.
IF IT'S A QUESTION ABOUT A
PRODUCT, WE WILL GO TO THE
MARKETING WEBSITE.
AND WE WILL TELL THE PERSON IN
THE ANSWER THAT THIS IS BASED ON
WHAT WE CAN FIND ON THE
MARKETING WEBSITE BY THE LABEL
ALONE.
THEY ALWAYS WANT TO KNOW IS THIS
PRODUCT SAFE, AM I GOING TO POP
POSITIVE.
OF COURSE WE CAN'T REALLY ANSWER
IF THE PRODUCT WILL BE SAFE OR
NOT.
AND WE DO EDUCATE ON THEIR
PARTY'S CERTIFICATION.
WE HAVE A BIG PRESENCE, WE TRY
TO HAVE A BIG PRESENCE ON SOCIAL
MEDIA.
I KNOW WE SHARE INFORMATION
THAT'S PUSHED OUT FROM THE
OFFICE OF DIETARY SUPPLEMENTS.
AND IF ANYONE FOLLOWS ME ON MY
PERSONAL PAGE ON LINKED IN, I
ALSO PUSH OUT INFORMATION FROM
OPERATION SUPPLEMENT SAFETY AND
OUR FEDERAL PARTNERS.
AND AS I MENTIONED, IT'S NOT
JUST WHAT WE DO ON OPSS.ORG BUT
ACROSS THE ENTIRE DIGITAL
PLATFORM.
YOU SEE A FEW EXAMPLES OF WHAT
WE RECENTLY PUSHED OUT.
PLEASE FOLLOW US.
ALSO SIGN UP FOR OUR NEWSLETTER
ON THE MAIN PAGE OF OPSS AT THE
BOTTOM.
WHAT IS NEXT?
WELL, WE WILL CONTINUE OF COURSE
TO PROVIDE MORE EVIDENCE-BASED
INFORMATION ON THE WEBSITE BUT
WE HAVE SOME HUGE INITIATIVES
PER THE DODI.
ON THE NEXT SLIDE WE SEE JUST A
LITTLE SNAPSHOT OF THE MODULE
WHICH WE'RE WORKING ON.
SO THE MODULE HAS FIVE SECTIONS.
AGAIN, THIS IS MANDATED IN THE
DODI.
AND WE PROBABLY WILL NOT HAVE
THIS READY UNTIL THE END OF THE
FIRST QUARTER OF 2023, THE LINK
WILL BE ON OPERATION SUPPLEMENT
SAFETY, AND ANYONE WILL BE ABLE
TO TAKE THE MODULE.
YOU DON'T HAVE TO HAVE A
MILITARY CARD OR SOMETHING.
THAT'S OUR INTENT WITH CEUs
BUT WE'RE STILL DEVELOPING THE
CONTENT.
I KNOW THAT FDA IS GETTING READY
TO LAUNCH THEIR HEALTH
PROFESSIONAL AND CONSUMER
INFORMATION ON DIETARY
SUPPLEMENTS, THEY TEAMED UP WITH
AMA.
WE WILL OF COURSE INCORPORATE
ANY OF THAT NEW INFORMATION IN
THE MODULE.
I RECENTLY PRESENTED ON OUR OPSS
INGREDIENT DATABASE, OPPS I.D.
AT THE NUTRIENT DATABASE
CONFERENCE.
AND THIS DATABASE WE NOW HAVE,
WE CREATED BACK IN 2020 TO
SUPPORT THE EFFORT WE'RE WORKING
ON, BUT WE HAD NO IDEA HOW BIG
IT WAS GOING TO GET, AND THAT IT
WAS GOING TO BE SO CRITICAL IN
HELPING US UPDATE AND POPULATE
LIST OF DoD-PROHIBITED DIETARY
SUPPLEMENT INGREDIENTS.
WE NOW HAVE A BIND BOGGLING 1400
INGREDIENTS AND 8,000 SYNONYMS
FOR EACH, WE'RE METICULOUS ABOUT
TRACKING BECAUSE PEOPLE WILL ASK
QUESTIONS.
WE'LL AT SOME POINT USE THIS
INGREDIENT DATABASE HOPEFULLY ON
THE WEBSITE BUT AGAIN RIGHT NOW,
ONE IS THE PROHIBITED LIST, TWO
IS THE APP WE'RE W ON.
NEXT SLIDE.
THANK YOU.
SO, THIS IS JUST A PICTURE OF
HOW WE LEFT OUR APPS.
WE HAD TO STOP WORKING ON IT FOR
A FEW MONTHS, DO A CHANGE IN
I.T. CONTRACTS, AND IT'S CALLED
OPSSUPP, WE'LL RESUME WORK IN
JULY, AND HOPEFULLY OUR SERVICE
MEMBERS AND AUDIENCE WILL BE
ABLE TO SCAN A SUPPLEMENT.
WE ARE NOT GOING TO HAVE THE
BARCODE FOR ALL SUPPLEMENTS ON
THE MARKET, OF COURSE, BUT WE
HOPE THAT SERVICE MEMBERS WILL
BE ABLE TO NAVIGATE THE
PROHIBITED LIST OF INGREDIENTS,
MUCH EASIER WITH THE APP.
I DON'T HAVE TIME TO DIG INTO
OUR RATINGS SYSTEM.
WE HAVE RATINGS SYSTEM IN THE
APP, BUT HOPEFULLY NEXT YEAR AT
THE PRACTICUM I WILL DO A LIVE
DEMO OF OUR RECENTLY LAUNCHED
APP AND I DO WANT TO THANK THE
OFFICE OF DIETARY SUPPLEMENTS.
WE'RE WORKING SO CLOSELY WITH
THE DIETARY SUPPLEMENT LABEL
DATABASE, USING THEIR API AND WE
SO APPRECIATE THE PARTNERSHIP AS
WE TRY TO BUILD OUT THIS APP.
NEXT SLIDE.
SO THERE'S OUR CONTACT
INFORMATION.
AGAIN, WE THANK YOU SO MUCH FOR
THE OPPORTUNITY TO TALK WITH YOU
ALL TODAY.
PLEASE REACH OUT TO US AS YOU
LEAVE TODAY, IF YOU THINK OF A
QUESTION.
WE'RE ALWAYS HERE TO HELP SO
THANK YOU AGAIN.
>> THANK YOU, ANDREA.
AND JONATHAN.
WHAT A WONDERFUL OVERVIEW.
YOU HAVE SO MUCH MATERIAL, SO
MUCH INFORMATION TO SHARE WITH
US ALL.
ONE QUESTION, ANDREA, I WANT YOU
TO HIGHLIGHT THAT THE POSTERS
AND FLYERS AND SOME
COMMUNICATIONS THAT YOU
DEVELOPED, THEY ARE AVAILABLE
FOR ANYONE, IS THAT RIGHT?
>> THAT'S CORRECT.
>> TO DOWNLOAD FROM THE WEBSITE?
>> THAT'S CORRECT.
SOME OF THEM ARE EASILY
PRINTABLE FROM A LOCAL COMPUTER.
WE ALSO HAVE THEM IN THE
e-CATALOG AT THE ARMY PUBLIC
HEALTH CENTER, AND IF ANYONE HAS
ANY TROUBLE GETTING ANY OF OUR
PROMOS PLEASE REACH OUT TO ME
DIRECTLY.
>> GREAT.
OKAY.
WE DO HAVE SOME QUESTIONS IN THE
CHAT.
DR. DWYER AND I WERE TYPING THE
SAME QUESTION ABOUT THE SAME
TIME.
IS FDA DOING ANYTHING ABOUT THE
PRODUCTS YOU FIND ARE VIOLATING
BY NOT LABELING THE INGREDIENTS
OR HAVING UNLABELED INGREDIENTS?
>> YES, THEY ARE.
AS A MATTER OF FACT, WE JUST MET
WITH THEM YESTERDAY, TWO DAYS
AGO, AND WE SHARE ALL OF OUR
INFORMATION WITH THEM.
AND SOME OF THESE HAVE RESULTED
IN WARNING LETTERS.
AND SO WE WILL CONTINUE TO SEND
THEM AS WE UNCOVER THINGS, AS WE
WRITE AN ASK THE EXPERT ANSWER
CAN SEE HOW IT'S LABELED IN THE
MARKETING WEBSITE AND SHARE NOT
ONLY WITH FDA BUT WE SHARE WITH
FTC AND DEPARTMENT OF JUSTICE,
AND DEA.
>> GREAT.
WONDERFUL TO KNOW.
DR. SCOTT, YOU INTRODUCED
MILITARY SURVEYS ONGOING, I
WONDER IF YOU COULD SPEAK TO ARE
THERE -- THERE MAY HAVE BEEN
SOME SURVEYS DONE IN THE
MILITARY ACADEMY.
HOW DO WE EDUCATE THOSE IN
MILITARY ACADEMIES AN GET THEY
WILL WHILE THEY ARE YOUNG?
>> A GREAT POINT AND GREAT
QUESTION THAT REALLY OUR
EDUCATION NEEDS TO TRANSCEND A
SERVICE MEMBER'S CAREER, NOT
ONLY THOSE AT OUR SERVICE
ACADEMIES THAT WILL BE
COMMISSIONED OFFICERS, BUT ALSO
WITH OUR ENLISTED PERSONNEL
DURING INITIAL TRAINING.
AT MAIN OF OUR INITIAL ENTRY
TRAINING SITES THE USE OF
DIETARY SUPPLEMENTS ARE NOT
PERMITTED, AND SO IT'S REALLY
FINDING THAT SWEET SPOT AS FAR
AS WHEN AND HOW TO EDUCATE OUR
SERVICE MEMBERS ON DIETARY
SUPPLEMENTS.
WHAT WE'VE SHOWN IN SOME OF OUR
DATA, THOSE THAT ARE GOING
THROUGH OUR MILITARY ENTRANCING
PROCESSING STATION, MEP STATION,
THE LAST MEDICAL CHECK BEFORE
YOU SHIP OFF TO YOUR BOOT CAMP
OR YOUR INITIAL MILITARY
TRAINING FOR OUR ENLISTED
PERSONNEL, THE PREVALENCE OF
DIETARY SUPPLEMENT USE IS ONLY
AROUND 25 TO MAYBE 30%.
AND AS INDIVIDUALS SINCE THEN
GRADUATE FROM THEIR INITIAL
MILITARY TRAINING AND MOVE ON TO
THEIR NEXT PHASE OF TRAINING,
WHERE HAPPENS DIETARY
SUPPLEMENTS MAY BE PERMITTED,
THAT PREVALENCE DOESN'T CHANGE
MUCH, BUT AT SOME POINT IN TIME
THAT CHANGE DOES OCCUR.
CONSISTENTLY WE AND OTHERS HAVE
SHOWN THAT THE PREVALENCE IS
ABOUT 75% OF SERVICE MEMBERS
REGARDLESS OF GENDER, REGARDLESS
OF SERVICE.
SO CLEARLY THERE IS A NEED FOR
EDUCATION AT THAT POINT IN TIME
TO HELP INDIVIDUALS TO BECOME
INFORMED USERS.
>> GREAT.
NOW, SOME OF THAT USE MIGHT BE
FOR MULTI-VITAMINS OR, SAY,
CALCIUM SUPPLEMENTS?
>> YEAH, ABSOLUTELY.
IT COVERS THAT FULL SPECTRUM.
SO CERTAINLY MULTI-VITAMINS ARE
VERY COMMON, FISH OILS ARE VERY
COMMON, BUT AS WE HAVE SEEN
RECENTLY THE COGNITIVE
ENHANCEMENT BRAIN HEALTH
PRODUCTS HAVE CERTAINLY BECOME
MORE POPULAR AS OF LATE.
OUR PRODUCTS MARKETS FOR
PRE-WORKOUT ARE VERY COMMON.
PRODUCTS MARKETED FOR WEIGHT
LOSS, RECOVERY, CONTINUE TO BE
AMONGST THE MOST COMMON
SUPPLEMENTS THAT FOLKS USE.
REALLY THOSE WE'RE MORE
CONCERNED ABOUT.
IT'S NOT SO MUCH THE
MULTI-VITAMINS OR PRENATAL
VITAMINS OR INDIVIDUAL VITAMINS.
>> SINCE YOU MENTIONED FISH OIL,
WE HAVE A QUESTION, IT WAS
MENTIONED THAT CONGRESS HAS
ASKED ABOUT OMEGA 3 LEVELS.
WHAT OR WHY IS THIS AN EXPRESS
CONCERN BY CONGRESS?
>> GREAT QUESTION.
I'M NOT EXACTLY SURE WHERE THEIR
QUESTION IS COMING FROM, OTHER
THAN THEY ARE LOOKING AT
LITERATURE THAT SUGGESTS AS MUCH
AS MEMBERS HAVE LOW LEVELS OR
SUBOPTIMAL LEVELS OF OMEGA 3,
AND SO AGAIN REALLY THE INTENT
WITH THAT INTERVENTION IS TO SEE
CAN WE TAKE THE FOOD-FIRST
APPROACH AND CHANGE OMEGA 3
INDEX LEVELS IN A POSITIVE
MANNER SIMPLY ALTERING THE FOODS
BEING SERVED IN THE DINING
FACILITY OR IS THERE PERHAPS A
NEED FOR USE OF DIETARY
SUPPLEMENTS OR IS IT THE
COMBINATION.
THERE'S SOME INTEREST IN THE
BRAIN HEALTH AREA, THERE'S SOME
EMERGING EVIDENCE IN THERE AS
FAR AS EITHER TREATMENT OR
PROPHYLACTICALLY BEING USED FOR
TRAUMATIC BRAIN INJURY.
MANY SERVICE MEMBERS MAY BE
EXPOSED TO, ALBEIT MILD,
TRAUMATIC BRAIN INJURY
THROUGHOUT THE CAREER AND COULD
THIS BE USED AS A MEANS TO
EITHER BE USED PROPHYLACTICALLY
OR USED TO HELP IMPROVE BRAIN
HEALTH DURING THAT TIME PERIOD
REMAINS TO BE SEEN.
>> THIS QUESTION MAY BE FOR
ANDREA.
AND A WRITER IS ASKING IF
THERE'S SOME WAY THAT THEY CAN
LOAD EVIDENCE-BASED INFORMATION
INTO THE DODI OR MAYBE ANOTHER
PORTAL ON DIFFERENT INGREDIENTS
AND PRODUCTS.
>> WELL, BECAUSE THE DODI IS A
DoD-WIDE REGULATION THAT
WOULDN'T BE POSSIBLE.
THOSE ARE ISSUED AND THEN THEY
ARE GOOD FOR ABOUT 10 YEARS, BUT
THAT'S REALLY WHAT WE DO ON
OPERATION SUPPLEMENT SAFETY WHEN
WE'RE ABLE TO PULL ALL THE
LITERATURE AND WRITE AND
EVIDENCE-BASED ARTICLE ABOUT AN
INGREDIENT.
THE INGREDIENT DATABASE AND
THEREFORE THEN THE APP WILL HAVE
BEHIND IT THAT EVIDENCE-BASED
INFORMATION ON THE INGREDIENTS.
AND AS I MENTIONED, I DIDN'T
HAVE TIME TO GET INTO THE
DIFFERENT RATINGS, BUT THAT'S
ALL BASED ON IT'S GOING TO BE
GREEN, RED, YELLOW, AND THEN
GRAY.
THAT'S BASED ON THE SCIENTIFIC
LITERATURE.
>> OKAY.
GREAT.
AND HOW ARE THE ASK THE EXPERTS
EDUCATED ABOUT NEW INGREDIENTS
THAT COME ON THE MARKETPLACE?
IT'S A NEVER-ENDING TRAIL OF
THESE PRODUCTS.
HOW DO YOU KEEP UP WITH THEM?
>> IT IS A NEVER-ENDING TRAIL.
I CAN TELL YOU FROM NOW HAVING
OUR ASK THE EXPERT QUESTIONS
DOUBLE, LAST MONTH WE LOOKED UP
172 PRODUCTS, SOME OF WHICH
WE'VE NEVER SEEN BEFORE.
AND I'VE BEEN DOING THIS, I'VE
BEEN ANSWERING THESE QUESTIONS
FOR 10 YEARS, AND WE HAVE A VERY
SMALL TEAM.
I CAN TELL YOU IT'S VERY, VERY
CHALLENGING.
BUT WE HAVE TO KEEP OUR EYE ON
THE BALL AND THAT IS WE JUST,
AGAIN, ANSWER THE QUESTION.
IF THERE'S A TREND THAT WE
UNCOVER, I'M GOING TO GIVE AN
EXAMPLE, WE STARTED RECEIVING A
LOT OF QUESTIONS ABOUT THE
INGREDIENT TURKESTERONE, AND
PULLED THE DATA AND COULDN'T
FIND ENOUGH INFORMATION TO WRITE
AN EVIDENCE-BASED ARTICLE.
SO WE PUT FOUR SENTENCES ON THE
OPERATION SUPPLEMENT SAFETY
WEBSITE.
AND THEN WE PUSHED THE
INFORMATION OUT ON SOCIAL MEDIA.
SO THERE IS THAT OPPORTUNITY.
WE HAVE TO WORK WITH OUR LAWYERS
A LOT TO GET THAT APPROVED, OF
COURSE.
BUT WE TRY TO PUSH OUT ANYTHING
THAT WE GLEAN FROM THE ASK THE
EXPERT QUESTIONS ON SOCIAL MEDIA
OR, AGAIN, BY CREATING CONTENT
ON THE WEBSITE.
>> ONE LAST QUESTION DEALS WITH
WORKING WITH THE PXs ON THE
MILITARY BASES.
WELL, IF THEY SELL IT ON THE
BASE IT MUST BE SAFE.
SO, WHAT'S YOUR LEVEL OF
CONTROL, SO TO SPEAK,
PROHIBITING SOME OF THESE
PRODUCTS GOING INTO THE PXs?
>> WELL, FIRST, THANK YOU FOR
THAT QUESTION.
WE GET THAT QUESTION AT EVERY
PRESENTATION.
AND I THINK IT'S VERY, VERY
IMPORTANT.
THE DODI ACTUALLY STIPULATES
THAT THERE WILL BE NO PRODUCTS
SOLD ON BASE WITH A PROHIBITED
INGREDIENT.
WE'RE MEETING WITH ALL THE
EXCHANGES TO TALK TO THEM, TO
ENSURE THAT THEIR BUYERS ARE
NAVIGATING THE PROHIBITED LIST.
WE'RE NOT WALKING ENCYCLOPEDIAS.
WE HAVE 800 SUBSTANCES, 1700
SYNONYMS.
IT'S EXTREMELY CHALLENGING.
WE'RE GOING TO CONTINUE TO HAVE
THE DISCUSSION, WHAT WE'RE
LOOKING FOR IS A LIST.
WE'D LIKE TO HAVE MORE INPUT
BECAUSE WE, AGAIN, DON'T WANT TO
BE IN A SITUATION WHERE A
SERVICE MEMBER TAKES A PRODUCT
THAT THEY SHOULDN'T TAKE.
WE WANT TO STEER THEM TO THOSE
SAFE PRODUCTS.
WE KNOW THERE ARE SAFE PRODUCTS.
WE WANT TO OFFER MORE -- WE HOPE
THEY ARE THERE ON THE BASE, MORE
THIRD-PARTY CERTIFIED PRODUCTS,
BECAUSE IF THEY WANT TO TAKE
OMEGA 3 OR MULTI-VITAMIN OR
MAYBE CREATINE OR WHATEVER WE
WANT TO MAKE SURE THOSE ARE
AVAILABLE SO THEY CAN MAKE THE
INFORMED DECISION FOR
THEMSELVES.
JONATHAN, DID HAVE YOU ANYTHING
TO ADD TO THAT?
>> NO, THAT'S A GREAT SUMMARY.
I KNOW WE'RE COMING UP AGAINST
OUR TIME.
>> RIGHT.
SO THANK YOU AGAIN.
YOU ALL ARE EXTREMELY VIGILANT.
TO KEEP OUR SERVICE MEMBERS
SAFE.
WE THANK YOU FOR THAT AND
ENCOURAGE EVERYONE TO GO VISIT
THE OPSS WEBSITE AND LEARN MORE
ABOUT WHAT YOU DO.
SO AT THIS TIME I THINK WE WILL
MOVE ON TO ANOTHER EXPERT, WHO
HANDLES ASK-THE-EXPERT
QUESTIONS, CAROL HAGGANS, WHO
HAS JOINED US, WITH ODS AND
HANDLES A VARIETY OF HEALTH
COMMUNICATION ACTIVITIES FOR ODS
TO INCLUDING WRITING OF
FACTSHEETS.
PERFECT SEGUE TO ANOTHER
ASK-THE-EXPERT AND, CAROL, TAKE
IT AWAY.
>> GREAT.
THANK YOU, DR. COSTELLO.
LET ME GO AHEAD AND SHARE MY
SCREEN.
OKAY.
HOW DOES THAT LOOK?
CAN YOU SEE MY SLIDES?
>> IT'S GREAT.
>> OKAY, GREAT.
GOOD MORNING, EVERYONE.
THANK YOU, DR. COSTELLO, AND DR.
GAHCHE, FOR THE INTRODUCTION AND
CHANCE TO SPEAK TODAY.
MY TALK RELATES TO THE FACT THAT
WE ALL INTERACTING REMOTELY FOR
THE PRACTICUM.
WE'RE IN A CONFERENCE ROOM IN
YEARS PAST BUT NOT THIS YEAR.
IT'S A TOPIC OF COURSE THAT HAS
AFFECTED ALL OF US, SOME MORE
THAN OTHERS, AND THAT OF COURSE
IS COVID-19.
AND MORE BROADLY, IMMUNITY.
CAN DIETARY SUPPLEMENTS AFFECT
IMMUNE HEALTH?
AND WHAT HAVE WE LEARNED OVER
THE LAST 2 TO 2 1/2 YEARS?
I'LL PROVIDE SOME BACKGROUND
INFORMATION ON IMMUNE FUNCTION,
WHAT WE'VE SEEN IN TERMS OF
CONSUMER INTEREST, AND
SUPPLEMENTS PROMOTED FOR IMMUNE
FUNCTION.
AND THEN I'LL GO INTO DETAIL
ABOUT SOME STUDIES COMPLETED FOR
CERTAIN INGREDIENTS.
THE IMMUNE SYSTEM, I'LL START BY
SAYING THAT I'M A NUTRITIONIST,
NOT AN IMMUNOLOGIST.
THIS IS A VERY BRIEF OVERVIEW.
BUT BASICALLY THE IMMUNE SYSTEM
IS A NETWORK OF CELLS, TISSUES,
ORGANS THAT WORK TOGETHER TO
PROTECT THE BODY.
IT'S COMPRISED OF INNATE
RESPONSES WHICH ARE THE FIRST
LINE OF DEFENSE, AND ADAPTIVE
RESPONSES, WHICH BECOME ENGAGED
LATER.
AND THE INNATE IMMUNE SYSTEM
INCLUDES PHYSICAL BARRIERS LIKE
THE SKIN, GUT EPITHELIUM, THEY
HELP PREVENT PATHOGEN ENTRY.
AND IT ALSO INCLUDES LEUKOCYTES
WHICH ARE WHITE BLOOD CELLS SUCH
AS NEUTROPHILS, MACROPHAGES,
NATURAL KILLER CELLS.
THEY ATTEMPT TO IDENTIFY AND
ELIMINATE FOREIGN PATHOGENS.
AND THESE COMPONENTS ARE
NON-SPECIFIC.
SO, UNLIKE ADAPTIVE IMMUNE
SYSTEM, THEY DON'T RECOGNIZE AND
RESPOND TO SPECIFIC PATHOGENS.
ADAPTIVE IMMUNE SYSTEM ON THE
OTHER HAND CONSISTS OF T
LYMPHOCYTES, ALSO CALLED T
CELLS, AND B CELLS THAT SECRETE
ANTIBODIES INTO BLOOD AND
TISSUES, BOTH ARE PATHOGEN
SPECIFIC.
ADAPTIVE IMMUNE RESPONSE TAKES
SEVERAL DAYS OR WEEKS TO
DEVELOP.
BUT GENERATES IMMUNOLOGICAL
MEMORY SO SUBSEQUENT EXPOSURE TO
SAME PATHOGEN LEADS TO VIGOROUS
IMMUNE RESPONSE.
VACCINATIONS TARGET ADAPTIVE
IMMUNE SYSTEM PROTECTING FROM
EXPOSURE TO THE SAME PATHOGEN IN
THE FUTURE.
THE BODY'S IMMUNE RESPONSE LEADS
TO INFLAMMATION, THIS IS
RELEVANT FOR COVID-19 AND MANY
OTHER DISEASES BECAUSE
INFLAMMATION DOES HELP ELIMINATE
A PATHOGEN AND INITIATE THE
HEALING PROCESS, BUT CAN ALSO
CAUSE PROBLEMS.
FOR EXAMPLE, ACTIVATION OF CD8 T
CELLS CAN INCREASE INFLAMMATION
AND CALL PULMONARY DAMAGE, CAN
LEAD TO ACUTE RESPIRATORY
DISTRESS SYNDROME, ALSO SOME
COVID-19 PATIENTS EXPERIENCE
CYTOKINE STORM, WHICH IS A
CRITICAL CONDITION CAUSED BY
EXPRESSIVE PRODUCTION OF
INFLAMMATORY CYTOKINES.
THIS INCREASES DISEASE SEVERITY
AND RISK OF DEATH.
SO KEEPING THE BODY'S
INFLAMMATORY RESPONSE IN CHECK
IS AN IMPORTANT COMPONENT OF
DISEASE MANAGEMENT.
DIETARY SUPPLEMENTS, THIS CHART
SHOWS SALES FOR SUPPLEMENTS
PROMOTED FOR IMMUNE HEALTH.
ON THE FIRST DAY OF THE
PRACTICUM DR. GAHCHE NOTED HOW
SUPPLEMENT SALES INCREASED IN
2020 AND WE SAW THIS IN THIS
CATEGORY.
YOU CAN SEE THE STEADY GROWTH
SINCE 2016, DURING 2020 SALES
REACHED $5.9 BILLION.
AND THIS WAS UNDOUBTEDLY DUE TO
COVID-19.
NOW, VALUES FOR 2021 HAVEN'T
BEEN FINALIZED JUST YET, BUT
SALES ARE ESTIMATED TO HAVE
DECLINED SOMEWHAT FROM 2020 BUT
STILL VERY HIGH COMPARED TO
PREVIOUS YEARS.
AND THIS IS THE BREAKDOWN DURING
2020 OF INGREDIENTS COMMONLY
FOUND IN THESE PRODUCTS.
MULTI-VITAMINS AND VITAMIN C TOP
THE LIST.
FOLLOWED BY VARIOUS HERBS,
PRE-BIOTICS AND PROBIOTICS, AND
ELDERBERRY SPECIFICALLY, ONE OF
THE TOP SELLERS DURING 2020 IN
THE HERBAL CATEGORY.
OF COURSE, THESE DIETARY
SUPPLEMENTS LIKE OTHERS ARE NOT
INTENDED TO PREVENT OR TREAT
DISEASE.
WE HAVE VACCINES, WE HAVE
PHARMACOLOGIC TREATMENTS.
BUT WE ALSO HAVE SOME FALSE
CLAIMS.
ON MONDAY TAWANA DAVIS FROM FTC
MENTIONED THEY ARE CRACKING DOWN
ON DIETARY SUPPLEMENTS THAT ARE
BEING ILLEGALLY ADVERTISED FOR
PREVENTING OR TREATING COVID-19.
HERE'S AN EXAMPLE OF ONE OF
THESE BULLETINS FROM THE FTC,
BUT NEVERTHELESS THERE IS A LOT
OF INTEREST WITH RESPECT TO
DIETARY SUPPLEMENTS AND IMMUNE
SUPPORT.
SO NOW I'LL TURN TO WHERE THE
SCIENCE REALLY STANDS RIGHT NOW.
SO IN TERMS OF SUPPLEMENT
INGREDIENTS, WE KNOW THAT MANY
VITAMINS AND MINERALS INCLUDING
VITAMINS A AND C, D, E, AND ZINC
AND SELENIUM, ARE IMPORTANT FOR
PROPER IMMUNE FUNCTION AS ARE
ESSENTIAL FATTY ACIDS AND SOME
AMINO ACIDS.
DEFICIENCIES OF THESE NUTRIENTS
CAN INCREASE SUSCEPTIBILITY TO
INFECTION.
BUT THE QUESTION IS, ASSUMING
SOMEONE IS GETTING SUFFICIENT
AMOUNTS, DOES GETTING MORE HELP?
AND AS FAR AS OTHER INGREDIENTS,
BOTANICALS, PROBIOTICS, THEY
DON'T HAVE ESSENTIAL ROLES IN
THE BODY BUT DO THEY AFFECT
IMMUNE FUNCTION OR INFLAMMATION?
UNFORTUNATELY, FOR MANY OF THESE
INGREDIENTS WE SIMPLY DON'T HAVE
AS MUCH INFORMATION AS WE WOULD
LIKE.
BUT NOW I'LL GO IN SOME DETAIL
ABOUT SEVERAL INGREDIENTS AND
WHAT WE HAVE LEARNED FROM
STUDIES INVOLVING COVID-19, AND
I'LL START WITH VITAMIN D
BECAUSE IT HAS GARNERED A LOT OF
ATTENTION.
AS YOU ALL KNOW IT HAS WELL
ESTABLISHED EFFECT ON CALCIUM
ABSORPTION AND BIOIMMUNITY
INCREASING LEVEL OF T
REPRESENTING LAKER TO CELLS AND
AFFECTS SUSCEPTIBILITY TO
INFECTION, ASSOCIATED WITH FLU
AND HEPATITIS C AND THERE IS
EVIDENCE OF REDUCING RESPIRATORY
TRACT INFECTION ESPECIALLY WITH
VITAMIN D DEFICIENCY.
ADULTS NEED 15 TO 20 MICROGRAMS
A DAY, 600 TO 800 IUs, UNITS
HAVE CHANGED.
AND D OF STATUS IS MEASURED BY
SERUM CONCENTRATION OF
25-HYDROXY D, OPTIMAL
CONCENTRATIONS AREN'T PRECISELY
DEFINEDRY R. ADEFINED DEFINED
-- DEFINED BUT ABOVE 50 IS
ADEQUATE FOR BONE HEALTH.
IN ADDITION, ASSESSING VITAMIN D
STATUS IS COMPLICATED BY
VARIABILITY OF AVAILABLE ASSAYS.
MANY RECOMMENDED INCREASE IN
INTAKE AT THE BEGINNING OF THE
PANDEMIC, THIS RECOMMENDED
ADULTS INCREASE FROM ALL SOURCES
TO ACHIEVE SERUM LEVELS ABOVE 30
NANOGRAMS PER MILLILITER TO
PREVENT OR REDUCE SYMPTOMS, AND
2,000 TO 4,000 IUs, DOSES MUCH
HIGHER THAN THE RDAs, AND IN
ADDITION RECOMMENDED THAT
HOSPITALS MEASURE SERUM VITAMIN
D LEVELS OF ALL PATIENTS
HOSPITALIZED FOR COVID-19, AND
THOSE WITH LEVELS BELOW 30
NANOGRAMS RECEIVED VITAMIN D
SUPPLEMENTATION.
EVEN CONGRESS GOT INVOLVED WITH
HOUSE RESOLUTION 116 A YEAR AGO,
STATES VITAMIN D DEFICIENCIES
ARE LINKED TO POOR COVID-19
OUTCOMES AND ENCOURAGES THE CDC
AND FDA TO ISSUE GUIDANCE ON
VITAMIN D DURING THE PANDEMIC.
THIS BILL HAS NOT MOVED OUT OF
COMMITTEE.
BUT IT DOES SHOW YOU THE STRONG
LEVEL OF INTEREST IN DIETARY
SUPPLEMENTS INGREDIENTS LIKE
VITAMIN D.
BUT OF COURSE THE IMPORTANT
QUESTION IS WHAT DOES THE
SCIENCE SAY?
WELL, MANY BUT NOT ALL, BUT MANY
OBSERVATIONAL STUDIES DO SHOW
ASSOCIATION BETWEEN LOWER
VITAMIN D CONCENTRATIONS OR
VITAMIN D DEFICIENCY AND HIGHER
RISK OF COVID-19 AS WELL AS
SEVERITY OF DISEASE.
AND MOST OF THESE STUDIES WERE
CONDUCTED BEFORE VACCINES WERE
DEVELOPED.
HERE'S A STUDY FROM SPAIN,
EXAMINED LEVELS IN HOSPITALIZED
PATIENTS WITH COVID-19, AND
COMPARED THEM WITH HEALTHY
LEVELS IN HEALTH HEALTHY
CONTROLS, LOWER LEVELS IN
PATIENTS WITH COVID-19, BARS IN
BLACK, COMPARED WITH CONTROLS.
AND THEY ALSO FOUND HIGHER RATES
OF VITAMIN D DEFICIENCY IN THE
PATIENTS WITH COVID-19.
HERE'S ANOTHER STUDY CONDUCTED
IN CHINA, EXAMINED VITAMIN D
CONCENTRATIONS IN PATIENTS WITH
COVID-19, AND HEALTHY CONTROLS,
AND FOUND SIGNIFICANTLY LOWER
CONSERVATIONS IN THE PATIENTS
THAN THE CONTROLS.
AND HERE YOU CAN SEE VITAMIN D
DEFICIENCY WHICH THEY DEFINED AS
25-HYDROXY D LESS THAN 30
NANOMOLES PER LITER WAS
ASSOCIATED WITH MORE SEVERE
COVID-19.
THERE'S A SYSTEMATIC REVIEW AND
META-ANALYSIS OF 13
OBSERVATIONAL STUDIES
ASSOCIATION BETWEEN VITAMIN D
LEVELS AND INCIDENCE OF
COVID-19, AND FOUND THAT LOW
SERUM VITAMIN D LEVELS ARE
SIGNIFICANTLY ASSOCIATED WITH
RISK OF SARS-COV-2 INFECTION.
SO THIS IS JUST IF SOMEONE HAS
LOW VITAMIN D LEVELS THEY ARE
MORE LIKELY TO GET COVID-19 BUT
THESE ARE OBSERVATIONAL STUDIES
AND CAN'T PROVE CAUSE AND
EFFECT.
IN ADDITION THERE ARE VERY
IMPORTANT CONSIDERATIONS WHEN
LOOKING AT CORRELATIONS WITH
VITAMIN D LEVELS.
FIRST IT'S IMPORTANT TO CONSIDER
WHEN THE VITAMIN D LEVELS WERE
MEASURED TO RULE OUT REVERSE
CAUSALITY, MEANING THE DISEASE
MIGHT HAVE CAUSED THE LOW
VITAMIN D LEVEL.
THIS WAS A STUDY FROM THE
NETHERLANDS, THEY HAD HEALTHY
MALE VOLUNTEERS THAT RECEIVED
BOLUS OF E. COLI-DERIVED LIPO
LIPOPOLYSACCHARIDE, MEASURED THE
25-HYDROXY D LEVEL
SIMULTANEOUSLY.
YOU CAN SEE PLASMACYTE KIND
LEVELS INCREASED TO PEAK OF 3
HOURS, VITAMIN D LEVELS
DECREASED SIGNIFICANTLY.
THIS MAKES SENSE BECAUSE VITAMIN
D IS NEGATIVE ACUTE PHASE
REACTANT, LEVELS DECREASE IN
RESPONSE TO INFLAMMATION AND OF
COURSE WE KNOW THAT INFLAMMATION
OCCURS IN COVID-19 PATIENTS.
SO THEREFORE ANY VITAMIN D
MEASUREMENTS TAKEN BEFORE --
SHORTLY BEFORE, OR AFTER A
COVID-19 DIAGNOSIS LIKE WHEN
SOMEONE IS ADMITTED TO A
HOSPITAL ARE LIKELY TO BE
REDUCED DUE TO DISEASE ONSET.
SO YOU REALLY NEED TO CONSIDER
VITAMIN D LEVELS BEFORE SOMEONE
COMES DOWN WITH COVID-19 OR
ANOTHER ILLNESS.
IT'S ALSO IMPORTANT TO CONSIDER
CONFOUNDERS SUCH AS OBESITY AND
RACE.
FOR EXAMPLE, MANY AFRICAN
AMERICANS AND PEOPLE WHO HAVE
OBESITY HAVE LOWER VITAMIN D
STATUS AS WELL AS MORE SEVERE
COVID.
THIS ANALYSIS OF DATA FROM THE
U.K. BIOBANK EXAMINED
ASSOCIATIONS BETWEEN VITAMIN D
CONCENTRATIONS AND STATUS AND
CONFIRMED SARS-COV-2 INFECTION
IN ABOUT 1500 PEOPLE WHO WERE
TESTED FOR COVID.
YOU CAN SEE THAT VITAMIN D
CONCENTRATIONS AND DEFICIENCY
WERE SIGNIFICANTLY ASSOCIATED
WITH CONFIRMED INFECTION,
VARIABLE ANALYSIS, BUT AFTER
ADJUSTMENT FOR COVARIATES
INCLUDING ETHNICITY AND BMI
CATEGORIES THE ASSOCIATIONS NO
LONGER HELD.
HOWEVER, ONE OF THE LIMITATIONS
OF THIS STUDY IS THE VITAMIN D
MEASUREMENTS WERE TAKEN SEVERAL
YEARS BEFORE EMERGENCE OF
COVID-19 SO IT'S POSSIBLE
PARTICIPANTS' LEVELS HAVE
SUBSEQUENTLY CHANGED.
THIS WAS AN INTERESTING
RETROSPECTIVE STUDY BY DR. DAVID
MELTZER AND COLLEAGUES FROM
UNIVERSITY OF CHICAGO, EXAMINING
ASSOCIATION BETWEEN VITAMIN D
LEVELS AND COVID-19 TEST RESULTS
AND VITAMIN D WAS MEASURED
DURING THE PREVIOUS YEAR, BUT
NOT WITHIN 14 DAYS OF THE
COVID-19 TESTING.
THEY ANALYZED DATA BY RACE,
OVERALL SAMPLE IS ON THE LEFT,
AND THEN BROKEN DOWN BY BLACK
AND WHITE INDIVIDUALS.
YOU CAN SEE BLACK INDIVIDUALS
WITH 25-HYDROXY D LEVELS BELOW
40 NANOGRAMS PER MILLILITER HAD
HIGHER RISK OF COVID BUT NO
ASSOCIATIONS BETWEEN VITAMIN D
LEVELS AND COVID-19 RISK AMONG
WHITES.
CLEARLY THE RELATIONSHIP BETWEEN
VITAMIN D CONCENTRATIONS AND
COVID-19 RISK IN SEVERITY ARE
COMPLICATED.
A FEW COMPLETED RCTs ON
VITAMIN D, ONE WAS IN BRAZIL,
240 HOSPITALIZED PATIENTS WITH
MODERATE TO SEVERE COVID-19.
EXAMINED EFFECTS OF A SINGLE
ORAL DOSE OF 5,000 MICROGRAMS,
200,000 IUs, OF VITAMIN D,
PLACEBO, TEN DAYS AFTER SYMPTOM
ONSET, PUBLISHED IN JAMA LAST
YEAR, MEAN BASELINE D LEVEL
AMONG PARTICIPANTS WAS 20.9
NANOGRAMS PER MILLILITER, ON THE
BORDERLINE FOR ADEQUATE STATUS,
MEASURED ON THE DAY OF
RANDOMIZATION INTO THE TRIAL.
CHART ON THE LEFT SHOWS DATA FOR
ALL PATIENTS, CHART ON THE RIGHT
IS JUST THE 115 PATIENTS WITH
VITAMIN D DEFICIENCY AT
BASELINE.
YOU CAN SEE VITAMIN D TREATMENT
DID NOT SIGNIFICANTLY REDUCE
LENGTH OF HOSPITALIZATION, ALSO
DID NOT AFFECT RISK OF MORTALITY
OR NEED FOR MECHANICAL
VENTILATION EVEN FOR DEFICIENT
PATIENTS.
FOLLOW-ON ANALYSIS OF THOSE WITH
LESS THAN 10 NANOGRAMS PER
MILLILITER AT BASELINE FOUND NO
EFFECT, PUBLISHED LATER LAST
YEAR.
THERE WAS A RECENTLY PUBLISHED
POST HOC ANALYSIS OF
PRE-SPECIFIED AND EXPLORATORY
SECONDARY OUTCOMES FROM THIS
TRIAL, AJCN A FEW MONTHS AGO,
EXAMINED EFFECT ON CYTOKINES,
CHEMOKINES, GROWTH FACTOR, AND
THEY FOUND NO SIGNIFICANT
DIFFERENCES BETWEEN GROUPS.
SO THE CURRENT NIH COVID-19
GUIDELINES STATE THAT THE DATA
ARE INSUFFICIENT TO RECOMMEND
EITHER FOR OR AGAINST USE OF
VITAMIN D TO PREVENT OR TREAT
COVID-19.
THE BOTTOM LINE IS PEOPLE SHOULD
ENSURE THEY ARE MEETING RDA FOR
VITAMIN D AND IF NEEDEDs
NEEDED A SUPPLEMENT BUT UNCLEAR
IF UPPER LEVELS ARE NEEDED.
4,000 IUs FOR ANYONE 9 OR
OLDER.
SO WHAT ABOUT VITAMIN C AND
ZINC?
LIKE VITAMIN D BOTH PLAY A ROLE
IN IMMUNE FUNCTION.
VITAMIN C HAS ANTIOXIDANT
EFFECT, AND MICROBEALLY AND
ANTI-VIRAL ACTION.
DEFICIENCY IMPAIRS IMMUNE
FUNCTION, INCREASES
SUSCEPTIBILITY TO INFECTION,
EFFECT MIGHT VARY DEPENDING ON
INDIVIDUAL STATUS.
INTEREST IN VITAMIN C AND COVID
COMES FROM RESEARCH SHOWING
TAKING 200 MILLIGRAMS A DAY OR
MORE ON A REGULAR BASIS HELPS
REDUCE DURATION OF THE COMMON
COLD AND SEVERITY OF SYMPTOMS.
VITAMIN C SUPPLEMENTS APPEAR TO
REDUCE RISK OF DEVELOPING COLDS
IN PEOPLE EXPOSED TO EXTREME
PHYSICAL STRESS, LIKE MARATHON
RUNNERS, SKIERS, SOLDIERS AND
SUBARC ARCTIC, NOT THE AVERAGE
PERSON.
ZINC HAS ANTI-VIRAL AND
ANTI-INFLAMMATORY PROPERTIES.
AND IT HELPS MAINTAIN THE
INTEGRITY OF TISSUE BARRIERS
SUCH AS RESPIRATORY EPITHELIA.
AND RESEARCH INDICATES ZINC
DEFICIENCY ADVERSELY AFFECTS
IMMUNE FUNCTION IN SEVERAL WAYS.
SEVERAL CLINICAL TRIALS SUGGEST
THAT ZINC LOZENGES THAT DISSOLVE
IN THE MOUTH MIGHT HELP SHORTEN
DURATION OF THE COMMON COLD, AND
RDA IS 8 TO 12 MILLIGRAMS A DAY
FOR ADULTS.
IN TERMS OF RESEARCH IN PATIENTS
WITH COVID THERE HAVE BEEN
RETROSPECTIVE STUDIES AND CASE
REPORTS OF VITAMIN C
ADMINISTERED ORALLY AND
INTRAVENOUSLY IN PATIENTS WITH
COVID-19.
INTRAVENOUS ADMINISTRATION CAN
PRODUCE MUCH HIGHER BLOOD LEVELS
THAN ORAL DOSES, AND IT IS NOT
CLASSIFIED AS DIETARY
SUPPLEMENT, IT'S CONSIDERED A
DRUG.
ONLY ORAL ADMINISTRATION IS
DIETARY SUPPLEMENT.
THESE STUDIES HAVE MIXED
RESULTS, IN TERMS OF WHETHER IT
AFFECTED MORTALITY OR OTHER
OUTCOMES LIKE BLOOD OXYGENATION
LEVELS, SAME TRUE FOR ZINC.
RETROSPECTIVE STUDIES AND CASE
REPORTS HAVE NOT FOUND
CONSISTENT EFFECTS, ZINC
SUPPLEMENTATION OR ZINC STATUS,
ON DISEASE SEVERITY, HOSPITAL
LENGTH OF STAY OR MORTALITY
RATES.
ONE CLINICAL TRIAL HAS BEEN
COMPLETED IN ADULTS DIAGNOSED
WITH COVID-19, AND WERE
RECEIVING OUTPATIENT CARE BEFORE
VACCINATIONS, PATIENTS RECEIVE
EITHER HIGH DOSE OF ASCORBIC
ACID, ZINC OR BOTH, TRIAL WAS
STOPPED EARLY DUE TO FUTILITY,
STOPPED RECRUITMENT AT 214
PATIENTS, INTENDED TO ENROLL 520
BUT WITH DATA FOR THE PRIMARY
OUTCOME NUMBER OF DAYS REQUIRED
TO REACH A 50% REDUCTION IN
SYMPTOMS THERE WERE NO
SIGNIFICANT DIFFERENCES AMONG
THE FOUR STUDY GROUPS.
LIKEWISE THERE WAS NO
SIGNIFICANT DIFFERENCE IN ANY OF
THE SECONDARY OUTCOMES INCLUDING
NUMBER OF DAYS TO REACH NO
PRESENCE OF FEVER, COUGH,
SHORTNESS OF BREATH, OR FATIGUE.
SO LIKE VITAMIN D, THE NIH COVID
TREATMENT THE GUIDELINES STATE
DATA ARE INSUFFICIENT TO
RECOMMEND USE OF VITAMIN C OR
ZINC, AND RECOMMENDS AGAINST DUE
TO POTENTIAL FOR ADVERSE EFFECTS
AT HIGH DOSES INCLUDING COPPER
DEFICIENCY.
PEOPLE SHOULD ENSURE THEY ARE
MEETING RDA TO AVOID DEFICIENCY
AND BE MINDFUL OF ULs.
I MENTIONED EARLIER THERE ARE
OTHER NUTRIENTS THAT ARE
IMPORTANT FOR IMMUNE HEALTH LIKE
SELENIUM, VITAMIN E, VITAMIN A,
SAME MESSAGE HERE, ENSURE
SUFFICIENT INTAKE FROM DIET, IF
NEEDED A SUPPLEMENT.
YOU WANT TO AVOID ANY DEFICIENCY
BUT THERE'S NO STRONG EVIDENCE
THAT EXTRA AMOUNTS ARE
BENEFICIAL.
AND WE HAVE DIETARY SUPPLEMENTS
FACTSHEETS ON THE WEBSITE, JOYCE
MERKEL MENTIONED THESE MONDAY.
THEY LIST RECOMMENDED INTAKES,
FOOD SOURCES, HEALTH EFFECTS.
THEY ALSO LIST ULs AND COMMON
MEDICATION INTERACTIONS SO YOU
CAN REFER TO THOSE FOR MORE
DETAIL.
I'D LIKE TO TURN TO A FEW OTHER
TYPES OF INGREDIENTS, STARTING
WITH PROBIOTICS, BECAUSE THEY
HAVE ALSO GARNERED SOME
ATTENTION WITH RESPECT TO
IMMUNITY AND COVID.
LIVE MICROORGANISMS SUCH AS
BACTERIA AND YEASTS, MEASURED IN
CFUs, COMMON AMOUNTS VARY, ON
THE ORDER OF ONE BILLION OR TEN
BILLION CFUs.
THEY ACT IN THE GASTROINTESTINAL
TRACT, MIGHT IMPROVE IMMUNE
FUNCTION BY ENHANCES GUT BARRIER
FUNCTION AND ONE IMPORTANT
CONSIDERATION IS THAT RESEARCH
FINDINGS FOR ONE STRAIN OR
VARIETY CAN'T BE EXTRAPOLATED TO
OTHERS, AND THIS CAN MAKE IT
DIFFICULT TO COMPARE OR COMBINE
RESULTS FROM DIFFERENT STUDIES.
IN GENERAL, PROBIOTICS HAVE A
VERY GOOD SAFETY PROFILE FOR
HEALTHY PEOPLE.
PROBIOTICS HAVE BEEN EXAMINED
FOR DIARRHEA AND RESPIRATORY
ILLNESS.
INFECTIOUS DIARRHEA IN CHILDREN,
EARLIER STUDIES LOOKED
PROMISING.
BUT RESULTS FROM RECENT STUDIES
HAVE BEEN CONFLICTING, 2020
COCHRANE REVIEW CONCLUDED THEY
DO NOT APPEAR TO AFFECT RISK OF
DIARRHEA FOR 48 HOURS OR LONGER.
GASTROENTERITIS, SOME STRAINS
HAVE NOT BEEN SHOWN TO BE
EFFECTIVE SO THEY RECOMMEND
AGAINST THEM.
NOT FOR SAFETY CONCERNS, JUST
BECAUSE THEY DON'T APPEAR TO BE
HELPFUL.
AS FAR AS RESPIRATORY TRACT
INFECTION, SEVERAL SYSTEMATIC
REVIEWS AND META-ANALYSES FOUND
BENEFICIAL EFFECTS ON SOME BUT
NOT ALL OUTCOMES AND MIGHT
BENEFIT PATIENTS WITH
VENTILATOR-ASSOCIATED PNEUMONIA.
WHAT ABOUT COVID-19?
THERE HAVE BEEN A FEW SMALL
HUMAN STUDIES OF VARYING
QUALITY.
HERE IS ONE OF THEM, CONDUCTED
IN ITALY AMONG HOSPITALIZED
ADULTS.
ALL RECEIVED ONE OR MORE
MEDICATIONS, 28 ALSO RECEIVED
PROBIOTIC THREE TIMES A DAY FOR
14 DAYS.
MOST COMMON SIGNS AND SYMPTOMS
AMONG THE PATIENTS WERE FEVER,
COUGH, DIFFICULTY BREATHING,
DIARRHEA.
WHAT THEY FOUND THE LIGHT GRAY
ARE SUBJECTS WHO RECEIVED
PROBIOTICS IN ADDITION TO
MEDICATION, BLACK BARS DIDN'T,
NO PLACEBO, ONLY RECEIVED
MEDICATIONS IN THE BLACK BARS.
CHART ON THE LEFT SHOWS
CUMULATIVE PERCENTAGE OF
PATIENTS WITH DIARRHEA RESOLVED.
YOU CAN SEE HOW IT RESOLVED
QUICKLY, BY DAY 7 RESOLVED IN
ALL, BUT ONLY A THIRD WHO DID
NOT RECEIVE ANTIBIOTICS.
ON THE RIGHT THIS RECOMMENDS
MANY OF THE OTHER SIGNS AND
SYMPTOMS, FEVER, WEAKNESS,
HEADACHE, MUSCLE PAIN,
DIFFICULTY BREATHING.
YOU CAN SEE THESE SYMPTOMS ALSO
RESOLVED MORE QUICKLY IN THOSE
RECEIVING PROBIOTIC.
THERE ARE SOME LIMITATIONS TO
THIS STUDY, IT WASN'T PLACEBO
CONTROLLED, DR. SORKIN DISCUSSED
YESTERDAY THE IMPORTANCE OF
HAVING PLACEBO-CONTROLLED IS
IMPORTANT BECAUSE EVENING
PLACEBO PILL CAN ELICIT A
BIOLOGICAL RESPONSE.
ALSO IN THIS TRIAL MEDICATION
USE VARIED SLIGHTLY AMONG
PATIENTS, WE CAN'T DRAW FIRM
CONCLUSIONS BUT IT IS A
PROMISING INDICATOR.
HERE'S ANOTHER CLINICAL TRIAL
THAT USED A DIFFERENT
FORMULATION, IT WAS CONDUCTED IN
200 ADULTS HOSPITALIZED WITH
COVID-19 PNEUMONIA.
ALL RECEIVED MEDICATIONS AND 99
RECEIVED PROBIOTIC THREE TIMES A
DAY UP TO 14 DAYS, THE OTHER
PATIENTS DIDN'T.
THERE WAS NO PLACEBO, JUST A
CONTROL GROUP.
RESULTS FOR SURVIVAL, A MAIN
OUTCOME, ON THE LEFT IS ALL
PATIENTS, MIDDLE JUST PATIENTS
WITH CARDIOVASCULAR DISEASE,
RIGHT IS PATIENTS WITH DIABETES.
DOTTED LINES THOSE WHO RECEIVED
PROBIOTICS, SOLID LINES THOSE
WHO DIDN'T.
NO SIGNIFICANT DIFFERENCES.
ALSO NO SIGNIFICANT EFFECTS ON
DURATION OF DISEASE, HOSPITAL
LENGTH OF STAY, ICU ADMISSION,
NEED FOR MECHANICAL VENTILATION.
LIKE WE SEE WITH DIETARY
SUPPLEMENT TRIALS, TRIAL DESIGN
AND OUTCOMES ARE OFTEN
DIFFERENT, AND WE SEE
CONFLICTING FINDINGS SO IT IS
HARD TO FORM ANY KIND OF
CONSENSUS.
OF COURSE WITH PROBIOTICS YOU
HAVE ADDITIONAL COMPLICATION OF
A WIDE VARIETY OF PRODUCT
FORMULATIONS.
OMEGA-3 FATTY ACIDS ARE GETTING
ATTENTION FOR COVID-19 AND
IMMUNITY, FOUND IN FATTY FISH
AND SEAFOOD, FISH OIL, FLAX
SEED, OTHER NUTS AND SEEDS.
MAJORITY OF RESEARCH FOCUSES ON
LONG CHAIN OMEGA 3s, EPA, DHA.
OMEGA 3s CAN AFFECT
INFLAMMATION AND IMMUNITY.
THEY FORM LESS POTENT MEDIATORS
THAN THOSE FROM OMEGA 6 FATTY
ASSED AND MAY LOWER CYTOKINE AND
ENHANCE IMMUNE FUNCTION.
PEOPLE WHO REPORTED USING OMEGA
3s, THREE TIMES A WEEK FOR
THREE MONTHS OR LONGER, 12%
LOWER RISK BECOMING INFECTED
WITH COVID.
DR. SESSO AND OTHER SPEAKERS
HAVE DISCUSSED THIS FINDING IS
CONFOUNDED BY THE FACT THAT
PEOPLE WHO TAKE SUPPLEMENTS SUCH
AS OMEGA 3s ARE LIKELY TO HAVE
OTHER HEALTHY BEHAVIORS THAT
COULD ALSO IMPACT THIS FINDING.
HERE'S ANOTHER STUDY FROM DR.
HARRIS' GROUP EXAMINING OMEGA 3
INDEX WHICH DR. SCOTT AND
MS. LINDSAY DISCUSSED THIS
MORNING, 100 PATIENTS
HOSPITALIZED WITH COVID-19, AND
HERE IS A TABLE SHOWING
ASSOCIATION BETWEEN QUARTILES
AND DEATH AFTER ADJUSTING FOR
AGE AND SEX.
YOU CAN SEE A TREND TOWARD LOWER
RISK OF DEATH COMPARING HIGHEST
QUARTILE WITH OTHER QUARTILE, IT
DIDN'T REACH STATISTICAL
SIGNIFICANCE.
A COUPLE CLINICAL TRIALS HAVE
BEEN CONDUCTED CALLED PREPARE
IT, USING PRESCRIPTION FORM OF
EPA, ONE EXAMINED HIGH DOSE OF
IPE, 8 GRAMS FOR 3 DAYS,
FOLLOWED BY 4 GRAMS A DAY FOR 60
DAYS VERSUS PLACEBO IN HEALTHY
ADULTS.
TO SEE FIT AFFECTS IMMUNE
FUNCTION, I'M SORRY, INFECTION
RATES OF SARS-COV-2.
AND THERE WAS NO SIGNIFICANT
EFFECT.
PREPARE IT 2 WAS ADULTS WITH A
POSITIVE COVID-19 DIAGNOSIS,
SIMILAR DOSING REGIMEN FOR 28
DAYS, THE IPE HAD NO SIGNIFICANT
EFFECT COMPARED WITH PLACEBO ON
HOSPITALIZATION OR DEATH,
ALTHOUGH RESEARCHERS DID NOTE
STUDY WAS UNDERPOWERED AND THEY
RECOMMEND FURTHER RESEARCH.
FINALLY I'D LIKE TO DISCUSS
BOTANICALS OF INTEREST FOR
IMMUNITY.
ONE OF THE CHALLENGES DISCUSSED
YESTERDAY IS CHEMICAL
COMPLEXITY.
THERE'S VARIABILITY IN LEVELS OF
ACTIVE COMPOUNDS AND THEY ARE
DIFFICULT TO STANDARDIZE.
ANDROGRAPH IS NATIVE TO
SOUTHEAST ASIA, IT MIGHT REDUCE
SEVERITY OF RESPIRATORY TRACT
INFECTION, HAS BEEN STUDIED IN
THAILAND, ECHINACEA IS A WESTERN
TRADITIONAL MEDICINE PURCHASE
-- PURPORTED TO INHIBIT VIRUSES,
SEVERAL STUDIES SUGGEST IT MIGHT
SLIGHTLY REDUCE RISK OF CATCHING
THE COMMON COLD.
THERE HAVEN'T BEEN CLINICAL
TRIALS FOR COVID-19 PUBLISHED IN
THE PEER-REVIEWED LITERATURE.
AN GINSENG IS THE COMMON NAME
FOR SEVERAL SPECIES OF GENUS
PANAX, SOME ANIMAL LABORATORY
STUDIES SUGGEST IT MIGHT AFFECT
IMMUNITY AND INFLAMMATION.
IT'S NOT CLEAR WHETHER IT HAS
ANY CLINICALLY MEANINGFUL
EFFECTS IN HUMANS.
IT HAS BEEN EXAMINED FOR
REDUCING RISK OF UPPER
RESPIRATORY TRACT INFECTION BUT
RESULTS FROM STUDIES HAVE BEEN
MIXED.
FINALLY ELDERBERRY IS THE FRUIT
OF THE EUROPEAN ELDER TREE, A
SMALL TREE THAT GROWS IN MANY
PARTS OF THE WORLD INCLUDING
NORTH AMERICA.
IT CONTAINS SEVERAL COMPOUND
THAT MIGHT IMPROVE IMMUNITY AND
RESISTANCE TO DISEASE.
MILD REDUCE RISK OF UPPER
RESPIRATORY TRACT INFECTION BUT
THERE HAVEN'T BEEN PUBLISHED
CLINICAL TRIALS FOR COVID-19.
FULL CIRCLE, YOU CAN SEE EVEN
FOR THE BETTER STUDIED
INGREDIENTS LIKE VITAMIN C AND D
AND ZINC, WE DON'T HAVE ENOUGH
INFORMATION TO RECOMMEND FOR OR
AGAINST THEIR USE.
PEOPLE SHOULD ENSURE THEY ARE
CONSUMING A HEALTHY DIET,
GETTING SUFFICIENT AMOUNTS OF
ALL NUTRIENTS, SUPPLEMENTS CAN
HELP BOOST INTAKE BUT CAN'T TAKE
THE PLACE OF A HEALTHY DIET.
IT IS IMPORTANT TO CONSIDER THE
ULs.
HERBS AND PROBIOTICS, EVEN
EVIDENCE IS LESS CONCLUSIVE, FOR
SOME SAFETY IS LESS WELL
STUDIED.
ONE IMPORTANT POINT, SOME PEOPLE
ARE HESITANT TO TALK ABOUT
DIETARY SUPPLEMENTS, IF YOU'RE
WORKING IN HEALTH CARE FIELD ASK
YOUR PATIENTS ABOUT SUPPLEMENT
USE TO KEEP THE LINES OF
COMMUNICATION OPEN SO YOU CAN
GIVE YOUR PATIENTS APPROPRIATE
EVIDENCE-BASED ADVICE.
FINALLY AS I MENTIONED WE HAVE
FACTSHEETS ON OUR WEBSITE, ON
DIETARY SUPPLEMENT INGREDIENTS,
SO YOU CAN REFER TO THEM FOR
DETAILS ABOUT SAFETY AND
EFFICACY.
HERE'S OUR WEB PAGE THAT HAS OUR
FULL LIST OF DIETARY SUPPLEMENT
FACTSHEETS, VITAMINS AND
MINERALS, HERBS, PROBIOTICS,
OMEGA 3s AND OTHER
INGREDIENTS, AND WE HAVE SOME
THAT ARE CONDITION SPECIFIC
INCLUDING DIETARY SUPPLEMENTS
FOR WEIGHT LOSS, AND SUPPLEMENTS
FOR EXERCISE AND ATHLETIC PER
FORMANCE.
HERE IS A LINK TO DIETARY
SUPPLEMENTS IN THE TIME OF
COVID-19.
A SCREEN SHOT OF THE FIRST PAGE,
INTRODUCTION, GOES INTO DETAIL
ABOUT SEVERAL INGREDIENTS, SOME
OF WHICH I COVERED TODAY, OTHERS
THAT I DIDN'T HAVE TIME FOR.
WE HAVE VERSIONS FOR HEALTH
PROFESSIONALS FULLY REFERENCED,
AND FOR CONSUMERS THAT ARE LESS
DETAILED AND EASIER TO READ AND
CONSUMER VERSIONS ARE AVAILABLE
IN ENGLISH AND SPANISH.
WE ARE WORKING ON A FACT SHEET
THAT ADDRESSES IMMUNE FUNCTION
MORE BROADLY, AND THAT WILL BE
POSTED TO OUR WEBSITE WHEN WE
ARE FINISHED WITH IT.
SO, THANK YOU VERY MUCH FOR YOUR
ATTENTION.
I'LL BE HAPPY TO TAKE SOME
QUESTIONS.
>> WONDERFUL.
THANK YOU SO MUCH, CAROL, FOR
THE OVERVIEW.
THERE'S AS YOU SAY, THE DATA ARE
MIXED AND ALL OVER THE PLACE.
WE HAVE SOME QUESTIONS, A COUPLE
TEND AROUND WHAT DO WE KNOW
ABOUT COMBINATION ALSO OF
SUPPLEMENTS FOR COVID OR FOR
IMMUNE FUNCTION?
SO WHETHER IT'S COMBINATION OF
NUTRIENTS OR COMBINATIONS OF
BOTANICALS AND BOTH TOGETHER,
WHAT DID YOU FIND IN YOUR
LITERATURE SEARCHES?
>> YEAH, THAT'S A VERY GOOD
QUESTION BECAUSE A LOT OF THE
TIMES CLINICAL TRIALS DO
ADMINISTER COMBINATIONS OF
PRODUCTS.
YOU KNOW, EITHER MULTI-VITAMINS
AND MINERALS, LIKE A
MULTI-VITAMIN TYPE OF
SUPPLEMENT, OR COMBINATIONS OF
HERBS, THERE HAVE BEEN SOME
STUDIES, THE PROBLEM IS IT'S
VERY DIFFICULT TO DETERMINE WHAT
THE CONTRIBUTION OF THE VARIOUS
INDIVIDUAL INGREDIENTS MIGHT BE.
I'M NOT AWARE OF STUDIES THAT
HAVE SHOWN ANY OF THOSE
COMBINATIONS ARE HELPFUL FOR
PREVENTING OR TREATING COVID.
SIMILAR TO THE INDIVIDUAL
INGREDIENTS THAT I DISCUSSED.
BUT THERE IS THAT COMPLICATING
FACTOR.
BUT MAGNESIUM IS ONE, FOR
EXAMPLE, THAT'S USUALLY
ADMINISTRATION IN COMBINATION
WITH OTHER INGREDIENTS.
SO, THOSE STUDIES ARE BEING
DONE.
BUT AS I SAID, THERE ISN'T ANY
EVIDENCE THAT ANY OF THOSE
SPECIFIC FORMULATIONS ARE
HELPFUL FOR COVID-19.
>> THANK YOU.
ARE THERE ANY INDICATORS TO THE
CHARACTERISTICS OF THE
RESPONDERS VERSUS NON-RESPONDERS
IN THE STUDIES FOR VITAMIN D, C,
OR ZINC?
SO IS THERE ANYTHING THAT SORT
OF STANDS OUT ON WHO MAY BE A
RESPONDER, WHO MAY NOT BE A
RESPONDER?
>> SOME OF THE STUDIES MIGHT
LOOK AT THAT WHEN THEY LOOK AT
SUBGROUP ANALYSES, AND THAT KIND
OF THING.
YOU KNOW, I MEAN, OFTEN PEOPLE
ARE MORE CRITICALLY ILL, PERHAPS
IF THEY HAVE UNDERLYING HEALTH
CONDITIONS, OBESITY,
CARDIOVASCULAR DISEASE,
DIABETES, THAT TYPE OF THING,
ELDERLY, WE KNOW THOSE TEND TO
TRACK WITH COVID-19 DISEASE
SEVER ITY BUT I'M NOT AWARE OF
RESERVE THAT SAYS THIS PROBIOTIC
OR VITAMIN D OR WAS EFFECTIVE M
THIS GROUP BUT NOT IN ANOTHER
GROUP, WHERE IT MIGHT BE
INDICATED FOR CERTAIN
POPULATIONS.
SO OFTEN WITH VITAMIN D, AS I
MENTIONED, ONE CLINICAL TRIAL,
EVEN LOOKED AT PATIENTS
SPECIFICALLY THAT WERE VITAMIN D
DEFICIENT BECAUSE BASELINE
MICRONUTRIENT STATUS IS VERY
IMPORTANT TO CONSIDER AND THEY
DIDN'T FIND ANY EFFECT, THAT WAS
ONE CLINICAL TRIAL WITH A LARGE
BOLUS DOSE OF VITAMIN D.
S SO ARE BEING INVESTIGATED IN
STUDIES BUT I'M NOT AWARE OF ANY
EVIDENCE THERE ARE PARTICULAR
SUBGROUPS THAT MIGHT BENEFIT
FROM THESE.
>> OKAY.
AND WE'LL TOUCH ON A COUPLE
OTHER SUPPLEMENTS, IF YOU KNOW,
HAVE ANY INFORMATION ON
GLUTATHIONE, POSSIBLY MELATONIN
FOR COVID?
>> YES, GLUTATHIONE IS A
TRIPEPTIDE, ACTUALLY SYNTHESIZED
ENDOGENOUSLY BY THE BODY, FROM
GLUTAMINE 15 AND GLYCINE.
WHICH ARE AMINO ACIDS.
IT'S ALSO AVAILABLE AS A DIETARY
SUPPLEMENT, DOES APPEAR TO HAVE
ANTIOXIDANT ACTIVITY.
ONE OF THE CHALLENGES WITH
GLUTATHIONE IS THAT THE ORAL
BIOAVAILABILITY, WHEN
GLUTATHIONE IS CONSUMED ORALLY
THE BODY TENDS TO BREAK IT DOWN
INTO THOSE CONSTITUENT AMINO
ACIDS, SO IT'S NOT CLEAR WHETHER
TAKING GLUTATHIONE ORALLY
ACTUALLY BOOSTS YOUR LEVELS OF
GLUTATHIONE.
CYSTEINE IS ANOTHER DIETARY
SUPPLEMENT ALSO MARKETED, ALSO A
DRUG, THAT IS SHOWN TO RAISE
GLUTATHIONE LEVELS, ALSO BEING
INVESTIGATED FOR COVID-19 AND
OTHER CONDITIONS.
BUT GLUTATHIONE, THERE ISN'T ANY
RESEARCH THAT I'M AWARE OF OF
GLUTATHIONE SUPPLEMENTATION
SPECIFICALLY FOR COVID-19, IT'S
ALSO ADMINISTERED INTRAVENOUSLY,
LIKE SITE VITAMIN C STUDIES IT
BYPASSES THE TRACT.
DOING ORAL SUPPLEMENTATION
STUDIES DOES THE COMPOUND GET
ABSORBED, IN THE FORM THAT IS
INTENDED AND DOES IT GET TO THE
TARGET AREAS?
SO THAT'S A VERY IMPORTANT
CONSIDERATION.
AS FAR AS MELATONIN, MELATONIN
OF COURSE IS A HORMONE THAT'S
PRODUCED IN THE BRAIN, IT HELPS
REGULATE CIRCADIAN RHYTHM, ALSO
AVAILABLE AS A SUPPLEMENT,
MOSTLY STUDIED FOR PROMOTING
SLEEP AND REDUCING JET LAG.
SOME PRELIMINARY RESEARCH
SUGGESTS IT MIGHT
ANTI-INFLAMMATORY OR ANTIOXIDANT
EFFECT, NO EVIDENCE ON TREATMENT
OF COVID.
A SMALL STUDY IN SPAIN AMONG
HEALTH CARE WORKERS LOOKING AT
MELATONIN FOR REDUCING RISK OF
COVID.
I THINK IT WAS 2 MILLIGRAMS A
DAY FOR 12 WEEKS, HEALTH CARE
WORKERS RECEIVED MELATONIN,
OTHERS RECEIVED PLACEBO.
IT HAD NO EFFECT ON THEIR RISK
OF COMING DOWN WITH THE DISEASE.
IN TERMS OF PATIENTS WITH
COVID-19, I'M NOT AWARE OF ANY
CLINICAL TRIALS OF MELATONIN
ALONE.
THERE HAVE BEEN A COUPLE
PRELIMINARY STUDIES USED IN
COMBINATION WITH OTHER
THERAPIES, THOSE WERE VERY SMALL
AND NOT PLACEBO CONTROLLED.
SO, YOU KNOW, AT THIS TIME WE
REALLY DON'T HAVE DEFINITIVE
INFORMATION ABOUT MELATONIN.
>> OKAY.
ALL RIGHT.
MOVING ON TO MICRONUTRIENT
STATUS, OPTIMIZING VACCINE
EFFICACY, DO WE HAVE ANY DATA ON
THAT?
>> THAT'S BEEN AN INTERESTING
TOPIC.
IT HASN'T BEEN THOROUGHLY
STUDIED FOR THE COVID VACCINE,
BUT THERE WAS A PAPER, MARGARET
RAYMOND AND PHILIP CALDER OF
UNIVERSITY OF SOUTHHAMPTON IN
THE U.K. PUBLISHED LAST YEAR, I
THINK IN THE BRITISH JOURNAL OF
NUTRITION, THEY NOTED PEOPLE
WITH WEAKENED IMMUNE SYSTEM,
OFTEN OLDER ADULTS, THEY MAY
RESPOND LESS WELL TO VACCINES,
OF COURSE IT'S HARD TO MEASURE
THIS.
THERE ARE MANY VARIABLES.
BUT IDEALLY YOU WANT -- YOU WANT
IDEAL NUTRITION STATUS, ADEQUATE
STATUS FOR EFFECTIVE IMMUNE
RESPONSE.
AND THERE HAVE BEEN A FEW
CLINICAL TRIALS, FOR EXAMPLE,
PEOPLE WHO ATE FIVE FRUITS OR
VEGETABLES A DAY OR MORE, VERSUS
THOSE WHO ATE TWO OR LESS,
APPEARED TO HAVE BETTER IMMUNE
RESPONSE TO SOME VACCINES.
THIS WASN'T COVID BUT OTHER
VACCINES, ALSO STUDIES ON
VITAMIN E, SELENIUM
SUPPLEMENTATION, IN OLDER ADULTS
SHOWING THOSE HELPED BOOST
IMMUNE RESPONSE FOLLOWING
VACCINATION.
IT'S THE SAME MESSAGE THAT WE
HAVE FOR MAINTAINING IMMUNE
HEALTH AND PREVENTING DISEASE IS
EAT A NUTRITIOUS VARIETY OF
FOODS, WANT TO AVOID DEFICIENCY,
SUPPLEMENT CAN HELP INSURE
ADEQUATE INTAKE BUT CAN'T TAKE
THE PLACE OF A HEALTHY DIET.
>> ABSOLUTELY.
ABSOLUTELY.
THAT'S THE MANTRA A NUTRITIONIST
GREW UP WITH.
LET'S SEE.
ONE LAST QUESTION HERE.
VITAMIN B3, WE'LL FINISH UP WITH
VITAMIN B 3, IN TERMS OF ITS
FUNCTION FOR IMMUNE HEALTH.
IT'S NECESSARY TO SUPPORT THE
BODY.
DID YOU COME ACROSS INTERESTING
TRIALS FOR VITAMIN B3?
>> NOT SPECIFICALLY.
NIACIN, I MENTIONED INTEREST IN
NAD, IT'S A PRESCRIPTION
MEDICATION THAT IS USED FOR
BRONCHOPULMONARY DISEASE AND
THAT TYPE OF THING, THERE'S BEEN
INTEREST IN NAD BUT NOT SO MUCH
NIACIN.
SPECIFICALLY NIACIN HAS BEEN
STUDIED FOR CARDIOVASCULAR
DISEASE, BUT I'M NOT AWARE OF
LITERATURE SPECIFICALLY ON
NIACIN FOR COVID-19.
>> GREAT.
WELL, THANK YOU SO MUCH FOR A
WONDERFUL TALK.
A WONDERFUL SESSION, TO OUR
OTHER SPEAKERS.
IF THERE ARE ANY QUESTIONS, THEY
CAN SEND QUESTIONS TO THE ODS
ASK-THE-EXPERT, THE ADDRESS IS
ON THE WEBSITE.
>> YES, FEEL FREE TO REACH OUT
TO US ANYTIME.
>> THANK YOU.
>> THANK YOU VERY MUCH.
>> I'LL TURN IT OVER TO DR.
GAHCHE.
>> THANK YOU, BECKY.
THANK YOU, CAROL.
THAT WAS A GREAT SESSION.
LET'S TAKE A SHORT BREAK, 15
MINUTES, COME BACK AT 12:45 FOR
OUR LAST SESSION, SESSION 7,
MEETING THE STAKEHOLDERS.
>>WELCOME BACK TO OUR LAST
SESSION, SESSION 7, MEETING THE
STAKEHOLDERS.
JUST A REMINDER, PLEASE SUBMIT
QUESTIONS FOR PRESENTERS IN THE
Q&A PANEL AND DIRECT THOSE TO
ALL PANELISTS.
AGAIN, TECHNICAL QUESTIONS IN
THE CHAT BOX PLEASE.
OUR MODERATOR IS DR. PAUL
COATES, CURRENTLY PRESIDENT OF
THE AMERICAN SOCIETY FOR
NUTRITION, ALSO RECENTLY JOINED
THE FACULTY OF THE INDIANA
UNIVERSITY SCHOOL OF PUBLIC
HEALTH AS AN ADJUNCT PROFESSOR,
HAS MODERATED THIS SESSION MANY
TIMES IN THE PAST.
WE'RE HAPPY TO HAVE HIM BACK.
>> THANK YOU VERY MUCH, JAIME.
IT'S ALWAYS AN INTERESTING
SESSION, WE'LL HEAR FROM THREE
SPEAKERS FROM TRADE ASSOCIATIONS
THAT REPRESENT THE DIETARY
SUPPLEMENT INDUSTRY, SINCE
BIOSKETCHES ARE IN THE MEETING
MATERIALS I WON'T PROVIDE
DETAILED INTRODUCTIONS OF THEM.
I'LL ASK EACH TO TAKE 15 MINUTES
NO MORE THAN 15, TO DESCRIBE THE
PURPOSE OF THEIR ORGANIZATION AS
WELL AS ACTIVITIES THEIR
ORGANIZATION ENGAGES IN
SPECIFICALLY RELATED TO DIETARY
SUPPLEMENTS.
A BRIEF PANEL DISCUSSION WILL
FOLLOW PRESENTATIONS, TO THE
AUDIENCE REMEMBER TO USE THE Q&A
FUNCTION TO ASK YOUR QUESTIONS
AND DIRECT THEM TO ALL
PANELISTS.
I'LL INTRODUCE THE SECOND PANEL
AFTER THAT DISCUSSION.
SO, LET ME GO AHEAD AND
INTRODUCE DR. JAY SIROIS FROM
CONSUMER HEALTHCARE PRODUCTS
ASSOCIATION.
JAY?
>> THANKS, PAUL.
GOOD TO BE HERE WITH EVERYBODY.
I'LL GO AHEAD AND SHARE MY
SCREEN HERE.
HOPEFULLY YOU CAN ALL SEE THAT.
I'M JAY SIROIS, VICE PRESIDENT
OF REGULATORY.
>> ONE MORE TIME, JAY.
>> WITH CONSUMER HEALTH CARE
PRODUCTS ASSOCIATION.
BECAUSE I'M A HISTORY NERD I'LL
GIVE A BRIEF HISTORY OF CHPA,
STARTED IN 1881, AS PROPRIETARY
ASSOCIATION, DURING THE CIVIL
WAR U.S. TAXED PATENT MEDICINES
TO UNDER IF THE WAR EFFORT, PART
OF THE REASON WE STARTED WAS TO
GET THIS TAX REMOVED FROM PATENT
MEDICINES.
WE BECAME THE NON-PRESCRIPTION
DRUG MANUFACTURERS ASSOCIATION
IN 1989, AND THEN IN 1999
CHANGED OUR NAME TO CONSUMER
HEALTH CARE PRODUCTS
ASSOCIATION.
AT THAT TIME WE ALSO STARTED
REPRESENTING DIETARY SUPPLEMENT
COMPANIES, PREVIOUSLY JUST
REPRESENTED OTC MEDICINES BUT
NOW WE REPRESENT OTC MEDICINES,
DIETARY SUPPLEMENTS, AND
CONSUMER MEDICAL DEVICES.
SO, HERE IS KIND OF A
PICTOGRAPHIC.
THERE'S 30 OR SO COMPANIES WE
HAVE IN SUPPLEMENTS,
REPRESENTING 20% OF RETAIL SALES
FOR THE CATEGORY, CHPA
STRUCTURE, WE HAVE REGULATORY
AND SCIENTIFIC AFFAIRS
DEPARTMENT THAT I'M IN
GOVERNMENT AFFAIRS,
COMMUNICATIONS, LEGAL, ALWAYS
ASKED BY FOLKS, I TELL THEM I
WORK FOR A TRADE ASSOCIATION,
FIRST QUESTION IS IF I'M A
LOBBYIST.
I SAY, NO, I WORK WITH
LOBBYISTS, I'VE BEEN TO CAPITOL
HILL, WHICH IS A GRAND OLD TIME
BUT I'M NOT A LOBBYIST, I'M A
SCIENTIST BY BACKGROUND.
SO, WE KNOW -- I'M SURE YOU'VE
HEARD A LOT SO FAR ABOUT THE
PERCENTAGE OF CONSUMERS THAT
REPORT TAKING DIETARY
SUPPLEMENTS, FOR SELF-CARE OR
PREVENTIVE HEALTH, FROM 60 TO
75%, AND YOU PROBABLY HEARD TOO
THE INDUSTRY EXPERIENCED A
SIGNIFICANT GROWTH LAST YEAR DUE
PRIMARILY TO COVID.
HOWEVER, YOU PROBABLY ALSO HEARD
ABOUT THE LACK OF CREDIBILITY IN
THE CATEGORY AMONG A NUMBER OF
DIFFERENT CONSUMERS, HEALTH
AGENCIES, THINGS LIKE THAT.
AND THIS IS BECAUSE PRIMARILY OF
THE ADULT RATE RATED SUBSTANCES,
A PROBLEM WITH MINORITY OF
COMPANIES MARKETING ADULTERATED
PRODUCTS, RECENTLY FDA WARNING
LETTERS TO COMPANIES FOR
ADULTERATED PRODUCTS THAT EITHER
WEREN'T APPROVED OR RECOGNIZED
AS -- APPROVED AS FOOD ADDITIVES
OR RECOGNIZED AS SAFE, OR WERE
CONSIDERED DIETARY INGREDIENTS.
THOSE ARE THINGS LIKE
HYGIENEAMINE, OCTOPAMINE,
THERE'S SAM WORK TO CLIP UP THE
BAD ACTORS IN A CATEGORY AND
WE'RE DOING OUR PART TO MINIMIZE
THE INSTANCES OF THIS.
PART OF THE WAY WE DO THIS, WE
HAVE AN EDUCATIONAL FOUNDATION,
WHICH IS A 501(c)3 NON-PROFIT
THAT PROVIDES CONSUMERS
INFORMATION AND GUIDANCE ON HOW
TO SAFELY USE, STORE, DISPOSE OF
OTC MED SUPPLEMENTS AND MEDICAL
DEVICE.
WE HAVE PROGRAMS TARGETED TO
OTCs SUCH AS UP AND AWAY
CAMPAIGN, KNOW YOUR DOSE, TREAT
WITH CARE FOR COUGH AND COLD
INGREDIENTS.
BUT IN RECENT YEARS WE'VE REALLY
PRIORITIZED BUILDING OUT OUR
DIETARY SUPPLEMENT CONTENT, BOTH
ON THE WEBSITE AS WELL EASY ON
SOCIAL CHANNELS TO REACH
CONSUMERS AND HOPEFULLY RESONATE
WITH THEM ABOUT SAFE USE AND
STORAGE.
OVER THE PAST YEAR OR SO WE'VE
ADDED EXPERT ARTICLES ON HOW TO
SUPPORT A HEALTHY IMMUNE SYSTEM,
COMMON NUTRITIONAL DEFICIENCIES,
SO SUPPLEMENTS CAN ADDRESS
THESE, INFORMATION ON MEDICINE
AND SUPPLEMENT INTERACTIONS,
SCIENCE BEHIND SUPPLEMENTS,
WE'LL ALSO IN THE FUTURE DEVELOP
CREATIVE CONTENT TO ENHANCE
CONSUMER UNDERSTANDING.
PART OF WHAT WE'VE DONE IS OUR
NEW INTERACTIVE SUPPLEMENT FACTS
LABEL WEB PAGE.
IT BASICALLY JUST GOES
THROUGH -- GIVES CONSUMERS A 101
ON HOW TO READ A SUPPLEMENT
LABEL.
WHAT YOU SHOULD KNOW BEFORE
TAKING A DIETARY SUPPLEMENT,
INCLUDING VITAMINS.
THERE ARE LINKS WITHIN THE
SUPPLEMENT FACTS BOX SHOWN HERE,
TO INFORMATION ON SUCH THINGS AS
AMOUNT PER SERVING, PERCENT
DAILY VALUE, MICROGRAMS, AND
OTHER INGREDIENTS.
AND WE'VE MADE THIS AVAILABLE ON
OUR WEBSITE.
WE ALSO RECENTLY INTRODUCED
SOMETHING CALLED THE DIETARY
SUPPLEMENT INDEX.
AND THIS WAS TO BETTER
UNDERSTAND THE ROLE OF
SUPPLEMENTS IN HEALTH AND
WELLNESS AS WELL AS TO ANALYZE
AND UNDERSTAND THE TRENDS AND
CHANGES IN THE MARKET.
THE DSX AS WE CALL IT LOOKS AT
DIETARY SUPPLEMENTS IN A NUMBER
OF PRIMARY CATEGORIES INCLUDING
GENERAL HEALTH, DIGESTIVE
HEALTH, IMMUNITY, AND SLEEP.
AND IT USES DATA FROM SPINS, AN
ANALYTICS AND TECHNOLOGY
PROVIDER, THAT REALLY FOCUSES ON
WELLNESS DATA AS ITS PRIMARY
SOURCE.
AND THE DSX IS A SCORE THAT
REFLECTS DIETARY SUPPLEMENT
CATEGORY SALES FOR A PERIOD,
WHETHER IT BE A QUARTER OR YEAR,
AND CAN -- SCORE CAN BE
CALCULATED AT COUNTY, STATE,
REGIONAL LEVEL, AND A NUMBER OF
COMPARISONS CAN BE MADE ACROSS
DEMOGRAPHICS.
WE CAN ALSO LOOK AT THIS IN THE
CONTEXT OF OTHER PUBLIC DATA
SOURCES LIKE NHANES.
AND WE'RE GOING TO USE THIS TOOL
TO SUPPORT MAKING THE CASE TO
LEGISLATORS AND HEALTH INSURERS,
AND BENEFIT CONSULTANTS THAT
DIETARY SUPPLEMENTS CAN AND
SHOULD BE INCLUDED IN HEALTH
CARE PLANS.
CHPA HAS A NUMBER OF VOLUNTARY
CODES AND GUIDELINES, RELATED TO
MEDICINES AND SUPPLEMENTS.
FIRST OF THESE WAS DEVELOPED
NEARLY 90 YEARS AGO, AND OVER
THE YEARS MANY OF THESE
VOLUNTARY GUIDELINES WHICH WE
REALLY DON'T CONSIDER VOLUNTARY,
WE EXPECT FOLKS TO FOLLOW THEM,
DID PRE-DATE FDA REGULATIONS ON
TOPICS.
FOR SUPPLEMENT RELATED WE HAVE A
COUPLE EXAMPLES HERE, CAFFEINE,
WHERE WE SAY YOU SHOULD DISCLOSE
TOTAL CAFFEINE CONTENT PER
SERVING, INCLUDE SAFETY
INFORMATION ON THE LABEL SUCH AS
NOT INDICATED FOR CHILDREN AND
PREGNANT WOMEN SHOULD CONSULT A
HEALTH CARE PROVIDER BEFORE USE,
PROVIDE SERVING SIZE, DAILY
INTAKE RECOMMENDATIONS ON THE
LABEL, RESTRICTIONS ON SALE AND
MARKETING OF BULK AMOUNTS OF
PURE OR HIGHLY CONCENTRATED
CAFFEINE IN POWDER OR LIQUID
FORM.
WE ALSO HAVE ONE ON PROBIOTICS,
WHERE WE RECOMMEND FOLKS LABEL
IN COLONY FORMING UNITS, REFLECT
THE LIVE MICROORGANISMS AT THE
END OF THE SHELF LIFE, AMONG
OTHER THINGS.
WE ALSO HAVE A NUMBER OF
DIETARY INGREDIENT SPECIFIC
GUIDANCE AVAILABLE TO CHPA
MEMBERS AND THE GENERAL PUBLIC.
THE PROCESS, I'M GOING OVER IT
QUICKLY, IT'S A MECHANISM FOR
EVALUATING FOOD INGREDIENTS, YOU
CAN SUBMIT A GRAS NOTIFICATION
TO FDA WITH SAFETY INFORMATION
THAT SHOWS YOUR INGREDIENT IS
SAFE FOR ADDITION TO A FOOD.
YOU CAN ALSO GO TO AN
INDEPENDENT CONCLUSION OF GRAS
PROCESS, SELF-GRAS, WHEREBY THE
INFORMATION ON THE SAFETY IS
EVALUATED BUT NOT SUBMITTED TO
FDA.
AND IN A NUTSHELL THIS IS UNDER
CRITICISM FOR THE PAST 10 OR 15
YEARS FROM A NUMBER OF GROUPS
REPRESENTED HERE ON THIS SLIDE.
AND AS A WAY TO TRY TO SHOW THAT
THIS IS A VALID AND RIGOROUS
PATHWAY, WE ARE WORKING WITH OUR
MEMBERS TO DEVELOP A BEST
PRACTICES GUIDANCE FOR
PERFORMING AN INDEPENDENT
CONCLUSION OF GRAS
DETERMINATION.
AND SO WE'VE BEEN WORKING WITH
MEMBERS ON THIS FOR THE PAST
YEAR, MAYBE YEAR AND A HALF OR
SO.
WE FEEL IT'S A RIGOROUS PROCESS
BUT WE'RE FOCUSING ON WHAT YOU
NEED TO DO IF YOU'RE A COMPANY,
IF YOU WERE DOING AN INDEPENDENT
GRAS AFFIRMATION, WHAT TO LOOK
FOR IF YOU'RE PURCHASING AN
INGREDIENT FROM A SUPPLIER
TELLING YOU AN INGREDIENT HAS
GONE THROUGH THE PROCESS, WE
HOPE TO FINALIZE THIS SOON.
I WANTED TO INTRODUCE SOME
RECENT LEGISLATION THAT'S BEEN
INTRODUCED, THE FDA SAFETY AND
LANDMARK ADVANCEMENTS ACT OF
2022.
THERE WAS A DISCUSSION DRAFT
RELEASED ON THIS LAST WEEK.
THIS IS LEGISLATION THAT
REAUTHORIZING THE FDA
PRESCRIPTION DRUG, GENERIC DRUG,
BIOSIMILAR AND MEDICAL DEVICE
USER FEE AGREEMENTS.
BUT THE LEGISLATION ALSO
INCLUDES PROVISION TO STRENGTHEN
OVERSIGHT OF COSMETICS AS WELL
AS DIETARY SUPPLEMENTS.
DIETARY SUPPLEMENT PROVISIONS IN
THE BILL ARE AIMING TO IMPROVE
FDA OVERSIGHT OF SUPPLEMENTS BY
REQUIRING AMONGST OTHER THINGS
FOR MANUFACTURERS TO LIST THEIR
PRODUCTS WITH THE FDA, SOMETHING
CALLED A MANDATORY PRODUCT
LISTING.
SO WE'RE SUPPORTIVE OF THIS, OF
LISTING, BUT WE ALSO ADVOCATING
FOR INCLUSION OF THIRD PARTY
INSPECTION OR AUDIT AUTHORITY
WHICH WE FEEL WOULD ADD A
VERIFICATION MECHANISM AND
INCREASE THE NUMBER OF INSPECTED
DIETARY SUPPLEMENT FACILITIES ON
A YEARLY BASIS AND WITHOUT THIS
THERE'S NO REAL VALIDATION
PROCESS, IT WON'T CUT DOWN ON
BAD ACTORS.
WE KNOW THERE'S A VERY SMALL
PERCENTAGE OF FACILITIES
INFECTED EVERY YEAR AND WE FEEL
THAT IF THIS THIRD PARTY GMP
AUDITS WAS ENACTED WE COULD
INCREASE NUMBER OF INSPECTED
FACILITIES AND CUT DOWN ON BAD
ACTORS.
CHPA PARTICIPATES IN THE
COLLABORATIVE, MISSION TO
ADVANCE QUALITY AND SAFETY OF
SUPPLEMENTS IN THE U.S.
WE DEVELOPED A NUMBER OF
DIFFERENT PIECES INCLUDING A
WHITE PAPER, A DIVERSE GROUP OF
STAKEHOLDERS, YOU CAN SEE LISTED
ON THE RIGHT-HAND SIDE OF THE
SLIDE.
WE MEET REGULARLY TO DISCUSS THE
POLICY PRINCIPLES AND HOW WE CAN
PROMOTE THE SAFETY OF THESE
PRODUCTS, INCREASE TRANSPARENCY,
AND EMBRACE QUALITY AND
SUPPORTING EFFORTS BY BOTH FDA
AND INDUSTRY TO INCREASE
MANUFACTURER AWARENESS OF GNP
REGS.
WE'RE PART OF THE USP COUNCIL
CONVENTION, A GLOBAL GOVERNANCE
COMMITTEE THAT REPRESENTS USP
MEMBERSHIP.
AND THERE'S SEVERAL SECTORS THAT
ONE IS THE DIETARY SUPPLEMENT
SECTOR, I'M THE CHAIR OF THAT.
THERE'S OTHER GROUPS INVOLVED
INCLUDING AMERICAN MEDICAL
ASSOCIATION, NATIONAL CONSUMERS
LEAGUES, WE'VE HELD A SERIES OF
MEETINGS TO DETERMINE HOW TO
EDUCATE GROUPS ON SUPPLEMENTS
AND WHERE TO FOCUS AND WE'RE
THINKING OF LOOKING AT
PHARMACISTS BECAUSE THEY
REPRESENT A CRITICAL TOUCH POINT
FOR CONSUMERS PURCHASING
SUPPLEMENTS.
50% OF THOSE WHO REPORT TAKING
SUPPLEMENTS MADE THEIR PURCHASE
IN A BRICK AND MORTAR PHARMACY,
ONLY 10% REPORTING ASKING A
PHARMACIST FOR INFORMATION.
RIGHT NOW WE'RE DETERMINING HOW
BEST TO REACH OUT AND WHAT TIMES
OF CON -- TYPES OF CONTENT TO
TARGET TO FOCUS ON QUALITY AND
INCREASED CONSUMER
UNDERSTANDING.
THAT'S ALL.
I LIKE FORWARD TO PANEL
DISCUSSION AND THANK YOU FOR
HAVING ME.
>> THANK YOU, JAY.
NICE TO CATCH UP WITH YOU A
LITTLE BIT.
IT'S BEEN A COUPLE OF YEARS.
I'M VERY INTERESTED IN SOME OF
THE ACTIVITIES THAT YOU AND YOUR
ORGANIZATION HAVE BECOME
INVOLVED WITH.
PERHAPS WE'LL GET INTO SOME OF
THAT DURING THE PANEL DISCUSSION
SESSION.
NOW I'D LIKE TO CALL ON MERLE
ZIMMERMANN, WHO IS GOING TO BE
TALKING ABOUT THE ROLE OF THE
AMERICAN HERBAL PRODUCTS
ASSOCIATION IN THIS SPACE, I'LL
TURN IT OVER TO YOU, MERLE.
>> GIVE ME A SECOND, I'M GETTING
MY SLIDES TURN ON.
AND THEN WE CAN LOOK AT THIS
TOGETHER.
IS THAT WORKING?
>> WORKING.
>> GREAT.
SO IT'S WONDERFUL TO BE HERE
TODAY.
GETTING TO JOIN EVERYONE
ATTENDING.
I'M GOING TO SHARE AN OVERVIEW
OF THE ACTIVITIES OF THE
INDUSTRY TRADE ORGANIZATION I
WORK FOR, AMERICAN HERBAL
PRODUCTS ASSOCIATION.
YOU CAN LEARN ABOUT THE TYPE OF
SUPPORT WE'RE ABLE TO PROVIDE
FROM THE COMMERCIAL SIDE
ASSISTING FRIENDS AND FAMILY TO
INCLUDE PLANT-BASED PRODUCTS IN
THEIR LIVES.
MISSION TO SUPPORT RESPONSIBLE
COMMERCIAL WE ENGAGE IN THREE
MAIN AREAS OF ACTIVITY,
EDUCATIONAL ACTIVITY TO SUPPORT
INDUSTRY MEMBERS, LEGISLATIVE
AND REGULATORY SUPPORT, GENERAL
COMMUNICATIONS WITH INDUSTRY AND
THE PUBLIC.
OVER THE LAST COUPLE DAYS WE'VE
HEARD ABOUT SPECIFIC PROJECTS
INCLUDING MANDATORY SERIOUS
EVENT REPORTING, WHICH CONTINUES
TO ENGAGE WITH SUCH AS THE ONE
WE MENTIONED IN DR. HARDY'S TALK
YESTERDAY.
WE'LL VISIT A SELECTION OF THESE
OVER THE COURSE OF THE
PRESENTATION AND SHARE SOME
GUIDANCE REFERENCES WE'VE BEEN
DEVELOPING.
WE HAVE A SISTER ORGANIZATION
ENGAGING IN SEVERAL PLANT
HARVEST SUSTAINABILITY STUDIES
THAT I'LL MENTION AT THE END OF
THE PRESENTATION.
SO, HERE'S A SUMMARY OF OUR
SCOPE.
FOUNDED IN 1982, WITH CONTINUING
MISSION, AT OUR 40th
ANNIVERSARY WE HAVE OVER 400
MEMBERS AND AFFILIATES, DOMESTIC
AND INTERNATIONAL COMPANIES THAT
GROW, PROCESS, MANUFACTURE,
MARKET, HERBS AND PRODUCTS
INCLUDING DIETARY SUPPLEMENT AND
OTHER TRADE CATEGORIES.
WE FOCUS ON A VARIETY OF AREAS
INCLUDING REPRESENTING INDUSTRY
EXPERTISE IN THINKING TO
REGULATORS AND LEGISLATORS,
PROVIDING INDUSTRY MEMBERS WITH
EDUCATIONAL AND TRAINING TO GIVE
THEM FULL ACCESS TO BEST
PRACTICES, GUIDANCE ON
RESPONSIBILITIES IN THOSE
REGULATORY AND CURRENT BEST
PRACTICE AREAS.
WE HAVE COMMUNICATION, IN
SELF-REGULATORY WE HAVE A COUPLE
ETHICS, NOMENCLATURE TOOLS TO
PROVIDE COMMON NAMES CAME UP
WITH DR. BETZ ON LABELING
REQUIREMENTS ON MONDAY.
AND WE DID HEAR ALSO ABOUT SOME
OF THE INGREDIENTS, STANDARDS,
CHARACTERIZATION THAT'S REQUIRED
IN THE REGULATORY STRUCTURE FOR
DIETARY SUPPLEMENTS IN DR.
KUSZAK'S PRESENTATION YESTERDAY.
SO, AHPA HAS COLLABORATIVE
PARTNERSHIPS WITH ORGANIZATIONS
SUCH AS ANALYTICAL COLLABORATION
INTERNATIONAL, HERE AT NIH THE
NATIONAL CENTER FOR
COMPLEMENTARY AND INTEGRATIVE
HEALTH, OFFICE OF DIETARY
SUPPLEMENTS, UNITED STATES
PHARMACOPEIA AND OTHERS.
SO I'M GOING TO START BY LOOKING
OVER A FEW SELF-REGULATORY
ACTIVITIES IN THE FIRST 40
YEARS, TRADE REQUIREMENTS,
GUIDANCE, EDUCATIONAL
REQUIREMENTS AND TOOLS.
FIRST, PUBLISHED IN 1992,
INCORPORATED BY REFERENCE AND
FDA RULE IN 1997, SECOND EDITION
IN 2000 HAD 2,000 INGREDIENTS.
WE'VE PRODUCED GUIDANCE IN A
LARGE VARIETY OF AREAS INCLUDING
GOOD AGRICULTURE AND COLLECTIVE
PRACTICES IN GENERAL AS WELL AS
MORE SPECIES SPECIFIC CASES.
WE HAVE SOME GOOD STEWARDSHIP
HARVESTING ACTIVITIES WHICH WILL
COME UP LATER IN THIS TALK.
ALL OF THESE -- OOPS.
ALL OF THESE ARE AVAILABLE
THROUGH OUR WEBSITE
YOU HAVE MY E-MAIL ADDRESS, SEND
A NOTE OR GET IN TOUCH THAT WAY.
SO, LOOKING AT THE EDUCATIONAL
SPACE, YEARLY CONGRESS,
WORKSHOPS, PROVIDE SELF-SERVICE
ONLINE TOOLS TO HELP TECHNICAL
EXPERTS DO THEIR WORK BETTER.
ONE OF THESE IS COMPENDIUM WITH
REGARD TO IDENTITY OPERATIONS,
ON A VARIETY OF COMMONLY USED
INGREDIENTS.
WE HAVE A SAFETY TEXT OFFICE,
WHICH COLLECTS REVIEW ARTICLES,
DISCUSSING SAFETY INFORMATION,
FIRST EDITION HAD ABOUT 500
HERBS, SECOND EXPANDED THAT TO
700.
AND THAT TALKS ABOUT THE DRUG
INTERACTION POTENTIAL.
IF YOU'RE INTERESTED IN GETTING
ACCESS, WANT TO SHOOT ME A NOTE
I CAN DO A COMPLEMENTARY
ACCOUNT.
AHPA PROVIDES ANALYTICAL REVIEW
NDI NOTIFICATIONS RELEASED BY
FDA TO OPTIMIZE TIME NEEDED WHEN
WORKING WITH THIS CLASS OF SORT
OF DOCUMENTS.
WE HAVE A FEW TOOLS FOR
CONSUMERS INCLUDING FIELD GUIDES
TO TALK ABOUT HERBAL DIETARY
SUPPLEMENTS, YEARLY EDUCATIONAL
EVENT THAT CELEBRATES IMPORTANCE
OF HERBS AND HERBAL PRODUCTS,
AND SOME GOOD STEWARDSHIP
HARVESTING INFORMATION ON NOW WE
HAVE THREE HERBS, AMERICAN WILD
GINSENG, PALMETTO, OSHA.
SO WE'LL LOOK AT A QUICK
OVERVIEW OF WHAT AHPA HAS BEEN
UP TO WITH REGARD TO REGULATORS.
OVER THE LAST 20 YEARS WE'VE
BEEN ENGAGED WITH CLAIMS
REGULATION, ORGANIC LABELING,
REVISION TO ADVERSE EVENT LAWS,
AS WELL AS DRAFT GUIDANCE AND
FSMA WHICH EXPANDS REGULATORY
COVERAGE IN DIETARY SUPPLEMENTS
ALREADY TO MORE FOODS IN
GENERAL.
IN THIS AREA WE ALSO HAVE BEEN
DIRECTING OUR ATTENTION TOWARD
EFFICIENT USE OF REGULATORY
RESOURCES, SO WE HAD A BIG SET
OF COMMENTS WE SUBMITTED IN 2017
LOOKING AT WAYS THAT WE COULD
APPROACH USING RESOURCES
AVAILABLE TO ENSURE OUR PUBLIC
HEALTH.
WORKING WITH REGULATORS, WE HAVE
ALSO TEAMED UP WITH SOME
COLLEAGUES, SOME ARE HERE TODAY
AS WELL, TO CONDUCT REGULAR
REGULATORY SUMMITS TALKING
ABOUT SHARED GOALS OF HELPING
CONSUMERS HAVE CONTINUED ACCESS
TO HIGH QUALITY SUPPLEMENTS.
SO GETTING TOWARD THE END OF THE
PRESENTATION CONTINUING
ENGAGEMENT IN LEGISLATIVE AREA
TO SUPPORT TRANSPARENT
DISCUSSION OF THESE NEW
FRAMEWORKS LIKE HEMP FARMING ACT
OR POTENTIAL NEXT GENERATION
TOOLS TO HELP MAKE SURE THAT OUR
MARKETPLACE IN THE UNITED STATES
IS THE WORLD'S BEST.
AND RELIABLE ACCESS TO WIDE
RANGE OF SAFE AND EFFICIENTLY
REGULATED PRODUCTS.
SO, THE FLIP SIDE TO WHAT AHPA
DOING, OUR RESEARCH FOUNDATION
IS FOCUSED ON PROMOTING
EDUCATION RESEARCH ON MEDICINAL
AND THERAPEUTIC HERBS, OUR AREA
OF FOCUS, TALKING MOSTLY IN THE
LAST FEW YEARS ABOUT HARVEST
SUSTAINABILITY QUESTIONS FOR
HERBS AVAILABLE DOMESTICALLY IN
THE UNITED STATES.
SO, MOST RECENTLY WE CONDUCTED A
STUDY IN PARTNERSHIP WITH
UNIVERSITY OF KANSAS ON OSHA
HARVEST SUSTAINABILITY, NOW IN
EXTENDED STATE, WE'VE BEGUN
STUDY ON GOLDENSEAL SUSTAINABLE
HARVESTING, I THINK THERE'S
PUBLIC REPORTS EXPECTED SOON ON
THAT ONE.
AND WE HAVE AN RFP CURRENTLY, IF
YOU HAVE FRIENDS INTERESTED IN
FIELD WORK AND WANT TO TAKE A
LOOK AT SLIPPERY ELM POPULATION
IN THE UNITED STATES.
I THINK THAT GETS ME TO THE END
OF MY OVERVIEW.
HOPEFULLY I GOT YOU A COUPLE
MINUTES BACK ON THE SCHEDULE.
LOOKING FORWARD TO HEARING
QUESTIONS AND DISCUSSION.
>> THANK YOU, MERLE.
ALWAYS INTERESTING TO HEAR WHAT
AHPA IS UP TO.
WE'RE STARTING TO GET QUESTIONS.
WHEN WE GET TO THE PANEL
DISCUSSION I'M SURE YOU'LL BE
REENGAGED.
SO NOW IT'S A PLEASURE TO
INTRODUCE MR. BRIAN WOMMACK,
COUNCIL FOR RESPONSIBLE
NUTRITION, ANOTHER OF THE TRADE
ASSOCIATIONS IN THIS SPACE.
I'D LIKE TO CALL ON YOU, BRIAN,
TO LET US KNOW WHAT CRN DOES.
>> THANK YOU, DR. COATES.
LET ME SHARE MY SCREEN.
THERE WE GO.
DOES EVERYBODY SEE THAT OKAY?
>> YES, INDEED.
>> GOOD.
THANK YOU FOR THE INTRODUCTION.
I WANT TO BRIEFLY INTRODUCE CRN.
YOU CAN SEE WE HAVE A STAFF OF
ABOUT 19, I HAVE 120 VOTING
MEMBERS, DEFINED AS A COMPANY
THAT EITHER PRODUCES FINISHED
PRODUCTS OR INGREDIENTS THAT GO
INTO THOSE PRODUCTS, AND WE'VE82
GOT ASSOCIATE MEMBERS WHICH
ARE ENTITIES THAT SUPPORT THE
VOTING MEMBERS.
IT'S EVERYTHING FROM TESTING
LABS, LAW FIRMS, PR FIRMS, THAT
SORT OF THING.
WE'RE ABOUT TO CELEBRATE OUR
50th BIRTHDAY, WE'RE EXCITED
ABOUT THAT.
LIKE THE TWO YOU HEARD BEFORE ME
WE DO A LOT OF THINGS YOU WOULD
EXPECT A TRADE ASSOCIATION TO
DO.
I LEAD COMMUNICATIONS
DEPARTMENT, I'M A RECOVERING
LAWYER AND RECOVERING LOBBYIST,
WE HAVE A FULL SCIENCE
DEPARTMENT, EXPERTISE, IN
ADDITION TO COMMUNICATION,
GOVERNMENT RELATION IS A BIG
PART.
I GET ASKED IF I'M A LOBBYIST,
I'M NOT ANY LONGER BUT I HAVE
BEEN BEFORE.
HERE YOU SEE SOME BRANDS THAT WE
REPRESENT.
A SNAPSHOT OF SOME.
HOPEFULLY YOU RECOGNIZE SOME,
MAYBE HAVE SOME IN YOUR MEDICINE
CABINET.
WE EXIST TO ENHANCE AND SUSTAIN
A CLIMATE TO MANUFACTURE
NUTRITIONAL INGREDIENTS AND
START WITH WHAT'S AT OUR CORE.
WE NEVER FORGET THAT RESPONSIBLE
IS OUR MIDDLE NAME.
WE TRY TO MAKE SURE EVERYTHING
WE DO AND OUR MEMBERS DO TO
EXTEND OUR MISSION KEEPS THAT IN
MIND.
AND I'M GOING TO TALK ABOUT A
FEW THINGS WE DO TO TRY TO KEEP
THAT EVERY PRESENT.
CONSUMER SAFETY, PRODUCT
INTEGRITY, MAKING SURE WE'VE GOT
A FULLY TRANSPARENT AND ACCURATE
CONSUMER MARKET.
THESE ARE THE THREE PRONGS OF
RESPONSIBLE INDUSTRY BEHAVIOR,
WE'RE IN SOME OF THE SAME TYPE
OF THINGS, WE COOPERATE AMONGST
OURSELVES AS AN INDUSTRY.
A LOT OF THE INDUSTRY
ASSOCIATION THAT YOU HEARD
ABOUT, JAY AND MERLE TALKED
ABOUT, THINGS WE COLLABORATE ON.
A LOT ARE MULTI-ASSOCIATION
EFFORTS.
WE'RE VERY ACTIVE ENGAGING WITH
BOTH OF OUR PRIMARY REGULATORS,
FDA AND FTC, TO MAKE SURE WE
AMPLIFY MESSAGES THEY PUT OUT
THERE.
WHETHER THAT'S CRACKING DOWN ON
A COMPANY BREAKING THE LAW OR
MAKING SURE OUR MEMBERS KNOW
ABOUT SOME NEW DEVELOPMENT.
WE'RE ALSO VERY CONSCIOUS OF THE
FACT THAT THESE AGENCIES ARE
OFTEN NOT AS WELL FUNDED AS THEY
OUGHT TO BE AND SO WE DO
REGULARLY ADVOCATE FOR
ADDITIONAL ENFORCEMENT BUT FOR
BOTH OF THEM.
SO, I DESCRIBED A LOT OF
COOPERATION WITH THE FDA.
WE SOMETIMES DON'T ALWAYS SEE
THINGS QUITE THE SAME WAY.
ONE OF THOSE AREAS UNFORTUNATELY
HAS BEEN CBD.
SINCE THE 2018 FARM BILL THIS
HAS BEEN AN ISSUE.
IT'S BEEN A LACK OF REGULATORY
CLARITY AROUND CBD AS A DIETARY
INGREDIENT FOR USE IN
SUPPLEMENTS.
THE FDA HAS SPOKEN AT TIMES AS
IF THIS IS A SAFETY ISSUE.
BUT IT'S MORE A QUESTION
FUNDAMENTAL TO DSHEA AS WE HEARD
IN FIRST SESSIONS ON DAY 1
THERE'S A RACE TO MARKET BETWEEN
A PHARMACEUTICAL USE AND
SUPPLEMENT USE, AND IN THIS CASE
PHARMACEUTICAL USE GOT THERE
FIRST SO IT'S A MATTER OF DRUG
PRECLUSION LANGUAGE.
IT'S CREATED AN UNCERTAIN
MARKETPLACE WHERE THINGS AREN'T
ENFORCED, DEVELOPED A PATCHWORK
OF REGULATIONS WHICH WE DON'T
THINK IS A GOOD THING EITHER FOR
COMPANIES OR CONSUMERS.
ACTIVITIES WE'VE ENGAGED IN
AROUND CBD TO CLARIFY THINGS, WE
SUBMITTED A CITIZENS PETITION
EARLY ON.
WE'VE ISSUED WHITE PAPER TO MAKE
SURE STAKEHOLDERS UNDERSTAND
EVERYTHING GOING ON HERE.
AND WHY WE GET RILED UP ABOUT
THIS.
AND WE'VE ADVOCATED FOR A
LEGISLATIVE FIX IN THE FORM OF
H.R. 841.
TURNING TO SELF-REGULATION, I
WANT TO GIVE A QUICK TOUR OF A
COUPLE THINGS THAT WE PROMOTE
WITH OUR MEMBERS.
YOU HEARD JAY TALK ABOUT SOME OF
THIS, WE HAVE MORE VOLUNTARY
GUIDELINES AND BEST PRACTICES
AROUND A NUMBER OF INGREDIENTS
THAT OUR MEMBERS ADHERE TO.
BEST PRACTICES IN TERMS OF HOW
THESE INGREDIENTS ARE TREATED,
IN TERMS OF WHAT THE DOSE SHOULD
BE, WHAT LABELING SHOULD BE,
THAT SORT OF THING.
JUST A WAY OF MAKING SURE THE
MARKETPLACE IS SAFE AND WELL
REGULATED AND THAT CAN INCLUDE
SELF-REGULATION.
YOU SEE OUR SIX ETHICAL PILLARS.
I WON'T READ THEM BUT THESE ARE
THE THINGS WE LOOK FOR WHEN
VETTING MEMBERS, WE'RE A
MEMBERSHIP ORGANIZATION THAT
VETS CAREFULLY AND MAKE SURE
MEMBERS STICK TO THESE AS THEY
ARE MEMBERS.
ONLINE WELLNESS LIBRARY, A
VOLUNTARY PRODUCT REGISTRY,
CREATED A NUMBER OF YEARS AGO
MANDATORY FOR CRN MEMBERS TO BE
IN IT, A DATABASE OF FULL
LABELS, WE ENCOURAGE OTHERS TO
BE IN IT, A FAIR NUMBER HAS
GOTTEN IN IT.
WE HOPED THAT IT WOULD FORM
PERHAPS A TEMPLATE OR BASIS THE
FDA MIGHT DO A MANDATORY
LISTING, WE'VE HAD CONVERSATIONS
WITH THE FDA, WE KNOW THAT THEY
DO CHECK THE OWL, THEY ARE AWARE
OF IT AND PERHAPS THAT COULD BE
INTEGRATED IF A MANDATORY
PRODUCT LISTING DOES COME AT
SOME POINT.
RECENTLY WE HAD A FEW UPGRADES
AND ENHANCEMENTS, TRYING TO MAKE
IT EASIER TO PUT LABELS IN,
ESPECIALLY WHEN THERE'S MANY
SIMILAR LABELS, YOU CAN IMAGINE
ALL THE SKEWS THAT A BIG COMPANY
MIGHT HAVE, WE MADE THAT EASIER
TO GET THOSE IN.
WE'VE MADE IT EASIER FOR THOSE
WHO USE IT, A BUSINESS OR
RETAILER WHO IS GOING TO LOOK AT
LABELS OR A CONSUMER WHO IS
USING THE OWL AND INCREASINGLY
CONSUMERS ARE CHECKING THE OWL
OUT.
WE'VE GOT THREE PATHWAYS,
DEPENDING ON WHAT YOUR USER FACE
IS.
THIS IS WHY WE STARTED THE OWL.
IT FORMS THE BASIS FOR WHY WE
THINK A MANDATORY PRODUCT
LISTING IS ACTUALLY IMPORTANT,
IT'S IMPORTANT FOR REGULATOR TO
KNOW WHAT PRODUCTS AND BRANDS
ARE OUT THERE, AT PRESENT THE
FDA BY ITS OWN WORD SAYS IT
DOESN'T KNOW EXACTLY WHAT
PRODUCTS ARE ON THE MARKET.
DOESN'T EVEN KNOW HOW MANY
PRODUCTS ARE ON THE MARKET.
SIMILARLY DOESN'T KNOW ALL THE
INGREDIENTS ARE ON THE MARKET,
WHICH PRODUCTS CONTAIN THEM.
SO WE THINK THAT THE OWL CAN BE
A WAY TO HELP WITH THAT IN THE
MEANTIME BUT WE THINK ULTIMATE
SOLUTION IS A MANDATORY PRODUCT
LISTING.
JAY TALKED ABOUT THAT.
WE'RE VERY SUPPORTIVE OF
MANDATORY PRODUCT LISTING,
THERE'S A COUPLE LEGISLATIVE
VEHICLES MOVING, WE'RE INVOLVED
IN THOSE DISCUSSIONS, BUT THE
LISTING WOULD ESSENTIALLY
PROVIDE DATA ON SIZE AND SCOPE
OF INDUSTRY, WOULD HELP
DIFFERENTIATE BETWEEN FRAUDULENT
AND DIFFERENT PRODUCTS, IN A
CRISIS WHEN THE FDA NEEDS TO
PRODUCTS WITH A PARTICULAR
INGREDIENT, COULD BE HELPFUL.
WE THINK IT WILL PROMOTE GOOD
MANUFACTURING COMPLIANCE, IT'S A
NEW ENFORCEMENT TOOL BECAUSE
THOSE WHO DON'T COMPLY IT WOULD
BE AN EASILY PROVEABLE
ADMINISTRATIVE VIOLATION.
PRODUCT LABELS CONTINUES, WE PUT
TOGETHER TO GATHER INFORMATION
ABOUT THE CONNECTION BETWEEN
VITAMIN D AND COVID, AROUND
COVID AND VITAMIN D.
THERE'S A FEW SCREEN SHOTS OF
SOME OF THE INTERVIEWS THERE,
VITAMIN D AND ME, A LINK FROM
THE WEBSITE AT THE END OF MY
PRESENTATION, I ENCOURAGE YOU TO
CHECK THAT OUT, A LOT OF GOOD
INFORMATION THERE.
FOR PROBIOTICS, WE BECAME AWARE
THAT RETAIL BUYERS HAD CONFUSION
AROUND PROBIOTICS, DIDN'T KNOW
HOW TO CURATE, THIS PRODUCT IN
SOME CASES SAT, NOT ALWAYS
UNDERSTANDING BENEFITS SO WE SAY
NEED FOR EDUCATIONAL CAMPAIGN,
LAUNCHED THIS LAST MARCH, IT
STARTED AS A RETAIL CAMPAIGN, WE
HAD A RETAIL BUYERS' GUIDE,
FOCUSING ON QUESTIONS FROM THEM,
A SCIENTIFIC WHITE PAPER MADE A
CASE FOR WHY PEOPLE MIGHT WANT
TO TAKE PROBIOTICS, WHAT THEY
ARE, HOW THEY CAN HELP, SERIES
OF INFOGRAPHICS AND EDUCATIONAL
VIDEOS, AND QUESTIONS THAT YOU
MIGHT ASK YOUR VENDOR.
WE RAN A CAMPAIGN BEGINNING IN
APRIL OF 2019 CALLED LABEL WISE,
TO INFORM ABOUT THE CHANGES THAT
WERE COMING THAT AT THAT POINT
WERE IN THE FUTURE, WE'VE ALL
SEEN THAT HAPPEN TO PRODUCT
LABELS IN OUR SPACE.
BECAUSE THERE WAS -- BECAUSE OF
THE PANDEMIC, DATES WERE MOVED
FORWARD, CONSUMERS ARE STILL
LEARNING ABOUT THESE, EVEN
THOUGH IT'S BEEN A WHILE, WE'VE
LEFT THE CAMPAIGN UP, MERGED
INTO A LABEL LITERARY SITE OVER
THE YEARS, WE ALSO HAVE A FACT
LABEL, AN IMPORTANT TOOL FOR
CONSUMERS, THEY OUGHT TO KNOW
WHAT THINGS ON THE LABEL MEAN
AND HOW TO READ IT.
EITHER IN THE STORE OR IN A
PRODUCT DATABASE.
WE'LL CLOSE WITH A COUPLE
SNAPSHOTS FROM OUR ANNUAL
CONSUMER SURVEY, CRN CONDUCTS A
ROBUST SURVEY EVERY YEAR, FAIRLY
HIGH TRUST NUMBER WHICH IS
ENCOURAGING, ONE OF THE NUMBERS
WE ALWAYS WATCH IS HOW MANY
AMERICANS TAKE DIETARY
SUPPLEMENTS, 80% IS A HIGH WATER
MARK.
WE'VE NEVER SEEN IT THAT HIGH,
PEOPLE THINK ABOUT THIS AS
SOMETHING OF A NICHE MARKET,
FOUR OUT OF FIVE TO ME IS NOT A
NICHE MARKET, WE NEED TO THINK
AND BEHAVE IN THOSE WAYS AS
WELL.
THOSE ARE OF SUPPLEMENT USERS,
HOW MANY USE EACH OF THOSE
VARIOUS CATEGORIES, NOT
SURPRISINGLY MOST SUPPLEMENT
USERS DO TAKE VITAMIN OR MINERAL
SUPPLEMENT, AND YOU CAN SEE HOW
THEY TRAIL.
ONE OTHER DATA POINT FROM THE
ANNUAL SURVEY THAT I LIKE TO
INCLUDE, THERE ARE CRITICS WHO
SAY PEOPLE WHO TAKE DIETARY
SUPPLEMENTS ARE TAKING IT AS A
MAGIC PILL, NOT ENGAGING IN
OTHER HEALTHY BEHAVIORS, TRYING
TO LET THIS BE SOMETHING THAT
CAN REPLACE THOSE THINGS.
THE RESEARCH SHOWS QUITE THE
CONTRARY.
YOU SEE HERE SUPPLEMENT USERS
TEND TO EAT A HEALTHIER DIET,
EXERCISE REGULARLY, VISION IT
DOCTORS -- VISIT DOCTORS MORE
FREQUENTLY, TEND TO BE LESS
SMOKERS, ASSOCIATED WITH A HOST
OF OTHER CONSTELLATION OF
HEALTHY BEHAVIOR, ONE PART OF
THAT, IT'S NOT SOMETHING SOMEONE
IS DOING THEORETICALLY TO
SUBSTITUTE WHICH WE STILL HEAR
THAT A LOT, THE DATA DOESN'T
SHOW.
A QUICK TOUR.
THAT'S HOW YOU REQUEST GET HOLD
OF ME.
ANY OF THE CAMPAIGNS OR
MATERIALS I TALKED ABOUT,
EVERYTHING IS AVAILABLE ON THE
WEBSITE, NOTHING IS PROPRIETARY,
BEHIND THE FIRE WALL.
CHECK IT OUT, IF YOU HAVE
QUESTIONS OR WANT TO GET
INVOLVED OR PARTNER, I'D BE
HAPPY TO HEAR FROM YOU.
GREAT TO BE HERE.
THANK YOU FOR THE OPPORTUNITY.
I LOOK FORWARD TO FURTHER
DISCUSSIONS.
>> THANK YOU VERY MUCH.
THERE HAVE BEEN A NUMBER OF
QUESTIONS, I'M GOING TO TURN TO
DISCUSSION.
THERE HAVE BEEN A NUMBER OF
QUESTIONS POSTED ON THE Q&A.
I ENCOURAGE YOU TO DO MORE,
FOLKS.
NOT EVERYBODY WILL HAVE SEEN THE
RESPONSES THAT SOME OF OUR
COLLEAGUES HAVE PROVIDED IN
RESPONSE TO QUESTIONS.
SO, A QUESTION FROM MARY LEE,
DUE TO THE VERY HIGH SALES OF
DIETARY SUPPLEMENTS, YOUR STATED
CONCERN FOR QUALITY AND SAFETY,
WHAT ABOUT THE ROLE OF MANDATORY
FEES TO WEED OUT BAD ACTORS?
THIS WAS POSED TO ALL OF THE
PANELISTS.
SO I'M GOING TO ASK IF IT'S OKAY
I'LL ASK YOU IN ORDER.
JAY, WHAT DOES CHPA, AHPA, AND
CRN THINK?
JAY?
>> GREAT QUESTION.
WE'RE NOT SUPPORTIVE OF
MANDATORY FEES WE'RE SUPPORTIVE
FOR INCREASED FDA FUNDING TO
TARGET THE BAD ACTORS AND TO
INCREASE INSPECTION AND PART OF
MY TALK I MENTIONED FDA
AUTHORIZATION OF THIRD PARTY GNP
INSPECTIONS WHICH WOULD INCREASE
THE NUMBER OF INSPECTIONS OF
DIETARY SUPPLEMENT FACILITIES
THAT WOULD HAPPEN.
AND THAT BY DOING SO FDA COULD
TARGET SOME OF THE PROBLEMATIC
AREAS, PARTICULAR WEIGHT LOSS,
SEXUAL ENHANCEMENT,
BODY-BUILDING CATEGORIES THAT
ARE PROBLEMS OR SHOW UP ON THE
AGENCY'S RADAR.
IF YOU DO THAT AND TARGET
HIGHER-RISK CATEGORIES WE COULD
PROBABLY CUT DOWN SIGNIFICANTLY
ON THE INSTANCES OF THE ILLEGAL
ADULTERATED PRODUCTS OUT THERE.
>> MERLE, YOU RESPONDED IN THE
Q&A.
MAYBE YOU'D LIKE TO SUMMARIZE
THAT.
>> SO, AHPA IS ENGAGED IN
LOOKING AT EFFICIENT USE OF
RESOURCES, NOTHING COMES WITHOUT
A PRICE SO WE WANT TO MAKE SURE
FEES DON'T DISPROPORTIONATELY
AFFECT SMALL BUSINESSES, AND
FOLKS PURSUING THE AMERICAN
DREAM MORE THAN THEY WOULD
ANYONE ELSE, THERE'S A LOT OF
EXCITING TOOLS THE AGENCIES HAVE
COME UP WITH WHICH WOULD MAKE A
GREAT EVENT FOR A SECOND ODS
AFTER THIS ONE.
>> SURE.
BRIAN?
>> I'M NOT ABLE TO SAY THAT MY
ASSOCIATION SUPPORTS MANDATORY
FEES ON OUR MEMBERS BUT WE DO
CERTAINLY SEE THE NEED FOR
ROBUST INFECTIONS AND SUPPORT
ADEQUATE FUNDING TO MAKE THAT
HAPPEN.
>> THIS QUESTION WILL COME UP IN
THE CONTEXT OF SOME OF THE OTHER
DISCUSSION POINTS, BUT RESOURCES
FOR THE FDA, THIS IS OFTEN
SPOKEN ABOUT BY INDUSTRY TRADE
ASSOCIATIONS.
I GUESS A QUESTION THAT I COULD
ASK YOU WITHOUT BEING TOO
CHALLENGING, FOLKS, WHY HASN'T
IT HAPPENED?
WHY HASN'T THERE BEEN INCREASED
RESOURCE ALLOCATION FOR THIS,
AND WHAT THE FDA DOES?
>> MERLE HERE.
I'D BE HAPPY TO JUMP IN.
I BELIEVE CONGRESS IS TRYING TO
MAKE SURE BUDGETS BALANCE
SOMETIMES BUT WE ALSO HAVE SEEN
FDA USING NICE PRIORITIZATION
AND SORTING TOOLS PROVIDING MORE
ATTENTION TO FACILITIES THAT
THEY HAVE ESTIMATED HAVING A
HIGHER RISK PROFILE.
THAT MIGHT BE PART OF THE REASON
IF YOU LOOK AT OVERVIEW OF DATA
WHAT FOLKS CONTINUING TO DO A
WONDERFUL JOB AND WE CAN SEE SO
IN THE STATE INSPECTIONS AREN'T
SEEING THEIR FEDERAL RESOURCES
BEING SPENT SORT OF
UNNECESSARILY TO SEE THE SAME
BARS OF EXCELLENCE.
>> ANY OTHER COMMENTS?
>> FROM OUR SURVEY DATA, THERE'S
INDICATIONS THE AMERICAN PUBLIC
TRUST THEIR DIETARY SUPPLEMENTS
FOR THE MOST PART.
IF THOSE NUMBERS WERE LOWER YOU
WOULD SEE A POLITICAL WILL FOR
MORE SPENDING IN THIS AREA.
THERE ARE ABSOLUTELY SOME BAD
ACTORS OUT THER AND BAD
PRODUCTS, BUT THERE ARE WAYS OF
AVOIDING THOSE.
YOU HAVE THREE GREAT
ORGANIZATIONS HERE WITH
FANTASTIC MEMBERS DOING THINGS
RIGHT.
IF YOU MAKE GOOD PRODUCTS
SELECTIONS YOU CAN STAY AWAY
FROM BAD ACTORS.
THE CHALLENGE IS FOR US TO GET
THAT WORD OUT THERE ARE SOME
DARK QUARTERS OF THIS INDUSTRY
WE NEED TO BE AWARE OF AND I
THINK ALL OF US SPEND A FAIR
AMOUNT OF TIME SHEDDING LIGHT ON
THAT.
IT'S NOT THAT IT'S NOT NEEDED.
I WISH THOSE PRODUCTS WEREN'T
OUT THERE FRANKLY AND THEY WERE
BEING STAMPED OUT BECAUSE THEY
ARE A POX ON ALL OF US BUT THERE
ARE WAYS OF AVOIDING IT, AND
MUCH OF THE PUBLIC DOES THAT,
THERE'S NOT A PUBLIC OUTCRY.
TO MERLE'S POINT THINGS GET
FUNDED ACCORDING TO WHAT PEOPLE
ARE COMPLAINING ABOUT.
>> WE SUPPORT THE INCREASES IN
FUNDING TO OFFICE OF DIETARY
SUPPLEMENT PRODUCTS OVER THE
YEARS, CERTAINLY YOU'LL SEE
CRITICISM IN THE TRADE PRESS
OCCASIONALLY ABOUT HOW FDA NEEDS
TO BE MORE FORCEFUL IN SOME OF
THESE ACTIONS THEY TAKE AGAINST
THE BAD ACTORS, AND TO SOME
EXTENT THAT'S TRUE.
I THINK FDA REALLY SHOULD CRACK
DOWN ON THESE FOLKS AND SEEK TO
MAKE AN EXAMPLE OF SOME OF THESE
PEOPLE THAT ARE FLAUNTING THE
LAW.
BUT WE CERTAINLY HAVE ALWAYS
EXPRESSED A WILLINGNESS TO
SUPPORT FDA AS THEY GO AFTER
THESE FOLKS.
WE REPRESENT AS MERLE AND BRIAN
DO THE RESPONSIBLE COMPANIES
THAT ARE OUT THERE.
AND UNFORTUNATELY AS BRIAN
MENTIONED, IT'S A MINORITY OF
THE INDUSTRY, BUT THEY DO
TARNISH THE REST OF THE INDUSTRY
AND WE DO HAVE A RESPONSIBILITY
TO CALL THEM OUT, TO DO WHAT WE
CAN TO DECREASE INCIDENCE.
>> THANK YOU VERY MUCH.
I'M GOING TO REMIND THE AUDIENCE
IF YOU HAVE A FOLLOW-UP QUESTION
TO SOMETHING THAT'S BEEN
DISCUSSED DON'T HESITATE TO PUT
IT INTO THE Q&A I'M MONITORING
IN REAL TIME.
IF YOU HAVE AN INTEREST IN
CONTINUING THE DISCUSSION ABOUT
ANY OF THESE POINTS, I'LL DO MY
BEST TO KEEP YOU ENGAGED IN THE
CONVERSATION.
NEXT QUESTION THAT I SAW WAS
ALSO FROM MARY LEE, FROM THE
MANUFACTURER STANDPOINT, ARE
THERE CONCERNS ABOUT MARKETING
OF BOTANICAL SUPPLEMENTS NOT
CLEARLY TO HUMANS IN DOSAGE AND
FORM SOLD?
WHAT SHOULD THE MANUFACTURER'S
ROLE BE IN THAT CONTEXT?
I IMAGINE MERLE WOULD BE THE
FIRST TO RESPOND.
>> YEAH, I HAD THIS WONDERFUL
OPPORTUNITY TO BE A GUEST OF THE
KOREAN FDA, TO LOOK AT A BUNCH
OF WELLNESS PRACTICES,
DOMESTICALLY OVER THERE.
AND I FOUND IT REALLY EYE
OPENING TO KIND OF GET A LITTLE
BIT OF A BETTER UNDERSTANDING
FOR SOME PRODUCTS THAT I HAD
SEEN MANUFACTURED AND SOLD IN
OUR DOMESTIC MARKET DIRECTED
TOWARDS DIFFERENT CULTURAL
SUBSET OF PEOPLE LIVING HERE IN
THE UNITED STATES.
SO I THINK FROM THE MANUFACTURER
STANDPOINT, SOME OF THOSE
BENEFICIAL SORT OF PRACTICES
HAVEN'T REALLY BEEN LOCALIZED
OUT OF THEIR HNTE COU YET
AND THERE'S A RESPONSIBILITY AND
OPPORTUNITY FOR INDUSTRY TO LOOK
AT THE THIRD PARTY LITERATURE
THAT WAS DISCUSSED IN THE LAST
COUPLE DAYS AS A SOURCE FOR
SHARING INFORMATION AS PART OF
THE TOOLS TO MAKE MORE SENSE OF
WHAT'S AVAILABLE IN OUR MARKET.
>> JAY OR BRIAN, ANYTHING TO
ADD?
>> IT'S IMPORTANT TO RECOGNIZE
IF YOU'RE A MANUFACTURER OF A
SUPPLEMENT, AND YOU'RE MAKING
ANY TYPE OF CLAIM ON YOUR
PRODUCT, WHETHER IT BE
STRUCTURE/FUNCTION CLAIM,
GENERAL WELL-BEING, YOU HAVE TO
HAVE SUBSTANTIAL THAT THE CLAIM
IS TRUTHFUL AND NOT MISLEADING.
AND FDA HAS A GUIDANCE FOR THIS
THAT GOES OVER WHAT THE
SUBSTANTIATION STANDARD IS, HOW
YOU WOULD IDENTIFY THE MEANING
OF THE CLAIM, RELATIONSHIP OF
THE EVIDENCE TO THE CLAIM, SO AS
A MANUFACTURER YOU CAN'T JUST GO
OUT AND MAKE SOME WILD AND CRAZY
CLAIM UNLESS YOU HAVE
SUBSTANTIATION.
>> THANK YOU.
BRIAN, ANYTHING ELSE TO ADD ON
THAT?
>> I DON'T THINK I HAVE ANYTHING
ELSE TO ADD.
FEELS LIKE IT'S WELL COVERED BY
MY COLLEAGUES ON THAT ONE.
>> GOOD, GOOD.
SO, HERE WAS A QUESTION, ARE
THERE PLANS FOR LABELING
RECOMMENDATION ON CANNABIS AND
PSILOCYBIN?
MERLE, YOU OFFERED A RESPONSE TO
THAT.
WOULD YOU CARE TO SUMMARIZE THAT
ANSWER SO EVERYBODY GETS A
CHANCE TO HEAR IT?
>> YEAH, HAPPY TO SUMMARIZE
THAT.
AHPA ENGAGED PREVIOUSLY IN
LOOKING AT BEST PRACTICES IN
RELATION TO I THINK HEMP AND
CANNABIS-TYPE CROPS.
THAT WAS ONE OF THE THINGS I
MENTIONED IN THE PRESENTATION.
WE ALSO THIS YEAR HAVE COMMITTEE
CHARTERED BY BOARD OF TRUSTEES
TO LOOK AT PSYCHEDELIC PLANTS
AND FUNGI IN THE SAME MANNER.
YOU'LL PROBABLY SEE
RECOMMENDATIONS GIVEN HOW WILD
WE ALL ARE AS FAR AS BEING
WORKAHOLICS IN THE NEXT YEAR OR
TWO.
>> OKAY.
IS THERE ANY ROLE CHPH OR CRN
PLAYED IN THIS SORT OF
DISCUSSION, JAY?
>> IN TERMS OF LABELING, NO,
BECAUSE AS YOU KNOW CBD RIGHT
NOW IS NOT TECHNICALLY A LEGAL
DIETARY SUPPLEMENT.
WE DID SUBMIT A CITIZEN PETITION
ABOUT 2 1/2 YEARS AGO, ASKING
FDA TO ESTABLISH A PATHWAY TO
ALLOW FOR EVIDENCE TO BE
EVALUATED CONCERNING THE SAFETY
OF CBD.
CERTAINLY AS YOU KNOW OVER THE
LAST COUPLE YEARS IT'S BEEN A
HOT TOPIC.
BUT THAT HASN'T BEEN RESPONDED
TO YET.
I KNOW OTHER ASSOCIATIONS
SUBMITTED PETITIONS AND TRIED TO
GET FDA TO ACT IN THIS REGARD
BUT IN TERMS OF ANYTHING WITH
LABELING WE HAVEN'T DONE
ANYTHING THERE.
>> OKAY.
BRIAN, ANY ADDITIONAL COMMENTS?
>> YEAH, OTHER THAN THE ADVOCACY
AROUND CBD, THE OTHER
INGREDIENTS ARE NOT IN OUR
PURVIEW.
>> THANK YOU.
THERE'S-- I'M SCROLLING DOWN
HERE.
THERE WAS A QUESTION THAT MERLE
ALSO ANSWERED.
ARE THERE INDEPENDENT BODIES,
FROM JOSEPH NATHAN, FOR EXAMPLE,
ACADEMIC CENTERS AND INSTITUTES,
AVAILABLE FOR CONSUMERS AND
HEALTH CARE PROFESSIONALS TO
PROVIDE OBJECTIVE EVIDENCE-BASED
CLINICAL INFORMATION ON SPECIFIC
DIETARY SUPPLEMENTS?
IF NOT, DO YOU SEE A NEED FOR A
CENTER TO BE CREATED?
I'LL JUMP IN WITH A SEMI
RESPONSE, ALTHOUGH THE QUESTION
SEEMED TO FOCUS ON ACADEMIC
CENTERS AND INSTITUTES, THOSE
WHO HAVE BEEN AT THE PRACTICUM
THIS WEEK KNOW ONE OF THE THINGS
THAT THE OFFICE OF DIETARY
SUPPLEMENTS DOES IS PROVIDE
PRETTY MUCH WHAT YOU'RE ASKING
FOR THERE, WHICH OBJECTIVE
EVIDENCE-BASED CLINICAL
INFORMATION ABOUT A WHOLE RANGE
OF DIETARY SUPPLEMENTS.
ODS IS NOT THE ONLY PLACE THAT
DOES THIS.
THAT'S FOR SURE.
BUT THAT IS A SIGNIFICANT AND
INDEPENDENT RESOURCE.
SIMILARLY NATIONAL CENTER FOR
COMPLEMENTARY AND INTEGRATIVE
HEALTH ALSO AT THE NIH PROVIDES
THOUGHTFUL REVIEWS THAT SEEM TO
ME TO ADDRESS THE QUESTION THAT
WAS RAISED HERE.
AND IN ADDITION, MERLE, YOU MADE
AN INTERESTING COMMENT ABOUT
ANOTHER ORGANIZATION.
TELL THEM ABOUT IT PLEASE.
>> RIGHT.
SO, THERE'S A WONDERFUL GROUP AT
THE UNIVERSITY OF MISSISSIPPI
CALLED THE NATIONAL CENTER FOR
NATURAL PRODUCTS RESEARCH, WHICH
HAS A LOT OF WORK IN THE
BOTANICALS AREA.
THEY HAVE A REGULAR SORT OF
ACADEMIC CONFERENCE WITH POSTER
PRESENTATIONS CALLED OXFORD
ICSB, I SHARED THE LINK IN THE
Q&A.
I ATTENDED ONCE, FANTASTIC GROUP
OF PEOPLE, ALL OF US WITH BE
WELCOME TO SIT TOGETHER AND HEAR
THE LATEST THAT'S GOING ON IN
THE RESEARCH SPACE, THAT'S ITS
DIRECTION.
>> AND I ACKNOWLEDGE THAT THIS
IS IN ADDITION TO THE MATERIAL
THAT ALL THREE OF YOU HAVE
TALKED ABOUT THAT'S PROVIDED BY
YOUR ORGANIZATIONS OR USING YOUR
ORGANIZATION'S ABILITY TO GET
THE WORD OUT.
I DID TAKE THE POINT ABOUT
INDEPENDENT, AND SO I DIDN'T
SPECIFICALLY EXCLUDE YOU BUT I
DIDN'T WANT YOU TO THINK I WAS
BUT I GUESS THE WORD
"INDEPENDENT" HERE HAD
CONNOTATION FOR THE QUESTIONER.
ANY OTHER COMMENTS ABOUT THIS,
THIS NOTION OF AN INDEPENDENT
PERHAPS ACADEMIC BODY?
SHOULD IT BE CREATED TO DO WHAT
THE QUESTIONER WAS ASKING?
BRIAN, JAY?
>> THERE'S CERTAINLY CENTERS OF
EXCELLENCE AT LOTS OF
UNIVERSITIES ALREADY.
I'M NOT SURE IT NEEDS A MORE
FORMAL STRUCTURE.
I MEAN, MAYBE IT'S JUST A
REMINDER OF WHERE SOME CENTERS
OF EXCELLENCE ARE.
MERLE MENTIONED UNIVERSITY OF
MISSISSIPPI, A GREAT PLACE,
WE'VE BEEN INVOLVED IN THE
PROGRAM THERE.
TEXAS A & M IS DOING FANTASTIC
THINGS.
PURDUE, UNIVERSITY OF ILLINOIS,
TUFTS, LOTS OF GREAT CENTERS OUT
THERE THAT ARE PROVIDING A LOT
OF INFORMATION AND ARE CERTAINLY
INDEPENDENT.
I MEAN, WHAT AM I MISSING BY
WHAT'S NOT ALREADY OUT THERE?
>> I JUST WANTED TO BE SURE
THERE WASN'T ANOTHER POINT TO BE
MADE ON THAT.
JAY, ANYTHING TO ADD?
>> YEAH, I'LL CERTAINLY PUT A
PLUG IN FOR NIH ODS.
THEY HAVE A GREAT WEBSITE THAT
YOU MENTIONED, PAUL.
I'LL ALSO NOTE ANOTHER REALLY
GOOD SITE, IT'S NOT NECESSARILY
INDEPENDENT, IT'S ANOTHER -- I
DON'T KNOW IF THEY CONSIDER
THEMSELVES A TRADE ASSOCIATION
OR NOT BUT THE AMERICAN
BOTANICAL COUNCIL.
THEY HAVE A LOT OF INFORMATION
ON THEIR SITE ABOUT HERBAL
PRODUCTS AND THEY HAVE
EDUCATION, SCIENCE-BASED
TRADITIONAL INFORMATION, THAT
SORT OF THING, PROMOTING THE
RESPONSIBLE USE OF HERBAL
MEDICINES AND, YOU KNOW, I'M
LOOKING ON THEIR WEBSITE.
THEY CALL THEMSELVES AN
INDEPENDENT NON-PROFIT SUPPORTED
BY THOUSANDS OF MEMBERS AROUND
THE WORLD.
REALLY SMART GUY, MARK
BLUMENTHAL, RUNS THE SHOW THERE
AND HAS LOTS OF REALLY GOOD
INFORMATION ABOUT INDIVIDUAL
BOTANICALS.
THEY HAVE SOMETHING CALLED THE
BOTANICAL ADULT PREVENTION
PROGRAM WHICH PROVIDES INFO ON
HOW TO, YOU KNOW, AVOID BUYING A
PRODUCT THAT COULD BE
POTENTIALLY ADULTERATED, THINGS
LIKE THAT.
>> THANK YOU.
LET ME SEE IF THERE ARE A COUPLE
MORE QUESTIONS BEFORE WE TAKE A
LITTLE BIT OF A BREAK.
CAROL STILLER ASKS, SEEMS TO BE
A SIGNIFICANT DIFFERENCE BETWEEN
FDA RULES FOR DIETARY SUPPLEMENT
BOTANICALS AND BOTANICAL DRUG
PRODUCTS.
I GUESS THERE'S A QUESTION IN
THERE.
BUT PERHAPS MERLE COULD ADDRESS
THIS AND MAYBE ONE OR TWO OF THE
OTHERS COULD AS WELL.
>> YEAH, SO I THINK THE KEY TO
DIFFERENCES COMES DOWN TO THE
DIFFERENT LEGISLATIVE
REQUIREMENTS APPLIED TO THE TWO
CLASSES.
IF YOU WANT ANOTHER FUN WEEK OF
DISCUSSIONS I HAVE A THREE-HOUR
TALK ABOUT THE DIETARY
SUPPLEMENT REGULATION IN THE
U.S. THAT I'D BE HAPPY TO SHARE.
>> THANK YOU.
ANY OTHER COMMENTS?
SO HERE'S A QUESTION THAT I
THINK I'M GOING TO POSTPONE
UNTIL WE GET TO THE GENERAL
DISCUSSION AT THE END BUT I'LL
RAISE IT NOW SO THAT WE DON'T
FORGET IT.
ARE THERE LABORATORIES WHERE WE,
CONSUMERS, MAY BE ABLE TO SEND
PRODUCTS -- I APOLOGIZE, FOLKS.
THIS KEEPS MOVING AROUND.
AMAZING, THIS Q&A FUNCTION JUMPS
AROUND A LOT.
>> TO BE TESTED FOR HEAVY METALS
OR TOXINS, LET'S POSTPONE UNTIL
THE END, I HOPE ONE OF YOU WILL
BRING IT UP.
LET ME JUST SEE IF THERE'S
ANOTHER ONE HERE.
FROM MARY LEE, ANOTHER QUESTION.
YOU GUYS ARE FASTER AT DOING
THIS THAN I AM.
WHAT ABOUT SUPPLEMENTS MARKETED
WITHOUT CLAIMS THAT MAY HAVE NO
PROVEN HEALTH BENEFIT, SEEMS TO
BE A FOLLOW-ON TO ISSUE ABOUT
MARKETING, RESPONSIBILITY OF
MANUFACTURERS FOR MARKETING
BOTANICAL PRODUCTS FOR WHICH THE
EVIDENCE SEEMS TO BE SLENDER IN
TERMS OF HEALTH BENEFIT, WHAT
ABOUT SUPPLEMENTS THEN THAT MAKE
NO CLAIMS, AND MOST DON'T,
EXCEPT STRUCTURE/FUNCTION CLAIMS
OR CONTENT CLAIMS.
THEY HAVE BEEN SHOWN TO HAVE NO
BENEFIT AT ALL, THIS MAY NOT BE
A FAIR QUESTION TO ASK YOU BUT
I'LL TRY IT ANYWAY.
ANY COMMENTS FROM --
>> MERLE HERE.
I KNOW THERE'S A LOT OF THINGS
THAT MY PARENTS AND GRANDPARENTS
REALLY LOVED TO DO, WHICH I
DIDN'T SUPER UNDERSTAND AS A
YOUNG PERSON, AND ONE OF THE
THINGS IS TRYING TO DO AS FAR AS
BOTANICALS MAKE SURE ALL THOSE
MEMBERS OF THE FOLKS' FAMILIES
WILL BE ABLE TO GET CONTINUED
ACCESS TO THE VARIETY OF HERBS
THAT THEY HAVE IN THEIR PERSONAL
FAMILY TRADITIONS THEY ARE USED
TO.
THAT'S ONE OF THE REASONS WHY
WE'RE LOOKING AT THESE
EXPANSIONS TO OUR HERBS OF
COMMERCE TO ENGAGE WITH NARROWER
AREAS OF THE UNITED STATES.
WONDERFUL COLLECTION OF
DIFFERENT CULTURES.
WE CAN INCLUDE THE THINGS THAT
THEY WERE USING ALL ALONG IN OUR
FORMAL DIRECTORY.
>> ANY LAST WORDS FROM YOU,
BRIAN OR JAY ON THIS PARTICULAR
TOPIC?
>> SO, I'M NOT SURE ABOUT HOW
MANY PRODUCTS ARE OUT THERE THAT
DON'T MAKE ANY CLAIMS.
THERE'S EXPRESS CLAIMS AND
THERE'S IMPLIED CLAIMS.
YOU KNOW, AND THE EVIDENCE
STANDARD IS THE SAME.
SO IF YOU'RE NOT MAKING ANY
CLAIM WHATSOEVER, YOU'D STILL
HAVE TO HAVE SOME VERIFICATION
FOR SUBSTANTIATION OF THE SAFETY
OF THE INGREDIENT BEING ON THE
MARKET.
BUT IF YOU DON'T HAVE A CLAIM,
AGAIN, I DON'T KNOW HOW FREQUENT
THOSE PRODUCTS SHOW UP ON THE
MARKET, BUT YOU WOULD STILL HAVE
TO HAVE SUBSTANTIATION OF SAFETY
WHETHER IT BE THROUGH NEW
DIETARY INGREDIENT NOTIFICATION
OR GRAS, OR MARKETEDDED PRIOR TO
DSHEA, THINGS LIKE THAT.
>> THANK YOU VERY MUCH.
I'M GOING TO TURN TO OUR OTHER
PANEL, AND WE'RE GOING TO MEET
THREE DISTINGUISHED INDIVIDUALS
WHOM WE'VE DUBBED THE WATCHDOGS.
AND I'LL ASK THEM EACH TO TAKE
15 MINUTES AGAIN TO DESCRIBE THE
PURPOSE OF THEIR ORGANIZATION,
AS WELL AS ACTIVITIES THAT THEY
OR THEIR ORGANIZATIONS ENGAGE IN
SPECIFICALLY RELATED TO
SUPPLEMENTS.
A PANEL DISCUSSION WITH THESE
FOLKS WILL FOLLOW THEIR
PRESENTATIONS, WE'LL THEN HAVE A
SHORT BREAK FOLLOWED BY GENERAL
DISCUSSION WITH ALL OF THE
PANELISTS.
IF THERE ARE QUESTIONS THAT
STILL REMAIN, THEY CAN BE
ANSWERED IN THAT GENERAL
DISCUSSION SESSION AT THE END.
LET ME INTRODUCE DR. TOD
COOPERMAN FROM CONSUMERLAB.COM.
WE HAVEN'T SEEN ONE ANOTHER FOR
A WHILE, TOD.
YOU'RE MUTED.
TRY AGAIN.
>> CAN YOU HEAR ME?
>> YES, I CAN HEAR YOU.
>> OKAY.
THANKS, PAUL.
IT'S GREAT TO SEE YOU.
YOUR BEARD CONTINUES TO GET
LARGER AND YOUR MOUSTACHE TOO.
THANK YOU VERY MUCH TO ODS FOR
INVITING ME, THIS IS ONE OF MY
FAVORITE PLACES TO TALK EACH
YEAR.
SO I'LL JUMP RIGHT INTO IT
BECAUSE I NEVER HAVE ENOUGH TIME
TO PRESENT WHAT I WANT TO
PRESENT HERE.
LET ME GO RIGHT TO MY
PRESENTATION.
CAN YOU SEE THAT ALL RIGHT?
>> NOT YET.
YOU MAY HAVE TO HIT ANOTHER
BUTTON.
>> CHOOSE WHAT YOU WANT TO
SHARE, HIT ANOTHER SHARE BUTTON
BELOW THAT.
>> OH, I'M SORRY.
OKAY.
>> THERE WE GO.
>> OKAY.
>> I'M DR. TOD COOPERMAN WITH
CONSUMERLAB, FOUNDER OF
CONSUMERLAB, AND -- SORRY, I'M
TRYING TO -- THERE WE GO.
I FOUNDED CONSUMERLAB IN 1999,
23 YEARS NOW, WHERE I GRABBED A
RESEARCHER FROM THE FDA AND WE
BEGAN TESTING SUPPLEMENTS REALLY
TO ADDRESS THE QUESTIONS THAT
HAVE COME IN, IN THE LAST PIECE,
PEOPLE ASKING WHERE CAN
CONSUMERS GET PRODUCTS TESTED,
ARE THERE GROUPS OUT THERE
LOOKING AT THE EVIDENCE AND
RECORDING ON THAT OBJECTIVELY,
THESE ARE THINGS WE DO AT
CONSUMERLAB.
WE DON'T ACCEPT PRODUCTS FROM
CONSUMERS OR COMPANIES BUT WE GO
OUT AND BUY THESE PRODUCTS.
OUR GOAL IS TO IDENTIFY THE BEST
QUALITY HEALTH AND NUTRITION
PRODUCTS THROUGH INDEPENDENT
TESTING.
WE'VE TESTED OVER 6800 PRODUCTS,
REPRESENTING NEARLY A THOUSAND
BRANDS.
WE HAVE OVER 95,000 INDIVIDUAL
MEMBERS, PEOPLE WHO SUBSCRIBE TO
OUR INFORMATION.
$54 A YEAR.
WE ALSO HAVE ALL KINDS OF
INSTITUTIONS THAT SUBSCRIBE TO
CONSUMERLAB.
WHY DO PEOPLE DO THAT?
CONSUMERS NEED TO UNDERSTAND
WHICH SUPPLEMENTS ARE BEST
QUALITY, AND GET OTHER OBJECTIVE
INFORMATION ABOUT USING
SUPPLEMENTS, HEALTH CARE
PROFESSIONALS USE OUR
INFORMATION BECAUSE THEY ARE
TRYING TO PROTECT THEIR PATIENTS
AND RECOMMEND PRODUCTS THAT THEY
THINK ARE BEST.
NUTRITIONISTS, DOCTORS, NURSES,
ET CETERA.
AND THOSE IN THE INDUSTRY ALSO
USE OUR INFORMATION TO KEEP
ABREAST OF QUALITY ISSUES THAT
ARE GOING ON.
PEOPLE IN GOVERNMENT AS WELL.
AS I SAID I'M THE FOUNDER.
I'VE BEEN IN THE CONSUMER HEALTH
AREA FOR THE LAST 26 YEARS, AND
M.D. BY SCHOOLING, WENT INTO THE
PHARMACEUTICAL INDUSTRY,
GRAVITATED TOWARD CONSUMER
INFORMATION.
OUR HEAD OF RESEARCH NOW IS DR.
MARK ANDERSON.
HE REPLACED OUR ORIGINAL FOUNDER
WHO RETIRED AFTER 12 YEARS, WHO
IS FROM THE FDA, MARK IS FROM
THE INDUSTRY WHICH IS ACTUALLY A
REALLY NICE PERSPECTIVE.
HE'S BEEN WITH US I THINK NINE
YEARS NOW AND HE -- OR MORE.
A PHARMACOLOGIST, TOXICOLOGIST.
WE KNOW THIS AREA.
AND WE'RE IN THE NEWS ALL THE
TIME.
THESE QUESTIONS ALWAYS COME UP
HOW DO YOU CHOOSE SUPPLEMENTS
WISELY, CAN ELDERBERRY TREAT THE
FLU, ET CETERA.
OUR INFORMATION IS FREQUENTLY
CITED IN THE NEWS, IN THE
ARTICLES, WHY CAN'T YOU JUST
RELY ON THE FDA?
THIS PRACTICUM ADDRESSED THIS.
WE CAN'T JUST RELY ON THE FDA.
IT DOESN'T APPROVE SUPPLEMENTS,
IT REGISTERS COMPANIES WHO MAKE
SUPPLEMENTS.
GOOD MANUFACTURE PROGRESSES IS
REQUIRED, CAN HELP BUT THEY
DON'T CONTAIN CONTAMINATION
LIMITS, AND 52% OF INSPECTIONS
RESULTED IN CITATIONS, BASICALLY
ESSENTIALLY FOR PRODUCTS FOR
COMPANIES NOT ESTABLISHING
PRODUCT SPECIFICATIONS FOR
IDENTITY PURITY STRENGTH.
A NEED FOR A GROUP, TO BUY, TEST
PRODUCTS.
THIS IS WHAT WE DO.
ONE, WE TEST PRODUCTS.
WE PUT OUT NEW PRODUCT REVIEWS
EVERY TWO TO THREE WEEKS.
I'LL MENTION A COUPLE.
AS MANY AS I CAN BEFORE I GET
YANKED OFF THE STAGE HERE.
WE ALSO HAVE ONE OF THE OLDEST
QUALITY CERTIFICATION PROGRAMS
WITH OUR SEAL.
WE'RE ACTUALLY THE ONLY ONE,
OTHERS ARE DOING USF, NSF, WE
HAVE THE ONLY ONE THAT PUBLISHES
OUR TESTING METHODS AND
STANDARDS, SO EVERYONE KNOWS
WHAT WE'RE DOING AND HOW WE'RE
DOING IT, HOW WE'RE EVALUATING
PRODUCTS.
WE DO SOME SPECIAL TESTING FOR
ACADEMIC RESEARCHERS, AND WE
TAKE THIS INFORMATION AND WE
CREATE THESE PRODUCT REVIEWS WE
PUBLISH ON OUR SITE, WE COVER
ALL MAJOR SUPPLEMENTS AND
CONTINUE TO GO AND TEST MORE.
WE PUBLISHED CLINICAL UPDATES,
CONSTANTLY PICKING OUT IMPORTANT
ARTICLES, WRITING ABOUT THEM,
CRITICALLY.
WE ANSWER QUESTIONS FROM
CONSUMERS, WE GET GREAT
QUESTIONS FROM OUR MEMBERS.
AND LEARN A LOT FROM THEM AS
WELL.
AND PUBLISH THAT ON OUR SITE.
WE PUBLISH RECALLS AND WARNINGS
THAT COME OUT ABOUT SUPPLEMENTS.
AND WE PUT OUT A NEWSLETTER
THREE TIMES A WEEK LETTING
PEOPLE KNOW WHAT THE LATEST
INFORMATION IS ON THE SITE.
THESE ARE JUST SOME EXAMPLES OF
CATEGORIES THAT WE'VE TESTED.
AND WHEN I SAY TESTED, WE'VE
BOUGHT A BUNCH OF PRODUCTS ON
THE MARKET AS A CONSUMER WOULD
AND PUT THEM THROUGH RIGOROUS
TESTING, WHAT HAVE WE FOUND
DOING THAT?
WELL, ONE OUT OF FIVE
SUPPLEMENTS WE FOUND TO BE OF
POOR QUALITY, AND WE'RE NOT OUT
THERE TYING TO FIND PROBLEMS,
WE'RE TRYING TO FIND GOOD
PRODUCTS.
I HAVE A FEELING THE RESULTS
WOULD BE WORSE IF YOU FOCUSED ON
WHAT WAS ON AMAZON RIGHT NOW BUT
IN TERMS OF WHAT WE FIND, 31% OF
HERBAL PRODUCTS FAIL OUR TESTS,
17 ADVISORY OF VITAMINS AND
MINERALS, HERBALS ARE MORE
COMPLICATED PRODUCTS.
SUPPLEMENTS, 14%, CoQ10s,
SAMMY, ET CETERA.
NUTRITIONAL PRODUCTS, 25%.
DARK CHOCOLATES, PROTEIN
POWDERS, OLIVE OILS, ET CETERA.
OVERALL 1 OUT OF 5 FAIL OUR
TESTS.
AND MOST COMMON PROBLEMS ARE WE
FIND TOO LITTLE OR NO
INGREDIENT, AND REALLY GOOD
EXAMPLE IS SOMETHING WE PUT OUT
A FEW DAYS AGO ON RED YEAST
RICE, 4 OUT OF 10 PRODUCTS HAD
NO LOVASTATIN, THE ACTIVE
COMPOUND THAT LOWERS
CHOLESTEROL, SHOCKING, SMALL
AMOUNTS IN MANY OTHERS, ONLY 1
OUT OF 10 WAS WE THOUGHT A GOOD
PRODUCT.
SOME HAVE TOO MUCH INGREDIENT,
COMPANIES CAN PUT IN OVERAGE BUT
200%, 300% CAN BE DANGEROUS.
INADEQUATE LABELING TO DESCRIBE
INGREDIENTS.
JUST OTHER REASONS FOR POOR
QUALITY INGREDIENTS, THEY DON'T
HAVE KEY COMPOUNDS EXPECTED IN
THERE, SPOILAGE OF OILS,
CONTAMINATION OF HEAVY METALS,
WE'RE TESTING ALL HERBAL
PRODUCTS AND MINERAL PRODUCTS
FOR HEAVY METALS AS WELL AS
OTHER TYPES OF PRODUCTS.
SO THAT WOULD BE LEAD, CADMIUM,
MERCURY, ARSENIC, INADEQUATE
DISINTEGRATION OF PILLS, SO
EVERY TABLET OR CAPLET IS TESTED
TO BREAK APART PROPERLY, RELEASE
INGREDIENTS, UNAPPROVED LABEL
CLAIMS.
SO, THE WAY WE DO THIS IS WE
PICK PRODUCTS THAT ARE POPULAR
AMONG OUR READERS PRIMARILY.
WE DO A BIG SURVEY EVERY YEAR TO
FIND OUT WHAT THEY USE AND DO
SMALLER SURVEYS FOR MORE DETAILS
PRODUCT SUGGESTIONS.
MULTIPLE SAMPLES PURCHASED AT
RETAIL FROM THE SAME LOT SO WE
HAVE ALWAYS A RESERVE SAMPLE WE
CAN RETEST OR SEND OUT TO A
LABORATORY FOR RETESTING.
IT'S ALWAYS CONFIRMED.
ALL THE OTHER TESTS ARE DONE IN
EXPERT LABORATORIES, OUR HEAD OF
RESEARCH, THAT'S HIS MAIN JOB
MAKING SURE WE'RE DOING THE
RIGHT TEST TEST RIGHT
LABORATORIES AND INTERPRETING
THE DATA PROPERLY.
INFORMATION IS PUBLISHED ONLINE
FOR MEMBERS.
AND ALL THOSE WHO ATTENDING ARE
WELCOME TO GET A FREE
THREE-MONTH MEMBERSHIP TO
CONSUMERLAB.
I'LL HAVE MY E-MAIL AT THE END.
PRODUCTS APPROVED IN VOLUNTARY
TESTING ARE APPROVED, THOSE THAT
GET OUR SEAL ARE ON OUR SITE.
AND AS I MENTIONED WE PUBLISH
HOW WE DO THESE TESTS, WHAT
PARAMETERS ARE FOR FAILING OR
PASSING.
I'LL JUMP OVER TO SHOW AN
EXAMPLE OF ONE OF OUR REVIEWS.
I'VE CHOSEN MAGNESIUM HERE.
WE PUT THIS OUT RECENTLY AS
WELL.
AND THESE INCLUDE NOT ONLY
MAGNESIUM SUPPLEMENT BUT
COMBINATION, BONE PRODUCTS HAVE
IT.
WE START OFF WITH WHAT IT IS, WE
GET INTO WHAT IT DOES.
THAT'S EXTENSIVE INFORMATION
ABOUT LOOKING AT STUDIES OUT
THERE.
I CAN'T EVEN -- I WON'T SPEND
MUCH TIME LOOKING AT -- THERE'S
DEMENTIA AND MAGNESIUM.
EXTENSIVE CLINICAL INFORMATION,
WHAT THIS PRODUCT MAY OR MAY NOT
DO.
WE OF -- FOUR PRODUCTS FAILED
OUR TEST, WASN'T BECAUSE OF
MAGNESIUM, MOST MINERALS ARE IN
THERE AT RIGHT AMOUNTS BUT TURNS
OUT MAGNESIUM DOESN'T PLAY WELL
WITH VITAMIN K, SO ONE HAD 4% OF
VITAMIN K.
IF YOU HAVE IT WITH MAGNESIUMS
AND CALCIUM, YOU CAN LOSE THAT,
PUTTING ALL THE RIGHT
INGREDIENTS, THEY CAN HAVE
PRODUCTS THAT FAIL.
WE HAD ANOTHER PRODUCT WITH --
THIS ONE WAS LOW IN MAGNESIUM,
ANOTHER ONE THAT HAD 240% OF ITS
VITAMIN D, SO ANOTHER PROBLEM.
WE COMPARED AMOUNTS THAT WE
FOUND IN PRODUCTS, WE LOOKED AT
COST, YOU CAN SAVE MONEY IF YOU
IF COST COMPARISON, YOU CAN GET
200 MILLIGRAMS FOR 4 CENTS OR
$4.35.
WE GO THROUGH ALL THAT, HAVE TOP
PICKS FOR CONSUMERS, SO THEY CAN
JUST GO RIGHT TO WHICH PRODUCT
MIGHT BE BEST FOR THEM.
DIFFERENT TIPS ABOUT HOW TO USE,
HOW MUCH YOU NEED, AND THEN
CONCERNS AND CAUTIONS, WHAT SIDE
EFFECTS, DRUG INTERACTIONS, LET
ME JUMP BACK AND STOP SHARING.
I BELIEVE THIS IS IT.
CAN YOU STILL HEAR AND SEE ME?
I'LL TAKE THAT AS A YES.
>> YES.
>> ALL RIGHT.
HERE ARE RECENT FINDINGS.
I MENTIONED RED YEAST RICE.
IN ADDITION TO FINDING NO
LOVASTATIN, WE FOUND CITRININ, A
POTENTIAL KIDNEY TOXIN.
WE HAVE EXTENSIVE INFORMATION,
CAN BE EFFECTIVE, BUT YOU DON'T
WANT TO USE SOMETHING WITH NO
LOVASTATIN IN THAT.
I'LL SKILL VITAMIN K.
ALOE, ONE PRODUCT FOUND NO KEY
COMPOUND YOU EXPECT TO FIND IN
ALOE VERA.
BIG VARIATIONS IN AMOUNT OF
ACEMANNAN, PSYLLIUM SUPPLEMENTS,
EXCESSIVE AMOUNTS OF LEAD IN
FIVE OUT OF EIGHT.
CRANBERRY PRODUCTS, WE LOOKED
FOR TYPE A PACs, BIG
VARIATION, YOU CAN SAVE CAL LIST
GETTING - SAVE CALORIES WITH A
JUICE RATHER THAN COCKTAIL.
HUGE RANGE, YOU WOULD NOT KNOW
FROM LABEL.
GREEN TEA, LOOKING FOR EGCG
PRIMARILY, AND FOUND THAT
ACTUALLY WE LOOKED AT TEA BAGS
AND FOUND SOME HAD VERY LITTLE
EGCG DUE TO THE BAGS PROBABLY
THEMSELVES RETAINING THE ACTIVE
COMPOUNDS.
AGAIN, I'M GOING QUICKLY.
WE TESTED SEAWEED SNACKS, HIGH
LEVELS OF IODINE, SOME HAD
18,000 MICROGRAMS.
LEAD, POTASSIUM SUPPLEMENTS, ONE
PROVIDING 27 0 MILLIGRAMS
INSTEAD OF 105, PILLS OF ANOTHER
WOULDN'T BREAK APART SO YOU
WON'T GET THE POTASSIUM YOU
EXPECT.
SOME MADE WITH KELP WERE
CONTAMINATED WITH ARSENIC.
GOLDENSEAL, BURBERINE, WE FOUND
FAKE GOLDENSEAL.
ONE ARE NO BURBERINE EVEN WITH A
GMP CERTIFIED LOGO.
GINGKO, 4 OUT OF 10 SUPPLEMENTS
APPROVED.
RED FLAGS, DON'T -- BE AWARE OF
LABELS THAT DON'T TELL YOU HOW
MUCH, IT'S A PROPRIETARY BLEND,
ET CETERA.
MEANINGLESS CLAIMS LIKE FDA
APPROVED, PHARMACEUTICAL GRADE,
UNCERTAIN CERTIFICATION SEALS,
LIKE I MENTIONED BEFORE GMP
APPROVED BY BY WHOM?
LOOK FOR SEALS LIKE CONSUMERLAB,
USP, NSF.
PRICE IS NOT AN INDICATOR OF
QUALITY.
PEOPLE NEED TO KNOW UPPER
TOLERABLE INTAKE LEVELS OF
SUPPLEMENTS BECAUSE IT'S NOT
GOING TO BE ON THE BOTTLE.
YOU'LL SEE DAILY VALUE
PERCENTAGES BUT NOT THAT.
THAT'S IT.
HOPEFULLY I MADE IT UNDER THE
INQUIRE.
NO ONE YANKED ME OFF SO THAT'S
GREAT.
AGAIN, IF YOU'RE INTERESTED IN
GETTING FREE MEMBERSHIP FOR
THREE MONTHS AS A TRIAL, YOU'RE
NOT ALREADY A MEMBER, E-MAIL ME
AND WE'LL SET THAT UP FOR YOU
NEXT WEEK.
SO THANK YOU.
>> YOU WERE CLOSE TO TIME.
IT'S A FUN THING TO DO.
ALL INTRODUCE MR. JENSEN JOSE
FOR CENTER FOR SCIENCE IN THE
PUBLIC INTEREST.
TAKE IT AWAY.
>> THANKS FOR THAT.
MY SHARE CONTENT BUTTON IS NOT
THERE.
>> JAMES, CAN YOU HELP?
>> IT SHOULD BE APPEARING NOW.
>> THERE IT IS.
CAN EVERYBODY SEE MY SCREEN?
>> YEP.
LOOKS GREAT.
>> ALL RIGHT.
THANK YOU VERY MUCH.
GOOD AFTERNOON.
I'M JENSEN JOSE, I'VE BEEN
DEALING WITH A THREE-MONTH-OLD
AND 2-YEAR-OLD WITH DOUBLE
INFECTION, FLU, NEW DAY CARE AND
COVID, SO VERY LITTLE SLEEP,
APOLOGIZE IF IT SHOWS IN THE
PRESENTATION.
I'LL START THE PRESENTATION.
I WORK ON FOOD ADDITIVES AND
DIETARY SUPPLEMENT ISSUES.
IT'S ONE OF THE AMERICA'S OLDEST
FOOD AND NUTRITION WATCH DOG
ORGANIZATIONS, WE MONITOR MARKET
TO ENSURE UNSAFE FOODS INCLUDING
DIETARY SUPPLEMENTS ARE KEPT OFF
THE MARKET.
WE PUSH FOR POLICIES THAT ALLOW
CONSUMERS TO MAKE HEALTHY
CHOICES.
ALSO PUBLISHES THE NUTRITION
ACTION HEALTH LETTER PROVIDING
ADVICE ON NUTRITION AND HEALTH.
IN OUR WORK WE HAVE COME ACROSS
A NUMBER OF CONCERNING HEALTH
AND SAFETY ISSUES WITHIN THE
MARKETPLACE.
MOST DIETARY SUPPLEMENTS ARE BEE
NINE BUT WE'VE -- ARE BENIGN
BACKUP DISEASE THERE ARE
UNSUBSTANTIATED CLAIMS.
THIS PRESENTATION WILL COVER
THESE THREATS TO CONSUMER SAFETY
IN MORE DETAIL.
I'LL GO OVER EXAMPLES OF CSPI
WORK ON ADDRESSING THESE ISSUES
AS WELL AS REFORMS WE'RE TRYING
TO PUSH THROUGH FDA AND
CONGRESS.
MANY SUPPLEMENTS ARE SOLD ONLINE
ARE TAINTED WITH DANGEROUS
SUBSTANCES SUCH AS PRESCRIPTION
DRUGS, SYNTHETIC CHEMICALS,
OTHER INGREDIENTS.
WITH THED E ADVENT OF INTERNET
THIS INCLUES THOSE FOUND ON
AMAZON AND E-BAY, SOLD ON MAIN
RETAILER WEBSITE DOESN'T MEAN
THEY ARE SAFE OR NOT TAINTED.
SHEER NUMBER OF ONLINE RETAILERS
MAKES IT IMPOSSIBLE FOR THE FDA
TO SAFELY MONITOR THE MARKET.
FDA FOUND DANGEROUS UNLISTED
INGREDIENTS IN THOUSANDS OF
SUPPLEMENTS BUT THE AGENCY
STATES THAT THEIR LIST ONLY
INCLUDES A SMALL FRACTION OF THE
POTENTIALLY HAZARDOUS AND
DANGEROUS PRODUCTS WITH HIDDEN
INGREDIENTS.
THE SLIDE LOOKS CROWDED BUT
THAT'S THE POINT.
AND PUT SIMPLY THE FDA DOES NOT
HAVE THE RESOURCES OR AUTHORITY
TO KEEP DANGEROUS PRODUCTS OFF
THE MARKET.
COMPANIES DON'T ALWAYS SECRETLY
INCLUDE UNSAFE INGREDIENTS.
SOMETIMES THEY OPENLY MARKET
SYNTHETIC CHEMICALS OR SUPER
CONCENTRATED IN PLANTS TO CREATE
PHARMACEUTICAL GRADE.
PURE CAFFEINE, A TEASPOON COULD
BE LETHAL.
THOSE BOTH PASSED AWAY.
IT TOOK FOUR YEARS FOR THE FDA
TO WARN COMPANIES TO STOP
SELLING POWDERED CAFFEINE
THROUGH GUIDANCE.
HERE DESPITE CLEAR THREAT FDA
FELL SHORT OF OUTRIGHT BANNING
PURE POWDER CAFFEINE.
SUPPLEMENT MANUFACTURERS MAKE AS
STRONG OR DANGEROUS AS
PRESCRIPTION DRUGS, USING RED
YEAST EXTRACTS IDENTICAL TO
LOVASTATIN TO SELF-TREAT
CHOLESTEROL, HYDRO CHLORIDE IS
FOR ERECTILE DYSFUNCTION, THE
BARK IS EXTRACTED AS SEXUAL
ENHANCEMENT SUPPLEMENTS IN THE
U.S., THESE HAVE BEEN ASSOCIATED
WITH HEART ATTACKS, SEIZURES,
ANXIETY, AND HIGH BLOOD
PRESSURE.
COMPANIES CAN USE SELF-GRAS
NON-DIETARY INGREDIENTS AND
DISCLAIMERS TO AVOID BEING
REGULATED AS DIETARY
SUPPLEMENTS.
FOR EXAMPLE, IN 2018 FDA ISSUED
LETTERS WARNING COMPANIES TO
STAMP MARKETING TIANEPTIN BUT
CONTINUES TO BE SOLD, WITH LABEL
NOT FOR HUMAN CONSUMPTION.
RETAILERS WILL LINK TO
INFORMATION ON TIANEPTIN USE AS
A COGNITIVE SUPPLEMENT.
MANY PRODUCTS COULD STILL FALL
UNDER OTHER FDA AND DEA
AUTHORITIES BUT THE GRAY AREA
MEAN MANY FAIL TO GET ON FDA'S
RADAR OR DEA'S RADAR AND FALL
THROUGH THE GAPS IN OVERSIGHT.
ANOTHER PROBLEM IN DIETARY
SUPPLEMENTS ARE DISEASE AND
TREATMENT CLAIMS.
DIETARY SUPPLEMENTS CANNOT
LEGALLY CLAIM TO TREAT,
MITIGATE, CURE OR PREVENT
DISEASE.
THESE CLAIMS ARE COMMON.
NUTRITION ACTION HEALTH LETTER
WRITES ABOUT SUPPLEMENT AND
EVALUATES EVIDENCE BEHIND
CLAIMS.
SUCH AS THE ONE IN THE ARTICLE,
MARKETS WITH IMPLIED DISEASE
CLAIMS.
THERE'S VERY LITTLE EVIDENCE TO
SUPPORT SUCH CLAIMS AS EFFECTIVE
IN PREVENTING OR TREATING
DIABETES.
SUCH CLAIMS POSE RISK TO
CONSUMERS WHO MAY MISUNDERSTAND
EFFICACY.
OVER THE PAST FEW YEARS ASKED
FDA ENFORCEMENT AND SOUGHT
ENFORCEMENT ON CLAIMS RELATED TO
OPIOID ADDICTION.
WE'VE REQUESTED ACTION AGAINST
COMPANIES MARKETING DISEASE
AND TOBACCO ADDICTION.RTILITY
LAST YEAR FDA SENT WARNING
LABELS TO FIVE COMPANIES WITH
CLAIMS.
MANY DISEASE CLAIMS CAPITALIZE
ON WHATEVER THE PUBLIC HEALTH
CONCERN IS MOST PREVALENT.
SUCH AS OPIOID CRISIS, H1N1, OF
COURSE MOST RECENTLY COVID-19.
FDA'S OPERATION QUACK HACK IS
THE CAMPAIGN TO COME BAD
COVID-19 FRAUD, MOST COVID-19
WARNING LETTERS INVOLVE DIETARY
SUPPLEMENTS.
WE CSPI IS MONITORING, INCLUDING
THAT SOLD BY JIM BAKKER, AND
SENT LETTERS, AND AGAINST DR.
JOSEPH McCOLA TWO ADVISES TO
CONTRACT CORONAVIRUS AFTER
TAKING WHAT HE SELLS.
HE IS A MAJOR DONOR TO
ANTI-VACCINATION CAMPAIGNS.
AFTER RECEIVING OUR ENFORCEMENT
REQUEST ACTION WAS TAKEN AGAINST
BAKKER AND MERCOLA.
MANY COMPANIES STARTED
CAPITALIZING ON FEARS BY
CLAIMING PRODUCTS COULD PREVENT
OR TREAT VIRUSES.
NOT EXPRESSLY MARKETING
SUPPLEMENTS FOR COVID THEY ARE
TRYING TO CASH IN ON CORONAVIRUS
FEARS SELLING PRODUCTS WITH
LITTLE TO NO EVIDENCE FOR
ANTI-VIRAL PROPERTIES.
MANY CLAIMS ARE NEVER
SUBSTANTIATED.
MANY USE LITTLE TO NO EVIDENCE
TO SUPPORT CLAIMS.
WHEN COMPANIES DO CITE EVIDENCE,
IT'S WEAK OR MISLEADING.
FOR EXAMPLE, SOME COMPANIES USE
PRACTICE KNOWN AS FAIRY DUSTING,
CITING TO STUDIES SHOWING
EFFECTIVENESS AT LEVELS MUCH
HIGHER THAN WHAT THEY ARE
MARKETING.
AND CLINICALLY TESTS, HERE IS AN
ARTICLE WITH THREE EXAMPLES, ALL
THREE TEST PERFORMED NO BETTER
THAN PLACEBO OR NO EVIDENCE OF
EFFICACY.
UNFORTUNATELY, THE PRODUCTS THAT
CONSUMERS TAKE TO KEEP THEM
HEALTHY AND SAFE CAN BE
DANGEROUS AND INEFFECTIVE,
BAKKER AND MERCOLA TOLD PEOPLE
TO CONTRACT COVID AFTER TAKING
THEIR VITAMINS.
CONSUMERS ARE USING THEIR MONEY
AND TIME ON UNSAFE SUPPLEMENTS,
PUTTING THEMSELVES IN HARM'S
WAY.
THE MESSAGE THAT OUR HEALTH
PROBLEMS AND FEARS CAN GO AWAY
WITH SIMPLE POWDER OTHER PILL IS
EXTREMELY ALLURING.
FDA IDENTIFIED SOME CATEGORIES
OF SUPPLEMENTS THAT HAPPEN TO
HAVE MORE SAFETY AND EFFICACY
ISSUES THAN MOST OTHER
SUPPLEMENTS.
THESE CATEGORIES INCLUDE WEIGHT
LOSS, PERFORMANCE ENHANCING,
WORKOUT, SEXUAL ENHANCEMENT, COG
ANY COGNITIVE ENHANCEMENT.
YOU'VE BEEN APPROACHED BY
SCAMMERS OR FRIENDS ON SOCIAL
MEDIA TRYING TO SELL
SUPPLEMENTS, TENDING TO RELY ON
MARKETING TECHNIQUES AND SOCIAL
MEDIA TO MAKE UNFOUNDED CLAIMS
AND AVOID DETECTION BY THE FDA.
HOW DO THESE BAD ACTORS GET AWAY
WITH THIS?
FOLLOWING IS JUST SOME OF THE
PROBLEMS AS WELL AS SOLUTIONS
THAT CSPI IS ADVOCATING FOR.
FDA CAN CARRY OUT
RECOMMENDATIONS WITH CURRENT
STATUTORY AUTHORITY.
NUMBER ONE, FDA IS OVERWHELMED.
WHAT WAS A $4 BILLION INDUSTRY
COMPRISED OF 4,000 PRODUCTS IS
NOW WORTH MORE THAN $40 BILLION,
WITH MORE THAN 50 TO 80,000
PRODTS AVAILABLE TO CONSUMERS.
FDA RESOURCES HAVE NOT GROWN
WITH THE MARKET.
AGENCY NEEDS ADDITIONAL STAFF
AND FUNDING TO MANAGE THIS
GROWING INDUSTRY.
PROVIDING STATE A.G.s WITH
ABILITY TO ENFORCE DSHEA IN
THEIR STATE WILL HELP THEM
ADDRESS THE SMALL FLY BY NIGHT
COMPANIES.
MANY SOLUTIONS WILL HELP FDA
TRACK AND ADDRESS UNSAFE
SUPPLEMENTS.
TWO, COMPANIES INTRODUCE
INGREDIENTS AND SUPPLEMENTS
WITHOUT INFORMING THE FDA,
IMPOSSIBLE TO KNOW WHAT IS ON
THE MARKET LET ALONE
SUBSTANTIATE CLAIMS.
THE FDA SHOULD CREATE DIETARY
SUPPLEMENT LISTING DATABASE,
COMPANIES SHOULD BE REQUIRED TO
LIST THEIR PRODUCTS IN A PUBLIC
DATABASE WHICH DESCRIBES THE
PRODUCT INGREDIENT, CLAIMS,
SAFETY CONCERNS, EVIDENCE, AND
OTHER IMPORTANT PRODUCT
INFORMATION.
THIS WILL HELP TRACK AND
UNDERSTAND WHAT'S ON THE MARKET
AND CLAIMS MADE BY SUPPLEMENTS.
MAKING THESE LISTINGS AVAILABLE
TO THE PUBLIC WILL HELP
RESEARCHERS AND WATCH DOGS LIKE
OURSELVES BRING IT TO FDA
ATTENTION.
CLOSING THE GRAS LOOPHOLE IS
IMPORTANT, MANY USE IT FOR FOOD
TO BYPASS FDA REVIEW, THIS MEANS
COMPANIES CAN MAKE THEIR OWN
DETERMINATIONS AND ADD DIETARY
INGREDIENTS WITHOUT NOTIFYING
FDA.
INSTEAD OF GRAS SHOULD REVISE
GUIDANCE TO SHARE INFORMATION TO
ASSESS SAFETY OF EACH DIETARY
SUPPLEMENT.
THREE, AS MENTIONED BEFORE,
COMPANIES SELL NON-DIETARY
INGREDIENTS AS SUPPLEMENTS.
THE FDA SHOULD TO REGULATE AS
ADULTERATED SUPPLEMENTS
REGARDLESS OF WHETHER IT
CONTAINS DIETARY INGREDIENTS.
FOUR, COMPANIES CAN EVADE
PENALTIES, MANY VIOLATE DSHEA
KNOWING THEY WILL GET A WARNING
LETTER AND ASSUME THEY WILL GET
A SLAP ON THE WRIST, OR REBRAND
OR REFORMULATE SO FDA WOULD HAVE
TO RESEND A WARNING LETTER FOR A
NEW PRODUCT.
BAD ACTORS WILL DISSOLVE AND THE
FDA SHOULD ADMINISTER CIVIL
PENALTIES FOR FIRST TIME,
INCREASE FOR REPEATED VIOLATIONS
WHEN COMPANIES REBRAND AND
REFORMULATE.
APOLOGIES FOR MISNUMBERING, I
WAS UPDATING AT 1 A.M. AFTER
SICK BABIES WERE GOING TO SLEEP.
THERE'S INTEREST ON THE HILL FOR
REFORM.
SUSPECTORS DID YOUR -- -
SENATORS HAVE INTRODUCED
LEGISLATION.
THIS INCLUDES SOME REFORM SUCH
AS CREATION OF LISTING DATABASE,
IMPROVING OVERSIGHT, PROTECTING
PRODUCTS AND REQUIRING FDA TO
FINALIZE GUIDANCE.
WE'RE WORKING WITH CONGRESSIONAL
OFFICES TO IMPLEMENT SOME OF OUR
RECOMMENDATIONS IN THE PREVIOUS
SLIDE, SO I WOULD URGE EVERYONE
TO CONTINUE TO PAY ATTENTION TO
WHAT WE'RE DOING AND WHAT'S
GOING ON ON THE HILL, AND WE'RE
ALWAYS TRYING TO PRESS FDA TO DO
REFORMS THEMSELVES AND ALSO WE
CONTINUE TO NOTIFY FDA OF
VIOLATING SUPPLEMENTS ON THE
MARKET THAT WE DISCOVER.
BECAUSE I'M OUT OF TIME I HAVE
TO STOP HERE.
THERE ARE MORE CONSUMER SAFETY
ISSUES AND REFORMS I'VE YET TO
TOUCH ON.
FOR MORE INFORMATION CONTACT ME.
THANK YOU VERY MUCH FOR YOUR
TIME AND I LOOK FORWARD TO
EVERYONE'S QUESTIONS.
>> MANY THANKS, JENSEN.
APPRECIATE YOUR TALK AND ROLE
THAT CSPI HAS BEEN PLAYING.
I'M GOING TO TURN TO AN OLD
FRIEND, SALLY SQUIRES, WHO IS
REPRESENTING A DIFFERENT
PERSPECTIVE.
SHE WAS FOR MANY YEARS A
JOURNALIST WITH THE "WASHINGTON
POST," AND CONTINUES HER
ACTIVITIES IN NUTRITION USING
THE LEAN PLATE CLUB, IT'S NICE
TO SEE YOUR FACE.
YOU MAY BE MUTED.
I'M NOT SURE.
SALLY, CAN YOU HEAR ME?
>> HELLO.
NICE TO SEE YOU.
>> YOU CAN SHARE YOUR SCREEN
WHENEVER YOUR READY.
>> WONDERFUL.
THERE WE GO.
SO, SHALL I GO THROUGH AND
START?
>> I'M NOT SURE THE SHARE IS
COMING THROUGH YET.
CLICK THE SHARE BUTTON AT THE
BOTTOM AND CHOOSE THE WINDOW YOU
WANT TO SHARE AND CLICK THE
SHARE BUTTON AGAIN.
>> LET'S SEE.
>> A COUPLE EXTRA STEPS.
THERE WE GO.
LOOKS GREAT.
>> GOOD.
OKAY.
HOPEFULLY WE CAN MOVE FORWARD.
OKAY.
THAT'S GREAT.
WELL, THANK YOU.
I'M DELIGHTED TO BE HERE.
AND THIS IS ONE OF MY FAVORITE
CONFERENCES.
TODAY I AM GOING TO GIVE YOU
JUST AN OVERVIEW OF HOW I HAVE
APPROACHED AS A LONGTIME
JOURNALIST, HOW I'VE APPROACHED
COVERING DIETARY SUPPLEMENTS,
AND I SPENT 24 YEARS AT THE POST
COVERING HEALTH AND MEDICINE,
AND THEN WAS IN PUBLIC AFFAIRS
FOR 12 YEARS.
NOW BACK BEING PART OF THE
"POST" TALENT NETWORK, THIS IS
MY PERSPECTIVE ON HOW I COVER
THIS AREA.
LET'S SEE IF I'M GOING -- THERE
WE GO.
I AM ALSO REALLY THRILLED TO BE
HERE BECAUSE I HAD THE PLEASURE
OF KNOWING MARY FRANCES PICCIANO
AND HER LATE HUSBAND, I'M
DELIGHTED WE'RE USING THIS TO
HONOR THEM AND REALLY THINK IT'S
TERRIFIC WAY TO HONOR THEIR
MEMORIES AND THEIR WORK.
I THOUGHT I WOULD PUT HER
PICTURE UP BECAUSE SHE WAS A
SPECIAL PERSON AND I KNOW WAS
VERY IMPORTANT TO THE OFFICE OF
DIETARY SUPPLEMENTS.
SO, WHAT I PLAN TO COVER TODAY,
I DON'T KNOW IF YOU'RE SEEING
THIS.
WHAT I PLAN TO COVER IS HOW I
REPORT STORIES AND WHAT YOU CAN
DO AS A SCIENTIST TO BE PART OF
THE CONVERSATION WHICH I THINK
IS IMPORTANT, WHETHER DIETARY
SUPPLEMENTS OR OTHER WORK YOU
MIGHT BE DOING.
IT'S REALLY IMPORTANT FOR ALL OF
US TO BE PART OF A GROWING
CONVERSATION ABOUT SCIENCE AND
MEDICINE AND HEALTH.
SO, LET'S SEE.
SOMEHOW MY -- SOMEHOW THE
ADVANCE FOR MY NEXT --
>> CLICK ON THE SLIDES ONCE.
>> GOT IT.
WHAT MAKES A STORY?
IN THE NEWSROOM WE USED TO SAY A
STORY WAS ANYTHING THAT HAPPENED
TO A REPORTER, AND THEN A SERIES
WAS ANYTHING THAT HAPPENED TO AN
EDITOR, AND A PROJECT WAS
ANYTHING THAT HAPPENED TO THE
MANAGING EDITOR.
THAT'S TONGUE IN CHEEK BUT
REPORTERS AND JOURNALISTS HAVE
LIVES THAT ALL KINDS OF THINGS
HAPPEN, THAT OFTEN IS THE SOURCE
OF HAVING THEM THINK ABOUT WHAT
MIGHT BE A STORY.
OBVIOUSLY THERE ARE MANY OTHER
SOURCES AS WELL FROM SCIENTIFIC
JOURNALS, THINGS THAT HAPPEN IN
THE NEWS, OR EVENTS, I THINK
SADLY WE'RE SEEING ANOTHER EVENT
THAT IS GOING TO HAVE ANOTHER
FOCUS ON MENTAL HEALTH, ET
CETERA.
SO I THINK LOTS OF THINGS MAKE A
STORY BUT IN TERMS OF -- THERE
IS SOME TRUTH TO THE FACT THAT
IT'S WHAT HAS GRABBED THE
JOURNALIST OR EDITORS OR THE
MANAGING EDITOR'S INTERESTS,
THAT CAN HELP DRIVE WHAT MAKES A
STORY.
WHAT HAS CHANGED OVER THE LAST
30 YEARS THAT I'VE BEEN IN THIS
BUSINESS IS THAT INFORMATION
SOURCES HAVE MULTIPLIED, AND
SOCIAL MEDIA AS MANY OF YOU WILL
BE WELL AWARE HAS VERY MUCH
OUTPACED NEWSPAPERS AS AN
INFORMATION SOURCE.
AND THAT'S -- THERE ARE PLUSES
AND MINUSES BUT IT'S MADE FOR A
DIFFERENT KIND OF ATMOSPHERE AND
HOW PEOPLE GET THEIR NEWS.
AND AS YOU MAY KNOW, MAYBE YOU
ARE SOMEONE THAT DOES THIS
YOURSELF, THAT MUCH OF THE NEWS
THAT IS NOW DISSEMINATED IS NOT
COMING IN FROM LEGACY
ORGANIZATIONS LIKE THE
"WASHINGTON POST" OR "NEW YORK
TIMES" OR "WALL STREET JOURNAL."
BUT RATHER FROM INSTAGRAM,
FACEBOOK, TIKTOK AND YouTube
AND TWITTER AND ALL DIFFERENT
KINDS OF PLACES.
SO, THAT'S REALLY EXPANDED IN
MANY WAYS THE INFORMATION THAT
IS AVAILABLE.
AND THEN ONE WAY THAT'S GOOD BUT
IN ANOTHER WAY THAT'S NOT SO
GOOD BECAUSE TO MY MIND
JOURNALISTS ARE TRAINED AS
PROFESSIONALS, JUST AS
SCIENTISTS ARE, AND YOU ARE A
SENSE OF WHAT A STORY SHOULD BE
AND HOW IT SHOULD BE SOURCED,
NOT EVERYTHING THAT COMES ACROSS
A DIGITAL CHANNEL HAS A RIGOROUS
LOOK FROM A JOURNALIST AND THEIR
EDITOR.
IT CAN BE GOOD AND BAD.
BUT THERE ARE A LOT OF
SIMILARITIES BETWEEN JOURNALISTS
AND SCIENTISTS.
SO SCIENTISTS ARE LOOKING AT A
PREMISE AND THEY INVESTIGATE A
PARTICULAR THEORY.
AND THEY GO ABOUT IT TESTING
THAT THEORY AND THEY WRITE IT UP
FOR SCIENTIFIC JOURNAL.
HOPEFULLY GETS ACCEPTED.
AND JOURNALISTS DO MUCH THE SAME
THING.
YOU HAVE AN IDEA FOR A STORY,
YOU REPORT IT, AND MANY TIMES
YOUR IDEA WAS RIGHT ON TARGET,
BUT A LOT OF TIMES IT'S NOT.
YOU LEARN SOMETHING THAT MIGHT
TAKE YOU ON A DETOUR AND MIGHT
NOT HAVE BEEN WHAT YOU IMAGINED
AT ALL BUT THE IDEA IS THAT YOU
WILL THEN PUBLISH OR DISPLAY IN
VIDEO, HOWEVER IT'S SEEN BY THE
WORD, BUT THAT'S WHAT WILL
HAPPEN.
IN SOME WAYS THERE ARE MANY
SIMILARITIES.
WHAT I DO WHEN I START TO REPORT
A STORY OR IDEA, I GO TO THE
NATIONAL LIBRARY OF MEDICINE,
SPECIFICALLY PubMed.
I START SEARCHING THE SCIENTIFIC
LITERATURE.
IT'S A WONDERFUL, OF WAY TO GET
A SENSE OF WHAT HAS BEEN
PUBLISHED, AND HOW MANY PEOPLE
HAVE LOOKED AT THOSE KINDS OF
STUDIES, AND TO GET AN IDEA OF
THE LITERATURE AND THEN IT ALSO
GIVES ME NEW SOURCES TO TAP.
I HAVE A BIG DATABASE OF
SCIENTISTS I'VE KNOWN THROUGH
THE YEARS BUT THERE ARE NO ONES,
IT GIVES ME NEW EXPERTS TO TRY
TO MEET.
SORRY, OKAY.
SO THEN I ALSO LOOK FOR --
CHECKED CREDIBLE AND INDEPENDENT
SOURCES, AND AMONG THOSE ARE
OBVIOUSLY THE FDA, AND THIS IS
THE DIETARY SUPPLEMENTS PAGE FOR
THE FDA.
I'M A BIG USER OF THE OFFICE OF
DIETARY SUPPLEMENTS AT NIH WHICH
OBVIOUSLY IS SPONSORING THIS
CONFERENCE.
THEY ARE NOT PAYING ME TO SAY
THAT.
I JUST LIKE WHAT THEY DO AND HOW
THEY LOOK AT IT.
AND THEN I GO TO THE NATIONAL
ACADEMIES OF SCIENCE,
ENGINEERING, AND MEDICINE WHICH
AS MANY OF YOU KNOW ESTABLISHES
THE DIETARY REFERENCE INTAKES
AND THINGS IMPORTANT IN MEDICINE
AND NUTRITION, FOOD, WHERE I
LOOK FOR NEW SOURCES AND NEW
REPORTS, NEW INFORMATION.
I EXPAND FURTHER GOING TO PLACES
LIKE THE FEDERAL TRADE
COMMISSION, AMERICAN SOCIETY FOR
NUTRITION, LINUS PAULING
INSTITUTE, U.S. PHARMACOPEIA AND
USE CONSUMERLAB AND TOD DOESN'T
PAY ME TO SAY THIS, I SUBSCRIBE
ON MY OWN, BUT I'VE BEEN A FAN
OF THIS ORGANIZATION SINCE IT
BEGAN AROUND -- I GUESS NOW 22
YEARS AGO OR SO.
I THINK THEY DO A GOOD JOB AND
A PLACE I CROSS-REFERENCE.
AS I TALK TO EXPERTS AND DO
INTERVIEWS I KNOW I'VE COMPLETED
THE CIRCLE WHEN I ASK THE PEOPLE
THAT I'M INTERVIEWING WHO ELSE
SHOULD I TALK TO, WHAT ELSE
SHOULD I KNOW AND READ, AND WHEN
I HEAR THEY OFFER THE PEOPLE OR
PLACES OR PAPERS OR WHATEVER
THAT I'VE ALREADY TAPPED, THE
TRADE ASSOCIATIONS, INCLUDING
COUNCIL FOR RESPONSIBLE
NUTRITION, ET CETERA, THEN I
KNOW I'VE COMPLETED THE CIRCLE
AND PROBABLY HAVE TAKEN AS MUCH
OF THE LANDSCAPE AS I CAN, AND
THEN IT'S ON TO WRITING.
A BRIEFCASE STUDY HOW THIS CAN
WORK.
I'M ONE OF THOSE PEOPLE WHO HAS
KNEE PROBLEMS AND I DISCOVERED
THIS GUY RICHARD BEDARD,
BLOOMBERG EDITOR, BLEW OUT HIS
KNEES ON HONG KONG ON MOUNTAIN
BIKE, LEADING ME TO DOUG KELSEY,
PHYSICAL THERAPIST IN AUSTIN.
AND HAS DEVELOPED IN THIS -- -
THIS IS BASED IN SCIENTIFIC
FACT, PROMOTES A WAY TO HELP
ACTUALLY REBUILD CARTILAGE IN
KNEES, IT'S NOT AS PRISTINE AS
WHAT WE'RE BORN WITH BUT IT DOES
HELP.
HE HAS A LOT OF DIETARY
SUPPLEMENTS THAT HE RECOMMENDS
IN THIS BOOK, SO I LOOKED AT IT
VERY SKEPTICICALLY BECAUSE I
WANTED TO KNOW SCIENCE BEHIND
IT.
I MADE SURE HE HAD NO FINANCIAL
INTEREST IN THE DIETARY
SUPPLEMENTS THAT HE WAS
ADVOCATING AND HE CERTAINLY
DIDN'T.
NO FINANCIAL INTEREST IN
EXERCISE EQUIPMENT HE
RECOMMENDED.
HE HAS A VARIABLE TRAINER HE
RECOMMENDS, AGAIN HE HAS NO
FINANCIAL INTEREST IN BUT ALLOWS
YOU TO STRESS YOUR KNEES AT
DIFFERENT LEVELS THAT WILL BE
APPROPRIATE FOR YOUR INJURY OR
PROBLEM IS.
FOR EACH SECTION, PARTICULARLY
DIETARY SUPPLEMENTS, I EXAMINED
THE SCIENTIFIC LITERATURE,
CHECKED ODS DATABASE,
CROSS-REFERENCED ALL OF THAT
WITH CONSUMERLAB, IT WAS ALL
VERY MUCH ON CAR GET, ONE OR TWO
THINGS I WASN'T COMPLETELY
CONVINCED BUT FOR THE MOST PART
THAT TRUST BUT VERIFY APPROACH
THAT WE'VE HEARD THROUGH THE
YEARS.
AND I JUST WANTED TO GIVE A
SENSE OF WHAT I LOOK FOR WHEN
I'M COVERING A TOPIC OR TRYING
TO WRITE A STORY THAT I HOPE
WILL GIVE AS MUCH TRUTH AS IS
POSSIBLE.
WHAT CAN YOU DO?
THIS IS WHERE I THINK IT'S
REALLY IMPORTANT FOR SCIENTISTS
AND MEDICAL PROFESSIONALS TO BE
PART OF THE CONVERSATION,
ESPECIALLY ONLINE.
WE HAVE SO MANY -- SO MUCH BAD
INFORMATION ONLINE IT'S CRITICAL
FOR THOSE EXPERIENCED AND HAVE
EXPERTISE TO SHARE AND ARE WELL
EDUCATED TO SHARE THAT
INFORMATION AS MUCH AS POSSIBLE.
BECAUSE OTHERWISE IF YOU DON'T
CARE IT, THERE'S A VACUUM AND IT
ALLOWS FOR OTHER PEOPLE WHO
DON'T NECESSARILY ALWAYS HAVE
THIS GOOD INFORMATION, GOOD
QUALITY INFORMATION, TO COME TO
THE TABLE AND SHARE THEIR PER
-- EXPERTISE WHICH MAY NOT BE
ACCURATE.
I WANT TO HIGHLIGHT THE
CONVERSATION, OUT OF BOSTON,
IT'S A NON-PROFIT.
YOU HAVE TO BE APPROVED TO BE
PART OF IT.
IF YOU'RE AN ACADEMIC, YOU CAN
GET APPROVED, PITCH STORIES, GET
PICKED UP BY NEWSPAPERS ALL OVER
THE WORLD, CIRCULATION OF 2 TO 3
MILLION, YOU DON'T GET PAID BUT
IT'S A GREAT WAY TO HAVE YOUR
INFORMATION AND EXPERTISE
SPREAD.
SAME THING TRUE OF MEDIUM, IT'S
A PLACE TO WRITE ARTICLES AND
GET SOME REALLY QUALITY
INFORMATION OUT.
I REALIZE THIS IS NOT AN EASY
THING TO DO.
I'M A MEMBER OF NATIONAL
ASSOCIATION OF SCIENCE WRITERS.
HALF REPORTED LOSING INTEREST IN
COMMUNICATING WITH THE MEDIA
ABOUT SCIENCE, AND I THINK
THAT'S A REAL SHAME.
THE REASON YOU COULD PROBABLY
IMAGINE.
THEY GET INUNDATED SOMETIMES
WITH PEOPLE WHO ARE NOT NICE TO
THEM ONLINE SO THAT'S A PROBLEM.
AND SO SOME SCIENTISTS DON'T
WANT TO RAISE THEIR HEAD BUT
IT'S IMPORTANT THAT WE STAY IN
THE CONVERSATION.
THE REASON IS THAT THIS IS A PEW
FOUNDATION -- THE PEW FOUNDATION
DOES A WONDERFUL SURVEY OF
MEDIA, PEOPLE WHO ARE CONSIDERED
AS TRUSTED SPOKESPEOPLE, AND
WHAT PUBLIC CONFIDENCE THERE IS
IN VARIOUS GROUPS LIKE THE
MILITARY, POLICE OFFICERS,
PUBLIC SCHOOL PRINCIPALS, YOU
GET THE IDEA.
YOU WILL SEE MEDICAL SCIENTISTS
AND SCIENTISTS WHO HAVE BEEN
AMONG THE MOST TRUSTED PEOPLE
THAT THE PUBLIC TURNS TO,
EXPERTS THE PUBLIC TURNS TO, YOU
SEE THAT THERE IS A SHARP
DECLINE IN HOW MUCH THE PUBLIC
TRUSTS SCIENTISTS AND WE'VE SEEN
THIS PLAY OUT DURING THE COVID
PANDEMIC.
WHICH IS REALLY UNFORTUNATE.
UNLESS WE GET IN THERE AND HAVE
MORE SCIENTISTS TALKING AND
EXPLAINING, WE'RE GOING TO -- WE
RUN THE RISK OF SEEING THIS
DECLINE CONTINUE WHICH WOULD BE
TERRIBLE.
I THOUGHT IT WOULD BE
INTERESTING TO KNOW WHO SOME OF
THE TOP 50 SCIENCE STARS OF
TWITTER ARE, FROM SCIENCE
MAGAZINE.
I LAUGHED, I'M NOT REALLY
FAMILIAR WITH THE KARDASHIAN
INDEX BUT I KNOW TO WHOM THAT
REFERS, THAT SCIENCE THEN
COMPILED A LIST OF THE MOST
FOLLOWED SCIENTISTS ON THE
SOCIAL MEDIA PLATFORM OF
TWITTER, AND YOU CAN SEE NEIL
DEGRASSE TYSON, 2.4 MILLION,
RICHARD DAWKINS A MILLION
FOLLOWERS, POSSIBLE FOR GOOD
SCIENTISTS WITH STRONG
FOLLOWINGS, WE NEED THESE VOICES
OF REASON AND SCIENCE OUT THERE
AND I HOPE MAYBE YOU WOULD
CONSIDER DOING THAT AS WELL.
IF YOU DO, I'LL LEAVE YOU WITH A
FEW TIPS HOW YOU COULD BUILD
YOUR OWN FOLLOWING.
I REALIZE THAT YOU PROBABLY HAVE
A LOT TO DO, TIME IS OF THE --
NO ONE HAS A LOT OF EXTRA TIME
BUT THERE ARE, IF YOU START WITH
ONE DIGITAL PLATFORM, AND START
POSTING ON IT, REGULARLY, AND
LINKED IN IS A WONDERFUL
PLATFORM IN TERMS OF BEING
PROFESSIONAL, I SEE A LOT OF
SCIENTISTS ON IT.
IT'S A GREAT PLACE TO BE.
TWITTER IS ANOTHER ONE,
INSTAGRAM, AND FOR THOSE WHO
AREN'T FAMILIAR WITH IT, TIKTOK
IS REALLY STARTING TO GROW SO IF
YOU LIKE DOING VIDEO, THAT'S A
PLACE TO DIP YOUR TOE INTO THE
DIGITAL WORLD.
IF YOU'RE WORRIED ABOUT TIME, I
WANT TO OFFER SOME TOOLS THAT
YOU CAN HELP DO SPECIAL POSTING.
HOOT SUITE, SPRINKLER, LOOMLY,
TWEETBOT ARE OTHER OPTIONS, A
MONTHLY FEE WITH FREE TRIALS,
SET UP WHATEVER YOU WANT TO
WRITE AND HAVE IT DONE AT A
PARTICULAR TIME AND THEN
SCHEDULED TO GO OUT SO THAT YOU
DON'T HAVE TO SPEND A LOT OF
TIME FIGURING OUT WHEN YOU'RE
GOING TO POST, ET CETERA.
AND THEN IT'S IMPORTANT TO POST
CONSISTENTLY, WHETHER OR NOT
THAT'S ONCE A WEEK OR ONCE A DAY
OR ONCE A MONTH, WHATEVER YOU
WANT TO DO, AND TO LIKE AND
CREDIT OTHERS, BUT I URGE YOU TO
DO SO CAUTIOUSLY SINCE WE HAVE
FOUND SOMETIMES THAT PEOPLE HAVE
AGENDAS OR FOLLOWERS OR THINGS
THAT YOU JUST WANT TO BE CAREFUL
WHAT YOU'RE DOING.
AND THEN STICK WITH FACTS,
RATHER THAN OPINION, WHEN IN THE
EARLY DAYS OF MY JOURNALISM
CAREER JOURNALISTS WERE MUCH
MORE KIND OF LIMITED IN WHAT YOU
COULD SAY AND HOW COULD YOU DO
THINGS AND I THINK STICKING WITH
FACTS RATHER THAN OFFERING
OPINIONS ALWAYS KEPT PEOPLE IN A
GOOD PLACE.
OBVIOUSLY BE AUTHENTIC TO YOUR
OWN INTERESTS BECAUSE THAT'S
WHAT COMES THROUGH AND I THINK
PEOPLE ARE QUICK TO FIND PEOPLE
WHO ARE NOT AUTHENTIC.
IF YOU ARE TALKING ABOUT
SOMETHING THAT MEANS A LOT TO
YOU THAT'S IMPORTANT, AND THEN
LASTLY BE KIND WHICH CLEARLY WE
DON'T HAVE ENOUGH OF THAT
LATELY.
SO, I'M JUST GOING TO LEAVE YOU
WITH THIS THANK YOU, AND WHERE
YOU CAN FIND ME AND I AM
STARTING A NEW FREE WEEKLY
E-MAIL NEWSLETTER ABOUT
NUTRITION.
IF YOU WANT TO BE ADDED TO THE
FUTURE SUBSCRIPTION LIST HERE IS
THE PLACE TO E-MAIL ME.
THANK YOU VERY MUCH FOR THE
OPPORTUNITY TO BE WITH ALL OF
YOU TODAY AND I'LL BE STICKING
AROUND.
WITH THAT, I WILL -- GUIDE ME
THROUGH, I'LL STOP SHARING MY
SCREEN.
OF
>> FANTASTIC.
THANK YOU, SALLY.
WE'RE GOING TO MOVE INTO A PANEL
DISCUSSION THAT INCLUDES SALLY
SQUIRES, JENSEN JOSE AND TOD
COOPERMAN WITH A BREAK AND A
PANELIST OPPORTUNITY TO ENGAGE
WITH ONE ANOTHER AND WITH
QUESTIONS THAT MIGHT HAVE COME
UP.
I'D LIKE TO TAKE THE OPPORTUNITY
TO LOOK AT SOME OF THE QUESTIONS
THAT HAVE COME IN.
THE FIRST ONE THAT I SEE IS MOST
LIKELY FOR TOD, REGARDING
PRODUCTS YOU TESTED WITH RESULTS
SHOWING OUT OF SPEC WITH LABEL
CLAIMS, IS THERE A PERCENTAGE OF
THOSE RESULTS THAT YOU THINK IS
DUE TO MATRIX INTERFERENCE
AND/OR NOT USING APPLICABLE TEST
METHODS?
>> THOSE ARE GOOD QUESTIONS.
IF WE THINK THERE'S MATRIX
INTERFERENCE WE WOULDN'T FAIL ON
THAT BASIS BUT WOULD INDICATE ON
THE DECISION.
THAT WOULD HAPPEN FOR EXAMPLE
WITH ORANGE, YOU KNOW, CITRUS
AND FISH OIL INGREDIENTS YOU
CAN'T TEST FOR RANCIDITY
PROPERTIES.
IF WE SEE SOME WEIRD RESULTS OR
FIND SOMETHING DOESN'T PASS, WE
MUST SEND IT TO A SECOND
LABORATORY.
AND THIS IS BLINDED TO OF TO THE
LABORATORIES.
THEY DON'T KNOW WHAT WE FOUND
BEFORE AND DON'T KNOW THE NAME
OF THE PRODUCT.
WE WORK LARD TO MAKE SURE WHEN
WE PUBLISH A PROBLEM, WE FIND A
PROBLEM, WE'RE PRETTY SURE ABOUT
IT AND A COMPANY CAN ASK FOR
RESULTS FROM US AND WE'LL GIVE
IT TO THEM FOR FREE.
AND WE KEEP A RESERVE SAMPLE
UNOPENED, WHICH WE'RE HAPPY TO
SEND TO ANOTHER LABORATORY OF
MUTUAL AGREEMENT, IF THE COMPANY
IS WILLING TO PUBLISH THE
RESULTS OF THAT TEST.
MOST COMPANIES ARE NOT.
>> OF COURSE IF ANYBODY ELSE
WANTS TO JUMP IN, EVEN THOUGH
I'M STRIKE TO DIRECT THE
QUESTIONS, WHERE I THINK THEY
NEED TO GO, DO JUMP IN, SALLY OR
JENSEN.
A QUESTION THAT COMES UP IN
MAYBE A DIFFERENT FORMAT, A
COUPLE PLACES.
PEOPLE ARE GENERALLY GLAD THE
CONSUMERLAB DOES THIS BUT
THERE'S SOME LIMITATIONS THAT
ARE POSSIBLE.
PRODUCTS THAT ARE NOT CHOSEN FOR
TESTING.
DO GET PAID BY SOME SUPPLEMENT
COMPANIES?
THIS WAS IN THE CONTEXT OF
SOMEBODY ASKING IS THERE A
SOURCE OF BIAS.
>> RIGHT.
SURE.
I RESPONDED WITH A LINK AS WELL.
BUT 85% OF REVENUE IS FROM
MEMBERSHIP FROM 95,000
SUBSCRIBERS, 15 BY COMPANIES TWO
SUBSCRIBE IN THE PROGRAM,
THERE'S NO MEMBERSHIP FOR A
COMPANY BUT WHEN WE TEST
PRODUCTS ANY COMPANY IS WELCOME
TO HAVE US TEST THEIR PRODUCT AS
WELL.
WE DO IT BECAUSE IT HELPED US
HOPEFULLY FIND MORE GOOD
PRODUCTS THAT WE CAN SHOW
CONSUMERS.
WE HAVE TO BUY THOSE PRODUCTS ON
THE MARKET.
A COMPANY CAN'T SEND IT TO US.
THEY HAVE NO CONTROL OVER OUR
TESTING.
THEY KNOW OUR METHODS, IT'S ON
THE WEBSITE.
IF IT PASSES WE WILL ALLOW THEM
TO USE OUR SEAL, IT WILL BE IN
THE REPORT.
IF IT DOESN'T PASS, THAT'S THEIR
INFORMATION, HOPEFULLY THEY WILL
GO BACK AND FIX SOMETHING, OFTEN
THEY ARE NOT AWARE OF THE
PROBLEMS THAT WE IDENTIFY.
>> THANK YOU.
THERE'S ANOTHER QUESTION THAT
CAME UP.
I SEE THAT YOU ANSWERED IT IN
THE CHAT, TOD, BUT LET'S HAVE
THIS OUT FOR DISCUSSION.
IS THE ISSUE REALLY A MATTER
MATTER OF A FEW BADS ACTORS IF
ONLY 1 IS 5 IS NOT PASSING, AND
YOUR ANSWER WAS, I WANT TO BE
SURE EVERYBODY HEARS IT.
>> YEAH, THE 1 OUT OF 5 IS
PROBABLY A BEST CASE SCENARIO,
FRANKLY, BECAUSE WE'RE LOOKING
AT PRODUCT QUALITY.
AND AS I SAID BEFORE, WE'RE NOT
LOOKING FOR PROBLEMS.
SO, THE 20% OF PROBLEMS WE FIND
IT'S NOT LIKE WE HAD TO GO FAR
TO FIND PROBLEMS.
ONE SUPPLEMENT COMPANY, NOW,
N-O-W, IS TESTING PRODUCTS ON
AMAZON, INTERESTING, I THINK
THEY ARE DOING GOOD TESTING
BECAUSE I GUESS THEIR UP AGAINST
ALL THESE PRODUCTS OUT THERE,
THEIR OWN PRODUCTS, VERSUS THESE
ONES ON AMAZON, THEY ARE FINDING
TREMENDOUS AMOUNTS OF PROBLEMS,
VERY CONSISTENT WITH PROBLEMS
THAT WE'VE SEEN BUT WE DON'T SEE
THEM AS OFTEN BECAUSE WE'RE
TYPICALLY LOOKING AT BRANDS OUR
MEMBERS ARE USING AND TELLING US
ABOUT.
LIKE TEND TO BE THE MORE COMMON
BRANDS.
BUT THERE ARE SO MANY BRANDS OUT
THERE ON AMAZON NOW, THAT HAVE
NOT BEEN AROUND VERY LONG,
REALLY FLY BY NIGHT BRANDS, THE
REAL PROBLEM IS MUCH GREATER
THAN WE'RE REPORTING 1 OUT OF 5.
>> SALLY OR JENSEN, ANY
COMMENTS?
>> TOD COVERED IT.
THAT WAS GOOD.
I HAD NOT -- I HAD FORGOTTEN YOU
ARE 95,000 PRESCRIBERS, THAT'S
GREAT.
>> YOU'RE ONE OF THEM, THANKS.
>> THERE'S A QUESTION, I'M NOT
SURE QUITE WHAT THIS QUESTION
IS.
CHEMICAL TESTING WOULD EXPAND A
LOT OF MANUFACTURING COMPANIES.
I THINK I UNDERSTAND WHAT THIS
QUESTION IS.
MAYBE ONE OF YOU DO.
IT'S THE VER LASTUESTION.
>> CHEMICAL TESTING WOULD BE
EXPANDED A LOT OF MANUFACTURE
COMPANIES, I'M NOT 100% SURE I
UNDERSTAND.
ARE THEY ASKING THAT -- I CAN'T
TELL IF IT'S A PUBLIC RULE FOR
RESEARCH.
I'M NOT REALLY SURE.
>> YEAH, LET'S LEAVE QUESTION
OPEN UNTIL THAT PERSON PERHAPS
COMES BACK WITH CLARIFICATION.
FOLKS, IT'S 2:45, LET'S TAKE A
SHORT BREAK.
WE'LL COME BACK PROMPTLY AT 3:00
AND THE DISCUSSION WILL INCLUDE
ALL SIX PANELISTS, LOOK FORWARD
TO IT.
TAKE A BIT OF A BREAK.
LET'S REJOIN WITH SALLY SQUIRES,
BRIAN WOMMACK, JENSEN JOSE, TOD
COOPERMAN, IF YOU HAVE QUESTIONS
FOR YOUR COLLEAGUES ON THE
PANEL?
>> GOOD QUESTION.
>> MERLE, I'LL JUMP IN.
I WOULD ASK HOW EVERYONE IS
DOING.
HOPE YOU HAVE PLENTY OF WATER,
U.S. IS HAVING A HEAT WAVE,
STAYING HYDRATED IS A CHALLENGE.
>> YOU MIGHT THINK OF
OPPORTUNITIES TO ENGAGE AS
QUESTIONS COME UP.
ONE QUESTIONS LEFT OVER FROM
BEFORE, PROBABLY BEST FOR TOD TO
TRY TO ANSWER THIS AT LEAST TO
BEGIN WITH.
DO YOU OR ANYBODY TEST BRAND
PRODUCTS?
THEY PROBABLY CONTAIN MORE
TOXINS BECAUSE OF HERBICIDES,
SOLD AS FOOD IN THE UNITED
STATES, AND SUPPLEMENTS IN THE
U.S. AND IN OTHER COUNTRIES.
ANY COMMENTS OR ANYTHING ON
THAT, TOD?
>> SURE, YEAH.
BRAN, B-R-A-N?
>> YES.
>> WE ONCE TESTED A PROTEIN
POWDER, THAT WAS HEAVILY
CONTAMINATED WITH -- I FORGET
WHICH HEAVY METAL, BUT WE
BELIEVE IT WAS DUE TO BRAN.
WE'VE ALSO SEEN IT WITH RICE
BRAN.
BROWN RICE BRAN.
AND WE'VE ALSO TESTED OATS.
WE HAVE A WHOLE REVIEW OF OATS,
OATMEAL, ALL TYPES OF OAT
PRODUCTS, THERE WAS MORE HEAVY
METAL IN THOSE MORE LIKE HEAVILY
BRAN PRODUCTS, THE ANSWER IS
YES, ISSUES WITH BRAN.
>> OKAY, THANKS.
AND I'M SORRY, I'M NOT ABLE TO
UNDERSTAND A QUESTION THAT WAS
POSED.
I DIDN'T WANT YOU TO THINK I WAS
FORGETTING YOU.
I'M SORRY, I DON'T UNDERSTAND
THE QUESTION YOU'RE ASKING.
PERHAPS IT COULD BE SENT TO ODS
LATER ON AND THEY CAN TRY TO
HELP WORK THROUGH IT WITH YOU.
I HAVE A COUPLE QUESTIONS THAT I
WANTED TO -- SPECIFIC ONES, THEY
MIGHT ENGAGE EVERYBODY.
SALLY, YOU SHOWED THAT
PROVOCATIVE AND INTERESTING
SLIDE ABOUT DECLINE IN TRUST,
GENERALLY TRUSTED INDIVIDUALS.
AND YOU POINTED TO THE DECLINE
THAT WAS VERY LIKELY COVID
RELATED, BECAUSE IT WAS THAT
RECENT, MIGHT BE TRUE AND
UNRELATED BUT I DOUBT IT
ESPECIALLY WITH SCIENCE OF
SCIENCE AND MEDICAL SCIENCE.
WHAT I HAVE OBSERVED, IT'S A
LITTLE MORE SHAKING FOR ME,
BEING INVOLVED WITH THE AMERICAN
SOCIETY FOR NUTRITION, NUTRITION
SCIENTISTS, OF ALL SCIENTISTS,
TEND TO BE THE LEAST TRUSTED
THESE DAYS.
I DON'T KNOW THAT IT'S EXACTLY A
FUNCTION OF COVID.
DO YOU CARE TO COMMENT ON THAT?
AND OFFER ANY SOLUTIONS OR
THOUGHTS?
>> YEAH, YOU KNOW, THIS IS
SURPRISING TO ME.
I'M NOT SURE I HAVE A SOLUTION
BUT IT USED TO BE THAT WHEN IN
MY EARLY DAYS OF JOURNALISM, NOW
GOING BACK A WAYS, BUT WE USED
TO SAY, OKAY, WE'RE GOING TO --
DEAR READER, WE'RE GOING TO GIVE
BOTH SIDES OF THE STORY, TELL
YOU, YOU KNOW, THIS EXPERT SAYS
THIS, THIS EXPERT SAYS THAT.
AND WE'RE GOING TO LET YOU KIND
OF DECIDE FOR YOURSELF WHAT YOU
THINK IS GOING ON.
IT SEEMS AS THOUGH WE HAVE A
PUBLIC THAT IS -- SCIENCE
LITERACY SEEMS TO BE A VERY BIG
PROBLEM.
AND I THINK THAT, YOU KNOW, BAD
ON US FOR NOT BEING STRONGER ON
THAT BECAUSE I THINK THAT THAT
CONTRIBUTED, I'VE HAD TO BAT
DOWN A FEW GOOD FRIENDS WHO
SAID, OH, YOU KNOW, WE CAN'T
TAKE THIS COVID VACCINE BECAUSE
IT CAUSES THAT, AND THEN I WOULD
SEARCH THE LITERATURE AND WOULD
SHOW THEM, AND THEY WOULD GO,
OH, DIDN'T REALIZE THAT, BUT
THEY WERE GOING OFF FACEBOOK AND
OTHER SOCIAL MEDIA POSTINGS.
NUTRITION HAS BEEN A LITTLE BIT,
WITH A GRADUATE DEGREE IN
NUTRITION, NUTRITION HAS ALWAYS
BEEN VIEWED AS A LITTLE BIT OF A
STEP CHILD IN SOME OF THE
SCIENTIFIC WORLD AND I WONDER IF
BECAUSE EVERYONE EATS AND
EVERYONE COOKS AND EVERYONE
THINKS THAT THEY KIND OF KNOW
THIS, OR KNOW IT, IN
PARENTHESES, THEY FEEL LIKE THEY
ARE EXPERTS.
WHAT'S NOT TO KNOW ABOUT EATING
AND FOOD?
AND SO I WONDER IF THAT'S PART
OF WHY THERE IS SO MUCH
DISTRUST, BUT IT'S VERY
CONCERNING BECAUSE I THINK IT
COSTS, DURING THE COVID
PANDEMIC, OBVIOUSLY COST A LOT
OF LIVES.
AND FOR PEOPLE WHO JUST DID NOT
GET VACCINATED.
AND WE DON'T KNOW WHAT'S GOING
TO HAPPEN WITH MONKEYPOX, I
DON'T THINK IT'S GOING TO BE
ANYTHING LIKE COVID BUT AS WE
KNOW THERE'S GOING TO BE ANOTHER
PANDEMIC, THERE'S GOING TO BE
SOMETHING ELSE THAT'S GOING TO
HAPPEN.
THE FACT THAT PEOPLE ARE LOSING
TRUST IN SCIENCE IS SURPRISING
TO ME.
ONE OF THE THINGS WE USED TO DO
AT THE POST WAS EXPLAIN TO
PEOPLE THAT SCIENCE EVOLVES.
THINK BACK.
WE USED TO THINK THE WORLD WAS
FLAT, WE KNOW IT'S ROUND, WE'VE
BEEN IN SPACE.
BUT SOMEHOW PEOPLE GET CAUGHT UP
IN THESE IDEAS AND DOGMA AND
JUST DON'T SEEM TO WANT TO LET
GO.
I REALLY DON'T KNOW WHAT THE
ANSWER IS OTHER THAN INCREASING
THE CONVERSATION AND MAKING SURE
THAT THERE ARE PLENTY OF
CREDIBLE PLACES AND TRUSTED
VOICES.
WHAT THAT WILL BE FOR WHATEVER
POPULATION.
>> ANYBODY ON THE PANEL HAVE A
COMMENT ABOUT THIS?
TOD?
>> YEAH.
SO, YOU KNOW, IF WE DIDN'T HAVE
TRUST WE WOULDN'T HAVE 95,000
SUBSCRIBERS.
DURING COVID, WE HAVE BEEN
WRITING ALSO WHICH SUPPLEMENTS
MAY OR MAY NOT BE HELPFUL IN
COVID, AT ANY POINT INCLUDING
PREVENTION.
AND SO WE BEGAN TO GET ALL KINDS
OF INTERESTING RESPONSES TO
THAT.
AND THEN, YOU KNOW, IF PEOPLE
WRITE ABOUT IVERMECTIN, OTHER
THINGS AS WELL, AND CLEARLY
PEOPLE WHO TRUST US AND TRUST
OUR INFORMATION WOULD STILL SAY,
LIKE, WHY DON'T YOU STAY OUT OF
IT?
YOU KNOW, STICK TO YOUR
SUPPLEMENTS, YOU KNOW, BECAUSE
WE'RE TRYING TO HELP PEOPLE STAY
HEALTHY, YOU KNOW, AND TRYING TO
GIVE THEM INFORMATION THAT IS
HELPFUL BUT WHEN WE VENTURED
INTO AREAS RELATING TO COVID AND
THINGS LIKE THAT, IT WASN'T THAT
PEOPLE DIDN'T TRUST OUR
INFORMATION BUT THEY DIDN'T WANT
US GOING THERE.
THAT'S A MINORITY OF PEOPLE BUT
WE HAD NEVER SEEN THAT BEFORE.
>> ANY OTHER THOUGHTS FROM
FOLKS?
>> IN TERMS OF NUTRITION SCIENCE
I WOULD GO BEYOND DIETARY
SUPPLEMENTS.
AND IF YOU LOOK AT FOOD
COMPANIES AND HOW THEY MARKET
HEALTH CLAIMS OR LIKE HEALTHY
EATING, YOU KNOW, YOU HAVE THE
LOW FAT CRAZE IN THE '90s
WHERE ADDED INSANE AMOUNTS OF
SALT TO FOOD.
TRYING TO MARKET UNHEALTHY FOOD
AS HEALTHY.
AND THEN PEOPLE ARE CHOOSING
PRODUCTS BASED ON, YOU KNOW,
WHAT'S MARKETS WITH SCIENCE AND
THEY ARE NOT GETTING HEALTHIER,
NOT GETTING -- NOT SAFER.
AND THEN SO WHEN WE TRY TO SAY
SOMETHING IT'S ALL NOISE AND
CONSUMERS DON'T UNDERSTAND WHAT
TO CHOOSE.
WHEN YOU GET A MESSAGE, TAKE
THIS PILL, TAKE THIS POWDER, IT
WILL PROTECT YOU FROM COVID OR
HELP YOU LOSE WEIGHT OR DO X, Y,
AND Z, A SIMPLE MESSAGE, EASY TO
UNDERSTAND, WHEN YOU GET BRAND
AMBASSADORS ON FACEBOOK, PEOPLE
THAT YOU TRUST, YOU KNOW,
SAYING -- PARROTING THESE
THINGS, IT'S HARD FOR SCIENTISTS
TO SPEAK THROUGH THE NOISE AND
CONSUMERS DON'T UNDERSTAND
WHAT'S COMING FROM SCIENTISTS
AND WHAT'S JUST COMING FROM
NOISE.
>> WELL, THANK YOU.
YES, SALLY?
>> IF I MAY, I THINK THE OTHER
THING THAT HAS BEEN DIFFICULT
AND I'D SAY THIS HAVING COVERED
DIETARY GUIDELINES FOR 25 YEARS,
THAT SIMPLE MESSAGES ABOUT WHAT
TO EAT, WHAT NOT TO EAT, IF YOU
LOOK AT DIETARY GUIDELINES, THE
ACTUAL MESSAGE, I'M PREACHING TO
THE CHOIR HERE, ACTUAL MESSAGES
HAVE CHANGED VERY LITTLE, BUT WE
STILL DON'T HAVE SIMPLE MESSAGES
THAT PEOPLE COULD JUST SAY, OH,
I SHSHOULD DO THIS OR THAT.
WE'VE ARE FIVE A DAY, NINE A
DAY, FRUITS AND VEGETABLES,
PEOPLE NEED SIMPLE MESSAGES THAT
WILL RESONATE, THEY WANT
SOMETHING SIMPLE, SCIENTISTS
HAVE NOT ALWAYS DONE A GREAT
JOB, EVEN WITH COVID, BOTTOM
LINE, IT'S BEEN CONFUSING.
>> I APPRECIATE SALLY'S TALK HOW
THINGS EVOLVED, IN THE PRESS
OVER THE YEARS.
AND I THINK IT'S IMPORTANT TO
RECOGNIZE HERE, SCIENCE OF
COURSE IS IMPORTANT, BUT
SCIENTISTS MAKE PROGRESS BY
USING SCIENTIFIC METHOD, WHICH
IS A WAY OF CHECKING CONCLUSIONS
AGAINST WHAT HAPPENS IN NATURE.
THEY DEVELOP HYPOTHESES,
PUBLICATION OF A SINGLE STUDY
ISN'T NECESSARILY -- DOESN'T
NECESSARILY MEAN SOMETHING IS
TRUE, RIGHT?
YOU GO ON, AND WHEN THERE'S
ENOUGH EVIDENCE THAT
ACCUMULATES, IN REGARDS TO
PHENOMENON, YOU HAVE A THEORY
AND PEOPLE WILL DO DIFFERENT
TESTS TO EVALUATE THAT THEORY.
AND THEN IT DEVELOPS OVER A
TIME.
AND IT'S IMPORTANT TO USE A
WEIGHT OF EVIDENCE APPROACH LIKE
WHAT SALLY DESCRIBED, IN HOW SHE
LOOKS AT THE DIFFERENT -- WHAT'S
IN PubMed OR DIFFERENT
DATABASES, THINGS LIKE THAT.
THAT'S IMPORTANT TO CONSIDER.
WE DON'T WANT TO JUST -- IT IS
IMPORTANT FOR SIMPLE MESSAGING
BUT ALSO IMPORTANT FOR CONSUMERS
TO BE SMART SHOPPERS, WHETHER IT
COMES TO WHAT FOODS THEY EAT OR
WHAT DIETARY SUPPLEMENTS THEY
TAKE.
AND THINGS LIKE THAT.
THERE IS A RESPONSIBILITY THERE,
ON THE MANUFACTURER BUT ALSO
CONSUMERS TO KNOW WHAT THEY ARE
PURCHASING AND TALK TO THEIR
DOCTOR ABOUT THINGS LIKE THAT.
>> GOOD.
THANK YOU.
I APPRECIATE THE DISCUSSION.
I HAVE ANOTHER QUESTION AIMED AT
THE THREE REPRESENTATIVES OF THE
TRADE ASSOCIATIONS.
ONE OR TWO OF YOU MENTIONED THE
UPCOMING OR THE PROPOSED
LEGISLATION FROM DURBIN ET AL.
IN THE SENATE ON MANDATORY
PRODUCT LISTING, AND I KNOW THAT
THE TRADES ARE NOT ALL SINGING
OFF THE SAME SHEET, ON THIS.
AND I'D LIKE TO UNDERSTAND, SO,
WHAT THE ISSUES ARE AND WHY
DIFFERENT TRADE ORGANIZATIONS
WHO REPRESENT OVERLAPPING
COMPONENTS OF THE DIETARY
SUPPLEMENT INDUSTRY ARE SEEING
THIS IN SUCH DIFFERENT WAYS.
DOES SOMEBODY WANT TO START WITH
WHAT THE -- WHAT'S THE ISSUE
HERE AND WHY IS THERE A
DISCREPANCY OF OPINION AMONG
PEOPLE WHO YOU WOULD THINK WOULD
BE ON THE SAME PAGE ABOUT THIS?
>> I'LL BE HAPPY TO JUMP IN
FIRST IF YOU'D LIKE.
>> OKAY, GO AHEAD.
>> SO, THINK IT MAY BE AS WE'RE
ALL IN THE SAME MARKET AND DO
HAVE ASPECTINGS IN COMMON WITH
EACH OTHER, EACH IS FOCUSED ON
SLIGHTLY DIFFERENT PRODUCT AREAS
AND SLIGHTLY DIFFERENT SORT OF
SEGMENTS OF THE UNITED STATES
MARKET AS WELL.
SO, I KNOW I SAT IN MEETINGS
WITH AHPA, SMALL BUSINESSES CAN
ACHIEVE REGULATORY
RESPONSIBILITIES FOR SIMPLE
HERBAL PRODUCTS, LIKE TEA BAGS,
FOR EXAMPLE.
BUT AS THERE ARE ADDITIONAL
REQUIREMENTS FOR THEM, IF THAT
MARKETPLACE ISN'T CONSIDERED AS
A REGULATION IS BEING WRITTEN,
IT CAN REALLY CAUSE A LOT OF
SORT OF -- AS A SMALL BUSINESS
PERSON YOU NEED YOUR GOVERNMENT
TO SUPPORT YOU, WITH MANDATORY
PRODUCT LABELING, FOR EXAMPLE,
FOR TRADITIONAL PLANT PRODUCTS,
LISTING, I'M SORRY, IT'S KIND OF
A LITTLE DID IT REFERENCE
T HAN -- DIFFERENT THAN ESOTERIC
EXTRACTS OR SOME SECTORS IN A
MIGHT BE MORE COMMON IN OTHER
AREAS I THINK.
>> THAT WE PRESIDENT-ELECTS
OPPOSITION ON OPPOSING THE
MANDATORY PRODUCT LISTING.
>> I THINK POSITION IS THERE
NEEDS TO BE A GOOD LAW THAT
HELPS THE GENERAL PUBLIC WITH
OUR MISSION OF MAKING SURE
CONSUMER HAS ACCESS TO SAFE HIGH
QUALITY PRODUCTS.
IF SOME ARE PUSHED OUT OF THE
MARKET BY REGULATIONS THAT MAKE
IT IMPOSSIBLE FOR BUSINESSES TO
OPERATE THAT'S SOMETHING THAT
HAS COME UP IN MEETINGS WE WANT
TO MAKE SURE ISN'T FORGOTTEN IN
THE GENERAL CONVERSATION.
>> FOLLOWING ON THAT, WHY WOULD
IT BE A BURDEN TO PROVIDE THE
PRODUCT LABELS?
A LOT OF COMPANIES AS BRIAN
POINTED OUT WITH OWL AND THAT
ODS KNOWS WITH ITS DIETARY
SUPPLEMENT LABEL DATABASE, A LOT
OF PEOPLE, A LOT OF COMPANIES
HAVE BEEN WILLING TO VOLUNTEER
THEIR LABELS.
I'M NOT QUITE SURE WHAT THE
CHALLENGE WOULD BE FOR SMALL
COMPANY.
>> A SMALL COMPANY HAS TWO
EMPLOYEES, AND RIGHT NOW ONE OF
THE EMPLOYEES GOES TO THE FOREST
AND GATHERS GINSENG ROOTS AND
THE OTHER FILLS OUT PAPERWORK
FOR FISH AND WILDLIFE SERVICE TO
MAKE SURE THOSE ARE RECORDED
CORRECTLY.
IF THEY HAVE TO SUBMIT EXTRA
FORMS TO FDA AND AGENCY IS
UNABLE TO PROVIDE THEM WITH HELP
OR SUPPORT OR CHARGES FEES, THAT
SEGMENT OF THE MARKET IS
AFFECTED MORE THAN BUSINESSES
WHICH MIGHT HAVE TENS OR
HUNDREDS OF PEOPLE WORKING THERE
WHO WOULD BE ABLE TO ADD A
SMALL-LOOKING REQUIREMENT TO
SUBMIT LABELS, BUT WHO HAVE A
LITTLE MORE WIGGLE ROOM AS FAR
AS CHANGING AROUND THINGS THAT
THE GENERAL PUBLIC HAVE TO WORK
WITH, AS A VERY SMALL BUSINESS.
THIS IS ONE SMALL SEGMENT AREA.
TRIED TO FOCUS ON HOW CAN WE
MOVE AND ACT TO BEST IMPROVE OUR
SYSTEMS.
THERE WERE A LOT OF DIFFERENT
SUGGESTIONS INCLUDING PRODUCT
LABELING, DATABASES, THAT WE
MENTIONED.
THAT MIGHT BE A NICE PANEL
DISCUSSION ON ITS OWN.
>> BRIAN?
>> SO I DON'T DISAGREE WITH
MERLE WE DON'T WANT TO BURDEN
SMALL BUSINESSES AND I WOULDN'T
DISAGREE WITH THAT.
HOWEVER, THIS IS SOMETHING
REGULATOR IS ASKING FOR THAT IT
DOESN'T SEEM UNREASONABLE TO
PROVIDE.
AND IT SEEMS LIKE IT WILL
PROVIDE A LOT OF ADDITIONAL
TRANSPARENCY TO THE MARKET.
I THINK THE SUCCESS OF THE OWL
HAS TO SOME EXTENT SHOWN THIS
CAN WORK, AND THERE WERE FOLKS
INITIALLY WHO WERE CONCERNED THE
OWL WOULD BE TOO BURDENSOME, AND
WE WORK WITH THEM TO MAKE IT NOT
BE SO BURDENSOME.
WE'VE GOT SMALLER MEMBERS, IF WE
HAVE TO PUT OUR LABELS IN THERE
THAT'S GROWING TO CREATE THIS
BURDEN.
PART OF THE IMPROVEMENTS TO THE
OWL I MENTIONED WERE ABOUT
MAKING IT EASIER TO GET LABELS
IN.
IN OUR DISCUSSIONS WITH FDA WE
PUT THAT FORWARD AS, ALL RIGHT,
AS YOU DO THIS, IF YOU GET THIS
AUTHORITY, YOU NEED TO MAKE SURE
IT'S NOT A BURDEN.
BENEFIT NEEDS TO BE MUCH GREATER
THAN THE BURDEN.
SO, I THINK OWL IS SOMETHING OF
A TEMPLATE TO SHOW THIS CAN WORK
AND IN A WAY THAT'S NOT OVERLY
BURDEN SOME BUT TWO-PERSON
COMPANY MAY BE A SITUATION IT IS
TOO BURDEN SOME.
I FEEL FOR THOSE FOLKS BUT I DO
THINK THE OVERALL LEVEL OF
TRANSPARENCY TO THE INDUSTRY IS
SOMETHING THAT WILL HELP ALL OF
US, I THINK IT WILL HELP THE FDA
DO ITS JOB BETTER.
THERE ARE OTHER TRADE
ASSOCIATIONS NOT REPRESENTED
HERE WHO ARE DEAD SET AGAINST
IT, CALLING IT PRE-MARKET
APPROVAL AND THINK IT GOES
AGAINST DSHEA.
I HAVE A HARD TIME SEEING HOW
SUBMITTING A LABEL IS PRE-MARKET
APPROVAL IF REGULATOR IS OBLIGED
TO ACCEPT THE LABEL AS IT'S
GIVEN.
BUT THAT'S MORE CROSS-TALK WE'RE
HAVING WITH THE INDUSTRY.
>> AND, JAY, YOU DON'T HAVE
BOTANICAL DIETARY SUPPLEMENT
MEMBERS, I DON'T THINK.
>> WE DO?
>> YOU DO?
>> WE DO.
>> YOU DON'T HAVE AN OWL
DATABASE.
I WAS JUST THINKING YOU MIGHT
HAVE A DIFFERENT PERSPECTIVE ON
THIS.
>> YEAH, AND I ALLUDED TO IT IN
MY TALK THAT WE DO SUPPORT THE
MANDATORY PRODUCT LISTING THAT'S
IN THE LEGISLATION, BUT WE THINK
IT SHOULD BE TAKEN EVEN FURTHER
AND THERE SHOULD BE A PROVISION
IN THERE FOR FDA TO AUTHORIZE
THIRD PARTIES TO DO INSPECTIONS,
WHICH WOULD ALLOW A MUCH GREATER
AMOUNT OF COMPANIES TO BE
INSPECTED EVERY YEAR.
I THINK I MENTIONED IT'S
SOMETHING AROUND 5% OF COMPANIES
THAT ARE INSPECTED IN A GIVEN
YEAR.
AND WE JUST FEEL -- OUR MEMBERS
FEEL THAT THERE'S NO TEETH TO
THE LISTING, YOU KNOW, IF
THERE'S NO SORT OF ENFORCEMENT
BEHIND IT, SOME PENALTY FOR
PUTTING OUT A PRODUCT ON THE
LIST, OR SENDING IN A LABEL,
THAT MIGHT NOT ACCURATELY
REFLECT WHAT'S ACTUALLY IN
THERE.
AND IT'S NOT GOING TO WORK.
SO, WE WOULD LOVE TO SEE THE
MANDATORY PRODUCT LISTING
ENACTED BUT WE ALSO WOULD LIKE
TO SEE THIS AUTHORIZATION OF
THIRD PARTY GMP INSPECTIONS.
WE THINK IT WOULD INCREASE
ABILITY TO ACT ON THE BAD ACTORS
THAT ARE OUT THERE.
>> THANK YOU.
BRIAN, A COMMENT CAME IN WHILE
URN TALKING FROM JOHANNA DWYER.
ISN'T IT TRUE MOST OF THE OWL
LABELS COME ACTUALLY FROM THE
ODS DIETARY SUPPLEMENT LABEL
DATABASE?
>> THEY COME FROM THERE?
>> YEAH.
>> I'M NOT AWARE OF ANY COMING
FROM THERE.
I THINK OUR MEMBERS PUT THEM IN,
INTO THE OWL.
THEY COME FROM COMPANIES.
I MEAN, ODS DATABASE I THINK
IT'S FANTASTIC BUT SERVES
DIFFERENT PURPOSES SEEMS TO ME,
IT'S MORE OF -- I MEAN IT'S A
HISTORICAL LOOK BACK AS WELL AS
WHAT'S ON THE MARKET NOW, NOT A
COMPLETE LOOK AT WHAT'S ON THE
MARKET NOW, SO THERE HAVE BEEN
SOME THAT SAY THERE ARE OTHER
DATABASES, WHY DO WE NEED ONE
MORE?
EACH OF THE OTHER ONES PERFORMS
SOMEWHAT OF A DIFFERENT PURPOSE
TO SOME EXTENT.
THE FACT THEY ARE ASKING THEY
DON'T THINK THE ONES OUT THERE
ARE SUFFICIENT.
>> OR THE WAY THEY ARE
INSTRUCTED DOES NOT MEET THEIR
PURPOSES.
>> RIGHT, RIGHT.
>> THANK YOU.
SALLY, THERE WAS -- I DON'T KNOW
YOU READ --
>> I SAW THAT, YES.
SOMEONE HAD --
>> TELL ME IF YOU DISAGREE.
>> SOMEONE SAID THAT THE -- THIS
IS FROM LORI, SHE SAID THAT IT'S
TRUE OVERALL THINGS HAVEN'T
CHANGED MUCH OVER THE YEARS WITH
DIETARY GUIDELINES BUT THE
MESSAGE IS SIMPLER WITH THE
PLATE.
I AGREE IT IS SIMPLER BUT I
LOOKED TO SEE THE USDA ECONOMIC
RESEARCH SERVICE REPORTED IN
2021 THAT STILL WHILE THE
MESSAGES MAY HAVE GOTTEN SIMPLER
90% OF AMERICANS FALL SHORT ON
EATING RIGHT AMOUNT OF
VEGETABLES DAILY, 80% DON'T EAT
ENOUGH FRUIT.
I WOULD CONTEND WE STILL --
MAYBE THE MESSAGE IS SIMPLER BUT
STILL NOT RESONATING, PEOPLE ARE
NOT DOING THE THINGS THEY OUGHT
TO BE DOING OR EATING WAIT THEY
COULD BE EATING TO BE MORE
HEALTHFUL.
>> WE'RE COMING TO THE END.
WE'VE GOT TIME TO DISCUSS MORE
BUT I WONDERED ONCE AGAIN ARE
THERE ANY QUESTIONS OR COMMENTS
THAT EACH OF YOU HAVE FOR THE
OTHER MEMBERS OF THE PANEL?
>> I'M INTERESTED TO SEE WHAT
EVERYONE THINKS, IF WE WERE TO
PROJECT FIVE YEARS FROM NOW,
WHERE DO WE THINK WE'RE GOING TO
BE WITH DIETARY SUPPLEMENTS AND
WITH, YOU KNOW, ALL THAT'S
HAPPENING, IF WE'RE LOOKING AT
THE FUTURE, WHAT DO WE THINK THE
COUNTRY IS GOING IN TERMS OF
THIS WITH AN AGING POPULATION
AND OBVIOUSLY INFLATIONARY
PRESSURES RIGHT NOW, BUT THE
POST-PANDEMIC, ET CETERA, WHERE
DO WE THINK WE'RE GOING TO BE?
>> BRIAN?
>> I'M GOING TO START.
I'M FOND OF SAYING WHEN I GET A
CHANCE TO TAKE A PODIUM THAT I
THINK WE'RE MOVING TOWARD A TIME
WHERE WE'RE NOT SO MUCH RELYING
ON SUPPLEMENTS TO FILL
SHORTFALLS BUT TO ACTUALLY KIND
OF HACK OUR HEALTH IN CERTAIN
WAYS, AS MORE STUDIES COMING
OUT, THIS MAY DO THIS OR THAT,
YOU KNOW, I DON'T THINK SOME OF
THOSE THINGS ARE UP TO THE LEVEL
OF PROOF THAT PERHAPS SOME
PEOPLE WANT.
I'M SURE THE OTHER THREE
MEMBERS, THE TRADE SIDE, BUT I
THINK THERE'S A LOT OF
OPPORTUNITY THERE TO OPTIMIZE
HEALTH.
IT'S NOT JUST ABOUT FULFILLING
DIETARY NEEDS, THERE'S SORT OF
THIS OTHER USE CASE THAT PEOPLE
ARE MORE ONTO.
PEOPLE STILL AREN'T MEETING
DAILY NUTRITIONAL NEEDS.
THERE'S A HUGE UNDERNOURISHMENT
PROBLEM TOO.
THE NUMBERS ARE GOING UP.
PEOPLE ARE TAKING MORE OF A ROLE
IN THEIR OWN SELF-CARE.
THEY ARE FINDING THESE PRODUCTS
TO BE USEFUL.
I KEEP THINKING THE SQUEEZE OUT
THE BAD ACTORS, WHY MANDATORY
LISTING IS IMPORTANT, WE KNOW
THERE'S SOME SKETCHY PRODUCTS
OUT THERE.
I HATE TO HAVE TO BE CALLED BY
SALLY, YOU AND YOUR PEERS,
YOU'RE TELLING ME THERE ARE BAD
PRODUCTS, YES, THERE ARE BAD
PRODUCTS, YOU NEED TO KNOW THERE
ARE BAD PRODUCTS AND I NEED TO
EDUCATE YOU HOW TO STAY AWAY
FROM THEM.
IT WOULD BE NICE IF WE DIDN'T
KEEP HAVING THAT CONVERSATION.
>> OTHER COMMENTS?
JANSSEN?
>> I WOULD SAY IN FIVE YEARS IT
DEPENDS ON HOW THE FDA AND FTC
TREAT SOCIAL MEDIA PLATFORMS,
WE'RE SEEING A LOT OF THESE
CLAIMS THAT AREN'T SUBSTANTIATED
OR DISEASE CLAIMS, ON FACEBOOK,
INSTAGRAM, WHATEVER THE NEXT BIG
PLATFORM WILL BE.
FTC RECENTLY SENT OUT A BUNCH OF
LETTERS TO DIETARY SUPPLEMENT
COMPANIES AND C.C.'ED SOCIAL
MEDIA COMPANIES.
AND NOT SURE, LITERALLY
EXPLAINED WHY, BUT IT WAS
INTERESTING TO SEE AND IT WILL
BE INTERESTING TO SEE IN THE
FUTURE HOW THESE COMPANIES CAN
BE HELD ACCOUNTABLE FOR THE
CLAIMS THAT ARE MADE ON THEIR
PLATFORMS.
>> I WOULD SAY JUST WITH THE
AGING POPULATION, I THINK THAT'S
DRIVING A LOT OF GROWTH IN THE
INDUSTRY.
COVID DROVE A LOT OF INTEREST IN
SUPPLEMENTS BUT ASIDE WE DO A
SURVEY EVERY YEAR AND WE ASK
PEOPLE HOW MANY SUPPLEMENTS THEY
ARE USING, WHAT THEY ARE USING,
ALL THAT STUFF, THEIR AGE.
AND 25% OF OUR READERS USE TEN
OR MORE SUPPLEMENTS DAILY.
AND OUR READERS TEND TO BE 45 TO
85 YEARS OLD.
SO, CLEARLY THE MARKET IS GOING
TO CONTINUE IN MY OPINION TO
GROW AS PEOPLE AGE.
I'VE BEEN DOING THIS FOR 23
YEARS.
WE'VE SEEN VERY LITTLE CHANGE
FROM REGULATORY PERSPECTIVE, IN
23 YEARS.
ALL THAT REALLY CAME OUT WERE
THE GMPs, PROMISED EARLIER.
SO I'M NOT SAYING IN THE
REGULATORY SIDE.
>> IF I COULD JUMP IN, YOU KNOW,
I THINK IT'S IMPORTANT TO POINT
OUT, YOU KNOW, WE'VE HEARD FROM
THE WATCHDOGS AS YOU CALL THEM,
AND WHEN I FIRST STARTED DOING
THESE I THOUGHT WE WERE GOING TO
BE AT ODDS, AND EVERYTHING WE
WERE GOING TO DISAGREE ON BUT I
DON'T THINK THAT'S THE CASE.
I THINK FOR A LOT OF THE THINGS
THAT THEY WERE TALKING ABOUT THE
RESPONSIBLE PLAYERS IN THE
INDUSTRY ARE WORKING TO TRY TO
ADDRESS SOME OF THOSE THINGS.
WHETHER IT'S GRASS PROCESS OR
ENSURING SAFETY OF SUPPLEMENTS,
THINGS LIKE THAT, THERE'S A LOT
OF GOOD TRIALS GOING ON WITH
SUPPLEMENTS.
WE'VE TALKED, I'M SURE YOU'VE
TALKED DURING THIS PRACTICUM OF
AMOUNT OF SUPPLEMENT USE, 80% I
THINK, BRIAN NOTED.
IT'S IMPORTANT WE ALL SHARE THE
FDA'S GOALS HERE OF SAFETY,
PRODUCT INTEGRITY, AND INFORMED
CONSUMER DECISION MAKING AND I
THINK, YOU KNOW, THE TRADE
ASSOCIATIONS ALL SHARE THOSE
GOALS WITH FDA AND WE NEED TO
KEEP WORKING ON THOSE AND I
THINK WE'RE GOING TO SEE
PROGRESS IN THE NEXT FIVE YEARS.
>> THANK .
WE'RE GOING TO CLOSE OUT AND I
WANTED TO MAKE A COUPLE CLOSING
REMARKS.
ONE FOR AUDIENCE PARTICIPANTS.
THIS SESSION HAS ALWAYS BEEN A
FEATURE OF THE DIETARY
SUPPLEMENT RESEARCH PRACTICUM,
AND IT'S NEVER INTENDED TO BE A
GOTCHA KIND OF SESSION.
AND IT ISN'T.
THE DISCUSSION TODAY DISPLAYS
THAT.
I'M INTERESTED IN YOUR FINAL
COMMENTS THERE, JAY.
PEOPLE ARE ALL TRYING TO DO THE
RIGHT THING.
THERE ARE DIFFERENT WAYS THAT
THEY HAVE AND DIFFERENT TOOLS
THAT THEY HAVE FOR BEING ABLE TO
WORK EFFECTIVELY IN THE DIETARY
SUPPLEMENT ARENA.
AND WHAT I'VE ALWAYS THOUGHT WAS
VALUABLE WAS FOR YOU, THE
AUDIENCE, TO SEE THIS
CONVERSATION AMONG PEOPLE WHO
REALLY WANT TO DO THE RIGHT
THING, AND HAVE IN SOME AREAS
SOMEWHAT VIGOROUS DISAGREEMENTS
BUT THIS CAN ALL BE HANDLED,
WHAT WAS IT YOU SAID, SALLY, AT
THE END OF YOUR SLIDE?
BE TRUE TO YOURSELF, ALSO BE
KIND.
I THINK THAT'S WHAT'S BEING
DISPLAYED WITH THIS KIND OF
DISCUSSION.
I'M GLAD I HAD THE CHANCE TO BE
WITH YOU AGAIN.
AND WISH YOU ALL WELL.
I'M NOW GOING TO TURN THIS BACK
OVER TO JAIME AND THE ODS STAFF
FOR CLOSING IT OUT.
THANK YOU VERY MUCH, FOLKS.
>> THANK YOU, DR. COATES.
THANK YOU TO ALL THE PANELISTS.
THAT WAS A GREAT, GREAT SESSION.
I'M JUST GOING TO CLOSE THIS OUT
SO I'M GOING TO DO A QUICK
LITTLE PRESENTATION.
ONE SECOND.
JAMES, DO YOU SEE MY SLIDES?
>> WE DO NOT YET SEE YOUR
SLIDES.
LOOKS LIKE IT'S STARTING UP NOW.
>> OKAY.
WONDERFUL.
EVERYTHING LOOK OKAY?
NO.
>> I SEE YOUR TITLE SLIDE.
>> DO YOU SEE A FULL SCREEN?
>> YES, I SEE A FULL SCREEN.
>> OKAY, GREAT.
ALL RIGHT.
SO, I JUST WANT TO THANK
EVERYONE FOR ATTENDING.
I HOPE THAT YOU FOUND THE
PRESENTATIONS INFORMATIVE.
AND THAT YOU'LL USE THE
INFORMATION GOING FORWARD IN
YOUR WORK.
THE FIRST DAY PROVIDED
INFORMATION ON DIETARY
SUPPLEMENT USE IN THE UNITED
STATES AND REALLY HIGHLIGHTED
THE HIGH USAGE OF THESE PRODUCTS
AMONG THE U.S. POPULATION.
FOR EXAMPLE, OVER HALF OF ALL
U.S. ADULTS TAKE AT LEAST ONE
DIETARY SUPPLEMENT.
70% OR MORE OF U.S. ADULTS OVER
60 ARE TAKING AT LEAST ONE
SUPPLEMENT.
THIS NUMBER IS HIGHER IN CERTAIN
SUBGROUPS LIKE CANCER SURVIVORS.
WE HEARD ABOUT WHY PEOPLE ARE
USING SUPPLEMENTS.
WE HAD GREAT PRESENTATIONS ON
DIETARY SUPPLEMENT REGULATION.
DAY 2 FOCUSED ON RESEARCH ON
DIETARY SUPPLEMENT AND REALLY
HIGHLIGHTED SOME OF THE ISSUES
THAT WE NEED TO CONSIDER WHEN
WE'RE STUDYING THEM.
AND THEN WE HAD SPECIAL
PRESENTATIONS, BOTH YESTERDAY
AND TODAY.
>> I'M ONLY SEEING THE MAIN
TITLE SLIDE.
I'M NOT SURE IF YOU'RE SHOWING
MULTIPLE SLIDES.
>> NO, THAT'S FINE.
>> OKAY, GREAT.
>> AND THEN LET'S SEE, WE HAD
THAT GREAT DISCUSSION FROM THE
STAKEHOLDERS THAT I THINK GAVE
US DIFFERENT PERSPECTIVES.
AND WITH THIS I WANT TO MENTION
THAT THIS ENTIRE PRACTICUM HAS
BEEN RECORDED.
LINKS WILL BE SEND TO ATTENDEES
TO REWATCH OR WATCH SESSIONS
THAT YOU MAY HAVE MISSED.
PLEASE FEEL FREE TO SHARE THE
LINKS WITH YOUR COLLEAGUES AND
ANYONE WHO YOU THINK WOULD BE
INTERESTED.
I MENTIONED IN MY INTRODUCTION
THAT OFFICE OF DIETARY
SUPPLEMENTS' MISSION IS TO
STRENGTHEN, WITH A MAIN GOAL TO
MAKE THE MOST UP-TO-DATE
SCIENTIFIC KNOWLEDGE ABOUT
DIETARY SUPPLEMENTS PUBLICLY
AVAILABLE.
PLEASE USE US AS A RESOURCE.
WHEN YOU HAVE A CHANCE, IF YOU
HAVEN'T ALREADY, TAKE A LOOK AT
OUR WEBSITE.
THERE ARE A LOT OF GREAT
RESOURCES AVAILABLE FROM THE
OVER 100 FACTSHEETS ON DIETARY
SUPPLEMENT INGREDIENTS AND TYPES
OF SUPPLEMENTS, AS WELL AS
DATABASE ON DIETARY SUPPLEMENTS,
DIETARY SUPPLEMENT LABEL
DATABASE WHICH NOW HAS OVER
140,000 PRODUCT LABELS.
CHECK OUT THE PROGRAMS AT ODS
AND FUNDING OPPORTUNITIES AND
SEMINARS, CONFERENCES AND
WORKSHOPS WE HOSTED AVAILABLE
FOR YOU TO VIEW.
ODS PUBLICATIONS WITH LINKS ARE
ALSO AVAILABLE ON OUR WEBSITE.
RESEARCH ON A HOST OF DIFFERENT
TOPICS RELATED TO DIETARY
SUPPLEMENTS, AND THESE MAY BE OF
GREAT INTEREST TO YOU.
PLEASE ALSO SIGN UP FOR OUR
LISTSERV.
YOU WILL RECEIVE NEWSLETTERS AND
OTHER ANNOUNCEMENTS FROM ODS AND
HERE IS THE BARCODE.CA
YOSCAN IT.
IT WILL TAKE YOU RIGHT TO THE
PLACE YOU CAN SIGN UP.
AND FINALLY I'D LIKE TO THANK
ALL OF OUR PRESENTERS,
MODERATORS, OF COURSE JAMES WHO
RAN THE WEBEX AND KEPT THIS
PRACTICUM RUNNING SMOOTHLY.
I THANK OUR ODS COMMUNICATIONS
TEAM FOR PROMOTING THE
PRACTICUM, SPECIAL THANKS TO
HELPING WITH LOW LOGISTICS AND
ACTING DIRECTOR JOE BETZ, AND TO
ATTENDEES AND FOR THOUGHTFUL
QUESTIONS.
WE HOPE YOU TAKE BACK KNOWLEDGE
YOU GAINED AND APPLY TO YOUR
WORK OR RESEARCH.
IF YOU HAVE ANY QUESTIONS,
PLEASE REACH OUT TO US.
E-MAIL IS RIGHT HERE.
WITH THAT, THIS CONCLUDES THE
2022 MARY FRANCES PICCIANO
DIETARY RESEARCH PRACTICUM.
THANK YOU.