I WOULD LIKE TO WELCOME EVERYONE
TO THE MARY FRANCIS PICCIANO
DIETARY SUPPLEMENT RESEARCH
PRACTICUM WHICH IS HOSTED BY THE
NATIONAL INSTITUTE OF OFFICE OF
DIETARY SUPPLEMENTS.
I'M JAMIE GAHCHE, I WORK AT THE
OFFICE OF DIETARY SUPPLEMENTS,
OR I WILL REFER TO IT AS ODS AND
I'M ALSO THE DIRECTOR OF THIS
PRACTICUM.
SO THIS INTENSIVE PRACTICUM WILL
PROVIDE A THOROUGH OVERVIEW
ABOUT DIETARY SUPPLEMENTS AND
SUPPLEMENT INGREDIENTS.
WE'RE GOING TO BE INCLUDING
PRESENTATIONS ON SUPPLEMENT USE
IN THE UNITED STATES, THE
MOTIVATIONS BEHIND WHY PEOPLE
ARE USING THEM, PRESENTATIONS ON
THE REGULATORY FRAMEWORK,
GOVERNING SUPPLEMENTS, SEVERAL
PRESENTATIONS ON THE IMPORTANCE
OF SCIENTIFIC INVESTIGATIONS TO
EVALUATE EFFICACY, SAFETY, THE
VALUE OF THESE PRODUCTS FOR
HEALTH PROMOTION AND DISEASE
PREVENTION AS WELL AS HOW TO
CARRY OUT THIS TYPE OF RESEARCH.
PLUS WE HAVE SEVERAL OTHER
PRESENTATIONS, WE WILL HEAR FROM
VARIOUS STAKEHOLDERS, THE
VARIOUS DIETARY INDUSTRY TRADE
GROUPS, CONSUMER ADVOCABULARYS
KACCTY, GROUP, THE MEDIA, THOSE
WHO STUDY, ADVOCATE OR EDUCATE
ABOUT DIETARY SUPPLEMENTS.
SO JUST TO START OFF, THE
DIETARY RESEARCH PRACTICUM IS
NAMED FOR MARY FRANCIS PICCIANO,
WHO WAS A SENIOR NUTRITION
SCIENTIST FROM THE ODS FROM WENT
TO THOUSAND 1-2010 AFTER A LONG
BATTLE WITH CANCER.
HER CONTRIBUTIONS TO NUTRITION
RESEARCH, TEACHING COMMUNITY
SERVICE AND NUTRITION POLICY DID
MUCH TO SHAPE THE FIELD OF
NUTRITION.
DR. PICCIANO, LED THE CREATION
AND DEVELOPMENT OF THIS
PRACTICUM WHICH WAS FIRST HELD
IN MAY, 2007.
HAS BEEN HELD EVERYWHERE WITH
THE ACCEPTION OF 2015 AND ALSO
IN 2020.
AND IT INITIALLY STARTED AS A 5
DAY ANNUAL COURSE PROVIDE
FUNDAMENTAL SCIENTIFIC KNOWLEDGE
OF DIETARY SUPPLEMENTS TO THOSE
IN ACADEMIA AND THEIR ADVANCED
STUDENTS.
HOWEVER, OWEVER THE YEARS, THE
PRACTICUM HAS CHANGED, IT HAS
BEEN SHORTENED OVER TIME AND
THIS YEAR, FOR THE SECOND YEAR
NOW, IT'S HELD VIRTUALLY AND YOU
KNOW A GOOD WAY TO OPEN TO A
BROADER AUDIENCE THAN BEFORE.
AND SO THIS FIGURE JUST SHOWS
THE NUMBER OF PARTICIPANTS THAT
WE'VE HAD AT THE PRACTICUM SINCE
2007.
AND IN GENERAL, WE'VE HAD ABOUT
90 OR MORE PARTICIPANTINGS EACH
YEAR.
THE PRACTICUM WAS HELD IN PERSON
AT NIH AND WE WERE LIMITED IN
THE NUMBER OF DEATHS AND SPACES
AVAILABLE BUT THEN LAST MAY WE
DID HOLD THE PRACTICUM
VETERINARY RESOURCESSUALLY AND
WE WERE ABLE TO HOLD THE
PRACTICUM UP TO EVERYONE.
WE HAD 478 PARTICIPANTS AT OUR
PEAK DURING THOSE 3 DAYS AND
THIS YEAR WE HOPE TO TOP THAT
NUMBER.
SO JUST TO START OFF WITH A FEW
HOUSEKEEPING ISSUES, THE
PRACTICUM STARTS EVERY DAY AT 11
AMEASTERN TIME.
I JUST WANT TO REMIND EVERYONE
THAT THE WEBEX LINKS ARE
DIFFERENT FOR EACH DAY SO PLEASE
MAKE SURE YOU CLICK ON THE
CORRECT 1.
WE WILL HAVE MODERATORS FOR EACH
SESSION, HOWEVER IN ORDER TO
SAVE TIME, THEY WILL OHM BRIEFLY
INTRODUCE THE SPEAKERS AND THE
SESSIONS.
SO PLEASE REFER MORE TO OUR
OGENDA ONLINE FOR INFORMATION ON
EACH TALK'S OBJECTIVE AND PLEASE
SEE SPEAKER BY OS FOR MORE
INFORMATION ON EACH SPEAKER.
SO HERE'S THE LINKS TO BOTH,
THIS SLIDE WILL ALSO BE UP
DURING ALL THE BREAKS, SO YOU
WILL HAVE THOSE LINKS.
NEXT, PLEASE SUBMIT ANY
TECHNICAL ISSUES OR PROBLEMS
YOU'RE HAVING IN THE CHAT BOX.
AND SUBMIT QUESTIONS FOR THE
PRESENTERS IN THE SESSION IN THE
Q&A PANEL AND DIRECTED IT TO ALL
PANELISTS.
SO ALTHOUGH WE'RE VIRTUAL THIS
YEAR AND LAST YEAR, WE STILL
RELY HEAVILY ON AATTENDEES
PARTICIPATION TO MAKE THIS A
SUCCESSFUL PRACTICUM SO WE
REALLY WELCOME YOUR QUESTIONS,
WE WILL HAVE TIME AFTER SPEAKERS
OR DURING POWER DISCUSSIONS, SO
PLEASE SUBMILT YOUR--PANEL
DISCUSSIONS SO PLEASE SUBMIT
YOUR QUESTIONS.
I WANT TO MENTION THAT THIS WILL
BE RECORDED AND TELL BE
AVAILABLE SOON AFTER SO WE WILL
BE SPENDING LINKS TO WHERE YOU
CAN WATCH THE RECORDED PRACTICUM
AFTERWARDS.
SO, I WANT TO START OFF BRIEFLY
JUST BY INTRODUCING THE DIETARY
SUPPLEMENT, HEALTH AND EDUCATION
ACT OF 1994 OR WHAT WILL REFER
TO AS THE SHEA, AND YOU WILL
HEAR MORE ABOUT THIS IN OTHER
PRESENTATIONS BUT I WILL GIVE A
BRIEF OVERVIEW RIGHT NOW BECAUSE
THIS LAW REALLY CREATED THE
REGULATORY FRAMEWORK FOR THE
SAFETY AND LABELING OF DIETARY
SUPPLEMENTS AND THIS LAW
CONTINUES TO DEFINE SUPPLEMENT
POLICY TO THIS DAY.
AFTER THAT I'M GOING TO PROVIDE
AN OVERVIEW OF OUR OFFICE,
OFFICE OF DIETARY SUPPLEMENTS
AND TELL YOU A BIT ABOUT OUR
MISSION AND SOME OF WHAT WE DO.
SO, DIETARY SUPPLEMENTS HAVE
BEEN MARKETED AND USED FOR
CENTURIES IN ALL DIFFERENT
FORMINGS.
AND IN 1994 CONGRESS PASSED
AND THE PRESIDENT SIGNED THIS
PIECE OF LEGISLATION CALLED
DSHEA, AND IT WAS THE FOOD AND
COSMETIC ACT.
AT THE TIME IT THE IT WAS
GROWING AND A LARGE NUMBER BE OF
U.S. ADULT REPORTED TAKING
DIETARY SUPPLEMENTS SO IT WAS
IMPORTANT TO ESTABLISH STANDARDS
FOR CONSUMERS AS WELL AS EXPLORE
MORE FULLY THE ROLE OF DIETAR I
SUPPLEMENTS IN THE DIETS AND
HEALTH OF THE U.S. POPULATION.
SO IN DOING AND PASSING THIS
LAW, CONGRESS STATED THERE MIGHT
BE A POSITIVE RELATIONSHIP
BETWEEN SOUND DIETARY PRACTICE
AND GOOD HEALTH AND ALTHOUGH
FURTHER RESEARCH IS NEEDED THERE
MAY BE A CONNECTION BETWEEN
SUPPLEMENT USE, REDUCED HEALTH
EXPENSES AND DISEASE PREVENTION.
SO THIS LAW DEFINE WHAT IS WOULD
BE CONSIDERED A DIETARY
SUPPLEMENT.
IT ESTABLISHED A REGULATORY
FRAMEWORK WITHIN THE U.S. FOOD
AND DRUG ADMINISTRATION, FDA,
AND BASICALLY IT'S THAT DIETARY
SUPPLEMENTS ARE A SPECIAL
CATEGORY OF FOODS AND THEY'RE
NOT REGULATED BY DRUGS.
DSHEA ESTABLISHED LABELING RULES
AND CREATED THE OFFICE OF
DIETARY SUPPLEMENTS AT THE
NATIONAL INSTITUS OF HEALTH.
SO IN GENERAL, THE LABELING
GUIDELINE STATE THAD SUPPLEMENTS
HAVE TO BE CLEARLY LABELED AS A
SUPPLEMENT, HAVE A SUPPLEMENT
FACT PANEL THAT LIST ALL
INGREDIENTS IN THE PRODUCT AND
HAVE A DISCLAIMER STATING THAT
THE PRODUCT HAS BEEN--NOT BEEN
EVALUATED BY THE FDA IS NOT
INTEND TO DIAGNOSE, TREAT, OR
CURE CERTAIN DISEASES.
SO DSHEA DEFINED WHAT A DIETARY
SUPPLEMENT IS AND PRIOR TO THAT
THERE WERE SUPPLEMENTSOT MARKET
BUT THERE WAS NO REGULATORY
DEFINITION OF THEM.
SO THEY'RE NOW DEFINED AS A
PRODUCT OTHER THAN TOBACCO THAT
CONTINUES TO SUPPLEMENT THE
DIET, CONTAINS 1 OR MORE DIETARY
INGREDIENTS, SO VITAMINS, WATER,
AMINO ACIDS, BOTANICALS, RGTD
SUBSTANCES, THEY CAN PROVIDE
INDIVIDUAL COMPONENTS OR IT CAN
BE A COMBINATION OF THESE WILL
YOU PLEASE CEMENTS.
AND FINALLY THEY'RE INTENDED TO
BE TAKEN BY MOUTH.
THEY'RE AVAILABLE IN MANY FORMS,
TABLETS, CAPSULES, SOFT
GELSOLINS, LIQUIDS, CHEWS,
POWDERS AND THEN BASICALLY
ALMOST ANY INGREDIENT IN A FOOD
OR PRODUCT OF MAJOR CAN BE
TURNED INTO A DIETARY SUPPLEMENT
AS LONG AS IT'S NOT OBVIOUSLY
POISONOUS AND A WAY TO GET THAT
RAW MATERIAL INTEREST I FINISHED
PRODUCT.
AND WE LIKE TO SHOW THIS SLIDE
BECAUSE THESE ARE MANY EXAMPLES,
WE'RE NOT JUST TALKING ABOUT
VITAMINS AND MINERALS, WE'RE
TALKING ABOUT MANY, MANY
DIFFERENT TYPES OF INGREDIENTS.
SO CONGRESS AS I ALSO STATED
MANDATED THE OFFICE OF DIETARY
SUPPLEMENTS, ODS AND THAT IT
SHOULD BE PLACED IN THE NATIONAL
INSTITUTES OF HEALTH AND OUR
MISSION AT ODS IS TO STRENGTHEN
THE KNOWLEDGE AND UNDERSTANDING
OF DIETARY SUPPLEMENTS, WE DO
THIS IN SEVERAL WAYS THROUGH
STIMULATING AND SUPPORTING
RESEARCH TO VPGHT THE ROLE OF
DIETARY SUPPLEMENTS AND
PROMOTING HEALTH AND REDUCING
DISEASE RISK.
SUPPORTING THE DEVELOPMENT OF
RESEARCH TOOLS, EVALUATING
SCIENTIFIC FINDINGS AND MAKING
THE MOST UP TO DATE SCIENTIFIC
KNOWLEDGE ABOUT SUPPLEMENTS
PUBLICLY AVAILABLE.
THIS SLIDE SHOWS SUPPLEMENT
SALES FROM THE NUTRITION
BUSINESS JOURNAL AND THIS
JOURNAL PUBLISHES SALES
ANNUALLY.
AFTER DSHEA WAS PASSED IN 1994,
YOU CAN SEE 8.6 BILLION DOLLAR A
YEAR INDUSTRY AND YOU CAN SEE
THAT IT'S A REALLY QUITE A
STEADY INCREASE SINCE THEN.
AND WE ARE NOW AT 55.8 BILLION
IN 2020.
AND I WOULD LIKE TO POINT OUT
THAT IN 1994, IT WAS ESTIMATED
THAT THERE WAS A ABOUT 4000
PRODUCTS ON THE MARKET AND NOW
WE ESTIMATE THAT THERE ARE
PROBABLY OVER A HUNDRED THOUSAND
PRODUCTS ON THE MARKET AT A
GIVEN TIME.
SO THE NUTRITION BUSINESS
JOURNAL RECENTLY PUBLISHED
SALINGS FROM 2020--SALES FROM
2020.
IT ACTUALLY PUT GROWTH IN 20
TWEBT AS THE LARGEST EVER, UP 14
AND HALF PERCENT OR ADDING 7
BILLION IN ADDITIONAL SALES.
AND AGAIN, BUILDING A MARKET
NOW, ESTIMATED AT 55.8 BILL 1.
THE INCREASE MOST LIKELY DUE TO
COVID-19 AND A LOT OF ATTENTION
THAT WAS GIVEN TO DIETARY
SUPPLEMENTS, AND NOT PRIZING THE
VITAMIN, DC, BEING BIG LEADERS
AND THEN.
THE NUTRITION BUSINESS JOURNAL
ALSO PROVIDES DATA ON HOW SALES
ARE DISTRIBUTED, AMONG VITAMINS,
MINERALS, HERBS, SPECIALTY OTHER
PRODUCTS.
YOU KNOW SOME OF THESE ARE NOT
HAQUE WE WOULD CONSIDER DIETARY
SUPPLEMENTS FROM A REGULATORY
PURPOSE BUT FOR REPORTING
PURPOSES THEY DO PUT THEM INTO
THE CATEGORIES, BUT YOU KNOW WE
DO LOOK AT THINGS A LITTLE
DIFFERENTLY ABOUT THIS KIND OF
SHOWS YOU THE DISTRIBUTION OF
2020 AND BASICALLY IT'S BEEN
PRETTY STABLE FOR THE SALES OVER
THE YEARS ALTHOUGH THE EXACT
PERCENTAGES CAN CHANGE A BIT.
CAN YOU SEE HERE THAT VITAMINS
ARE THE BIG SELLERS, THIS ALSO
INCLUDES THE MULTIVITAMIN
FORMULATION AND YOU CAN SEE THIS
IS FOLLOWED BY BOTANICAL HERBS
AND THEN THE OTHER SPECIALTY
PRODUCTS.
SO THE ODS HAS BEEN OPERATING
SINCE 1995.
WE'RE ALWAYS GUIDED BY A
TRANSLATIONAL RESEARCH TEEJIC
PLAN, WHICH IS OF COURSE IS
IMPORTANT BECAUSE THERE ARE A
LOT OF PEOPLE INVOLVED IN
DIETARY SUPPLEMENTS FROM
CONSUMERS, TO RESEARCHERS,
REGULATORS, PEOPLE WHO DEVELOP
METHODS AND MEASUREMENTS OF
THINGS IN DIETARY SUPPLEMENTS,
CLINICIANS.
OUR 2017-2021 STRATEGIC PLAN HAS
ENDED.
WE ARE CURRENTLY FINALIZING OUR
2022-2026 PLAN AND THIS WILL
GUIDE US THROUGH THE NEXT 5
YEARS.
OUR GOALS SAID A LITTLE SLIGHTLY
DIFFERENT THAN I MENTIONED
EARLIER BUT IT EXTENDING THE
KNOWLEDGE BASE IN A NUMBER OF
DIFFERENT WAYS AND WE DO THIS
ALWAYS IN COLLABORATION
COLLABORATION WITH OTHER
INSTITUTES AT THE NIH, OTHER
PART OF THE FEDERAL GOVERNMENT,
PRIVATE SECTOR, ACADEMIC SECTOR,
EXPANDING KNOWLEDGE BASE, SO
EXPABDING THE WORKFORCE THROUGH
TRAINING AND CAREER DEVELOPMENT
BY DEVELOPING RESEARCH RESOURCES
AND BASICALLY ALL OF THIS IS IN
SERVICE OF RELY TRANSLATING
INFORMATION INTO USEFUL
INFORMATION FOR A HOST OF END
USERS, CONSUMERS, HEALTH
PROFESSIONALS, RESEARCHERS,
POLICY MAKERS, HEALTHCARE
PROVIDERS.
SO NEW FOR 2022, 2026 STRATEGIC
PLAN, NUMBER 5 IS FUNDING AND
SUPPORT THE DEVELOPMENT OF
COLLABORATIVE INITTIAIVE ITS
ADDRESS GAPS IN DIETARY
SUPPLEMENT RESEARCH.
SO IN IDENTIFYING RESEARCH
NEEDS, YOU KNOW DEVELOPING
RESOURCES, AND ESTABLISHING KEY
PARTNERS AND COMMUNICATION
STRATEGIES, ODS TAKES IT'S
MULTIPRONGED APPROACH AND GUIDED
BY SEVERAL REALLY IMPORTANT KEY
QUESTIONS.
AND GENERALLY SPEAKING, WHAT
DRIVES THE QUESTIONS IF THE
PUBLIC HEALTH ISSUE, SO, ARE
THERE TRENDS IN CERTAIN DIETARY
SUPPLEMENTS THAT WE NEED TO BE
TRACKING?
ARE THERE SAFETY CONCERNS THAT
NEED TO BE CONSIDERED?
ARE THERE EVENTS THAT HAVE
CAUSED PEOPLE TO USE MORE OR
LESS, SO ALL THINGS THAT WE CAN
LOOK AT TO IDENTIFY EMERGING
NEEDS FOR RESEARCH.
WE HAVE LEARNED A LOT ABOUT THE
MEASUREMENT OF NUTRITIONAL
STATUS, THIS APLOYS TO A LOT TO
THE SUBSTANCES IN DIETARY
SUPPLEMENT MARKETPLACE,
SUBSTANCES THAT CAN COME FROM
FOODS BUT ALSO DIETARY
SUPPLEMENTS, BUT IN TERMS OF
FOODS AND DIETARY SUPPLEMENT
SOURCES, IT'S REALLY IMPORTANT
TO MONITOR NUTRITIONAL STATUS
AND BE SURE THAT THE MEASURES OF
THESE THINGS ARE RELIABLE, AND
REHAVE AS AN OFFICE, REALLY
INVESTED IN THAT.
AND THEN THERE'S WHAT EVIDENCE,
THE EVIDENCE FOR HEALTH EFFECTS,
IN ODS, WE TRY AND BE VERY
NEUTRAL, THERE ARE STRONGLY HELD
VIEWS ON HEALTH EFFECTS, OF
DIETARY SUPPLEMENTS, SOMETIMES
POSITIVE USE, NEGATIVE VIEWS AND
WE REALLY AIM TO PIECE THROUGH
THE OPINIONS AND TRY TO HELP
PEOPLE UNDERSTAND WHAT IS THE
EVIDENCE?
AND THEN FINALLY WE'RE ALWAYS
LOOKING FOR WAYS TO REALLY FILL
THE GAPS IN KNOWLEDGE AND
TRANSLATE RESULTS.
SO WE DO SOME OF THIS BY CO
FUNDING GRANTS WITH SOME
INSTITUTES AT THE NIH AND THIS
PIE CHART REFLECTS TYPES OF
SUPPLEMENT INGREDIENTS AND WE
ANNOUNCED WE ARE FUNDED OF SOME
OF THESE IN FISCAL YEAR 2020.
AND IT REFLECTS MORE OR LESS THE
DISTRIBUTION OF USE OF PRODUCTS
IN THE POPULATION.
AND TO COVERS THE LANDSCAPE
ALTHOUGH ON A VERY SMALL SCALE.
SO YOU'LL LEARN MORE ABOUT THE
NIH, THE RESEARCH AND TRAINING
ON NUTRITION AND DIETARY
SUPPLEMENTS WHEN PATRICIA
HAGGATORY TALKS TOMORROW AT 3:45
AND SHE WILL REALLY TALK MORE
ABOUT RESEARCH FUNDING AT THE
NIH.
SO ODS HAS LOTS OF PROGRAMS AND
INITIATIVES IN ORDER TO MEET OUR
GOALS.
AND I WOULD LIKE TO SPEND SOME
TIME TALKING TODAY PARTICULARLY
BECAUSE WE HAVE INDIVIDUALS THAT
WILL BE PRESENTING MORE ON THESE
PROGRAMS DURING THE PRACTICUM,
SO I WILL BE HIGHLIGHTING SOME
OF THESE PROGRAMS.
ONE VERY IMPORTANT PROGRAM IS
THE ANALYTICAL METHODS AND
REFERENCE MATERIALS PROGRAM OR
AMRAM.
SO, THE CHIEWR O ANALYTICAL
CHARACTERIZATION OF DIETARYETARY
SUPPLEMENTS AND A CRITICAL STEP
IN DEMONSTRATING SAFETY AND
UNDERSTANDING THEIR HEALTH
EFFECTS AND THE ODS AMRM IS
FOCUSED ON DEVELOPING AND
DISSEMINATING RESOURCES THAT
SCIENTISTS AND ANALYSTS REALLY
NEED TO INSURE THAT THE
CHARACTERIZATION OF DIETARY
SUPPLEMENTS, NATURAL PRODUCTS
AND NUCLEOTIDES THRIENT
BIOMARKERS ARE PREICIZE,
ACCURATE AND RELIABLE.
AMRM WORKS IN COLLABORATION WITH
OTHERS LIKE THE NATIONAL
INSTITUTES OF STANDARDS AND
TECHNOLOGY OR NIST TO DEVELOP
LABORATORY TOOLS, THESE TOOLS
GIVE RESEARCHERS REGULATORS,
MANUFACTURES, THE TOOLS THEY
REALLY NEED TO EVALUATE THE
INTEGRITY OF THE PRODUCTS THEY
ARE STUDYING.
AMRM HAS FUNDED WORKSHOPS, AND
GUIDELINES ON METHODS WITH A BIG
EMPHASIS ON DEVELOPING METHODS
AS PART OF OUR STRATEGIC PLAN
BUT ALSO AS PART OF AN NIH WIDE
INITIATIVE WHICH IS REALLY TO
IMPROVE REPRODUCIBILITY IN
BIOMEDICAL RESEARCH.
OUR ODS WEBSITE INCLUDES A
SEARCHABLE DATABASE FOR
ANALYTICAL PRODUCTS.
AND DR. ADAM KUSZAK, WE DIRECTS
THIS PROGRAM AND HE WILL PRESENT
TOMORROW AT 11 AMAND SPEAKING
ABOUT THE PRINCIPLES OF DIETARY
SUPPLEMENT CHARACTERIZATION AND
HE WILL BE INTRODUCING CONCEPTS
OF IDENTITY, EQUALITY AND
COMPOSITION, HE WILL GIVE MORE
OF AN OVERVIEW OF THE ANALYTICAL
CHALLENGES AND NEEDS AND DIETARY
SUPPLEMENT RESEARCH AND REALLY
THE IMPORTANCE OF STANDARDS AND
REFERENCE MATERIALS WHEN
STUDYING DIETARY SUPLEAPTS OR
JUST ANALYZING THEM.
SO THE OFFICE OF DIETARY
SUPPLEMENTS ALSO HAS THE
CONSORTIUM FOR ADVANCING
RESEARCH ON BOTANICAL AND OTHER
NATURAL PRODUCTS OR CARBON
PROGRAM AND IN IS IN PARTNERSHIP
WITH THE NATIONAL CENTER IF YOU
COMPLIMENTARY AND INTEGRATIVE
HEALTH, 1 OF THE THE CENTERS AT
NE H AND THIS WAS STARTED IN
1999 IN RESPONSE TO A
CONGRESSIONAL MANDATE.
THE PURPOSE OF THE CARBON
PROGRAM IS TO PROMOTE
COLLABORATIVE AND DISCIPLINARY
RESEARCH ON THE SAFETY,
EFFECTIVENESS AND MECHANISMS OF
ACTION OF BOTANICAL DIETARY
SUPPLEMENTS THAT HAVE HIGH
POTENTIAL TO BENEFIT HUMAN
HEALTH AND TO SUPPORT THE
DEVELOPMENT OF METHODS AND
RESOURCES THAT WILL ENHANCE THE
PROGRESS OF THIS RESEARCH.
THIS PROGRAM IS DIRECTED BY
DR. BARBARA SORKIN AND SHE WILL
BE PRESENTING TOMORROW AT 11:45.
THE TALK WILL PROVIDE MORE
DETAILS ABOUT THE CARBON PROGRAM
BUT WILL ALSO FOCUS ON HOW
CONCEPTS OF EFFICACY, SAFETY AND
IDENTITY ARE ADDRESSED IN
STUDYING BOTANICALS AND PLANT
DERIVED INGREDIENT.
WE ALSO HAVE THE POPULATION
STUDIES PROGRAM, AND THIS
PROGRAM IS DIRECTED BY DR. NANCY
POTTESMAN, AND IT WAS START
INDEED 2008 AND STARTED TO
EXPAND COLLABORATION WITH GROUPS
TO CHARACTERIZE DIETARY
SUPPLEMENT USE IN THE UNITED
STATES.
THE MAIN GOAL OF THIS PROGRAM IS
TO CONDUCT RESEARCH ON PADERNS
OF SUPPLEMENT USE IN THE NEW
UNITED STATES POPULATION AND
SUBGROUPS, IDENTIFY GAPS,
RESEARCH NEEDS FOR THE OFFICE
AND HOW BEST TO ANSWER THEM,
SUPPORT RESEARCH ON BIOMARKERS
OF NUTRIENT EXPOSE AND YOU ARE
NUTRITIONAL STATUS, PROVIDE
GUIDANCE ON TON KACT WITH OTHER
ICs, REPORTED OR REGARDING
STUDIES RELEVANT TO POPULATION
STUDIES, DIET, SUPPLEMENT,
NUTRITIONAL ASSESSMENT AND
BIOMARKERS.
OUR NEXT SPEAKER DR. BAILEY WILL
BE PRESENTING RIGHT AFTER ME,
WAS WITH THE PROGRAM SINCE THE
BEGINNING, HELP SHAPE WHAT IT IS
TODAY.
SHE HAS SINCE LEFT ODS AND
PROFESSOR NOW AT TEXAS A&M
UNIVERSITY.
ONE VERY IMPORTANT PART OF THIS
PROGRAM WHICH SHE REALLY HELPED
TO START IS FUNDING CRITICAL
SURVEYS, LIKE THE NATIONAL
HEALTH AND NUTRITION EXAM NATION
SURVEY AND ALSO AT TIMES THE
NATIONAL HEALTH INTERVIEW
SURVEY, TO COLLECT NATURALLY
REPRESENTATIVE INFORMATION ON
THE U.S. POPULATION ON THE USAGE
OF DIETARY SUPPLEMENTS.
SO DR. BAILEY'S PRESENTATION
WILL REALLY FOCUS ON NHANES AND
WHAT THE DATA HAS SHOWN IN TERMS
OF SUPPLEMENT USE, WHAT PEOPLE
ARE TAKING, THE TRENDS OVER
TIME, AND THEN I ALSO WANT TO
MENTION THAT THE NHANES SURVEY
IS ALSO CRITICAL FROM PROVIDING
INFORMATION ON HOW SUPPLEMENTS
REALLY CONTRIBUTE TO TOTAL
NUTRIENT INTAKE CROSS LINKING,
FOODS, BEVERAGES, SUPPLEMENTS
AND HOW THAT IMPACTS NUTRITIONAL
STATUS AND HEALTH FOR THE U.S.
POPULATION.
OKAY, AND THEN WE ALSO HAVE
DIETARY SUPPLEMENT DATABASES,
THAT WE'VE HELPED TO CREATE IN
COLLABORATION WITH WITH OTHERS.
GREAT RESOURCES FOR RESEARCHERS,
AND CONSUMERS AMONG OTHER
STAKEHOLDERS.
AND 1 THAT PEER PARTICULARLY
PROUD OF IS THE DIETARY
SUPPLEMENT LABELED DATABASE OR
DSLD, EASILY ACCESSIBLE PUBLIC
DATABASE RECREATED TO PROVIDE
INFORMATION ON DIETARY
COMPOSITION FROM THE PRODUCT
LABEL, SO INFORMATION FROM THE
PRODUCTA LABEL AND IT CAN BE
USED BY RESEARCHERS, CONSUMERS,
AND THE AIM IS TO REALLY INCLUDE
ALL AVAILABLE LABELS AND
SUPPLEMENTS THAT ARE MARKETED
AND SOLD IN THE UNITED STATES.
THIS DATABASE RIGHT NOW AS OVER
125,000 LABELS WITH ABOUT A
THOUSAND BEING ADDED EACH MONTH.
IT ALSO INCLUDES NOT JUST
INFORMATION ON THE INGREDIENTS
THAT'S ON THE LABEL, AND THE
AMOUNT AND EVERYTHING BUT IT
ALSO HAS A COMPLETE IMPAG
INCLUDED AS WELL OF THAT LABEL.
THE NEXT DATABASE, ON THE
DIETARY SUPPLEMENT OR DSID, IS
THE INITIATIVE OF THE OFFICE OF
DIETARY SUPPLEMENTS BUT WAS
DEVELOPED BY THE METHODS AND
APPLICATION OF FOOD COMPOSITION
LABORATORY AT THE U.S.
DEPARTMENT OF AGRICULTURE.
AND THIS DATABASE PROVIDES
ANALYTICALLY VALIDATED
ESTIMATINGS OF INGREDIENTS IN
DIETARY SUPPLEMENTS, SO
NOT--IT'S NOT BASING THE
INFORMATION OF INGREDIENTS FROM
THE LABELS BUT ACTUALLY
ANALYZING THE PRODUCTS.
THE CURRENT VERSION OF DSID
PROVIDES ESTIMATE OF INGREDIENTS
FOR CONTENT FOR ADULT AND
CHILDREN MULTIVITAMIN MINERALS,
NONPRESCRIPTION PRENATAL
MINERALS AND THEN AN OMEGA 3
FATTY ACID SUPPLEMENT.
AND THEN I ALSO WANTED TO
MENTION THAT ODS DEVELOPED THE
COMPUTER ACCESS TO RESEARCH ON
DIETARY SUPPLEMENTS OR CARDS
DATABASE AND THIS PROVIDES
INFORMATION ON ALL FEDERALLY
FUNDED RESEARCH ON DIETARY
SUPPLEMENTS THAT HAVE BEEN
CONDUCTED SINCE 1999 AND JOYCE
MERKEL WILL TALK ABOUT ALL OF
THESE AS WELL AS OTHER USEFUL
DATABASES DURING HER TALK TODAY,
LATER TODAY AT 3:15 P.M.
SO ANOTHER VERY IMPORTANT GOAL
OF ODS IS TO ENHANCE THE DIETARY
SUPPLEMENT RESEARCH WORKFORCE
THROUGH TRAINING AND CAREER
DEVELOPMENT.
WE DO THIS IN SEVERAL WAYS,
AGAIN BY USING NIH GRANT AWARDS
THAT SERVES THE EXTRAMURAL
COMMUNITY AND AGAIN PATRICIA
HAGERTY'S TALK AT 3:45 TOMORROW
WILL GO THROUGH THIS.
ODS ALSO SPONSORS INTRAMURAL
SCHOLARS AWARDS WITH OTHER NIH
INSTITUTES AND CENTERS, WE
DEVELOPED THE WORKFORCE BY
COLLABORATING WITH OTHER FEDERAL
AGENCIES, TO SUPPORT MENTOR, OR
PROVIDE TECHNICAL GUIDANCE TO
POST DOC FELLOWS, EARLY CAREER
SCIENTISTS FOR EXAMPLE, OVER THE
YEARS WE HAVE FUNDED POST DOCS
OVER AT THE NATIONAL INSTITUTES
OF STANDARDS AND TECHNOLOGY AS
WELL AS THE U.S. DEPARTMENT OF
AGRICULTURE AND THEN WE CAN ALSO
OFFER SHORT-TERM TRAINING
OPPORTUNITIES FOR ODS STUDENTS
AND FACULTY MEMBERS, SHORT-TERM
TRAINING OPPORTUNITIES.
WE'VE HAD THE GREAT OPPORTUNITY
TO HAVE SEVERAL TRIPLE AF
FELLOWS TO COME AND TRAIN WITH
US AND WE ALSO HOST THIS
PRACTICUM ANNUALLY.
AND THEN THE COMMUNICATING THE
SCIENCE AND SUPLEMS, THE THIS IS
REALLY, REALLY AGAIN A VERY KEY
GOAL, VERY STRONG COMMUNICATION
TEAM WITHIN ODS THAT DO A GREAT
JOB OF GETTING RELIABLE
INFORMATION OUT TO THE PUBLIC TO
RESEARCHERS AND POLICY MAKERS
AND WE HAVE A WEBSITE THAT
RECOMMEND EVERYONE CHECKING OUT
THAT PROVIDES SO MANY RESOURCES.
ONE BEING THE DIETARY
SUPPLEMENTS FACT SHEET
AVAILABLE, AGAIN ON OUR WEBSITE,
RIGHT NOW WE HAVE OVER A HUNDRED
FACT SHEETS ON DIETARY
SUPPLEMENT INGREDIENTS AND
SUPPLEMENTS MARKETED FOR
SPECIFIC PURPOSES, FOR EXAMPLE,
WEIGHT LOSS.
WE OFFER HEALTH PROFESSIONAL AND
CONSUMER VERSION, MANY OF THEM
ARE TRANSLATED INTO SPANISH, THE
FACT SHEET THAT MIGHT BE OF
GREAT INTEREST FOR EVERYONE
RIGHT NOW IS OUR DIETARY
SUPPLEMENTS IN THE TIME OF COVID
FACT SHEET, WHICH WE HAVE FOR
BOTH AVAILABLE FOR HEALTH
PROFESSIONALS AND 1 FOR
CONSUMERS.
WE HAVE A WONDERFUL PRESENTATION
TITLED DIETARY SUPPLEMENTS AND
IMMUNITY LESSONS LEARNED FROM
COVID-19 AND THIS 1 IS SCHEDULED
TOMORROW--I MEAN WEDNESDAY AT
11:45 BY CAROL HIGGINS AND SHE
IS 1 OF THE ODS STAFF THAT PUT
TOGETHER THIS FACT SHEET AND
THEN FINALLY ODS ALSO PROVIDES
ENEWS LETTERS FOR PROFESSIONAL
AUDIENCE AND THE SCOOP FOR
CONSUMERS.
I ALSO WANT TO MENTION OUR ODS
EVIDENCE-BASED REVIEW PROGRAM,
SO IN 2001, THE NIH VUF OFFICE
OF DIETARY SUPPLEMENT RECEIVED
CONGRESSIONAL MANDATE TO REVIEW
THE CURRENT SCIENTIFIC EVIDENCE
ON THE EFFICACY AND SAFETY OF
DIETARY SUPPLEMENTS AND IDENTIFY
RESEARCH NEEDS, SO ODS RESCINDED
BY DEVELOPING AN EVIDENCE-BASED
REVIEW PROGRAM, AND WE BASICALLY
USED EVIDENCE-BASED PRACTICE
CENTERS PROGRAM THAT'S
ESTABLISHED BY ARC, AGENCY FOR
HEALTHCARE RESEARCH AND QUALITY,
THIS IS ALL TO CONDUCT
SCIENTIFIC REVIEWS OF THE
SCIENTIFIC LITERATURE AND REPORT
THEIR FINDINGS.
AND ODS IN COLLABORATION WITH
OTHER INSTITUTES AND CENTERS
HAVE FOUND THESE PREPORTS
BASICALLY INVALUABLE IN
PRESENTING WHAT IS AND WHAT IS
NOT KNOWN IN A RESEARCH AREA.
AND REALLY LAYS SOLID FOUNDATION
FOR IDENTIFYING GAPS IN
KNOWLEDGE, AND PROVIDING A
STRONG SCIENTIFIC BASIS FOR THE
DEVELOPMENT OF I RESEARCH
AGENDA.
AND THAT LEADS ME TO THIS, WE
LEARNED A LOT OVER THE YEARS,
ESPECIALLY FROM THESE FINDINGS
OF THIS THESE REPORTS THAT HAVE
REALLY HIGHLIGHTED THE
CHALLENGES IN STUDYING
SUPPLEMENTS AND HERE'S SCRUOF
THE A LIST OF ISSUES THAT REALLY
CAN IMPACT YOUR RESULTS AND
THESE WILL BE DISCUSSED FURTHER
THROUGHOUT THE PRACTICUM BUT
JUST TO HIGHLIGHT A FEW QUICKLY,
A NUMBER OF STUDIES CAN FAIL
STATUS AT BASE LINE WHICH CAN
REALLY IMPACT RESULTS, STUDIES
MAY NOT BE GENERALIZABLE, PEOPLE
MAY METABOLIZE SUPPLEMENTS AND
INGREDIENTS SNCHTLY WHICH CAN
AFFECT RESULTS DIFFERENTLY.
TIMING AND DURATION, HOW LONG
DOES AN INTERVENTION NEED TO GO
ON FOR TO YOU SEE RESULTS, YOU
NEED TO HAVE A GOOD HYPOTHESIS,
END POINTS CAN BE VERY HARD TO
COME UP WITH, DOSES CAN ALSO BE
AN ISSUE AND CAN IMPACT HOW WE
CAN COMPARE ALSO ACROSS STUDIES
AND THEN FINALLY, MEASUREMENT OF
COURSE, A HUGE, HUGE, ISSUE.
FOR DIETARY SUPPLEMENTS, THERE'S
RESEARCH PRODUCT ISSUES AND
THERE'S A HOW TO CORRECTLY
IDENTIFY THE CONSTITUENTS IN THE
PRODUCT AND THIS CAN BE
CHALLENGING, WE REALLY NEED TO
DO VERY CLEAR CHARACTERIZATION,
THERE CAN BE ISSUES LIKE
CONTAMINATION, BACTERIA,
PRESCRIPTION DRUGS, AND
REPRODUCIBILITY DEPENDS ON ALL
THESE THINGS AND OF COURSE
HAVING VERY, VERY GOOD
PLEASUREMENT.
SO YOU'RE GOING TO HEAR
DEFINITELY MORE ABOUT THIS,
DURING OUR SESSION TOMORROW
MORNING ON RIGOR AND
REPRODUCIBILITY IN DIETARY
SUPPLEMENT RESEARCH.
SO THIS CONCLUDES MY
INTRODUCTION AND DEFINITELY FOR
MORE INFORMATION ABOUT ODS AND
WHAT WE DO AND OUR DIFFERENT
PROGRAMS AND RESOURCES ON
DIETARY SUPPLEMENTS, PLEASE
VISIT OUR WEBSITE.
YOU CAN ALSO JOIN OUR LISTSERV,
IF YOU EVAPORATE ALREADY FOR
INFORMATION AND UPDATES AND WITH
THAT I WOULD LIKE TO START THE
FIRST SESSION WHICH WILL PROVIDE
AN OVERVIEW OF DIETARY
SUPPLEMENT USE IN THE UNITED
STATES AND I WOULD ALSO LYING TO
WELCOME YOU TO--LIKE TO WELCOME
YOU TO THE RESEARCH PRACTICUM.
SO OUR SPEAKER NEXT IS DR. REGAN
BAILEY, SHE'S AN ASSOCIATE
INSTITUTE DIRECTOR FOR THE
INSTITUTES FOR ADVANCING HEALTH
THROUGH AG RICULTURE AND
PROFESSOR OF NUTRITION AT TEXAS
A&M UNIVERSITY.
AS I MENTIONED BEFORE, SHE
WORKED AT THE ODS FOR MANY, MANY
YEARS AND HAS DONE A TREMENDOUS
AMOUNT OF WORK AT CHARACTERIZING
SUPPLEMENT USE IN THE UNITED
STATES AND HOW THESE PROD UBTS
CONTRIBUTE TO NUTRIENT INTAKE,
TODAY SHE WILL BE PRESENTINGOT
PREVALENCE OF DIETARY SUPPLEMENT
USE IN THE U.S. AND SUBGROUPS
AND SOME OF THE CHARACTERISTICS
OF SUPPLEMENT USERS.
THANK YOU OTHER REGAN.
>>IT'S AN HONOR TO BE
WITH YOU TODAY TO DISCUSS USE OF
DIETARY SUPPLEMENTS IN AMERICA
AND HOW THOSE TREND VS CHANGED
OR IN SOME CASES HAVE NOT
CHANGED ACROSS TIME.
MY NAME IS REGAN BAILEY, I'M A
PROFESSOR OF NUTRITION SCIENCE
AT TEXAS A&M, AND
BEFORE TRANSITIONING TO ACADEMIC
LIFE I WAS A POST DOC
FELLOW AND STAFF RESEARCH
SCIENTIST AT ODS.
SO THE 1994 DSH EA REGULATION
CONTINUES TO BE THE LAW THAT
REGULATES DIETARY SUPPLEMENTS IN
THIS COUNTRY.
AND THEY DID AN EXCELLENT JOB
DESCRIBES THIS TO YOU.
I WANT TO START THE PRESENTATION
BY TALKING ABOUT HOW WE KNOW
WHAT PEOPLE ARE USING.
SO THE METHODS TO ASSESS DIETARY
SUPPLEMENTS ARE IN SOME CASES
VERY SIMILAR TO THAT OF FOODS
AND BEVERAGES SO IT COULD BE A
DIETARY RECORD, RECALL,
FREQUENCY QUESTIONNAIRE OR A
HISTORY OR SCREENING METHOD BUT
WHAT'S INTERESTING AND WHAT'S
VERY IMPORTANT TO DISCUSSIONS
WILL BE HAVING TODAY IS THAT
MOST OF THE NATIONAL DATA THAT
WE HAVE ON SUPPLEMENT USE COMES
FROM AN IN-HOME PRODUCT,
INVENTORY IN WHICH TRAINED
INTERVIEWERS VIEW AND RECORD
VERY DETAILED INFORMATION ABOUT
EACH AND EVERY PRODUCT THAT AN
INDIVIDUAL IS USING.
AND WHILE DSHEA DEFINED WHAT A
DIETARY SUPPLEMENT IS, AS AN
UMBRELLA TERM, THERE ARE NO
LEGAL OR REGULATORY DEFINITIONS
FOR WHAT IS A MULTIVITAMIN,
MULTIVITAMIN MINERAL OR A
MULTIVITAMIN MULTIMINNIAL.
THESE ARE OFTEN TIMES
INTERCHANGEABLY USED BUT ALSO
WITHIN THE SCIENTIFIC LITERATURE
AND THERE ARE MANY WAYS THAT
RESEARCHERS OPERATIONALIZE
PRODUCTINGS INTO THESE SPECIFIC
CATEGORIES AND MORE INFORMATION
ON THAT CAN BE FOUND IN THE
REFERENCES LISTED ON THIS SLIDE.
BUT WA'S IMPORTANT IS THAT WE
HAVE THE BEST METHODS TO ASSESS
SUPPLEMENT USE BECAUSE THE SALES
DATA THAT DR. BETS INTRODUCED
AND THE PREVALENCE DATA I WILL
DESCRIBE TO YOU TODAY INDICATE
THAT MICRONUCLEOTIDES KRE TINS
END OR VITAMIN AND MINERAL
SUPPLEMENTS ARE THE MOST
COMMONLY USED PRODUCTS IN THIS
COUNTRY AND THAT THOSE COMMONLY
USED PRODUCTS CAN PROVIDE
UPREGARDS OF A HUNDRED PERCENT
OF THE DAILY VALUE FOR SOME
NUTRIENTS.
SO IF WE DO NOT INCLUDE
SUPPLEMENTS IN OUR TOTAL
ESTIMATES OF NUTRIENT EXPOSURE,
WE OVERESTIMATE THE PROPORTION
OF THE POPULATION AT RISK FOR AN
ADEQUATE.
SO UNDERESTIMATE THE PROPORTION
AT RISK FOR POTENTIALLY
EXCESSIVE INTAKES.
SO MOST OF THE DATA THEY WILL BE
DESCRIBING TODAY COMES FROM THE
NATIONAL HEALTH AND NUTRITION
EXAM NATION SURVEY OR NHANES
WHICH I REFER TO AS OUR NATIONAL
TREASURE BECAUSE IT HAS SUCH
DETAILED INFORMATION ACROSS A
WHOLE HOST OF THE DIFFERENT
NUTRITION AND HEALTH RELATED
TOPICS.
BUT OF COURSE WHAT WE ARE GOING
TO FOCUS ON TODAY IS DIETARY
SUPPLEMENTS.
SO NHANES AND WONDERFUL AND
NATIONALLY REPRESENTATIVE OF THE
U.S. POPULATION, NHANES HAS THAT
GOLD STANDARD IN HOME PRODUCT
DIETARY SUPPLEMENT USE.
WE CAN THEN RELATE DIETARY
SUPPLEMENT USE TO CLINICAL AND
OTHER DIETARY DATA FOR MEDICAL
EXAM NATION CENTER, AS WELL AS
ANOTHER 24 RECALL, SO
SUPPLEMENTS SINCE 2007 HAS BEEN
COLLECTED BOTH AS PART OF A 24
HOUR RECALL AND AS PART OF HOME
PRODUCT INVENTORY.
THIS IS INFORMATION FROM
DR. JAMIE GASHCHE, IN THE OFFICE
OF DIETARY SUPPLEMENTS SHOWING
THEY PRE, POETIC POST, DSHEAA IN
THE USE OF ANY DIETARY
SUPPLEMENTS.
WHAT YOU WILL SEE HERE AT THIS
TIME AND WHAT CONTINUES TO BE
TRUE, IS THAT WOMEN USE MORE
DIETARY SUPPLEMENTS THAN MEN
BOTH IN TERMS OF PREVALENCE OF
USE AND ALSO THE NUMBER OF
PRODUCTS.
IN THIS SLIDE, I'M SHOWING YOU
DATA FROM A PUBLICATION FROM
DR. ELIZABETH CANTER AND HER
TEEM THAT ILTRAIT STRAIGHTS
STRAIGHT--ILLUSTRATES THE USE OF
SUPPLEMENTS FROM 2009-2012.
SO AS I MENTIONED SIGNIFYETARY
USE AFTER DSHEA HAS BEEN
RELATIVELY STABLE WITH WOMEN
CONSISTENTLY REPORTING MORE USE
ARE THAN MEN BUT WE HAVE
OBSERVED A SIGNIFICANT INCREASE
OVER TIME AND THE USE OF ANY
DIETARY SUPLEAPTS FOR OLDER
ADULTS AND NONHISPANIC BLACK
AMERICANS.
ANY SUPPLEMENT USE DECREASED
AMONG ADULTS AGES 20-39 YEARS
WAS STABLE AMONG MIDLIFE, SO
40-64 YEARS, AND INCREASED IN
AMERICAN 65 YEARS OR OLDER.
WHAT I WOULD LIKE TO SHOW YOU
NOW IS HOW SUPPLEMENT USE
CHANGES BY LIFE STAGE IN THE
UNITED STATES.
AND WHILE THESE BOUNCE AROUND IN
TIME IN THE USE IT SERVES BUT WE
SEE USE AND LOW, AND INSTANTS
SEEMS TO BE HIGHER IN CHILDREN,
DIPS IN ADOLESCENCE AND
CONTINUES TO INCREASE ACROSS THE
LIFE COURSE.
SO IT'S A BIT IRONIC IS IF WE
LOOK AT DIET QUALITY FROM FOODS
AND BEVERAGES, SO NOT INCLUSIVE
OF DIETARY SUPPLEMENTS SO WE ARE
LOOKING AT HEALTHY EATING INDEX
SCORES OR HEI SCORES FOR
AMERICANS SO THE HEI CONFIRMS TO
THE U.S. DIETARY GUIDELINES FOR
AMERICAN.
MUCH LIKE I TELL MY STUDENTS,
HEI IS LIKE A DEOF THE OR AN
EXAM SCORE WITH 0 BEING THE
WORST AND 100% BEING PERFECT.
SO AS YOU CAN SEE ACROSS THE
LIFE COURSE, MOST AMERICANS ARE
NOT FOLLOWING DIETARY GUIDELINES
BUT MY POINT HERE IS THAT HIGHER
DIET QUALITY IS OBSERVED IN
THOSE LIFE STAGES THAT TEND TO
BE MORE LIKELY TO REPORT DIETARY
SUPPLEMENT USE, SO I DON'T HAVE
TIME TO SHOW YOU THE DATA ON
THIS, TODAY IN THIS
PRESENTATION, BUOY WOO WE HAVE
DONE WORK THAT DEMONSTRATES THAT
ADULT WHO IS USE SUPPLEMENTS
TEND TO HAVE HIGHER VITAMIN
INTAKES FROM FOODS AND BEVERAGES
BEFORE WE EVEN ACCOUNT FOR
SUPPLEMENTS.
SO THAT SAME PHENOMENON IS NOT
TRUE IN CONCERN CHILDREN.
SO WHAT I WOULD LIKE TO DO IS
NOW TRANSITION TO SHOW YOU
DIFFERENTIAL SUPPLEMENT USE BY
LIFE STAGES IN THE UNITED
STATES, STARTING WITH PREGNANCY
AND LACTATION.
SO THE DATA ON PREGNANCY AND
LACTATION, I WILL BE PRESENTING
COMES FROM 2 RECENT PAPERS IN MY
LAB.
THE FIRST IS LED BY DR. JUNE
PICTURED HERE AND FOCUSED ON DS
USE AND CHARACTER IEOF THETICS
OF WEALTH, IN THE SECOND PAPER
FOCUSES ON TOTAL NUTRIENT
INTAKES OF PREGNANT U.S. WOMEN.
SO AS I ALLUDED TO, MOST
PREGNANT AND LACTATING WOMEN USE
A DIETARY SUPPLEMENT AND YOU CAN
SEE IN THE GREEN BARS ARE
PREGNANT WOMEN, THE DARKER
ORANGE, LACTATING WOMEN AND THE
LIGHTER ORANGE WOMEN OF THE SAME
AGES WHO ARE NEITHER PREGNANT,
NOR LACTATING SO THERE ARE
SIGNIFICANT DIFFERENCES BETWEEN
THOSE GROUPS FOR ANY USE, FOR
MULTIVITAMIN USE, AND FOR
PRENATAL SUPPLEMENT USE.
BUT NOT FOR SINGLE OR MULTIPLE
MICRONUTRIENT SUPPLEMENTS.
IN THIS SLIDE, WE ARE PRESENTING
DATA BY TRIMESTER OF PREGNANCY
FOR THE SURVEY YEARS IN WHICH IT
WAS AVAILABLE AND WHAT'S
INTERESTING HERE IS THE
PREVALENCE OF USE TENDS TO
INCREASE WITH TRIMESTER OF
PREGNANCY, WHAT'S ALSO
INTERESTING IS THOSE
STATISTICALLY IT'S NOT
DIFFERENT, FOLIC ACID IS REALLY
RECOMMENDED PERICONCEPTUALLY OR
IN THE FIRST 6 WEEKS OF
PREGNANCY AND THAT'S WHEN FOLIC
ACID CONTAINING SUPPLEMENT USE
TENDS TO BE THE LOWEST.
ANOTHER INTERESTING POINT HERE
IS THAT THE USE OF EYE O DINE
CONTAINING DIETARY SUPPLEMENTS
IS QUITE LOW.
SO LESS--OR AROUND 1 IN 4
PREGNANT WOMEN REGARDLESS OF
TRIMESTER ARE USING A PRODUCT
THAT CONTAINS IODINE.
AND IODINE NEEDS DURING
PREGNANCY ARE INCREASED.
THE PREVALENCE BY CERTAIN
POPULATION CHARACTERISTICS, SO
WE WILL START WITH AGE HERE,
OLDER PREGNANT WOMEN, SO 35-44
YEARS SIGNIFICANTLY USE MORE OF
ANY TYPE OF DIETARY SUPPLEMENT
THAN YOUNGER WOMEN.
AND YOU WILL SEE THE PREVALENCE
DIFFERENCES HERE FOR PRENATALS
EXCLUSIVELY, BUT THOSE WERE NOT
STATISTICALLY DIFFERENT.
IN THIS SLIDE, WE ARE LOOKING AT
POVERTY TO INCOME RATIO, SO THIS
IS A MEASURE THAT REPRESENT
HOUSEHOLD INCOME TO THE POVERTY
THRESHOLD AFTER ADJUSTING TO
FAMILY SIZE.
SO THE RATIO IS USED TO QUALIFY
FOR THINGS LIKE FEDERAL FOOD
ASITTANCE PROGRAMS AMONG OTHER
THINGS SO A HIGHER PIR IS
INDICATIVE OF A HIGHER FAMILY
INCOME AND WE SEE SIGNIFICANT
LYNNIAN TRENDS IN ANY SUPPLEMENT
USE AND PRENATAL SUPPLEMENT USE
SPECIFICALLY BY INCOME.
IN THIS SLIDE, WE'RE LOOKING AT
PREVALENCE OF ANY USE AND
PRENATAL USE BY RACE AND
ETHNICITY.
AND SO NONHISPANIC WHITE WOMEN
HAVE SIGNIFICANTLY DIFFERENT
PREVALENCE OF ANY USE WHEN
COMPARED WITH NONHISPANIC BLACK
AND HISPANIC AND MEXICAN
AMERICAN WOMEN WHEREAS PRENATALS
DO NOT DIFFER BETWEEN
NONHISPANIC BLACK AND HISPANIC
AND MEXICAN AMERICAN WOMEN.
SO, THERE ARE DATA AVAILABLE ON
ASIAN AMERICAN WOMEN BUT THEY
WERE NOT AACROSS ALL THESE
SURVEY YEARS, AND OF COURSE,
THIS DOESN'T REPRESENT OTHER
RACE AND ETHNIC GROUPS.
HERE WE'RE LOOKING AT
MOTIVATIONS OR REASONS WHY
PREGNANT AND LACTATING WOMEN ARE
USING THESE PRODUCTS.
AND THE MAJORITY OF BOTH
PREGNANT AND LACTATING WOMEN ARE
USING ANY TYPE OF PRENATAL
SUPPLEMENTS BASED ON THE
RECOMMENDATION OF A HEALTHCARE
PROVIDER.
SO YOU WILL SEE THAT'S IN THE
LIGHTER ORANGE BOXES, SO MOVING
ON NOW TO DATA ON INFANT ANDS
TODDLERS.
THIS IS ANOTHER COLLABORATIVE
PROJECT BETWEEN MY TEAM AND
RESEARCHERS AT ODS BED BY
DR. GAHCHE, AND
DRS. [INDISCERNIBLE] AND
[INDISCERNIBLE] PICTURES HIRE
HERE, SO ABOUT 18% OF INFANTS
AND TODDLERS USE DIETARY SUPLEMS
BUT THE TYPE AND FORMS CHANGE
BASED ON LIFE STAGE.
SO THIS SLIDE WE'RE LOOKING MORE
GRANULARLY ACROSS AGE GROUPS AND
YOU SLEEP APNEA AND OBESITYY
WHAT I DISCUSSION ON THE PRIOR
SLIDE THAT VITAMIN D AND
MULTIVITAMIN DROPS ARE HIGHER IN
YOUNGER ENFANTS AND REALLY A
TRANSITION TO JEWABLE AND GUMY
PRODUCTS STARTS AT ABOUT 1 YEAR
OF AGE.
LOOKING AT TRENDS OVER TIME,
THERE'S A SIGNIFICANT INCREASE
IN DIETARY SUPPLEMENT USE AMONG
OUR NATION'S YOUNGEST INFANTS SO
0-6 MONTHS AND THIS IS LARGELY
BEING DRIVEN BY AN INCREASE IN
VITAMIN D DROPS AND SUPPLEMENTS.
MOVING ON NOW TO LOOK AT
SUPPLEMENT USE AMONG U.S.
CHILDREN, WE KNOW ACROSS VARIOUS
NHANES CYCLES AT ABOUT ONE-THIRD
OF CHILDREN USE DIETARY
SUPPLEMENTS DOES NOT TEND TO
VARY BY SEX OR GENDER AS WE
PREVIOUSLY DESCRIBED FOR ADULTS.
MOST CHILDREN TAKE 1 PRODUCT
MOST COMMONLY A MULTIVITAMIN
MULTIMINERAL.
ON THIS SLIDE, WE SEE THE
GENERAL DIFFERENCE, THAT
CHILDREN OF HIGHER AGE HAVE A
HIGHER USE OF SUPPLEMENT USE
COMPARED TO OTHER AGE GROUPS.
AS I MENTIONED MOST COMMON
PRODUCTS MULTIVITAMIN,
MULTIMINERAL AND WHILE MOST
CHILDREN TAKE ON 1, 5% OF
CHILDREN TAKE 3 OR MORE DIETARY
SUPPLEMENTS PER DAY.
IN THESE SURVEY YEARS WE HAVE
DATA AVAILABLE TO US ON
NONHISPANIC ASIAN CHILDREN WHO
HAVE A SIMILAR USE OF
NONHISPANIC WHITE CHILDREN AND
THAT'S JUST HIGHER AND THAT
NONHISPANIC BLACK AND HISPANIC
AND MEXICAN-AMERICAN CHILDREN DO
NOT DIFFER STATISTICALLY IN
THEIR PREVALENCE OF USE.
THIS IS LOOKING AT WEIGHT STATUS
BY SUPPLEMENT USE AND WE
OBSERVED A SIGNIFICANT LINEAR
TREND SUCH THAT CHILDREN WHO ARE
UNDERWEIGHT TEND TO REPORT THE
HIGHEST PREVALENCE OF USE AND
THOSE CHILDREN WHO ARE OBESE
REPORT THE LOWEST PREVALENCE OF
USE.
THIS IS LOOKING AT SCREEN TIME
SO THE AMERICAN ACADEMY OF
PEDIATRICS RECOMMENDS 2 OR FEWER
HOURS OF SCREEN TIME PER DAY AND
CHILDREN WHO HAVE 4 OR MORE
HOURS OF SCREEN TIME TEND TO
HAVE LESS PREVALENCE OF DIETARY
SUPPLEMENT USE.
LOOKING AT HEALTH INSURANCE, SO
CHILDREN WHO HAVE PRIVATE HEALTH
INSURANCE, ARE MORE LIKELY TO
REPORT DIETARY SUPPLEMENT USE
THAN EITHER CHILDREN WHO HAVE NO
INSURANCE, OR USE PUBLIC HEALTH
INSURANCE.
SIMILAR TO TRENDS THAT WE SAW
WITH PREGNANCY, INCOME AS
MEASURED BY THE POVERTY INCOME
RATIO IS ASSOCIATED WITH
SUPPLEMENT USE, AND THE SIMILAR
TREND.
AGAIN THE PIR IS USED TO QUALIFY
PER MOST MAJOR FEDERAL FOOD
ASSISTANCE PROGRAMS LIKE SNAP
AND WIC.
IN THIS SLIDE, WE ARE LOOKING AT
THE PREVALENCE OF USE AMONG
CHILDREN WHO ARE ELIGIBLE FOR
THESE PROGRAMS BY INCOME.
THOSE ARE PARTICIPANTS.
THEY COULD BE ELIGIBLE BUT NOT
PARTICIPANTS OR THEY'RE NOT
ELIGIBLE AND NONPARTICIPANTS SO
FOR SNAP PARTICIPATION, THERE'S
A SIGNIFICANTLY DIFFERENT
PREVALENCE OF USE WHEREAS FOR
CHILDREN IN THE WIC PROGRAM
WHICH IS LIMITED TO CHILDREN
BIRTH-5 YEARS OF AGE, ONLY
NONPARTICIPANT INCOME ELIGIBLE
CHILDREN HAD A HIGHER PREVALENCE
OF USE THAT DID NOT DIFFER FROM
INCOME ELIGIBLE PARTICIPANTS OR
NONPARTICIPANTS AND SO INCOME
DIDN'T TELL THE ONLY STORY.
WE ALSO HAVE LOOKED AT DATA BY
FOOD SECURITY STATUS, SO FOOD
INSECURITY IS DEFINED AS LIMITED
OR UNCERTAIN AVAILABILITY OF
NUTRITIONALLY ADEQUATE AND SAFE
FOODS AND THE ABILITY TO ACQUIRE
THESE FOODS IN SOCIALLY
ACCEPTABLE WAYS.
SO THERE ARE 4 LEVELS OF FOOD
SECURITY.
AND THIS IS A VALIDATED MODULE
THAT WAS DEVELOPED BY THE USDA
TO CATEGORIZE PEOPLE INTO FOOD
SECURITY GROUPS.
SO WHILE WE HAVE THESE 4
SECURITY GROUPS WE TEND TO
COMBINE HIGH AND MARGINAL INTO
HIGH AND MARGINAL AND THEN LOW
AND VERY LOW INTO INSECURE SO WE
SAW DIFFERENT SUPPLEMENT USE BY
FOOD SECURITY CATEGORIES.
SO MOVING ON NOW TO LOOK AT
TRENDS OVER TIME AND NONVITAMIN,
NONMINERAL DIETARY SUPPLEMENTS,
SO THESE ARE THINGS LIKE
HERBALS, BOTANICALS, OMEGA 3s,
FIBER, MELATONIN AND THE BAR ON
THE BOTTOM IN ORANGE IS THE
PREVALENCE OF NONVITAMIN,
NONMINERAL SUPPLEMENT USE OVER
TIME WHICH HAS STATISTICALLY
INCREASED WHERE I MENTIONED WITH
ALL OTHER SUPPLEMENTS HAVE BEEN
PRETTY STABLE ACROSS TIME IN
ABOUT ONE-THIRD OF CHILDREN
REPORTING USE.
IN THIS SLIDE WE'RE LOOKING AT
TRENDS OVER TIME IN NONVITAMIN,
NONMINERAL IN CHILDREN WHO USE
THESE PRODUCTS.
SO IN PANEL A, WE CAN SEE
DIFFERENCES BY SEX AND GENDER
WHICH DID NOT DIFFER UNTIL ABOUT
2015-2016 AND THIS IS WHEN BOYS
HAD A HIGHER PREVALENCE OF
NONVITAMIN MINERALS WHEN
COMPARED WITH GIRLS.
SO IN PANEL B, WE CAN SEE THAT
OLDER CHILDREN CONSISTENTLY USE
MORE NONVITAMIN, NONMINERAL
PRODUCTS IN YOUNGER CHILDREN,
WHICH IS DIFFERENT FROM WHAT WE
WE VAW WITH THE NUCLEOTIDES TRI
EPT CONTAINING SUPPLEMENTS.
NONHISPANIC WHITE CHILDREN HAD
THE HIGHEST PREVALENCE EVER
NONVITAMIN NONMINERAL
SUPPLEMENTS WHEN COMPARE WIDE
HISPANIC AND NONHISPANIC
CHILDREN, THAT'S VISUALIZED IN
PANEL C.
AND FINALLY LOOKING AT INCOME
CATEGORIES IN PANEL D, CHILDREN
LIVING IN HIGH INCOME HOUSEHOLDS
TENDED TO HAVE NONVITAMIN,
NONMINERAL USE THAN THOSE IN THE
LOW OR MIDDLE INCOME CATEGORIES
AMONG SPECIFIC NONVITAMIN
NONMINERAL PRODUCTS, THE
PRESENCE OF PROBIATIC OR
MECHANICAL USE, APPEARS TO BE
RELATED TO THE CHILD AND THESE
ARE THE MOTIVATIONS FOR THESE
PRODUCTS SO NONVITAMIN,
NONMINERAL USERS ARE MORE LIKELY
TO REPORT USE OF SUPPLEMENTS FOR
RELAXATION, FOR STRESS AND
SLEEP, FOR MENTAL HEALTH, FOR
THINGS LIKE COLON AND BOWEL
HEALTH AS OPPOSE TO THE MORE
TRADITIONAL MOTIVATIONS FOR USE
FOR VITAMIN MINERAL CONTAINING
SUPPLEMENTS WHICH ARE MAINLY FOR
HEALTH RELATED REASONS OR TO
SUPPLEMENT THE DIET.
SO IN THIS LAST SECTION, WE WILL
LOOK AT ADULTS AND OLDER ASULTS.
FIRST WE WILL LOOK AT ALL
ADULTDS COMBINED SO YOUNGER
ADULTS AND OLDER ADULTS FROM
DATA FROM 2011-2014.
AS WE ALREADY DISCUSSED IN THE
PREBEGINNING OF THIS
PRESENTATION, WE KNOW THAT HALF
OF U.S. REDULTS REPORT ANY
DIETARY SUPPLEMENT, WE KNOW
THERE ARE TRENDS BY SEX AND AGE,
AND THOSE ARE THE PREVALENCE
ESTIMATES PRESENTED HERE,
SIMILAR TO CHILDREN, NONHISPANIC
WHITE AND ASIAN ADULTS HAVE
SIMILAR PREVALENCE OF USE,
WHEREAS NONHISPANIC BLACK AND
MEXICAN AMERICANS, HAVE LOWER
USE.
SUPPLEMENT USE IS TIED TO
EDUCATIONAL ATTAINMENT.
SO OVERALL SIGNIFICANT
DIFFERENCES BY ASULT WHO IS HAVE
LESS THAN A HIGH SCHOOL
EDUCATION, A HOOL SCHOOL DIPLOMA
OR EQUIVALENT OR GREATER THAN A
HIGH SCHOOL EDUCATION AND YOU
WILL SEE THAT THAT SAME TREND IS
TRUE FOR MEN WHEREAS AMONG WOMEN
PREVALENCE IS SIMILAR FOR THOSE
WHO HAVE A HIGH SCHOOL OR MORE
EDUCATION.
WHAT'S DIFFERENT IN ADULTS THAN
CHILDREN IS THAT MOST ADULTS
TEND TO TAKE MORE THAN 1
PRODUCT.
SO AMONG USERS, 43% TAKE 1
PRODUCT REGULARLY BUT MORE THAN
10% TAKE 5 OR MORE PRODUCTS.
AGAIN VERY SIMILAR THEME,
MULTIVITAMIN, MULTIVITAMIN
MINERAL IS THE MOST COMMONLY
USED PRODUCT ACROSS ALL AGE
GROUPS.
LOOKING AT ASSOCIATIONS WITH
SUPPLEMENT USE AND WEIGHT STATUS
IN U.S. ADULTS, WE SEE THAT
UNDERWEIGHT AND OBESE TEND TO
HAVE LESS PREVALENCE OF USE THAN
ADULTS WHO ARE CATEGORIZED AS
NORMAL OR OVERWEIGHT BY BODY
MASS INDEX CATEGORIES.
WE INTRODUCED THE CONCEPT OF
FOOD SECURITY AND SECTION ON
CHILDREN AND THE TRANSFER WERE
SEEN IN ADULTS REGARDLESS OF SEX
OR GENDER SUCH THAT INDIVIDUALS
WITH FOOD INSECURITY ARE MORE
LIKELY TO USE DIETARY SUM
ELEMENTS.
SO AS WE LOOK AT DATA AND OTHER
LIFE STAGES BY POVERTY INCOME
RATIO, WE SEE THE EXACT SAME
TRENDS HERE IN U.S. ADULTS.
AND WHAT'S INTERESTING IS NOT
ONLY PREVALENCE BUT THE NUMBER
OF SUPPLEMENTS, VARY ACCORDING
TO POVERTY TO INCOME RATIO AND
YOU CAN SEE THOSE NUMBERS
PRESENTED HERE AND THEY'RE
EXPLAINED IN FULL DETAIL IN THIS
PUBLICATION.
IN TERMS OF PARTICIPATE NOTHING
SNAP, REMEMBER WE TALKED ABOUT
SNAP BEFORE, THE SUPPLEMENTAL
NUTRITION ASSISTANCE PRESENTLY,
OVER ALL AND BY SEX THERE ARE
SIGNIFICANT DIFFERENCES BY THOSE
WHO PARTICIPATE IN THE PROGRAM,
THOSE WHO ARE INCOME ELIGIBLE
BUT CHOOSE NOT TO PARTICIPATE
AND THOSE WHO ARE NOT ELIGIBLE
BASED ON THEIR INCOME.
SO VERY SIMILAR TRENDS IN,A
DULTS THAT WE SAW IN OTHER LIFE
STAGE GROUPS.
AND THEN FINALLY WE'LL TALK MORE
SPECIFICALLY ABOUT OLDER ADULTS
AND DR. GAHCHE LED THIS ANALYSIS
AS WELL, AND OLDER ASULTS USE
AROUND--70% OF THE U.S. OLDER
ADULTS ROUTINELY TAKE A DIETARY
SUPPLEMENT.
I WILL NOT SHOW YOU THE INTER
DATA, BUT IT MIRRORS WHAT WE SAW
ON THE ENTIRE ADULT POPULATION.
WHAT I WILL COMMENT ON IS NEARLY
ONE-THIRD OF OLDER ADULTS TAKE 4
OR MORE PRODUCTS DAY SO THIS IS
SLIGHTLY HIGHER THAN ADULTS IN
GENERAL AND WE KNOW THAT OLDER
ADULTS ALSO TEND TO USE MORE
PRESCRIPTION MEDICATIONS SO THIS
IS SOMETHING WE ALWAYS ASK
ADULTS TO DISCLOSE TO THEIR
HEALTHCARE PRACTICE
RESEARCHITION BECAUSE THERE CAN
BE NUTRIENT-NUCLEOTIDES
T-REGENT, AND NUTRIENT-DRUG
ACTIONS.
LOOKING AT THE U.S. OLDER ADULT
POPULATION BY SPECIFIC AGE
CATEGORIES AND THOSE SAME TRENDS
WE TALKED ABOUT CONTINUE TO
PERSIST WITH MORE THAN 80% OF 80
YEAR-OLDS REPORTING THE USE OF A
DIETARY SUPPLEMENT.
PRIMARILY AS WE'VE SEEN IN OTHER
AGE GROUPS, MULTIVITAMIN OR
MINERAL VITAMIN D SUPPLEMENT SO
WE ARE LOOKINGA THE USERS AND
NONUSERS COMBINED WHEN WE GIVE
YOU AN ESTIMATE LIKE 39%.
SO 39% OF THE ENTIRE U.S. ADULT
POPULATION OVER THE AGE OF 60 IS
USING A MULTIVITAMIN
MULTIMINERAL.
AS WE'VE TALKED ABOUT AD
NAUSEUM, WOMEN USE MORE THAN MEN
ACROSS MOST LIFE STAGES,
PARTICULARLY IN ADULTHOOD.
THIS IS LOOKING AT AGAIN, THE
POPULATION OF OLDER ADULTS AND
THESE SAME THEMES EXIST IN OLDER
ADULTINGS AND THE ENTIRE ADULT
POPULATION SO WE WON'T SPEND
VERY MUCH TIME GOING THROUGH
EACH OF THESE ESTIMATES HERE.
I'D LIKE TO DO A REALLY QUICK
CONCLUSION AND SUMMARY AND SOME
CAVEATS.
SO I HOPE I'VE CONVINCE YOU THAT
DIETARY SUPPLEMENT USE AND WIDE
SPREAD IN THE U.S. WITH MORE
THAN A THIRD OF CHILDREN, AND
MORE THAN HALF OF ADULTS
ROUTINELY REPORTING USE.
WE KNOW THIS FROM THE AT-HOME
PRODUCT INVENTORY FROM THE
NHANES SURVEY.
THERE ARE SOME POPULATION
SUBGROUPS THAT TEND TO USE MORE.
WE TALKED ABOUT PREGNANT AND
LACTATING WOMEN AND WE ALSO
TALKED ABOUT OLDER ADULTS BUT
THERE ARE SPECIFIC POPULATIONS
THAT ARE IN THE U.S. THAT ARE
ALSO HIGH USE GROUPS THAT ARE
NOT CAPTURED IN NHANES.
SO WE KNOW THAT ACTIVE MILITARY
FOR EXAMPLE HAVE A VERY HIGH
PREVALENCE OF USE, CANCER
SURVIVORS HAVE A VERY HIGH
PREVALENCE OF USE.
WHEY WANTED TO DO TODAY WAS GIVE
YOU VERY BROAD BRUSH STROKES OF
THE U.S. LANDSCAPE BUT THERE ARE
OTHER GROUPS THAT ARE HIGH USERS
THAT NEED TO BE CONSIDERED.
WE TALKED ABOUT THE VARIOUS
DEMOGRAPHIC AND LIFESTYLE
FACTORS, THAT ARE ASSOCIATED
WITH DIETARY SUPPLEMENT USE.
WE TALKED ABOUT HOW MOST OF
THOSE ARE SIMILAR IN ADULTS AND
CHILDREN, BUT THERE ARE SOME
DIFFERENCES PARTICULARLY WITH
REGARD TO SEX AND GENDER
DIFFERENCES, AND MULTIVITAMIN
MINERAL USE IN CHILDREN, VERSUS
ADULTS.
BY AND LARGE, WE HAVE SAID IN AT
LEAST 3 TIMES, MULTIVITAMIN
MINERALS ARE THE MOST COMMONLY
USED REGARDLESS OF WHAT STAGE OF
THE LIFE COURSE WE LOOKED AT.
AND IT'S IMPORTANT THAT WE
MEASURE ACCURATELY THE NUTRIENT
CONTRIBUTIONS FROM DIETARY
SUPPLEMENTS BECAUSE OTHERWISE,
WE ARE UNDER ESTIMATING NUTRIENT
EXPOSURES.
SO THERE'S ALWAYS LIMITATIONS
AND CAVEATS TO CONSIDER WITH ANY
TYPE OF ANALYSIS AND OURS IS NO
DIFFERENT.
SO SELF-REPORTED DIETARY DATA
ARE PRONE TO SYSTEMATIC ERRORS,
IN SOME WAYS WE CAN GET AROUND
THAT WITH THE AT-HOME PRODUCT
INVENTORY BUT THERE'S ALWAYS
MEASUREMENT ERROR AND WE KNOW
VERY LITTLE ABOUT THE
MEASUREMENT ERROR STRUCTURE OF
REPORTING OF DIETARY SUPPLEMENTS
WHICH IS LIKELY TO DIFFER VERY
MUCH FROM THAT OF FOODS AND
BEVERAGES.
SO WITH THAT I WILL CLOSE AND I
WILL SAY AGAIN, HAPPY BOTHER
DAY, HAPPY ANNIVERSARY OFFICE OF
DIETARY SUPPLEMENTS, I HAD A
WONDERFUL TIME WHEN I WORKED
THERE, NOT ONLY PROFESSIONAL BUT
PERSONALLY, WITH SO MANY PEOPLE.
AND THESE ARE JUST A FEW PHOTOS
THAT I HAD ON MY COMPUTER OF
REALLY HAPPY MOMENTS WITH PEOPLE
IN THE OFFICE AND IT'S A GREAT
PLACE TO WORK AND I HOPE THAT
YOU CONTINUE TO DRIVE IN THE
NEXT 25 YEARS.
SO THANK YOU IF ARE YOUR TIME
AND ATTENTION, THANK YOU TO ALL
THE WONDERFUL COLLEAGUES AND
COLLABORATORS THAT I HAVE BOTH
AT ODS AND TO PURDUE UNIVERSITY
AND HERE'S MY E-MAIL ADDRESS IF
YOU WOULD LOAMACYIC TO CONTACT
ME, IF HAVE YOU ANY QUESTIONS
REGARDING ANY OF THE DATA I
PRESENTED.
THANKS AGAIN.
>>THANK YOU
DR. BAILEY WILL BE TAKING
QUESTIONS RIGHT AFTER OUR NEXT
SPEAKER, WE WILL DO A PANEL
DISCUSSION.
BUT NOW WE HAVE DR. JOHANNA,
DWYER, SHE IS A SENIOR NUTRITION
SCIENTIST IN THE OFFICE OF
DIETARY SUPPLEMENTS SHE IS ALSO
DIRECTOR OF THE FRANCIS TUSTS
CENTER, AS WELL AS A SENIOR
SCIENTIST AT THE GENE MIER FREED
MAN SCHOOL OF NUTRITION SCIENCE
AND POLICY [INDISCERNIBLE].
I'M SORRY AT THE UNITED STATES
DEPARTMENT OF AGRICULTURE HUMAN
NUTRITION RESEARCH CENTER ON
AGING AT TUFSs, SO PLEASE TELL
US ABOUT WHY AMERICANS ARE USING
DIETARY SUPPLEMENTS AND WE THEN
WE WILL HAVE A PANEL DISCUSSION
AFTERWARDS.
THANK YOU.
>> DR. JOHANNA DWYER, SHE IS
PROFESSOR AT THE COMMUNITY OF
HEALTH AT TUSTS UNIVERSITY
SCHOOL OF MEDICINE AND ALSOA
FREED MAN SCIENCE AND POLICY AT
TUFTs AND AS WELL AS A
SCIENTIST WITH HUMAN NUTRITION
RESEARCH CENTER ON AGING AT
TUFTs, SO PLEASE WELCOME
DR. DWYER AND SHE WILL TELL US
ALL ABOUT WHY AMERICANS ARE
USING DIETARY SUPPLEMENTS.
>> I'LL TELL YOU A LITTLE BIT
ABOUT IT.
>> [LAUGHTER]
>> LET ME GO THROUGH 5
QUESTIONS, FIRST OF ALL WHY DO
MOTIVATIONS MATTER, HOW WE FIND
OUT ABOUT MOTIVATIONS.
>> WHAT REASONS PEOPLE ARE
GIVING FOR USING SUPPLEMENTS.
HOW THE REASONS DIFFER FROM
GROUP TO GROUP.
AND THEN FINALLY FOR THOSE THAT
ARE PRACTITIONERS ARE SOME
PRACTICE IMPLICATIONS.
SO LET'S FIRST OF ALL THINK
ABOUT WHY WE REALLY CARE ABOUT
MOTIVATIONS.
IT SEEMS TO ME THERE ARE 3 BIG
REASONS.
ONE IS WE WANT TO KNOW WHY
PEOPLE USE SUPPLEMENTS FOR
DEALING WITH HEALTH PROBLEMS AND
THERE ARE MANY REASONS.
THE SECOND IS SOMETIMES KNOWING
MOTIVATIONS CAN GIVE US WARNING
SIGNS OF INAPPROPRIATE USE AND
THIRD, IT CAN GIVE US STRATEGIES
FOR ENCOURAGING OR DISCOURAGING
USE AND LET ME JUST GIVE YOU 1
LITTLE EXAMPLE OF THAT.
I THINK REGAN WAS THE 1 WHO
TALKED ABOUT VITAMIN D AND SO
LET'S TAKE A CASE IN POINT.
VITAMIN D STATUS IN EXCLUSIVELY
BREAST FED INFANTS, THESE ARE
INFANTS EXCLUSIVELY BREAST FED
FOR LIKE 6 MONTHS OR SO AND
ABOUT 45% OF WOMEN WHO
EXCLUSIVELY BREAST FEED THEIR
INFANTS DIDN'T SUPPLEMENT WITH
VITAMIN D.
THIS WAS IN A LITTLE STUDY.
AND WHEN THEY WENT IN
INVESTIGATED WHY, IT TURNED OUT
SOME OF THEM ASSUME THAD BREAST
MILK HAD ENOUGH.
OTHERS WERE FEEDING A LITTLE BIT
OF FORMULA NOW AND THEN AND
BECAUSE THEY--THE FORMULAS ARE
ADVERTISED AS BEING COMPLETE
WITH ALL NUTRIENTS AND OF COURSE
THEY ARE, THEY FELT LIKE FEEDING
A LITTLE BIT OF FORMULA WAS
ENOUGH AND THEY WOULD BE FINE.
SOMETIMES THE MOTHERS SAID THE
BABY DIDN'T LIKE IT OR MAYBE THE
MOTHER DIDN'T LIKE IT WHEN SHE
TASTED THE SUPPLEMENT AND
FINALLY THERE WAS A LACK OF
KNOWLEDGE.
SO BASIC POINT HERE IS THAT
KNOWING THE REASONS WHY WOMEN
WERE NOT USING SUPPLEMENTS
REALLY HELPED A LOT IN TERMS OF
COMING UP WITH SOLUTIONS THAT
WOULD FOCUS ON DEALING WITH
THOSE REASONS ONCE IT BECAME
CLEAR WHAT WAS GOING ON.
SO IT IS IMPORTANT TO KNOW ABOUT
MOTIVATION.
LET'S JUST SPEND A LITTLE BIT OF
TIME FINDING OUT ABOUT
MOTIVATIONS FOR SUPPLEMENT USE.
AND REGAN POINTED OUT THE MANY
DIFFERENCES BETWEEN PEOPLE IN
TERMS OF DIETARY SUPPLEMENT USE
THAT REALLY DIFFERENT PEOPLE
FROM THOSE WHO DON'T USE
SUPPLEMENTS WILL SEE THAT AS WE
GO THROUGH THE TALK.
LET'S JUST THINK OF 4 DIFFERENT
WAYS THAT CAN YOU FIND OUT A
LITTLE BIT ABOUT MOTIVATIONS, 1
IS SALES, 1 IS SURVEYS, 1 IS
FOCUS GROUPS, AND THEN THE LAST
1 I LIKE TO TALK ABOUT IS WEB
RELATED.
AND THIS IS NEW THIS YEAR
BECAUSE WE'VE JUST DONE SOME
STUDIES ON THIS.
OKAY.
STARTING OFF WITH SALES, JAMIE
MENTIONED THIS IN HER TALK AND
IT IS A USEFUL THING TO LOOK AT
NATIONAL BUSINESS JOURNAL OR
NUTRITION BUSINESS JOURNAL OR
OTHER SOURCES OF SALES DATA BUT
YOU CAN ONLY INFER THE
MOTIVATIONS FROM THESE DATA,
NEVERTHELESS, THEY DO GIVE YOU
PRETTY GOOD IDEA OF WHAT PEOPLE
ARE WILLING TO PAY FOR.
THE THEMES ARE THAT SALES
REFLECT PRICE AND NOT PREVALENCE
OF USE.
SO, FOR INSTANCE, A MULTIVIETA
VITAMIN SUPPLEMENT YOU GET AT
CVS OR REXALL, IS A FAIRLY CHEAP
PRODUCT, NOT VERY EXPENSIVE AND
SOME OF THE CONDITION SPECIFIC
SUPPLEMENTS I'LL SHOW YOU IN A
MINUTE ARE VERY EXPENSIVE.
SO SALES DON'T REFLECT
PREVALENCE OF USE AND THEN THE
OTHER THING IS YOU CAN'T REALLY
TELL WHICH IS THE CHICKEN AND
WHICH IS THE EGG, WHETHER THE
MOTIVATIONS THAT ARE INFERRED
FROM SUPPLEMENTS MARKETING
PITCHES OR ACTUALLY THE
BEGINNING, FOR INSTANCE, A
PERFORMANCE ENHANCER, PEOPLE WHO
TAKE PERFORMANCE ENHANCERS DO IT
BECAUSE THEY WANT TO ENHANCE
THEIR PERFORMANCE OR IS IT THAT
THEY'RE CONVINCED FROM THE END?
I'LL COME BACK TO THAT LATER.
REGAN DID A GREAT JOB TALKING
ABOUT SOME OF THE FEDERAL
POPULATION BASED SURVEYS AND I
WILL GO THROUGH THEM RATHER
QUICKLY.
BUT THEY'RE EXTREMELY VALUABLE
INCLUDING FOR MOTIVATION.
THE COMMERCIAL SURVEYS AND SMALL
SURVEYS ALSO HAVE A PLACE
THOUGH, BECAUSE THE FEDERAL
SURVEYS ARE COMMINATED BY THE
PREVALENCE OF USE OF
MULTIVITAMIN VALENTINED
SUPPLEMENTS SO IT'S HARD TO GET
AT THESE OTHER SUPPLEMENTS THAT
MAY BE OF INTEREST PARTICULARLY
FOR CLIN IPGZS AND FOR CONCERNS
ABOUT DRUG NUTRIENT IRCHT
ACTIONS.
OKAY, LET'S START WITH THE
NATIONAL HEALTH AND YOU HAD
TRICIAN EXAM NATION SURVEY.
CAN YOU GET TOTAL DIETARY
EXPOSURE FROM ALL FOOD
SUPLEAPTS, DRUGS, YOU CAN GET
ASSOCIATIONS OF MOTIVATIONS WITH
DEMOGRAPHICS AND WITH LAB
VALUES, YOU CAN GET TIME TRENDS,
THEY'RE REPRESENTATIVE OF THE
U.S. AMBULATORY POPULATION AND
THEY'RE FREE.
SO THERE'S EVERY REASON TO USE
THIS RESOURCE.
THE PROBLEMS THOUGH,
PARTICULARLY TODAY BECAUSE OF
THE COVID YEAR, ARE THAT
RESPONSE RATES ARE LOW AND THE
OTHER POINT IS THAT THE DATA ARE
IECIALLY A COUPLE YEAR AND HALF
OR SO AFTER THEY WERE COLLECTED
AND CROSS SECTIONAL AND A COMMON
MISTAKE IS ASSUMING THAT YOU CAN
INFER CAUSATION FROM THAT, AND
YOU REALLY CAN'T JUST BECAUSE
THERE'S A CORRELATION DOESN'T
MEAN CAUSATION.
AND THE AMOUNT OF NUCLEOTIDES
T-REGENT CONTAINING SUPPLEMENTS
ARE PROVIDED BUT FOR NONMUSEUM
TRIENT SUPPLEMENTINGS IT'S
DIFFICULT TO GET THEM OUT.
SECOND BIG NATIONAL SURVEY AND
THE NATIONAL HEALTH SURVEY, IT'S
POPULATION BASED.
WHAT I LIKED ABOUT IT, WE USED
IT FOR RESEARCH ON 1 PAPER,
THEY'RE VERY LARGE NUMBERS AND
YOU CAN GET AT SOME OF THESE
LESS COMMONLY USED SUPPLEMENTS
LIKE MELATONIN, COQ10 AND SO
FORTH, AND THE PROBLEM IS THAT
THE SOUP ELEMENTS ARE GROUPED IN
BIG CATEGORIES LIKE MULTIVITAMIN
MINERAL, SINGLE VITAMIN,
NONNUTRIENT, NONVITAMIN,
NONMINERAL BUT IT DOES GET AT
THESE LESS POPULAR PRODUCTS.
THE OTHER NICE THING ABOUT IT IS
ABOUT EVERY 5 YEARS BUT I DON'T
THINK LATELY, THE NATIONAL
INSTITUTION OF INTEGRATED AND
ALTERNATIVE MEDICINE DOES A
SUPPLEMENT WHICH GOES INTO GREAT
DEPTH IN TERMS OF COMPLEMENTAR
SKPE BAKUGAN ALTERNATIVE
MEDICINE AND ALSO A FAIR AMOUNT
OF DIETARY SUPPLEMENTS.
THE PROBLEM IS, THERE AREN'T ANY
MEASURES OF HEALTH OR OUTCOMES
LIKE THERE ARE FOR HANES WHERE
YOU CAN HITCH UP WITH THE
NATIONAL DEATH INDEX, THERE'S NO
NATIONAL DIETARY INDEX SO YOU
CAN'T CALCULATE NUCLEOTIDES TRI
INTAKE AND THE DATA IS QUITE
BIG, BECAUSE THE LAST BIG SURVEY
TOO INCLUDED A LOT ON
SIGNIFYETARY SUPPLEMENTS WAS
BACK IN 2012 SO THERE'S LITTLE
CURRENT DATA.
THE OTHER NATIONAL SURVEYS
INCLUDE THE NATIONAL MARKETING
INSTITUTE SURVEYS AND ALSO
SOMETIMES NEILSEN WILL DO A
NATIONAL SURVEY.
THE PRO HERE, IS THAT SOME
LIMITED TREND DATA ARE
AVAILABLE.
THE SURVEY, YOU PAY TO PLAY.
WHAT YOU DO IS YOU BUY A
QUESTION IF YOU'RE A COMPANY AND
THEY GET IT TO TEST IT FOR YOU
AND THEN THEY PUT IT ON THE
SURVEY AND YOU GET AN ANSWER
USUALLY IN A COUPLE MONTHS.
SO THE TURNOVER IS RAPID, AND
AGAIN, THE SURVEY TENDS TO GET
IT RARELY USED SUPPLEMENTS WHICH
IS OF INTEREST AND THERE ISN'T
MUCH NHANES ON SOME OF THEM.
THE CONS ARE, THIS ISN'T FOR
PUBLIC USE, YOU HAVE TO PAY THIS
GOET THIS SURVEY AND THE MORE
YOU PAY, THE MORE INFORMATION
YOU GET.
THE QUESTION HERE IS THERE ARE
PROBLEMS WITH WITH SOME OF THE
QUESTIONS AREN'T REALLY CONSUMER
CONTESTED SO IT CAN BE DIFFICULT
TO INTERPRET WHAT ACTUALLY IS
BEING GOTTEN AT.
THERE'S LIMITED DIETARY, ISICAL
AND OUTCOME DATA AND I THINK IN
SOME CASES, THE SURVEYS AREN'T
REPRESENTATIVE EVEN THOUGH
THEY'RE INNATE, IT SEEMS LIKE
THEY OVERSAMPLE USERS WHEN YOU
COMPARE IT TO SOMETHING LIKE
HANES FOR EXAMPLE.
AND THE FORMAT IS LARGELY WEB
BASED SO IF YOU'RE CONCERNED
ABOUT COMPUTER ILLITERATE PEOPLE
AS MANY ELTONJOHNERLY PEOPLE ARE
AND IMMIGRANTS WHO DON'T SPEAK
ENGLISH, YOU WILL NOT GET VERY
MUCH NECESSARILY FROM THESE
SURVEYS.
WHAT ABOUT SPECIAL GROUPS?
THERE ARE A LOT OF SPECIAL USE
THINGS HERE.
THERE WERE [INDISCERNIBLE]
SURVIVORS, CANCER SURVIVORS, HIV
PATIENTS AND SURVEY PROVIDERS
PHYSICIANS, DIETITIANS AND SO
FORTH, THE PURPOSE OF THESE
SURVEYS ARE THAT THEY EXPLAIN
THE BEHAVIOR AND MOTIVATION OF
SUBGROUPS OF SPECIAL INTEREST OR
SPECIAL RISK, THERE ARE U.S.
LEADERSHIP VERY USEFUL IN
GETTING INSIGHT ON USERS, 1 FOR
CRAFTING INTERVENTIONS, IN TERMS
OF SOME OF THE DISADVANTAGES
HERE, 1 IS THAT AGAIN THE ITEMS
MAY BE POORLY WORDED AND
UNTESTED SO THE MEANING IS
DIFFICULT TO GET FOR THE
RESPONDENT AND WHAT I WOULD
SUGGEST IF YOU'RE THINKING OF
DOING SUCH A SURVEY.
USE THE NATIONALLY TESTED 1S
THAT ARE ON HANES OR ON THE
NATIONAL HEALTH INTERVIEW
SURVEY, THEY'RE FREE AND YOU CAN
USE THEM WITHOUT ASKING, CAN YOU
JUST USE THEM AND THEY HAVE BEEN
TESTED.
THE OTHER PROBLEMS WITH THESE
SURVEYS, IS VERY OFTEN THEY'RE
REPRESENTED, IT'S JUST A GROUP I
DIETITIANS RATHER THAN ALL THE
DIETITIANS IN THE COUNTRY OR ALL
THE PHARMACISTS AND THE RESPONSE
RATES ARE OFTEN VERY LOW,
PARTICULARLY IF THEY'RE WEB
BASED, SOMETIMES THEY RUN, 1,
2,S 3,% WHICH PROBABLY ISN'T
ENOUGH TO BE REPRESENTATIVE.
NEVERTHELESS, THEY GIVE REALLY
USEFUL INFORMATION.
LET ME GIVE AN EXAMPLE AGAIN OF
WHY IT IS IMPORTANT TO STUDY
SOME OF THESE THINGS AND AGAIN,
IT GOES RIGHT BACK TO SOMETHING
I THINK REGAN TALKED ABOUT,
WHICH WAS PRENATALS.
AND I CHOSE AN IRISH EXAMPLE
BECAUSE I'M OF IRISH DESCENT BUT
IN IRELAND THE FOOD SUPPLY TENDS
TO BE UNFORTIFIED WITH FOLIC
ACID AND FOALATE INTAKES TEND TO
BE ON THE LOW SIDE, SO 1 OF THE
PROBLEMS IN IRELAND WAS A HIGH
PREVALENCE OF NARROW 2 DEFECTS
EVEN AS A THIS HAD A COMPAIN ON
FOA05 ON CONNECTIONS AND THE
NEED FOR INCREASING FOLIC ACID,
PRECONCEPT EALSZ AND IN FIFTH
AND 96% OF WOMEN TOOK FOLIC ACID
DURING PREGNANCY BECAUSE THEY
HAVE A NATIONAL HEALTH SERVICE
AND THEY GO TO THE DOCTOR AND
THE DOCTOR WILL GIVE THEM A
FOALATE IRON SUPPLEMENT, THE
PROBLEM WAS ONLY 25% TOOK FOLIC
ACID SUPPLEMENT CONTAINING
SUPPLEMENT PREINATE,
PRECONCEPTIONALLY, AND
PRECONCEPTUALLY, TOO, I GUESS AT
THE VERY TIME WHEN YOU REALLY
NEEDED IT IF YOU'RE GOING TO
LOWER THE PREVALENCE OF NEURAL
TUBE DEFECTS BECAUSE THE NEURAL
TUBE CLOSES IN THOSE FIRST FEW
WEEKS OF PREGNANCY, NOT LATER
ON.
WELL THEY DID SOME INVESTIGATION
OF WHAT WAS GOING ON HERE AND
WHAT THEY FOUND WAS THAT MANY
WOMEN DIDN'T EXPECT TO GET
PREGNANT SO THEY WEREN'T LOOKING
TO GET PREGNANT AND FIGURED THEY
WOULDN'T ALTHOUGH THEY DID AND
SO THEY WEREN'T PACIFIC
NORTHWESTING A SUPPLEMENT.
ARGTS WERE POOR OR THEY WERE
IMMIGRANTS WHO DIDN'T SPEAK
ENGLISH AND THEY WERE UNAWARE OF
THE NEURAL TUBE DEFECT RISK AND
THIS MEDIVATION LED TO BETTER
PUBLIC HEALTH PRESSURES TO
ADDRESS THE PROBLEM.
OKAY, FOCUS GROUPS, JUST TO
MENTION HERE, THEY DO PROVIDE
NUANCED INSIGHT INTO WHAT IS
BEHIND THE USE AND THIS IS DONE
BY TD NATIONAL CENTER FOR HEALTH
STATISTICS TO CLAWRIFY THEIR
QUESTIONS AND THAT'S WHY I SAY
USE THEM IF YOU CAN, THOSE
QUESTION SAYS.
THE PROBLEM IS IT'S VERY
EXPENSIVE, THE USERS, THE
INTERVIEWERS HAD TO BE VERY WELL
TRAINED AND YOU ALSO NEED
COGNITIVE PSYCHOLOGIST TO REALLY
UNDERSTAND WHAT'S GOING ON WHEN
YOU THE ANALYSIS OF REPLAY AND
REREADING WHAT THE PEOPLE HAVE
SAID AND IN INTERPRETATION TENDS
TO BE QUALITATIVE AND
SUBJECTIVE.
HERE AT ODS, WE FOUND THEM VERY
USEFUL FOR GETTING AT THE
DIFFERENCES BETWEEN USERS WHO
ARE BASICALLY MULTIVITAMINERAL
SUPPLEMENT USERS AND SOME OF THE
VERY HEAVY USERS THAT REGAN WAS
TALKING ABOUT HERBALS AND
BOTANICALS, IT'S A SMALL GROUP
OF SUPPLEMENT USERS BUT IT'S
VERY IMPORTANT AS YOU WILL SEE
IN A MINUTE WHEN WE TALK ABOUT
CONDITION SPECIFIC SUPPLEMENTS.
THE FINAL WAY OF STUDYING
MOTIVATIONS, I WOULD LIKE TO
TALK ABOUT IS A LITTLE FARTHER
UPFIELD AND THAT IS USING
DATABASES, OF THE DIETARY
SUPPLEMENT LABELED DATABASE THAT
JAMIE MENTIONED AND YOU WILL
HEAR MORE ABOUT LATER I THINK IS
USEFUL TO SEARCH SUPPLEMENT
DATABASES LIKE THIS FOR SLAIBL
CLAIMS AND SEE WHAT'S GOING ON
HERE, AND TRY TO ELABORATE ON
THIS IN THE NEXT IF YOU MINUTES.
THE PROS OF THIS ARE THE
DATABASE CONTAINS EVERYTHING ON
THE LABEL INCLUDING CLAIMS.
AND IT'S POSSIBLE TO AT LEAST
GET SOME IDEA OF MOTIVATIONS
FROM PURCHASES, PRODUCTS, WITH
CERTAIN MARKETING CLAIMS, AGAIN
IT'S ALL IN PRINT, IT'S NOT
REALLY THE MOTIVATION ITSELF,
THE PERSON ISN'T TELLING YOU.
THEY'RE JUST BUYING SOMETHING.
DURING THESE KINDS OF SEARCHES
OF DATABASES DOES REQUIRE SOME
TECHNICAL EXPERTISE AND IT TAKES
A LOT OF TIME.
AND IT'S LIMITED TO THE LABELS
THAT ARE INCLUDED IN THE
DATABASE BUT WE'RE UP TO 126,000
NOW, IN TERMS OF THE DIETARY
SUPPLEMENT LABELED DAILY BASIS
THEA BASE, IT'S A PUBLIC USE
DATABASE, CAN YOU GO ON WEB AND
GET IT.
AND YET THERE'S STILL SOME
SUPPLEMENTS THAT ARE STILL NOT
IN THERE.
NEVERTHELESS, LOOKING AT IT
TELLS A LOT AND I WILL TRY TO
TALK MORE ABOUT THAT IF YOU WANT
LATER.
LET ME JUST GO OVER AND MENTION
AGAIN, WHY PEOPLE USE
SUPPLEMENTS.
REGAN MENTIONED THE LAW AND I
THINK JAIME DID TOO WHICH IS TO
SUPPLEMENT THE DIET.
THERE ARE MANY OTHER REASONS AS
WELL.
WE KNOW THIS FROM EVERYTHING
WE'VE STUDIED HERE IS A PAPER
THAT REGAN DID AND JAIME WAS ON,
LOOKING AT SOME OF THE
MOTIVATIONS FOR USING
SUPPLEMENTS AND PEOPLE SAID,
SUPPLEMENT THE DIET BUT THEY
SAID IT ONLY ABOUT 20% OF THE
TIME.
THE MAIN REASONS WERE OTHER
THINGS LIKE IMPROVING HEALTH AND
MAINTAINING HEALTH, PREVENTING
HEALTH PROBLEMS.
SO HEALTH PROMOTION, MAINTENANCE
AND PREVENTION ARE COMMON
MOTIVATIONS FOR SUPPLEMENT USE.
AND THE MOTIVATIONS ALSO VARY AS
CAN YOU SEE IN THIS SLIDE,
DEPENDING ON WHICH SUPPLEMENT
YOU'RE TALKING ABOUT.
IF YOU ARE TALKING ABOUT A
MULTIVITAMIN MINERAL SUPPLEMENT
DOWN AT THE BOTTOM OF THIS
SLIDE, CAN YOU SEE THAT ABOUT
HALF OF ALL PEOPLE GAVE THAT AS
THEIR FIRST REASON FOR USING
SUPPLEMENTS, WHEREAS FOR
BOTANICALS IT WAS ONLY ABOUT 25%
AND IT VARIED WITH OTHER
VITAMINS AND MINERAL
COMBINATIONS WITH RESPECT TO HOW
COMMON THIS WAS AS A REASON.
WHEN WE GO TO NONVITAMIN,
NONMINERAL SUPPLEMENTS, THINGS
LIKE MELATONIN, COQ10, THINGS
LIKE THAT, WELLNESS REASONS
CONTINUE TO BE A MAIN REASON,
BUT THEN AGAIN THERE'S THIS
SMALL SUBGROUP BUT NEVERTHELESS
A BIG SUBGROUP WHICH IT COMES TO
THE NUMBER OF AMERICANS WHO ARE
USING IT TO TREAT A CONDITION
AND PARTICULARLY FOR THE
NONVITAMIN NONMINERAL
SUPPLEMENTS THIS SEEMS TO BE AN
ISSUE.
SO ALTHOUGH MOST SUPPLEMENTS ARE
BEING USED FOR WELLNESS, NOT
DISEASE TREATMENT, THERE IS A
GROUP THAT ARE USING THEM FOR
THIS PURPOSE.
SO THE MOTIVATIONS VARY ALL OVER
THE MAP AND I WOULD LIKE TO
SPEND A LITTLE MORE TIME ON THE
CONDITION SPECIFIC, THAT IS
THOSE THOSE THAT ARE USED OR
ASSOCIATED WITH ILLNESS OR
DISEASE BECAUSE I THINK THIS IS
VERY IMPORTANT TO RESEARCH
FURTHER.
NOW, WHAT WE CALL DISEASE OR
CONDITION SPECIFIC REASONS FOR
USE, HAVE TO DO WITH SOME
CONDITION, WHETHER IT'S OBESITY,
OR COPD, OR KIDNEY DISEASE,
WHATEVER IT MIGHT BE, SOME
DISEASE OR ILLNESS OR CONDITION.
WHY DO PEOPLE DO THIS, WELL,
PART OF IT, I THINK COMES
BECAUSE SUPPLEMENTS ARE VIEWED
BY MANY, MANY PEOPLE IN THE
UNITED STATES, IT'S HARMLESS AND
OVERLOOKED, AND POWERFUL
EFFECTIVE TREATMENTS, PEOPLE
TURN TO SUPPLEMENTS, IF OTHER
PEOPLE AREN'T CURED OR THEY'RE
INEFFECTIVE FOR EXAMPLE IN THE
EARLY--LATE 80S AND EARLY 90S,
WE DID A LOT OF STUDIES UP AT
TUFTs, AND TUFTs MEDICAL
CENTER ON HIV PATIENTS, HIV/AIDS
IN THOSE DAYS BEFORE PROTEASE
INHIBITORS, MANY, MANY OF THESE
PATIENTS WERE TAKING BOTANICALS,
PARTICULARLY ST. JOHNS WART FOR
DEPRESSION, THEY WERE VERY
MUCH--THEY WERE TAKING THEM
BECAUSE THERE WAS NO EFFECTIVE
TREATMENT AS THE AIDS ADVANCED.
ADVANCED CANCERS IS ANOTHER
COMMON CONDITION WHERE PEOPLE
AREN'T FINDING ANY TREATMENT
THAT'S HELPFUL AND THEY TURN TO
SUPPLEMENTS AS A LAST RESORT.
AND THEN THERE ARE PEOPLE WHO
FOR A VARIETY OF REASONS, REGAN
MENTIONED FINANCIAL, BUT THERE
ARE ALSO PERSONAL REASONS AND
OTHER REASONS BUT PEOPLE ARE
USING FOR SELF-TREATMENT.
SO FOR ALL THESE REASONS, THEY
MAY BE USING A CONDITION
SPECIFIC SUPPLEMENT.
AND REGAN AND JAMIE DID SOME
INTERESTING WORK ON MOTIVATIONS
FOR THESE CONDITION SPECIFIC
SUPPLEMENTS.
AGAIN, WITH HANES, THIS IS HANES
27 HPV 10 IN ADULTS, WHAT YOU
SEE HERE IS A NUMBER OF THE
SUPPLEMENTS FOR INSTANCE, IMMUNE
WHICH IS PURPLE, IT WAS VITAMIN
C THAT SEEMED TO BE THE
FAVORITE.
OR HEART HEALTH IT SEEMED TO BE
THE OMEGA 3s WHICH YOU
WOULDN'T BE SURPRISED ABOUT AND
THEN FOR CALCIUM AND VITAMIN D,
IT WAS BONE HEALTH.
IN A SENSE THESE SORT OF MARKETS
OR MOTIVATIONS ARE THE SAME AS
THE MARKETING CLAIMS AND SO THE
QUESTION IS WHICH COMES FIRST,
IS IT THE MARKETING CLAIM OR THE
MOTIVATION.
WELL, I THINK ALL OF THIS SHOWS
THAT CONSUMERS SEE SUPPLEMENTS
AS SAFE AND EFFECTIVE BECAUSE
THEY THINK THEY'RE APPROVED BY
THE GOVERNMENT BECAUSE THEY
THINK THEY'RE TESTED FOR SAFETY
AND EFFECTIVENESS AND THAT
THEY'RE ANALYZED FOR THEIR
CONTENTS BY SOMEBODY, PROBABLY
THE GOVERNMENT AND THEN, THE
PRODUCERS ARE REQUIRED TO
DISCLOSE KNOWN ADVERSE EFFECTS
TO CONSUMERS AND WHILE SOME OF
THIS IS TRUE, IT'S NOT
NECESSARILY TRUE THAT ALL OF
THOSE THINGS ARE PRESENT.
SO THOSE ARE THE MOTIVATING
INFLUENZS, REGAN MENTIONED THE
WHOLE ISSUE OF AUTHORITY WITH
RESPECT TO PRENATALS AND HOW
VERY OFTEN A DOCTOR WOULD
PRESCRIBE A PRENATAL BUT THERE
ARE ALSO TRUSTED SOURCES,
SOMETIMES IT'S A WIFE OR PARENT
OR FRIEND OR ROLE MODEL.
THERE ARE ALSO PEOPLE WHO ON
THEIR OWN WANT TO LOOK BETTER,
WEIGH LESS WHARKS HAVE YOU.
WELL THEY HAVE DIFFERENT WORLD
VIEW AND THAT'S WHAT WE FOUND
WITH SOME PEOPLE WHO WERE VERY
HIGH USERS OF HERBALS AND
BOTANICALS AND NONVITAMIN
NONMINERAL SUPPLEMENTS IT WAS
PART OF A WHOLE LIFESTYLE AND
THERE'S FINALLY ADVERTISING, LET
ME TOUCH ON A FEW OF THEM IN A
BIT MORE DEPTH BEFORE WE WIND UP
AND HAVE LUNCH.
FIRST OF ALL, IT'S USED BASED ON
AUTHORITATIVE ADVICE.
WE TALKED ABOUT PRENATALS ABOUT
YOU WHO PEOPLE REGARD AS
AUTHORITIES, AND WHAT THEY
CONSIDER EVIDENCE, VARIES A LOT.
SOMETIMES IT'S THE DOCTOR, BUT
SOMETIMES IT'S A COACH OR
TRAINER, AND THE QUESTION IS
WHETHER THE AMOUNT OF EVIDENCE
THEY'RE USE NOTHING ALL OF THOSE
CASES IS EXACTLY THE SAME.
NOW TONY FAUCI, DR. FAUCI AT
NIH, WE ARE VERY PROUD OF HIM,
SOME PEOPLE SAY HE'S THE BEST
KNOWN PHYSICIAN IN AMERICA, I'M
NOT SURE THAT'S RIGHT, I THINK
DR. GOOGLE IS EVEN MORE FAMOUS
THAN DR. FAUCI, AND THIS A PAPER
FROM A FEW YEARS AGO, SAYING
DR. GOOGLE WAS THE KEY
CONSULTANT FOR THE MAIORITY OF
CANCER PATIENTS AND I HAD A
COUPLE OF WONDERFUL STUDENTS UP
AT TUFTs MEDICAL CENTER AND WE
GOT INTEREST IN THIS.
SO WE DECIDE WE WOULD USE A WEB
BASEDDA, PROACH TO LOOKING AT
MOTIVATION TO ASK A QUESTION
LIKE SUPPLEMENTS AND CANCER, IF
YOU ARE DIAGNOSED WITH CANCER,
THE FIRST THING YOU TEND T DO
IS TO GO TO THE WEB AND TAKE A
LOOK ANDEE WHAT IT SAYS THERE.
AND SO, THE IDEA OF THIS WAS
THAT IT MORE OR LESS MIMICS SOME
PEOPLE'S BEHAVIOR WHEN THEY'RE
TRYING TO SEEK HELP AND GET
INFORMATION AND IT PROVIDES A
GLIMPSE OF WHAT'S OUT THERE.
IT'S NOT THE SAME AS WEBMD,
BECAUSE THAT'S NOT AVAILABLE TO
THE AVERAGE PERSON BUT A GOOGLE
SEARCH IS AVAILABLE TO MOST
EVERYBODY AND GOOGLE HAS A VAST
MAJORITY OF THE SEARCH ENGINE
USE IN THE COUNTRY AND PROBABLY
THE WORLD.
THE PROBLEM WITH THIS APPROACH
BEFORE GOING TO IT IS YOU CAN
ONLY MAKE INFERENCES AND WHAT
YOU GET IS A MIX OFADS AND
RESULTS PAGES WITH INFORMATION
ON THEM AND IT'S CALLITATIVE AND
SUBJECTIVE AND INTERPRETATION IS
HIGHY UBIQUITIN JECTIVE SO WITH
ALL THOSE CAVEATS, LET ME SHOW
WHAT YOU WE FOUND.
WE ASKED DR. GOOGLE, JUST TYPED
IN THE SEARCH TERM SUPPLEMENTS
AND CANCER AND WHAT
[INDISCERNIBLE] WHO WAS FIRST
AUTHOR ON THIS PROBLEM AND
[INDISCERNIBLE], WE CAME UP WITH
A TOTAL OF SOME 496 ADS AND
ABOUT 160 CONTENT PAGES SO THE
OVERWHELMING MAJORITY WERE THE
ADS, NOT THE CONTENT.
AND LET ME JUST BEFORE I SHOW
YOU THE RESULTS, MENTION THAT
THE DIETARY SUPPLEMENTS, ADS
THAT CAME UP DIDN'T REALLY HAVE
ILLEGAL CLAIMS ON THE LABEL, BUT
WHEN YOU TYPED IN SEARCH ENGINE
TERMS AND I WILL SHOW YOU THE
TERMS WEB CONNECTED TYPED IN,
YOU DID GET A DISPLAY OF ADS FOR
SPECIFIC SUPPLEMENTS SO IT WAS A
LITTLE SUBTLE.
NOW REMEMBER THAT A STRUCTURED
FUNCTION CLAIMS TO HELP MAINTAIN
OR SUPPORT THE BODY ARE LEGAL
AND SUPPLEMENTS, CAN YOU SAY
IMMUNE HEALTH, BUT YOU CAN'T SAY
IMMUNO DEFICIENCY AND YOU CAN'T
SAY CANCER.
BUT YOU CAN CLAIM TO DIAGNOSE,
TREAT OR PREVENT CANCER, YOU
CAN'T SAY TREATS OR PREVENTS
CANCER ON THE LABEL.
SO LET ME SHOW YOU WHAT THE
SEARCH DID.
PART OF THIS WAS THE PAPER AND
PART WAS THAT I DID LATER.
IF YOU SEARCH THE TERM
SUPPLEMENTS AND CANCER, WHAT YOU
COME UP WITH IS A LOT OF ADS, SO
LOOK AT THE PRICES ON SOME OF
THESE, 1 IS $650; IF YOU TYPE IN
SUPPLEMENTS TO PREVENT CANCER,
AGAIN, A WHOLE BUNCH OF THINGS
COME UP, IT'S NOT ON A LABEL BUT
IT COMES UP IN THE SEARCH.
IF YOU LOOK AT SUPPLEMENTS TO
TREAT CANCER, AGAIN, MANY
PRODUCTS COME UP.
AND SUPPLEMENTS TO SUPPORT
CANCER TREATMENT, AGAIN, A LOT
OF DIFFERENT SUPPLEMENTS COME UP
AGAIN.
IF YOU TYPE IN SUPPLEMENTS TO
CURE CANCER WHICH IS CLEARLY
ILLEGAL, NOTHING COMES UP SO
PEOPLE ARE A LITTLE HERE LEERY I
THINK OF ADVERTISING THAT
SOMETHING CURES CANCER BECAUSE
THEY KNOW THE FDA'S GOING TO
COME AFTER THEM OR FDC WILL COME
AFTER THAT.
OKAY, BACK TO THE STUDY THOUGH,
WHEN WE ASKED DR. GOOGLE IN
ADDITION TO THOSE HALF THOUSAND
ADS THAT WE FOUND, WE ALSO FOUND
ABOUT 160 CONTENT OR RESEARCH
RESULTS BEIGES AND WE--WE TRIED
TO RATE THEM IN TERMS OF THEIR
AUTHORITATIVENESS OR IN TERMS OF
THEIR HEALTH INFORMATION THAT
THEY CONTAIN.
AND WHAT WE FOUND IS THAT OHM
25% OF THEM, THAT ARE CIRCLED ON
THIS SLIDE REALLY SCORED HIGH IN
TERMS OF THE HEALTH INFORMATION
INDEX CRITERIA THAT WE USED.
TWENTY-FIVE% WERE HIGH QUALITY,
BUT EVEN THOSE WERE NOT EASY TO
COME UP WITH ON THE SEARCH, THEY
CAME UP LATER IN THE SEARCH
RATHER THAN EARLY AND OFTEN
THOSE THAT DID COME UP EVEN
THOUGH THEY WERE VERY HIGHLY
REPUTABLE GROUPS LIKE THE
NATIONAL CANCER INSTITUTE, VERY
OFTEN THEY WEREN'T EASILY
READABLE BY SOMEONE WITH AN
EIGHTH GRADE READING ABILITY.
SO THERE ARE STILL PROBLEMS IN
TERMS OF THE QUALITY.
AND THEN I SAW THIS IN A
DOCTOR'S OFFICE, PLEASE DON'T
CONFUSE YOUR GOOGLE SEARCH WITH
MY MANAGE DEGREE.
BACK TO SOME THEORIES THAT HAVE
BEEN ADVANCED BY SOCIAL STOF
THEDS TO EXPLAIN MOTIVATION,
THERE'S THE ADVERTISING AND
MARKETING, MEDICAL
SELF-TREATMENT, INSURANCE POLICY
SORT OF IDEAS AND LICENSING, LET
ME JUST RUN THROUGH THEM
QUICKLY.
AVERAGE, AS WE ALREADY TALKED
ABOUT IS COMMERCIAL SPEECH TO
SELL OR PERSUADE CONSUMERS, I
THINK IS SOMETHING WE NEED TO
STUDY A LOT MORE ABOUT.
THE IDEA HERE IS YOU NOTICE THE
AD, YOU UNDERSTAND WHAT IT'S
SAYING AS IN SOME OF THE ADS
I'VE JUST SHOWN YOU, YOU
CONCLUDE WELL THAT MAYBE THEY DO
SUPPORT CANCER TREATMENT, RETAIN
THAT BELIEF AND THEN YOU GO
AHEAD AND BUY THE SUPPLEMENT.
THIS IS ALL DETAILED FOR THOSE
WHO WANT TO DO FURTHER READING
ON IT IN THIS PARTICULAR BOOK.
LET ME ALSO MENTION A BIT MORE
ABOUT SELF-MEDICATION.
I THINK THERE ARE MANY REASONS
FOR THIS, THERE'S CERTAINLY A
PREFERENCE FOR SELF-MEDICATION,
I THINK WE ALL LIKE TO AVOID
GOING TO A HOSPITAL,
PARTICULARLY IN THESE DAYS OF
COVID.
OTHERS DISTRUST MEDICAL
CONVENTIONAL MEDICINE AND FEEL
THAT SELF-MEDICATION IS A BETTER
IDEA.
I'VE ALREADY TALKED ABOUT
DESPAIR DUE TO FAILED
CONVENTIONAL TREATMENTS, I KNOW
MY OWN BROTHER WHEN HE WAS DYING
OF COLON CANCER, HIS WIFE WAS
CONVINCED THAT SHARK CARTILAGE
WAS THE WAY TO GO AND HE DID NOT
TAKE IT BUT HE THROUGH IT DOWN
THE TOILET, BUT SHE WAS TRYING
TO GET HIM TO TAKE IT.
THERE'S A RELUCTANCE TO REVEAL A
HEALTH PROBLEM IN SOME CASES
THAT LEADS TO SELF-MEDICATION,
FOR EXAMPLE, USING GINGO-BILOBA,
IF YOU'RE AN OLDER PERSON WHO
BEGINS TO SEE THEIR MEMORY SLIP,
PEOPLE WITH PROBLEMS WITH SEXUAL
PERFORMANCE, PEOPLE WHO ARE
TRYING TO GET RID OF A HANG OVER
OR PEOPLE WHO ARE TRYING TO GET
RID OF AN ADDICTION.
AND THEN THERE'S THE WHOLE ISSUE
OF LACK OF MONEY FOR
CONVENTIONAL MEDICINE, THERAPIES
AND PARTICULARLY WITH PEOPLE WHO
LACK MONEY FOR ANTIPSYCHOTICS,
FOR EXAMPLE, THEY MAY GO TO
SUPPLEMENTS.
NOW LET ME JUST MENTION THE
BUSINESS AGAIN OF, I TALKED
ABOUT DESPAIR DUE TO FAILED
CONVENTIONAL TREATMENTS AND
JAMIE SHOWED THESE DATA BUT LOOK
AT THIS, THIS UPTICK DURING 2020
OF HERBAL AND BOTANICAL
SUPPLEMENT SALES.
IT WENT WAY UP AND I THINK PART
OF THAT MAY HAVE BEEN A COVID
EFFECT.
PEOPLE DIDN'T KNOW WHAT TO DO SO
THEY SAID I WILL TAKE SOME
HERBALS OR BOTANICALS OR MAYBE I
WILL TAKE VITA MINE D BECAUSE
MAYBE WILL BE GOOD FOR THAT
FUNNY PNEUMONIA THAT PEOPLE WERE
GETTING.
IN TERMS OF IDEAS TO COVER ALL
THE BASES JUST IN CASE AND I
THINK A LOT OF PEOPLE TOOK
VITAMIN D FOR THAT REASON,
DURING THE COVID TIME, AND THEN
THERE ARE THE PEOPLE WHO--AND
THERE ARE VERY FEW IN NUMBER BUT
THERE ARE PEOPLE WHO THINK THAT
SUPPLEMENTS CONFER A LICENSE TO
ENGAGE IN UNHEALTHY HEALTH
BEHAVIORS AS IT SORT OF BLOTS
OUT THE BAD THINGS THAT THEY'VE
DONE AND OF COURSE IT DOESN'T
WORK THAT WAY BUT NEVERTHELESS
THERE ARE SOME PEOPLE WHO THINK
IT.
SOMEBODY ELSE, I THINK REGAN, A
QUESTION ABOUT SOME OF THE
DIFFERENT GROUPS AND LET ME JUST
QUICKLY RUN THROUGH A COUPLE OF
THOSE DIFFERENT GROUPS AND THEN
CONCLUDE.
[INDISCERNIBLE] USE, I WANTED TO
SHOW THIS SLIDE WHICH I LIKE
FROM THE WORK OF PEOPLE AT
D.O.D. AND WHAT THEY DID WAS
THEY STUDIED SOLDIERS AND THEIR
USE OF VARIOUS DIETARY
SUPPLEMENTS AND WHAT YOU SEE
HERE IS 2 THINGS, 1 IS THE
SOLDIER WHO IS WERE DEPLOYED IN
PLACES LIKE AFGHAN TAN OR IRAQ,
AND THE OTHER WERE PEOPLE WHO
WERE IN GARRISON WHO WERE NOT
ACTIVELY FIGHTING BUT ACTIVE
SERVICE MEMBERS AND WHAT YOU SEE
IS FIRST OF ALL AN ENORMOUSLY
HIGH USE OF SUPPLEMENTS OVERALL,
ABOUT 80% AND THEN IF YOU LOOK
OVER TO THE PROTEIN AND AMINO
ACIDS AND COMBINATIONS, YOU SEE
A VERY HIGH PROPORTION OF THE
SOLDIERS IN BOTH CATEGORIES WERE
USING THOSE PRODUCTS AS WELL AND
I THINK YOU WILL HEAR A LOT MORE
ABOUT THAT FROM 1 OF OUR OTHER
SPEAKERS LATER BUT THE MILITARY
IS DOING SOME VERY INTERESTING
WORK ON DIETARY SUPPLEMENTS.
AND FOR YOUNG ADPULTS WHO ARE
INTERESTED IN PERFORMANCE,
PHYSICAL PERFORMANCE I WOULD
STRONGLY SUGGEST THIS IS AN
EXCELLENT SOURCE OF MATERIAL ON
THOSE PARTICULAR KINDS OF USERS.
LET ME JUST SHOW YOU 1 OTHER
SLIDE THAT JAIME AND REGAN DID
INVOLVING LOOKING AT PEOPLE WITH
VARIOUS ILLNESSES AND THEIR USE
OF CONDITION SPECIFIC
SUPPLEMENTS AND WHAT YOU SEE
HERE FOR ARTHRITIS ON YOUR LEFT
IS MUCH HIGHER USE OF
GLUCOSAMINE AND CHOND
REORGANIZATION OF THE
INSTITUTEIN SUPPLEMENTS IN THOSE
WHO HAD THIS TYPE OF ILLNESS AND
HERE ON YOUR RIGHT IS A HISTORY
OF OSTERPOROSEIS OR FRACTURE,
THERE'S A MUCH HIGHER USE OF
VITAMIN D AND CALCIUM IN PEOPLE
WITH THOSE PARTICULAR
CONDITIONS.
AND FOR CANCER HERE'S A NICE
STUDY THAT WAS PUBLISHED A
COUPLE YEARS AGO ON CANCER
PATIENTS OVER TIME IN THIS
NHANES, THESE WERE SURVIVORS AND
PEOPLE ACCOUNTIVELY UNDERGOING
TREATMENT WHO ARE LIVING AT HOME
AND WHAT YOU SEE AGAIN IS THAT
MUCH HIGHER USE OF CANCER AMONG
CANCER PATIENTS OVER THE YEARS.
SO LOTS OF IMPLICATIONS HERE
THAT WE NEED TO TAKE INTO
ACCOUNT AS WE'RE GOING THROUGH
THE REST OF THE COURSE, 1 WAS
THAT MOTIVATIONS MAY REVEAL
HEALTH NEEDS AND THAT'S WHY
THEY'RE SO IMPORTANT TO THOSE OF
US WHO WORK IN CLINICAL HEALTH
AND PUBLIC MEDICINE.
THE SECOND IS THAT METHODS ARE
FINDING MOTIVATIONS DO EXIST AND
WE CAN USE THEM.
THIRD, SUPPLEMENT USERS ARE
DIFFERENT AND WE KNOW THAT THE
REASONS FOR USE VARY AMONG USERS
AND FROM 1 SUPPLEMENT TO ANOTHER
AND FINALLY, WE NEED TO REMEMBER
TO ASK ABOUT USE TO BETTER HELP
OUR PATIENTS IF WE'RE IN
CLINICAL SITUATIONS IF YOU'RE
SEEING PATIENTS, TAKE A LITTLE
EXTRA TIME PARTICULARLY TO TALK
TO PATIENTS WHO HAVE MAIN
CHRONIC ILLNESSES, ESPECIALLY
THOSE WITH POOR PROGNOSIS OR
ADVANCE STAGES BUT MANY
MEDICATIONS WITH PAINFUL OR
COMPLICATED OR INEFFECTIVE
CONVENTIONAL THERAPIES AND THE
OTHER BIG GROUP IS THOSE WITH
POSSIBLY RISKY PATTERNS OF USE.
THAT IS PEOPLE WHO ARE TAKING
MANY, MANY MEDICATIONS AT THE
SAME TIME BECAUSE THERE'S A RISK
OF INTERREACTIONS WITH THE
SUPPLEMENT AND ALSO,
INTERACTIONS OR RISKY PATTERNS
WHERE PEOPLE ARE USING THE
SUPPLEMENTS TO DELAY OR REPLACE
EFFECTIVE MEDICAL TREATMENT.
AND REMEMBER THAT IF YOU DON'T
ASK, PEOPLE ARE NOT GOING TO
TELL YOU.
YOU HAVE TO ASK, IS THIS STUDY
DONE ALMOST 10 YEARS AGO NOW,
SHOWS, IN OVER 50% OF THE CASES
IN THIS PARTICULAR STUDY,
PATIENTS, THE REASON WHY THEY
DIDN'T TELL THE DOCTOR ABOUT THE
SUPPLEMENT USE WAS THAT THE
DOCTOR DIDN'T ASK.
OR THEY DIDN'T THINK THE DOCTOR
NEEDED TO KNOW BECAUSE THEY
DIDN'T ASK SO THE QUESTION HERE
IS TO SIMPLY GO AHEAD AND ASK IF
IF YOU ASK USUALLY PEOPLE WILL
TELL YOU.
THANK YOU VERY MUCH AND LOOK
FORWARD TO ANSWERING ANY
QUESTIONS I CAN.
>> THANK YOU DR. DWYER, I WOULD
LIKE TO ASK THAT DR. BAILEY AND
DR. DWYER JOIN US NOW.
WE WILL DO A DISCUSSION FOR OUR
ATTENDEES.
PLEASE SUBMIT QUESTIONS FOR ALL
OF US THROUGH THE Q&A PANEL.
AND DIRECT THOSE TO ALL
PANELISTS.
OKAY, SO WE HAVE A FEW QUESTIONS
THAT I DID RESPOND TO IN THE Q&A
BUT WE CAN JUST READ THEM OUT
FOR NOW SO EVERYBODY HEARS.
NANCY GOMEZ ASKED HOW OFTEN IS
THE RESEARCH HIGHLIGHTED IN THE
SUPPLEMENT FACT SHEETS REVIEWED
AND UPDATED?
AND BASICALLY WE UPDATE THE FACT
SHEETS AS NEEDED WITH NEW
IMPORTANT STUDIES AS THEY COME
IN.
WE TRY TO THOROUGHLY REVIEW EACH
FACT SHEET EVERY 1-3 YEARS AND
UPDATE THEM BUT IT'S THE END OF
EACH FACT SHEET WE ALSO WANT TO
POINT OUT THERE'S A LINK TO THE
HISTORY OF INFORMATION THAT
WE'VE CHANGED OR MODIFIED SO YOU
KNOW HOW RECENT EACH FACT SHEET
IS.
AND JOHANNA AND REGAN YOU CAN
JUMP IN FOR SOME OF THESE OTHER
QUESTIONS, THAT CAME IN IF YOU
HAVE SOMETHING ELSE.
WE DID HAVE SOMEONE WHO
MENTIONED THAT SOME OF THE DATA
THAT REGAN SHOWED, IT CAN BE OLD
DATA, YOU KNOW SOME OF IT'S
COMING FROM THE 2011-2014 NHANES
SURVEY AND YOU KNOW HOW
BASICALLY HAS THE CHANGE IN
CLIMATE RELATED TO DIETARY
SUPPLEMENT USAGE CHANGED
ESPECIALLY NOW THAT WE HAVE--WE
HAD COVID AND DO HAVE A CHANCE
IN SUPPLEMENT USE?
AND SO I WANTED TO START OFF BY
JUST SAYING THAT NHANES DOES
COLLECT DATA CONTINUOUSLY, SO
EVERY YEAR, THE MOST RECENT
ESTIMATES AVAILABLE THAT WE HAVE
ARE USAGE FROM 27-2018 NHANES
SURVEY SORE BASICALLY THEY GO
INTO THE FIELD, THEY COLLECT THE
DATA BUT THEN THERE'S STILL A
LAG PERIOD WHERE THEY HAVE TO
PROCESS THAT DATA AND IT COULD
BE ABOUT 2 YEARS BEFORE IT'S
POSTED ON THEIR WEBSITE FOR
RESEARCHERS TO USE.
BUT THEN ON TOP OF IT, COVID HIT
AND NHANES DID HAVE TO STOP
OPERATIONS IN EARLY 2020 SO
UNFORTUNATELY WE DON'T HAVE
INFORMATION ON SUPPLEMENT USE ON
THE POPULATION DURING THAT
PERIOD FROM NHANES.
THERE ARE A LOT OF IT WE CAN GET
FROM THE SALES DATA SO YES WE DO
KNOW THAT WE DO BASICALLY
HYPOTHESIZE THAT THERE ARE SOME
PROD UBTS THAT HAVE INCREASED,
PROBABLY VITAMIN D, VITAMIN C,
ZINC, SOME OF THE PROJECTION
NEURONS OR PIONS TANICALS DUE TO
COVID AND THEN THIS LEADS AND
JOHANNA, CAN YOU JUMP IN, TOO,
SOMEONE ELSE ASKED HAS THE
MOTIVATIONS CHANGED SINCE WE
LOOKED AT IT YEARS AGO?
AND PROBABLY FOR A LOT OF
PRODUCTS MAYBE THE MOTIVATION
HAVEN'T CHANGED ENORMOUSLY BUT
YES, FOR COVID-19,IME SURE FOR
CERTAIN PRODUCTS THAT'S GOING TO
BE SOME OF THE MOTIVATION AT
THIS POINT.
UNFORTUNATELY THOUGH, WE DON'T
HAVE THAT NATIONALLY
REPRESENTATIVE DATA.
>> GOOD POINT JAIME, YES ISSUES
IT'S A PITY.
YOU'RE RIGHT, IF WE LOOK AT THE
TRADE JOURNALS, WHICH WE GET IN
THE OFFICE, IT DOES LOOK AS
THOUGH THE MOTIVATIONS MAY HAVE
CHANGED BECAUSE PEOPLE WERE SO
DESPERATE AT THE BEGINNING OF
COVID, THEY DID ANYTHING
POSSIBLE TO TRY TO AVERT THIS
TERRIBLE PROBLEM.
SO I THINK PROBABLY WE WILL FIND
IN RETROSPECT THAT THERE WERE
SOME CHANGES.
>> YEAH.
AND THEN SOMETHING ELSE THAT
GOES BACK A LITTLE--SWITCHING
BACK TO MY PRESENTATION, WE HAD
SOMEONE MENTION THAT DEFINITELY,
THERE ARE SO MANY SUPPLEMENTS ON
THE MARKET AND WE NEED SO MUCH
MORE RESEARCH ON THE EFFICACY OF
DIETARY SUPPLEMENTS, AND YOU
KNOW WHAT IS NIH DOING ABOUT
THIS?
AND IS THE FUNDING ENOUGH?
AND YEAH, THIS IS ALWAYS GOING
TO BE--THIS IS A DILEMMA.
DEFINITELY, WE NEED TO BE ABLE
TO SUPPORT MORE RESEARCH ON
SUPPLEMENTS BUT YES THERE, IS
LIMITED FUNDING OVER WHAT WE
THINK OVER A HUNDRED THOUSAND
PROD UBT ON THE MARKET, YOU KNOW
HOW DO YOU REALLY TACKLE THAT
AND REALLY STUDY THIS AND IT'S
OF COURSE, IT'S A CHALLENGE, IT
CONTINUES TO BE A CHALLENGE.
, YEAH, I THINK 1 THING NEW
JAIME, IS WISELY, THE FOOD AND
DRUG ADMINISTRATION FOCUSES
FIRST ON SAFETY BECAUSE SAFETY
OF COURSE IS THE ULTIMATE THING
THAT WE WANT TO MAKE SURE THAT
IF PRODUCTS ARE TAINTED AND
GOING TO HURT PEOPLE THAT
THEY'RE TAKEN OFF THE MARKET BUT
EFKASP A R SEA BIG ISSUE.
YOU KNOW EFKASP A R SEA BIG
ISSUE FOR DIETARY SUPPLEMENTS
AND IT'S ALSO A BIG ISSUE FOR
COSMETICS.
I NOTICED, THAT CREAM I BOUGHT
DIDN'T DO ANY GOOD AND IT MAY BE
TRUE FOR SOME OF THE DIETARY
SUPPLEMENTS.
[LAUGHTER]
>> YES.
>> OKAY, NOW WE DO HAVE A
QUESTION FROM LINDA, HOW IS THE
MILITARY SOURCING SUPLEAPTS AND
WOULD THIS SOURCING BE A GUIDE
FOR PRODUCT QUALITY FOR PEOPLE
OUTSIDE THE MILITARY.
IF SO, HOW WOULD A CONSUMER
OBTAIN ACCESS TO THIS
INFORMATION?
>> WELL, THERE'S 1--I CAN'T GIVE
YOU AN EXAMPLE OF HOW THEY
SOURCE IT, BUT I CAN SAY THAT
THE INFORMATION ON DIETARY
SUPPLEMENTS IN THE MILITARY, I
THINK YOU WILL HEAR MORE ABOUT
LATER IN THE SYMPOSIUM, BUT THE.
>> YES ON WEDNESDAY.
>> BUT THE WORD TO KEEP IN MIND
IS OPPS.
OPERATION SUPPLEMENT SAFETY,
SO--
>> I DON'T THINK THEY REGULATE
WHAT'S SOLD TO THE MILITARY BUT
THEY DO A REALLY GOOD GOB OF
RECORDING ADVERSE EVENTS AND
THING LIKE THAT AND YOU WILL
HEAR MORE ABOUT THAT THIS WEEK.
>> WEDNESDAY MORNING WE DO HAVE
SOME BOOKS FROM THE MILITARY
THAT WILL BE PROVIDING
INFORMATION ON SUPPLEMENT USE IN
THE MILITARY AND THIS WOULD BE A
GREAT QUESTION TO ASK THEM.
>> YEAH, THE THING--JUST AS A
PRELUDE TO THAT, YOU KNOW
SERVICE MEN AND WOMEN ARE
CITIZEN TOO SO THEY CAN--THEY
HAVE FREEDOM OF CHOICE, BUT THE
MILITARY HAS DONE A SUPERB JOB,
I THINK IN DEVELOPING
INFORMATION AND EDUCATION
PROGRAMS TO HELP HIDE WHAT THEY
WISH TO CHOOSE BECAUSE SOME OF
THESE FOLKS, IN FACT MOST OF
THEM ARE ON THE OTHER LIMITED
INCOMES, YOU KNOW, SERVICE MEN
DON'T MAKE A LOT OF MONEY.
AND YET IF THEY'RE TAKING A
PERFORMANCE SUPPLEMENT AND IT'S
GOING TO DO GOOD AND IT DOESN'T,
AND IT'S COSTING $300 A MONTH
MAYBE THEIR MONEY WOULD BE
BETTER SPENT SOME OTHER WAY.
SO I THINK YOU WILL ENJOY THOSE
PRESENTATIONS BY THE MILITARY
FOLK, THEY ARE JUST TERRIFIC
PEOPLE TO WORK WITH.
>> GREAT.
ALL RIGHT, WE HAVE A QUESTION BY
MARY LEE, ARE THERE ANY STUDIES
LOOKING AT SUPPLEMENT USE IN
CANCER PATIENTS USING SUPPLEMENT
THAT HAVE BEEN ASSOCIATED WITH
HIGHER INDENSE FOR EXAMPLE, BETA
CAR O TEEN.
>> THERE'S A LOT OF RESEARCH IN
CANCER SURVIVORS AND THEY'RE THE
HIGHEST POPULATION SUBGROUP FOR
THE USE OF DIETARY SUPPLEMENTS,
SO UPWARDS OF 80%.
THERE ARE INCIDENCES WHERE IT
WAS PREVENTATIVE TO CANCER, AND
THERE WAS STUDIES WITH A
SUGGESTED INCREASE RISK WITH
SUPPLEMENT USE SO IT'S REALLY
SOMETHING THAT NEEDS TO BE
CAREFULLY CONSIDER WIDE THE
CANCER SURVIVOR AND HIS OR HER
OR THEIR HEALTHCARE PRACTITIONER
ON AN INDIVIDUAL BASIS, I
WOULDN'T SAY ODS OR ANYONE HERE
WOULD MAKE ANY RECOMMENDATIONS
ABOUT YOU THERE'S A VERY
EQUIVOCAL LITERATURE BASED ON
WHAT NUTRIENT AND WHAT CANCER
TYPE.
SO I DON'T THINK--THE ISSUE IS 1
THAT DEFINITELY IS 1 WHERE
ANYBODY WHRO'S AFFLICTED WITH
ANY KIND OF CANCER SHOULD
DISCUSS THIS WITH THEIR
PHYSICIAN AND THEY SHOULD ALSO
GO TO THE NATIONAL CANCER
INSTITUTE SITE WHICH HAS GOOD
MATERIAL ON IT.
BUT, THE REASON FOR CONCERN IS
BECAUSE ON MANY THERAPIES,
YOU'RE TAKING MULTIPLE
MEDICATIONS AND SOME OF THOSE
MEDICATIONS MAY INFACT, INTERACT
WITH A SUPPLEMENT AND THAT WOULD
BE A TERRIBLE THING, YOU KNOW,
IT MIGHT NOT MAKE THE MEDICATION
WORK THE WAY IT SHOULD SO
CAUTION IS WARRANTED, I THINK.
>> OKAY.
THANK YOU.
THIS QUESTION IS FROM LEAH, I
DON'T HAVE THE ANSWER BUT MAYBE
JOHANNA AND REGAN DO, IS THERE
ANY SORT OF DATA THAT GOES
ALONGSIDE DIETARY SUPPLEMENTS
REGARDING THE EXTENT OF THESE
SUPPLEMENTS?
THIS WOULD SEEM TO BE CONCERNS
WHEN YOU SEE DIETARY SUPPLEMENT
USAGE AT HIGH LEVELS FOR THOSE
70% WHO ARE LIKELY ON A FIXED
INCOME?
>> THAT'S KIND OF WHY WE RESENT
THE USAGE DATA WITH THE SALES
DATA BECAUSE SOME SUPPLEMENTS
ARE MORE EXPENSE I REALLY THAN
OTHERS SO IF WE LOOK AT THEUSAGE
PATTERN AND THE SALES DATA WE
CAN GET SOME KIND OF PIECES TO
THE PUZZLE FROM EACH OF THOSE
BUT YOU'RE ABSOLUTELY CORRECT.
THOSE OLDER ADULTS ARE THE
HIGHEST USER GROUPS, THEY TEND
TO BE ON FIXED INCOMES AND HOW
THEY USE SUPPLEMENTS IS PART OF
THAT FIXED INCOME, THERE'S NOT A
LET OF RESEARCH THAT I KNOW OF,
JOHANNA, YOU MAY KNOW OF MORE?
>> NO, NO.
IN MY OTHER HAT BACK IN BOSTON,
WE TEND TO DO IS TO SUGGEST TO
OUR OLDER PATIENTS IF THEY NEED
A SUPPLEMENT LIKE A MULTIVITAMIN
MINERAL SUPPLEMENT THAT SOME OF
THE GENERIC 1S THAT YOU CAN BUY
IN DRUG STORES ESPECIALLY WHEN
THEY'RE ON SALE OR GOOD, FOR
INSTANCE A LOT OF OLDER WOMEN
ASK ABOUT CALCIUM VITAMIN D ASK
THAT'S WHAT I DO, I GO AND GET
IT AT 1 OF THE BIG DRUG STORES
RATHER THAN ON THE WEB.
THE WEB TENDS TO BE MORE
EXPENSIVE AT LEAST IN MY
IMPRESSION, THE PRODUCTSOT WEB
SEEM TO BE A LITTLE BIT MORE EBS
PENSIVE THAN THE BIG BOX STORES
OR THE DRUG STORES.
SPHRK HERE'S A QUESTION, HOW
OTHER INDUSTRIALIZED NATIONS
DEAL WITH SUPPLEMENTS, ARE
SUPPLEMENTS PART OF THEIR
MEDICAL PROTOCOL.
>> WELL I CAN ANSWER THAT A
LITTLE, BUT NOT A LOT.
>> IN MANY PARTS OF THE WORLD,
FOR EXAMPLE WE HAVE A CATEGORY,
DIETARY SUPPLEMENTS ARE UNIQUE
IN THIS COUNTRY BAIZE THEY
INCLUDE OTHER DIETARY
INGREDIENTS THAT AREN'T
NUTRIENTS AND IN THE EUROPEAN
UNION, MOST OF THE FOOD
SUPPLEMENTS ARE NUTRIENTS SO
THEY'RE RESTRICTED TO SPECIFIC
NUTRIENTS SO THE REGULATIONS ARE
ARE FOCUSED ON THE NUTRIENTS AND
IT'S QUITE DIFFERENT FROM OUR
LAW WHICH HAS A MUCH BROADER
CATEGORY.
IN TERMS OF THE ASIAN, SOME OF
THE ASIAN COUNTRIES AND
ELSEWHERE IN THE WORLD, SOME
THINGS THAT ARE CALLED DIETARY
SUPPLEMENTS WE WOULD CALL
TRADITIONAL AND COMPLIMENTARY
MEDICINES AND SO THAT
GERONTOLOGYSTSS INTO A WHOLE
OTHER CATEGOR THAT'S QUITE
DIFFERENT.
BUT WE HAVEN'T DONE ANY BIG
STUDIES, I THINK THE 1 PAPER
THAT'S QUITE GOOD ON THAT, WAS
DONE BY ANDREW CHOW AND I DON'T
HAVE THE REFERENCE I CAN GIVE
BUT ANDREW DID A NICE STUDY
ACROSS ALL THE DIFFERENT
COUNTRIES WITH RESPECT TO THE
REGULATIONS, OR NOT THE
REGGULESS BUT THE LEGISLATION
THAT GOVERNS THE SUPPLEMENTS AND
THE QUESTIONER MIGHT ENJOY READ
THAGOREAN STUDY.
>> AND JOE BETS WILL BE
PRESENTING TODAY OR FURTHERMORE
--TOMORROW
AND HE IS A GOOD PERSON TO ASK
QUESTIONS OF INTERNATIONAL
REGULATIONS AS WELL.
>> YEAH, BECAUSE HE DOES A LOT
OF WORK WITH PARTICULARLY IN
ASIA ON SOME OF THE SUPPLEMENTS
THERE SO HE KNOWS A LOT ABOUT
THEM.
HE WILL BE PRESENTING IN THE
NEXT SESSION.
>> GREAT.
>> THIS WAS INTERESTING, IT'S
HOW HAVE YOU CHANGED THE MIND
SET FOR INDIVIDUALS THAT NEED
IRON SUPPLEMENT.
THERE'S SUFFERING WITH ANEMIA
BUT THERE'S A LOT OF SIDE
EFFECTS WITH TAKING IRON SO HOW
DO WE OVERCOME THAT BASICALLY?
>> IT'S A GOOD QUESTION.
>> I KNOW.
>> WELL, THE FIRST THING THAT'S
INTERESTING AND REGAN YOU CAN
SPEAK TO THE PRENATALS BETTER
THAN I CAN, BUT I KNOW THAT
[INDISCERNIBLE] AND DR. SALD ANO
IS TALKING LATER TOO, SHE WILL
BE GOOD TO LOOK AT THESE AND THE
IRON THEY CONTAIN, SO MUCH IRON
IN THEM THAT THEY ALSO CONTAIN A
STOOL SOFTENER WHICH JOE BETS
WILL TELL YOU IS ILLEGAL OR IT
WAS ON THE LABEL SO IT WAS
ILLEGAL, SO THE FIRST TECHNOLOGY
TRANSFER I THINK WOULD BE TO
TALK WITH WHOEVER THE HEALTHCARE
PROVIDER IS, TO FIND OUT IF THE
DOSE IS REALLY THE DOSE THAT IS
NEEDED BECAUSE SOMETIMES A
PHYSICIAN WILL JUST SAY, OH TAKE
AN IRON SUPPLEMENT AND THEY
DON'T REALLY HELP TO YOU PICK
WHICH 1 AND YOU MAY PICK THE 1
THAT NEEDS A STOOL SOFTENER AS
WELL, BUT REGAN YOU DID SAY--
>> YEAH, SO A LOT OF WHAT ODS
DOES, ESPECIALLY FROM THE
POPULATION--TREND ONE-ON-ONE
PATIENT PERCEPTIONS AND
MOTIVATIONS, IS MORE POPULATION
LEVEL AND SO, IT'S HARD TO KIND
OF COMMENT ON THAT, I CAN SAY,
YOU KNOW HAVING 3 CHILDREN, TAKE
AN IRON SUPPLEMENT IS VERY HARD
ON YOUR GI SYSTEM AND CAN BE
DISCOURAGING AT TIMES.
BUT IN TERMS OF HOW I WOULD
RESPOND TO YOUR QUESTION, I JUST
DON'T THINK I'M THE QUALIFIED
PERSON TO ANSWER THAT DIRECTLY.
>> WELL, SHEILA 1 OF OUR
ATTENDEES DID SUGGEST SOMETHING,
A GOOD SUGGESTION SHE'S A
PRACTITIONER AND SHE TYPICALLY
SUGGESTS STARTINGA AN IRON
SUPPLEMENT EVERY OTHER DAY
BECAUSE AT LEAST THEY'RE GETTING
SOME, MIGHT NOT BE SO
OVERWHELMING TO THEIR SYSTEM,
AND THEN WE ALSO HAVE THE ISSUE
OF THE FORM OF IRON OF COURSE
BECAUSE IT'S NOT JUST DOSE, IT
CAN ALSO BE THE FORM THAT THE
IRON'S COMING IN.
>> AS WELL AS THE BACKGROUND
DIET, SO VEGETARIANS HAVE
DIFFERENT COMPOUNDS IN THEIR
DIETARY PATTERNS THAT MAY
INHIBIT IRON CONSON AND THERE'S
BEEN ARE DISCUSSIONS ABOUT WHAT
SPACE, WHAT FORM, WHAT AMOUNT,
HOW OFTEN TO PRODUCE THE RISK OF
PRENATAL IRON INSUFFICIENCY FOR
SURE.
>> OKAY, THANK YOU DR. BAILEY
AND DR. DWYER, WE ARE COMING TO
THE END OF OUR SESSION 1.
WE WILL TAKE A 10 MINUTE BREAK,
WELL, 9 MINUTES AT THIS POINT
AND COME BACK AT 1 AND THEN
WE'RE GOING TO HAVE A SESSION ON
RULES AND REGULATIONS, WE WILL
HEAR FROM SPEAKER--A SPEAKER
FROM FDA, FTC AND ALSO OUR
ACTING DIRECTOR AT ODS.
SO I WILL SEE EVERYONE BACK AT
1.
THANK YOU.
THIS IS SESSION 2, RULES AND
REGULATION, DR. THOMAS WILL BE
MODERATING, HAS BEEN WITH THE
OFFICE OF DIETARY SUPPLEMENTS
SINCE 2005.
THANK YOU, DR. THOMAS.
>> THANK YOU.
I'LL BE MODERATING THE SECOND
SESSION, RULES AND REGULATIONS,
WE'LL GIVE A SOLID GROUNDING IN
THE OVERSIGHT AND REGULATION OF
DIETARY SUPPLEMENTS WITHIN THE
FEDERAL GOVERNMENT.
YOU'LL GET AN OVERVIEW OF THE
FOOD, DRUG, DIETARY SUPPLEMENTS
SIMILARITIES AND DIFFERENCES
FOLLOWED BY PERSPECTIVES OF THE
FOOD AND DRUG ADMINISTRATION AND
FEDERAL TRADE COMMISSION.
THREE SPEAKERS, AFTER THEIR
PRESENTATIONS WE'LL HAVE TIME
FOR YOUR QUESTIONS TO THE PANEL.
PLEASE SUBMIT QUESTIONS FOR THE
PRESENTERS IN THE Q&A PANEL OF
YOUR WEBEX, AND DIRECT THEM TO
ALL PANELISTS.
PLEASE ONLY USE THE CHAT BOX
FUNCTION FOR TECHNICAL QUESTIONS
OR ISSUES WITH WEBEX.
I'M GOING TO BRIEFLY INTRODUCE
EACH SPEAKER, GO TO TO THE
WEBSITE FOR BIOS.
FIRST IS JOSEPH BETZ, DIRECTED
ANALYTICAL METHODS AND REFERENCE
MATERIALS PROGRAM AS PHARMA
COGNICIST BY TRAINING, BEFORE
THAT RESEARCH CHEMIST AT THE
FDA.
DR. BETZ WILL EXPLAIN HOW FOOD,
DRUGS, DIETARY SUPPLEMENTS ARE
REGULATED.
WELCOME, DR. BETZ.
>> THANK YOU FOR THE KIND
INTRODUCTION.
LET ME LEAP RIGHT IN.
THAT SHOULD WORK.
CAN EVERYBODY SEE MY SLIDES?
LOOKS GREAT.
>> OKAY.
GOOD MORNING OR GOOD AFTERNOON,
DEPENDING WHAT PART OF THE WORLD
YOU'RE IN.
THIS IS GOING TO PROVIDE JUST A
BRIEF OVERVIEWS OF CONTROVERSIAL
ISSUES.
YOU HEARD FROM DR. DWYER AND DR.
GAHCE THIS MORNING, LET'S GO TO
THE ACT.
IN 2006, PASSED BY CONGRESS,
AMENDED IN 1938, THE PRODUCTS
ARE REGULATED BY FDA BASED ON
INTENDED USE.
THE CATEGORIES ARE FOODS, DRUGS,
COSMETICS, MEDICAL DEVICES.
FOODS INCLUDES VETERINARY FOODS,
ANIMAL FEEDS, CHOWS, VETERINARY
DRUGS AND DRUG CATEGORY.
INTENDED USE, THEY LOOK AT THE
LABEL, LOOK AT THE ADVERTISING,
LOOK AT ANY ORAL OR WRITTEN
STATEMENTS MADE BY THE COMPANY
ABOUT THE PRODUCT.
IN SOME CASES THERE'S GUESS WORK
BUT FOR THE MOST PART FDA CAN
FIGURE OUT INTENDED USE BASED ON
THOSE THINGS.
WHATEVER FDA CONCLUDES AND
WHATEVER THE COMPANY INTENDED TO
SELL, THE REGULATIONS FOR THAT
CATEGORY APPLY.
WE'LL FIND OUT THERE'S A LITTLE
BIT OF DIFFERENCE BETWEEN THE
VARIOUS REGULATORY CATEGORIES.
I WILL NOTE BECAUSE I'VE BEEN
ASKED TO DO A TALK IN JUNE IN
CANADA THERE'S TO REGULATORY
CATEGORY FOR FUNCTIONAL FOOD IN
THE U.S.
THERE WAS A WORKSHOP BY FDA
SEVERAL YEARS BACK, THEY
CONCLUDED THE CURRENT REGULATORY
STRATEGY FOR CONVENTIONAL FOODS
THAT ALLOW HEALTH CLAIMS IS GOOD
ENOUGH FOR FUNCTIONAL FOODS.
THEREFORE NO SPECIAL CATEGORY
WAS NEEDED.
I ALSO POINT OUT FDA REGULATES
PRODUCTS AND INTERSTATE
COMMERCE, FINISHED PRODUCTS THAT
MOVE, END UP ON THE WEB AND
RETAIL STORES, DOES NOT REGULATE
PRACTICE OF MEDICINE, REGULATED
ON A STATE-BY-STATE BASIS, BY
THE STATES THEMSELVES.
WE'LL LEAP STRAIGHT INTO THE ONE
WE'RE GOING TO TALK THE LEAST
ABOUT THIS MORNING, OR THIS
AFTERNOON, THAT IS DRUGS.
A DRUG AN ARTICLE INTENDED TO
DIAGNOSE, CURE, MITIGATE, TREAT,
PREVENT A DISEASE IN MAN OR
ANIMALS.
OR TO AFFECT STRUCTURE OR
FUNCTION OF THE BODY.
WE'LL GET INTO CONFUSION FROM
THAT LATER IN THE TALK.
A DRUG MULTIPLE GENERALLY
RECOGNIZED AS SAFE AND
EFFECTIVE.
THE ACRONYM IS GRASE.
YOU MAY HAVE HEARD IT IN
CONJUNCTION WITH FOODS, WE'LL
TALK ABOUT THAT LATER.
FREE MARKET APPROVAL IS REQUIRED
FOR DRUGS, INVESTIGATIONAL AND
NEW DRUG APPLICATION ROUTE.
THE SPONSOR FUNDS, FDA REVIEWS
RESULTS AND MAKES CONCLUSION OF
SAFETY AND EFFICACY BEFORE THE
PRODUCT IS ALLOWED ON THE
MARKET.
ALL THIS HAPPENS BEFORE THE
PRODUCT HITS THE MARKET.
PRE-MARKET APPROVAL.
A FOOD, THIS IS THE DEFINITION
COPIED FROM THE ACT, DON'T
ACCUSE ME OF PARAPHRASING, USE
FOR MAN OR OTHER ANIMALS,
CHEWING GUM, ARTICLES FOR
COMPONENTS, CONSUMED FOR TASTE,
AROMA, NUTRITIVE VALUE.
THERE'S A CATEGORY CALLED
MEDICAL FOODS, IF YOU WANT TO
REPLY TO THE URL AND CITATION,
I'M NOT GOING TO TALK ABOUT IT
VERY MUCH TODAY.
FOODS ARE SAFE BY DEFINITION,
GENERALLY RECOGNIZED BY SAFE,
THE ACRONYM, UNLESS A SUBSTANCE
ADDED TO FOODS, SUBSTANCE USED
IN OR AS FOOD PRIOR TO JANUARY
1, 1958, IS CONSIDERED TO HAVE A
HISTORY OF SAFE USE AND
GRANDFATHERED.
FDA CAN DO A POST-1958 REVIEW OF
SAFETY AND IN FACT HAS REVIEWED
A NUMBER OF MATERIALS,
CYCLAMATES, BEING ONCE.
FOODS MUST BE GRAS, GENERALLY
RECOGNIZED AS SAFE,
DETERMINATION MADE BY QUALIFIED
EXPERTS USING SCIENTIFIC
PROCEDURES.
THERE ARE SPECIAL RULES FOR
PESTICIDES, COLORS, FOOD CONTACT
SURFACES, ALL ARE FOOD ADDITIVE,
DIRECT OR INDIRECT, I WON'T TALK
ABOUT THOSE EITHER.
IF YOU'RE INTERESTED, WE CAN
HAVE AN OFFLINE CONVERSATION,
SEND ME AN E-MAIL AND I WILL
SEND YOU TO THE APPROPRIATE
PERSON AT FDA TO SPEAK.
THERE HAVE BEEN A NUMBER OF
AMENDMENTS TO THE FOOD DRUG
COSMETIC ACT SINCE IT WAS
PASSED.
FOR THE PURPOSE OF OUR
DISCUSSION TODAY THE TWO MOST
SIGNIFICANT ARE THE ONE THAT DR.
GHACHE MENTIONED, BUT PRECEDING
WAS THIS ONE, NUTRITION LABELING
AND EDUCATION ACT OF 1990.
IT PROVIDED FOR -- REQUIRED
NUTRITION LABELS BY 1994, THE
PURPOSE WAS TO MAKE IT EASIER
FOR CONSUMERS TO PLAN HEALTHY
DIETS.
YOU'LL NOTICE THIS IS SOMETHING
THAT'S SELDOM MENTIONED WHEN WE
TALK ABOUT BOTH, THE WORD
"EDUCATION" IS IN BOTH, INTENT
TO PROVIDE ACCURATE INFORMATION
TO CONSUMERS TO MAKE INFORMED
DECISIONS ABOUT WHAT THEY PUT IN
THEIR MOUTHS.
THERE HAVE BEEN SEVERAL RULES
SINCE THEN.
THERE WAS AN FDA RULE ON
TRANSFATS, 2003 AND THEN
REVISION IN 2006.
FDA RULE ON FOOD ALLERGENS, IN
DECEMBER OF 2018 NEW LABELING
REGULATIONS.
WE'LL A BIT ABOUT THOSE.
I PROVIDED INFORMATION, URLs
FOR THOSE FOR YOU.
THEY WILL BE AVAILABLE WHEN YOU
ASK FOR THE SLIDE DECK.
THERE'S A NEW SECTION, WHAT'S
NEW SECTION, IN THE FDA WEBSITE
AS WELL.
WHEN YOU GO TO THE LABELING AND
NUTRITION GUIDANCE DOCUMENTS,
THIS IS THE LANDING PAGE.
AGAIN, THE URL AT THE TOP.
I DON'T PLAN ON SPENDING TOO
MUCH TIME GOING THROUGH ALL THIS
STUFF.
THIS IS A VERY BRIEF OVERVIEW.
SO, IN ADDITION TO THE
PROVISIONS ABOUT HEALTH CLAIMS,
THE NLEA ESTABLISHED RULES FOR
WHAT THE FOOD LABEL SHOULD LOOK
LIKE.
SO, IT LAYS OUT SIMPLE STUFF, ON
THE PRINCIPAL DISPLACE PANEL FOR
A CEREAL BOX WOULD BE THE BIG
FRONT OF THE BOX.
YOU NEED TO LIST STATEMENT OF
IDENTITY, NAME OF THE FOOD, NET
QUANTITY OF THE PRODUCT IN THE
PACKAGE, AMOUNT OF PRODUCT, ALL
OF THOSE GO ON A DISPLAY PANEL.
STANDARDIZED FOOD IS ANOTHER CAN
OF WORMS THAT I WON'T OPEN
TODAY.
JUST BE AWARE THERE ARE SOME
FOODS DIVINED IN THE
REGULATION, ICE CREAM AND TOMATO
JUICE, ALL QUITE OFTEN MANDATORY
TESTS ONE HAS TO DO TO DETERMINE
WHETHER OR NOT THEY COMPLY WITH
THE RULES FOR STANDARDIZED FOOD.
IN ADDITION TO PDP, THERE'S AN
INFORMATION PANEL, AND THAT'S
WHERE YOU PUT ALL THE OTHER
STUFF.
THIS IS ACTUALLY CODIFIED, THE
INFORMATION PANEL IS IMMEDIATELY
TO THE RIGHT OF THE PRINCIPAL
DISPLAY PANEL.
IT MUST CONTAIN NAME, ADDRESS,
PLACE OF BUSINESS OF THE
MANUFACTURER.
IT HAS TO HAVE AN INGREDIENT
LIST THAT INCLUDES NUTRITION
LABELING, IT HAS TO HAVE ANY
REQUIRED ALLERGY LABELING YOU
MAY HAVE SEEN LABELS LIKE THIS
PRODUCT WAS MANUFACTURED IN A
FACILITY THAT ALSO PROCESSES
PEANUTS, SO BEWARE.
IT HAS TO HAVE A LABEL
IDENTIFICATION OF ARTIFICIAL
FLAVORING, COLORING, CHEMICAL
PRESERVATIVES.
THE NUTRITION LABELING, CONTENT
OF THE NUTRIENTS, IS LISTED IN A
NUTRIENT FACT PANEL.
THERE WERE NEW REGULATIONS
PUBLISHED IN 2018, AGAIN THERE'S
THE CFR REFERENCE IF YOU'RE
INTERESTED.
IT REQUIRES ONE TO ADD NUTRIENT
CONTENT CLAIMS TO THE LABEL, IF
THERE'S A PERCENT DAILY VALUE.
SO, THERE'S A SIDE-BY-SIDE
COMPARISON OF THE OLD ORIGINAL
NUTRITION FACTS LABEL, AND THE
NEW LABEL.
I KNOW YOU CAN'T READ A LOT OF
THAT PROBABLY UNLESS YOU HAVE A
PRETTY GOOD MONITOR, BUT I WILL
HIGHLIGHT SOME THINGS.
SERVING SIZE, THE FONT HAD TO BE
PUT INTO A LARGER FONT FOR THE
SERVING SIZE.
NUMBER OF CALORIES, OLD LABEL
HAD A VERY SMALL FONT SIZE,
NUMBER OF CALORIES AND PRODUCT
PER SERVING HAD TO BE PUT IN
LARGER FONT AND BOLDED.
ADDED SUGARS HAVE TO BE DECLARED
IN THE NEW LABEL.
THERE'S A CHANGE IN REQUIRED
NUTRIENTS.
UPDATED DAILY VALUE.
ACTUAL AMOUNTS HAVE TO BE
DECLARED INSTEAD OF
INTERNATIONAL UNITS, MICROGRAMS,
MILIGRAMS HAVE TO BE DECLARED
FOR CERTAIN VITAMINS.
A NEW FOOTNOTE WAS ADDED.
THE NUTRIENT CONTENT CLAIM IS
THERE, SO YOU'LL SEE FATS, FOR
INSTANCE, THERE WILL BE A
LISTING OF THE ACTUAL AMOUNT OF
FAT IN THE PRODUCT.
ALONG WITH THE PERCENT DAILY
VALUE FOR A CERTAIN SIZE CALORIE
INTAKE.
SO THAT'S THE NUTRIENT CONTENT
CLAIM AND DAILY VALUE.
OKAY.
CLAIMS, THIS IS PROBABLY THE
MOST CONTROVERSIAL PART, THE
PART I'LL SPEND THE MOST TIME O
HEALTH CLAIMS DESCRIBE THE
RELATIONSHIP BETWEEN A SUBSTANCE
AND DISEASE OR HEALTH-RELATED
CONDITION.
HEALTH CLAIMS FOR FOODS REQUIRE
PRIOR AUTHORIZATION BY FDA.
THERE'S ALSO A CATEGORY OF
HEALTH CLAIMS THAT DO NOT
REQUIRE -- THEY SORT OF REQUIRE
PRIOR AUTHORIZATION BUT I'LL
TALK MORE ABOUT THAT IN DETAIL.
SO, THERE ARE TWO TYPES OF
HEALTH CLAIMS.
THERE ARE QUALIFIED HEALTH
CLAIMS AND UNQUALIFIED HEALTH
CLAIMS.
THE FIRST HEALTH CLAIMS THAT
WERE PERMITTED BY THE NLEA ARE
WHAT WE CALL UNQUALIFIED HEALTH
CLAIMS.
THE STANDARD FOR THAT AS I
MENTIONED EARLIER IS SIGNIFICANT
SCIENTIFIC AGREEMENT WHICH IN
THE PROCESS INVOLVES RULEMAKING,
ONE SUBMITS ONE'S DATA TO FDA.
FDA REVIEWS AND IF THEY AGREE
DATA ARE SUPPORTED THEY WILL
ISSUE A REGULATION, A RULE THAT
SAYS YOU CAN MAKE THIS CLAIM AND
THERE'S CAVEATS AND ALL SORTS OF
THINGS.
THE CLAIM HAS TO BE WORDED A
CERTAIN WAY.
IT HAS TO BE PRESENTED USING
CERTAIN WORDS IN TERMS OF --
CLAIM, THE INTENDED USE MUST BE
THE SAME AS PRESENTED IN THE
EVIDENCE.
SO, THERE ARE STILL -- THERE ARE
SOME RULES ASSOCIATED WITH THE
HEALTH CLAIM.
QUALIFIED HEALTH CLAIMS IS
DIFFERENT.
A FIRST AMENDMENT CASE WAS
BROUGHT AGAINST -- SOMETIME IN
THE LATE '90s, AND IT SAID
BASICALLY THAT COMPANIES ARE
ALLOWED TO SAY THINGS THAT ARE
TRUE ON A LABEL.
AND SO THERE WAS SOME BACK AND
FORTH IN THE COURTS, FDA,
RULE-MAKING PROCESS.
9
THE END WAS COMPANIES ARE
ALLOWED TO MAKE QUALIFIED HEALTH
CLAIMS MEANING YOU CAN SAY THAT
AN INGREDIENT DOES GOOD THINGS
FOR YOU, AS LONG AS YOU PROVIDE
ALL OF THE CAVEATS AND
DISCLAIMERS THAT ARE IN THE
EVIDENCE.
IF, SAY, FOR AN UNQUALIFIED
CLAIM YOU MAY HAVE TEN STUDIES
ALL OF WHICH SAY AN INGREDIENT
OR NUTRIENT IS GOOD FOR REDUCING
CHOLESTEROL.
THAT WOULD BE A GOOD BASIS FOR
AN UNQUALIFIED HEALTH CLAIM.
IF THREE OF SEVEN STUDIES SAID
THIS MATERIAL MAY LOWER
CHOLESTEROL, TWO STUDIES WERE
EQUIVOCAL IN RESULTS, ONE STUDY
SAID THERE WAS NO, YOU KNOW,
THERE WAS NO REDUCTION, THEN YOU
COULD MAKE THE CLAIM THAT THIS
INGREDIENT MAY LOWER
CHOLESTEROL, BUT YOU WOULD ALSO
HAVE TO INCLUDE ALL OF THOSE
CAVEATS AND DISCLAIMERS AS PART
OF THE CLAIM, ON THE LABEL.
WHICH OF COURSE LEADS TO TINY
FONT AND LARGE LABELS, NOT
PRACTICAL ON A SMALL PACKAGE
SIZE.
QUALIFIED HEALTH CLAIMS DON'T
UNDERGROW RULEMAKING.
FDA DRAFTS A LETTER OF
REGULATORY ENFORCEMENT
DISCRETION, WHEREBY THEY JUST
SAY, WELL, WE'RE NOT GOING TO GO
AFTER THESE GUYS THAT MAKE THESE
CLAIMS AS LONG AS THOSE CAVEATS
ON THE LABELING IS APPROPRIATE.
NO RULEMAKING.
YOU GET TO MAKE YOUR CLAIM.
AND IF YOU MESS UP SOMEHOW, THEN
FDA CAN REVOKE THAT ENFORCEMENT
DISCRETION LETTER.
HEALTH CLAIMS COULD BE MADE FOR
CONVENTIONAL FOODS AND DIETARY
SUPPLEMENTS.
THERE WAS A FIGHT FOR A WHILE
ABOUT WHETHER OR NOT FIBER
SHOULD OR SHOULD NOT BE
CONSIDERED A NUTRIENT.
AND THESE CLAIMS MUST IDENTIFY
THE NEW OF NUTRIENT LABEL TO
WHICH THE CLAIM REFERS.
SO, X AMOUNT OF THIS INGREDIENT
HAS SHOWN THAT THE CAN REDUCE
CHOLESTEROL LEVELS, FOR
INSTANCE, AS AN EXAMPLE.
SO, WHY IS ALL THIS IMPORTANT?
WELL, BACK JUST IN THE LEAD UP
TO NLEA THERE WAS SOME RESEARCH
THAT SHOWED THINGS LIKE FIBER
MAY HELP PREVENT -- LOWER
CREDITS WHICH MIGHT PREVENT
CARDIOVASCULAR DISEASE.
YOU STARTED SEEING HEART SYMBOLS
ON CEREAL BOXES, BY THE
INTERPRETATION OF LAW, THAT
CLASSIFIED AS DRUG.
THE ONLY REASON YOU'RE LOWERING
CHOLESTEROL IS PREVENT HEART
DISEASE, THEREFORE PUTTING THAT
HEART SYMBOL ON YOUR CHEERIOS
BOX COULD ACCIDENTLY RECLASSIFY
YOUR CHEERIOS AS A DRUG.
AND OF COURSE IF YOUR CHEERIOS
HAD NOT GONE THROUGH PRE-MARKET
REVIEW PROCESS WITH FDA, THEN IT
WAS AN ADULTERATED DRUG, HAD NOT
BEEN APPROVED, HAD NOT GONE
THROUGH THE APPROVAL PROCESS.
THEREFORE IT WAS ILLEGAL.
SO, THE CONGRESS WANTED TO MAKE
A COMMON SENSE REMEDY TO THAT.
SO, WHAT THEY DID IS PERMITTED
HEALTH CLAIMS.
SO, CURE, TREAT, PREVENT,
MITIGATE IS NOW PERMITTED.
YOU CAN SEE NOW SEE A CHEERIOS
BOX WITH THAT HEART OR LOWER
CHOLESTEROL SYMBOL THANKS TO
NLEA.
THERE IS A FAIRLY SHORT LIST,
KIND OF STABLE FOR A NUMBER OF
YEARS, SO THERE'S A RELATIVELY
SHORT LIST OF AUTHORIZED HEALTH
CLAIMS THAT MEET THAT
SIGNIFICANT SCIENTIFIC AGREEMENT
STANDARD.
THESE ARE THE AUTHORIZED HEALTH
CLAIMS.
CALCIUM, VITAMIN D AND
OSTEOPOROSIS LIPIDS AND CANCER,
SATURATED FAD AND CHOLESTEROL,
DENTAL CARIES.
ALL HAVE BEEN AROUND FOR A
WHILE.
THE MAIN CHANGE IN THE LAST
NUMBER OF YEARS IS THAT FDA
PROPOSED TO REVOKE THE SOY
PROTEIN AND CARDIOVASCULAR
DISEASE AUTHORIZED HEALTH CLAIM,
THAT PROPOSAL WAS MADE IN 2017,
AS FAR AS I KNOW THAT HAS NOT
GONE ANYWHERE SINCE.
A RELATIVELY SHORT LIST OF
AUTHORIZED HEALTH CLAIMS.
THE SLIDES ARE AVAILABLE.
I GOT THIS DIRECTLY FROM FDA'S
WEBSITE, YOU SEE THE URL DOWN
THERE.
THEN THERE ARE THE QUALIFIED
HEALTH CLAIMS.
AS MENTIONED THEY ARE SUPPORTED
BY SCIENTIFIC EVIDENCE BUT DON'T
MEET RIGOROUS SCIENTIFIC
AGREEMENT STANDARD.
THE DISCLAIMER OR OTHER
QUALIFYING LANGUAGE TO
ACCURATELY COMMUNICATE LEVEL OF
EVIDENCE HAS TO BE ON THE LABEL
AS PART OF THE CLAIM.
FDA DOESN'T APPROVE THESE
QUALIFIED HEALTH CLAIMS.
FOOD MANUFACTURERS PETITION THE
AGENCY TO CONSIDER EXERCISING
INENFORCEMENT DISCRETION AND FDA
CAN ISSUE A LETTER OF
ENFORCEMENT DISCRETION, THE
PROCESS DOES NOT INVOLVE
RULEMAKING SO THAT'S KIND OF
COMPLICATED.
THEN WE COME TO DIETARY
SUPPLEMENTS.
THE DEFINITION, THIS IS THE KEY,
THE FIRST SENTENCE, FIRST
BULLET, ANY PRODUCT OTHER THAN
TOBACCO THAT CONTAINS A VITAMIN,
MINERAL, HERB OR BOTANICAL OR
AMINO ACID INTENDED AS A
SUPPLEMENT TO THE DIET, INTENDED
USE, DEFINES A DIETARY
SUPPLEMENT.
CONGRESS ADDED SOME OTHER
THINGS, WHAT CAN BE INCLUDED IN
THAT SUPPLEMENT, THE DIET,
CATEGORY.
CONCENTRATE METABOLITE
CONSTITUENT OR COMBINATION OF
VITAMIN, MINERAL, HERB,
BOTANICAL, ET CETERA CAN ALSO BE
DIETARY INGREDIENT.
AS FOR FOODS FDA BE ON CONGRESS
SET OUT A GRANDFATHER DATE,
DIETARY INGREDIENTS THAT HAVE
BEEN PRESENT IN THE FOOD SUPPLY
PRIOR TO 1994, AS ARTICLES USED
FOR FOOD IN A FORM IN WHICH THE
FOOD HAS NOT BEEN CHEMICALLY
ALTERED ARE GRANDFATHERED.
IF YOU CAN SHOW YOUR INGREDIENT
WAS ON THE MARKET PRIOR TO 1994,
THEN YOU'RE GRANDFATHERED AND DO
NOT NEED TO FILE A NEW DIETARY
INGREDIENT NOTIFICATION.
IF IT'S NOT GRANDFATHERED YOU
NEED TO FILE A NEW DIETARY
INGREDIENT NOTIFICATION.
IT SHOULD BE A 75-DAY NOVEMBER,
SORRY.
NOBODY REQUIRES A 74-DAY
NOTIFICATION.
SO, I'M NOT GOING TO COVER THAT.
ACCORDING TO FDA AND INDUSTRY
SOURCES THE INDUSTRY HAS BEEN
WOEFULLY INADEQUATE IN FILING
DIETARY INGREDIENT
NOTIFICATIONS.
IT WON'T COMMENT ON ACCURACY OF
THAT, OF THAT CLAIM.
I WOULD JUST SAY THAT THERE
SEEMS TO BE MORE INGREDIENTS ON
THE MARKET THAN NEW DIETARY
INGREDIENT NOTIFICATIONS.
TWO THINGS WE'LL COVER TODAY
INGREDIENT CANNOT BE PRE-1994
APPROVED DRUG.
WE'LL TALK ABOUT THIS LATER BUT
THE MAIN EXAMPLE WAS APPROVED IN
1963 AS A DRUG, CANNOT BE THE
SUBJECT OF PUBLICLY AVAILABLE
PRE-94 INVESTIGATIONAL DRUG
APPLICATION.
THAT COMES UP IN A VERY
CONTROVERSIAL INGREDIENT, CBD,
SUBJECT OF A PRE-1994
INVESTIGATIONAL NEW DRUG
APPLICATION FOR CERTAIN FORMS OF
EPILEPSY, CHILDHOOD EPILEPSY.
DIETARY SUPPLEMENTS ARE
CONSIDERED A SPECIAL CATEGORY OF
FOOD AND CANNOT BE REPRESENTED
AS A FOOD OR MEAL REPLACEMENT.
THESE ARE SUPPLEMENTARY, YOU'RE
NOT ALLOWED TO CLAIM IF YOU TAKE
THIS PILL IT'S LIKE HAVING A
STEAK DINNER.
IT DOESN'T WORK THAT WAY.
DR. GHACHE NOTED ABOUT THE
VITAMIN SUPPLEMENTS AND THEIR
HISTORY ALMOST FROM THE FIRST
DAYS OF THE DISCOVERY OF
VITAMINS, ENTREPRENEURS AND
SCIENTISTS, MEDICAL DOCTORS,
THOUGHT IT WOULD BE A GOOD IDEA
TO MAKE SURE EVERYBODY GETS
ENOUGH OF THESE NEWLY DISCOVERED
VITOMERS AS ORIGINAL COMPOUNDS
WERE CALLED, PEOPLE SOLD THEM.
REGULATIONS GOVERNING FOR FOR
SPECIAL DIETARY USE BEGINNING IN
1941.
NOW, THE STRICTURES FOR WHEN
SOMETHING MIGHT BE CONSIDER FOR
SPECIAL DIETARY USE WERE FAIRLY
CONTAINED, FAIRLY STRICT, AND
THEREFORE KIND OF RESTRICTIVE IN
THE MARKETPLACE.
BUT FDA HAD SOME HIGH PROFILE
CASES WHERE THEY STARTED GOING
AFTER A COUPLE COMPANIES SELLING
VITAMIN AND MINERAL SUPPLEMENTS.
MEAN 1962 AND 1973 FDA ATTEMPTED
TO PASS MORE RESTRICTIVE
REVELATIONS WHEN DIETARY USE
INDICATIONS SEEMED TO BE GETTING
OUT OF HAND.
AND IN RESPONSE TO THAT,
CONGRESS PASSED A VITAMIN AND
MINERAL LEGISLATION IN 1976, THE
ROGERS/PROXMIRE AMENDMENT, THAT
SPECIFICALLY PROHIBITED FDA FROM
CLASSIFYING VITAMIN AND MINERAL
SUPPLEMENTS AS DRUGS BASED
SOLELY ON THEIR COMBINATIONS OR
POTENCY UNLESS AN ACTUAL DRUG
CLAIM WAS MADE FOR THE PRODUCT.
SO THAT'S A LITTLE BIT OF THE
HISTORY OF DIETARY SUPPLEMENT
REGULATION.
THERE'S AN AWFUL LOT OF
LITERATURE PRIOR TO THAT TIME
THAT REFERRED TO NUTRITIONAL
SUPPLEMENTS RATHER THAN DIETARY
SUPPLEMENTS.
I SPECULATE THE REASON THE WORD
DIETARY SUM ELEMENT WAS THERE TO
INCLUDE THINGS NOT NUTRIENTS, SO
IT WOULD BE INAPPROPRIATE TO
CALL ST. JOHN'S WORT A
NUTRITIONAL SUPPLEMENT, SO
CONGRESS CAME UP WITH THE WORD
DIETARY SUPPLEMENT INSTEAD.
ANYBODY THAT KNOWS WHETHER
THAT'S SPECULATION IS TRUE,
PLEASE PIPE UP.
THIS IS PROBABLY A PRE-1970
PRODUCT BECAUSE CYCLAMATES WERE
BANNED IN 1970 BUT THERE WAS
CONTROVERSY WHETHER OR NOT THEY
WERE BAD FOR YOU BEFORE 1970.
THIS WAS AN IMAGE BY SEARCHING
E-BAY FOR IMAGES OF OLD DIETARY
SUPPLEMENT LABELS.
THIS IS CHOCKS VITAMINS.
I PROBABLY TOOK THESE AS A KID
MYSELF, SOMETHING SIMILAR.
MULTI-VITAMINS, IT WAS A BUCK
FOR 25 CAPSULES, THAT SHOWS HOW
OLD IT IS.
BACK IN THE DAY IF YOU WALKED IN
A HEALTH FOOD STORE, I ADMIT TO
CHEATING, THIS IS A CONTEMPORARY
PACKAGE BUT TYPICAL OF A HEALTH
FOOD STORE PRIOR TO 1994.
TO AVOID INTENDED USE STUFF,
WHAT YOU WOULD DO IS WALK INTO A
HEALTH FOOD STORE AND THERE
WOULD BE THIS CELLOPHANE-WRAPPED
PACKAGE OF MISTLETOE, OR ST.
JOHN'S WORT, OR SOMETHING LIKE
THAT, ALL ON THE LABEL IS
AMOUNT IN THE BAG AND WORD
MISSILE TO TO AVOID HAVING FDA
COME AFTER YOU BECAUSE YOU WERE
MAKING A CLAIM.
YOU HAD TO KNOW WHAT YOU WERE
SUPPOSED TO USE MISTLETOE FOR OR
IN MANY CASES THE CLERK WAS MORE
THAN HELPFUL TO RECOMMEND
MISTLETOE FOR THIS OR THAT
AILMENT.
YOU GO TO TO THE STORE, SAY TO
THE CLERK, I NEED SOMETHING
BECAUSE I'M CONSTIPATED, THE
CLERK WOULD DIRECT YOU TO THE
CASCERA BARK OR SOMETHING LIKE
THAT.
HERBAL PRODUCTS BEFORE 1994 WERE
LESS WELL LABELED; THE CONSUMER,
UNLESS THEY WERE INFORMED OR
CONSUMER WILLING TO LISTEN TO A
CLERK WHO MAY OR MAY NOT HAVE
HAD SOME EDUCATION IN HERBS OR
MEDICINE, REALLY DIDN'T KNOW
WHAT TO DO WITH A LOT OF THESE
BOTANICALS.
THERE WAS NO INTERNET, ONE WOULD
HAVE TO GET ONE'S INFORMATION
ELSEWHERE.
FAST FORWARD TO 1994, DIETARY
SUPPLEMENT LABEL, FROM THAT KIND
OF PRIMITIVE LABEL I JUST SHOWED
YOU, THE DIETARY SUPPLEMENT
LABEL LOOKS LIKE THIS, SIMILAR
TO FOOD LABEL WITH PRINCIPAL
DISPLAY PANEL, INFORMATION
PANEL.
WORD DIETARY SUPPLEMENT HAD TO
APPEAR ON THE LABEL.
ACTUALLY NUTRITIONAL SUPPLEMENT,
I'VE SEEN THAT COUNT AS WELL BUT
I'M NOT QUITE SURE HOW GRAY THAT
AREA IS.
THE NAME AND ADDRESS OF THE
PLACE OF BUSINESS HAS TO APPEAR
ON THE LABEL.
NUTRITION LABELING.
AND AGAIN, IT'S THE SAME IN SOME
WAYS AS THE FOOD LABEL,
NUTRITION LABELING IS REQUIRED.
EXCEPT INSTEAD OF NUTRITION FACT
OR NUTRIENT FACT PANEL YOU HAVE
TO HAVE A SUPPLEMENT FACT PANEL,
REQUIRES INGREDIENT LIST, YOU'LL
SEE DIETARY SUPPLEMENTS THAT SAY
THIS PRODUCT WAS MANUFACTURED IN
IN A FACILITY THAT ALSO PROCESS
PEANUTS, ET CETERA, ET CETERA.
IT ALSO REQUIRES SAME LABEL
IDENTIFICATION OF ARTIFICIAL
FLAVORING, COLORING, CHEMICAL
PRESERVATIVES AS THE FOOD LABEL.
IT REQUIRES INGREDIENT AMOUNT
AND IDENTITY.
THE IDENTITY IS REASONABLY EASY
FOR NUTRIENTS.
WE ALL PRETTY MUCH KNOW WHAT
VITAMIN B 6 AND B-12 ARE AND
WHAT THEY ARE CALLED.
THEY ARE STANDARD NAMES.
BOTANICALS, NOT SO MUCH.
A TALK I USED TO GIVE ABOUT A
DOZEN DIFFERENT LOCAL NAMES FOR
THE HERB BLACK COHOSH.
AND SO THE AMERICAN HERBAL
PRODUCT ASSOCIATION WHICH IS THE
TRADE ASSOCIATION CAME UP WITH A
LIST OF STANDARDIZED NAMES.
SO YOU WOULDN'T HAVE 27
DIFFERENT COMMON NAMES FOR THE
SAME LATIN BINOMIAL NAME.
IF THE INGREDIENT IS NOT IN
HERBS OF COMMERCE YOU'RE
REQUIRED TO USE THE LATIN NAME
ON THE LABEL.
WHETHER IT'S IN HERBS OF
COMMERCE OR NOT YOU'RE ALSO
REQUIRED TO LIST THE PLANT PART
THAT WAS USED IN THE
MANUFACTURER, WHETHER IT'S A
ROOT, LEAF, OR WHATEVER.
THERE'S ALSO PROPRIETARY BLEND
CONCEPT WHICH I'LL COVER IN A
BIT.
IT HAS TO BE -- LABEL HAS TO BE
21 CFR PART 101 COMPLIANT WHICH
IS LABELING REGULATIONS DEALING
WITH SUPPLEMENT FACTS, NUTRIENT
FACTS.
SO, HERE WE ARE, DIETARY
SUPPLEMENT LABELS, STATEMENT OF
IDENTITY, GINSENG, DIETARY
SUPPLEMENT, NET QUANTITY DOWN AT
THE BOTTOM, 60 CAPSULES INSTEAD
OF 9 OUNCES, NUTRITION LABEL,
INGREDIENT LIST, NAME AND PLACE
OF BUSINESS.
SO, THIS SUPPLEMENT FACTS PANEL
SHOWS ALL THE NUTRIENTS THAT ARE
IN THIS PARTICULAR PRODUCT.
VITAMIN A THROUGH POTASSIUM,
IT'S NOT ALPHABETICAL, HERE IS
ZINC TOWARDS THE MIDDLE.
IF THERE'S A DAILY VALUE
ESTABLISHED, THAT NOT ONLY THE
AMOUNT BUT DAILY VALUE HAS TO BE
GIVEN ON THE LABEL.
FOR DIETARY -- FOR DIETARY
SUPPLEMENTS, YOU ARE ALLOWED TO
LIST INGREDIENTS THAT HAVE NO
ESTABLISHED DIETARY VALUE.
OR DAILY VALUE.
SO, BORON, NICKEL
THEY ARE LISTED BUT YOU'RE
ALLOWED TO PUT AN ASTERISK FOR
DAILY VALUE.
I TOLD YOU I WOULD TALK ABOUT
PROPRIETARY BLEND CONCEPT.
TALK TO THE SUPPLEMENT FOLK,
THEY WILL TELL YOU THIS IS THE
SAME CONCEPT IN CONVENTIONAL
PACKAGED FOODS.
CAMPBELL'S SOUP COMPANY IS NOT
GOING TO TELL YOU THE EXACT
AMOUNT OF THE HERBS, SPICES, AND
TOMATOES THEY PUT INTO THEIR
CAMPBELL'S SOUP BECAUSE THAT'S A
TRADE SECRET AND THEY DON'T WANT
PEOPLE REVERSE ENGINEERING
THINGS FROM THE LABEL.
SO, IT'S A PROPRIETARY BLEND.
SO YOU'RE REQUIRED TO LIST THE
TOTAL AMOUNT OF THE PROPRIETARY
BLEND, IN THIS CASE 1,000
MILLIGRAMS OF THE BLEND.
YOU CAN CALL SOME FANCY NAME
LIKE, YOU KNOW, THE X FACTOR
PROPRIETARY BLEND, AND YOU HAVE
TO LIST THE AMOUNT OF X FACTOR
ON THE LABEL.
BUT THEN YOU ALSO HAVE TO LIST
WHAT IS ACTUALLY IN THE
PROPRIETARY BLEND, AND YOU HAVE
TO LIST IT IN TERMS OF THE
AMOUNT OF ITS PRESENCE IN THE
BLEND FROM THE HIGHEST AMOUNT TO
THE LOWEST AMOUNT.
SO IN THIS CASE IT'S EXTRACTS,
THE HIGHEST CONCENTRATION AT
THE TOP, CAYENNE WOULD BE THE
LOWEST.
THE PERCENT DAILY VALUE IN THIS
CASE THEY USE A SWORD INSTEAD OF
ASTERISK TO INDICATE NO DAILY
VALUE HAS BEEN ESTABLISHED.
HEALTH CLAIMS FOR DIETARY
SUPPLEMENTS ARE PERMISSIBLE, CAN
BE QUALIFIED OR UNQUALIFIED, BUT
HEALTH CLAIMS ARE ONLY ALLOWED
TO BE MADE FOR NUTRIENTS.
YOU CAN'T MAKE A HEALTH CLAIM
FOR THE ST. JOHN'S WART IN THE
PRODUCT BECAUSE IT'S NOT A
NUTRIENT.
STATEMENTS OF NUTRITIONAL
SUPPORT ARE PERMITTED ON DIETARY
SUPPLEMENTS, ALSO ON FOODS BUT
SELDOM USED.
THESE ARE ALSO KNOWN AS
STRUCTURE FUNCTION CLAIMS,
REQUIRE 30-DAY NOTIFICATION TO
FDA, MAINLY SO FDA CAN TELL YOU
WHETHER OR NOT IT'S A LEGITIMATE
STRUCTURE/FUNCTION CLAIM, IF YOU
CROSS THE LINE INTO A DRUG CLAIM
IT'S IN YOUR BEST INTEREST IF
YOU PROVIDE THE 30-DAY
PRE-MARKET NOTIFICATION TO FDA
BECAUSE THEY CAN TELL YOU
WHETHER OR NOT YOU NEED TO PRINT
UP A NEW BATCH OF LABELS BEFORE
YOU HAVE TO PRINT UP A NEW BATCH
OF LABELS.
THEY MAY CLAIM WHILE DISCLOSING
PREVALENCE OF IN THE U.S.,
SCURVY, USUAL STUFF.
DESCRIBE THE ROLE OF NUTRIENT OR
DIETARY INGREDIENT INTENDED TO
AFFECT STRUCTURE OR FUNCTION OF
HUMANS.
CHARACTERIZE MECHANISM TO
MAINTAIN STRUCTURE OR FUNCTION,
DESCRIBE GENERAL WELL-BEING FROM
CONSUMPTION OF NUTRIENT OR
DIETARY AGREEMENT.
THEY MUST NOT CLAIM TO DIAGNOSE,
MITIGATE, CURE, OR PREVENT
DISEASE.
JAMIE TOLD US ABOUT THAT
EARLIER.
NOW, PEOPLE MAKE THE ASSERTION
THAT DIETARY SUPPLEMENTS WITH
NOT REGULATED.
THAT'S NOT TRUE.
THEY ARE IN FACT REGULATED.
THEY HAVE ALL SORTS OF
REGULATIONS.
THEY JUST ARE NOT REGULATED THE
SAME WAY AS DRUGS ARE.
SO, MANUFACTURERS ARE REQUIRED
TO HAVE SUBSTANTIATION THAT
CLAIMS ARE TRUTHFUL AND NOT
MISLEADING, JUST NOT REQUIRED TO
SHOW IT TO ANYBODY.
IF FDA IS ABLE TO DETERMINE THAT
THERE'S NO SUBSTANTIATION AND
THE PRODUCT AND CLAIM IS MADE,
THE PRODUCT IS MISBRANDED.
THERE IS NO PRE OR POST MARKET
FOR FDA SUBSTANTIATION REVIEW.
IF THERE'S REVIEW IT'S A
REVIEW -- AT ALL IT'S BY THE
FEDERAL TRADE COMMISSION, NOT
THE FDA.
MANDATORY LABELING, AND IF
CLAIMS ARE MADE NOTICE ON THE
LABEL CLAIMS HAVE NOT BEEN
EVALUATED BY THE FDA.
SO REGULATORY SUMMARY IS THIS.
DRUG IS INTENDED TO CURE, TREAT,
MITIGATE A DISEASE, UNSAFE BY
DEFINITION, UNTIL THE SPONSOR
APPROVES OTHERWISE.
PRE-MARKET APPROVAL FOR EFFICACY
AND SAFETY, MANDATORY
FORMULATION STANDARDS AND
PRODUCT REGISTRATION ALL OF
WHICH ARE ESTABLISHED DURING THE
NEW DRUG APPLICATION PROCESS.
THERE ARE LABELING RULES,
MANDATORY ADVERSE EVENT
REPORTING.
THERE ARE CURRENT GOOD
MANUFACTURING PRACTICE
REQUIREMENTS FOR DRUGS AS WELL.
SUPPLEMENTS ARE INTENDED TO
SUPPLEMENT THE DIET.
SUPPLEMENTS ARE FOOD, THEREFORE
THEY HAVE TO BE GRAS, THEY HAVE
SAFE BY DEFINITION UNLESS A NEW
DIETARY INGREDIENT OR NOT
ELIGIBLE TO BE A DIETARY
INGREDIENT.
ONCE YOU FILE NOTIFICATION AND
FDA FILES A LETTER OF NO
OPPOSITION, THEN YOU'RE ALLOWED
TO MARKET YOUR NEW INGREDIENT.
LIMITED PRE-MARKET REVIEW, THAT
REVIEW IS NEW DIETARY AGREEMENT
NOTIFICATION PROCESS, THERE'S NO
PRE-MARKET APPROVAL.
NO MANDATORY FORMULATION
STANDARDS AND NO PRODUCT
REGISTRATION FOR DIETARY
SUPPLEMENTS.
THERE ARE LABELING RULES, AS WE
WENT THROUGH.
THERE IS MANDATORY SERIOUS
ADVERSE EVENT REPORTING.
AND THERE ARE REQUIRED MANDATORY
CURRENT GOOD MANUFACTURING GOOD
PRACTICE REGULATIONS.
SUPPLEMENTS ARE IN FACT
REGULATED.
SO, I THINK I'M PRETTY MUCH AT
THE END OF MY TIME.
SO I DO HAVE A LITTLE BIT OF
CASE STUDY, I WILL ASK THE CHAIR
IF HE WANTS ME TO COVER THE CASE
STUDY OR WHETHER I SHOULD JUST
STOP HERE AROUND WAIT FOR
QUESTIONS.
>> YOU HAVE FIVE MORE MINUTES.
>> EXCELLENT.
OKAY.
I SHOULD BE ABLE TO GO THROUGH
THIS FAIRLY QUICKLY.
SO I REMEMBER COMING BACK FROM A
MEETING ON THE WEST COAST, I
THINK SOMETIME IN EARLY 2000s,
BEING PRESENTED WITH A PLETHORA
OF BEVERAGES AT A BREAK AT THIS
MEETING.
AND THERE WERE ALL THESE ENERGY
DRINKS AND STRANGE COLAS AND
THINGS LIKE THAT THAT WERE
LABELED AS DIETARY SUPPLEMENTS.
AND A COUPLE YEARS LATER THOSE
PRODUCTS WERE SUDDENLY NOT
DIETARY SUPPLEMENTS ANYMORE BUT
THEY WERE CONVENTIONAL FOODS.
THERE'S A COUPLE REASONS FOR
THAT.
ONE IS COMPANIES STARTED
LABELING, MARKETING THESE
PRODUCTS DECLARING THEM DIETARY
SUPPLEMENTS BECAUSE THEY WANTED
TO PUT THINGS IN THEM THAT WERE
NOT GRAS, NOT GENERALLY
RECOGNIZED AS SAFE.
THE WAY TO DO THAT WAS TO USE A
DIETARY INGREDIENT AND PUT THOSE
IN THE PRODUCT.
WELL, A COUPLE YEARS LATER FDA
STARTED SAYING, NO, NO, NO,
DON'T DO THAT.
AND THEN YOU SAW SOME OF THESE
PRODUCTS REFORMULATED.
YOU SAW SOME INGREDIENTS HAVE
SELF-AFFIRMED GRAS
APPLICATIONS -- OR NOTIFICATIONS
TO FDA.
AND SO YOU ENDED UP WITH HAVING
THESE THINGS THAT HAD BEEN
CALLING THEMSELVES DIETARY
SUPPLEMENTS SUDDENLY WITH
NUTRITION FACT PANELS INSTEAD OF
SUPPLEMENT FACT PANELS.
AND THEN AT THE SAME TIME
THERE'S THESE LITTLE TINY
THINGS, FIVE-HOUR ENERGY AND
PRODUCTS SIMILAR TO THOSE, THAT
STILL HAVE A SUPPLEMENT FACTS
PANEL THAT CALL THEMSELVES
SUPPLEMENTS RATHER THAN
CONVENTIONAL FOODS.
SO, WHY IS THAT?
WELL, FDA EVENTUALLY STEPPED IN
AND CLARIFIED.
IN ADDITION TO THE WHOLE, YOU
KNOW, YOU CAN'T PUT ST. JOHN'S
WORT IN A CONVENTIONAL FOOD
BECAUSE IT'S NOT GENERALLY
RECOGNIZED AS SAFE, YOU KNOW, IT
BECOMES A FOOD ADDITIVE, IT'S
NOT GENERALLY RECOGNIZED AS SAFE
FOR USE IN FOODS THEREFORE YOU
CAN'T PUT THAT INTO YOUR
PRODUCT.
SO FDA SAID YEAH, DON'T DO THAT.
SO, FDA PROMULGATED GUIDANCE ON
DISTINGUISHING LIQUID DIETARY
SUPPLEMENTS FROM BEVERAGES.
THE URL IS THERE.
THE RULES, THE GUIDANCE IS
THERE.
WHAT IT BOILS DOWN TO IF THE
PRODUCT PROVIDES A SIGNIFICANT
AMOUNT OF WATER FOR HYDRATION
PURPOSES, THEN YOU SHOULDN'T
CALL IT A DIETARY SUPPLEMENT,
BUT CALL IT A BEVERAGE WHICH IS
CONVENTIONAL FOOD.
SO, A BIG BOTTLE OR BIG CAN LIKE
THIS WHICH IS 12 OR 16 OUNCES
PROVIDES SIGNIFICANT AMOUNT OF
WATER TO MEET YOUR DAILY
HYDRATION NEEDS.
PRODUCT LIKE THIS I THINK IT'S 1
OTHER ORE -- 1 OR 2 OUNCES DOES
NOT PROVIDE SIGNIFICANT
HYDRATION NEEDS SO THAT CANNOT
BE CALLED A DIETARY SUPPLEMENT.
PROBLEM SOLVED.
VERY OLD PRODUCTS THAT OCCURRED
AROUND THE TIME THAT ABOUT FIVE
YEARS AFTER WHERE SOME PEOPLE
TRIED TO GET CREATIVE.
THERE WAS A LINE BY HAIN'S
COMPANY THAT OWNS CELESTIAL
SEASONINGS, MARKETING SOME
PRODUCTS THEY CALLED HAIN'S
KITCHEN PRESCRIPTION.
ONE PRODUCT WAS CHICKEN BROTH
AND NEWED ALSO WITH ECHINACEA,
ANOTHER WAS TOMATO BASIL SOUP
WITH ST. JOHN'S WORT.
COMPANY SUBMITTED NOTICE OF
CLAIMS WITH LABELED TO FDA
ASSERTING THESE PRODUCTS WERE
DIETARY SUPPLEMENTS.
THESE WERE CANS OF SOUP.
LABELS HAD PICTURE OF SOUP, USE
OF THE WORD SOUP, USE OF THE
PHRASE HEAT AND SERVE, MADE
REFERENCE TO POTATOES, SPLIT
PEA, CHICKEN BROTH AND NOODLES,
INGREDIENTS INCLUDED ECHINACEA
AND ST. ST. JOHN'S WORT, STILL
NOT GENERALLY RECOGNIZED AS SAFE
FOOD ADDITIVES.
THEY MADE STRUCTURE-FUNCTION
CLAIMS.
THEY WANTED TO INCLUDE THOSE
INGREDIENTS, AND WENT DIETARY
SUPPLEMENT ROUTE AND THOUGHT THE
ACT GAVE THEM SAFE HAVEN TO DO
THAT.
AND THEY ALSO WANTED TO MAKE
STRUCTURE-FUNCTION CLAIM.
HERE'S A WAY TO GET THIS INTO
THE MARKETPLACE, WE'LL CAUGHT IT
A DIETARY SUPPLEMENT, WE'LL BE
ABLE TO GIVE PEOPLE THESE NEW
INGREDIENTS WITHOUT HAVING TO
FILE FOOD ADDITIVE POSITION OR
GO THROUGH GRAS AFFIRMATION
PROCESS.
SO, THE COMPANIES CALL THESE
PRODUCTS HERBAL SUPPLEMENTS BUT
AFTER REVIEW, FDA CONCLUDED THE
LABEL STATEMENTS REPRESENT THE
PRODUCT AS A CONVENTIONAL FOOD
INTENDED USE.
THEREFORE, CANNOT BE A DIETARY
SUPPLEMENT.
SO, AS I ALREADY SAID, UNDER THE
ANT, MUST BE USED IN ACCORDANCE
WITH FOOD ADDITIVE REGULATIONS
AND THE AGENCY WAS NOT AWARE OF
THE BASIS FOR CONCLUDED THESE
INGREDIENTS WERE GENERALLY
RECOGNIZED AS SAFE FOR USE IN
CONVENTIONAL FOODS.
SO, THE STATEMENTS, THE
STRUCTURE FUNCTION CLAIMS,
AGENCY SAID WERE NOT HEALTH
CLAIMS, STRUCTURE-FUNCTION
CLAIMS, THEY WEREN'T NUTRIENT
RELATED, THEREFORE THEY WERE NOT
APPROPRIATE TO CONVENTIONAL
FOOD.
THE NAME OF THE PRODUCT, KITCHEN
PRESCRIPTION, SUGGESTED THE
PRODUCT MAY BE INTENDED TO
DIAGNOSE, CURE, MITIGATE OR
TREAT A DISEASE.
THEREFORE, IT WAS AN UNAPPROVED
NEW DRUG.
THIS COMPANY KIND OF SCREWED UP
IN EVERY POSSIBLE WAY THEY COULD
SCREW UP IN TERMS OF THE
PRODUCT.
SO, THE CLAIMS THEY MADE ON THE
LABEL MADE THEIR PRODUCT BOTH A
DRUG BUT ALSO ADULTERATED FOOD.
THE INGREDIENT ST. JOHN'S WORT,
ECHINACEA, WERE NOT GRAS.
FDA SAID YOU CAN CONTINUE TO
SELL THIS STUFF IF YOU'LL SHOW
FDA THAT THOSE SUBSTANCES ARE
SAFE.
>> I NEED YOU TO WRAP UP.
>> OKAY.
PRODUCTS ARE PROPERTY LABELED
WITH NUTRITION FACTS RATHER THAN
SUPPLEMENT FACTS PANEL.
LABEL DOES NOT SUGGEST EFFECT ON
DISEASE, STRUCTURE-FUNCTION
EFFECTS CLAIMS ON LABEL ACHIEVED
VIA NUTRITIVE VALUE.
AND THE PICTURES OF TOMATOES,
USE OF THE WORD DELICIOUS, FDA
DECIDED THOSE TERMS, THOSE
CLAIMS, CLASSIFIED THE PRODUCT
AS CONVENTIONAL FOOD BASED ON
INTENDED USE.
REMEMBER THE ORIGINAL DEFINITION
OF A FOOD, YOU KNOW, TASTE,
ODOR, NUTRITIVE VALUE.
SO, CONCLUSION IS THAT PRODUCTS
ARE CLASSIFIED BY THE
MANUFACTURER AS FOODS, DIETARY
SUPPLEMENTS OR DRUGS IF THEY DO
IT RIGHT, RANGING FROM BASIC
NUTRITION, HEALTH PROMOTION,
CURE, TREAT, MITIGATE.
RULES CHANGE DEPENDING WHICH BOX
YOU DECIDE YOUR PRODUCT IS
SUPPOSED TO BE IN.
AGAIN, YOU'RE IN CONTROL.
THE MANUFACTURER DECIDES ON THE
BOX THROUGH INTENDED USE.
LABELING CLAIMS, ALL THAT KIND
OF STUFF.
IF THE COMPANY MESSES UP AS HAIN
COMPANY DID, FDA IS LEFT TO
FIGURE OUT WHICH BOX IS INTEND
AND WILL USE APPROPRIATE RULES
FOR THAT BOX.
IF YOU END UP PUTTING YOUR THING
IN A BOX YOU DID NOT INTEND IT
TO YOU COULD END UP REGULATED AS
A DRUG RATHER THAN WHAT YOU
INTENDED AS A FOOD OR AS A
DIETARY SUPPLEMENT.
I WILL END THERE AND, PAUL,
THANKS FOR YOUR PATIENCE.
>> OKAY.
THANKS VERY MUCH, JOE.
NEXT SPEAKER IS GERIE VOSS WHO
WILL JANE WHAT THE U.S. FOOD AND
DRUG ADMINISTRATION DOES,
DIRECTS DIVISION OF POLICY AND
REGULATION IMPLEMENTATION AT
FDA OFFICE OF DIETARY
SUPPLEMENTS, AN ATTORNEY WITH
THE FDA SINCE 2009.
WE
WE WELCOME YOU.
TAKE IT AWAY.
>> I'M GOING TO SHARE MY SCREEN.
GREAT.
LET ME GRAB THAT.
POWERPOINT.
SHARE.
OKAY.
THERE WE GO.
HI, EVERYONE.
YES, I'M GERIE VOSS, DIRECTORY
DIVISION OF POLICY AND
REGULATION, FOR FDA CENTER FOR
FOOD SAFETY AND APPLIED
NUTRITION OFFICE OF DIETARY
SUPPLEMENT PROGRAMS.
IN THE GOVERNMENT AWHILE, YOU
KNOW WE USE A LOT OF ACRONYMS,
WE REFER TO DPRI AS PART OF
ODSP.
TODAY I'M SPEAKING HOW THE FDA
REGULATES DIETARY SUPPLEMENTS.
MY WORK AT FDA INVOLVES ALL OF
THE AREAS WE'RE GOING TO TALK
ABOUT TODAY.
AND THAT INCLUDES NEW DIETARY
INGREDIENT NOTIFICATION
REQUIREMENTS, CURRENT GOOD
MANUFACTURING PRACTICE
REGULATIONS, SUPPLEMENT LABELS,
ADVERSE EVENT REPORTING, DIETARY
SUPPLEMENT POLICY DEVELOPMENT,
ENFORCEMENT OF DIETARY
SUPPLEMENT LAWS AND REGULATIONS.
SOME OF THIS IS PART OF WHAT DR.
BETZ TOUCHED ON ALREADY SO I MAY
MOVED QUICKLY IN SOME OF THOSE
AREAS HE'S TOUCHED ON AND FOR
SOME AREAS IT'S HELPFUL REVIEW.
AS THIS SLIDE SHOWS, THE PRIMARY
AUTHORITY FOR DIETARY SUPPLEMENT
REGULATION COMES FROM THE
FEDERAL FOOD DRUG AND COSMETIC
ACT, THAT'S THE LAW THAT GOVERNS
ALL FDA REGULATED COMMODITIES.
THE FIRST LAW THAT DEFINES
REGULATION OF DIETARY IS DSHEA,
PASSED IN 1994, LAYING OUT
FRAMEWORK AND PROVIDING MOST OF
THE REQUIREMENTS WE'LL TALK
ABOUT FOR THE REMAINDER OF THE
PRESENTATION.
IT ESTABLISHED REQUIREMENTS FOR
NEW DIETARY INGREDIENT
PRE-MARKET REVIEW, AS DR. BETZ
MENTIONED THIS IS THE ONLY TIME
THAT FDA HAS THE ABILITY TO DO
ANY SORT OF PRE-MARKET REVIEW
REGARDING A DIETARY SUPPLEMENT.
IT MADE IT A REQUIREMENT ALL
DIETARY SUPPLEMENTS BE PRODUCED
IN ACCORDANCE WITH CURRENT GOOD
MANUFACTURING PRACTICES,
INCLUDING SUPPLEMENTS UNDER
ADULTERATED PROVISIONS OF THE
ACT BASICALLY GIVING FDA ABILITY
TO ENFORCE DENSE ADULTERATED
DIETARY SUPPLEMENTED.
IN ORDER TO DISCUSS HOW THE FDA
REGULATES DIETARY SUPPLEMENTS
LET'S REVIEW THE DEFINITION OF
WHAT WE DO REGULATE AND DON'T
REGULATE.
DIETARY SUPPLEMENT IS DEFINED AS
PRODUCT OTHER THAN TOBACCO,
OBVIOUSLY, THAT PORTION WAS PUT
IN LATER INTO THE ACT, AFTER FDA
RECEIVED AUTHORITY TO ALSO
REGULATE TOBACCO PRODUCTS.
IT'S A PRODUCT OTHER THAN
TOBACCO INTENDED TO SUPPLEMENT
THE DIET.
SUPPLEMENTING THE DIET MEANS
AUGMENTING THE DIET TO PROMOTE
HEALTH, A PRODUCT INTENDED FOR
INGESTION, REFERRING TO
INTERNALLY INTO THE STOMACH OR
G.I. TRACT, THEREFORE DIETARY
SUPPLEMENT COULDN'T BE A NASAL
SPRAY OR INHALED OR SUBLINGUALS,
INJECTABLES.
WE SEE THESE WHERE WE LEARN THAT
PRODUCTS ARE NOT INTENDED FOR
INGESTION.
DR. BETZ MENTIONED IT CAN'T BE A
SOLE ITEM OF A MEAL OR DIET AND
MAY NOT BE REPRESENTED AS
CONVENTIONAL FOOD AND MUST BE
LABELED AS A DIETARY SUPPLEMENT,
THAT'S KEY.
DIETARY SUPPLEMENT NEEDS TO
CONTAIN ONE OR MORE OF DIETARY
INGREDIENTS, THOSE ARE LISTED
HERE, VITAMIN, MINERAL, HERB OR
BOTANICAL, AMINO ACID, SOME
EXAMPLES OF DIETARY SUPPLEMENTS
THAT YOU MAY HAVE HEARD OF, FOR
EXAMPLE, LACTOBACILLUS
ACIDOPHILUS, I'M NOT GOOD AT
PRESENTING LATIN TERMS BUT
HOPEFULLY I SAID THAT CORRECTLY.
CHONDROITIN SULFATE,
CONCENTRATIONS, METABOLITES,
GREEN TEA EXACTS, THOSE SORTS OF
THINGS WILL BE CONSIDERED
DIETARY SUPPLEMENTS.
THE LAW SPECIFICALLY
DISTINGUISHES DIETARY
SUPPLEMENTS FROM DRUGS IN
SEVERAL WAYS.
IT STATES THAT THE DIETARY
SUPPLEMENT CAN'T BE AN ARTICLE,
THERE'S A LOT OF CASE LAW TO
EXPLAIN APPROVED AS NEW DRUG,
ANTIBIOTIC OR BIOLOGIC, OR
AUTHORIZED BY INVESTIGATION AS A
NEW DRUG FOR WHICH SUBSTANTIAL
CLINICAL INVESTIGATIONS HAVE
BEEN INSTITUTED AND FOR WHICH
THE EXISTENCE OF SUCH
INVESTIGATIONS HAS BEEN MADE
PUBLIC, UNLESS THE ARTICLE WAS
MARKETED AS DIETARY SUPPLEMENT
OR FOOD BEFORE SUCH APPROVAL OR
AUTHORIZATION.
YOU CAN IMAGINE THAT WHEN WE ARE
TRYING TO FIGURE OUT WHETHER OR
NOT A PRODUCT IS IN FACT A
DIETARY SUPPLEMENT VERSUS A DRUG
THERE IS A LOT OF INFORMATION
THAT WE HAVE TO CONSIDER, ALL OF
THESE FACTORS, AND MANY TIMES
THE OFFICE OF DIETARY SUPPLEMENT
PROGRAMS WILL HAVE TO REACH OUT
TO OUR CENTER FOR DRUGS TO HAVE
THEM TELL US WHETHER OR NOT, FOR
EXAMPLE, A PRODUCT HAS BEEN
AUTHORIZED BY INVESTIGATION,
HAVE CLINICAL INVESTIGATIONS
BEEN MADE PUBLIC, THERE'S CASE
LAW THAT PROVIDES MORE
EXPLANATION AS TO WHAT EXACTLY
ALL OF THOSE TERMS MEAN.
SO MORE ON DIETARY SUPPLEMENTS
VERSUS DRUGS, DIETARY
SUPPLEMENTS ARE DISTINGUISHED
FROM DRUGS BECAUSE A DRUG IS AN
ARTICLE INTENDED TO DIAGNOSE,
CURE, MITIGATE, TREAT, OR
PREVENT DISEASE.
SUPPLEMENTS CAN'T MAKE THOSE
CLAIMS HOWEVER BOTH CAN BE
INTENDED TO AFFECT STRUCTURE OR
FUNCTION OF HUMAN BODY AND THEN
REQUIREMENTS FOR MANUFACTURERS
TO FOLLOW IF THEY WISH TO MAKE
THOSE STRUCTURE-FUNCTION CLAIMS
IN PRODUCTS THAT ARE DIETARY
SUPPLEMENTS.
AGAIN, AS HAS BEEN MENTIONED
PREVIOUSLY DRUGS MUST UNDERGO
FDA APPROVAL AFTER CLINICAL
STUDIES TO DETERMINE
EFFECTIVENESS AND SAFETY.
THERE ARE NO SIMILAR PRE-MARKET
APPROVAL REQUIREMENTS FOR
DIETARY SUPPLEMENTS, THE ONLY
TYPE OF PRE-MARKET APPROVAL WE
GET IS IN THE NDI CONTEXT, NEW
DIETARY INGREDIENT CONTEXT, I'LL
SPEAK ABOUT THAT IN A FEW
MINUTES.
SO NOW DIETARY SUPPLEMENTS AND
DRUG APPLICATIONS, THIS IS A BIT
OF A COMPLICATED EVOLVING AREA,
SO THE BEST THING TO DO IS IF
YOU HAVE A QUESTION WITH RESPECT
TO THIS AREA, IT'S BEST TO
CONTACT FDA.
YOU CAN EITHER CONTACT THE
OFFICE OF DIETARY SUPPLEMENT
PROGRAMS AND WE CAN PUT YOU IN
TOUCH WITH PROPER FOLKS AT CDER,
CENTER FOR DRUGS, OR REACH OUT
TO CDER DIRECTLY.
THERE ARE SEVERAL CONSIDERATIONS
THOUGH FOR WHETHER AN IND IS
REQUIRED FOR YOUR PRODUCT
INCLUDING WHETHER THE INTENDED
POPULATION IS QUOTE/UNQUOTE
VULNERABLE.
BASICALLY IF THE CLINICAL
INVESTIGATION IS INTENDED ONLY
TO EVALUATE THE DIETARY
SUPPLEMENT'S EFFECT ON STRUCTURE
OR FUNCTION OF THE BODY, THEN AN
IND WOULD NOT BE REQUIRED.
THAT'S SORT OF THE GENERAL
PRINCIPLE HELPFUL TO WORK WITH
HERE.
HOWEVER, IF THE CLINICAL
INVESTIGATION IS INTENDED TO
EVALUATE THE DIETARY
SUPPLEMENT'S ABILITY TO EITHER
DIAGNOSE, CURE, MITIGATE, TREAT
OR PREVENT DISEASE, THEN AN IND
IS REQUIRED.
THAT'S THE CATCH PHRASE YOU'VE
HEARD FOR DISTINGUISHING BETWEEN
DRUGS AND DIETARY SUPPLEMENTS,
IT'S ALSO THE INFORMATION WE
LOOK CLOSELY AT WHEN WE'RE
CONSIDERING LABELING CLAIMS.
SO, FURTHER DISTINGUISHING
DIETARY SUPPLEMENTS FROM
CONVENTIONAL FOODS, CONVENTIONAL
FOOD IS DEFINED UNDER THE ACT AS
AN ARTICLE USED FOR FOOD OR
DRINK FOR MAN OR OTHER ANIMALS,
CHEWING GUM, INTERESTING THAT
GETS A SEPARATE CATEGORY.
SOUPS, CANDY, CONVENTIONAL
FOODS.
DIETARY SUPPLEMENTS MAY NOT BE
REPRESENTED FOR USE AS
CONVENTIONAL FOOD, CAN'T BE
REPRESENTED AS THE SOLE ITEM OF
A MEAL OR THE DIET SO IT'S
HELPFUL TO LOOK OBVIOUSLY AT ALL
OF THEIR LABELING, INSERTS,
ADVERTISING TO KNOW WHETHER OR
NOT THEY ARE HOLDING THEIR
PRODUCT OUT THAT WAY.
DIETARY SUPPLEMENTS ALSO HAVE
DIFFERENT LABELING THAN
CONVENTIONAL FOODS.
CONVENTIONAL FOODS AS DISCUSSED
USED THE NUTRITION FACTS PANEL,
SUPPLEMENTS USE THE SUPPLEMENT
FACT PANEL, THERE'S A BUNCH OF
OTHER REQUIREMENTS SUPPLEMENTS
NEED TO USE IN TERMS OF
LABELING.
NOW THAT WE'VE DISCUSSED
SUPPLEMENTS, WHAT THEY ARE AND
ARE NOT, WHAT ARE FDA'S
AUTHORITIES RELATED TO THEIR
REGULATION?
SO REGULATORY RESPONSIBILITIES,
DIETARY SUPPLEMENT REGULATION
GENERALLY COVERS THESE MAIN
POINTS.
FACILITY REGISTRATION, THAT'S
THE REGISTRATION OF THE
MANUFACTURER.
NEW DIETARY INGREDIENT
NOTIFICATION.
THAT'S NDI OR NDIN PROCESS.
CURRENT GOOD MANUFACTURING
PRACTICES.
LABELINGPROVISIONS INCLUDING
STRUCTURE/FUNCTION CLAIM
NOTIFICATIONS, ADVERSE EVENT
REPORTING.
LET ME TALK FIRST ABOUT THE
FACILITY REGISTRATION.
WE'RE TALKING ABOUT FACILITY
REGISTRATION AND NOT INDIVIDUAL
PRODUCT REGISTRATION.
ALL FOOD FACILITIES MUST
REGISTER WITH FDA.
THAT MEANS IF THEY ARE DOMESTIC
OR FOREIGN THEY HAVE TO PROVIDE
BASIC INFORMATION, NAME,
ADDRESS, TYPE OF FACILITY,
RESPONSIBLE PARTY, AND THEY NEED
TO RENEW THAT INFORMATION EVERY
EVEN-NUMBERED CALENDAR YEAR.
WE USE THAT INFORMATION TO HELP
US DETERMINE WHICH FACILITIES
WE'RE GOING TO BE INSPECTING.
OKAY.
ONE MORE THING I WANTED TO
MENTION REGARDING REGISTRATION.
REGISTRATION IS SOMETHING THAT
WAS ADDED AS PART OF THE
BIOTERRORISM ACT OF 2002 AS AS A
RESULT OF 9/11, FOR THAT REASON
THIS INFORMATION CAN'T BE
DISCLOSED.
SO, IF YOU'RE TRYING TO FIND OUT
MORE INFORMATION ABOUT A
MANUFACTURER, YOU WON'T BE ABLE
TO FIND OUT THROUGH THAT
REGISTRATION PROCESS.
NOW I'M GOING TO MOVE TO THE
SLIDE 10, NEW DIETARY INGREDIENT
NOTIFICATION.
SECTION 413A 2 OF THE ACT
ESTABLISHED REQUIREMENT THAT
MANUFACTURERS OR DISTRIBUTORS OF
DIETARY SUPPLEMENT MUST SUBMIT
NOTIFICATION TO FDA 75 DAYS
BEFORE THAT NEW DIETARY
INGREDIENT IS MARKETED.
AND AS HAS BEEN MENTIONED BEFORE
BUT IT'S SO IMPORTANT, IT'S
CRITICAL TO KEEP REFERENCING
THIS IS FDA'S ONLY OPPORTUNITY
FOR SOME LEVEL OF PRE-MARKET
REVIEW, SO IT'S CRITICAL THAT
FDA GET THAT SAFETY INFORMATION
TO HELPFUL FILL ITS
RESPONSIBILITIES.
THE NOTIFICATION HAS TO INCLUDE
A BUNCH OF INFORMATION THAT IS
INCLUDED IN THE CODE OF FEDERAL
REGULATIONS, 21 CFR 190.6, THAT
INCLUDES NAME AND ADDRESS,
SIGNATURE OF RESPONSIBLE PARTY,
NAME OF THE INGREDIENT,
DESCRIPTION OF THE PRODUCT OR
PRODUCTS CONTAINING THE NDI,
AMOUNT OF NDI IN THE PRODUCT,
CONDITIONS OF USE, AND HISTORY
OF USE FOR ANY OTHER EVIDENCE OF
SAFETY ESTABLISHING THE NDI WILL
REASONABLY BE ACCEPTED TO BE
SAFE.
THAT IS THE STATUTORY
REQUIREMENT IN THE ACT, SO WE
NEED EVIDENCE ESTABLISHING THAT
THE NDI WILL BE EXPECTED TO BE
SAFE.
SO, IT'S IMPORTANT TO ALSO NOTE
THAT THIS IS ACTUALLY A
NOTIFICATION AND REVIEW PROCESS
BY FDA, SO FDA IS NOT APPROVING
THE INGREDIENT TO BE USED IN A
DIETARY SUPPLEMENT, IT'S
ACTUALLY JUST REVIEWING AND
EITHER ACCEPTING OR REJECTING
THAT DIETARY INGREDIENT
NOTIFICATION.
SO, THE NEW DIETARY INGREDIENT
NOTIFICATION REQUIREMENT IS FOR
THOSE PRODUCTS THAT CONTAIN AN
NDI AND SO AN NDI IS A DIETARY
INGREDIENT THAT WAS NOT MARKETED
IN A DIETARY SUPPLEMENT BEFORE
OCTOBER 15, 1994, THAT'S
ACTUALLY THE DATE DSHEA WAS
SIGNED INTO LAW.
DURING THAT REVIEW PERIOD WHERE
FDA HAS THIS INFORMATION, FDA
REVIEWS NOW HAVE INDICATION AND
PROVIDES THE RESPONSE,
ESSENTIALLY FDA'S RESPONSE IS
GOING TO CONSIST OF TWO
CATEGORIES.
IT'S EITHER ACKNOWLEDGMENT OF
THE NOTIFICATION WITHOUT
OBJECTION TO IT OR
ACKNOWLEDGMENT WITH OBJECTION.
OBJECTION IS BASED ON EITHER THE
APPLICANT NOT BEING ABLE TO
PROPERLY IDENTIFY THE INGREDIENT
THAT IS THE NDI OR BASED ON THE
MANUFACTURER'S SAFETY
INFORMATION.
THERE ARE ALSO TIMES WHERE FDA
WILL RESPOND WITH A LETTER THE
INGREDIENT IS NOT A DIETARY
INGREDIENT AND THEREFORE IF IT
DOESN'T FIT THE DEFINITION OF
DIETARY INGREDIENT WHICH I
TALKED ABOUT EARLIER, CAN'T BE
NDI, THEREFORE THAT'S NOT THE
PROPER MECHANISM FOR THE PRODUCT
TO BE USING FOR PRE-MARKET
NOTIFICATION.
IN THAT CASE IT'S MORE LIKELY IT
COULD BE A -- MUCH MORE LIKELY
THAT THE PRODUCT WILL END UP
BEING A DRUG OR FOOD OR
SOMETHING ELSE.
FDA THEN MAKES SAFETY
CONCLUSIONS THAT ARE BASED UPON
THE CHEMICAL IDENTITY AND
MANUFACTURING PROCESS.
THEY LOOK AT SPECS FOR EACH
COMPONENT, ANALYTICAL METHODS,
THAT SORT OF THING.
FDA'S INFORMATION THAT WE
RECEIVE, IT'S REDACTED BUT ALSO
PUT ON REGS.GOV AND FDA'S
RESPONSE LETTER SO FOLKS CAN SEE
THAT.
REVIEWERS WILL DETERMINE IF
THERE'S A HISTORY OF SAFE USE IN
FOOD OR IF THERE'S ANY OTHER
EVIDENCE OF SAFETY BASED ON
INFORMATION PROVIDED.
THAT WOULD BE PUBLISHED
LITERATURE, TOXOLOGICAL, ANY
OTHER INFORMATION AND, AGAIN,
THAT WOULD BE INCLUDED AS PART
OF THE SUBMISSION THAT WOULD BE
ADDED TO THE REGULATION'S.GOV
WEBSITE, WITH THE CONFIDENTIAL
INFORMATION REDACTED.
SO THIS IS JUST A CHART THAT
EXPLAINS A LITTLE BIT MORE ABOUT
WHETHER OR NOT IT IS A NEW
DIETARY INGREDIENT.
AS YOU CAN SEE, THAT IS ON FDA'S
WEBSITE.
THESE QUESTIONS ARE INSTRUCTIVE
IN HELPING A POTENTIAL NOTIFIER
DETERMINE IF THEY NEED TO -- IF
THEIR PRODUCT CONTAINS AN NDI.
WAS THE PRODUCT MARKETED AFTER
OCTOBER 15, 1994?
WAS THE PRODUCT PRESENT IN THE
FOOD SUPPLY AS AN ARTICLE USED
FOR FOOD?
WAS IT CHEMICALLY ALTERED?
THIS CHART PROVIDES SOME
ADDITIONAL INFORMATION.
SO, CONTINUING ALONG WITH THE
NEW DIETARY INGREDIENT
NOTIFICATIONS, AND SOMETHING
ELSE THAT I THINK IS CRITICAL TO
REFERENCE HERE, DR. BETZ
MENTIONED THAT FDA HAS MADE
STATEMENTS ABOUT THE LACK OF NDI
AND FROM MANUFACTURERS.
NOW, LAST WEEK IN ORDER TO
ADDRESS THIS, FDA PUBLISHED A
DRAFT GUIDANCE SEEKING COMMENT
ON WHAT'S REFERRED TO AS A
TEMPORARY ENFORCEMENT DISCRETION
POLICY, AND THAT'S AIMED AT
INCREASING AMOUNT OF SAFETY
INFORMATION THE AGENCY HAS ABOUT
THE DIETARY SUPPLEMENT
MARKETPLACE FOR PROVIDING THE
INDUSTRY AN OPPORTUNITY TO
SUBMIT LATE NEW DIETARY
INGREDIENT NOTIFICATION IS.
IF FINALIZED THEY WILL HAVE SIX
MONTHS TO PROVIDE LATENT DIETARY
INGREDIENT NOTIFICATIONS AND
WON'T BE PENALIZED FOR PROVIDING
THEM TO FDA AFTER THAT 75-DAY
NOTIFICATION PERIOD WHEN THEY
WERE SUPPOSED TO DO IT.
NOW I'M GOING TO MOVE TO CURRENT
GOOD MANUFACTURING PRACTICES.
THIS AREA IS A LARGE PART OF
FDA'S POST-MARKET REGULATION OF
DIETARY SUPPLEMENTS.
APPLIES TO DOMESTIC AND FOREIGN
MANUFACTURERS.
FDA PUBLISHED THEIR FINAL RULE
ABOUT CURRENT GOOD MANUFACTURING
PRODUCTS, THIS IS IN 2007, AND
IT'S CODIFIED AT 21 CFR 111.
THIS IS AN EXTENSIVE REGULATION
THAT ESTABLISHES MINIMUM
cGMPs NECESSARY FOR
MANUFACTURING, PACKAGING,
LABELING AND HOLDING OF
SUPPLEMENTS, 16 SUBPARTS,
REGULATION HAS AN EMPHASIS ON A
PRODUCTION AND PROCESS CONTROLS,
BASICALLY BUILDING QUALITY INTO
THE PRODUCT, REQUIREMENT FOR
TESTING OF RAW MATERIAL AND
FINISHED PRODUCT STAGE.
INVESTIGATORS WILL CONFIRM
COMPLIANCE DURING INSPECTION.
FAILURE COULD TO COME BY MAY
RESULT IN FURTHER ENFORCEMENT
ACTION.
OKAY.
SO, THIS NEXT SLIDE IS ABOUT
DIETARY SUPPLEMENT LABELING,
AGAIN SOMETHING I KNOW THAT'S
BEEN TOUCHED ON PREVIOUSLY SO
I'M GOING TO MOVE QUICKER
THROUGH THESE SLIDES.
BASICALLY DIETARY SUPPLEMENTS
HAVE A REQUIREMENT SPECIFIC TO
SUPPLEMENTS EVEN THOUGH
CONSIDERED A CATEGORY OF FOOD.
FOR EXAMPLE, LABELED PROPERLY,
LIST ALL INGREDIENTS PROPERLY
FORMATTED SUPPLEMENT FACTS
LABEL, ET CETERA.
AS SHOWN PREVIOUSLY, THIS IS
WHAT A SUPPLEMENT FACTS PANEL
LOOKS LIKE.
WE'VE GOT THE SERVINGS,
DIFFERENT NUTRIENTS, WITH THEIR
AMOUNT PER SERVING, PERCENT OF
DAILY VALUE, AND OTHER
INGREDIENTS THAT MIGHT BE
INCLUDED IN THE DIETARY
SUPPLEMENT THAT MIGHT BE
FILLERS, PRESERVATIVES,
SWEETENERS, FLAVORINGS, OR OTHER
COLORS.
THIS IS JUST AN EXAMPLE OF WHAT
WE LOOK AT ON THE DIETARY
SUPPLEMENT LABELING, FRONT AND
BACK, YOU CAN SEE ON ONE SIDE
YOU SEE THE DIETARY SUPPLEMENT
DISCLAIMER.
YOU SEE IT'S MARKETED WITH A
WORDS THIS IS A SUPPLEMENT, FACT
PANEL ON THE BACK, BLACKED OUT
BUT DOES HAVE THE ADDRESS AND
PHONE NUMBER TO CONTACT FOR
ADVERSE EVENTS.
SO NOW MORE STRUCTURE/FUNCTION
CLAIM NOTIFICATIONS, BEAR CLAIMS
AND NUTRIENT DEFICIENCY CLAIMS
AND WELL-BEING CLAIMS.
NUTRIENT DEFICIENT CLAIMS MIGHT
BE VITAMIN D DEFICIENCY CAN
CAUSE RICKETS IN CHILDREN,
OBVIOUSLY VERY RARE IN THE
UNITED STATES.
GENERAL WELL-BEING CLAIM HELPS
MAINTAIN VITALITY OR INVIGORATE
YOUR BODY.
REQUIRED TO MAINTAIN
SUBSTANTIATION, MIGHT BE TESTS,
ANALYSES, RESEARCH STUDIES, ET
CETERA.
REQUIREMENTS ASSOCIATED WITH
STRUCTURE/FUNCTION CLAIMS, THIS
HAS BEEN DISCUSSED A LITTLE BIT
BUT HAS TO HAVE THAT DISCLAIMER.
MANUFACTURERS SELLING THE
PRODUCT WITH STRUCTURE/FUNCTION
CLAIM HAVE TO NOTIFY FDA WITHIN
30 DAYS OF MARKETING THE PRODUCT
CONTAINING THE CLAIM.
THAT NOTIFICATION WILL INCLUDE
TEXT OF THE CLAIM, AND FDA WILL
REVIEW AND PROVIDE A RESPONSE IF
THERE'S ANY CONCERNS WITH
RESPECT TO THAT CLAIM.
THIS IS MORE ON
STRUCTURE/FUNCTION CLAIMS, I'LL
SKIP THIS BECAUSE WE'RE RUNNING
SHORT ON TIME.
SLIDE 20, THIS IS INTERESTING
FOR FOLKS THROUGHOUT THE
PANDEMIC, FDA HAS SENT WARNING
LETTERS TO COMPANIES MARKETING
DIETARY SUPPLEMENTS WITH
UNLAWFUL DISEASE CLAIMS.
MAKING THESE PRODUCTS CONSIDERED
UNAPPROVED DRUGS IN VIOLATION OF
THE ACT BUT I'M HAPPY TO REPORT
MOST FIRMS DO MAKE CORRECTIONS
TO THEIR CLAIMS AFTER THEY
RECEIVE A WARNING LETTER IN THIS
INSTANCE.
HERE'S AN EXAMPLE OF A PACKAGE
OF ZINC CHARGE PRODUCTS,
MISLEADING PROBLEMATIC CLAIMS
WITH RESPECT TO CORONAVIRUS
GIVEN HOW SERIOUS THIS PANDEMIC
IS IT'S GREAT TO SEE FIRMS ARE
MAKING -- MANY FIRMS ARE MAKING
CHANGES WHEN THEY RECEIVE AN FDA
WARNING LETTER.
THE WARNING LETTER ALSO INCLUDES
LANGUAGE STATING FDA'S ADVISING
CONSUMERS NOT TO PURCHASE OR USE
THESE PRODUCTS.
SO SLIDE 21, ADVERSE EVENT
REPORTING, IF A MANUFACTURER
RECEIVES A REPORT AND DETERMINE,
IT'S SERIOUS THEY HAVE 15
BUSINESS DAYS TO FORWARD TO FDA.
A YEAR LATER THE MANUFACTURER
SHOULD ALSO PROVIDE AN UPDATE
WITH ANY NEW OR RELEVANT
INFORMATION PERTAINING TO THAT
ADVERSE EVENT REPORT.
REPORTING SYSTEM WORKS THROUGH
FDA'S ADVERSE EVENT REPORTING
PROGRAM AND SUBMISSIONS RECEIVED
THROUGH ELECTRONIC PORTAL, ALSO
RECEIVED THROUGH E-MAIL, PHONE
CALLS, OR LETTERS.
AND ONCE THAT'S IN OUR SYSTEM
BOTH ESP REVIEWERS WILL EVALUATE
CASES AND DETERMINE IF ANY
FOLLOW-UP IS NEEDED, ODSP
MEDICAL OFFICERS ARE RESPONSIBLE
FOR RECOGNIZING ANY TRIGGERS
THAT MAY BE EVIDENCE WITH
RESPECT TO SPECIFIC FIRMS,
PRODUCTS, OR INGREDIENTS.
SO IN ADDITION TO SENDING OUT
WARNING LETTERS FOR cGMP AND
LABELING VIOLATIONS, THAT'S
PROBABLY WHAT IS -- WHAT MOST
PEOPLE KNOW THE FDA IS DOING
WITH RESPECT TO THESE
VIOLATIONS, THERE ARE OTHER
STEPS THAT FDA IS TAKING, FDA IS
RESPONSIBLE FOR TAKING ACTION
AGAINST UNSAFE PRODUCTS AFTER
THEY ARE MARKETED.
WE PUT OUT FOR EXAMPLE GUIDANCE
FOR INDUSTRY ON HIGHLY
CONCENTRATED CAFFEINE IN DIETARY
SUPPLEMENTS, THIS PRESENTS A
SIGNIFICANT PUBLIC HEALTH THREAT
AND IS CONTRIBUTED TO TWO DEATHS
IN THE U.S. SO WE DID ISSUE MANY
WARNING LETTERS AND GUIDANCE ON
THIS TO MAKE SURE PEOPLE WHO
INTENT TO USE POWDERED CAFFEINE
USE IT PROPER.
THERE'S EXAMPLES OF WARNING
LETTERS WE SENT OUT IN RECENT
YEARS.
ALSO I WANT TO HIGHLIGHT WHAT WE
REFER TO AS CLAIMS INITIATIVES,
THESE ARE SOME ACTIONS THAT FDA
HAS TAKEN OVER THE LAST COUPLE
YEARS.
SOME IN COMBINATION WITH THE
FEDERAL TRADE COMMISSION, AND
THESE JUST HELP TO HIGHLIGHT
ACTIONS THAT FDA'S TAKING WITH
RESPECT TO CERTAIN TYPES OF
PRODUCTS, AND ALSO HELPS TO
HIGHLIGHT THE DANGERS OF
PRODUCTS AND OF USING PRODUCTS
THAT ARE NOT CONSIDERED SAFE AND
EFFECTIVE TREATMENTS FOR CERTAIN
DISEASES.
SO, FINALLY I'LL CLOSE WITH SOME
INFORMATION ON INSPECTION.
IN MARCH 2020 FDA DID ANNOUNCE
THAT DUE TO THE PANDEMIC IT WAS
TEMPORARILY POSTPONING ALL
DOMESTIC AND FOREIGN ROUTINE
SURVEILLANCE ACTIVITY.
BUT WE DID CONTINUE TO MISSION
CRITICAL INSPECTIONS WHEN
POSSIBLE, ENGAGED IN ALTERNATIVE
FORMS OF REVIEW WHEN POSSIBLE,
AS WELL.
AND DURING THE PAUSE IN
INSPECTIONS INITIATED OTHER
PROGRAMS THAT MANUFACTURERS
COULD PARTICIPATE IN LIKE, FOR
EXAMPLE, VOLUNTARY REMOTE
REGULATORY ASSESSMENTS, THAT
WOULD ALLOW FDA TO REMOTE INTO A
MANUFACTURER'S FACILITY
BASICALLY TO EVALUATE
DOCUMENTATION, MAYBE CLEAR UP
CERTAIN THINGS THAT MIGHT NEED
TO BE HANDLED LATER IN AN --
THAT WOULD HAVE BEEN NEEDED TO
HAVE BEEN HANDLED LATER IN
INSPECTION BUT THAT'S A WIN FOR
FDA, A WIN FOR CONSUMERS AND THE
MANUFACTURER IF THEY ARE ABLE TO
HANDLE THAT ALL BEFORE THE
LARGER INSPECTION DOES IN FACT
HAPPEN.
SO, I KNOW I RUSHED AT THE END
BUT I WAS TRYING TO MAKE SURE WE
STAY WITHIN OUR TIMING.
THIS CONCLUDES MY PRESENTATION
ON HOW FDA REGULATES DIETARY
SUPPLEMENTS AND I'M HAPPY TO
ANSWER ANY QUESTIONS YOU MAY
HAVE DURING OUR PANEL
DISCUSSION.
THANK YOU SO MUCH.
>> THANK YOU SO MUCH.
FINAL SPEAKER FOR THIS SESSION
IS MISS TAWANA DAVIS, EXPLAINING
WHAT THE FEDERAL TRADE
COMMISSION DOES WITH SPECIAL
FOCUS ON ITS SUPPLEMENT RELATED
RESPONSIBILITIES.
SHE IS ASSISTANT DIRECTOR IN THE
DIVISION OF ADVERTISING
PRACTICES, BUREAU OF CONSUMER
PROTECTION AT THE FTC.
AN ATTORNEY, HAS BEEN WITH THE
FTC SINCE 2002.
SO WELCOME, MS. DAVIS.
I'M VERY GLAD TO BE HERE WITH
YOU TODAY.
WE IN THE DIVISION OF
ADVERTISING PRACTICES CONSIDER
THIS TO BE ONE OF THE FTC'S MOST
IMPORTANT OUTREACH OPPORTUNITIES
ON DIETARY SUPPLEMENTS.
THERE'S PRODUCTS THAT OFFER
PROVEN HEALTH BENEFITS, AND
OTHER THAT SHOW PROMISE.
BUT NEED NUTRITIONAL STUDY.
UNFORTUNATELY, THERE ARE ALSO
PRODUCTS ON THE MARKET THAT
AREN'T BACKED BY ANY SCIENCE
THAT THEY WILL PROVIDE BENEFIT
CLAIM OR WORSE MAY EVEN BE
HARMFUL.
THOSE ARE THE PRODUCTS FTC
FOCUSES ON.
TODAY I'LL TALK ABOUT THE FTC
ROLE IN POLICING HOW SUPPLEMENTS
ARE ADVERTISED AND HOW WE'RE
WORKING TO MAKE SURE CLAIMS FOR
SUPPLEMENTS ARE BACKED BY SOLID
SCIENCE, NOT JUST MARKETING
HYPE.
AND WHAT WE'VE BEEN DOING TO
PROTECT CONSUMERS DURING THE
PANDEMIC.
BEFORE WE BEGIN, LET ME START
WITH THE DISCLAIMER MY COMMENTS
REFLECT MY OWN VIEWS AND DO NOT
NECESSARILY REFLECT THE VIEWS OF
THE COMMISSION OR ANY INDIVIDUAL
COMMISSIONER.
TODAY I'M GOING TO SPEND A
LITTLE TIME EXPLAINING THE
JURISDICTION OVER SUPPLEMENTS,
AUTHORITY AND HOW THEY
COORDINATE AND HOW WE APPROACH A
LAW ENFORCEMENT CASE AGAINST
FALSE OR MISLEADING CLAIMS ABOUT
THE ADVOCACY AND SAFETY OF
SUPPLEMENTS.
I HAVE SOME BRIEF EXAMPLES OF
HEALTH FRAUDS IN THIS INDUSTRY
WHERE THE FTC HAS TAKEN ACTION.
IT'S ALL PART OF THE FTC CHARGE
TO PROTECT CONSUMERS.
WE'RE A SMALL INDEPENDENT LAW
ENFORCEMENT AGENCY, WITH A BROAD
MANDATE, TO STOP DECEPTIVE
CLAIMS AND UNFAIR PRACTICES IN
COMMERCE.
WE LOOK AT ALL FORMS OF
MARKETING, ANYTHING DESIGNED TO
INDUCE SOMEONE TO PURCHASE A
PRODUCT, LOOK AT MARKETING IN TV
AND RADIO COMMERCIALS, PRINT ADS
IN NEWSPAPERS AND MAGAZINES,
DIRECT MAIL, MUCH OF TODAY'S
MARKETING IS ALSO IN THE
INTERNET SO WE LOOK AT WEBSITES,
FACEBOOK, TWITTER, YouTube,
INSTAGRAM, BLOG POSTS, MARKETING
E-MAILS, TEXTS.
ALTHOUGH WE DEFER TO FDA ON
LABELING, WE DO LOOK AT THE
PACKAGING AND INSERTS THAT ARE
INCLUDED WITH THE PRODUCT.
HERE ARE THE THINGS OVER THE
YEARS, ILLEGAL ROBO CALLS, SHAM
CHARITIES, GET RICH QUICK
SCHEMES, IDENTITY THEFT, COLD
AND FLU REMEDIES, FLUSHABLE
WIPES THAT AREN'T AS
ENVIRONMENTALLY FRIENDLY AS THEY
CLAIM AND LOOK AT FOOD PRODUCTS
LIKE POM WONDERFUL AND CASES
AGAINST KELLOGG FOR CLAIMING
FROSTED MINI WHEATS
(INDISCERNIBLE) AND PROBIOTIC
PRODUCTS AFFECTS COLD AND FLU.
WE'VE LOOKED AT A NUMBER OF
PRODUCTS CLAIMING TO IMPROVE
COGNITIVE FUNCTION OR PREVENT
ELEMENT OF ALZHEIMER'S AND
DEMENTIA.
AS MORE PEOPLE ARE DIAGNOSED
WITH THESE CONDITIONS, MARKETERS
ARE DEVELOPING PRODUCTS THAT
CAPITALIZE ON CONSUMERS'
ANXIETIES AND DESIRE TO PREVENT
THEM.
MANY OF YOU MAY BE FAMILIAR WITH
THE BRAIN TRAINING GAME LUMOSITY
CLAIMING IT PROVIDES COGNITIVE
BENEFITS BUT RESEARCH SHOWS
IMPROVEMENT ON GAINS BUT NO
EVIDENCE OF A REAL WORLD
BENEFIT.
THIS IS ONE OF MY CASES, YOU MAY
HAVE HEARD OF TOMMY COPPER.
WE SAW TONS OF TV ADS TOUTING
COP YOU ARE INFUSED COMPRESSION
SLEEVES FOR JOINTS, BACK,
SHOULDER, YOU NAME IT.
TOMMIE COPPER WAS A LEADER IN
THIS INDUSTRY, THE COMPANY
CLAIMED THE COPPER IN ITS
GARMENTS PENETRATED SKIN AND
TRANSDETERMINEALLY TREATED OR
CURED DISEASE SUCH AS ARTHRITIS,
MULTIPLE SCLEROSIS,
FIBROMYALGIA.
THEY EVEN CLAIMED CONSUMERS
COULD WEAR THESE SLEEVES INSTEAD
OF GETTING SURGERY.
UNFORTUNATELY THE COMPANY DID
NOT HAVE SCIENCE TO SUPPORT
THESE CLAIMS.
TOMMIE COPPER AGREED TO ENTER
INTO AN FTC SETTLEMENT THAT
PROHIBITED THE COMPANY FROM
MAKING CLAIMS WITHOUT COMPETENT
RELIABLE SCIENTIFIC EVIDENCE
INCLUDED $87 MILLION JUDGMENT,
MOST SUSPENDED BASED ON
INABILITY TO PAY.
THE FCC'S AUTHORITY OVER DIETARY
SUPPLEMENT MARKETING OVERLAPS
WITH FDA.
OUR AGENCY HAS LIAISON AGREEMENT
UNDER WHICH FDA HAS PRIMARY
AUTHORITY OVER CLAIMS MADE IN
LABELING, FTC HAS PRIMARY
AUTHORITY OVER ADVERTISING.
GIVEN OUR SHARED AUTHORITY WE
STRIVE TO HAVE CONSISTENCY IN
POLICIES AND ENFORCEMENT
EFFORTS.
AS I INDICATED BEFORE, THE FTC
IS PRIMARILY A LAW ENFORCEMENT
AGENCY RATHER THAN REGULATORY
AGENCY.
THAT MEANS WE DO NOT ENGAGE IN
ANY KINDS OF PRE-MARKET
REGULATORY APPROVAL PROCESS.
FTC LAW REQUIRES CLAIMS IN
ADVERTISING BE SUBSTANTIATED
BEFORE THEY ARE MADE BUT WE DO
NOT REQUIRE COMPANIES TO SUBMIT
ADS IN ADVANCE AND WE DO NOT
EVALUATE OR PRE-APPROVE CLAIMS,
EVEN HEALTH CLAIMS.
ALSO UNLIKE FDA OUR REGULATORY
FRAMEWORK DOES NOT MAKE
DISTINCTION BETWEEN PRODUCT
CATEGORIES.
OUR APPROACH TO EVALUATING AN AD
WILL BE THE SAME WHETHER THE
PRODUCT IS POSITIONED AS A FOOD
OR DIETARY SUPPLEMENT, DRUG OR
DEVICE.
DSHEA DOES NOT APPLY TO
ADVERTISING.
THERE'S NO BRIGHT LINE
DISTINCTION UNDER FTC LAW
BETWEEN HEALTH CLAIMS OR
STRUCTURE/FUNCTION CLAIMS OR
DISEASE CLAIMS.
ALL CLAIMS THE FTC IS ASKING
ARE THEY BACKED BY GOOD SCIENCE.
BECAUSE THE FTC AND FDA BOTH
HAVE ACTIVE ENFORCEMENT PROGRAMS
INVOLVING THE MARKETING OF
SUPPLEMENTS, WE INTERACT
REGULARLY TO ENSURE CONSISTENCY.
MOST OF OUR ENFORCEMENT CASES,
WE'RE NOT BOTH PURSUING ONE
COMPANY.
WE TRY TO COMMUNICATE TO MAKE
SURE EFFORTS ARE COMPLEMENTARY
AND THAT WE'RE CONSISTENT ON THE
SCIENCE, AND WE GENERALLY AVOID
DUPLICATION OF EFFORTS.
BOTH AGENCIES TRY TO ALLOCATE
LIMITED RESOURCES IN THE MOST
EFFICIENT WAY.
SOME CASES BOTH AGENCIES MAY
DECIDE TO INVESTIGATE AND PURSUE
A JOINT ENFORCEMENT ACTION.
THOSE CASES WE WILL FORMALLY
SHARE INFORMATION ABOUT
COMPANIES, TRY TO PUT THE BEST
USE, UNIQUE ENFORCEMENT TOOLS
AVAILABLE TO EACH AGENCY.
FOR EXAMPLE, THE FTC HAS POWER
TO SUBPOENA DOCUMENTS FROM
SUPPLEMENT MARKETERS, FDA CAN
HAVE INSPECTION OF FACILITY AND
ORDER PRODUCT SEIZURE.
INTERACTION IS ESPECIALLY
IMPORTANT BECAUSE AS I SAID THE
FTC IS PRIMARILY A LAW
ENFORCEMENT AGENCY.
WE'RE LAWYERS AND ECONOMISTS,
NOT SCIENTISTS.
WE NEED TO RELY ON FDA WEALTH OF
NUTRITION AND HEALTH EXPERTISE.
WE FREQUENTLY TURN TO OTHER
AGENCIES FOR ASSISTANCE FOR
OVERVIEW OF SCIENCE OR HELP US
IDENTIFY EXPERTS.
THE SAME REASON, WE GENERALLY
DEFER TO FDA ON MATTERS RELATED
TO CONTENT, PURITY, OR SAFETY OF
DIETARY SUPPLEMENTS.
THEY HAVE THE AUTHORITY AND ARE
BETTER EQUIPPED TO DEAL WITH
THESE ISSUES.
WE WILL GENERALLY LIMIT OUR
ACTIONS ON SAFETY TO INSTANCES
WHERE A COMPANY MADE UNFOUNDED
CLAIMS IN ADVERTISING ABOUT THE
SAFETY OF A PRODUCT.
I'D LIKE TO GIVE YOU THE SHORT
VERSION TUTORIAL ON FTC
ADVERTISING LAW.
ILLUSTRATING HOW WE APPROACH OUR
CASES WITH A FEW EXAMPLES.
THE FTC AUTHORITY IN SECTION 5
AND SECTION 12, 5 PROHIBITS
UNFAIR OR DECEPTIVE ACT OR
PRACTICES IN COMMERCE INCLUDING
ADVERTISING.
SECTION 12 SPECIFICALLY
PROHIBITS DISSEMINATION OF FALSE
ADS DEFINED AS ADS THAT SHALL
MISLEADING IN MATERIALS THAT
SPECIFICALLY WITH RESPECT TO
FOODS INCLUDING SUPPLEMENTS,
DRUGS, AND DEVICES.
TWO STRAIGHTFORWARD AND SIMPLE
PROVISIONS, NOT A LOT OF
DETAILED REGULATIONS YOU NEED TO
BE FAMILIAR WITH TO UNDERSTAND
FTC LAWS.
ALL CAN BE DISTILLED DOWN TO TWO
PRINCIPLES.
CLAIMS ARE CONVEYED, ARE CLAIMS
SUBSTANTIATED?
THE FIRST QUESTION WE ASK
OURSELVES WHEN LOOKING AT AD FOR
A PRODUCT WHAT CLAIMS ARE BEING
CONVEYED?
CLAIMS ARE CONSUMER DRIVEN.
WE CONSIDER ANY CLAIM THAT A
REASONABLE CONSUMER WOULD TAKE
AWAY FROM AN IDEA, LOOK AT
EXPRESS CLAIMS, ABC SUPPLEMENT
CURES CANCER, AN EXPRESS CLAIM
AND LOOK AT IMPLIED CLAIMS, I'LL
SHOW YOU AN EXAMPLE LATER.
WE LOOK AT NET IMPRESSION OF AN
AD, CONSIDER ALL THE ELEMENTS.
WRITTEN TEXT, IMAGES, EVERYTHING
ABOUT THE AD AND IMPRESSION MADE
ON CONSUMER.
OFTEN ADS INCLUDE TESTIMONIALS
FROM CONSUMER SAYING THE PRODUCT
WORKED FOR THEM WHICH CONVEYS
THE PRODUCT WILL WORK FOR THEM
AS WELL.
WE LOOK TO SEE IF THE AD
DISCLOSES MATERIAL INFORMATION
AND HOW IT'S DISCLOSED.
TINY PRINT THAT CANNOT BE READ
IS NOT AN EFFECTIVE DISCLOSURE.
HERE IS A GOOD EXAMPLE OF HOW AN
IMAGE CAN CONVEY A CLAIM.
THE PROBIOTICS WERE EMBEDDED IN
LINING OF THE STRAW WITH THE
DRINK, STRAW JUMPING OUT OF THE
DRINK BOX AND FORMS A PROTECTIVE
BARRIER AROUND A GIRL, AS A BOY
SNEEZES.
THIS AD IS TELLING PARENTS IF
YOUR KIDS BRING BOOST IT WILL
KEEP THEM FROM CATCHING A NASTY
GERM FROM THE SICK KID NEXT TO
THEM IN CLASS.
AFTER THE CLAIMS WE GO TO THE
SECOND STEP.
IS THERE A SOLID SCIENCE TO BACK
THOSE CLAIMS?
ARE THEY SUBSTANTIATED?
OUR POLICIES ARE RIGOROUS
SCIENTIFIC STANDARDS BASED ON
ACCEPTED NORMS OF EXPERTS IN THE
FIELD.
WE'RE LOOKING FOR THE STUDIES,
QUALITY IS AS IMPORTANT AS
QUANTITY.
NO FIXED FORMULA OR NUMBER OR
LENGTH OR SIZE OF STUDIES.
WITH RARE EXCEPTIONS WE'RE
LOOKING FOR HIGH QUALITY HUMAN
CLINICAL TRIALS.
MARKETERS CAN'T RELY UPON ANY
STUDIES, STUDIES MUST BE SOUND,
SHOULD BE RANDOMIZED,
CONTROLLED, DOUBLE BLINDED.
SHOULD USE APPROPRIATE OUTCOME
MEASURES.
THEY SHOULD BE PEER REVIEWED.
PUBLISHED IN A REPUTABLE
JOURNAL.
INDEPENDENT, STUDIES CONDUCTED
BY MANUFACTURERS ON THEIR OWN
PRODUCTS MAY BE VIEWED AS
SUSPECT.
RESULTS SHOULD BE STATISTICALLY
SIGNIFICANT, CLINICALLY
MEANINGFUL.
WHAT DOES IT MATTER IF THERE'S
NO REAL GENUINE BENEFIT FOR CON.
NO P-HACKING.
THIS IS AN EXAMPLE HOW PHONE
COMPANIES RUN AFOUL OF THE LAW
LETTING MARKETERS GET AHEAD OF
THEIR RESEARCH DEPARTMENT.
WHEN LOOKING AT A COMPANY'S
SUBSTANTIATION WE DON'T EVALUATE
STUDIES IN ISOLATION.
WE CONSIDER ALL RELEVANT
EVIDENCE, TRY TO RECONCILE
INCONSISTENT AND CONFLICTING
RESULTS, SOMETIMES CLAIM MAY
NEED TO BE QUALIFIED.
OUR VIEW IS DON'T MAKE THE CLAIM
IF THE WEIGHT OF THE EVIDENCE
CONTRADICTS THAT CLAIM.
THE POM WONDERFUL INVOLVED
CLAIMS FOR POMAGRANATE JUICE AND
DIETARY SUPPLEMENT IN PILL AND
LIQUID FORM.
I BELIEVE THIS IS AN AD, A
BANNER, A BANNER AD THAT
APPEARED ON THE INTERNET.
IT WAS OUR VIEW THE ONLY THING
THAT YOU'RE SAVING PROSTATES
FROM IS CANCER, AND WHEN
CONSUMERS CLICKED ON THE LEARN
MORE LINK THROUGH TO THE WEBSITE
THEY WERE ABLE TO READ ABOUT
STUDIES THAT POM WONDERFUL
CONDUCTED THAT ALLEGEDLY SHOWED
A VARIETY OF BENEFITS SUCH AS
DECREASE IN ARTERIAL PLAQUE,
SLOWING OF PSA DOUBLING TIME,
AND A PRODUCT THAT WAS 40% AS
EFFECTIVE AS VIAGRA.
UNFORTUNATELY FOR POM WONDERFUL,
THE SCIENCE DID NOT WATCH THEIR
CLAIMS.
RESULTS OF THE HEART DISEASE
STUDIES WERE CONFLICTING.
ONE SMALL STUDY SUGGESTED
BENEFIT FOR ARTERIAL PLAQUE, A
SECOND FOUND NO BENEFIT.
PROSTATE CANCER STUDY WAS NOT
BLINDED.
ERECTILE DYSFUNCTION LACKED
STATISTICAL SIGNIFICANCE,
REPORTING ON FAVORABLE RESULTS,
IGNORED NOT SO FAVORABLE
RESULTS.
OUR MAN THAT IS PRODUCT AND
CLAIMS SHOULD MATCH THE SCIENCE.
THE AMOUNT OF INGREDIENT TESTED
IN A STUDY SHOULD MATCH WHAT IS
ACTUALLY IN THE PRODUCT.
RESEARCH SHOWS 10 GRAMS OF AN
INGREDIENT INTRAVENOUSLY
PROVIDES A BENEFIT YOU SHOULDN'T
CLAIM THE PRODUCT IS 1 GRAM IN
CAPSULE FORM PROVIDING THE SAME
BENEFIT OR STUDIED IN HEALTHY
30-YEAR-OLDS WILL WORK FOR AN
ELDERLY POPULATION WITH CHRONIC
DISEASES.
AND DEGREE AND NATURE OF EFFECT
CLAIMS SHOULD MATCH THE
RESEARCH.
THIS IS AN EXAMPLE OF A CASE
WHERE THE CLAIMS DID NOT MATCH
THE SCIENCE.
IF YOU LOOK CAREFULLY AT THE BOX
IT SAYS THAT 100 MILLIGRAMS OF
DHA PROMOTES HEALTHY BRAIN AND
EYE DEVELOPMENT.
BUT THERE'S ONLY ONE SERVING OF
THE PRODUCT PROVIDES 100
MICROGRAMS OF DHA.
THE FTC ENFORCEMENT PRIORITIES
ARE HEALTH AND SAFETY RISK,
SERIOUS DISEASES AND CONDITIONS,
CHILDREN, WIDESPREAD OR
SUBSTANTIAL INJURY.
OBVIOUSLY BOGUS COVID-19
PRODUCTS ARE HIGH PRIORITY AT
THE MOMENT.
IN 2021 CONGRESS ENACTED COVID
CONSUMER PROTECTION ACT,
UNLAWFUL UNDER SECTION 5 FOR ANY
PERSON OR ENTITY TO MAKE
DECEPTIVE CLAIMS THAT A PRODUCT
TREATS, CURES, PREVENTS,
MITIGATES, OR DIAGNOSES
COVID-19.
THE ACT ALLOWS THE FTC TO OBTAIN
CIVIL PENALTIES UP TO $47,000
PER VIOLATION, AND CHARGED
MARKETERS UNDER THIS NEW
STATUTE.
DOJ FILED COMPLAINTS ON BEHALF
OF THE COMMISSION AGAINST
MARKETERS WHO CLAIM THEIR
VITAMIN D PRODUCT, NASAL SPRAYS,
HERBAL TEAS TREAT COVID-19.
I ANTICIPATE THERE WILL LIKELY
BE MORE ACTION UNDER THE CCPA IN
THE FUTURE.
LET'S LOOK AT SOME RECENT FTC
DIETARY SUPPLEMENT CASES.
A MULTI-NATIONAL CORPORATION IS
BASED IN GERMANY, IT IS THE
PUBLICLY TRADED PARENT COMPANY
OF BASF GROUP WHICH HAS
SUBSIDIARIES AND JOINT VENTURES
IN 90 COUNTRIES INCLUDING THE
UNITED STATES.
THROUGH NUTRITION AND HEALTH
DIVISION PRODUCES SUPPLEMENTS
AND MEDICAL FOODS IN EUROPE,
NORTH AMERICA, SOUTH AMERICA,
AND IN THE ASIA PACIFIC REGION
AND DEVELOPED FISH OIL
SUPPLEMENTS FOR THE NORTH
AMERICAN MARKET TO TREAT
NON-ALCOHOLIC FATTY LIVER
DISEASE, OR NAFLD.
NAFLD IS BUILDUP FAT IN THE
LIVER FROM OBESITY, DIABETES,
HIGH CHOLESTEROL.
THE CLINICAL TRIAL WAS A
RANDOMIZED DOUBLE BLIND HUMAN
CLINICAL TRIAL DESIGNED TO
EVALUATE WHETHER HEPAXA REDUCES
LIVER FAT IN ADULTS WITH NAFLD.
AT THE END OF SIX MONTHS STUDY,
MRI DATA SHOWED NO STATISTICALLY
SIGNIFICANT REDUCTION OF LIVER
FAT IN THE HEPAXA PATIENTS AS
COMPARED TO PLACEBO PATIENTS.
WHEN THE STUDY FAILED TO SHOW
EFFECT RESEARCHERS SUBJECTED
DATA TO POST HOC ANALYSIS OF
DIFFERENT SUBGROUPS OF TEST
SUBJECTS TO FIND A POSITIVE
MESSAGE.
THAT ANALYSIS FOUND THAT SMALL
SUBGROUP OF PATIENTS WITH
BASELINE FATTY LIVER INDEX OVER
40 EXPERIENCED STATISTICALLY
SIGNIFICANT REDUCTION IN LIVER
FAT AFTER USING HEPAXA WHEN
COMPARED WITH PLACEBO.
THIS SUBGROUP INCLUDED FIVE
HEPAXA PATIENTS, 12 PLACEBO.
THEY DID NOT TEST THE PRODUCT IN
CHILDREN AT ALL.
THE COMPANY AGREED TO SETTLE
WITH FTC, ORDER PROHIBITS
COMPANIES FROM CLAIMING PRODUCTS
REDUCE LIVER FAT OR TREATS ANY
DISEASE UNLESS CLAIM IS TRUE AND
SUPPORTED BY COMPETENT RELIABLE
SCIENTIFIC EVIDENCE, IN THE
ORDER AS RANDOMIZED CLINICAL
TRIAL.
THE COUPLES AGREED TO PAY
$416,000 IN REDRESS TO
CONSUMERS.
BASF WAS AN EXAMPLE OF AN
ENFORCEMENT ACTION THE FTC TOOK.
ANOTHER MATTER, WE MAY WORK
JOINTLY WITH FDA TO TAKE ACTION
AGAINST ADVERTISERS MAKING
DECEPTIVE HEALTH CLAIMS.
LAST SEPTEMBER THE FTC SEND
CEASE AND DESIST LETTERS TO TEN
COMPANIES SUSPECTED OF
ADVERTISING UNPROVEN TREATMENTS
OR CURES FOR DIABETES.
AND ORDERs COMPANIES TO STOP
MAKING UNSUBSTANTIATED CLAIMS
WITHIN 15 DAYS OR FACE POTENTIAL
LEGAL ACTION.
THE DEMANDS WERE ISSUED JOINTLY
WITH FDA WARNING LETTERS, WHICH
THE FDA WARNED THE COMPANIES
THEIR DIABETES PRODUCTS WERE
BOTH UNAPPROVED AND MISBRANDED,
IN VIOLATION OF THE FEDERAL FOOD
DRUG AND COSMETIC ACT.
THESE TEN COMPANIES SOLD DIETARY
SUPPLEMENTS, SHAKES, DRINKS, AND
PRODUCTS ONLINE.
THE PRODUCTS HAD NAMES LIKE
SUGAR BALANCE, BERRY SUGAR
CONTROL, BALANCE DIABETES
SUPPLEMENT.
ONCE CEASE AND DESIST DEMANDS
WERE ISSUED, THE COMPANIES WERE
MONITORED TO TAKE DOWN DECEPTIVE
CLAIMS.
THROUGHOUT THE PANDEMIC, WARNING
LETTERS HAVE BEEN ONE OF THE
MOST IMPORTANT TOOLS THE FTC HAS
USED TO COMBAT UNSUBSTANTIATED
AND FALSE CLAIMS.
THEY ALLOW THE AGENCY TO ACT
QUICKLY AGAINST A NUMBER OF
MARKETERS ALL AT ONCE.
SINCE THE PANDEMIC BEGAN THE FTC
HAS ISSUED LETTERS TO MORE THAN
400 COMPANIES AND INDIVIDUALS.
IN JANUARY, WITH THE OMICRON
VARIANT ON THE RISE, 24 LETTERS
WERE ISSUED DEMANDING THEY STOP
MAKING CLAIMS.
THEY MARKETERS WERE HOCKING
SUPPLEMENTS, FILTERED WATER,
I.V. THERAPY TREATMENTS.
MOST OF THE DEMANDS WERE SENT TO
COMPANIES USING SOCIAL MEDIA
PLATFORMS TO SELL PRODUCTS AND
IN THOSE INSTANCES THE AGENCY
ALSO NOTIFIED THE PLATFORMS AS
WELL.
WARNING LETTERS HAVE PROVED
EXTREMELY EFFECTIVE DURING THE
PANDEMIC WITH MOST MARKETERS
REMOVING THEIR CLAIMS RATHER
THAN FACE A LAWSUIT.
IF YOU'RE INTERESTED IN LEARNING
MORE ABOUT THE COMMISSION'S
WORK, AND PARTICULARLY WORK ON
CORONAVIRUS, GO TO
WWW.CONSUMER.FTC.GOV, THE WEB
SIDE GOOD INFORMATION FOR
CONSUMERS AND SHOWS CONSUMERS
HOW TO PROTECT THEMSELVES FROM A
WIDE VARIETY OF SCAMS.
YOU WILL ALSO FIND CONSUMER
ALERTS ABOUT VARIOUS SCAMS.
AND WE INVITE THE PUBLIC TO
REPORT ANY SUSPECTED FRAUD THEY
ENCOUNTER AT
REPORTFRAUD.FTC.GOV.
THANK YOU FOR LISTENING TODAY.
IF YOU HAVE ANY QUESTIONS, FEEL
FREE TO ASK ME, DURING THE
PANEL, OR IF YOU WANT TO CONTACT
ME OFFLINE MY INFORMATION IS
LISTED ON THE SCREEN.
THANK YOU.
>> THANK YOU.
GLAD WE GOT TO HEAR THAT ENTIRE
PRESENTATION.
WE HAVE ABOUT 20 MINUTES SORE SO
FOR QUESTIONS AND ANSWERS, SO
LET'S BEGIN.
IT'S JUST YOU, DR. BETZ, AND
MS. VOSS.
FIRST QUESTION, COMPANIES USE
RESEARCH ON INGREDIENTS TO
SUBSTANTIATE THEIR CLAIMS THAT
IS IN THE SAME SPACE AS THEIRS
BUT IS NOT NECESSARILY THE SAME
INGREDIENT.
FOR EXAMPLE, RESEARCH ON
CREATINE MONO HYDRATE IS USED TO
SUBSTANTIATE CLAIMS ON PRIMITIVE
FORMS OF CREATINE.
IS THIS OKAY?
OR IS IT INAPPROPRIATE AND/OR
ILLEGAL?
>> DR. BETZ, I'M HAPPY TO LET
YOU START IF YOU'D LIKE.
>> I'M NOT GOING TO COMMENT ON
ANY REGULATORY OR LEGAL
QUESTIONS.
I WILL SAY THAT THE PRECEDENT
SEEMS TO BE IF IT'S NOT THE
EXACT SAME INGREDIENT, FOR THE
EXACT SAME CONDITION OF USE, AND
THE EXACT SAME POPULATION, THEN
THE CONCEPT THAT YOU'RE
REFERRING TO IS CALLED BORROWED
SCIENCE IN THE DIETARY
SUPPLEMENT INDUSTRY AND IT'S
FAIRLY COMMON.
THE SPECIFIC CASE I CAN'T
COMMENT ON BECAUSE I DON'T KNOW
THE FACTS OF THE CLAIMS OR
ANYTHING LIKE THAT.
SO I'LL LEAVE IT TO THE
REGULATORY AND TO THE FEDERAL
TRADE COMMISSION FOLK.
>> YEAH, I GUESS I WOULD SAY
WITH RESPECT TO THAT QUESTION,
IF THERE'S ISSUES WITH RESPECT
TO -- IF THIS IS COVERING
CONCEPT NEW DIETARY INGREDIENT
NOVEMBER INDICATION --
NOTIFICATION, WE ENCOURAGE THEM
TO COME TO OUR OFFICE TO HAVE A
PRE-MEETING TO DISCUSS IN THE
CONTEXT OF STRUCTURE/FUNCTION
CLAIM NOTIFICATIONS, THERE'S AN
SFCN MAILBOX REACHED THROUGH OUR
WEBSITE, SPECIFIC CLAIMS,
QUESTIONS, CAN BE DIRECTED
THERE.
>> OKAY.
THANKS.
IT SEEMS WE HAVE MS. DAVIS WITH
US FOR THE Q&A, SO FEEL FREE,
MS. DAVIS, TO OFFER YOUR POINTS
OF VIEW TO ANY OF THESE
QUESTIONS.
ANOTHER QUESTION, IT SEEMS LIKE
THERE ARE A LOT OF PRODUCTS THAT
ARE MARKETS IN A MANNER THAT IS
ILLEGAL, AND/OR PROMOTED IN AN
APPROPRIATE MANNER, WHAT CAN BE
DONE ABOUT IT?
REGULATION AGAIN.
>> YES, UNFORTUNATELY, I WOULD
AGREE WITH THAT.
FDA CERTAINLY IS UTILIZING ITS
RESOURCES TO THE BEST OF ITS
ABILITY TO GET SOWTH PRODUCTS
OFF THE MARKET.
WE ENCOURAGE CONSUMERS TO CON
CONTACT FDA TO FIND OUT IF
FURTHER ACTION NEEDS TO BE
TAKEN.
IF YOU WORK FOR A MANUFACTURER
AND YOU'RE AWARE EVER VIOLATIONS
OCCURRING, YOU CAN CONTACT THE
AGENCY AND WE CAN DETERMINE
WHETHER OR NOT AND HOW
APPROPRIATE FOLLOW-UP WOULD BE
NECESSARY.
WE CONTINUE TO SEND OUT WARNING
LETTERS, AND PERFORM OTHER
ENFORCEMENT ACTIONS AS THEY COME
UP.
SOME OF THESE ENFORCEMENT
ACTIONS HAVE LED TO CASES THAT
MORE RECENTLY HAVE RESULTED IN
LARGE FINES AND JAIL TIME, SO WE
CONTINUE TO WORK WITHIN THE
RESOURCES AND STATUTORY
AUTHORITY WE HAVE TO DO WHAT WE
CAN TO GET THOSE PRODUCTS OFF
THE MARKET.
>> OKAY.
AND WHAT ARE THE DIFFERENCES, IF
ANY, BETWEEN STRUCTURE/FUNCTION
CLAIMS ON FOODS AND ON DIETARY
SUPPLEMENTS?
WHY DO -- ALSO RELATED, WHY DO
SELLERS HAVE TO HAVE PROOF FOR
THESE TYPES OF CLAIMS BUT NOT
SHARE THIS PROOF WITH FDA OR
FTC?
HOW CAN WE BE SURE THEY ARE
BEING HONEST?
>> WELL, WITH REGARDS TO HAVING
THE PROOF OF INFORMATION WE CAN
OKAY WORK WITHIN LEGISLATIVE
AUTHORITY WE HAVE, THE
LEGISLATIVE AUTHORITY WE HAVE
DOESN'T REQUIRE -- DOESN'T ALLOW
FDA AS AUTHORIZED AGENCY TO
OBTAIN THIS INFORMATION FROM
MANUFACTURERS, SO WE HAVE TO AT
THAT RATE TRUST THAT THEY ARE
HOLDING ONTO THIS INFORMATION.
WE CAN OF COURSE CONDUCT
INSPECTION AND ASK FOR
INFORMATION AS WE SEE FIT BUT
CAN'T REQUIRE THEM TO PROVIDE
THE INFORMATION, THAT'S SOME OF
THE LIMITS ON OUR AUTHORITY.
>> ANOTHER QUESTION HERE, HOW DO
OTHER INDUSTRIALIZED NATIONS
DEAL WITH SUPPLEMENTS ARE
SUPPLEMENTS PART OF THEIR
MEDICAL PROTOCOL?
OBVIOUSLY THAT DEPENDS ON THE
COUNTRY OF COURSE.
>> YES, DEPENDS ON THE COUNTRY.
SOME REFER TO THEM AS MEDICAL
PRODUCTS, SOME REFER TO THEM AS
DIETARY SUPPLEMENTS, NUTRITIONAL
PRODUCTS.
IT REALLY DEPENDS ON THE
COUNTRY.
>> YEAH, CANADA FOR INSTANCE HAS
A PRODUCT CALLED NATURAL HEALTH
PRODUCTS THAT INCORPORATE A LOT
OF THE SORTS OF THINGS THAT ARE
AVAILABLE HERE AS DIETARY
SUPPLEMENTS, BUT IN CANADA THEY
ARE REGULATED AS A SPECIAL
CATEGORY OF OTC DRUGS RATHER
THAN SPECIAL CATEGORY OF FOOD.
AND THERE IS PRE-MARKET
APPROVAL, AND THINGS LIKE THAT.
THAT'S CANADIAN CASE.
I KNOW CERTAIN COUNTRIES IN
EUROPE, I'M NOT GOING TO TRY AND
PARSE A DIFFERENT COUNTRY IN
EUROPE OR ADDRESS THE E.U.
I DO KNOW THERE ARE CERTAIN
COUNTRIES THAT REGULATE DIETARY
SUPPLEMENTS, ESSENTIALLY
NUTRITIONAL SUPPLEMENTS, HERBS
ARE NOT CONSIDERED, ONLY
CONVENTIONAL NUTRIENTS ARE.
A NUMBER OF THESE PLACES
NUTRITIONAL VALUE CANNOT EXCEED
THE DAILY VALUE OR THE RDI FOR
THE NUTRIENT OF CONCERN.
AND AGAIN IT VARIES FROM COUNTRY
TO COUNTRY.
THERE ARE COUNTRIES THAT
REGULATE ESPECIALLY THE HERBS AS
TRADITIONAL MEDICINES.
SOME COUNTRIES HOLD THEM TO A
FAIRLY HIGH STANDARD PRE-MARKET
APPROVAL, OTHER ONES LESS HIGH
STANDARD.
YOU KNOW, MATERIAL TIME AND
EXTENT, YOU KNOW, HISTORY OF
USE, AS THEIR APPROVAL PROCESS.
IT REALLY IS -- IT REALLY VARIES
FROM COUNTRY TO COUNTRY AROUND
THE WORLD.
>> OKAY.
FDA OFFICIAL ABOUT THREE YEARS
AGO ESTIMATED THERE WERE 4600
NEW DIETARY INGREDIENTS IN THE
SUPPLEMENT MARKET BUT FDA HAS
ONLY RECEIVED AROUND 1200 TOTAL
NOTIFICATIONS.
AND THAT'S QUITE A DISCONNECT.
YOU SAID LAST WEEK FDA RELEASED
A DRAFT GUIDANCE TO GET MORE
NDIs SUBMITTED FOR THESE NOT
IMPROVED INGREDIENTS.
WHAT IS NEEDED TO MAKE THIS
FINAL?
>> SO THAT'S A GREAT QUESTION.
THIS GUIDANCE AS I MENTIONED WAS
ISSUED LAST WEEK.
WE WILL HAVE -- WHEN FDA PUTS
OUT GUIDANCE YOU CAN COMMENT AT
ANY TIME BUT WE'VE ASKED YOU
SUBMIT COMMENTS WITHIN 60 DAYS.
ONCE WE RECEIVE AND REVIEW THOSE
COMMENTS, WE'LL EVALUATE AND
DETERMINE WHETHER OR NOT THAT
POLICY NEEDS TO BE RESTRUCTURED
OR CHANGED IN ANY WAY, AFTER
THAT 60 DAYS AFTER WE'VE
EVALUATED ALL OF THE COMMENTS
WE'LL WRITE UP THE FINAL POLICY.
IT WILL GO THROUGH ALL OF THE
REQUIRED CLEARANCES AND THEN BE
ISSUED, BUT FDA WILL WORK
EXPEDITIOUSLY TO REVIEW THOSE
COMMENTS AND GET THIS FINAL
GUIDANCE OUT AS SOON AS
POSSIBLE, WE DO THINK IT'S
IMPORTANT TO ENCOURAGE MORE NDI
NOTIFICATIONS, MORE SAFETY
INFORMATION, TO MAKE IT INTO THE
HANDS OF THE AGENCY.
>> IF THERE WERE DIETARY
SUPPLEMENTS SHOWN TO HELP, SAY,
CANCER PATIENTS, MORE EFFECTIVE
IN THAT POPULATION THAN HEALTHY
INDIVIDUALS WOULD THAT
CATEGORIZE THE SUPPLEMENT AS A
DRUG OR COULD IT STILL STAY AS
SUPPLEMENT?
>> I WOULDN'T BE ABLE TO COMMENT
ON A SPECIFIC PRODUCT.
DR. BETZ MAY WANT TO ANSWER.
>> WHAT DO YOU MEAN BY HELP
SOMEBODY BE HEALTHIER?
YOU CAN BE A HEALTHY CANCER
PATIENT, YOU KNOW, MAYBE
SLIGHTLY LESS WASTING OR
SOMETHING LIKE THAT.
AND IT'S VERY DIFFERENT THAN
TREATS OR CURES THE CANCER.
YOU KNOW, IF YOU'RE CLAIMING TO
TREAT OR CURE THE CANCER, THEN
YOU'RE A DRUG, PERIOD.
MAINTAINING THE HEALTH OF A
VULNERABLE INDIVIDUAL WHO HAS A
CERTAIN DISEASE, I'M NOT SURE
WHERE THAT WOULD FIT.
YOU KNOW, IT WOULD BE VERY
NARROW TIGHTROPE TO BE WALKING
ON IF I WERE TO TRY TO MAKE THAT
CLAIM I THINK.
>> HOW ARE COMPANIES GETTING
AWAY WITH FORMULATING
SUPPLEMENTS AS GUMMIES IF,
QUOTE, CANDY IS CONSIDERED A
FOOD?
>> THAT'S A GREAT QUESTION.
IT WOULD WOULD MEET THE
DEFINITION OF DIETARY SUPPLEMENT
IF BEING MARKETED IN THE WAY
THAT WE HAVE EXPRESS EXPRESSED
EARLIER, CONTAINS REQUIRED
CLAIMS OF A DIETARY SUPPLEMENT,
A LIKELY A SUPPLEMENT BUT THERE
ARE PRODUCTS THAT WALK THAT LINE
A LITTLE BIT IN A MORE DIFFICULT
WAY IN THAT CASE ODPS WILL REACH
OUT TO -- WE HAVE AN OFFICE OF
NUTRITION AND FOOD LABELING, AND
THEY WILL HELP US EVALUATE AND
DETERMINE WHETHER OR NOT IT IS
IN FACT A DIETARY SUPPLEMENT.
>> YEAH, IT'S INTERESTING THAT
CASE STUDY, THE HAIN'S PRODUCT,
FDA SPECIFICALLY IN THE WARNING
LETTERS SPECIFICALLY CALLED OUT
THE FACT THAT THE COMPANY HAD
PROMOTED THEIR STUFF AS
DELICIOUS.
AS PROOF THEY WERE TRYING TO
SELL A CONVENTIONAL FOOD RATHER
THAN DIETARY SUPPLEMENT.
IF YOU REPRESENT YOUR GUMMY AS
GOOD TASTING, TASTES GOOD, YOU
MIGHT BE WALKING CLOSER TO THE
CONVENTIONAL CANDY LINE, YOU
KNOW.
SO IT COMES DOWN TO, YOU KNOW,
USING YOUR WORDS CAREFULLY.
>> AS A LAWYER WE SAY
CASE-BY-CASE BASIS,
UNFORTUNATELY IT'S THE SAME
THING HERE.
>> RIGHT.
>> ANOTHER QUESTION, I'M UNDER
THE IMPRESSION THAT GRAS STATUS
FOR FOOD IS APPLIED TO SPECIFIC
FOOD CONSTITUENTS AT SPECIFIC
LEVELS.
IF THIS IS SO, HOW CAN DIETARY
SUPPLEMENTS STATE THEIR PRODUCT
MEETS GRAS WHEN MAY CONTAIN TEN
TIMES OR SO THE LEVEL OF THE
NUTRIENT?
>> I'M NOT AS FAMILIAR WITH THE
SPECIFICS OF THE GRAS
NOTIFICATION PROCESS, AND WHAT
IS REQUIRED OF THEM.
I DO KNOW, AND I CAN STATE THAT
WE'RE AWARE UNFORTUNATELY
COMPANIES ARE USING SELF-GRAS
STATUS TO GET OUT OF THE NDI
NOTIFICATION PROCESS, BUT I'M
NOT AWARE OF SPECIFICALLY WHAT
THEY ARE CLAIMING IS GRAS IN
THEIR PRODUCTS.
>> AGAIN, THAT WOULD BE CASE BY
CASE I THINK.
SO THEIR GRAS SELF-AFFIRMATION
WOULD REQUIRE INFORMATION NOT
ONLY ABOUT THE SUBSTANCE BUT
ABOUT ALSO ITS INTENDED USE, HOW
WILL IT BE USED, AT WHAT LEVELS,
AND WHAT ARE THE RECOMMENDATIONS
FOR USE.
AND EACH GRAS SELF-AFFIRMATION
WOULD HAVE TO UNDERGO, YOU KNOW,
SOME KIND OF SCIENTIFIC REVIEW,
WHETHER IT'S A SELF-AFFIRMATION
OR FORMAL GRAS NOTIFICATION TO
FDA STILL HAS TO UNDERGO A
REVIEW BY QUALIFIED EXPERTS.
AND SO, YOU KNOW, YOU COULD MAKE
A GRAS SELF-AFFIRMATION FOR A
CERTAIN SUBSTANCE FOR A CERTAIN
USE, AND IT DOESN'T HAVE TO MEET
THE SAME GRAS-INTENDED USE
DEFINITION AS THE SAME
SUBSTANCE, FOR INSTANCE, IN A
CONVENTIONAL FOOD WHICH WOULD
BE -- MIGHT BE FOR A DIFFERENT
TECHNICAL EFFECT.
SO, AGAIN, CASE BY CASE I THINK.
AS LONG AS THE SCIENTIFIC
REVIEWERS HAVE DONE THEIR DUE
DILIGENCE AND ACTUALLY REVIEWED
IT AS THE COMPANY WILL USE IT,
THEN I THINK -- I THINK THAT
IT'S PROBABLY OKAY ALTHOUGH,
AGAIN, LIKE YOU I'M NOT AN
EXPERT ON THE GRAS PROCESS.
>> HAS THERE BEEN RESEARCHERS ON
CONSUMERS UNDERSTANDING OF
DISCLAIMER LANGUAGE ON LABELS
AND IN ADVERTISING, YOU KNOW,
THAT HAS NOT BEEN EVALUATED BY
THE FDA?
WHAT DO CONSUMERS THINK THAT
MEANS?
IS THE DISCLAIMER ITSELF
POTENTIALLY MISLEADING?
>> WELL, I THINK THAT OUR SOCIAL
SCIENTISTS HAVE PROBABLY DONE
SOME MORE EXTENSIVE RESEARCH.
I HAVE NOT SEEN ANY RESEARCH TO
SAY THAT THAT DISCLAIMER
LANGUAGE IS MISLEADING.
IT HAS BEEN IN PRACTICE FOR A
LONG TIME NOW.
I WOULD BE CERTAINLY INTERESTED
IF YOU'RE REFERRING TO RESEARCH
THAT YOU HAVE, YOU CAN CERTAINLY
REACH OUT TO FDA TO PRESENT THAT
RESEARCH.
>> A TECHNICAL QUESTION HERE,
DIETARY SUPPLEMENTS MAY NOT
INCLUDE ARTICLE AUTHORIZED FOR
INVESTIGATION AS NEW DRUG,
ANTIBIOTIC OR BIOLOGICAL FOR
WHICH SUBSTANTIAL CLINICAL
INVESTIGATIONS HAVE BEEN
INSTITUTE AND FOR WHICH THE
EXISTENCE OF SUCH INVESTIGATION
HAS BEEN MADE PUBLIC, UNQUOTE.
WHAT CONSTITUTES THE
INVESTIGATIONS BEING MADE
PUBLIC?
>> THERE'S CASE LAW THAT REALLY
GETS INTO THE NITTY-GRITTY OF
THAT.
THAT'S NOT SOMETHING THAT WE
COULD PROBABLY GET INTO IN A
LIMITED TIME WE HAVE HERE.
BUT AS SOON AS WE HAVE SEEN
GENERALLY IT'S SOMETHING THAT A
COMPANY PUTS IN THE MARKETPLACE,
A P.R. NEWS WIRE THEY PUT OUT,
SOMETHING LIKE THAT COULD BE
USED AS AN EXAMPLE OF THEM
MAKING IT PUBLIC.
BUT THAT ALSO COULD BE A
CASE-BY-CASE ANALYSIS.
I'D HAVE TO LOOK BACK AT CASE
LAW TO PROVIDE MORE INFORMATION.
>> HOW IS IT SUPPLEMENTS ARE
ABLE TO BE DISTRIBUTED IN,
QUOTE, THERAPEUTIC DOSES?
FOR EXAMPLE 5,000 IUs FOR
VITAMIN D 3 BEYOND THE UPPER
LEVEL WHEN OTHER MEDICAL SOURCES
STATE ANYONE TAKING THIS AMOUNT
SHOULD HAVE THEIR VITAMIN D
LEVELS REGULARLY CHECKED TO
AVOID RISK OF TOXICITY?
THAT PART ISN'T EXACTLY TRUE.
OKAY.
>> WELL, YOU KNOW, MY ANSWER TO
THAT IS THE PROXMIRE AMENDMENT.
YOU KNOW, THAT'S WHY WE HAVE
MEGADOSES OF VITAMINS WHETHER OR
NOT THAT'S SMART IS A DIFFERENT
ISSUE THAT I WON'T TALK ABOUT.
>> ARE PRESS RELEASES THAT SHARE
FINDINGS PUBLISHED IN A PER
REVIEW ARTICLE CONSIDERED
CLAIMS?
>> IT WOULD DEPENDS ON WHAT THE
PRESS RELEASES SAY, IF THEY MAKE
STATEMENTS ABOUT INTENDED USE OF
THE PRODUCT COULD BE CONSIDERED
CLAIMS THAT FDA WOULD EVALUATE.
>> YEAH, THERE'S INTERESTING
PART OF DSHEA THAT ALMOST NOBODY
EVER TALKS ABOUT, AND THAT IS
YOU USED TO WALK INTO A HEALTH
FOOD STORE AND FIND PAMPHLETS
THAT WERE FREE, THAT GAVE
CONSUMERS INFORMATION ABOUT, YOU
KNOW, WHAT TO USE YOUR ST.
JOHN'S WORT FOR, FOR INSTANCE.
FDA WAS TAKING ACTION AGAINST
PRODUCTS BASED ON THAT
LITERATURE, THAT THIRD PARTY
LITERATURE, THAT WAS PRESENT IN
THE HEALTH FOOD STORE.
SO THEY WERE CLAIMING THAT THIRD
PARTY LITERATURE IS HOW YOU KNEW
THAT THE ST. JOHN'S WORT WAS
INTENDED TO BE USED AS A DRUG.
IT COMES BACK TO INTENDED USE,
ALL SORTS OF THINGS.
CONGRESS SPECIFICALLY IN THE
DSHEA SAID THAT THAT LITERATURE
IS ALLOWED TO BE THERE, AS LONG
AS IT'S TRUTHFUL AND NOT
MISLEADING, AS LONG AS IT
DOESN'T MENTION A SPECIFIC
PRODUCT, SPECIFIC BRAND.
SO, YOU COULD HAVE A LITERATURE
ABOUT ST. JOHN'S WORT, AS LONG
AS IT WASN'T BRAND X ST. JOHN'S
WORT.
AND CONGRESS AUTHORIZED THAT AND
SAID IT'S PART OF DSHEA.
IT'S NOT EXACTLY THE SAME AS
PRESS RELEASE BUT THE THIRD
PARTY LITERATURE IS STILL LEGAL.
>> BOY, IN THOSE DAYS I USED TO
WORK IN HEALTH FOOD STORES,
PARTLY RESPONSIBLE FOR
DISTRIBUTING THAT LITERATURE.
AND FOR THAT I GUESS I APOLOGIZE
NOW.
WE HAVE A FINAL QUESTION, AND IF
MS. DAVIS IS HERE, HOW AND WHEN
DO FDA AND FTC WORK TOGETHER TO
ADDRESS DIETARY SUPPLEMENT
PRODUCTS IN THE MARKETPLACE?
CAN YOU GIVE SOME EXAMPLES AND
DO YOU ACTUALLY GET ALONG?
>> I'M HAPPY TO LET MS. DAVIS
START.
>> HELLO, CAN YOU HEAR ME?
>> YES.
>> OKAY, GREAT.
WELL, YOU KNOW, WE GET ALONG
FINE.
WE HAVE GREAT RESPECT FOR FDA
AND THEIR EXPERTISE.
YOU KNOW, THERE ARE REGULAR
INTERACTIONS, REGULAR MEETINGS,
BETWEEN OUR AGENCIES, WHERE
WE'RE ABLE TO DISCUSS PARTICULAR
PRODUCTS, PARTICULAR CASES THAT
WE MIGHT BE INTERESTED IN
BRINGING.
YOU KNOW, SOMETIMES WE HAVE A
CASE OR PRODUCT ABOUT WHICH WE
WANT TO, YOU KNOW, ISSUE A
WARNING LETTER, MAYBE FDA WANTS
TO DO SOMETHING SIMILAR.
SO WE COORDINATE.
SO WE'VE BEEN ABLE TO WORK
TOGETHER QUITE FREQUENTLY.
I THINK I POINTED TO THE
DIABETES WARNING LETTER IN MY
PRESENTATION SO THAT WOULD BE AN
EXAMPLE.
I KNOW FDA HAS DONE SOME WARNING
LETTERS WITH RESPECT TO COVID.
WE'VE DONE SOMETHING SIMILAR.
SO, YES, BOTH AGENCIES, I THINK
OUR RELATIONSHIP IS GOOD AND WE
TRY TO STAY ON THE SAME PAGE
WITH DIETARY SUPPLEMENTS WITH
THE SAME GOAL TRYING TO PROTECT
CONSUMERS.
>> I WOULD ECHO THAT WE HAVE AN
EXCELLENT RELATIONSHIP AND HAVE
BEEN WORKING CLOSELY TO TRY TO
DO THESE JOINT HEALTH CLAIM
INITIATIVES TO BRING MORE
ATTENTION, SOMETIMES WHEN FDA
AND FTC ARE TOGETHER TALKING
ABOUT AN ISSUE, MAYBE IT DRAWS
MORE ATTENTION FROM CONSUMERS
FROM THE MEDIA.
THESE TYPES OF CLAIMS
INITIATIVES ARE HELPFUL IN
ALERTING FOLKS TO POTENTIALLY
PROBLEMATIC PRODUCTS AND GETTING
THEM OFF THE MARKET.
>> OKAY.
THANKS VERY MUCH TO OUR THREE
SPEAKERS.
THIS WAS A TERRIFIC SESSION.
THAT'S IT FOR SESSION NUMBER 2.
I BELIEVE WE'RE GOING TO TAKE A
SHORT BREAK AND BE BACK IN A
LITTLE BIT.
THERE'S JAIME TO SAY EXACTLY
WHAT IT IS.
>> WE'RE NOT GOING TO TAKE A
BREAK BECAUSE WE GOT THE BREAK
BEFORE.
BUT FOR TIME WE'RE GOING TO HAVE
TO JUMP RIGHT IN TO SESSION 3,
WHICH IS DATABASES AND
RESOURCES, OUR LAST SESSION FOR
TODAY.
WE HAVE KAREN REGAN, OFFICE OF
DIETARY SUPPLEMENTS, SHE WILL BE
MODERATING THIS SESSION.
THANK YOU, KAREN.
>> GOOD AFTERNOON, EVERYONE.
THE SESSION IS 3, DATABASES AND
RESOURCES, MS. MERKEL WILL TALK
ABOUT DATABASES MAINTAINED BY
ODS THAT JAIME GAVE A GREAT
OVERVIEW OF THIS MORNING.
MS.MERKEL IS SCIENCE AND HEALTH
COMMUNICATIONS CONSULTANT,
OFFICE OF DIETARY SUPPLEMENTS,
PRIMARILY WORKS ON DIETARY
SUPPLEMENT AND LITERATURE
DATABASES.
AND SHE ALSO WORKS IN
COMMUNICATION AND PROMOTION
ACTIVITIES FOR THE OFFICE.
THERE'S A MORE DETAILED BIO OF
MS. MERKEL ON THE WEBSITE, THE
PRACTICUM WEBSITE.
MS.MERKEL?
YOU'RE ON MUTE.
>> AUDIO IS YET TO BE CONNECTED
MAYBE.
JOYCE, IF YOU GO TO THE BOTTOM
OF THE WEBEX WINDOW.
OH, I CAN UNMUTE YOU.
YOU'RE UNMUTED NOW.
>> CAN YOU HEAR ME NOW?
>> YEP.
>> OKAY.
I NEED THE SHARE ABILITY, SORRY.
>> LOOKING GOOD.
>> LOOKS GREAT.
>> OKAY, GREAT.
GOOD AFTERNOON, EVERYONE.
I'M HAPPY TO BE HERE TO TALK
ABOUT SOMETHING I ABSOLUTELY
LOVE, I'VE BEEN ABLE TO BLEND
BACKGROUND IN NUTRITION ALONG
WITH LIBRARY SCIENCE HAVING
WORKED IN A FEW LIBRARIES OVER
THE COURSE OF MY CAREER AS WELL
AS TECHNOLOGY.
SOME OF THESE YOU PROBABLY WILL
KNOW A LOT ABOUT, OTHERS I'M
HOPING I WILL BE ABLE TO GIVE
YOU ONE PIECE OF NEW INFORMATION
TO LOOK FOR ANSWERS OR TRY TO
FURTHER FIND RESEARCH ON DIETARY
SUPPLEMENTS.
SO, WHERE WE'RE GOING TODAY.
WE'RE GOING TO LOOK AT WHERE TO
FIND BIBLIOGRAPHIC LITERATURE,
PUBLISHED RESEARCH, THINGS
ONGOING, ALSO A VARIETY OF
DATABASES THAT HAVE INGREDIENTS,
METHODS, LABELS, NUTRIENTS, SO
MUCH OUT THERE WHICH YOU ALREADY
HAVE MAYBE SEEN.
AND THEN A VARIETY OF RESOURCES
AND MONOGRAPHS AND FACTSHEETS
AND EVIDENCE REPORTS.
SO IF YOU'RE LOOKING FOR
SOMEBODY THAT'S ALREADY DONE THE
WORK FOR YOU AND LOOKED AT
EVERYTHING, THIS IS A GREAT
PLACE THAT YOU DON'T HAVE TO
RECREATE THE WHEEL.
ALSO A LITTLE BIT ABOUT A COUPLE
PLACES YOU CAN GET ALERTS,
THINGS PUSHED TO YOUR E-MAIL
ABOUT NEW STUFF COMING OUT.
SO, FIRST OF ALL, I WOULD ASSUME
AND HOPE MOST OF YOU HAVE HEARD
OF PubMed AND MEDLINE
THROUGH THE NATIONAL LIBRARY OF
MEDICINE AT THE INSTITUTES OF
HEALTH.
BUT WE'RE ALSO GOING TO LOOK AT
ACRI COLA, AND AGRIS, THERE'S
DATABASES OR COLLABORATORS OR
COORDINATORS, WAYS ARTICLES ARE
INDEXED AND MADE AVAILABLE.
BIBLIOGRAPHIC SEARCHING, LOOKING
FOR ARTICLES, FOR THE PIECE OF
RESEARCH TO BACK UP IS AN ART.
THERE'S NO ONE WAY TO DO IT.
YOU CAN GET A BUNCH OF STUFF,
SOME MIGHT NOT BE VERY RELEVANT,
IF YOU WANT TO SEE EVERYTHING,
SENSITIVITY, OR IF YOU WANT TO
JUST LOOK FOR SOMETHING THAT'S
SPECIFIC, TINY PIECE, YOU HAVE
THE RISK OF MISSING SOMETHING.
MULTIPLE DATABASES, MULTIPLE
WAYS OF LOOKING AT THINGS,
MULTIPLE SEARCH STRINGS, A WAY I
APPROACH LITERATURE SEARCHING.
THESE ARE ALL PARTS OF THE NLM,
NATIONAL LIBRARY OF MEDICINE.
PubMed AND MEDLINE ARE
SIMILAR.
A KEY DIFFERENCE, MEDLINE
ARTICLES ARE INDEXED.
THAT EITHER A HUMAN OR MACHINE
HAS GONE THROUGH AND ASSIGNED
TOPIC AND INDEX WORDS SO IT'S
EASIER TO FIND THEM WHEN YOU'RE
SEARCHING.
A FEW MORE MILLION CITATIONS
THAN PubMed THAN IN MEDLINE,
33 MILLION CITATIONS RIGHT NOW
IN PubMed.
WE'LL LOOK MORE AT MEDLINE AND
PubMed COMING UP BUT
PubMed CENTRAL, PMC, YOU CAN
GET FULL TEXT.
YOU MAYBE HAD THE EXPERIENCE TO
CLICK ON FULL TEXT BUT GO TO THE
ARTICLE AND FIND YOU DON'T HAVE
ACCESS BECAUSE YOU NEED A
SUBSCRIPTION OR THROUGH YOUR
LIBRARY OR YOU HAVE TO PAY A FEE
TO GET THE ARTICLE.
HOWEVER, PUBMED CENTRAL IS FULL
TEXT.
A LOT OF THAT IS REQUIRED FOR
ARTICLES THAT HAVE SOME FUNDING
FROM NIH OR FROM GOVERNMENT
ENTITIES.
OTHER ARTICLES CAN BE IN THERE
AS WELL.
AUTHORS CAN SUBMIT THEM TO
PUBLIC METH CENTRAL.
SO THERE YOU CAN GET FREE TEXT,
WHICH IS GREAT.
THERE'S ALSO A BOOKSHELF WHERE
THINGS LIKE THE DIETARY
REFERENCE INTAKE DOCUMENTS ARE
PUT.
I'LL SHOW YOU ANOTHER BOOK A
LITTLE BIT LATER THAT'S USEFUL,
THAT'S IN THE BOOKSHELF.
THERE'S LOTS OF PIECES TO THE
NATIONAL LIBRARY OF MEDICINE,
ALL UNDER AUSPICES OF
PubMed, MEDLINE GROUP.
WE USED TO HAVE SOMETHING VERY
USEFUL.
I WANT TO POINT THIS OUT, THIS
CHANGED THIS YEAR.
THERE'S SOMETHING CALLED FILTERS
WHERE YOU CAN FILTER WHAT YOU'RE
SEARCHING FOR BY THINGS LIKE
DATE AND LANGUAGE, AND HUMAN OR
NON-HUMAN, HUMAN OR MONKEY, OR
SOMETHING.
OR RAT.
BUT WE USED TO HAVE SOMETHING
CALLED FILTERS WHERE WE ACTUALLY
HAD A DIETARY SUPPLEMENT FILTER,
CREATED IN COORDINATION WITH THE
OFFICE OF DIETARY SUPPLEMENTS.
THERE WAS ALSO A COMPLEMENTARY
MEDICINE SUBJECT, CAM, DONE WITH
THE NATIONAL CENTER FOR
COMPLEMENTARY AROUND INTEGRATIVE
HEALTH, NCCIH.
BOTH OF THOSE HAVE GONE AWAY,
WHICH IS KIND OF SAD.
I WILL ALSO SHOW YOU THOUGH
HOWEVER IF YOU WANT THE SEARCH
STRATEGY OR STRING OR WAY TO
SEARCH WHAT WE USED T USE WITH
DIETARY SUPPLEMENTS THERE'S A
LINK STILL ON THE PAGE.
YOU COULD ACTUALLY TAKE THIS
SEARCH STRATEGY, HUGE ASS, IT
YOU COULD SPEAK IT FOR WHAT YOU
NEED AND THROW IT INTO
PubMed.
IT'S NO LONGER UPDATED, LAST
TIME IT WAS UPDATED WAS IN MARCH
BUT SO THIS ACTUAL STRATEGY IS
STILL THERE.
HOWEVER, YOU'RE NOT ABLE TO
APPLY IT FROM THE MAIN
PubMed PAGE ANYMORE.
WHAT YOU USED TO FIND UNDER
SUBJECT IS GONE.
WHICH WAS A NEW FEATURE THIS
YEAR, UNFORTUNATELY.
BUT I'LL SHOW YOU SOMETHING THAT
NCCIH HAS DONE TO MAKE IT
REPLACED.
WITH SEARCHING, IF YOU DON'T
HAVE OUR FILTER YOU CAN USE THE
MeSH HEADING, MEDICAL SUBJECT
HEADING.
THERE'S ONE FOR DIETARY
SUPPLEMENTS WHICH BASED ON
INDEXING OF THE MEDLINE RECORD
PULLS OUT RECORDS WITH THAT
PARTICULAR TOPIC.
AND IT'S VERY EASY TO DO.
THIS GIVES YOU THE DETAILS OF
WHAT THE MeSH ENCOMPASSES, SO
IF YOU WERE TO PUT ANY TERMS
INTO YOUR SEARCH BOX IN
PubMed, IT WOULD DEFER TO
THIS PARTICULAR SUBJECT HEADING.
IT'S VERY EASY JUST TO ADD IT UP
INTO HERE, YOU ADD IT TO YOUR
SEARCH BUILDER, IT THROWS IT IN,
OR YOU CAN USE THE CODING
YOURSELF.
AND TAKE IT TO PubMed.
LET'S THROW THAT IN.
IT WILL APPLY THAT PARTICULAR
MeSH HEADING AND BINGO, GIVE
YOU A LIST OF ARTICLES YOU CAN
GO THROUGH OR FURTHER REFINE BY
DATE OR IF YOU WANT SYSTEMATIC
REVIEW OR A RANDOMIZED
CONTROLLED TRIAL, BUT MeSH
HEADINGS ARE THE THINGS TO BE
USING NOW SINCE WE DON'T HAVE
OUR FILTER ANYMORE.
THERE ARE ALSO MeSH HEADINGS
FOR CHINESE HERBAL DRUGS, HERBAL
MEDICINE, PROBIOTICS.
YOU CAN ALSO PUT IN ALL THE
INDIVIDUAL NUTRIENTS, SAY
VITAMIN D OR IRON OR ZINC AND GO
FROM THERE BECAUSE THERE ARE
MeSH HEADINGS FOR EACH OF
THOSE AS WELL.
IT HELPS AND MAKES THE SEARCHING
MUCH EASIER.
THIS IS A NEWER FEATURE IN
PubMed CALLED CLINICAL
QUERIES, WHERE THEY HAVE PUT
FILTERS IN FOR YOU, AND THEY MAY
NOT NECESSARILY BE SPECIFIC TO
DIETARY SUPPLEMENTS BUT MAY BE
OF INTEREST.
IT'S CALLED CLINICAL QUERIES.
AND YOU CAN DO IT BY CLINICAL
STUDIES OR COVID-19 BEING THAT'S
OF GREAT INTEREST THESE DAYS.
YOU CAN ALSO DO IT BY DIAGNOSES,
ETIOLOGY, PROGNOSIS, A BROAD
VERSUS NARROW, AGAIN YOU CAN PUT
IN -- I'M RANDOMLY PICKING
GINGKO, I HAVE NO PARTICULAR
INTEREST, A CAVEAT.
IT WILL GIVE A SET OF STUDIES
AND TAKE YOU THEN, RIGHT BACK
INTO PubMed AND DO MORE
REFINING IF YOU WANT.
IT'S ANOTHER WAY TO START
NARROWING OR GETTING AT WHAT
YOU'RE LOOKING FOR.
OH THE BOOKSHELF, LOTS OF BOOKS.
AS I SAID DIETARY REFERENCE
INTAKE BOOKS AS WELL AS LOTS OF
OTHERS.
BUT I FOUND THIS ONE OF
PARTICULAR USE.
IT'S SPECIFICALLY TO LACTATION
AND DRUGS.
HOWEVER, IF YOU LOOK AS I DID
THROUGH THIS LIST OF WHAT THEY
CALL DRUGS, YOU'RE GOING TO FIND
A LOT OF THINGS THAT MIGHT BE
CONSIDERED A DIETARY SUPPLEMENT
OR HERBAL.
LET'S SEE.
I'LL PICK ONE.
I'LL GO TO GINGKO.
THERE'S GINGKO.
WHAT IT DOES, SUMMARIZES USE
DURING LACTATION, AND TALKS
ABOUT -- GIVE REFERENCES, IT'S A
PLACE TO LOOK FOR MORE
INFORMATION THAT'S BEEN WRITTEN
UP ABOUT A SPECIFIC INGREDIENT.
THAT'S AVAILABLE THROUGH THE
BOOKSHELF AT PubMed OR --
YEAH.
THE OTHER THING I FOUND REALLY
USEFUL, AND THIS KIND OF
REPLACES THE CAM OR
COMPLEMENTARY MEDICINE FILTER,
THESE ARE PRE-FORMATTED FILTERS
FROM NCCIH THAT PULLS TOGETHER
SPECIFIC INGREDIENTS IN
SYSTEMATIC REVIEW SEARCH, RCT,
RANDOMIZED CONTROLLED TRIAL OR
HERB-DRUG INTERACTION SEARCH,
YOU CAN CHANGE THAT AS YOU'RE
SEARCHING, LET ME GO TO THAT.
EVIDENCE-BASED LITERATURE
REVIEW, YOU CAN SEE ACAI, YOU
CAN SEE WHAT IT GIVES YOU.
IT TAKES YOU TO PubMed,
WHICH IS GREAT.
YOU CAN ALSO SEARCH FURTHER OR
BREAK IT DOWN, 13 RESULTS ARE
NOT HARD TO TAKE A LOOK AT.
AGAIN, REMEMBER IT DOESN'T OF
GOES BACK FIVE YEARS.
IF YOU WANT TO GO FURTHER BACK
YOU HAVE TO DO ADJUSTING.
THIS IS A REALLY NICE FEATURE
THAT USES PubMed THANKS TO
NCCIH.
AGRICOLA, SIMILAR TO PubMed,
ARTICLES, REFERENCES, RESOURCES,
THE THING IS YOU MIGHT GET MORE
OF THE PLANT SCIENCE, MORE OF
THE GROWING OF THE HERBS, BUT
USDA DOES DEAL WITH FOOD AND
NUTRITION.
SO YOU'RE GOING TO FIND A LOT OF
OVERLAP BETWEEN PubMed AND
ACRICOLA BUT MAY FIND MORE OF
THE GROWING, AND THAT TYPE OF
USEFUL INFORMATION IN THIS
PARTICULAR DATABASE.
AGAIN, FREE AND OPEN, AT THE
USDA NATIONAL AGRICULTURAL
LIBRARY.
IT HAS PRINTED WORK TO THE
15th CENTURY, A BEAUTIFUL
COLLECTION OF SOME OF THE
ORIGINAL TURN OF THE CENTURY
1900s DRAWINGS OF THE PLANTS,
VERY, VERY INTERESTING CONTENT.
EASY TO USE INTERFACE.
I WON'T SHOW THAT BUT IT'S EASY
TO USE.
YOU CAN ALWAYS CONTACT THE
LIBRARIANS AT THE NATIONAL
AGRICULTURAL LIBRARY AS WELL, AS
WELL AS CONTACT LIBRARIANS AT
THE NATIONAL LIBRARY OF MEDICINE
IF YOU'RE HAVING ISSUES OR HAVE
SPECIFIC QUESTIONS.
AGRIS IS INTERNATIONAL THROUGH
FAO PART OF THE UNITED NATIONS,
NOT AS BIG OR ROBUST BUT HAS
MORE THAN 13 MILLION RECORDS,
THE NICE THING ABOUT AGRIS THAT
SOME OTHER DATABASES DON'T
CAPTURE IS THAT IT GETS
SOMETHING CALLED GRAY
LITERATURE.
YOU MIGHT FIND DISSERTATIONS,
OTHER DATASETS THERE.
EASY TO USE INTERFACE FOR
SEARCHING.
INTERESTING AND USEFUL, I WOULD
FIND A THESIS SOMEBODY HAD DONE
LOADED INTO THIS DATABASE.
THAT MAYBE HADN'T MADE IT TO
PUBLICATION YET.
I WILL PUT IN JUST ONE LITTLE
PLUG FOR DR. GOOGLE BECAUSE
GOOGLE SCHOLAR ALSO IS A WAY TO
START AS A VERY BROAD SEARCH OF
A TOPIC THAT THEN OFTEN TAKES
YOU RIGHT TO PubMed OR
DIRECTLY TO THE JOURNAL FOR THE
ARTICLE, SO, AGAIN, SEARCHING IS
AN ART.
YOU WANT TO USE MULTIPLE WAYS TO
TRY TO FIND JUST THE RIGHT
ARTICLES.
GOING ON, THIS IS -- THIS
CATEGORY IS MORE DATABASES THAT
ARE ONGOING, AND THERE'S A
NUMBER OF THEM THAT HAVE A
RECORD OF WHAT'S BEING DONE SO
IT'S NOT NECESSARILY BEEN
PUBLISHED YET.
YOU WON'T FIND IT.
IT DOES HAVE ACCESS TO SOME
PUBLICATIONS THAT HAVE RESULTED
IN SOME OF THESE.
WHO IS DOING IT?
WHO IS FUNDING IT?
WHAT'S IT ENTAIL?
WHAT'S THE TIME FRAME?
THESE ARE ALSO ONLINE AND
ACCESSIBLE TO THE PUBLIC.
NIH REPORTER IS THE MAIN PLACE
WHERE ALL NIH ACTIVITIES FOR
RESEARCH ARE REPORTED.
AND IT ALSO INCLUDES SOME OTHER
ENTITIES BESIDES NIH INCLUDING
CDC, V.A., A COUPLE OTHERS BACK
TO 1972 BUT IT'S EVERYTHING THAT
NIH DOES FROM AIDS TO COVID TO
MATERNITY TO CHILDREN TO DRUGS
AND ALCOHOL, AS WELL AS
NUTRITION SUPPLEMENTS.
IT'S HUGE.
EASY INTERFACE, NICE LOOKING.
BUT WHAT MIGHT BE MORE USEFUL IS
THAT WE HAVE CREATED THROUGH OUR
OFFICE SOMETHING CALLED CARDS,
COMPUTER ACCESS TO RESEARCH ON
DIETARY SUPPLEMENTS, AND THIS IS
A DATABASE OF DIETARY SUPPLEMENT
RESEARCH, SO IT HAS PULLED IN
FROM NIH REPORTERS AS WELL AS
OTHER SOURCES JUST THOSE THAT
ARE RELATED TO DIETARY
SUPPLEMENTS.
ALL THE INFORMATION THAT YOU
NEED, PROJECT, P.I., PRIMARY
INVESTIGATOR, INGREDIENT,
OUTCOMES, RESEARCH METHODOLOGY,
ALL THE WAY BACK FROM 1999.
THIS IS A GREAT RESOURCE.
EASY TO USE.
GOOD LOOKING INTERFACE.
AND ACTUALLY, OUR MODERATOR OF
THE SESSION, KAREN REGAN, IS
DIRECTOR OF CARDS, IF YOU HAVE
QUESTIONS ABOUT IT SHE WILL BE
THE RIGHT ONE TO ASK.
clinicaltrials.gov, THIS IS A
GREAT PLACE TO SEE WHAT'S BEING
DONE WITH CLINICAL TRIALS
OBVIOUSLY.
IT IS BOTH INTERNATIONAL AND
WORLDWIDE, RIGHT NOW THERE'S
OVER 400,000 TRIALS WITHIN THE
DATABASE.
AND THERE ARE QUITE A FEW THAT
ARE RECRUITING.
SO, AGAIN, IT'S VERY BROAD, ALL
DIFFERENT HEALTH CONDITIONS.
BUT THERE'S A NICE DIETARY
SUPPLEMENT FEATURE TO IT.
ON THE SEARCH PAGE, IF YOU GO
DOWN TO STUDIES BY TOPIC,
THERE'S ACTUALLY A DIETARY
SUPPLEMENT TOPIC, A FEW YEARS
AGO WE PROVIDED THEM A LIST OF
DIETARY SUPPLEMENTS AND
INGREDIENTS WHICH THEY THEN
INCORPORATED INTO THIS.
LET ME SHOW YOU THAT.
SO STUDY BY TOPIC DOWN AT THE
BOTTOM.
DIETARY SUPPLEMENTS,
ALPHABETICAL.
AND WE'LL GO TO MY FAVORITE,
LET'S SEE IF I CAN -- I WON'T
JUMP DOWN TO GINGKO.
BUT HOW ABOUT LET'S GO TO, YEAH,
ASCORBIC ACID.
IT GIVES ALL THE STUDIES
COMPLETED, RECRUITING, STATUS, A
LOT OF INFORMATION.
THIS IS A PLACE TO LOOK AT
WHAT'S CURRENTLY GOING ON, MOST
RECENTLY COMPLETED.
IF COMPLETED MORE THAN LIKELY
YOU'LL FIND ARTICLES THAT HAVE
BEEN PUBLISHED RELATED TO THAT
PROJECT, ALSO IN THIS DATABASE.
ANOTHER CLINICAL TRIAL DATABASE,
IN NEUROPATHY, PARTNERED WITH
HRA AND U.K., USED BY W.H.O. AND
MEDICAL JOURNAL EDITORS.
IT'S FREE TO USE, SEARCHABLE,
THERE'S A COST FOR THE
INVESTIGATORS TO INCLUDE THEIR
STUDY, AND RIGHT NOW HAS 21,000,
ALMOST 22,000 RECORDS IN IT.
ANOTHER PLACE TO LOOK.
A LOT OF IT IS DUPLICATED WITH
clinicaltrials.gov BUT YOU
NEVER KNOW WHAT MIGHT BE
DIFFERENT.
IT'S WORTH TAKING A LOOK AT.
AND USDA CURRENT DATABASE, NOT
JUST PLANTS AND ANIMALS, ALSO
HUMAN NUTRITION, CRIS.
STUDIES IN HUMAN NUTRITION
RESEARCH AND PLANT GROWING YOU
WILL FIND IN THEIR DATABASE,
ANOTHER PLACE TO SEE WHAT'S
GOING ON.
OKAY.
SORRY, A QUICK TOUR OF WHERE
CURRENT RESEARCH WAS BEING
REPORTED.
ALSO A LOOK AT DATABASES THAT
MIGHT BE AVAILABLE FOR
NUTRIENTS, INGREDIENTS, METHODS,
AND LABELS.
SOME YOU'VE ALREADY HEARD ABOUT.
JAIME TALKED ABOUT THE AMRM
PROGRAM, WE DO HAVE A DATABASE
SEARCHABLE.
IT'S ON THE AMRM HOME PAGE.
YOU JUST PUT IN YOUR TOPIC AND
SEARCH IT.
I WANT TO SHOW YOU PUBLICATION
CATEGORIES.
THERE ARE ARTICLES LISTED UNDER
METHOD DEVELOPMENT REPORTS,
VALIDATION REPORTS, YOU'LL FIND
SOME ARTICLES RELATED TO THOSE.
SOME OF THESE ARE IN PubMed
AS WELL.
SO, AGAIN, THIS IS ANOTHER PLACE
TO LOOK JUST IN CASE YOU'RE NOT
THINKING YOU'RE FINDING
EVERYTHING.
SO DATA CENTRAL THROUGH USDA
WHAT WE'RE FAMILIAR WITH WITH
FOOD COMPOSITION DATA, THEY HAVE
EXPANDED AND NOW HAVE MORE FOODS
AND MORE DATABASES INCORPORATED
INTO IT.
DOES IT SPECIFICALLY HAVE
DIETARY SUPPLEMENTS?
NO, BUT IF YOU'RE LOOKING FOR
ZINC OR SPECIFIC INGREDIENTS,
IT'S A GOOD PLACE TO SEARCH.
I WON'T DEMONSTRATE THAT.
MY TIME IS GOING REALLY FAST.
SO I'M GOING TO GIVE A SHAMELESS
PLUG FOR NEW FEATURE THAT USDA,
FDA AND ODS HAVE BEEN WORKING
ON.
THERE WASN'T INFORMATION ABOUT
IODINE CONTENT OF FOODS SO WHAT
WE'VE DONE, WHAT THEY HAVE DONE,
THEY HAVE DONE SOME BENCH WORK,
SOME INVESTIGATING, CREATED A
DATABASE OF IODINE CONTENT IN
FOODS.
YOU CAN ACCESS THROUGH FOOD DATA
CENTRAL OR ACCESS DIRECTLY --
OH.
THERE WE GO.
IT'S AN EXCEL SHEET SO I'M NOT
GOING TO DOWNLOAD IT FOR YOU.
BUT IT'S NICE THAT IT GIVES IT
IN 100-GRAM AMOUNTS AND COMMON
HOUSEHOLD AMOUNTS.
OKAY.
SO, CHECK OUT THIS NEW IODINE
CONTENT DATABASE.
THERE'S ALSO A PUBLICATION ON
THE DEVELOPMENT OF IT, IF YOU'RE
INTERESTED IN THAT.
NOW, ALL THESE THINGS THAT I'M
SHOWING YOU, YES, THEY ARE ON MY
SLIDES BUT ON THE AGENDA ON OUR
PRACTICAL OF PRACTICUM HOME PAGE
I HAVE A LEADING LIST OF LINKS
AND MORE ANNOTATED, SO YOU CAN
FIND THEM AND EASILY LINK USING
THAT.
DIETARY SUPPLEMENT INGREDIENT
DATABASE IS A PARTNERSHIP WITH
USDA AND ODS BUT WHAT THEY HAVE
DONE IS BENCH WORK, THEY HAVE
ACTUALLY TAKEN PRODUCTS OFF THE
SHELVES, ANALYZED.
YOU CAN'T LOOK AND SEE HOW MUCH
IS IN MY CENTRUM OR GENERIC
VITAMIN AT THE GROCERY STORE BUT
WHAT IT DOES IS GIVES AN
ESTIMATE OF THE CONTENT WHICH IS
THEN USEFUL IN THE SURVEYS THAT
ARE BEING DONE OF THE POPULATION
INTAKE.
THAT'S THE MAIN REASON FOR THAT.
THEN IT'S PUBLIC DOMAIN,
COPYRIGHT FREE, YOU CAN TAKE A
LOOK.
YOU WON'T BE ABLE TO
SPECIFICALLY LOOK AT CONTENT FOR
SPECIFIC BRAND OF VITAMIN.
MAINLY NOW IT'S MULTI-VITAMIN,
PRENATAL MULTI-VITAMIN, OMEGA 3,
STARTING IN GREEN TEA.
ZINC, IRON, COPPER, SELENIUM,
PHOSPHORUS, POTASSIUM,
MAGNESIUM, CRYPTONIGHT -- UH-OH.
YEP, DIETARY SUPPLEMENT LABELS
ARE CRITICAL.
WE HAVE 140,000 LABELS, I'M NOT
GOING TO TALK OTHER THAN TO SAY
A PRESENTATION FROM DR. SALDANHA
WILL GIVE YOU MORE INFORMATION.
TAKE A LOOK, VERY USEFUL.
WE DON'T MAKE RECOMMENDATIONS
BUT EVERYTHING ON THE LABEL OF
THE PARTICULAR PRODUCT.
YOU CAN SEE AN IMAGE OF THE
PRODUCT AND YOU CAN SEE HOW TO
CONTACT THE MANUFACTURER, YOU
CAN SORT AND SEARCH BY
INGREDIENT OR BY PRODUCER, OR
DIFFERENT THINGS LIKE THAT.
VERY USEFUL, IF YOU'RE LOOKING
FOR A SPECIFIC PRODUCT THAT YOU
WANT TO SEE WHAT'S ACTUALLY IN
IT, WHAT DOES THE LABEL ACTUALLY
SAY.
IT HAS ON MARKET AND OFF MARKET,
IN NO LONGER BEING SOLD IT
INDICATES THAT AS WELL.
THERE'S ALSO ANOTHER DIETARY
LABEL DATABASE, SUPPORTED BY
COUNCIL FOR RESPONSIBLE
NUTRITION, CRN, SUPPLEMENT OWL.
IT HAS FEWER PRODUCTS, INDUSTRY
BASED, ALSO A PLACE WHERE YOU
CAN LOOK THROUGH A VARIETY OF
LABELS.
SO, THE DIETARY SUPPLEMENT
DATABASE IS NOT THE ONLY GAME IN
TOWN.
I WILL GIVE TWO REFERENCES AND
THESE ARE ON MY READING LIST IF
YOU DOWNLOAD THAT, REVIEW ON
NATURAL PRODUCT DATABASES DONE A
COUPLE YEARS AGO WHICH IS AN
EXCELLENT ARTICLE.
AND THIS PARTICULAR ARTICLE
WHILE THE ARTICLE DEALS WITH
ETHNOBOTANICAL DATABASE FOR
BRAZILIAN FOODS THEY HAVE A
LOVELY SUPPLEMENTAL TABLE WITH
OF WHERE THEY COMPILED TONS OF
BOTANICAL DATABASES, LET'S SEE
IF I CAN SHOW YOU THAT.
IT IS ACTUALLY THE SUPPLEMENTARY
MATERIAL FOR THIS ARTICLE.
LET'S SEE, WHERE IS IT?
OKAY.
HERE IT IS.
WHAT'S NICE ABOUT IT, IT GIVES
THE NAME, HOW IT'S CLASSIFIED,
DESCRIBES WHERE IT'S LOCATED BUT
SAYS IF IT'S WORLDWIDE,
AUSTRALIA, CHINA, INDIA, AFRICA,
AND IT IS ONE OF THE BEST LISTS
OF BOTANICAL OR ETHNOBOTANICAL
OR PLANT INGREDIENT DATABASES,
LISTINGS, THAT I CAME ACROSS.
YES, ALL OF THESE ARE IN
INDIVIDUAL RESEARCH STUDIES AND
PRINTED ARTICLES, BUT THIS TABLE
IS EXCELLENT FOR GETTING A START
ON IF YOU'RE INTERESTED IN THE
PLANT DATABASE INGREDIENTS TYPE
THING.
IT'S EXCITING WHEN YOU COME
ACROSS A REALLY GOOD RESOURCE.
ALL RIGHT.
LAST THING I WANT TO HIT FAIRLY
QUICKLY IS ALL THE RESOURCES
THAT ARE ARE OUT THERE THAT HAVE
ALREADY DONE THE COMBINING AND
COORDINATING OF ALL THE
ARTICLES.
MONOGRAPHS, EVIDENCE REPORTS,
FACTSHEETS.
FIRST OFF, I DO HAVE TO PROMOTE
OUR ODS DIETARY SUPPLEMENT FACT
SHEET, EVIDENCE-BASED, REGULATED
REGULARLY, VITAMINS, MINERALS,
NUMBER OF HERBS AND BOTANICALS
AND SPECIAL INGREDIENTS.
WE HAVE PUT TOGETHER SEVERAL
COMBINATIONS AS WELL.
WE HAVE ONE ON WEIGHT LOSS,
EXERCISE, ATHLETIC PERFORMANCE,
MOST RECENT ONE COVID-19,
UPDATED REGULARLY AS THERE'S SO
MUCH RESEARCH COMING OUT ALL THE
TIME.
YOU'LL HEAR MORE ABOUT THAT FROM
CAREFUL HIGGINS MOMENT OR
WEDNESDAY. WE HAVE A THEM IN
HEALTH PROFESSIONAL, CONSUMER
VERSION, SPANISH VERSION, LINKED
TO PubMed.
I'LL SHOW YOU THAT QUICKLY.
A LONG LIST.
CLICK ON ONE, AND YOU CAN CHOOSE
THE CONSUMER, HEALTH
PROFESSIONAL, GO TO THAT.
YOU DON'T LIKE THAT, JUMP ACROSS
THE TOP AND GO TO HEALTH
PROFESSIONAL.
HEALTH PROFESSIONAL IS
REFERENCED, CONSUMER IS NOT.
HOPEFULLY IN AN EASIER TO READ
YET NOT TAKING THE SCIENCE DOWN
TOO MUCH IN THE CONSUMER
VERSION.
EXCELLENT RESOURCES.
YOU MAY BE AWARE OF NATURAL
MEDICINES DATABASE, SUBSCRIPTION
BASE WHICH ALSO HAS FACTSHEETS
AND A LOT OF MONOGRAPHS ON MANY,
MANY DIFFERENT PRODUCTS.
THEY TALK ABOUT ADVERSE
REACTION, SOME GRADING, IT'S A
USEFUL RESOURCE IF YOU HAVE
ACCESS TO THAT SUBSCRIPTION.
HEALTH CANADA, CANADA HAS A
DIFFERENT SYSTEM WHERE THEY DO
REQUIRE A DOCUMENTATION AND
MONOGRAPH FOR A NUMBER OF
PRODUCTS, IN FACT DR. BETZ
MENTIONED THE LICENSE NATURAL
HEALTH PRODUCTS DATABASE, THEY
HAVE A DATABASE FOR ALL THESE
MONOGRAPHS LISTED AND INCLUDED
SO YOU CAN GO AND READ THROUGH
AND GET ALL THE DATA.
IT'S LIKE A FACT SHEET WHICH IS
ALL REFERENCED, PROVIDED BY
HEALTH CANADA.
THE FDA HAS A LISTING OF TAINTED
PRODUCTS, NOT NECESSARILY A FACT
SHEET OR MONOGRAPH, IT'S A GOOD
RESOURCE THAT ANYBODY WORKING IN
SUPPLEMENTS SHOULD TAKE A LOOK
AT.
AS I SAID, BEFORE I GO ON TOO
FAR, I'LL SHOW YOU A REFERENCE
LIST.
THERE ARE SO MANY MORE.
YOU'LL HEAR LATER IN THE
PRACTICUM FROM THE MILITARY, THE
OPERATION SUPPLEMENT SAFETY
GROUP.
THEY HAVE GREAT FACTSHEETS AND
INFORMATION.
THE LINUS PAULING MICRONUTRIENT
INFORMATION CENTER HAS.
SO ALL OF THESE OTHER ENTITIES
ARE LISTED ON THE REFERENCE LIST
THAT I'M GOING TO SHOW YOU.
LAST COUPLE THINGS, MY TIME IS
GETTING SHORT, ALERTS.
SO, YOU DON'T HAVE TO LOOK FOR
SOME OF THESE THINGS.
YOU CAN HAVE THEM PUSHED TO YOUR
E-MAIL.
I USE A GOOGLE ALERT FOR DIETARY
SUPPLEMENTS AND SPECIFIC TOPIC.
AS OFTEN AAS I SET IT, ONCE A
DAY, ONCE A WEEK, THINGS THAT
ARE BEING FOUND ON THE INTERNET.
YOU CAN ALSO DO THE SAME THING
AT PubMed OR MEDLINE, AND
GET -- IF YOU HAVE A SPECIFIC
SEARCH YOU WANT RUN EVERY WEEK,
AND THEN SEND THAT INFORMATION
TO YOU, IN AN E-MAIL.
SO GOOGLE ALERTS.
AND THEN I'M SORRY, THIS IS VERY
SMALL, THIS IS A SEARCH STRATEGY
I HAVE SET UP FOR ARGININE, AND
WAR FIGHTERS.
WE WERE INTERESTED IN THE
MILITARY AND USE OF ARGININE.
I SET UP A SEARCH STRING SO NOW
EVERY WEEK THIS RUNS AND SENDS
ME AN E-MAIL OF ANY ARTICLES
THAT HAVE APPEARED IN PubMed
OR MEDLINE THAT ARE ON THIS THAT
FIT THE SEARCH STRING.
FREE AND EASY TO DO AT
PubMed.
WE HAVE A WEBSITE, OUR E-MAIL.
IF YOU HAVE SPECIFIC QUESTIONS
ABOUT SEARCHING LITERATURE I'M
HAPPY TO HELP.
YOU CAN E-MAIL ME.
I HAVE A -- ON THE PRACTICUM WEB
PAGE ON THE AGENDA UNDER MY
PARTICULAR NAME AND TIME, YOU
WILL FIND REFERENCES AND READING
LIST, ALL THE ARTICLES I'VE
TALKED ABOUT, DATABASES, THE
RESEARCH DATABASES, AND A WHOLE
LIST OF MONOGRAPHS AND
FACTSHEETS, WAY MORE THAN I
COULD HAVE POSSIBLY GONE
THROUGH, SO MUCH GREAT
INFORMATION.
HOPEFULLY, THIS IS GIVING YOU AT
LEAST ONE NEW PIECE OF
INFORMATION THAT YOU CAN USE.
AGAIN, USE THE QR CODE, STAY
CONNECTED.
WE DO REGULAR ODS UPDATES,
SCHOOLS FOR CONSUMERS.
ONCE A WEEK WE SEND OUT A TWEET
OF THE WEEK SO YOU CAN SEE
EVERYTHING WE TWEETED FOR THE
WEEK, FACEBOOK PAGE, TWITTER,
FOLLOW US.
GET MORE INFORMATION THAT WAY.
I THINK I'M DONE.
>> THANK YOU, JOYCE.
THAT WAS GREAT.
YOU HAVE SEVERAL KUDOS IN THE
Q&A AND WELL.
I HAVE A QUESTION, FIRST
QUESTION FROM YASMIN.
AND SHE SAYS THERE'S BEEN A
LONGSTANDING INTEREST IN
UNDERSTANDING THE ROLE OF
NUTRIENTS AND DIETARY .
ARE THERE DATABASES COLLECTING
DATA AND EVIDENCE OF BIOMARKERS
AND TOOLS FOR HOW TO EVALUATE
DIETARY SUPPLEMENTS TO SUPPORT
RESILIENCE AND HEALTH
OPTIMIZATION?
>> I DON'T KNOW OF A SPECIFIC
DATABASE RELATED TO BIOMARKERS.
I KNOW THAT ENTITIES SUCH AS
NATIONAL ACADEMIES OF SCIENCES,
THEY WERE STARTING TO LOOK AT
DIFFERENT NUTRIENTS, ARE
INTERESTED IN BIOMARKERS AND
THINGS LIKE THAT BUT I BELIEVE
THAT PubMed, MEDLINE, IS
PROBABLY THE BEST LIST OF WHERE
YOU'LL FIND THAT.
IT'S SO COMPREHENSIVE.
BUT I DON'T KNOW OF ANY SPECIFIC
BIOMARKER-TYPE DATABASE.
IF YOU DO, PLEAS LET US KNOW AND
WE CAN INCLUDE THAT INFORMATION.
IT'S NOTHING THAT'S COME ACROSS
MY RADAR.
SORRY.
>> THANKS, JOYCE.
THERE IS A TALK ON DIETARY
SUPPLEMENTS AND RESILIENCE
TOMORROW AFTERNOON.
>> YEP.
TALK TO LAVERNE ABOUT THAT.
>> NEXT QUESTION FOR ME, WHEN
WOULD ONE USE NIH REPORTER
VERSUS CARDS DATABASE TO SEARCH
UNFUNDED RESEARCH IN DIETARY
SUPPLEMENTS.
SO, CARDS IS LARGELY A SUBSET OF
NIH REPORTER.
WE DON'T HAVE EXACTLY THE SAME
PROJECTS BECAUSE CARDS DATA IS
MANUALLY CURATED.
AND SO SOMETIMES THINGS THAT
COME IN AS DIETARY SUPPLEMENTS
IN FACT AREN'T, WHEN LOOKED AT
MORE CLOSELY.
SO THOSE ARE REMOVED FROM CARDS.
AND THEN THERE ARE PROJECTS THAT
AREN'T PICKED UP BY THE DIETARY
SUPPLEMENT FINGERPRINT THAT PUTS
THEM INTO REPORTER, THAT WILL BE
PICKED UP BECAUSE WE --
[AUDIO DISTORTION]
WE CAN ADD PROJECTS WE'RE AWARE
OF.
AGAIN CARDS IS MANUALLY CURATED
SO YOU SEARCH SPECIFICALLY BY
DISEASE OR BY STUDY TYPE, OR BY
POPULATION.
AND HEALTH OUTCOME.
IT'S A LITTLE MORE TARGETED
THAN JUST A KEY WORD SEARCH AND
REPORTER.
I MEAN, I WOULD SUGGEST USING
BOTH.
BECAUSE CORE IS THE SAME BUT
THEY HAVE DIFFERENT PROJECTS AND
CARDS MAY BE A LITTLE EASIER TO
FOCUS YOUR SEARCH.
>> OKAY.
AND THEN ANOTHER QUESTION IS IS
ACRICOLA AND PubMed NETWORK
CONNECTED SO YOU CAN DO ONE
SEARCH ACROSS BOTH OF THEM OR
DOES A PERSON SEARCHING HAVE TO
KNOW ABOUT BOTH OF THEM IF THEY
WANT TO DO A SEARCH?
IF THEY HAVEN'T TAKEN BEEN HERE
FOR YOUR TALK.
>> SO, THEY ARE GOING TO BE
RECORDS THAT ARE THE SAME IN
BOTH BUT AT THIS POINT I DON'T
KNOW THAT THEY ARE MESHED OR
CONNECTED.
THERE HAVE BEEN TALKS IN THE
PAST BUT RIGHT NOW THEY ARE
SEPARATE.
YOU'LL FIND SOME SAME JOURNALS
INCLUDED IN BOTH, INDEXED IN
BOTH.
ESPECIALLY IN PubMed, IF
IT'S A PLANT SCIENCE JOURNAL BUT
TALKS ABOUT HERBAL TYPE OF THING
YOU MIGHT FIND THAT IN PUBLIC
-- PubMed.
AT THIS POINT I DON'T BELIEVE
THEY ARE MESHED.
UNLESS YOU HAVE ACCESS TO A
LIBRARY THAT HAS SOME TYPE OF
CONSOLIDATOR, AND I'M NOT SURE
IF ANY OF THEM DO THAT YET WHERE
THEY SEARCH BOTH AND PROVIDE YOU
ALL THE RESULTS.
THERE MAY BE SOME PLATFORM THAT
LIBRARY -- SOME PROPRIETARY
PLATFORM THAT DOES THAT BUT
RIGHT NOW I SEARCH BOTH
SEPARATELY.
>> THANKS.
THANK YOU.
ANOTHER QUESTION, DO DATABASES
HAVE AN API AVAILABLE TO GET
DATA OUT FOR FURTHER RESEARCH?
>> SOME OF THEM DO, YES.
IN FACT, I BELIEVE LIKE THE DSLD
ACTUALLY DOES.
I BELIEVE THAT -- I'M NOT SURE
WITH AGRIS.
THE API IS ABOVE MY PAY GRADE.
I'LL REFER BACK TO SAY I'M A
DIETITIAN WITH LIBRARY KNOWLEDGE
BUT I DON'T HAVE ALL THAT
TECHNICAL SO I'M NOT SURE ABOUT
THE API.
>> OKAY, GREAT.
THANK YOU.
MAYBE LEILA WOULD KNOW.
NEXT TALK.
I THINK THAT'S A GOOD SEGUE, IF
WE MOVE TO THE NEXT TALK.
THANK YOU SO MUCH.
>> HAPPY SEARCHING, EVERYBODY.
>> A WONDERFUL TALK.
THANK YOU.
>> NEXT IS LEILA SALDANHA,
CURRENTLY SERVES AS PART-TIME
SCIENTIFIC CONSULTANT AT ODS,
PLAYED A LEADERSHIP ROLE IN
CREATING AND SUBJECT MATTER
EXPERT FOR PRODUCT LABEL
DATABASE ABOUT WHAT THESE SHE'S
GOING TO TALK ABOUT.
>> THANK YOU.
LET ME ATTEMPT TO SHARE MY
SLIDES.
>> LOOKS GOOD.
>> OKAY.
YOU CAN SEE MY SCREEN PROPERLY?
>> YES.
>> EXCELLENT.
YOU CAN HEAR ME PROPERLY TOO?
>> YES.
>> OKAY.
GOOD AFTERNOON.
I'M LEILA LEILA SALDANHA.
FINDING INFORMATION ON DIETARY
SUPPLEMENT PRODUCTS.
THIS PRESENTATION REFLECTED MY
VIEWPOINTS AND KNOWLEDGE ABOUT
THE TOPIC, ANY USE OF PRODUCT
NAMES AND PRODUCT LABELS IN THIS
PRESENTATION IS FOR DESCRIPTIVE
PURPOSES ONLY.
AND DOES NOT IMPLY AND
ENDORSEMENT OR RECOMMENDATION OF
THESE PRODUCTS.
MY TALK AS WAS MENTIONED EARLIER
WILL FOCUS ON DIETARY SUPPLEMENT
LABEL DATABASE AND HOW THE
LABELING REGULATION AFFECTS
INFORMATION LISTED IN THE DSLD,
AND AND FEATURES OF DSLS.
IN 2004 CONGRESS ASKED THE
OFFICE TO DEVELOP, CREATE,
REGULARLY UPDATE, MAINTAIN, AND
MAKE AVAILABLE A DATABASE, IT
HAS GONE THROUGH FUNCTIONAL
UPGRADES.
IN 2017 WE DEVELOPED AND
LAUNCHED MOBILE FRIENDLY VERSION
OF THE DSLD.
IN 2021, LAST YEAR, THE DSLD WAS
REDESIGNED AND LAUNCHED AFTER 18
MONTHS OF DEVELOPMENT WORK.
CURRENTLY, THERE ARE OVER
140,000 PRODUCT LABELS IN THE
DATABASE WHICH JOYCE HAS
MENTIONED TO YOU.
SINCE THE LABELS ARE KEPT IN THE
DATABASE THIS NUMBER INCLUDES
LABELS OF PRODUCTS ENTERED ON
MARKET AND HISTORIC LABELS THOSE
ENTERED ON AND AFTER 2011.
YOUR GOAL IS TO MAKE THE DSLD A
SOURCE OF SUPPLEMENT LABEL
INFORMATION FOR RESEARCHERS AND
USERS INTERESTED IN WANTING
INFORMATION ABOUT THESE
PRODUCTS, WHICH IS WHY KEY KEEP
LABELS AFTER PRODUCTS ARE
DISCONTINUED OR REFORMULATED OR
LABELS ARE REVISED TO FOLLOW NEW
LABELING REGULATIONS.
WE MOVE THESE LABELS TO THE OFF
MARKET CATEGORY IN THE DATABASE.
SO THESE ARE SECTIONS OF MY
TALK, SINCE DIETARY SUPPLEMENTS
ARE REGULATED AS FOODS, HOW THIS
OF THEY DIFFER AND AFFECT
INFORMATION IN DSLD, A FEW
SLIDES HOW TO NAVIGATE AND WHAT
TO EXPECT IN THE DSLD.
AND FINALLY USE OF CONVERSION
FACTORS AS RELATES TO LABELING.
YOU HAVE HEARD ABOUT THE
REGULATIONS GOVERNING DIETARY
SUPPLEMENTS, BUT I WILL BE
TALKING ABOUT THEM IN THE
CONTEXT OF TRYING TO APPRECIATE
THE INFORMATION IN THE DSLD
SINCE THE LABEL INFORMATION IN
DSLD IS DERIVED FROM PRODUCT
LABELS.
WHAT INFORMATION CAN YOU EXPECT
IN THE DSLD?
ITS INCLUDES LABELS AS DIETARY
SUPPLEMENTS, CAPTURES ALL THE
INFORMATION PRINTED ON THE
LABELS, ALL INGREDIENT
INFORMATION, AS LISTED WITHIN
THE SUPPLEMENT FACTS.
PANELS, CLAIMS, INFORMATION ON
THE GRAND, IMAGE OF THE PRODUCT
LABEL, YOU CAN SEARCH FOR ANY OF
THE INFORMATION IN THE DSLD.
IT IS IMPORTANT TO KEEP IN MIND
THAT THE NIH AND ODS ARE NOT
REGULATORY AGENCIES, SO WE DO
NOT VERIFY THIS INFORMATION.
SORRY, OR CHECK FOR CONFORMANCE
WITH REGULATION BEFORE IT IS
ENTERED IN THE DATABASE.
SO THOSE OF YOU FAMILIAR WITH
FOOD LABELING WILL RECOGNIZE
THIS IS NOT CURRENT LABEL FOR
CALTRATE.
RATHER THAN REPLACE WITH CURRENT
LABEL I THOUGHT I WOULD USE THIS
LABEL AS A TEACHING MOMENT.
ONE QUICK WAY, IF YOU GO TO THE
GROCERY STORE AND LOOK AT
LABELS, TO TELL WHETHER THIS IS
AN OLD OR REVISED LABEL, TO LOOK
AT THE UNITS USED TO EXPRESS
AMOUNT OF FAT SOLUBLE VITAMIN IF
IT'S LISTED.
ON THIS LABEL THE AMOUNTS ARE IN
IUs.
NEW UNITS ARE IN MICROGRAMS.
THE FOOD LABELING REGULATIONS
WHICH BECAME FINAL IN 2016
REQUIRE THE AMOUNT OF FAT
SOLUBLE VITAMINS BE LISTED IN
MICROGRAMS, I WILL ADDRESS
CONVERSION FACTORS IN LABELING
AT THE END OF MY TALK.
SO WHAT ARE THE SIMILARITIES AND
DIFFERENCES IN LABELING FROM
CONVENTIONAL FOODS?
LIKE FOODS, THERE IS NO
MANDATORY PRODUCT REGISTRATION
REQUIREMENT, OR REQUIREMENT TO
PROVIDE PRODUCT INFORMATION TO
FDA, MANDATORY PRODUCT LISTING.
THERE'S NO OFFICIAL RECORD OF
DIETARY SUPPLEMENT PRODUCTS
MARKETS IN THE U.S.
HOWEVER, THERE ARE MANY
DIFFERENCES, THESE DIFFERENCES
ARE OUTLINED IN THE DIETARY
SUPPLEMENT HEALTH EDUCATION ACT
OF 1994.
SO, SOME OF THE KEY FEATURES OF
DIETARY SUPPLEMENTS RESULTS FROM
THE DSHEA, FOCUSING ON TWO,
DSHEA CREATED A REGULATORY
CATEGORY OF PRODUCTS CALLED
DIETARY SUPPLEMENTS.
AND MORE IMPORTANTLY, AND TO
APPRECIATE THE DIFFERENCE
BETWEEN FOOD AND DIETARY
SUPPLEMENT PRODUCT LABELS, AND
TO APPRECIATE THE INFORMATION IN
THE DSLD, DSHEA ALSO CREATED A
NEW CATEGORY OF INGREDIENTS
CALLED DIETARY INGREDIENTS, AND
IT'S REALLY VERY IMPORTANT TO
UNDERSTAND THIS CONCEPT OF
DIETARY INGREDIENTS, IF YOU DO,
YOU REALLY HAVE, IN MY OPINION,
KNOW THE DIFFERENCE BETWEEN
FOODS AND DIETARY SUPPLEMENTS.
AND WITHIN THIS CATEGORY SIX
CLASSES OF DIETARY INGREDIENTS,
WHICH CAN BE LISTED WITHIN THE
SUPPLEMENT FACT BOX.
THESE DIETARY INGREDIENTS CAN
BE GROUPED INTO THOSE WITH DAILY
VALUES, AS THOSE WITHOUT DAILY
VALUES.
SO FOR LABELING PURPOSES, DAILY
VALUES ARE REFERENCED AMOUNTS OF
NUTRIENTS TO CONSUME OR NOT TO
EXCEED EACH SOMEDAY.
SO, THERE ARE SIX CATEGORIES OF
DIETARY INGREDIENTS, YOU'VE
HEARD ABOUT THE LIST MANY TIMES
TODAY, LISTED WITHIN THE
SUPPLEMENT FACT BOX BUT I DON'T
KNOW IF THIS ONE POINT REALLY
REGISTERED WITH YOU.
BUT THERE ARE ONLY 35 OF THESE
DIETARY INGREDIENTS THAT HAVE
DAILY VALUES.
VITAMINS AND MINERALS IN GREEN
HAVE DAILY VALUES.
THE THIRD AND FOURTH CLASS
HIGHLIGHTED IN THE SLIDE IN
YELLOW, SOME HAVE DAILY VALUES,
AND THE DSLD WILL BE CLASSIFIED
LABELS BY THE PRODUCT TYPE, WE
INCLUDED PRODUCT WITH AMINO ACID
IN ORIGINAL DEFINITION OF A
DIETARY SUPPLEMENT, PROTEIN WAS
NOT INCLUDED WITH AMINO ACIDS.
AND WE INCLUDED IN THE FOURTH
CLASS ALL OTHER NUTRIENTS SUCH
AS FIBER, FAT, CARBOHYDRATES,
THAT ARE NOT LISTED IN THE FIRST
THREE CLASSES.
THAT'S THE WAY WE CLASSIFY
INGREDIENTS IN THE DSLD.
SO, SOME OF THESE NUTRIENTS HAVE
DAILIES, BUT NOT ALL.
THIS IS IMPORTANT TO KNOW.
AND THERE ARE -- THERE'S A DAILY
PROTEIN BUT THERE ARE NO DVs
FOR INDIVIDUAL AMINO ACIDS,
THERE ARE DVs FOR FATS BUT NOT
ALL FATTY ACIDS.
THE FIFTH AND SIXTH CLASS WHICH
HAVE HERBS AND BOTANICALS, AND
THEN CONCENTRATE METABOLITE
CONSTITUENT EXTRACT OR ISOLATES
DO NOT HAVE DAILY VALUES.
TO SIMPLIFY CLASSIFICATION WE
INCLUDED ALL INGREDIENTS THAT
CANNOT BE CLASSIFIED IN THE
FIRST FIVE CLASSES, IN THE
SIXTHS CLASS, IN SHORT WE CALL
THIS THE NON-BOTANICALS AND
NON-NUTRIENTS, SO KEEP IN MIND
THE FIRST FOUR CATEGORIES LISTED
IN THE SLIDE ARE ALL NUTRIENTS,
AND THEN WE HAVE BOTANICALS, THE
FIFTH, AND THEN THE SIXTH IS
ANYTHING THAT'S NOT A BOTANICAL
AND NOT A NUTRIENT.
IF A DIETARY INGREDIENT HAS A
DAILY VALUE IT CAN BE LISTED
WITHIN THE SUPPLEMENT FACTS BUT
NOT WITHIN THE NUTRITION FACT
BOX.
HOWEVER, IF A DIETARY INGREDIENT
DOES NOT HAVE A DAILY VALUE, IT
CANNOT BE LISTED WITHIN THE
NUTRITION FACT BOX.
A GOOD EXAMPLE IS DHA AS SHOWN
IN THE SLIDE.
DHA CURRENTLY CANNOT BE LISTED
WITHIN THE NUTRITION FACT BOX
BECAUSE IT DOES NOT HAVE A DAILY
VALUE.
ANOTHER EXAMPLE IS CAFFEINE.
A THIRD POINT I WANTED TO MAKE
WHICH IS THE DISTINCTION BETWEEN
DIETARY INGREDIENTS WITH AND
WITHOUT DAILY VALUES IS THAT YOU
CAN MAKE STRUCTURAL FUNCTION
CLAIMS FOR ANY DIETARY
INGREDIENT THAT IS LISTED WITHIN
THE SUPPLEMENT FACT BOX, AND
SINCE YOU SEE IN THE LABELS, NOT
FOUND ON FOOD LABELS, AS YOU CAN
SEE ON THE SLIDE YOU WITH MAKE A
STRUCTURE/FUNCTION CLAIM FOR DHA
BUT CANNOT MAKE THIS ON A FOOD
LABEL.
AS IT DOES NOT HAVE A DAILY
VALUE.
NOW, I THINK IT WAS MENTIONED IN
A PRESENTATION YOU CAN MAKE
NUTRIENT CLAIMS STATING WELL
ACCEPTED FUNCTION FOR NUTRIENTS
ON FOOD LABELS, YOU KNOW, THINGS
THAT EVERYBODY EVERYBODY IS
TAUGHT, DRINK MILK FOR YOUR
BONES, AND A DISCLAIMER IS NOT
NEED FOR LIKE THE DISCLAIMER ON
THE SLIDE HERE.
SORRY, MY POINTER IS NOT WORKING
TOO WELL.
YOU'VE READ MANY OF THESE
NUTRIENT FUNCTION CLAIMS ON
CEREAL BOXES.
I WORKED FOR THE KELLOGG COMPANY
FOR TEN YEARS AND HELPED WRITE
AND SUBSTANTIATE THESE.
THE THESE ARE CAPTURED, AND WE
GET THE QUESTION.
THEY ARE NOT CATEGORIZED AS
THERE IS NO OFFICIAL
CATEGORIZATION FOR THESE TYPES
OF CLAIMS.
ANOTHER IMPORTANT DIFFERENCE
BETWEEN INGREDIENTS WITH AND
WITHOUT DAILY VALUES, THIS WAS
MENTIONED IN A PRESENTATION, YOU
CAN LIST DIETARY INGREDIENTS
WITHOUT DAILY VALUES AND
PROPRIETARY BLENDS, BUT YOU
CANNOT LIST INGREDIENTS WITH
DAILY VALUES IN PROPRIETARY
BLENDS.
SO FOR THOSE OF YOU WHO ARE
FAMILIAR WITH THE REGULATIONS,
THESE ARE THE B2 INGREDIENTS
DESCRIBED IN THE B2 SECTION OF
THE REGULATIONS.
THOSE WITHOUT DAILY VALUES ARE
THE B 3 INGREDIENTS, AS THEY ARE
DESCRIBED IN THE B3 SECTION OF
THE REGULATIONS.
SO, WHAT IS THE DIFFERENCE
BETWEEN A BLEND AND A
PROPRIETARY BLEND?
WITH PROPRIETARY BLEND, THE
MANUFACTURER DOES NOT HAVE TO
DECLARE THE AMOUNT OF EACH
COMPONENT WITHIN THE BLEND.
THE LABELS TO YOUR RIGHT, ONLY
THE AMOUNT OF THE BLEND MUST BE
DECLARED.
THIS CONTRASTS WITH THE LABEL TO
YOUR LEFT, WHERE THE AMOUNT OF
THE BLEND AND EACH INDIVIDUAL
INGREDIENT IS DECLARED.
WITH PROPRIETARY BLENDS, THE
AMOUNT OF EACH DIETARY
INGREDIENT WITHIN THE BLEND MUST
BE LISTED IN THE THE DESCENDING
VALUE BY WEIGHT.
THIS IS THE EARLIER SLIDE TO THE
RIGHT OF THE PROPRIETARY BLEND,
WHERE YOU CAN SEE TOTAL AMOUNT
OF THE BLEND IS DECLARED,
THERE'S A LIST OF INGREDIENTS IN
DECLINING ORDER OF PREDOMINANCE
BUT THE WEIGHT OF EACH OF THOSE
INGREDIENTS IS NOT PROVIDED ON
THE LABEL OR DECLARED ON THE
LABEL.
SO, THIS IS IMPORTANT WHEN YOU
SEE THE DSLD.
THIS IS NOT BECAUSE NIH IS
SLOPPY AND THIS IS IMPORTANT TO
KEEP IN MIND.
IF YOU SEE THE VALUES ON THE
DSLD SHOWN FOR CAFFEINE IT'S
BECAUSE THE MANUFACTURER HAS
CHOSEN TO DECLARE CAFFEINE AS A
PROPRIETARY BLEND, AND NOT PRINT
THE AMOUNT OF CAFFEINE ON THE
LABEL.
REMEMBER, THE DSLD IS
INFORMATION DERIVED FROM
INFORMATION PRINTED ON THE
LABELS, SO FOR MAYBE BIOACTIVES
OF INTEREST TO RESEARCHERS,
DEPENDING ON THE BIOACTIVE
BETWEEN 20 TO 70% OF LABELS MAY
NOT LIST THE AMOUNT OF THESE
INGREDIENTS.
SO WHAT ARE THE IMPLICATIONS FOR
RESEARCHERS AND PRACTITIONERS?
A RESEARCHER MAY BE UNABLE TO
ESTIMATE POPULATION INTAKES AND
EXPOSURE AMOUNTS OR INGREDIENTS,
OR PUBLIC HEALTH INTERESTS,
EXAMPLE CATCH EVEN.
PRACTITIONERS MAY BE UNABLE TO
DETERMINE DOSAGE AND INTERACTION
WITH OTHER FOODS OR DRUGS IF
AMOUNTS OF INGREDIENTS ARE NOT
DECLARED ON THE LABEL.
SO IN MY NEXT SET OF SLIDES,
FINALLY, I WILL SHOW YOU THE
FEATURES OF THE DSLD.
ON THIS SLIDE IS A SNAPSHOT OF
THE HOME PAGE.
AS YOU CAN SEE ON THE SLIDE, THE
NUMBER OF LABELS IN THE DATABASE
IS PROMINENTLY DISPLAYED, IF YOU
WORKED WITH THE PREVIOUS SLIDE
THIS IS A NEW FEATURE OF THE
DATABASE THAT WAS LAUNCHED LAST
YEAR.
YOU CAN NAVIGATE DATABASE USING
THE TABS IN THE MENU BOX ABOVE.
IF YOU SCROLL DOWN, YOU WILL
FIND OTHER INFORMATION ABOUT THE
DATABASE, AND INFORMATION ON NEW
FEATURES AND UPDATES.
YOU CAN START YOUR SEARCH FROM
THIS STAGE, I PREFER TO GO TO
THE SEARCH PAGE.
ALL RIGHT.
ON THE SEARCH PAGE IS AN EXAMPLE
FOR A SEARCH FOR IRON.
SO WHEN YOU ENTER IRON IN THE
SEARCH BAR, IT WILL SEARCH FOR
IRON THAT IS PRINTED ANYWHERE ON
THE LABEL.
YOU CAN NARROW YOUR SEARCH USING
THE FILTERS IN THE LEFT-HAND
COLUMN, SIMILAR TO THE COLUMN
YOU WOULD SEE IN PubMed.
AS YOU CAN SEE HERE THE FIRST
THING I DID WAS I NARROWED THE
SEARCH TO PRODUCTS ON MARKET, I
FURTHER NARROWED THE SEARCH TO
PRODUCTS ENTERED BETWEEN 2018
AND 2020.
I FURTHER SELECTED THE TARGET
PREGNANT AND LACTATING WOMEN, I
WAS ONLY INTERESTED IN PRENATAL
SUPPLEMENTS, AND THEN I FURTHER
NARROWED THE SEARCH BY THE
PRODUCT TYPE AND DID NOT INCLUDE
ALL THE PRODUCT TYPES PRENATAL
SUPPLEMENTS COME IN.
AND THIS RESULTED IN 64 LABELS
IN THE DATABASE.
YOU CAN THEN DOWNLOAD THIS
SEARCH, AND THE DSLD GIVES YOU A
VARIETY OF OPTIONS FOR
DOWNLOADING YOUR SEARCH RESULT,
IF YOU'RE A RESEARCHER YOU CAN
GET IT IN XL FORMAT, A COMMA
SEPARATED FILE FORMAT OR JSON
FILE FORMAT.
ONCE YOU CLICK ON THIS BUTTON IT
WILL TAKE YOU TO ANOTHER PAGE,
WHERE IT WILL ALSO GIVE YOU
OPTIONS ON HOW MUCH INFORMATION
YOU REALLY WANT SO YOU CAN
CHOOSE WHAT INFORMATION YOU
WANT.
ON THIS PAGE IS THE INGREDIENTS
PAGE, CHANGED IN THE UPDATED
DATABASE.
SO, WHEN YOU GO TO THE BROWSER
INGREDIENT PAGE AND SEARCH FOR
AN INGREDIENT, UNLIKE THE OLD
SITE WHERE IT TOOK YOU AND GAVE
YOU A LIST OF PRODUCTS, HERE
I'LL SHOW YOU SHORTLY IT DOES
NOT DO THAT.
AND WHAT IT DOES IS WHEN YOU GO
TO THE NEXT WHAT IT TAKES YOU
TO, THIS IS SOME OF THE
INFORMATION THAT JOYCE JUST
SHARED WITH YOU, BUT A DIFFERENT
WAY OF FINDING IT THROUGH THE
DSLD SITE.
SO, STAYING WITH IRON, CLICKING
WITH IRON, THIS INFORMATION
ACTUALLY WORKS IN THE OLD
DATABASE BUT IT WAS BURIED IN
THE DATABASE AND WE THOUGHT THIS
WAS IMPORTANT INFORMATION PEOPLE
WOULD LIKE TO KNOW, A GOOD
STARTING POINT TO HELP YOU WITH
YOUR RESEARCH.
SO MANY THINGS JOYCE TALKED
ABOUT IN HER PRESENTATION, FACT
SHEET, PubMed SEARCHES,
HERE'S ANOTHER WAY TO GET TO IT
BY LOOKING, SEARCHING FOR THE
INGREDIENT.
SO, UNDER THE RESOURCES PAGE,
YOU FIND ALSO OTHER USEFUL
INFORMATION.
I DID WANT TO BRING YOUR
ATTENTION TO THE RELEASE HISTORY
BUTTON.
SO ON THE RELEASE HISTORY, YOU
WILL GET HISTORY OF WHEN THE
DATABASE WAS UPDATED, AND SO THE
NEWEST RELEASE WAS ACTUALLY JUST
TWO WEEKS AGO, PRIOR TO THAT IF
YOU SEARCHED YOU WOULD HAVE
GOTTEN 136,000 LABELS, SO THE
RELEASE WILL GIVE YOU A HISTORY
OF, YOU KNOW, WHAT THE UPDATES
HAVE BEEN -- UPDATES TO THE
DATABASE.
SO, MOVING TO MY LAST TWO SLIDES
ON THE USE OF CONVERSION
FACTORS, AS IT RELATES TO
DIETARY SUPPLEMENT LABEL
DATABASES, LABELS, SORRY, AS YOU
CAN SEE FROM THIS SLIDE THE
UNITS USED FOR EXPRESSING THE
AMOUNT OF NUTRIENTS ON LABELS
HAS CHANGED, AND ESPECIALLY FOR
THE FAT SOLUBLE VITAMINS, GONE
FROM IUs TO MICROGRAMS, AND
FOLATE HAS GONE TO MICROGRAMS TO
DIETARY FOLATE.
SO MY INTENT WITH THIS SLIDE IS
NOT TO TELL YOU WHAT CONVERSION
FACTORS TO USE BUT TO MAKE AN
IMPORTANT POINT ABOUT YOUR
CHOICE OF CONVERSION FACTORS.
USING FOLATE AS AN EXAMPLE, I
WANT TO SHOW YOU DEPENDING WHICH
CONVERSION FACTOR YOU USE, YOU
CAN GET DIFFERENT ANSWERS.
SO THE UNITS FOR EXPRESSING
FOLATE AS I SAID IS NOW DIETARY
FOLATE EQUIVALENCE.
AND THE FOOD AND NUTRITION BOARD
AND THEIR REFERENCE INTAKE
PUBLICATION FOR B VITAMINS GIVES
TWO FORMULAS, MULTIPLYING BY 1.7
OR IF THE PRODUCT IS CONSUMED
WITH FOOD YOU DIVIDE BY .6, IF
IT IS TAKEN ON EMPTY STOMACH YOU
DIVIDE BY .5.
SO, YOU CAN GET VERY DIFFERENT
ANSWERS, DEPENDING ON WHICH
FORMULA YOU USE TO CONVERT THE
800 MICROGRAMS OF FOLIC ACID
WHICH IS A TYPICAL AMOUNT FOUND
IN PRENATAL SUPPLEMENTS TO THE
NEW AMOUNT AS DIETARY FOLATE
EQUIVALENCE.
SO FOR LABELING PURPOSES, THE
FDA HAS A GUIDANCE DOCUMENT AND
IT'S A REALLY EXCELLENT GUIDANCE
DOCUMENT THAT I'M CURRENTLY
SEEING NOT ONLY GIVING YOU
CONVERGENCE FACTORS, FDA
SELECTED 1.7, BUT WALK YOU
THROUGH HOW TO DO THE
CALCULATION.
IF FOR LABELING PURPOSES, PLEASE
USE THE FDA GUIDANCE DOCUMENT.
IF IT'S FOR RESEARCH PURPOSES,
USE WHICH EVER CONVERSION FACTOR
IS COMMON FOR THAT PUBLICATION,
BUT FOR SITE FOR REFERENCE WHAT
YOU USED AND WHY.
MY TAKEAWAYS, ONE, DIETARY
SUPPLEMENTS ARE FOOD, DSHEA
CREATED A NEW CLASS OF
INGREDIENTS CALLED DIETARY
INGREDIENTS.
SINCE THE DSLD CONTAINS
INFORMATION PRINTED ON LABELS,
THIS AFFECT WHAT IS IS IN THE
DSLD.
REGARDING DIETARY INGREDIENTS,
MOST DO NOT HAVE DAILY VALUES.
YOU CAN MAKE STATEMENTS OF
NUTRITIONAL SUPPORT FOR ANY
DIETARY INGREDIENT DECLARED
WITHIN THE SUPPLEMENT FACT BOX.
AND YOU CAN DECLARE DIETARY
INGREDIENTS THAT DO NOT HAVE
DAILY VALUES AS PROPRIETARY
BLENDS.
HOW DOES THIS IMPACT THE DSLD?
IF AN INGREDIENT IS LISTED
WITHIN A PROPRIETARY BLEND, YOU
WILL FIND BLANK AMOUNT IN THE
DSLD.
AND WE DO NOT CATEGORIZE THE
CLAIMS BASED ON -- SORRY, DO NOT
CATEGORIZE PRODUCTS BASED ON
INTENDED USE BECAUSE THERE IS NO
CATEGORIZATION SCHEME FOR
CLAIMS.
AND THIS IS VERY IMPORTANT
BECAUSE WE KEEP GETTING ASKED,
YOU KNOW, IS THERE A SEARCH FOR
INTENDED USE AND THERE IS NOT OF
NO SEARCH FOR INTENDED USE.
THANK YOU FOR LISTENING.
ONE LAST SHAMELESS SLIDE.
I'M SORRY.
IF YOU'RE REGISTERED TO ATTEND
NUTRITION 2022, I ENCOURAGE YOU
TO LISTEN TO OUR SESSION ON
PROPRIETARY BLENDS.
WE HAVE TWO EXCELLENT PANELISTS
AT THE SESSION, THAT WILL
PROVIDE YOU WITH REGULATORY AND
INDUSTRY PERSPECTIVE ON BLENDS.
THANK YOU VERY MUCH.
I'M GOING TO SHOP SHARING.
AND ARE WE BACK TO -- I STOPPED
SHARING.
ARE WE BACK?
OKAY, GREAT.
>> YES.
OKAY.
SO, I THINK THIS QUESTION MIGHT
BE A LITTLE OUT OF SCOPE BUT I
WILL ASK.
IT SAID, OF THE NINE AMINO ACIDS
NOT SYNTHESIZED AND ARE
THEREFORE ESSENTIAL, OR
INDISPENSABLE NUTRIENTS, WHY
DON'T THEY HAVE A DV?
>> WELL, THE DAILY -- SO, THE
WAY FDA ARRIVES AT THE DAILY
VALUES, THE BOARD ARRIVED AT THE
DIETARY REFERENCE INTAKE.
THE FDA DOESN'T REALLY ARRIVE AT
DV IF IT HAS NOT BEEN ARRIVED AT
BY THE FOOD AND NUTRITION BOARD,
AND IF THE FOOD AND NUTRITION
BOARD DOES NOT HAVE A DIETARY
REFERENCE INTAKE OR ANY
NUTRIENTS, THERE IS NO DV.
SO THE CONCEPT OF DV IS DERIVED
FROM THE DRIs THAT THE FOOD
AND NUTRITION BOARD PUBLISHES.
DOES THAT HELP?
>> YES, I THINK SO.
IT SAYS THAT I THINK YOU
ANSWERED DIFFERENCE BETWEEN RDI
AND DV.
>> THE DV IS THE -- THE WAY THE
DV IS DERIVED IS IT'S ONLY --
THERE ARE ONLY FOUR DVs, FOR
OF AGES 4 AND ABOVE, FOR
INFANTS, PREGNANT AND LACTATING
WOMEN, FOR CHILDREN 1-4.
IF YOU GO TO THE DRI TABLES
YOU'LL SEE THAT THERE ARE A LOT
MORE AGE, GENDER GROUPS, IN THE
DRI TABLES.
WHAT THE FDA DOES IS SELECT, THE
HIGHEST AMOUNT WITHIN EACH OF
THOSE GROUPS, TO ARRIVE AT THE
DV.
>> GREAT.
THANK YOU.
AND THE QUESTIONER HAS ANOTHER
QUESTION RELATED, HE SEEMS TO BE
UNDER THE IMPRESSION YOU SAID
THAT ONE OF THE AMINO ACIDS DOES
HAVE A DV?
>> ONE OF THE AMINO ACIDS DOES
HAVE A DV?
NO AMINO ACID, TO THE BEST OF MY
KNOWLEDGE HAS A DRI.
AND THEREFORE IT CANNOT HAVE A
DV.
>> RIGHT, YEAH, I THINK THAT WAS
THE MISUNDERSTANDING.
OKAY.
I HAVE A QUESTION ABOUT THE
DSLD.
WHEN YOU'RE DOING A SEARCH, AND
YOU LIMIT IT BY YEARS, AS YOU
DID, SAY 2018 TO 2020, AND THEN
YOU SAY, ON MARKET, DOES THAT
MEAN YOU ONLY WANT SEARCH
RESULTS THAT THE PRODUCT WAS ON
MARKET DURING THOSE YEARS?
OR DOES IT HAVE TO BE ON MARKET
AT THE TIME OF THE SEARCH?
IT MAY HAVE BEEN ON MARKET AT
THE TIME BUT NOW IT'S NOT ON
MARKET.
>> SO, IT'S IMPORTANT TO
UNDERSTAND THE CONCEPT OF ON
MARKET AND OFF MARKET IN THE
DSLD.
SO, WHEN -- SO THERAPEUTIC
RESEARCH CENTER, AN ORGANIZATION
THAT JOYCE MENTIONED IN HER
PRESENTATION, HAS THE ODS
CONTRACT FOR SECURING LABELS,
CODING LABELS THAT ARE ENTERED
IN THE DATABASE.
ASSOCIATES HAS A CONTRACT FOR
DESIGN AND SEARCH AND FEATURES
OF THE DSLD.
WHEN THEY RECEIVE THE LABELS,
THEY ENTER IT IN THE DATABASE,
AND WHEN THEY RECEIVE
INFORMATION THAT THESE LABELS
ARE NO LONGER BEING -- NO LONGER
IN THE MARKETPLACE THEY TAKE
THEM OFF MARKET.
SO THIS ON MARKET/OFF MARKET IS
BASED ON THE CODING OF WHEN THE
LABELS WERE ENTERED AND ENTERED
INTO THE DATABASE, AND WHEN THEY
WERE TAKEN OUT.
SO WHEN I CHOSE LIKE 2018 TO
2020, AS MY SEARCH FOR IRON, FOR
EXAMPLE, AND I SEARCHED FOR
LABELS ON MARKET, DURING THOSE
YEARS THOSE LABELS WERE ON
MARKET.
>> OKAY.
>> IN 2021 SOME COULD HAVE BEEN
TAKEN OFF MARKET.
>> RIGHT.
BUT THEY WOULD STILL COME UP IN
SEARCH RESULTS.
>> IN 2021, NO, BECAUSE I WROTE
MY SEARCH FOR 2018 AND 2020,
WHICH MEANS I DID NOT INCLUDE
ANY LABELS BEFORE 2018 AND AFTER
2020.
>> RIGHT.
OKAY.
GREAT.
AND ANOTHER QUESTION COMING IN.
SAYS THE DSLD ALSO HAS
CONVERSION FACTORS FOR THE
NUTRIENT AMOUNTS IN THEIR
SEGREGATED LABELS?
I'M NOT SURE I --
>> I DON'T KNOW WHAT --
>> I'M NOT SURE I UNDERSTAND
THAT QUESTION.
JAMES, CAN WE UNMUTE SABA, OR HE
OR SHE CAN ASK THE QUESTION?
I THINK IT APPEARS IN THE CHAT.
YEAH.
ALSO HAVE CONVERSION FACTORS FOR
THE NUTRIENT AMOUNTS?
IN THEIR SEGREGATED LABELS.
>> OH, YOU MEAN IF IT'S IN
GRAMS, CAN YOU CONVERT TO
MICROGRAMS, ARE THEY TALKING
ABOUT CONVERTING THE WEIGHTS?
>> YES.
>> WE DID HAVE ONE FEATURE THAT
WE DISABLED, BECAUSE IT STARTED
TO GET VERY COMPLICATED, WHICH
WAS CONVERTING FROM THE OLD
UNITS OF DECLARATION TO NEW
UNITS.
AND IT BECAME VERY COMPLICATED
THAT VITAMIN A, WHICH IS WHY I
DIDN'T GO INTO ALL THE
CONVERSION FACTORS, BECAUSE
THE -- WITH CONVERSION FACTORS
IT ISN'T LIKE I SHOWED WITH
FOLATE OF COURSE, WITH FOLATE
THERE'S ONLY ONE 1.7, WITH
VITAMIN A THERE ARE A NUMBER OF
CONVERSION FACTORS, DEPENDING ON
THE FORM OF THE VITAMIN A.
AND IF THE FORM IS NOT REALLY
PROVIDED ON THE LABEL, IT
BECOMES DIFFICULT TO CONVERT AND
WE WERE SPENDING A LOT OF TIME
TRYING TO MAKE SURE WE WERE
ACCURATELY CONVERT WE GO DECIDED
WE WEREN'T GOING TO DO THAT AND
STOPPED DOING IT FOR ALL THE
NUTRIENTS.
AND BY NEXT YEAR, ACTUALLY BY
THIS YEAR, HOPEFULLY ALL THE
LABELS ON THE MARKET SHOULD
ACTUALLY BE HAVING THE NEW UNITS
BECAUSE ALL COMPANIES HAD TO BE
IN COMPLIANCE BY JANUARY OF LAST
YEAR, WHICH IS 2021.
AND WE'RE WELL INTO 2022 NOW.
SO, HOPEFULLY MOST OF THE LABELS
ON THE MARKETPLACE HAVE THE NEW
UNITS.
>> GREAT.
THANK YOU.
>> JAMES IS ASKING WHO HE SHOULD
UNMUTE.
>> YEAH, I ANSWERED HIM AND SAID
NEVER MIND, I THINK WE'VE GOT
IT.
SHE CLARIFIED IN THE CHAT.
>> OKAY.
OKAY.
>> I CAN ASK IF HER -- OR HE.
SABA, WOULD YOU LIKE TO ASK DR.
SALDANHA ANY QUESTIONS?
IF SO, WOULD YOU LIKE TO BE
UNMUTED?
SHE.
OKAY, SABA, WOULD YOU LIKE TO BE
UNMUTED?
NO?
IT'S CLEAR.
THANK YOU VERY MUCH.
YOU ANSWERED QUESTION.
DO WE HAVE ANY MORE QUESTIONS?
PLEASE PUT THEM IN THE Q&A, IF
SO.
GOING ONCE ...
GOING TWICE ...
OKAY.
WELL, THEN I GUESS THANK YOU
VERY MUCH, LEILA, A GREAT
PRESENTATION.
>> THANK YOU.
>> DO I TURN IT BACK OVER TO
YOU, JAIME?
>> YES.
THANK YOU, KAREN.
THANK YOU LEILA AND JOYCE.
THIS CONCLUDES THE FIRST DAY OF
THE PRACTICUM.
A BIG THANKS TO ALL THE SPEAKERS
AND MODERATORS.
AND JAMES TOO FOR RUNNING THE
WEBEX TODAY.
WE HAVE SOME GREAT SESSIONS
LINED UP FOR TOMORROW.
A SESSION ON RIGOR AND
REPRODUCIBILITY.
EFFICACY AND SAFETY.
AND THEN A FEW PRESENTATIONS,
ONE IS ON NUTRITION, GRANT
FUNDING AT NIH, THAT MAY BE OF
INTEREST TO MANY OF YOU.
WE START TOMORROW AT 11:00 A.M.,
EASTERN TIME.
PLEASE HAVE A GREAT EVENING.
THANK YOU AGAIN.
THANK YOU.