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Transcript of LIVE INTERACTIVE LEARNING @ YOUR DESKTOP Tuesday, April 28, 2009 FDA: Teaching Science Concepts and...
LIVE INTERACTIVE LEARNING @ YOUR DESKTOP
Tuesday, April 28, 2009
FDA: Teaching Science Concepts and Inquiry with Food
Dietary Supplements
Dr. Kenneth Taylor
Broad Responsibilities
Varied ProductsCommon food and food ingredientsComplex medical & surgical devicesTherapeutic pharmaceuticalsRadiation-emitting consumer and medical products
Varied Regulatory ApproachesReview of safety and efficacy for new drugs and
medical devicesPerformance standards for x-ray machines &
microwave ovensNo prior approval for cosmetics and dietary
supplements
Broad Responsibilities
Where do you think FDA offices are located?
Use clip art to show the location.
Pause Two Minutes for Pause Two Minutes for QuestionsQuestions
Dietary Supplement Health and Education Act of 1994
(DSHEA)
Public Law 103-417
Signed into law October 25, 1994
Congressional Record at 108 Stat. 4325
Intent of CongressIntent of Congress
Limit impediments to marketing Limit impediments to marketing and promotion of dietary and promotion of dietary supplementssupplements
Promote availability of Promote availability of supplements to consumers to supplements to consumers to improve healthimprove health
Promote disseminating Promote disseminating informationinformation
DSHEA Poll QuestionDSHEA Poll Question
Under DSHEA were Under DSHEA were supplements exempted from supplements exempted from regulation?regulation?
Yes Yes NoNo
What DSHEA Didn’t DoWhat DSHEA Didn’t Do
Changed way we regulate Changed way we regulate supplementssupplements
Did not exempt supplements Did not exempt supplements from regulationfrom regulation
Did not limit FDA’s ability for Did not limit FDA’s ability for enforcementenforcement
Did not undermine integrity of Did not undermine integrity of drug development incentivesdrug development incentives
Dietary Supplements Overview
General regulatory framework
Claims
General safety
Interpreting DSHEAInterpreting DSHEA
No legislative historyNo legislative history
Plain language of the statutePlain language of the statute
Statement of AgreementStatement of Agreement
Congressional FindingsCongressional Findings
Balance Congressional intent and Balance Congressional intent and consumer protectionconsumer protection
What is a dietary What is a dietary supplement?supplement?
1)
2)
Please Raise your hand to volunteer
What is a dietary What is a dietary supplement?supplement?
“…“…a product (other than tobacco) a product (other than tobacco) intended to supplement the dietintended to supplement the diet that that bears or contains one or more” bears or contains one or more” designated ingredientsdesignated ingredients
21 U.S.C. 321(ff)(1)21 U.S.C. 321(ff)(1)
““Intended to supplement the diet”Intended to supplement the diet”
DietDiet: “usual food or drink of man”: “usual food or drink of man”
SupplementSupplement: “augment diet to : “augment diet to promote health and reduce risk of promote health and reduce risk of disease”disease”
Dietary IngredientsDietary Ingredients
Vitamin, Mineral, Amino acidVitamin, Mineral, Amino acid
Not limited to “nutritionally recognized”Not limited to “nutritionally recognized”
Herb or other botanicalHerb or other botanical
Any part of a plantAny part of a plant
Dietary substanceDietary substance for for use by manuse by man to to supplement the diet by increasing the total supplement the diet by increasing the total dietary intakedietary intake
Concentrate, metabolite, constituent, extract, Concentrate, metabolite, constituent, extract, or combination of any ingredient aboveor combination of any ingredient above
321(ff)(1)21 U.S.C.321(ff)(1)21 U.S.C.
““Dietary substance for Dietary substance for use by man”use by man”
““of or pertaining to the diet” and of or pertaining to the diet” and “usual food or drink of man”“usual food or drink of man”
Mere presence in the diet does Mere presence in the diet does not confer status as “dietary not confer status as “dietary substance”substance”
Not include harmful substancesNot include harmful substancesFor use in diet of For use in diet of manman
Other RequirementsOther Requirements
A product that is intended for ingestionA product that is intended for ingestion
Pill, capsule, liquid, powder, “other”Pill, capsule, liquid, powder, “other”
Not Not represented for use as represented for use as conventional foodconventional food
Delivery system may resemble Delivery system may resemble conventional food formsconventional food forms
Not a sole item of a meal or dietNot a sole item of a meal or diet
Labeled a “dietary supplement”Labeled a “dietary supplement”21 U.S.C. 321(ff)(2)21 U.S.C. 321(ff)(2)
In the previous slide, the In the previous slide, the word “ingestion” refers to word “ingestion” refers to any route taken into the any route taken into the body.body.
Yes Yes NoNo
““Intended for ingestion”Intended for ingestion”
Ordinary and plain meaning of Ordinary and plain meaning of “ingestion”“ingestion”
Take into the stomach and Take into the stomach and gastrointestinal tract gastrointestinal tract
US v. Ten Cartons, Ener-B Nasal GelUS v. Ten Cartons, Ener-B Nasal Gel, , 888 F. Supp. 381, 393-94 888 F. Supp. 381, 393-94 (E.D.N.Y.), aff’d, 72 F.3d 285 (2d (E.D.N.Y.), aff’d, 72 F.3d 285 (2d Cir. 1995)Cir. 1995)
““Represented as conventional food”Represented as conventional food”
Think “how is it to be used” or Think “how is it to be used” or “what is it a substitute for”“what is it a substitute for”
named a snack or uses another named a snack or uses another common or usual food namecommon or usual food name
uses a standardized food nameuses a standardized food name
uses label uses label representations/pictures that representations/pictures that suggest conventional food usessuggest conventional food uses
““Represented as conventional food” Represented as conventional food” - Examples- Examples
““Supplement soups”Supplement soups”
(Jun. 21, 1999 ltr., Hain Food Group)(Jun. 21, 1999 ltr., Hain Food Group)
““Cereals”Cereals”
(Jun. 5, 2001 WL, US Mills, Inc.)(Jun. 5, 2001 WL, US Mills, Inc.)
Chewing gumChewing gum
Bottled waterBottled water
(Jun. 7, 2001 ltr., Better Health Labs)(Jun. 7, 2001 ltr., Better Health Labs)
Beverages/Drinks?Beverages/Drinks?
Drug Exclusion ClauseDrug Exclusion Clause
Does not include Does not include an articlean article that is an: that is an:approved new drug, antibiotic, or biologicapproved new drug, antibiotic, or biologicauthorized investigational new drug, antibiotic, or authorized investigational new drug, antibiotic, or biologicbiologic
UNLESS “UNLESS “MarketedMarketed as a dietary supplement or as a dietary supplement or as a food before such approval or authorization”as a food before such approval or authorization”
Relevant to OTCs with an approved NDA or IND Relevant to OTCs with an approved NDA or IND under 21 U.S.C 351under 21 U.S.C 35121 U.S.C. 321(ff)(3)21 U.S.C. 321(ff)(3)
Pharmanex, Inc. v. Shalala, No. 2:97CV262K, 2001 WL Pharmanex, Inc. v. Shalala, No. 2:97CV262K, 2001 WL 741419 (D. Utah, Mar. 30, 2001)741419 (D. Utah, Mar. 30, 2001)
Pause Two Minutes for Pause Two Minutes for QuestionsQuestions
New Dietary Ingredients (NDIs)New Dietary Ingredients (NDIs)
Those that were not marketed as a dietary Those that were not marketed as a dietary supplement or a food prior to Oct. 15, 1994supplement or a food prior to Oct. 15, 1994
FDA notification required before introducing FDA notification required before introducing a product with an NDIa product with an NDI
21 C.F.R § 190.621 C.F.R § 190.6
No authoritative list of “old” dietary No authoritative list of “old” dietary ingredients ingredients
21 U.S.C. 350(b)21 U.S.C. 350(b)
New Dietary Ingredients New Dietary Ingredients (NDIs)(NDIs)
The dietary supplement contains only dietary The dietary supplement contains only dietary ingredients that have been present in the ingredients that have been present in the food supply as an “article used for food” in a food supply as an “article used for food” in a form in which the food has not been form in which the food has not been chemically alteredchemically altered
““food" means (1) articles used for food or food" means (1) articles used for food or drink for man or other animals, (2) chewing drink for man or other animals, (2) chewing gum, and (3) articles used for components gum, and (3) articles used for components of any such article. [21 U.S.C. 321 (f)]of any such article. [21 U.S.C. 321 (f)]““chemically altered” – look to chemically altered” – look to Congressional RecordCongressional Record
21 U.S.C. 350b (a)(1)21 U.S.C. 350b (a)(1)
New Dietary Ingredients New Dietary Ingredients (NDIs)(NDIs)
The manufacturer or distributor The manufacturer or distributor submits asubmits a premarket notificationpremarket notification to to FDA that contains history of use or FDA that contains history of use or other evidence of safety other evidence of safety establishing that the NDIestablishing that the NDI “will “will reasonably be expected to be reasonably be expected to be safe”safe” when used as when used as recommended/ suggested in the recommended/ suggested in the product’s labelingproduct’s labeling
21 U.S.C. 350b (a)(2)21 U.S.C. 350b (a)(2)
Dietary Supplement ClaimsDietary Supplement Claims
Structure/Function ClaimsStructure/Function Claims
Health ClaimsHealth Claims
Significant Scientific AgreementSignificant Scientific Agreement
Qualified Health ClaimsQualified Health Claims
DiseaseDiseaseDrug: article intended to treat, cure, Drug: article intended to treat, cure, prevent, mitigate or diagnose a diseaseprevent, mitigate or diagnose a diseaseDisease or Health-Related ConditionDisease or Health-Related Condition““Damage to an organ, part, structure, or Damage to an organ, part, structure, or system of the body such that it does not system of the body such that it does not function properly (e.g. Coronary heart function properly (e.g. Coronary heart disease, or a state of health leading to disease, or a state of health leading to such dysfunctioning (e.g. hypertension)” such dysfunctioning (e.g. hypertension)”
(21 CFR 101.14(a)(5))/21 CFR 101.93(g)(1)(21 CFR 101.14(a)(5))/21 CFR 101.93(g)(1)
““Dietary Supplement Dietary Supplement Claims”Claims”
DSHEA (1994) DSHEA (1994)
Classical nutrient deficiency diseaseClassical nutrient deficiency disease
Effect on Structure or function of the Effect on Structure or function of the bodybody
Mechanism of effect on Mechanism of effect on structure/functionstructure/function
General well-beingGeneral well-being[21 U.S.C. 343 (r)(6)][21 U.S.C. 343 (r)(6)]
STRUCTURE/FUNCTION STRUCTURE/FUNCTION REGULATIONREGULATION
January 6, 2000 Federal Register January 6, 2000 Federal Register (65 FR 1000) [21 CFR §101.93](65 FR 1000) [21 CFR §101.93]
Not limited to serious diseasesNot limited to serious diseasesAct doesn’t distinguish minor vs. Act doesn’t distinguish minor vs. serious conditionsserious conditions
Congress was silent on this Congress was silent on this mattermatter
Caveat for Use of the Rule to Caveat for Use of the Rule to Define Disease ClaimsDefine Disease Claims
Context is Context is CRITICALCRITICAL
A disease claim may be explicit or implicitA disease claim may be explicit or implicit
Not always possible to have absolute Not always possible to have absolute distinctions between disease and non-distinctions between disease and non-disease claimsdisease claims
Need to consider all information in labeling Need to consider all information in labeling and elsewhereand elsewhere
Few claims are likely to be always or never Few claims are likely to be always or never appropriateappropriate
Please Match the Expressed Disease with the Implicit Claim by using clip art.
Arthritis Arthritis Cancer Cancer BPH BPH Fibromyalgia Fibromyalgia
For individuals experiencing constant muscle ache and stiffness, fatigue, and sleeping problems
Alleviates frequent urinating in older men
Alleviates degeneration of discs and joints; Reduces joint pain and inflammation
Prevent spread of neoplastic cells
Disease Claims Define the Disease Claims Define the ProductProduct
ExpressedExpressed ImplicitImplicitArthritis inflammationArthritis inflammation Alleviates degeneration of Alleviates degeneration of
discs and joints; Reduces discs and joints; Reduces joint pain joint pain
Cancer Cancer Prevent spread of Prevent spread of neoplastic neoplastic cellscells
BPHBPH Alleviates frequent urinating Alleviates frequent urinating in in older menolder men
FibromyalgiaFibromyalgia For individuals experiencing For individuals experiencing constant muscle ache and constant muscle ache and stiffness, fatigue, and stiffness, fatigue, and
sleeping sleeping problemsproblems
Disease Claims Define the Disease Claims Define the ProductProduct
DiseaseDisease Structure/FunctionStructure/FunctionAlternative to prozacAlternative to prozac Alternative to anabolic steroidsAlternative to anabolic steroidsHelp insulin maintain blood sugarHelp insulin maintain blood sugar Replace potassium losses Replace potassium losses
associated with diuretic drugsassociated with diuretic drugsHelps statin drugs lower cholesterolHelps statin drugs lower cholesterol Maintains normal blood Maintains normal blood
cholesterolcholesterolReduces pain and inflammationReduces pain and inflammation Maintains joint health and Maintains joint health and
comfortcomfortToxemia in pregnancyToxemia in pregnancy Alleviates ordinary morning Alleviates ordinary morning
sickness associated with sickness associated with pregnancy pregnancy
Supports antiviral responseSupports antiviral response Supports the immune systemSupports the immune system
Antibiotic; AnalgesicAntibiotic; Analgesic Energizer, adaptogenEnergizer, adaptogen
Alleviates colon ulcers for individualsAlleviates colon ulcers for individuals SSupports healthy colon functionupports healthy colon functiontaking doxorubicintaking doxorubicin
Pause Two Minutes for Pause Two Minutes for QuestionsQuestions
Dietary Supplement ClaimsDietary Supplement ClaimsNLEA Health Claims (1990)NLEA Health Claims (1990)
Characterize the Characterize the relationshiprelationship between the presence between the presence or level of a or level of a substancesubstance and a and a disease or health-disease or health-related conditionrelated condition
Claim or elements may be explicit or implicitClaim or elements may be explicit or implicit
New claims established by petition and rule making. New claims established by petition and rule making. Significant Scientific Agreement validity standard Significant Scientific Agreement validity standard appliesapplies
[21 U.S.C. 343 (r)(1) – r(5)][21 U.S.C. 343 (r)(1) – r(5)]
Dietary Supplement ClaimsDietary Supplement Claims
Health Claims (Continued)Health Claims (Continued)
Required Minimum Nutrient ContentRequired Minimum Nutrient Content
10% DV/serving of vitamins A & 10% DV/serving of vitamins A & C, calcium, iron, protein, fiberC, calcium, iron, protein, fiber
14 authorized SSA health claims14 authorized SSA health claims
[21 U.S.C. 343 (r)(1) – (5)][21 U.S.C. 343 (r)(1) – (5)]
Dietary Supplement ClaimsDietary Supplement ClaimsQUALIFIED HEALTH CLAIMSQUALIFIED HEALTH CLAIMS
Do not meet the SSA validity standardDo not meet the SSA validity standard8 authorized qualified health claims8 authorized qualified health claims
Selenium and cancerSelenium and cancerAntioxidant vitamins and cancerAntioxidant vitamins and cancerNuts and heart diseaseNuts and heart diseaseWalnuts and heart diseaseWalnuts and heart diseaseOmega-3 fatty acids and heart diseaseOmega-3 fatty acids and heart diseaseB vitamins and vascular diseaseB vitamins and vascular diseasePhosphatidylserine and dementiaPhosphatidylserine and dementia0.8 mg Folic acid and birth defects0.8 mg Folic acid and birth defects
Amendment for SafetyAmendment for Safety
A dietary supplement is adulterated if:A dietary supplement is adulterated if:Presents unreasonable risk of illness or injuryPresents unreasonable risk of illness or injury
conditions of use recommended or suggestedconditions of use recommended or suggested
Inadequate information for assurance of safety for new Inadequate information for assurance of safety for new dietary ingredientsdietary ingredients
Secretary declares to pose an imminent hazardSecretary declares to pose an imminent hazard
Contains a dietary ingredient that is poisonous or Contains a dietary ingredient that is poisonous or deleteriousdeleterious
21 U.S.C. 342(f)(1)21 U.S.C. 342(f)(1)
Amendment for SafetyAmendment for Safety
FDA shall bear the burden proof to show FDA shall bear the burden proof to show that a dietary supplement is adulteratedthat a dietary supplement is adulterated
21 U.S.C. 342(f)(1)21 U.S.C. 342(f)(1)
Amendment for SafetyAmendment for Safety
Ephedrine Alkaloids (February 11, 2004 Federal Ephedrine Alkaloids (February 11, 2004 Federal Register; 69 FR 6787) Register; 69 FR 6787)
Adulteration determination based on:Adulteration determination based on:
evidence on ephedrine pharmacologyevidence on ephedrine pharmacology
peer-reviewed scientific literature on ephedrine peer-reviewed scientific literature on ephedrine safety and effectivenesssafety and effectiveness
adverse event reportsadverse event reports
seminal report by an independent instituteseminal report by an independent institute
public comment on ephedrine-associated health public comment on ephedrine-associated health risks. risks.
SummarySummaryDSHEA remains a dynamic law subject to interpretationDSHEA remains a dynamic law subject to interpretationFDA’s implementation intended to balance Congress’ FDA’s implementation intended to balance Congress’ intent and consumer protectionintent and consumer protectionNo legislative historyNo legislative history
Plain language of the statutePlain language of the statuteStatement of AgreementStatement of AgreementCongressional FindingsCongressional FindingsInterpretation of Court Decisions and relevant case Interpretation of Court Decisions and relevant case lawlaw
November 9, 2004 Implementation and Enforcement November 9, 2004 Implementation and Enforcement Strategy (69 FR 64957) Strategy (69 FR 64957) (http://www.fda.gov/bbs/topics/news/2004/NEW01130.h(http://www.fda.gov/bbs/topics/news/2004/NEW01130.html)tml)
Office of Nutrition, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition
5100 Paint Branch ParkwayCollege Park, MD 20740-3835
(301)436-2375(301)436-2639 (fax)
Kenneth M.P. Taylor, Ph.D.
http://www.elluminate.com
http://learningcenter.nsta.org
National Science Teachers AssociationDr. Francis Q. Eberle, Executive Director
Zipporah Miller, Associate Executive Director Conferences and Programs
Al Byers, Assistant Executive Director e-Learning
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