Janet McDonald, Ph.D., R.D.
Regulation of Food & DietarySupplements
Today’s Topics
•Introduction to the legalauthority
•General requirements for foodand dietary supplements
•Structure/function claims
•Boundaries
FDA’s Legal Authority
•Federal Food, Drug, andCosmetic Act
•Fair Packaging and LabelingAct
Dietary Supplements
•Nutrition Labeling and EducationAct (NLEA)
•Dietary Supplement Health andEducation Act (DSHEA)
Interpretation of the Statute
•Code of Federal Regulations
•Guidance documents
•Case law
•Informal guidance
What is Food ?
“...articles used for food or drink forman…chewing gum…and articlesused for components of...” food ordrink or chewing gum
What is a food additive?
•Broad sense: Any substance added tofood.
•Legally: “Any substance the intended useof which results or may reasonably beexpected to result- directly or indirectly -in its becoming a component or otherwiseaffecting the characteristics of any food.”
–Direct additives
–Indirect additives
What is GRAS?
•Substances whose use is generallyrecognized as safe, based on theirextensive history of use in food before1958, or based on published scientificevidence.
•Not set in concrete!
What is a Drug ?
“…article intended for use in thediagnosis, cure, mitigation,treatment, or prevention ofdisease…”
What is a dietary supplement ?
“…a product (other than tobacco)intended to supplement the dietthat bears or contains one ormore” designated ingredients
What is a dietary supplement ?
•Vitamin, mineral, amino acid
•Herb or other botanical
•Dietary substance for use by manto supplement the diet byincreasing the total dietary intake
What is a dietary supplement ?
•Concentrate, metabolite,constituent, or combination ofthe ingredients above
What is a dietary supplement ?
•Intended for ingestion
•Pill, capsule, liquid, powder, “other”
•Not represented for use asconventional food
•Not sole item of meal or diet
•Labeled as a dietary supplement
Messages…..
•Definitions and Regulatory “Boxes”
•….And that they matter
•What to “think about” at this evolving point
Dietary SupplementComplianceBoundariesBoundariesFoodDietary SupplementDrug
Which Regulatory Box IsImportant Because…..
•Different legal requirements
•Different safety considerations
•Different substantiation for claims
Dietary Supplement or Food ?
Dietary Supplement or Food ?
Food Dietary Supplement
Represented for use as conventional food
•Safe ingredients
•Claims
•Labeling
What is “Functional Food?”
It is undefined but regulatedas food
“Functional Food?”
“Functional Food?”
“Functional Food” Claims
Structure/function claims
Truthful
Non-misleading
Based on nutritive value
No drug claims
“Functional Food” Claims
Disease claims - Drug
• Dietary support during thecold and flu season
• Prevents the onset of diseasecomplications
Dietary Supplement Drug
Structure/function claims
• 30-day post-market notification for structure/function claim
• Use of “disclaimer”
• Manufacturer is responsible for substantiation
30-Day Notification
Disease claims - Drug
• Reduces cholesterol
• Reduces fever
• Helps promote normal body functionafter taking too much drink
30-Day Notification
Structure/function claim
• Gingko biloba promotes healthy brainfunction
• Guar gum promotes healthy intestinal function
• Helps maintain cholesterol levels in normalrange
The Key to Almost EverythingIs……….
Intended Use
(claims)
Intended Use Gets You into TwoPossible Boxes…. initially
Functional Food
Drugs
Prescription
OTC
Foods
Conv Foods
Dietary
Supplements
?
More on This Perspective
•Functional Foods
-------> Assumption: probably about foods
•Dietary supplements are intended tosupplement the diet
What’s the Difference?
•Conv Foods versus Dietary Supplements
–Safety Standard
•Conv Food: GRAS/Food Additive
•Dietary Supplm: Signif-Unreasonable Risk
–Claim topic / substantiation
•Disease endpoint / Same: Rigorous--Pre-review
•Non-disease endpoint / Essentially Same*
=Truthful/Not Misleading
*What’s the Difference?
•Nutritive Value / Food-Like Effect
–Characterizes oversight of conv food claims
–Not well defined or articulated
–DSHEA specifies that dietary supplements donot have to have nutritive effect
–Point of resolution:
•NV Needed? Drug versus Food?
•What does it mean scientifically today?
More on This Perspective
•Do Functional Foods need their ownregulatory box?
–Probably not
•Do they need some special considerations?
–Probably yes
Food - Dietary Supplement - Drug
• Chewing Gum
• Breakfast cereal type products
• Product in bar form
• Bottled water
FOR MORE INFORMATION
•Check out FDA’s web site
–www.fda.gov
–Foods
•Food labeling
•Dietary supplements