1. Janet McDonald, Ph.D., R.D. Regulation of Food & Dietary Supplements

2. Today’s Topics Introduction to the legal authority General requirements for food and dietary supplements Structure/function claims Boundaries

3. FDA’s Legal Authority Federal Food, Drug, and Cosmetic Act Fair Packaging and Labeling Act

4. Dietary Supplements Nutrition Labeling and Education Act (NLEA) Dietary Supplement Health and Education Act (DSHEA)

5. Interpretation of the Statute Code of Federal Regulations Guidance documents Case law Informal guidance

6. What is Food ? “...articles used for food or drink for man…chewing gum…and articles used for components of...” food or drink or chewing gum

7. What is a food additive? Broad sense: Any substance added to food. Legally: “Any substance the intended use of which results or may reasonably be expected to result- directly or indirectly - in its becoming a component or otherwise affecting the characteristics of any food.” –Direct additives –Indirect additives

8. What is GRAS? Substances whose use is generally recognized as safe, based on their extensive history of use in food before 1958, or based on published scientific evidence. Not set in concrete!

9. What is a Drug ? “…article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease…”

10. What is a dietary supplement ? “…a product (other than tobacco) intended to supplement the diet that bears or contains one or more” designated ingredients

11. What is a dietary supplement ? Vitamin, mineral, amino acid Herb or other botanical Dietary substance for use by man to supplement the diet by increasing the total dietary intake

12. What is a dietary supplement ? Concentrate, metabolite, constituent, or combination of the ingredients above

13. What is a dietary supplement ? Intended for ingestion Pill, capsule, liquid, powder, “other” Not represented for use as conventional food Not sole item of meal or diet Labeled as a dietary supplement

14. Messages….. Definitions and Regulatory “Boxes” ….And that they matter What to “think about” at this evolving point

15. Dietary Supplement Compliance Boundaries Boundaries Food D ietary Supplement Drug

16. Which Regulatory Box Is Important Because….. Different legal requirements Different safety considerations Different substantiation for claims

17. Dietary Supplement or Food ?

19. Food Dietary Supplement Represented for use as conventional food Safe ingredients Claims Labeling

20. What is “Functional Food?” It is undefined but regulated as food

21. “Functional Food?”

23. “Functional Food” Claims Structure/function claims Truthful Non-misleading Based on nutritive value No drug claims

24. “Functional Food” Claims Disease claims - Drug Dietary support during the cold and flu season Prevents the onset of disease complications

25. Dietary Supplement Drug Structure/function claims 30-day post-market notification for structure/ function claim Use of “disclaimer” Manufacturer is responsible for substantiation

26. 30-Day Notification Disease claims - Drug Reduces cholesterol Reduces fever Helps promote normal body function after taking too much drink

27. 30-Day Notification Structure/function claim Gingko biloba promotes healthy brain function Guar gum promotes healthy intestinal function Helps maintain cholesterol levels in normal range

28. The Key to Almost Everything Is………. Intended Use (claims)

29. Intended Use Gets You into Two Possible Boxes…. initially Functional Food Drugs Prescription OTC Foods Conv Foods Dietary Supplements ?

30. More on This Perspective Functional Foods -------> Assumption: probably about foods Dietary supplements are intended to supplement the diet

31. 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

32. *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 do not have to have nutritive effect –Point of resolution: NV Needed? Drug versus Food? What does it mean scientifically today?

33. More on This Perspective Do Functional Foods need their own regulatory box? –Probably not Do they need some special considerations? –Probably yes

34. Food - Dietary Supplement - Drug Chewing Gum Breakfast cereal type products Product in bar form Bottled water

35. FOR MORE INFORMATION Check out FDA’s web site –www.fda.gov –Foods Food labeling Dietary supplements