Dietary Supplements, Nutraceuticals & Functional Foods

1. Dietary Supplements, Nutraceuticals & Functional Foods

3. Definitions • Dietary Supplements • Nutraceuticals • Functional Foods • Phytochemicals • Generally Recognized as Safe (GRAS) substances

4. Dietary Supplements • Legally defined in the Dietary Supplement Health and Safety Act (DSHEA) 1994 as: “any product taken by mouth that contains a so-called "dietary ingredient" and its label clearly states that it is a dietary supplement”

5. Dietary Ingredients • Dietary ingredients include: • Vitamins • Minerals • Herbs • Amino acids • Substances such as enzymes, organ tissues, metabolites, extracts or concentrates

6. Nutraceuticals • "Nutraceutical" is a made-up word combining the words nutrition and pharmaceuticals, creating the concept that extracts from food can be used as drugs, i.e. food supplements • Nutraceuticals (often referred to as phytochemicals or functional foods) are natural, bioactive chemical compounds that have health promoting, disease preventing or medicinal properties

8. Functional Foods • Functional foods are foods that provide health benefits beyond (in addition to) basic nutrition • Many foods may be considered functional foods: • Catechins in black and green tea reduce risk of cancer • Sulforaphane in broccoli reduces cancer risk • Omega-3 fatty acids in fish or flaxseed reduce risk of heart disease & aid joints • Fruits and vegetables contain many different phytochemicals which reduce risk for cancer and heart disease

9. More Functional Foods • Garlic has sulfur compounds that reduce risk for cancer and heart disease • Oats and oat-containing foods, with soluble fiber beta glucan, reduce cholesterol level • Polyphenolic compounds in purple grape juice support normal, healthy cardiovascular function • Soy protein reduces cholesterol levels • Lycopene in tomatoes and products reduce risk for cancer • Yogurt and fermented dairy products contain probiotics which may improve gastrointestinal health

10. Phytochemicals • A phytochemical is a chemical that acts as nutraceutical or dietary supplement that comes from plants • Isoflavones from soy • Antioxidants from vegetables • Lycopene from tomatoes

11. GRAS Substances • Salt, sugar, spices, vitamins and monosodium glutamate are classified as GRAS substances, along with several hundred other substances • General recognition of safety based on the views of experts • The basis of such views may be either • (1) Scientific procedures • (2) “Grandfathered” In the case of a substance used in food prior to January 1, 1958, through experience based on common use in food

12. GRAS Substances • General recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food • Manufacturers make a self-determined GRAS declaration, claiming exemption from the pre-market approval requirement for food additives

13. Government Regulations • For decades, FDA regulated dietary supplements as foods to ensure that they were safe and wholesome and that their labeling was truthful and not misleading

14. Government Regulations – NLEA 1990 • Nutrition Labeling and Education Act of 1990 (NLEA) defines how food is labeled, including nutrition labeling, in accordance with definitions established by FDA, and providing for the use of claims about the relationship between nutrients and diseases or health-related conditions

15. Government Regulation –DSHEA 1994 • In 1994 DSHEA was passed as an amendment to the Federal Food, Drug, and Cosmetic Act (1938) to establish standards with respect to dietary supplements

16. Government Regulations of Dietary Supplements • FDA traditionally considered dietary supplements to be essential nutrients, such as vitamins, minerals, and proteins. • NLEA added "herbs, or similar nutritional substances," to the term "dietary supplement." • DSHEA expanded the meaning of the term "dietary supplements" beyond essential nutrients to include such substances as ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these.

17. When Is a Dietary Supplement Not a Dietary Supplement? • Dietary supplements are not for use as a conventional food or as the sole item of a meal or diet

18. Examples • Benecol (http://www.benecol.com/), Take Control (http://www.takecontrol.com) • The FDA considers Benecol and its active ingredient a conventional food

19. Structure - Function Claims • DSHEA (Section 403(r)(6)) permits only structure/function claims for dietary supplements without prior FDA review that are not also disease claims • Structure/function claim -- claims that the products affect the structure or function of the body • Disease claim -- a claim that they can prevent, treat, cure, mitigate or diagnose disease • Health claims on foods are regulated by NLEA

20. Health Claims for Food • FDA initially authorized seven health claims in 1993 as part of NLEA • Since 1993, FDA has authorized four more, last was in October 1999 http://vm.cfsan.fda.gov/~dms/fdhclm.html

21. Calcium and osteoporosis Sodium and hypertension (high blood pressure) Dietary fat and cancer Dietary saturated fat and cholesterol and risk of coronary heart disease Fruits and vegetables and cancer Folate and neural tube birth defects Dietary sugar alcohol and dental caries (cavities) Fiber-containing grain products, fruits, and vegetables and cancer Health Claims

22. More Health Claims • Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease • Dietary soluble fiber, such as that found in whole oats and psyllium seed husk, and coronary heart disease • Soy protein and coronary heart disease

23. Dietary Supplement Label • Prepared by manufacturer • Presented in FDA-specified format • Must contain enough information about the composition of the product so that consumers can make informed choices • The information must be truthful and not misleading

24. Dietary Supplement Authentication • Under DSHEA a dietary supplement is adulterated if it or one of its ingredients presents "a significant or unreasonable risk of illness or injury" when used as directed on the label, or under normal conditions of use (if there are no directions).

25. Testing Health Claims of Nutraceuticals • Efficacy of supplement • What does it do? • How does the supplement work? • Active ingredient? • Standard of supplements • Consumer lab found that ¼ of ginkgo biloba extracts didn’t have the correct chemical profile

26. Analysis of Dietary Supplements • Not routinely analyzed by FDA • Manufacturers responsibility • Sources of Information • Consumer Lab • Institute for Nutraceutical Research • American Nutraceutical Association

27. Analysis of Dietary Supplements • Consumer Lab - Mission is to provide consumers and healthcare professionals with results of independent tests of products that affect health and well-being

28. Safety of Dietary Supplements • Manufacturers and distributors do not need to register with FDA or get FDA approval before producing or selling dietary supplements • Manufacturer is responsible for safety of all dietary ingredients in the supplements and preparation of label

30. Further Information • Web Pages: • NIH:http://dietary-supplements.info.nih.gov/ • FDA: http://vm.cfsan.fda.gov/~dms/fdhclm.html • International Food Information Council Foundation (IFIC): http://ificinfo.health.org/ • Functional Foods for Health (FFH): http://www.ag.uiuc.edu/~ffh/ • Consumer lab: http://www.consumerlab.com/ • Institute for Nutraceutical Advancement http://www.nutraceuticalinstitute.com/

31. More Information… • Books: • Commission E Monographs: Therapeutic Guide to Herbal Medicines • Tylers’ Honest Herbal • Physicians' Desk Reference for Nonprescription Drugs and Dietary Supplements 2000 (Physicians' Desk Reference for Nonprescription Drugs and Dietary Supplements)

32. Specialist Food • Dietary Supplements • Organic food • GMO