1. “FUNCTIONAL” AND HEALTH CLAIMS IN THE UNITED STATES Fred H. Degnan King & Spalding LLP fdegnan@kslaw.com

2. Background Regulated claims can be made in –“advertising” or –“labeling” “Advertising” and “Labeling” are legal terms and are broadly defined.

3. Advertising The act or practice of attracting public notice and attention; Includes all forms of public announcement that are intended to aid, directly or indirectly, the furtherance or promulgation of an idea Examples: any promotional publication or broadcast through audiovisual media such as radio, television, telephone communication systems, etc.

4. Labeling “Labeling” includes “all labels and other written printed or graphic material … accompanying” a product (Section 201(m) of the FDC Act) Thus, “labeling” encompasses –any written, printed or graphic material –brochures, bulletins –literature reprints –films, videos, CD-ROM disks –PowerPoint presentations –press releases –automated telemarketing In short, anything that is any promotional material that is not advertising is likely to be labeling

5. U.S. Regulators The Federal Trade Commission (FTC) regulates advertising The Food and Drug Administration (FDA) regulates labeling

6. U.S. Regulation of “Functional”/ Health-Related Benefit Claims BASIC Federal Trade Commission (FTC) Truthful, not misleading Substantiated by competent and reliable scientific evidence ADDITIONAL Food and Drug Administration (FDA) Is the claim permitted? If so, does the claim comply with applicable requirements?  “Drug” claim  “Health claim”: (including “Qualified Health claim”)  “Medical Food” claim  “Structure/Function” claim  “Nutrient Content” claim (including “Healthy” claim) * There is no precise regulatory category for “functional foods.”

7. FTC Jurisdiction Advertisers must have substantiation for objective product claims Making objective claims without a reasonable basis is an unlawful deceptive practice

8. FTC Advertising: Level of Substantiation A claim made in an advertisement represents either expressly or by implication that the claim is supported by a certain amount or level of substantiation, the advertiser must possess, prior to dissemination of the advertisement, at least that level of support for the claim

9. FTC: Substantiation Required for Specific Disease-Related Claims Such claims are prohibited unless they have been approved by FDA

10. FTC: Substantiation Required for Specified Health Benefit Claims For claims that are not frank disease claims but nonetheless convey a specific health benefit (e.g., weight loss claims, claims that a product will reduce children’s sick day absences, etc.), there must be –competent and reliable scientific evidence –including at least two adequate and well controlled human clinical studies This position by FTC is new and is being challenged in the courts.

11. FTC: Substantiation Required for Other Health-Related Claims Any claims about the health benefits, performance, or functional efficacy of a food product must be supported by “competent and reliable scientific evidence”: –the evidence must be “sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields; and –must be considered in light of the entire body of relevant evidence

12. FDA Regulation of “Functional”/Health Benefit Claims FDA will review every claim (whether on a website, on a product label, brochure, etc.) to determine the manufacturer’s intent FDA then categorizes the product itself based primarily on the manufacturer’s intent Thus, a product bearing a claim may be regulated as a “drug,” a “food,” a “medical food,” a “dietary supplement” or a combination of such categories

13. Drugs: Definition A product is a “drug” if, among other things, it is “intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease” FDA interprets the term “disease” broadly

14. Food: Definition “Food” is defined as –any article “used as food” and –any “component” of such an article (i.e., ingredients)

15. Dietary Supplement: Definition A “dietary supplement” is defined as any product –intended to supplement the diet –containing one or more  vitamin, mineral, herb/botanical, amino acids, etc. –intended for ingestion, and –is not represented as a conventional food

16. Drug Claims Express and implied “drug claims” must be supported by “substantial evidence” of “effectiveness” and, as a general rule, must be either preapproved or preauthorized by FDA before the product may be lawfully marketed Even though a product may meet the definition of a “food” or the definition of a “dietary supplement,” if the product bears a “drug” claim the product will be regulated as a drug Thus, foods and dietary supplements cannot, as a general rule, bear an express or implied “drug/disease” claim Exceptions to this rule include “health claims” (either on foods and dietary supplements) and “medical food” claims

17. “Health Claims” A health claim describes the relationship between a food or dietary supplement and the reduction in risk of a disease or health-related condition A health claim must be based upon “significant scientific agreement’ and be pre-reviewed and approved by FDA via a petition process FDA approved health claims may be found in FDA’s regulations, 21 CFR 101.72 - 101.83

18. Examples of Approved “Health Claims” Fiber/cancer risk: “low fat diets rich in fiber containing grain … may reduce the risk of some types of cancer …” Plant sterol esters/risk of coronary heart disease: “diets low in saturated fat and cholesterol that include two servings of foods providing a total of at least 1.3 grams of vegetable oil sterol esters may reduce the risk of heart disease”

19. “Qualified” Health Claims A “qualified” health claim must be preauthorized by FDA via a petition process but requires less evidence than “significant scientific agreement” A qualified health claim may be based on “emerging” scientific evidence regarding the relationship between a substance and a reduced risk of disease or a health- related condition A qualified health claim must be accompanied by an explanation clarifying the level of scientific evidence in support

20. Examples of FDA Authorized Qualified Health Claims “Scientific evidence suggests but does not prove that eating 1.5 ounces per day of nuts as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease” “Omega-3 fatty acids and cardiovascular disease: supportive but not conclusive research shows that the consumption of omega-3 fatty acids EPA and DHA may reduce the risk of cardiovascular disease”

21. “Medical Food”: Definition A “medical food” is a –food –formulated to be consumed or administered enterally –under a physician’s supervision and –is intended for specific dietary management –of a disease condition –for which distinctive nutritional requirements –are established by medical evidence

22. Medical Food Claims Medical foods are exempt from being considered “drugs” and from “health claim” status; the exemption applies only if product is –specially formulated and processed for partial or exclusive feeding of patient orally or by enteral tube; and –intended for dietary management of a patient under medical supervision when cannot be achieved by modifying the normal diet (e.g., chronic medical needs; limited/impaired capacity to ingest, digest, etc.; other special medically-determined nutrient needs); and –provides nutritional support to manage unique nutrient needs resulting from a specific disease/condition (per medical evaluation); and –intended for use only under medical supervision; and –intended only for patient receiving active/ongoing medical supervision

23. Medical Food Claims Although there is no approval process for medical foods, –FDA takes the view that there must be meaningful scientific evidence for the composition and effectiveness of medical foods. –In FDA’s view, the scientific standard contained in the statutory medical food definition may require some of the same types of data for medical foods as are needed to support drug claims (e.g., data from clinical investigations).

24. Examples of Medical Food Claims Restrict phenylalanine/PKU - “A phenylalanine-free food to aid in the nutritional management of hyperphenylalaninemia including PKU.” Hypermetabolic states, such as severe burns, trauma, or infection - “A nutritionally complete formula that provides a concentrated source of calories for patients with restricted fluid allowance or increased energy needs … useful in the dietary management of volume-restricted patients, oncology patients, hypermetabolic conditions, trauma, sepsis, and post major surgery.”

25. Other Permissible Functional/Health- Related Claims With the exception of medical food claims, health claims, and qualified health claims, only “drug” claims may mention disease or imply a disease-related effect “Structure/function” claims and nutrient content claims may discuss functional or health benefits as long as they do not expressly or by implication suggest a drug or disease endpoint

26. Structure/Function Claims Dietary supplements (“role of a nutrient”) Food (food function: e.g., “nutritive value”) Substantiation: truthful and not misleading (arguably similar to FTC reasonable substantiation standard)

27. Structure/Function Claims (cont.) Focus: A structure/function claim deals with how a substance affects the body or characterizes the mechanism by which the substance achieves that effect Example: –“inhibits platelet aggregation” –“helps maintain intestinal flora”

28. Structure/Function Claims (cont.) Focus: A structure/function claim may not imply or express usefulness in the cure, mitigation, treatment or prevention of disease. Examples: these are “drug” claims, not “structure/function” claims: –“prevents the spread of neoplastic cells” [implies prevention of cancer metastases] –“improves joint mobility and reduces joint inflammation and pain” [implies mitigation of rheumatoid arthritis]

29. Structure/Function or Drug/Disease Claim? Supports the immune system Supports the body’s antiviral capabilities Supports the role white blood cells play in the disposal of aging red blood cells or otherwise damaged cells Vitamin A helps maintain a healthy immune system Prevents wasting in persons with weakened immune systems

30. Nutrient Content Claims A “nutrient content claim” characterizes the level of nutrients Only FDA authorized nutrient content claims may be used on a product label or in product labeling Examples of authorized nutrient content claims: –“sodium free,” “low in fat” –“more,” “reduced,” “light,” and other claims comparing the level of a nutrient in food to that of another

31. “Healthy” Claims In the context of its authority over nutrient content claims, FDA has recognized that the use of the term “healthy” can implicitly characterize the level (including the absence) of a nutrient in food As a result, FDA has promulgated a regulation (21 CFR 101.65(d)) governing the use of the term “healthy” (or derivatives of the term, e.g., “healthful”) where –the use of the term characterizes the level of a nutrient in food and –“implies a judgment about the food itself.”

32. “Healthy” Claims (cont.) For a food to bear a “healthy” claim –at least one of the nutrients must provide at least 10% of the recommended daily intake for Vitamin A, Vitamin C, calcium, iron, or fiber and –the food may not exceed FDA established levels for fat, saturated fat, sodium, and cholesterol Moreover, for a food to bear the term “healthy,” the addition of nutrients to the food must comply with FDA’s “fortification policy” (21 CFR 104.20) –i.e., the addition must be rational, e.g., “snack” foods and candies cannot bear a “healthy” claim

33. Products/Claims No Statutory Counterpart Although the following terms are popularly used to refer to product categories, the terms have no legal status: –“Cosmeceutical” - “Cosmetic” + “pharmaceutical” –“Nutraceutical” - “Nutrition” + “pharmaceutical” –“Functional Food” - Food supplying a health/disease prevention benefit

34. U.S. Regulation of “Functional”/ Health-Related Benefit Claims BASIC Federal Trade Commission (FTC) Truthful, not misleading Substantiated by competent and reliable scientific evidence ADDITIONAL Food and Drug Administration (FDA) Is the claim permitted? If so, does the claim comply with applicable requirements?  “Drug” claim  “Health claim”: (including “Qualified Health claim”)  “Medical Food” claim  “Structure/Function” claim  “Nutrient Content” claim (including “Healthy” claim) * There is no precise regulatory category for “functional foods.”

35. Summary FDA Health-Related Claims: A Continuum of Regulatory Categories Drug Claim: Focuses on the “cure, mitigation, treatment, or prevention of disease” Health or “Qualified” Health Claim: “Characterizes the relationship of any nutrient … to a disease or health-related condition” Structure/Function Claim –Supplement: Describes the “role of a nutrient or dietary ingredient intended to affect the structure or function in humans” –Food: Describes the effect of a food or food component on the “structure or any function of the body” Medical Food Claim: For a patient under medical supervision for the “dietary management of a disease or condition for which distinctive nutritional requirements have been established by medical evaluation”

36. Conclusion FTC:You must prove your claim, clinical data may be necessary FDA:You are what you claim – the proof standard and degree of FDA focus depend on what regulatory category i.e., “drug,” “health claim,” “structure/function,” “medical food,” etc.) your claims place you in