1. Positioning Nutritional Food Products Sarah E. Taylor, Esq. Covington & Burling Washington, D.C.

2.  1998 Covington & Burling 2 Positioning Objectives:  Avoid “drug” regulation  Optimize health and nutritional claims  Optimize nutritional formulation

3.  1998 Covington & Burling 3 Position Product to Avoid “Drug” Regulation  “Drug” is any article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”

4. What is the manufacturer's “intended use “ for the product considering any “relevant source” of information (labeling, advertising, promotions, other)? Does manufacturer state/imply product is intended for use in the diagnosis, cure, migration, treatment, or prevention of disease? Premarket approval of new drug application required. “Drug” YES Flow Chart 4  1998 Covington & Burling

5. 5 “Drug” Definition: “Intended Use”  Vendor's intent  Determined from any relevant source  labeling  advertising  promotions  “circumstances” surrounding product distribution

6.  1998 Covington & Burling 6 “any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination thereof) of the body that is manifested by a characteristic set of one or more signs or symptoms, including laboratory or clinical measurements that are characteristic of a disease.” Drug Definition: “Disease”  May include —

7.  1998 Covington & Burling 7 Categories of Prohibited “Disease Claims”  Claims suggesting “the product has an effect on a specific disease or class of disease”  Examples:  “Protective against the development of cancer”  “Reduces the pain and stiffness associated with arthritis”  “Decreases the effects of alcohol intoxication”  “Alleviates constipation”

8. Claims suggesting that “the product has an effect, using scientific or lay terminology, on... signs or symptoms that are recognizable to health care professionals or consumers as being characteristic of specific disease(s).”  Examples:  “Improves urine flow in men over 50 years old” — (characteristic symptom of, e.g., benign prostatic hypertrophy).  “Lowers cholesterol” — (characteristic sign of, e.g., hypercholesterolemia).  “Reduces joint pain” — (characteristic symptom of arthritis).  “Relieves headaches” — (characteristic symptom of, e.g., migraine or tension headache). 8  1998 Covington & Burling

9. Claims suggesting that a product has an effect on disease through “a statement about the formulation of the product, including a claim that the product contains an ingredient that has been regulated by FDA as a drug and is well known to consumers for its use in preventing or treating disease.”  Examples  “Aspirin”  “Digoxin”  “Laetrile” 9  1998 Covington & Burling

10. Claims suggesting that a product “belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease.”  Examples  “antibiotic”  “laxative”  “analgesic”  “antiviral”  “vaccine”  “diuretic”  “antimicrobial”  “antiseptic”  “antidepressant”  “revitalizer”  “adaptogen”  Permissible S/F Claims  “energizer”  “rejuvenative” 10  1998 Covington & Burling

11. Claims suggesting that a product has an effect on disease through the “use of picture, vignettes, symbols, or other means.”  Examples  Electrocardiogram tracings  Pictures of organs that suggest prevention or treatment of a disease state  The prescription symbol (R X )  Any reference to prescription use of the product  Permissible S/F Claims  A picture of the human body 11  1998 Covington & Burling

12. Claims suggesting that a product “has an effect on a consequence of a natural state that presents a characteristic set of signs or symptoms recognizable to health care professionals or consumers as constituting an abnormality of the body.”  Examples:  “Treats toxemia in pregnancy.”  “For decreased sexual function.”  “For hot flashes.”  “Alzheimer’s disease.”  Permitted S/F Claims:  “For men over 50 years old.”  “To meet nutritional needs during pregnancy.” 12  1998 Covington & Burling

13. Prohibits claims suggesting that a product has an effect on disease “through the name of the product.”  Examples:  “Carpaltum” (Carpal Tunnel Syndrome).  “Raynaudin” (Raynaud’s Phenomenon).  “Hepatacure” (Liver Problems).  Permitted S/F Claims:  “Cardiohealth”  “Heart Tabs” 13  1998 Covington & Burling

14. 14 Position Product to Optimize Health and Nutritional Claims  Position product in optimal “nutritional food” category.  Options:  Conventional Food  Food for Special Dietary Use  Dietary Supplement  Medical Food

15.  1998 Covington & Burling 15 Conventional “Food:” Definition  Used for “Food” or “Drink” and Components  “Chewing Gum” and Components  “Food” — Consumed for “Taste, Aroma, Nutritive Value.”

16.  1998 Covington & Burling 16 Food for Special Dietary Use: Definition  Meets Conventional “Food” Definition  Intended to meet special nutritional needs associated with age, physiological conditions, or disease.

17.  1998 Covington & Burling 17 Food for Special Dietary Use: Definition  Distinction from Medical Food:  Useful in supplying special dietary needs for patient prevented from eating normally, BUT  “NOT specifically tailored for use as the nutritional component of the patient’s treatment.”

18.  1998 Covington & Burling 18 Food For Special Dietary Use: Definition  Distinction from Medical Food (cont.):  No required “medical supervision”  FDA has attempted to narrow “medical food” category, redefining as foods for special dietary use.

19.  1998 Covington & Burling 19 “Vitamin C Supplement” “Energy Bar Dietary Supplement” Dietary Supplement: Definition  Labeled as “Dietary Supplement”

20.  1998 Covington & Burling 20 Dietary Supplement: Definition  Intended to supplement the diet and contains a:  vitamin/mineral  herb/botanical  amino acid  dietary substance for use by man to supplement the diet by increasing the total dietary intake, or  concentrate, metabolite, constituent, extract, or combination of the above

21.  1998 Covington & Burling 21 Dietary Supplement: Definition  Intended for ingestion in tablet, capsule powder, softgel, or liquid form, OR  Intended for ingestion in another form AND is not represented as a conventional food or the sole item of a meal or the diet

22.  1998 Covington & Burling 22 Dietary Supplement: Definition  may not include a food which is “represented for use” as a conventional food,  it may include a food that “simulates” a conventional food.

23.  1998 Covington & Burling 23 “... there may be dietary supplements for which the presence of the term ‘dietary supplement’ constitutes the primary, if not the only, means by which consumers will be able to determine that the food is a dietary supplement.” Dietary Supplement: Definition -- “Simulate" FDA Statement:

24. Does manufacturer state/imply product is intended for use in the diagnosis, cure, migration, treatment, or prevention of disease? Is the product intended to supplement the diet with a dietary ingredient (e.g. herb, botanical, amino acid, or metabolite)? Represented as conventional food or as sole item of meal or diet? Dietary Supplement NO YES Flow Chart 24  1998 Covington & Burling

25. 25 Conventional Food: Claims  Approved Nutrient Content Claims  Amount/Percentage Claims  Approved Health Claims  Traditional Structure or Function Claims  Dietary Guidance Claims

26.  1998 Covington & Burling 26 “Calcium helps build and maintain strong bones.” Dietary Supplement Claims  Approved Nutrient Content & Health Claims  Amount/Percentage Claims (“40 percent allicin, 10 mg per capsule”)  Dietary Guidance  Traditional Structure or Function Claims (i.e., for DV nutrients only)

27.  1998 Covington & Burling 27  “Statements of Nutritional Support” for non-DV dietary ingredients (e.g., herbs):  Disclaimer  30 Day Postmarket Notice “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Dietary Supplement Claims

28.  1998 Covington & Burling 28 Third Party Literature -- Dietary Supplements  “Publication”  article  book chapter  official abstract/peer reviewed/appears in article  Reprinted in its Entirety  Not False/Misleading  Promotes No Specific Supplement Manufacturer or Brand  Displayed/Presented With “Other Such Items on Same Subject Matter” to present “balanced view” on supplement  If displayed in an Establishment is Physically Separate from the Dietary Supplements  Has no Information Appended/Attached to it.

29.  1998 Covington & Burling 29 “A claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling” for a food or dietary supplement. Scope of “Nutrient Content Claims”  Definition:

30.  1998 Covington & Burling 30 A nutrient content claim may not be made expressly or impliedly on the label or in labeling unless specifically authorized by FDA regulation (or in limited circumstances by premarket notification). Nutrient Content Claims Must Be Specifically Authorized

31.  1998 Covington & Burling 31  Implied health claims may include:  third-party references  brand names  symbols  vignettes. “Any claim made... in the labeling of food that expressly or impliedly characterizes the relationship of any “substance” to a “disease” or a health-related condition. Scope of “Health Claims”  Definition:

32.  1998 Covington & Burling 32 “Health Claims” Must be Specifically Authorized  A health claim may not be made in labeling unless:  specifically defined by FDA regulation, or  authorized under the premarket notification procedure.  An unapproved health claim = unlawful “drug” claim.

33.  1998 Covington & Burling 33 FDA Modernization Act (FDAMA) Claims  FDAMA Authorizes Health and Nutrient Content Claims Based on the Authoritative Statement of a Federal Scientific Body Under a Premarket Notification Procedure.  Premarket Notification Must Be Filed 120 Days Before Claim Introduced to the Market.  FDA Guidance and Interim Final Rules Issued June 1998.

34.  1998 Covington & Burling 34 FDAMA Health Claims  FDAMA provides that a health claim “shall be authorized” if “a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention) or the National Academy of Sciences or any of its subdivisions has  published an authoritative statement which is currently in effect,  [which is] about the relationship between a nutrient and a disease or health-related condition to which the [health] claim refers.”

35.  1998 Covington & Burling 35 FDAMA Health Claims  Premarket Notification  File 120 Days Before First Introduction of Labeled Food.  Exact Words of Claims.  Concise Description of Basis of Claim.  Copy of Authoritative Statement.  Balanced Representation of Scientific Literature.

36.  1998 Covington & Burling 36 “The USDA Food Guide Pyramid recommends at least 5 servings of fruits and vegetables daily to reduce the risk of certain chronic diseases.” Dietary Guidance Claims  Key : No reference is made to any specific disease/condition.

37.  1998 Covington & Burling 37 “Calcium helps build and maintain strong bones.” “Structure Function” Claims  Conventional “foods” and DV-nutrients:  Claims indicating that the food affects the structure or any function of the body.  E.g., Role of food or nutrient in sustaining normal growth and metabolism.

38.  1998 Covington & Burling 38 “Gingko biloba supports cerebral circulation and alertness.” “Statements of Nutritional Support” (S/F Claims)  Non-DV Dietary Ingredients  Describes role in affecting the structure or function,  Characterizes the mechanism of action, or  Describes benefit to general well-being.

39.  1998 Covington & Burling 39 Permitted S/F Claims Examples:  “Helps promote urinary tract health”  “Helps maintain cardiovascular function and a healthy circulatory system”  “Helps maintain intestinal flora”  “Promotes relaxation”

40.  1998 Covington & Burling 40 Permitted S/F Claims Examples:  “Reduces stress and frustration.”  “Inhibits platelet aggregation.”  “Improves absentmindedness.”  “Helps maintain a healthy cholesterol level.”  “Helps maintain regularity.”

41.  1998 Covington & Burling 41 Position Product to Optimize Nutritional Formulation  Considerations:  Dietary Supplements  More Flexible Safety Standards for Dietary Ingredients  May Fortify to Support Claims  Conventional Foods  Food Additive/GRAS Regulation  Standards for Identity  Fortification Policy  Cannot Fortify to Meet Criteria for Certain Claims

42.  1998 Covington & Burling 42 Formulation: Conventional “Foods” Fortification Policy:  “Guideline” to Promote “Rational Addition of Nutrients to Food”  Mandatory for “More,” “Healthy,” “High Potency”

43.  1998 Covington & Burling 43 Formulation: Conventional “Foods” Fortification Policy:  No fortification of fresh produce, meat, poultry, fish, sugars, snack foods  May correct a “scientifically recognized” dietary insufficiency  May fortify with prescribed nutrient package to “balance”nutrient composition of food

44.  1998 Covington & Burling 44 Formulation: Conventional “Foods” Fortification Policy:  May use nutrients for nonnutritional purpose  Must conform with food additive regulations (e.g., folic acid)  Must conform with nutritional criteria for claims  Examine Precedents case-by-case

45.  1998 Covington & Burling 45 Formulation: Dietary Supplements  Fortification Policy NA.  Dietary Ingredients Exempt from Food Additive/GRAS Requirements  More Flexible Safety Standards Apply.  Ordinary Food Additive/GRAS Requirements Apply to Excipients, Binders, etc.  FDA has Burden of Proof to Establish Dietary Supplement is Unsafe.

46.  1998 Covington & Burling 46 Presents Significant/Unreasonable Risk of Illness/Injury Under Ordinary Conditions of Use OR Causes Dietary Supplement to be Unsafe Under Recommended/Ordinary Conditions of Use Formulation: Dietary Supplements  A Dietary Ingredient is Prohibited if it:

47.  1998 Covington & Burling 47 Information Inadequate to Provide “Reasonable Assurance” that there is no Significant/Unreasonable Risk of Illness/Injury Under Ordinary Conditions of Use First Marketed in the United States On/After October 15, 1994  “New Dietary Ingredient” Formulation: Dietary Supplements  A “New Dietary Ingredient” is Prohibited if:

48.  1998 Covington & Burling 48 Formulation: Dietary Supplements  Ingredient in Food Supply  As Article of Food  Not Chemically Altered OR  History of Use/Evidence of Safety Establishing  “reasonably expected to be safe” under recommended conditions of use AND  75 Day Premarket Notice Filed

49.  1998 Covington & Burling 49 FTC Policy Governing Health and Nutritional Claims  The FTC Food Advertising Enforcement Policy Statement interprets and harmonizes FTC's general antideception policies with FDA regulations and policies governing health and nutrition related claims for foods.

50.  1998 Covington & Burling 50 FTC Policy: Nutrient Content Claims  Applies FDA's definitions for nutrient content claims (e.g., "low," "high," and "lean").  Requires synonyms ("packed with" or "lots of") to be used consistently with FDA-defined terms ("high").  Generally uses FDA's reference amounts as basis for claim.  Consults with FDA and other authorities in evaluating unapproved claims.  Requires the presence of a risk-increasing level of a nutrient to be disclosed.

51.  1998 Covington & Burling 51 FTC Policy: Health Claims  Applies FDA's "significant scientific agreement" standard as its principal guide in evaluating the support for unqualified health claims.  Requires unapproved health claims to be presented so that consumers understand the extent of scientific support and any significant contrary scientific evidence.  Prohibits qualified claims based on studies that are inconsistent with the larger body of scientific evidence.  Requires health claims to be qualified to account for nondietary risk factors.  Generally applies FDA's nutritional criteria for health claims except where claim qualified to avoid deception.  Requires health claims to disclose risk-increasing levels of nutrients.