1. 1 LEGAL FRAMEWORK Louisa Nickerson Food and Drug Division HHS Office of the General Counsel June 7, 2004

2. 2 Context The Food Advisory Committee’s role is to advise FDA on scientific issues. Information about legal framework and issues is for background only.

3. 3 Regulatory Categories: Drug vs. Dietary Supplement some overlap for products intended to affect the structure or function of the body or reduce the risk of disease if a product is intended to treat, mitigate or cure disease, FDA regulates it as a drug

4. 4 Examples Claims that would make a product a drug: “for relief of the signs and symptoms of osteoarthritis” “effective arthritis pain relief”

5. 5 Definition of “Health Claim” FDA’s definition of “health claim” is “any claim made on the label or in the labeling of food, including a dietary supplement, that expressly or by implication... characterizes the relationship of any substance to a disease or health-related condition.” 21 C.F.R. 101.14(a)(1). Different from ordinary English meaning of “health claim” as “any claim about health”

6. 6 Examples of authorized health claims Soy protein: “25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein.” 21 C.F.R. 101.82. Low sodium foods: “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.” 21 C.F.R. 101.74.

7. 7 Definition of “disease or health-related condition” “Disease or health-related condition” means “damage to an organ, part, structure, or system of the body such that it does not function properly... or a state of health leading to such dysfunctioning... except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition....” 21 CFR 101.14(a)(5).

8. 8 Examples Disease: diabetes Health-related condition: insulin resistance

9. 9 Scope of health claims Health claims are about reducing the risk of a disease or health-related condition, not treating, mitigating, or curing diseases. Whitaker v. Thompson, 353 F.2d 947 (D.C. Cir. 2004)

10. 10 Example Example of a claim that is not a health claim: “Consumption of 320 mg daily of saw palmetto extract may improve urine flow, reduce nocturia and reduce voiding urgency associated with mild prostatic hyperplasia (BPH).” Claim is about treating or mitigating BPH by relieving its symptoms. This is the claim that was at issue in the Whitaker v. Thompson case.