LEGAL FRAMEWORK

1
LEGAL FRAMEWORK

• Louisa Nickerson
• Food and Drug Division
• HHS Office of the General Counsel
• June 7, 2004

2
Context

• The Food Advisory Committees role is to advise
  FDA on scientific issues.
• Information about legal framework and issues is
  for background only.

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
Examples

• Claims that would make a product a drug
• for relief of the signs and symptoms of
  osteoarthritis
• effective arthritis pain relief

5
Definition of Health Claim

• FDAs 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
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
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
Examples

• Disease diabetes
• Health-related condition insulin resistance

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
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.