South-Western Legal Studies in Business

Drug Claims Subject to More Stringent FDA Regulations than Health Claims
Description Appeals court held that the FDA acted within its regulatory discretion to determine that a proposed product, to be marketed to deal with a specific health matter, could be classified as a drug claim rather than a health claim, which made the product subject to more extensive regulatory control.
Topic Consumer Protection
Key Words Drugs; Classification; Drug Claims; Health Claims; Commercial Speech
C A S E   S U M M A R Y
Facts Whitaker sought FDA approval for the marketing of “saw palmetto,” an extract from the dwarf American palm, under a label that makes a health claim. The label recommended consumption of 320 mg daily of saw palmetto extract to help reduce non-cancerous enlargement of the prostate (BPH), a common occurrence in men over 50 years old. The FDA held that BPH is a disease, which meant that the drug could not be marketed under a “health claim” label, which requires little regulation. Rather, it would be categorized as making a “drug claim,” which cannot be done without extensive testing before saw palmetto could be marketed for treating a disease. Whitaker appealed the FDA decision.

Affirmed. The FDA reasonably interpreted the Federal Food, Drug and Cosmetic Act, as amended by the Nutrition Labeling and Education Act, in classifying saw palmetto extract as a drug. When claims are made regarding the cure, mitigation, or treatment of a disease, it is a drug claim, not a health claim. The FDA did not violate Whitaker’s commercial speech rights by asserting that the label would make a drug claim rather than a health claim. Commercial speech enjoys First Amendment protection. However, the government may impose restrictions that advance a substantial government interest and are not more extensive than is necessary to serve that interest, as is the case here.

Citation Whitaker v. Thompson, --- F.3d --- (2004 WL 41498, D.C. Cir., 2004)

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