|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.|
|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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