mediabuyer
Saved
← All terms

Compliance & regulatory

FDA claim restriction

Federal Food, Drug & Cosmetic Act limits on supplement and OTC marketing claims.

FDA regulates structure-function vs disease claims for dietary supplements (DSHEA, 21 USC § 343) and OTC drugs. Supplements may make 'structure-function' claims ('supports healthy joint function') with the boilerplate disclaimer, but cannot claim to 'treat,' 'cure,' or 'prevent' disease. Crossing that line moves the product into 'unapproved drug' territory and triggers FDA warning letters and FTC follow-on enforcement. Affiliate marketers translate this into ad-copy hygiene rules.

Example

Joint-pain supplement copy says 'helps support flexible joint movement' (allowed) instead of 'treats arthritis pain' (disease claim, banned) — operator's compliance reviewer scrubs the latter on every creative submission.

Related terms