Rule CG-RFA-001
Disease claims: what rule CG-RFA-001 checks
Rule CG-RFA-001 is one of the checker's disease claims rules. It cites 21 CFR 101.93(g). The reason, source and safer wording are below.
CG-RFA-001 · Blocks approval · Citation checked against stored text
Saying a product cures, treats, prevents, relieves or fights a named disease or condition makes it an unapproved drug claim, and the FDA cites this wording in warning letters.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Health Products Compliance Guidance
Safer wording: Remove the disease claim. Describe only a lawful structure or function benefit and keep the disclaimer.
21 CFR 101.93(g) · Needs counsel review
Next step
Check your copy against this rule
Run the checker and every flag cites its rule and source.