Rule CG-RFA-003
Disease claims: what rule CG-RFA-003 checks
Rule CG-RFA-003 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-003 · Blocks approval · Citation checked against stored text
Anti-cancer, anti-inflammatory, immune-restoring, detox or regenerative claims describe the treatment or mitigation of disease and are unapproved drug claims when made for a supplement, cosmetic or biologic.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Health Products Compliance Guidance
Safer wording: Remove anticancer, anti-inflammatory and regenerative claims. Do not describe the product as acting on disease processes.
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.