Rule CG-RFA-008
Disease claims: what rule CG-RFA-008 checks
Rule CG-RFA-008 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-008 · Blocks approval · Citation checked against stored text
Pain, itch, swelling or symptom relief claims, sexual performance and fat-loss claims describe the effect of a drug on the body and are unapproved drug claims for a supplement, cosmetic or device.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Health Products Compliance Guidance
Safer wording: Remove the symptom-relief, sexual performance and fat-burning claims, or move the product through drug approval.
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.