Rule CG-EFF-050
Efficacy and proof: what rule CG-EFF-050 checks
Rule CG-EFF-050 is one of the checker's efficacy and proof rules. It cites 21 CFR 101.93(g), 21 CFR 201.128. The reason, source and safer wording are below.
CG-EFF-050 · Blocks approval · Citation checked against stored text
A promise that something heals or speeds recovery by a stated time, or faster than normal, is a performance claim that needs competent and reliable evidence. For a supplement, cosmetic or device it also describes an effect on a condition, which FDA treats as an unapproved drug claim.
Source: FTC Act section 5; FDCA 201(g)(1); 21 CFR 101.93(g); 21 CFR 201.128 (intended use); FTC Health Products Compliance Guidance
Safer wording: Drop the timeframe and the "faster" comparison. If you have a controlled study, say what was measured, in whom, and against what, and cite it.
21 CFR 101.93(g), 21 CFR 201.128 · Needs counsel review
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