Rule CG-RFA-009
Efficacy and proof: what rule CG-RFA-009 checks
Rule CG-RFA-009 is one of the checker's efficacy and proof rules. It cites 21 CFR 101.93(g). The reason, source and safer wording are below.
CG-RFA-009 · Blocks approval · Citation checked against stored text
Statements that a product really works, is safe and effective, miraculous or highly potent are unsubstantiated efficacy and safety claims, and testimonial claims of disease improvement carry the same weight as the product claim.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Health Products Compliance Guidance
Safer wording: Remove unsubstantiated efficacy and safety claims and any testimonial that describes disease improvement.
21 CFR 101.93(g) · Needs counsel review
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