Rule CG-SUP-051
Superiority: what rule CG-SUP-051 checks
Rule CG-SUP-051 is one of the checker's superiority rules. It cites FTC Policy Statement Regarding Advertising Substantiation, 21 CFR 202.1(e)(6). The reason, source and safer wording are below.
CG-SUP-051 · Blocks approval · Citation checked against stored text
A claim that a treatment has fewer side effects than, or works better than, another is a comparison that needs head-to-head evidence in the same patients. For drugs, FDA expects comparative claims to rest on substantial evidence from adequate comparative studies. A comparison with "any other" treatment can never be supported.
Source: FTC Act section 5; FTC Policy Statement Regarding Advertising Substantiation; 21 CFR 202.1(e)(6) (comparative claims in prescription drug advertising); FTC Health Products Compliance Guidance
Safer wording: Name the comparison, the study and the endpoint, for example "In a 2024 randomized trial of 400 patients, X had fewer grade 3 side effects than Y (Smith et al.)". Or drop the comparison and describe what the treatment is.
FTC Policy Statement Regarding Advertising Substantiation, 21 CFR 202.1(e)(6) · Needs counsel review
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