Rule CG-DIS-014
Disease claims: what rule CG-DIS-014 checks
Rule CG-DIS-014 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-DIS-014 · Blocks approval · Citation checked against stored text
A list of serious diseases next to a product or therapy, or a named therapy "for" a disease, claims the product treats them. These claims appear in many stem cell, exosome and wellness warning letters.
Source: 21 CFR 101.93(g); FDCA 201(g)(1); FTC Health Products Compliance Guidance
Safer wording: Remove the disease list. If the therapy is part of an FDA-regulated study, say it is investigational and cite the study.
21 CFR 101.93(g) · Needs counsel review
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