Rule CG-DIS-022
Disease claims: what rule CG-DIS-022 checks
Rule CG-DIS-022 is one of the checker's disease claims rules. It cites 21 CFR 101.93(g), 21 CFR 201.128. The reason, source and safer wording are below.
CG-DIS-022 · Blocks approval · Citation checked against stored text
Copy aimed at people who have a named disease ("Suffering from Crohn's?", "women with endometriosis love this") tells the reader the product is for that disease. FDA reads the intended use from this kind of audience targeting, and it makes a supplement an unapproved drug.
Source: 21 CFR 101.93(g); 21 CFR 201.128 - intended use; FDCA 201(g)(1); FTC Health Products Compliance Guidance
Safer wording: Describe the product and the normal function it supports, and do not address people by their disease. A clinic may describe who it treats and that results vary.
21 CFR 101.93(g), 21 CFR 201.128 · Needs counsel review
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