Rule CG-DIS-001
Disease claims: what rule CG-DIS-001 checks
Rule CG-DIS-001 is one of the checker's disease claims rules. It cites 21 CFR 101.93(g), 21 U.S.C. 321. The reason, source and safer wording are below.
CG-DIS-001 · Blocks approval · Citation checked against stored text
Saying a product or service cures a condition makes it an unapproved drug claim.
Source: FDCA 201(g)(1), 21 U.S.C. 321(g)(1) (drug definition); 21 CFR 101.93(g) (disease claims); FTC Health Products Compliance Guidance
Safer wording: Describe what the service does (for example "supports", "helps manage") and name only outcomes you can substantiate.
21 CFR 101.93(g), 21 U.S.C. 321 · Needs counsel review
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