Rule CG-DIS-002
Disease claims: what rule CG-DIS-002 checks
Rule CG-DIS-002 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-002 · Blocks approval · Citation checked against stored text
A treatment claim for a named disease is a drug claim for a product, and needs support for a clinical service.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Act section 5
Safer wording: For a clinical service, state who delivers care and what is offered ("our licensed clinicians evaluate and manage ..."). For a supplement, remove the disease reference.
21 CFR 101.93(g) · Needs counsel review
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