Rule CG-DIS-010
Disease claims: what rule CG-DIS-010 checks
Rule CG-DIS-010 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-010 · Blocks approval · Citation checked against stored text
Saying a product or service helps, improves or relieves a named disease or condition is a disease claim. For a product it makes the product an unapproved drug, and for a service it needs support.
Source: 21 CFR 101.93(g); FDCA 201(g)(1); FTC Act section 5; FTC Health Products Compliance Guidance
Safer wording: Describe what the product contains or what the service involves, and leave the disease out. For a service, say who delivers care and that individual results vary.
21 CFR 101.93(g) · Needs counsel review
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