Rule CG-DIS-016
Disease claims: what rule CG-DIS-016 checks
Rule CG-DIS-016 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-016 · Blocks approval · Citation checked against stored text
A sentence that names a disease or condition and says it was cured, reversed, cleared, beaten, fixed or removed is a disease claim, however it is worded. For a product it makes the product an unapproved drug. For a service it needs substantiation and a statement of typical results.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); 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 outcome out. If a clinician treats the condition, say who, and that results vary by patient.
21 CFR 101.93(g) · Needs counsel review
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