Rule CG-DIS-051

Disease claims: what rule CG-DIS-051 checks

Rule CG-DIS-051 is one of the checker's disease claims rules. It cites 21 CFR 201.128. The reason, source and safer wording are below.

CG-DIS-051 · Blocks approval · Citation checked against stored text
Saying a product works on a severe injury such as a third or fourth degree tear, or restores an organ, claims to treat or repair a serious condition. These are drug claims that need FDA approval, and a serious injury is the last place a consumer should use an unproven product in place of care.
Source: FDCA 201(g)(1); 21 CFR 201.128 (intended use); FTC Act section 5; FTC Health Products Compliance Guidance
Safer wording: Remove the claim about the injury or organ. Describe what the product is (an ingredient list, a comfort product) and say that severe tears and wounds need a clinician.
21 CFR 201.128 · Needs counsel review

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