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Rule CG-RFA-002

Disease claims: what rule CG-RFA-002 checks

Rule CG-RFA-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.

  1. CG-RFA-002 · Blocks approval · Citation checked against stored text

    Naming a disease as what a product, formula or package is for, or calling something a natural remedy for it, is an implied claim to treat or prevent that disease.

    Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Health Products Compliance Guidance

    Safer wording: Do not name a disease as the use of a supplement or cosmetic. Describe general wellness support only.

    21 CFR 101.93(g) · Needs counsel review

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