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Rule CG-RFA-005

Disease claims: what rule CG-RFA-005 checks

Rule CG-RFA-005 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-005 · Blocks approval · Citation checked against stored text

    Linking CBD, kratom or other cannabinoid products to cancer, seizures, anxiety, pain, withdrawal or other conditions is an unapproved drug claim; the FDA has sent many warning letters on this.

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

    Safer wording: Remove the condition and health-benefit claims from CBD and kratom copy.

    21 CFR 101.93(g) · Needs counsel review

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