Rule CG-DIS-054

Disease claims: what rule CG-DIS-054 checks

Rule CG-DIS-054 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-054 · Blocks approval · Citation checked against stored text
Naming a repurposed drug, supplement or alternative therapy as a treatment for cancer is a drug claim for a use FDA has not approved. FDA and FTC have sent joint warning letters over unproven cancer treatments, and patients who delay or replace proven care are harmed. Laetrile, black salve and similar products are on FDA's list of fake cancer cures.
Source: FDCA 201(g)(1); 21 CFR 201.128 (intended use); FTC Act section 5; FDA 187 Fake Cancer Cures Consumers Should Avoid; FTC Health Products Compliance Guidance
Safer wording: Do not name unapproved agents as cancer treatments. If you offer supportive or integrative care next to standard treatment, say it does not treat cancer and name the symptom it addresses (for example "acupuncture for nausea during chemotherapy").
21 CFR 201.128 · Needs counsel review

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