Rule CG-RFA-004
Disease claims: what rule CG-RFA-004 checks
Rule CG-RFA-004 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-RFA-004 · Blocks approval · Citation checked against stored text
Claims to prevent, treat, detect or protect against COVID-19 or other viruses, or to sell an unauthorized test kit, are unapproved drug and device claims that the FDA and FTC have repeatedly enforced.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Health Products Compliance Guidance
Safer wording: Remove the virus and COVID-19 claims. Link to CDC and FDA guidance instead.
21 CFR 101.93(g) · Needs counsel review
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