Rule CG-DIS-012
Disease claims: what rule CG-DIS-012 checks
Rule CG-DIS-012 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-DIS-012 · Blocks approval · Citation checked against stored text
Claims that a product prevents, treats or fights a virus or infection, including COVID-19, are disease claims. FDA and FTC have sent many warning letters on them.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Act section 5; FDA and FTC warning letters on unapproved COVID-19 products
Safer wording: Remove the claim. Link to CDC or FDA guidance instead of making your own claim.
21 CFR 101.93(g) · Needs counsel review
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