Rule CG-DIS-008
Disease claims: what rule CG-DIS-008 checks
Rule CG-DIS-008 is one of the checker's disease claims rules. It cites 21 CFR 101.93, 21 U.S.C. 343. The reason, source and safer wording are below.
CG-DIS-008 · Warns · Citation checked against stored text
Immune claims are structure/function claims that need substantiation and, for supplements, the standard FDA disclaimer.
Source: FDCA 403(r)(6), 21 U.S.C. 343(r)(6); 21 CFR 101.93
Safer wording: For supplements add the required disclaimer and notify FDA within 30 days of marketing; otherwise state plain facts such as "contains vitamin C".
21 CFR 101.93, 21 U.S.C. 343 · Needs counsel review
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