Rule CG-TRE-001

Disease claims: what rule CG-TRE-001 checks

Rule CG-TRE-001 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-TRE-001 · Blocks approval · Citation checked against stored text
Saying a product kills tumors, reverses dementia, replaces sunscreen, controls blood sugar, or treats autism or other named diseases is an unapproved disease claim that supplements, devices and clinics cannot make without FDA clearance and substantiation.
Source: FDCA section 201(g) and 201(h); DSHEA 21 USC 343(r)(6) and 21 CFR 101.93(g) (disease claims on supplements); FTC Act section 5; FTC Health Products Compliance Guidance
Safer wording: Remove any statement that the product treats, cures, prevents, reverses or protects against a named disease. Describe only what an approved label or competent scientific evidence supports.
21 CFR 101.93(g) · Needs counsel review

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