Rule CG-DIS-020
Disease claims: what rule CG-DIS-020 checks
Rule CG-DIS-020 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-020 · Blocks approval · Citation checked against stored text
A product claim that names a syndrome or condition as the thing it targets, fixes or addresses is a disease claim, and "leaky gut" is a condition FDA and FTC have treated as one in warning letters. A structure or function claim may not name a disease.
Source: 21 CFR 101.93(g); FDCA 201(g)(1); FTC Act section 5; FTC Health Products Compliance Guidance
Safer wording: Describe what the product contains and the normal function it supports, and leave the syndrome or condition out.
21 CFR 101.93(g) · Needs counsel review
Next step
Check your copy against this rule
Run the checker and every flag cites its rule and source.