Rule CG-DIS-011
Disease claims: what rule CG-DIS-011 checks
Rule CG-DIS-011 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-011 · Blocks approval · Citation checked against stored text
Claims to lower or regulate cholesterol, blood pressure or blood sugar are claims to treat the diseases those measurements define (high cholesterol, hypertension, diabetes), not general wellness claims.
Source: 21 CFR 101.93(g); FDCA 201(g)(1); FTC Health Products Compliance Guidance
Safer wording: Say what the product contains. If a clinician manages these measurements, describe the service and say results vary.
21 CFR 101.93(g) · Needs counsel review
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