Rule CG-DIS-024
Disease claims: what rule CG-DIS-024 checks
Rule CG-DIS-024 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-024 · Blocks approval · Citation checked against stored text
A claim to lower or improve a disease marker such as A1C, LDL or TSH is a claim to treat the disease the marker defines.
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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