Rule CG-DIS-013
Disease claims: what rule CG-DIS-013 checks
Rule CG-DIS-013 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-013 · Blocks approval · Citation checked against stored text
A pain-relief claim for a supplement or wellness product treats a symptom of disease, which is a drug claim. For an approved over-the-counter drug or a clinical service, check that the wording matches the label or what you can support.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FTC Health Products Compliance Guidance
Safer wording: For a drug, use the approved indication from the label. For a service, describe the care and say results vary.
21 CFR 101.93(g) · Needs counsel review
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