Rule CG-DIS-019
Disease claims: what rule CG-DIS-019 checks
Rule CG-DIS-019 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-019 · Blocks approval · Citation checked against stored text
Claims to slow, stop or prevent a serious disease, or to restore function after spinal cord injury, are disease claims that need drug approval and evidence.
Source: FDCA 201(g)(1); 21 CFR 101.93(g); FDA consumer alerts on stem cell and dietary supplement disease claims; FTC Act section 5
Safer wording: Remove disease slowing, prevention and recovery claims. Describe a supplement by its nutrients only, and a stem cell service only as an investigational study.
21 CFR 101.93(g) · Needs counsel review
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