Summary
US dietary supplement regime: supplement must be safe, labeled per 21 CFR 101.36, manufactured under cGMP (21 CFR 111).
Scope
Applies to dietary supplements sold in the US (DSHEA). Requirements: no adulteration (ingredient/safety), Supplement Facts label (21 CFR 101.36), cGMP (21 CFR 111), adverse event reporting (21 CFR 190.6).
Expert analysis
Our compliance experts are preparing a detailed analysis for this regulation. Check back soon.
