Federal Rules ApplySupplements
Capsules, tinctures and powders. Selling direct to consumers in Maine.
LawDSHEA
GMP21 CFR 111
LabelSupplement Facts
ClaimsStructure/function only
What is covered
Covered by this path
- Compliant dietary supplements
Needs a different path
- Disease claims
- Unapproved ingredients
Three compliance steps
AKnow the rules
DSHEA governs supplements.
CLabel
Supplement Facts panel.
Quick reference
| Item | Rule | Regulator |
|---|
| Manufacturing | cGMP | FDA |
| Claims | Notify FDA within 30 days | FDA |