Supplements
Dietary supplements are federally regulated: cGMP, label format and claim rules.
Federal Rules ApplyPart 111cGMP
30 daysClaim notice to FDA
FactsSupplement Facts panel
SeriousAdverse events reported
What is covered and what needs a different path
What this guide covers
- Vitamins, minerals and botanical supplements made under cGMP
- Products with accurate Supplement Facts panels
- Structure-function claims with the required disclaimer
- Products from a registered food facility
Needs a different path
- Disease treatment claims
- Products with undeclared ingredients
- Manufacturing in a home kitchen
- Unnotified structure-function claims
Three compliance steps
A
Build to cGMP
Follow 21 CFR Part 111 for manufacturing, testing and records.
B
Label right
Supplement Facts panel, ingredient list, name and address, domestic phone or address for adverse events.
C
Notify FDA
Structure-function claims require a notice within 30 days of marketing, and the disclaimer on the label.
Quick reference
| Item | Rule | Regulator |
|---|---|---|
| cGMP | Required for manufacturers | FDA 21 CFR 111 |
| Label | Supplement Facts and statement of identity | FDA 21 CFR 101.36 |
| Claims | Notice within 30 days; disclaimer | FDA |
| Adverse events | Serious events reported | FDA |
| Facility | Food registration and DPH permit | FDA; DPH 105 CMR 500 |
Frequently asked questions
Can I make them at home?No, supplements are not cottage foods.
Can I say it cures?No, that is a drug claim.
Do small makers need cGMP?Yes, cGMP applies to all makers.
Printable checklist
- cGMP system built
- Supplement Facts panel
- Disclaimer on label
- Structure-function notice filed
- Adverse event process
- Facility permit
- No disease claims