Missouri Direct-to-Consumer Guide 22 of 24
Supplements
Capsules, powders and tinctures
Federal Rules Apply
DSHEA1994 federal supplement law
cGMP21 CFR Part 111
30 daysStructure/function notice after marketing
0Missouri supplement license identified
What is covered, and what needs a different path
Covered
- Supplements with compliant labels
- Structure/function claims with notice
- Facilities following cGMP
Needs a different path
- Disease claims
- Unapproved new dietary ingredients
- Home-made capsules for sale
Three compliance steps
AFollow cGMP
Manufacturing, packaging and holding follow 21 CFR Part 111.
BLabel correctly
Supplement Facts panel, ingredients, name and address, and the FDA disclaimer.
CNotify FDA of claims
Send the structure/function notice within 30 days of first marketing.
Quick reference
| Item | Rule | Regulator |
|---|
| Facts panel | Required | FDA |
| cGMP | Required for manufacturers | FDA |
| Claims | Structure/function only | FDA / FTC |
| Adverse events | Report serious events | FDA |
| Sales tax | Retail sales are taxable; Missouri sales tax license, state plus local rate | MO DOR |
FAQ
Do I need a state license?
None specific was identified.
Can I say it cures anything?
No.
Is it a cottage food?
No.
Printable checklist
- Follow cGMP
- Draft Supplement Facts
- Add FDA disclaimer
- Send claim notice
- Set adverse event reporting
- Register for sales tax