Maryland direct-to-consumer guide, 2026
Supplements
Vitamins, herbal capsules, tinctures and powders
Federal Rules Apply
DSHEAGoverning law
cGMP21 CFR 111
Supplement FactsLabel panel
FDAPrimary regulator
What is covered
YESCovered by this path
- Supplements made under cGMP
- Properly labeled products with structure-function claims
- Third-party manufactured products
NONeeds a different path
- Disease treatment claims
- Unregistered new ingredients
- Homemade capsules sold to the public
Three compliance steps
AKnow the rules
Dietary supplements follow DSHEA and cGMP
BLabel
Supplement Facts panel, ingredients and a structure-function disclaimer
CReport
Serious adverse events must be reported
Quick reference
| Item | Rule | Regulator |
|---|
| Claims | Structure-function only with disclaimer | FDA |
| Manufacturing | cGMP required | FDA |
| Label | Supplement Facts panel | FDA |
| Adverse events | Report serious events | FDA |
| State | No separate state license found; confirm | MDH |
FAQ
Can I make capsules at home?
Not for sale to the public.
Can I claim it cures?
No.
Does Maryland add rules?
Confirm with MDH.
Checklist