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

A

Know the rules

Dietary supplements follow DSHEA and cGMP

B

Label

Supplement Facts panel, ingredients and a structure-function disclaimer

C

Report

Serious adverse events must be reported

Quick reference

ItemRuleRegulator
ClaimsStructure-function only with disclaimerFDA
ManufacturingcGMP requiredFDA
LabelSupplement Facts panelFDA
Adverse eventsReport serious eventsFDA
StateNo separate state license found; confirmMDH

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