FDA Registration for Dietary Supplements
Dietary supplement manufacturers must register with FDA and comply with dietary supplement GMP (21 CFR Part 111). FDA food facility registration is required for all domestic and foreign dietary supplements manufacturers selling in the United States.
FSMA CompliantBiennial RenewalForeign Facilities WelcomeSince 2009
FDA Requirements for Dietary Supplements
Dietary supplement manufacturers are subject to FDA facility registration, supplement GMP (21 CFR Part 111), and DSHEA labeling rules.
- FDA Food Facility Registration — biennial renewal required
- US FDA Agent — mandatory for all foreign food facilities
- DUNS / UFI Number — required for all FDA food registrations
- FSMA compliance — Preventive Controls or Produce Safety rule
- Biennial renewal October 1–December 31 of even-numbered years
Examples of Dietary Supplements Are:
- B Vitamins
- Calcium
- Cinnamon
- Coenzyme Q10
- Echinacea
- Fiber Supplements
- Fish Oil
- Folic Acid
- Garlic
- Ginger
- Ginkgo Biloba
- Ginseng
- Glucosamine
- Glucosamine Chondroitin
- Iron
- Melatonin
- Multivitamins
- Peppermint
- Resveratrol
- Vitamin C
- Vitamin E
- Zinc
Frequently Asked Questions
Common questions about Dietary supplment products FDA registration.
Do dietary supplement manufacturers need FDA registration?
Yes. All dietary supplement manufacturers must register their facilities with FDA.
What GMP rules apply to dietary supplements?
Dietary supplement manufacturers must comply with 21 CFR Part 111 — separate from food GMP requirements.
Ready to Register Your Dietary Supplements Facility?
LMG handles FDA food facility registration, US FDA Agent service, and FSMA compliance for dietary supplements manufacturers worldwide.
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