FDA Dietary Supplement Compliance for Foreign Manufacturers
Supplements are regulated as food — with extra rules layered on: cGMP (21 CFR Part 111), Supplement Facts labeling, structure-function claim notifications, NDI notifications for new ingredients, and FSVP obligations for importers. Axentra covers the full path for foreign makers and their U.S. importers
What we handle
food-facility registration & biennial renewal (Oct–Dec even years) · U.S. Agent · Supplement Facts & label review · structure-function claim 30-day notifications · NDI assessment & notification support · FSVP plans & supplier verification for importers · Part 111 cGMP readiness · import/prior-notice support.
Dietary Supplement FDA Compliance & FSVP— Frequently Asked Questions
Do dietary supplement manufacturers need FDA facility registration?
Facilities that manufacture, process, pack, or hold dietary supplements or dietary ingredients for consumption in the United States should register with FDA under the food facility registration framework before beginning those operations. Dietary supplements are included in the definition of “food” for registration purposes. Registration is not the same as FDA approving the supplement.
Does FDA approve dietary supplements before sale?
Generally no. Under DSHEA, FDA does not approve dietary supplements before they are marketed. Firms are responsible for ensuring products are not adulterated or misbranded; a notable premarket pathway is the new dietary ingredient (NDI) notification when applicable. Structure/function claims are not FDA-approved and require the statutory disclaimer and notification rules.
Do foreign dietary supplement facilities need a U.S. Agent?
Yes—when the facility is a foreign food facility subject to registration, it should designate a U.S. Agent as part of FDA food facility registration. FDA will not confirm registration until the agent confirms acceptance. Agent services for supplements are commonly paired with registration support; Axentra’s U.S. Agent service is a flat $249 per facility per year.
What is a new dietary ingredient (NDI) notification?
An NDI is a dietary ingredient not marketed in the United States before October 15, 1994 (with statutory nuances). Before introducing an NDI-containing dietary supplement into interstate commerce, the manufacturer or distributor should notify FDA at least 75 days in advance with the basis for concluding the NDI will reasonably be expected to be safe—unless an applicable exception applies (e.g., present in the food supply as food not chemically altered). NDI notification is separate from facility registration.
When must I notify FDA of a structure/function claim?
If you market a dietary supplement with a structure/function claim (or certain related claims), you should notify FDA no later than 30 days after first marketing with the claim, have substantiation, and include the required disclaimer on labeling. Notifications are submitted through FDA’s current electronic pathway (COSM for these claim notifications). This is not pre-approval of the claim.
Is FDA food facility registration the same as Prior Notice for imports?
No. Food facility registration identifies facilities that manufacture, process, pack, or hold food for U.S. consumption. Prior Notice is a separate import filing for food shipments offered for import into the United States. Foreign manufacturers commonly need both a valid facility registration (with U.S. Agent) and compliant Prior Notice processes at shipment time.