Who has to register
Dietary supplements are regulated as food under the FD&C Act, so the standard Food Facility Registration requirement applies. Any foreign facility that manufactures, processes, packs, or holds dietary supplements intended for US consumption must register with FDA, renewed on the biennial calendar shared across food categories.
Registration identifies who is producing what and where. It does not certify that the facility follows the dietary supplement current good manufacturing practice regulation (21 CFR Part 111), and it does not verify that any ingredient in the product has been properly notified to FDA — those are separate obligations.
The US Agent
Every foreign-registered supplement facility must appoint a US Agent — a person or firm physically located in the United States who acts as FDA's point of contact for that facility. FDA can and does contact the US Agent directly during an inspection or when following up on an adverse event report or import alert listing.
Product codes and entry data
At the time of import, customs entry filings for dietary supplements require an FDA product code identifying the product category (vitamin, mineral, botanical, amino acid, or combination) along with the facility's registration number. For Ayurvedic-tradition products specifically, entry filings also get cross-checked against active drug import alerts covering products found to contain heavy metals or undeclared pharmaceutical ingredients.
Registration doesn't confirm the product is even a "dietary supplement"
A facility can be properly registered and still ship a product that FDA classifies as an unapproved drug — because of the claims on the label or the ingredients used, not because of anything about the facility. Registration is necessary but not sufficient. See our compliance path overview for how the drug-vs-supplement classification is determined before registration status even becomes relevant.
What US importers need on file
- Confirmation the foreign facility is currently registered (registration numbers can lapse on the biennial renewal window)
- Confirmation the facility operates under dietary supplement CGMP (21 CFR Part 111), not standard food CGMP alone
- NDI notification records for any new dietary ingredient in the formulation
- Prior Notice filed and confirmed before the shipment arrives
Frequently asked
Do foreign dietary supplement manufacturers need FDA facility registration?
Yes — as food manufacturers under the FD&C Act, they must register and appoint a US Agent like any other food facility.
Does facility registration cover dietary supplement CGMP compliance?
No — registration identifies the facility. CGMP compliance under 21 CFR Part 111 is a separate obligation the facility must implement and document.