Who counts as the importer of record
The importer is the US owner or buyer of the dietary supplement at the time it's offered for import into the United States. If there's no US owner or buyer at the point of entry, the importer of record becomes the US agent representing the foreign exporter, confirmed by a signed statement of consent. This designation determines who FDA holds accountable if the shipment doesn't meet requirements — including, for this category, if it turns out not to qualify as a dietary supplement at all.
What the importer owns end to end
- FSVP or modified FSVP compliance — determining which framework applies and documenting it accordingly
- NDI verification — confirming any new dietary ingredient in the formulation has a notification on file with FDA, not just relying on supplier assurance
- Claim classification review — confirming labeling and marketing claims stay within structure/function bounds and don't cross into disease-claim territory
- Prior Notice — filed and confirmed before the shipment arrives, with facility and product details matched to the entry
- Import alert screening — checking suppliers, particularly Ayurvedic-tradition manufacturers, against active drug import alerts before importing
Classification risk sits with the importer, not the marketing department
If a product is imported as a dietary supplement but FDA determines its claims or ingredients make it an unapproved drug, the consequences — detention, warning letters, potential import alert listing — land on the importer of record. This makes claim review and ingredient screening a compliance function for the importer, not just a marketing sign-off, particularly for Ayurvedic-tradition products where the line is less obvious than it looks. See our label requirements guide for where that line sits.
Recordkeeping in practice
FSVP records, NDI notification confirmations, and claim substantiation files should be retained for at least two years and producible within a reasonable time of an FDA request. For Ayurvedic-tradition suppliers specifically, documented screening against current import alert listings — checked at each shipment, not just once at supplier onboarding — is good practice given how frequently these listings are updated.
Frequently asked
Who is legally the dietary supplement importer of record?
The US owner or buyer at the time of import, or the US agent representing the foreign supplier if there's no US owner or buyer, confirmed by signed consent.
Is the importer responsible for confirming a product isn't actually an unapproved drug?
Yes, in practice — if FDA reclassifies a shipment based on claims or ingredients, the importer bears the consequences, including possible detention and enforcement action.