The short answer
If you sell food, drinks or dietary supplements on Amazon US and your business is outside the United States, every shipment you send to an Amazon fulfillment center needs an FSVP importer named on the customs entry. FDA’s Foreign Supplier Verification Program (FSVP) rule says the FSVP importer is the U.S. owner or consignee of the food when it enters. If there is no U.S. owner or consignee, the foreign owner must appoint a U.S. agent or representative, with a signed consent, to take the role (21 CFR 1.500). Many people call this an “FSVP agent”.
For most FBA sellers there is no U.S. owner at entry: you still own the goods, and Amazon only stores and ships them. So you need either your own U.S. company or an appointed FSVP importer.
Why FBA shipments get stopped
For each food line entry, the FSVP importer’s name, email address and unique facility identifier must be sent electronically when the entry is filed with U.S. Customs and Border Protection (21 CFR 1.509). FDA accepts the D-U-N-S number as that identifier. When a seller ships by express courier without these details, the courier’s brokerage team often cannot complete the entry, and the goods are held or sent back.
Other common reasons food and supplement shipments to Amazon are held:
- No Prior Notice filed for the shipment
- The manufacturer’s FDA food facility registration has expired (registrations must be renewed between October 1 and December 31 of every even-numbered year)
- Labels that do not meet U.S. rules, such as missing allergens, metric-only net weight or the wrong nutrition panel
- The FSVP importer listed on the entry has no FSVP program or records for that product
What the FSVP importer actually does
Being named on the entry is only the visible part. The FSVP importer must have a written program for each food and each foreign supplier, which includes:
- Hazard analysis of each food: biological, chemical and physical hazards
- Supplier evaluation and approval, looking at the supplier’s food safety controls and compliance history (21 CFR 1.505)
- Verification activities, for example reviewing audit reports, certificates of analysis or test results
- Corrective actions when something goes wrong
- Reevaluation at least every three years, or sooner when new information comes up
- Records kept for at least two years and provided to FDA promptly when asked (21 CFR 1.510)
Supplement sellers have extra points to check, because the supplier must follow dietary supplement CGMP rules, and labels need a Supplement Facts panel.
Orionex can be your FSVP importer from $80 per shipment, with the program and Qualified Individual included.
Your three options
| Option | When it fits | Watch out for |
|---|---|---|
| Set up your own U.S. company | You plan a long-term U.S. business with staff or a U.S. partner | The company becomes the FSVP importer and must run the program itself, with a Qualified Individual |
| Sell through a U.S. distributor | A U.S. buyer owns the goods at entry | The distributor is the FSVP importer, but you lose the Amazon listing and margin |
| Appoint an FSVP importer service | You want to keep selling directly on Amazon from abroad | Choose a service that builds and keeps the full program, not just a name on the entry |
Documents to prepare
- Manufacturer name, address and FDA food facility registration number
- A food safety certificate (for example FSSC 22000, BRCGS, ISO 22000 or HACCP) and the latest audit report
- Product specifications, ingredient lists and allergen information
- Certificates of analysis or lab tests; for supplements, per lot
- The U.S. label for each product
- Your D-U-N-S number, or ask for one (Orionex sets it up free for onboarded clients)
Checklist before your next FBA shipment
- FSVP importer agreed in writing, with name, email and D-U-N-S given to your courier or broker
- FSVP program approved for each supplier and product
- Manufacturer’s FDA registration active
- Prior Notice filed (or confirmed that your courier files it)
- Labels checked against FDA rules
Frequently asked questions
Do Amazon FBA sellers need an FSVP importer?
Usually yes. For food and supplements sent to Amazon fulfillment centers, the seller normally still owns the goods when they enter the U.S. If the seller has no U.S. company, a U.S. agent or representative must be appointed in writing to act as the FSVP importer.
Can Amazon be my FSVP importer?
Amazon fulfillment centers store and ship your goods but do not take on the FSVP importer role for your products. You need your own FSVP importer, either your U.S. company or an appointed U.S. agent.
What does the broker need from my FSVP importer?
For each food line entry, the FSVP importer’s name, email address and an FDA-recognized unique facility identifier, which is the D-U-N-S number, are sent electronically with the entry (21 CFR 1.509).
Is the FSVP importer the same as the importer of record on my FBA shipment?
Not necessarily. The importer of record handles customs, duties and the bond, often through a courier or broker. The FSVP importer handles FDA supplier verification. They can be different companies.
Sources
- 21 CFR 1.500 — FSVP definitions, including “importer”
- 21 CFR 1.509 — How the importer must be identified at entry
- 21 CFR 1.505 — Evaluation and reevaluation of foreign suppliers
- 21 CFR 1.510 — How FSVP records must be kept
- FDA — Compliance policy for an acceptable unique facility identifier (UFI) for FSVP (April 2022)
- FDA — FSVP final rule at a glance
Dates, fees and regulation numbers checked against FDA and eCFR sources on November 13, 2026.