The short answer
FDA’s FSVP rule defines the importer as the U.S. owner or consignee of the food when it is offered for import. If there is no U.S. owner or consignee at entry, the importer is the U.S. agent or representative of the foreign owner or consignee, confirmed in a signed statement of consent (21 CFR 1.500). In everyday language that appointed company is often called an “FSVP agent”.
Two things follow from this definition. First, the FSVP importer is always a U.S. party: a foreign manufacturer or exporter cannot be its own FSVP importer. Second, the FSVP importer is decided by who owns or receives the food at entry, not by who files the customs paperwork.
Who is the FSVP importer? Common scenarios
| Scenario | Who owns the food at entry? | FSVP importer |
|---|---|---|
| A U.S. distributor buys a container from a manufacturer in Italy | The U.S. distributor | The U.S. distributor |
| A Canadian brand ships its own stock to Amazon warehouses | The Canadian brand (foreign) | A U.S. agent or representative appointed by the brand |
| A Japanese company sells to U.S. consumers through its own web store | The Japanese company until delivery | A U.S. agent or representative appointed by the company |
| A UK exporter sells to a U.S. company that owns a U.S. subsidiary | Depends on the sales terms | The U.S. owner or consignee; agree it in the contract |
The examples use well-known exporting countries; the same rules apply to every country.
What the FSVP importer is responsible for
The role carries real legal responsibility. The FSVP importer must:
- Analyze the hazards of each food it imports
- Evaluate and approve each foreign supplier, and reevaluate at least every three years (21 CFR 1.505)
- Carry out and document verification activities
- Take corrective action when a supplier or food does not meet U.S. standards
- Be identified on every food line entry by name, email and unique facility identifier (21 CFR 1.509)
- Keep FSVP records for at least two years and give them to FDA promptly on request; records stored offsite must be retrievable within 24 hours (21 CFR 1.510)
Much of this work must be done or reviewed by a Qualified Individual with the right training or experience.
Orionex can be appointed as your U.S. FSVP importer, with the program and Qualified Individual included.
FSVP importer vs other roles
- U.S. Agent — named on the foreign facility’s FDA registration as FDA’s contact. A different role from the FSVP importer. See U.S. Agent vs customs broker vs importer of record.
- Importer of record — the customs role responsible for the entry, duties and bond.
- Customs broker — the licensed company that files the entry, including the FSVP importer’s details.
Choosing who takes the role
If your buyer is a U.S. company that owns the goods at entry, agree in the purchase contract that it is the FSVP importer and ask what supplier documents it needs from you. If you sell directly to U.S. customers or through Amazon, you need to appoint a U.S. agent or representative. Read how to choose an FSVP importer service before you sign.
Frequently asked questions
Can a foreign company be the FSVP importer?
No. The FSVP importer must be in the United States: the U.S. owner or consignee of the food at entry, or, if there is none, a U.S. agent or representative of the foreign owner who has signed a statement of consent.
Can my customs broker be the FSVP importer?
Only if the broker is the U.S. owner or consignee, or agrees in writing to act as your U.S. agent or representative and runs the FSVP program. Filing the entry does not by itself make a broker the FSVP importer, and many brokers do not offer the role.
Does the FSVP importer need a D-U-N-S number?
Yes in practice. The FSVP importer’s name, email address and an FDA-recognized unique facility identifier must be sent with each food line entry, and FDA recognizes the D-U-N-S number for this.
Who is the FSVP importer when a U.S. distributor buys the food?
If the U.S. distributor owns the food when it enters the U.S., the distributor is normally the FSVP importer and must have an FSVP for that food and supplier.
Sources
- 21 CFR 1.500 — FSVP definitions, including “importer”
- 21 CFR 1.505 — Evaluation and reevaluation of foreign suppliers
- 21 CFR 1.509 — How the importer must be identified at entry
- 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.