The short answer
If your food or supplements have no U.S. owner or consignee at entry, you need a U.S. agent or representative to act as your FSVP importer, often marketed as an “FSVP agent” service. Their name, email and unique facility identifier go on every food entry (21 CFR 1.509), and they carry the FSVP responsibility in FDA’s eyes. A good service protects your shipments; a weak one can leave you with held goods and an import alert. Ask these ten questions before you sign.
10 questions to ask
1. Will you build a full written FSVP for each supplier and food?
The FSVP importer must analyze hazards, evaluate and approve each supplier, and verify them (21 CFR 1.505). A provider that only lends its name to the entry, without a program, puts your shipments at risk.
2. Who is the Qualified Individual?
Ask what training the QI has (for example FSPCA FSVP and Preventive Controls courses) and whether the QI fee is included or extra.
3. Which documents will you ask from my supplier?
Expect requests for the FDA registration number, a food safety certificate, specifications, allergen information, test results and labels. A provider that asks for nothing is not doing the evaluation.
4. How fast can you answer an FDA records request?
Records must be given to FDA promptly on request, and offsite records must be retrievable within 24 hours (21 CFR 1.510). Ask where your records are kept and who answers FDA.
5. Is the three-year reevaluation included?
Suppliers must be reevaluated at least every three years, or sooner when new information appears. Check whether this costs extra.
6. Do you monitor my suppliers?
Ask whether the provider checks your suppliers against FDA import alerts, warning letters and recalls, and tells you when something changes.
7. What exactly is included in the price?
Compare the yearly or per-shipment fee, the program set-up, extra suppliers, extra products and the QI. Ask for prices in writing.
8. Annual fee or per shipment?
If you ship often, for example monthly to Amazon, an annual plan is usually cheaper. Occasional exporters may prefer to pay per shipment.
9. What is not included?
FSVP importer services normally do not cover customs entry, duties, taxes or the customs bond; those stay with the importer of record and the broker. Prior Notice and facility registration are usually separate services.
10. Is there a written agreement and a signed consent?
The FSVP rule requires a signed statement of consent from the U.S. agent or representative (21 CFR 1.500). Ask for a clear agreement that sets out each side’s duties, fees and how to end the service.
Orionex lists its prices openly: $600/year or $80/shipment plus a $400 set-up, with the QI and 3-year reevaluation included.
Red flags
- No questions about your supplier or products before quoting
- “Name only” offers with no written FSVP
- No named Qualified Individual
- Prices not given in writing, or large extra fees for reevaluation or record requests
- Promises that FDA “approves” your products or that shipments can never be held
How Orionex answers these questions
- A full written FSVP for each supplier and product, reviewed and signed by our FSPCA-trained Qualified Individual
- Supplier documents collected through a no-login upload link
- Records kept and FDA requests answered by us
- Three-year reevaluation and supplier monitoring included
- $600 per year or $80 per shipment, plus a one-time $400 set-up (one supplier, up to five products); extra supplier $150, extra product $50
- Free D-U-N-S number set-up if you need one
Frequently asked questions
What does an FSVP importer service cost?
Prices vary by provider and by how many suppliers and products you have. Orionex charges $600 per year or $80 per shipment for the FSVP importer role, plus a one-time $400 FSVP program set-up for one supplier and up to five products.
Is an “FSVP agent” service the same as an FSVP importer service?
Yes. FDA’s rule uses the term FSVP importer; when the importer is a U.S. agent or representative appointed by a foreign owner, many providers call the service “FSVP agent”.
Can I change my FSVP importer later?
Yes. You can appoint a different FSVP importer for future entries. Make sure the new importer has an FSVP program and records for your foods before the next shipment, and give your broker the new details.
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 — FSVP final rule at a glance
Dates, fees and regulation numbers checked against FDA and eCFR sources on November 13, 2026.