If you import food or dietary supplements from a foreign supplier into the United States, FDA's FSMA rules require you — the U.S. importer — to verify that supplier meets U.S. food safety standards. Orionex builds and maintains your FSVP program, including Qualified Individual (QI) service, starting at $400 per supplier.
See FSVP Pricing & Get Started → FSVP vs. U.S. AgentQuick answer: FSVP applies to the U.S. importer of record, not the foreign manufacturer — it's a separate requirement from FDA facility registration and the U.S. Agent requirement. If you import food or supplements from abroad and sell them in the U.S. (including via Amazon FBA), you need an FSVP program on file before your goods can legally enter the country.
The Foreign Supplier Verification Program (FSVP) is an FDA requirement under the Food Safety Modernization Act (FSMA). It requires U.S. importers to perform risk-based activities to verify that the food, beverages, or dietary supplements they bring in from foreign suppliers are produced in a manner that meets U.S. food safety standards.
Unlike FDA facility registration or the U.S. Agent requirement — which apply to the foreign manufacturer — FSVP is an obligation on the U.S. importer. Failure to have a compliant FSVP on file can result in shipments being detained or refused entry at the U.S. border.
Designated by the foreign facility as its point of contact with the FDA. Required for the facility's own FDA registration (food, drug, device, or cosmetic). Does not verify anything about the product itself.
Managed by the U.S. importer of record. Requires hazard analysis and verification activities confirming the foreign supplier's food safety practices meet U.S. standards. Applies to food and dietary supplements only.
Many businesses — especially Amazon FBA sellers who both import and sell — need both a U.S. Agent (for their supplier's facility registration) and their own FSVP program (as the importer of record). See our guide to choosing a U.S. Agent or our Amazon FBA compliance page for more.
Transparent, per-supplier pricing — no hidden fees.
Any U.S. importer of record bringing food, beverages, or dietary supplements into the United States from a foreign supplier — including Amazon FBA sellers who import and sell food or supplement products under FDA jurisdiction.
The person responsible for developing, reviewing, and maintaining an importer's FSVP records, as required under FDA FSMA. The QI must review FSVP records annually and whenever significant changes occur.
Possibly both. A U.S. Agent is required for your foreign supplier's own FDA facility registration. FSVP is a separate obligation on you as the U.S. importer. They're not interchangeable — see the comparison above.
Work begins within one business day of payment. No hidden fees.
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