FSVP Explained: Who Is the FSVP Importer and What Food and Supplement Brands Must Keep on File

FDA COMPLIANCE · FOOD AND SUPPLEMENT IMPORTS

Updated November 2026. Brands importing snacks, teas, powders, gummies or capsules made abroad often meet FSVP when a customs broker asks who the “FSVP importer” is, or when an FDA investigator asks to review records. This guide covers who carries the duty, what the program contains, the lighter rules for supplements and small importers, and how FSVP fits with other FDA import steps. It is general information, not legal advice.

What is the Foreign Supplier Verification Program?

FSVP is one of the rules under the FDA Food Safety Modernization Act (FSMA). It became effective on January 26, 2016, and FDA says all compliance dates have now passed. The rule requires importers to perform risk-based foreign supplier verification activities to confirm three things about each imported food:

• It is produced in a way that gives the same level of public health protection as FDA’s preventive controls rules or, for certain fresh produce, the produce safety rule.
• It is not adulterated under section 402 of the FD&C Act.
• For human food, it is not misbranded with respect to food allergen labeling under section 403(w).

Who is the FSVP importer?

For FSVP purposes, the importer is the U.S. owner or consignee of the food when it is offered for import. The regulation defines that as the person in the United States who, at the time of entry, owns the food, has purchased it, or has agreed in writing to purchase it (21 CFR 1.500). If no such person exists, the importer is the U.S. agent or representative of the foreign owner or consignee, confirmed in a signed statement of consent.

Three common ecommerce setups:

• A U.S. brand buys finished goods from a foreign co-manufacturer. The U.S. brand owns the food at entry, so it is usually the FSVP importer.
• A foreign brand ships its own inventory to a U.S. fulfillment center. A fulfillment center stores the goods but does not buy them, so there may be no U.S. owner or consignee. The brand then needs a U.S. agent or representative to act as FSVP importer under a signed statement of consent.

Whoever is named as FSVP importer at entry is the party FDA contacts for an inspection.

What must an FSVP include?

An importer must develop, maintain and follow an FSVP for each food and each foreign supplier. If one food comes from three suppliers, that is three programs; if one supplier makes ten foods, that is ten. FDA lists these core steps:

1. Hazard analysis. Identify known or reasonably foreseeable biological, chemical and physical hazards in each food, such as allergens, pesticide residues or unapproved additives, and judge how likely and severe each is.
2. Evaluation of the food and the supplier. Consider who controls each hazard, the supplier’s food safety procedures and its FDA compliance history.
3. Supplier approval and verification. Approve suppliers in writing and verify them through on-site audits, sampling and testing, or review of supplier records. An annual on-site audit is generally expected for hazards that could cause serious harm or death, unless another documented method gives adequate assurance.
4. Corrective actions. Act promptly when a supplier falls short.
5. Reevaluation. Review the food risk and supplier performance at least every three years, or sooner when new information comes in.

The FSVP must be developed by a qualified individual, a person with the education, training or experience to do the work. An importer can rely on another entity, other than the foreign supplier itself, for the hazard analysis, evaluation or verification activities, as long as the importer reviews and assesses that documentation.

Do dietary supplement importers need an FSVP?

Yes, with modified requirements. Dietary supplements and their components are food, so FSVP applies, but the rule ties supplements to the existing dietary supplement CGMP regulation (21 CFR part 111):

• An importer that establishes and verifies component and packaging specifications under the supplement CGMPs is not required to meet most of the standard FSVP requirements.
• If the importer’s customer does that work, the importer needs an annual written assurance from the customer.
• Importers of finished supplements that fall under neither case must meet most standard FSVP requirements except the hazard analysis, and their verification focuses on whether the supplier follows the supplement CGMPs.

Allergen labeling is one of the three things FSVP checks. Our food labeling and allergen guide and Supplement Facts vs Nutrition Facts guide cover what the panel and allergen statements need.

Are small importers exempt from FSVP?

Not fully exempt, but they get modified rules. A very small importer averages less than $1 million a year in human food sales plus the U.S. market value of human food it imports or holds, over three years, adjusted for inflation (FDA publishes the current figure). Very small importers skip the full hazard analysis, verify suppliers with written assurances obtained before importing and at least every two years, and document their status by December 31 each year. Some imports are outside FSVP, including juice and seafood under FDA’s HACCP rules, food for personal use, alcoholic beverages and certain USDA-regulated products.

What do you enter at the border for FSVP?

For each line of food offered for import, the entry must give the importer’s name, email address and a unique facility identifier recognized by FDA, which is the DUNS number. Since July 24, 2022, FDA no longer accepts the “UNK” placeholder instead of a DUNS. Our guide to FEI, FDA registration and DUNS numbers explains which number goes where.

FSVP is one of several checks on the same shipment. Most food also needs FDA Prior Notice before it arrives, including food headed to a fulfillment center (see our answer on Prior Notice for Amazon FBA food shipments). The foreign plant usually needs food facility registration with a U.S. Agent, and the entry needs the right FDA product code.

What records does FDA expect, and how long do you keep them?

FDA’s records list covers the hazard analysis, supplier approval, procedures, verification results, corrective actions and reevaluations. Records must be signed and dated when completed or changed and kept for at least two years after they were created or obtained. Off-site records must be retrievable within 24 hours of an FDA request, and FDA can ask for English translations.

FSVP inspections are mostly records reviews, on site or remote; FDA’s Importer Portal accepts uploads after a written request. Significant findings go on Form FDA 483a, and FDA encourages a written response within 15 business days. Unresolved problems can lead to warning letters or detention of entries; see our guides on FDA import detention and import alerts and FDA warning letters for online sellers.

How Eva Commerce helps

Eva Commerce does not act as your FSVP importer or write your hazard analysis. We handle the FDA filings around it: food and supplement facility registration and renewal, U.S. Agent service for foreign facilities ($250 a year), DUNS application support, Prior Notice on each shipment and label review, so your entries carry the right numbers and your labels match what your FSVP verifies. Published prices for every FDA service are on our FDA compliance services page.

Because Eva also runs Amazon, Walmart, TikTok Shop and Shopify growth for food and supplement brands, the import paperwork, the label and the listing stay in step. Book a call or call 858-315-2020 to map who should be your FSVP importer before the next shipment.

Frequently asked questions

What does FSVP stand for?

FSVP stands for Foreign Supplier Verification Programs. It is an FDA rule under the Food Safety Modernization Act that requires U.S. importers of food to verify that their foreign suppliers produce food to U.S. safety standards.

Who is the FSVP importer for food sent to a U.S. fulfillment center?

The U.S. owner or consignee of the food at entry. If a foreign brand still owns the goods and no U.S. company has bought them, the brand needs a U.S. agent or representative to serve as FSVP importer under a signed statement of consent.

Is an FSVP filed with FDA?

No. There is no advance filing, number or approval. The importer keeps a written program and records and identifies itself with its name, email and DUNS number on each food entry. FDA reviews the records during inspections.

Do dietary supplements need an FSVP?

Yes, with modified rules. Importers that meet the supplement CGMP specification duties, or whose customers do, are spared most standard steps. Others follow most standard steps, but their verification centers on the supplier’s supplement CGMP compliance.

How long must FSVP records be kept?

At least two years after they are created or obtained. Off-site records must be produced within 24 hours of an FDA request, and records must be signed and dated when completed or changed.

Can Eva Commerce help with FSVP?

Eva does not serve as FSVP importer, but handles facility registration, U.S. Agent service, DUNS support, Prior Notice and label review for imported food and supplements. Book a call or call 858-315-2020.

Sources: FDA, FSMA Final Rule on Foreign Supplier Verification Programs; FDA, FSVP Key Requirements; FDA, FSVP Regulation Records Requirements; FDA, Am I Subject to FSVP?; FDA, What to Expect During an FSVP Inspection; FDA, FSMA Inflation Adjusted Cut Offs; FDA, FSVP Importer Portal for Records Submission; 21 CFR 1.500 to 1.514. General information, not legal advice.

Related Eva guides: FDA compliance services, FDA Prior Notice guide, FEI vs registration number vs DUNS, import detention and import alerts, do Amazon food sellers need FDA registration, FDA registration and U.S. Agent guide, FSMA 204 traceability guide.