FSVP means foreign supplier verification program. It is the written program a food importer uses to make sure each foreign supplier is producing food that meets U.S. safety rules. Shehadeh Giannamore, PLLC represents importers and foreign manufacturers when FDA holds a shipment or questions whether the supplier was checked before the food was offered for entry.
The rules are in 21 CFR Part 1, Subpart L, sections 1.500 through 1.514. For each food you import, you develop, maintain, and follow an FSVP, unless an exemption applies. The program has to give adequate assurances that the supplier’s processes provide at least the same level of public health protection as U.S. preventive controls or produce-safety standards, when those apply, and that the food is not adulterated and, when the allergen rule applies, not misbranded.
What FSVP means
FDA wrote the program under the FDA Food Safety Modernization Act. The point is to move the check to the importer, before the food is in a U.S. warehouse. Section 1.502 says the importer’s program must cover the foreign supplier’s compliance with processes that match section 418 of the Food, Drug, and Cosmetic Act, on hazard analysis and preventive controls, or section 419, on produce safety, if either applies. It also covers section 402, on adulteration, and section 403(w), on allergen labeling, when that section applies.
“Food” here includes food for humans and animals, and articles used as components of food. Dietary supplements are food under the statute, so an importer of a dietary supplement can have FSVP duties, with the modifications the rule sets for that category. FDA’s definition excludes pesticides. A cosmetic, a drug, or a device is not in this program just because it crosses a border.
A qualified individual must develop the FSVP and perform the activities the subpart requires. That is 21 CFR 1.503. This person is not automatically the preventive controls qualified individual at a U.S. plant. The FSVP role is about the foods you import and the suppliers you approve.
Who the FSVP importer is
The FSVP importer is the U.S. owner or consignee of the food at the time of entry. If there is no U.S. owner or consignee at that time, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee, as the regulation defines that role. The name is declared at entry.
That person is often not the importer of record for Customs and Border Protection. FDA’s participant list, current as of October 20, 2026, says so in those words. Being listed as an FSVP importer does not mean FDA approved you. A customs broker can file the entry. The broker does not, by filing, become the person who evaluated the supplier.
If your company is named at entry, your company needs the program for that food. A supplier’s packet in another country is useful only if your qualified individual used it in your FSVP. Pointing at the foreign plant’s certificate, with no evaluation of your own, is not the program.
What importers must verify
You approve the foreign supplier. You have written procedures so you import the food only from suppliers you have approved, or, when a temporary unapproved supplier is allowed, under the conditions the rule spells out. Approval is by food and by supplier, not a one-time vendor form for the whole catalog.
The verification activities have to give assurance that the hazards requiring a control in that food have been significantly minimized or prevented. You decide which activities fit the risk. Typical activities in an FSVP are an onsite audit, sampling and testing, and a review of the supplier’s food-safety records. The rule does not make every importer run an audit of every shipment. It does make you choose an activity that matches the hazard, write it down, and do it.
You also look at the supplier’s compliance history. A warning letter, an import alert, or another FDA action about that supplier belongs in the evaluation. A clean invoice does not erase a listed alert.
Very small importers, and importers of certain foods from certain small foreign suppliers, can use a modified program under 21 CFR 1.512 if they document that they qualify. For a very small importer who chooses that section, the verification piece includes a written assurance from the supplier, obtained before the food is imported and at least every two years after that. This article does not restate the sales cutoff. The cutoff is in the definition, and using the wrong year’s sales is how companies claim an exemption they do not have.
How FSVP differs from an import alert and from VQIP
An import alert is an enforcement list. It tells FDA and the port that a product or a firm may be detained without physical examination. It is what happens when a problem is already in the system. FSVP is the program you were supposed to be running before that entry. FDA import alerts and food import rules explains detention, reconditioning, and removal. It is not a substitute for the supplier evaluation.
VQIP, the Voluntary Qualified Importer Program, is a separate FDA program for expedited review. Joining it is optional. The older post on diligence and FDA imports describes VQIP benefits and the quality-assurance application. Those benefits are not the FSVP duties, and the fee discussion in that post is from that article’s time. Do not read it as the current FSVP text.
Prior notice is also separate. It is the electronic notice before the food arrives. Facility registration is separate again. A foreign food facility registers with FDA. The FSVP importer still has to verify the supplier. Registration, prior notice, and FSVP can all be missing on the same shipment, and FDA can refuse the food for any one of them.
What the file should contain
Keep the program in writing, food by food and supplier by supplier. Include the hazard analysis for the food, the evaluation of the supplier, the approval, the verification activity you chose, and the result. Sign and date the records when you complete them and when you change them. Store them so they stay legible.
When the hazard is one the supplier controls, your record should show how you know the control worked. An audit report from three years ago, for a different food, does not do that. When you rely on a written assurance under the very-small-importer option, keep the assurance and the document that shows you still qualify for that option.
FDA can ask for these records. If the entry names you and you cannot produce the evaluation, the practical result is a held shipment and a harder conversation about the next one. Import services for detentions, refusals, and import alerts are the response after the hold. The FSVP is the work that was due before the ship left.
Questions about FSVP importer requirements
What is FSVP?
A foreign supplier verification program. Under 21 CFR 1.502, an importer develops, maintains, and follows a program for each food imported, so the foreign supplier’s process provides the same level of public health protection as applicable U.S. preventive-controls or produce-safety rules, and the food complies with adulteration rules and, when they apply, allergen labeling.
Who must comply?
The FSVP importer named for that entry, unless an exemption applies. That is the U.S. owner or consignee at the time of entry, or the U.S. agent or representative if there is none. It is not automatically the customs importer of record or the broker.
What must you verify about the foreign supplier?
That you have approved the supplier for that food, that hazards requiring a control have been significantly minimized or prevented, and that the supplier’s history, including warning letters and import alerts, was part of the evaluation. You need written procedures and a record of the activity you performed.
Is a supplier certificate enough?
No. A certificate can be one document in the file. The qualified individual still has to evaluate the supplier and the food, approve the supplier, and follow the verification activity the risk calls for.
Do very small importers skip FSVP?
No. They may use the modified requirements in 21 CFR 1.512 if they document eligibility. That path still requires a written assurance from the supplier before import and at least every two years, plus the sections of the rule that still apply.
Does FSVP apply to drugs and cosmetics?
This program covers human food, animal food, and dietary supplements, as the FSVP rules define food. Drugs, devices, and cosmetics follow other import rules. A product marketed as a food can still be detained as a drug if the claims make it one.