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Foreign Supplier Verification Programs

The Foreign Supplier Verification Programs rule, 21 CFR part 1 subpart L, puts the duty to verify imported food on the United States importer: for every food and every foreign supplier, the importer must know the hazards, evaluate the supplier, approve it and verify that its food is made to the standard a domestic producer would be held to.

What it is
FSMA final rule
Where it lives
21 CFR part 1, subpart L
Final rule
November 2015
Effective
January 26, 2016
Docket
FDA-2011-N-0143
Published by
U.S. Food and Drug Administration

Who it covers

The importer, which the rule defines as the United States owner or consignee of a food offered for import, or, where there is none, the United States agent or representative of the foreign owner, confirmed by a signed statement of consent. It is not the foreign supplier and it is not the customs broker.

It reaches food for humans and for animals. Since July 24, 2022 every line entry of food offered for import has had to carry the importer's name, e-mail address and a unique facility identifier, for which the FDA accepts a DUNS number.

What it requires

An FSVP for each food from each foreign supplier: the same food from three suppliers is three programs, and thirty foods from one supplier is thirty. Each one covers a hazard analysis of the food, an evaluation of the risk the food poses and of the supplier's performance, approval of the supplier on the strength of that evaluation, verification activities matched to the risk, and corrective action when something goes wrong. The evaluation has to be redone at least every three years, or sooner when new information about the hazard or the supplier arrives.

The standard the importer is verifying against is the domestic one: that the food was produced with the same level of public health protection as the preventive controls or produce safety rules require, that it is not adulterated, and that it is not misbranded with respect to allergen labelling.

An importer that is also a manufacturer can be deemed in compliance with most of FSVP through the supply-chain program of its own food safety plan, and an importer whose customer will control the hazard can rely on written assurance from that customer, provided it discloses on the documents accompanying the food that the hazard has not been controlled.

In the FDA’s words

“For the purposes of FSVP, an importer is the U.S. owner or consignee of a food offered for import into the United States.”

U.S. Food and Drug Administration, FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals, updated 2026-05-01. Read 2026-09-16.

Not the foreign supplier and not the broker. The obligation lands on whoever owns the food when it arrives.

“If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers. Similarly, if the importer obtains many different foods from a single supplier, a separate FSVP would be required for each food.”

U.S. Food and Drug Administration, FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals, updated 2026-05-01. Read 2026-09-16.

One program per food per supplier. The count of programs an importer needs is the product of the two, not the sum.

“The evaluation of the risk posed by the imported food and the supplier's performance must be reevaluated at least every three years, or when new information comes to light about a potential hazard or the foreign supplier's performance.”

U.S. Food and Drug Administration, FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals, updated 2026-05-01. Read 2026-09-16.

A supplier's recall is new information about its performance, which is what makes the recall records on this site relevant to an importer's file.

Compliance dates

All compliance dates for the FSVP rule have passed.

The dates are the FDA’s, as stated on FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals, updated 2026-05-01, read 2026-09-16. Compliance dates have been extended before; check that page before planning against any of them.

Exemptions

Juice and seafood already under the HACCP rules, food imported for research or personal consumption, alcoholic beverages, and food transshipped or imported for export are outside the rule. Dietary supplement importers who verify the specifications the supplement good manufacturing practice rule requires are relieved of most of the standard requirements. Very small importers, and food from certain small foreign suppliers, are subject to the modified requirements of section 1.512.

Where it is in 21 CFR

The rule is codified at 21 CFR part 1, subpart L, General Enforcement Regulations. Title 21 is a work of the United States government and in the public domain, so the regulation is reproduced in full on this site. These are the sections a reader of this page most often needs.

What goes wrong in practice

A rule describes the controls; the FDA’s recall records are what happened where a control was missing. These are the hazards and the kinds of food whose records this rule is most often written against.

Questions

Who is the importer under FSVP?
The United States owner or consignee of the food at the time of entry. If there is no United States owner or consignee, the importer is the United States agent or representative of the foreign owner or consignee, confirmed in a signed statement of consent. The obligation sits with that party, not with the foreign supplier or the broker.
Does an importer need a separate FSVP for each product?
Yes. The rule requires an FSVP for each food and each foreign supplier of that food. Obtaining one food from several suppliers means a program for each supplier, and obtaining many foods from one supplier means a program for each food.
How often must an FSVP supplier evaluation be redone?
At least every three years, and sooner whenever new information comes to light about a potential hazard in the food or about the foreign supplier's performance.

The other FSMA rules

FSMA is enforced as 10 rules, and a single business frequently sits under several. The Act itself, and how the rules fit together.

An inspection under this rule asks for the records behind each requirement, and finding them is the work. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.