FSVP for Food Importers: Who Owns It and What FDA Checks

Every commercial food line that enters the United States names an FSVP importer, and FDA uses that name to decide whom to inspect. The Foreign Supplier Verification Program (FSVP) rule in 21 CFR part 1, subpart L, makes that company responsible for showing, in writing, that each foreign supplier produces each food to US safety standards. Most enforcement problems start before any food safety question is asked: the wrong company is named at entry, the DUNS number belongs to the broker, or nobody can produce the file when the investigator calls.

This guide is for importers of food ingredients, spices, ready-to-cook products such as noodles and sauces, and food-tech inputs such as protein concentrates: who the FSVP importer is, the verification work, the exemptions, the entry data FDA checks, the 2026 duty on typical lines and what an FSVP inspection asks for.

Who Is the FSVP Importer, and When It Is Not the Customs Importer

Under 21 CFR 1.500, the FSVP importer is the US owner or consignee of the food at the time of entry. If there is no US owner or consignee, it is the US agent or representative of the foreign owner or consignee, confirmed in a signed statement of consent. The definition follows ownership of the goods, not the customs filing, so the FSVP importer and the importer of record are often different companies.

A US brand buying delivered-duty-paid from an overseas exporter that acts as importer of record is still the US owner, and is still the FSVP importer. A foreign seller that ships on consignment to a US warehouse with no US buyer at entry has to designate a US agent as FSVP importer before the food is offered for import (21 CFR 1.509(b)); a non-resident importer structure does not change that. A customs broker that files the entry is not the FSVP importer unless it has signed on as the foreign owner’s US agent and accepted the obligations that come with it.

Manufacturers that import their own ingredients get a shortcut. A receiving facility under the preventive controls rules (21 CFR part 117 or 507) that controls the hazards itself, or runs a compliant supply-chain program for that ingredient, is deemed in compliance with FSVP for that food except for the entry identification in 1.509 (21 CFR 1.502(c)). A food-tech plant that imports a protein isolate and controls its hazards in its own process can rely on its part 117 program, but must still be named on every entry line.

Hazard Analysis, Supplier Evaluation and Verification Activities

The FSVP is built per food and per foreign supplier. Importing one ingredient from three suppliers means three programs, and importing twenty foods from one supplier means twenty. Each must be developed and run by a qualified individual: someone with the education, training or experience for the task who can read the language of the records reviewed. That person can be a consultant or a foreign government employee; it does not have to be on the importer’s payroll (21 CFR 1.500, 1.503).

Step 1: a written hazard analysis

The importer identifies and evaluates the known or reasonably foreseeable hazards in each food: biological, chemical (including radiological hazards, pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives and allergens) and physical hazards. It must also consider hazards introduced on purpose for economic gain, which is how ingredient substitution and dilution enter the analysis (21 CFR 1.504). The analysis is written even when it finds nothing. If it concludes that no hazard requires a control, the evaluation and verification steps fall away (1.504(f)). The importer may adopt a supplier’s or consultant’s analysis if it reviews it and documents that a qualified individual prepared it.

Step 2: evaluation and approval of the supplier

Before approving a supplier, the importer weighs the hazard analysis, who in the chain actually controls each hazard, the supplier’s procedures, its FDA compliance history including any warning letter or import alert, and its record on testing, audits and corrective actions (21 CFR 1.505). The evaluation is reevaluated whenever new information arrives and at least every three years. Approval is documented, and written procedures must ensure food comes only from approved suppliers.

Step 3: verification activities

The importer chooses, documents and repeats one or more verification activities: an onsite audit by a qualified auditor, sampling and testing, review of the supplier’s food safety records, or another appropriate activity (21 CFR 1.506). Where the supplier controls a hazard that can cause serious adverse health consequences or death, the default is an onsite audit before the first shipment and at least annually, unless the importer documents why another activity gives adequate assurance. An FDA inspection, or one by the authority of a country FDA recognizes as comparable or equivalent, within the past year can substitute for the audit.

Two limits trip importers up. The supplier cannot verify itself, except for sampling and testing (1.506(e)(2)(ii)), so a certificate of analysis alone is a test result, not an audit. And whoever performs verification must have no financial conflict of interest, with payment not tied to the outcome.

When the customer controls the hazard

When a food cannot be eaten without a control step, such as coffee or cocoa beans, or a customer will apply the control, the importer can skip supplier evaluation and verification if it documents that the food cannot be consumed without the control or, where it relies on a customer, discloses on the documents accompanying the food that it is “not processed to control” the named hazard (21 CFR 1.507). The rule also calls for annual written assurances from the customer, but FDA’s enforcement policy guidance states it will exercise enforcement discretion on those written assurances, including under 1.507, pending a new rulemaking. The disclosure statement is still required.

Exemptions and Modified Requirements for Small Importers and Certain Foods

Some imports sit outside FSVP entirely, and some qualify for a lighter program. The difference matters at entry because exempt lines must be declared as exempt, not left blank.

• Juice and seafood from suppliers in compliance with the HACCP rules in 21 CFR parts 120 and 123 (the importer follows 120.14 or 123.12 instead).
• Meat, poultry and egg products under USDA jurisdiction at import.
• Food for research or evaluation: labeled “Food for research or evaluation use”, small quantity, not sold, declared electronically at entry. Food-tech R&D samples are the typical case.
• Food transshipped through the US, or imported for processing and export, and not sold in the US; certain alcoholic beverages; US food returned unprocessed.
• Low-acid canned food is only partly covered: FSVP still applies to hazards other than the microbiological hazards controlled under 21 CFR part 113.

Very small importers and small suppliers

A very small importer of human food averages under $1 million a year, adjusted for inflation and counting affiliates, in human food sales plus the US market value of human food imported or held without sale (21 CFR 1.500). FDA’s inflation-adjusted figure for the 2023 to 2025 window is $1,372,952. It documents its status before importing and by December 31 each year, and obtains a written assurance from each supplier before importing and at least every two years (21 CFR 1.512). It skips hazard analysis, evaluation and verification, but still needs a qualified individual and still has to be identified at entry. The same modified program covers food from small suppliers such as qualified facilities under part 117, non-covered produce farms and egg producers with fewer than 3,000 laying hens.

A separate modified program covers food not intended for further processing (packaged food, or raw commodities eaten without commercial processing) from a supplier in a country whose food safety system FDA has officially recognized as comparable or equivalent, provided the supplier is in good compliance standing and the food is within the scope of the recognition (21 CFR 1.513).

The FSVP Identifier on the Entry and What CBP and FDA Check

For each line of food offered for import, the FSVP importer‘s name, email address and an FDA-recognized unique facility identifier must be transmitted electronically when entry is filed with CBP (21 CFR 1.509(a)). FDA recognizes the DUNS number as that identifier. It is free, but FDA’s guidance says it usually takes a few business days but can take 45 days or more in some cases, and an importer that cannot provide one should contact FDA’s Division of Import Operations before shipping.

In ACE the data goes in the FSVP Importer (FSV) entity. FDA’s March 10, 2026 quick reference to the ACE Supplemental Guide makes it mandatory unless certain industry codes are present or an exemption is declared in the Affirmation of Compliance with code FSX (FSVP exempt) or RNE (research and evaluation). When the FSV entity is sent, email and DUNS are mandatory. Common errors: the broker’s or shipper’s DUNS in place of the importer’s, an unmonitored mailbox, and a US buyer that does not know it was named.

The data is how FDA finds the importer later. FDA’s own fact sheet says the investigator contacts the entity identified at entry and will conduct the inspection at the address transmitted at entry even if contact fails. The FSVP line data is separate from FDA prior notice and from the supplier’s FDA registration, although all three are reviewed together. If FDA concludes the importer is not complying, the food is subject to refusal of admission under section 801(a)(3) of the FD&C Act, and importing without a compliant FSVP is a prohibited act under section 301(zz) (21 CFR 1.514). What a refusal or detention looks like in practice is covered in our FDA detention guide.

Duty on Typical Food Ingredient Lines in 2026

FSVP is a records obligation, not a filing, but the same supplier choice also sets the duty, and in 2026 the duty spread between origins is wide. Spices such as whole pepper and turmeric are exempt from the Section 301 forced labor duty under U.S. note 52(b), while processed foods carry it. Model your own lines with the China to US tariff calculator before committing to a supplier.

Reading the table

China additional combines Section 301 List 3 (25%) or List 4A (7.5%), confirmed per line in HTS chapter 99, with the 12.5% Section 301 forced labor tariffs where they apply. India additional is the 10% forced labor duty, or zero for spices exempt under note 52(b). AD/CVD duties and any product exclusions are not included.

FSVP Records and an FDA FSVP Inspection

FSVP records are signed and dated when completed and whenever modified, kept as originals, true copies or electronic records, and retained for at least two years; records of procedures, evaluations and determinations are kept for two years after they stop being used (21 CFR 1.510). They can be stored off site, including with a consultant, if they can be produced within 24 hours of a request, and an English translation must be provided within a reasonable time when FDA asks. FDA can also require the records to be sent electronically, which is the legal basis for remote FSVP inspections.

FDA’s fact sheet lists three inspection triggers: routine surveillance, follow-up on an earlier violative inspection, and products linked to a recall, outbreak or complaint. The investigator first contacts the importer named at entry and asks whether records are on site and in English. Records are requested in writing on Form FDA 482d, significant findings are issued on Form FDA 483a, FSVP Observations, and FDA encourages a written response with corrected records within 15 business days.

What the file should contain per food and supplier

Investigators work from FDA’s list of FSVP records. In practice the file per food and supplier should hold:

• The written hazard analysis, or the documented review of someone else’s, with the qualified individual identified.
• The supplier evaluation, approval and the date of the last reevaluation (three years at most).
• The written procedures for using approved suppliers and for verification.
• Verification records: audit reports with auditor qualifications, test results with lot, method and lab, or record reviews, each with the importer’s review of the results.
• Corrective actions taken, and any 1.507 disclosure statements.
• For very small importers: the annual status documentation and supplier assurances, plus three years of records supporting the status.

Where a broker fits

Where a US owner or consignee exists, the FSVP obligation stays with it whatever the purchase contract says, but the entry data and the paper trail can be run by a broker. Our food and beverage logistics team works as a licensed customs broker on FSVP line data, prior notice and FDA holds for ingredient and packaged-food importers. High-volume importers should know that FSVP compliance is an eligibility condition for the Voluntary Qualified Importer Program, which offers expedited entry and carries a FY2027 user fee of $9,994 (91 FR 48125).

Frequently Asked Questions