Foreign Supplier Verification Program (FSVP): Requirements and Compliance Support
FSVP makes the U.S. importer responsible for verifying that imported food, beverages and dietary supplements meet U.S. safety standards. We build and maintain FSVP files for importers, Amazon sellers and foreign brands: hazard analysis, supplier verification, records ready for FDA and, where the rule allows, FSVP importer support. We have served 1,000+ companies across 135+ countries, with 15+ years of FDA compliance experience.
Importing food or supplements? Send us your product and supplier list. We will tell you whether FSVP applies, who the FSVP importer should be and what your file needs.
Get FSVP HelpFSVP Meaning in Plain Terms
FSVP stands for Foreign Supplier Verification Program. It was created by Section 301 of the FDA Food Safety Modernization Act (FSMA) and is set out at 21 CFR Part 1, Subpart L. FSMA moved part of the responsibility for imported food safety onto the U.S. importer: instead of relying only on FDA to sample shipments at the border, the importer must verify, in writing, that each foreign supplier controls the hazards in its food.
FSVP is not a registration, a certificate or something FDA approves. There is no FDA form to file and no FDA fee. It is a documented program that the importer keeps on file and produces when FDA asks. See the FDA FSVP rule at a glance for FDA's own summary.
Who Has to Comply
| Situation | Who is the FSVP importer |
|---|---|
| A U.S. company buys food from a foreign supplier | The U.S. buyer, as the owner or consignee at entry |
| A U.S. brand has a foreign co-packer make private-label food | The U.S. brand owner |
| An Amazon, Shopify or eBay seller imports its own inventory | The seller, if it owns the food at entry |
| A foreign company ships to the U.S. with no U.S. buyer at entry | A U.S. agent or representative of the foreign owner, with signed consent |
| A customs broker files the entry | Not the broker, unless it also owns or has agreed to buy the food |
Definitions are in 21 CFR 1.500. The FSVP importer is often, but not always, the importer of record for customs. See importer of record vs. FSVP importer.
What an FSVP Must Include
Choosing the Right Verification Activity
| Hazard situation | What is usually required |
|---|---|
| SAHCODHA hazard controlled by the supplier | Onsite audit before first import and at least annually, unless you document an adequate alternative |
| Other hazards controlled by the supplier | Sampling and testing, review of supplier food safety records, an onsite audit or another suitable activity |
| Hazard controlled by your U.S. customer | Written assurances from the customer instead of supplier verification (21 CFR 1.507) |
| Supplier not meeting U.S. standards | Corrective action, which may mean stopping imports from that supplier |
Onsite audits are relevant again because FDA withdrew its temporary COVID-19 onsite audit policy on June 16, 2026. Under that policy, some importers had used testing or record reviews when travel was impractical.
When FSVP Does Not Apply, or Applies Differently
Exempt
- Juice and seafood covered by FDA HACCP rules (the importer follows those rules instead)
- Food for research or evaluation, when labeled and declared
- Food for personal consumption
- Certain alcoholic beverages and their ingredients
- Food transshipped, or imported for processing and export
- U.S. food returned without further processing
- Meat, poultry and egg products regulated by USDA
See 21 CFR 1.501.
Modified requirements
- Low-acid canned foods: microbiological hazards covered by 21 CFR Part 113 (21 CFR 1.502)
- Dietary supplements and supplement components (21 CFR 1.511)
- Very small importers, generally under $1 million a year in human food (21 CFR 1.512)
- Food from countries FDA recognizes as comparable or equivalent (21 CFR 1.513)
FSVP for Dietary Supplement Importers
Supplements are food under the FD&C Act, so imported supplements and ingredients fall under FSVP, with modified rules in 21 CFR 1.511:
- If you set and verify component specifications under 21 CFR 111.70(b) or (d), most FSVP requirements are replaced by your CGMP obligations. Entry identification still applies.
- If your U.S. customer does that work, you get its written assurance every year and keep records.
- For other supplements, including most finished products, you approve suppliers and verify that they follow the supplement CGMP in 21 CFR Part 111.
Supplement labels and claims are checked separately. See our dietary supplement compliance services.
Common FSVP Problems FDA Finds
What We Do for Importers
FSVP Development
Hazard analysis, supplier evaluation and approval, and verification procedures for each food and supplier, prepared by qualified individuals.
FSVP Importer Support
For foreign owners with no U.S. buyer at entry, we can discuss acting as the U.S. agent or representative FSVP importer with signed consent (21 CFR 1.500).
Entry Data and DUNS
We make sure the importer name, email and DUNS on your entries are correct. See DUNS request assistance.
Ongoing Maintenance
Verification scheduling, review of audits and test results, supplier changes and three-year reevaluations.
FDA Requests and Inspections
Records organized to send promptly when FDA asks, plus help answering findings.
Gap Reviews
Have an FSVP already? Our FSVP gap analysis finds what is missing before FDA does.
How We Build Your FSVP
Using a Friend as Your FSVP Importer vs. Professional Support
| Friend or informal contact | FDA Registration Assistance | |
|---|---|---|
| FDA fee | None | None. You pay only our professional fee |
| Knowledge of FSVP | Usually none | Documented FSVP prepared by qualified individuals |
| FDA records requests | May not answer or may not have records | Records organized and sent promptly |
| Ongoing upkeep | Rarely done | Verification scheduling and reevaluation tracked |
| Best for | Not recommended for commercial imports | Importers who need a reliable, inspection-ready FSVP |
FSVP, Registration and Prior Notice Compared
| Requirement | Who is responsible | When |
|---|---|---|
| FSVP | U.S. importer (FSVP importer) | Before importing, then ongoing |
| Food facility registration | Foreign facility that makes, packs or holds the food | Before export; renewed October to December of even years |
| Prior Notice | Any authorized filer for each shipment | Before each shipment arrives |
| Labeling | Brand owner and importer | Before the product is sold |
Related: foreign food facility registration, Prior Notice filing, HACCP plan review and FSVP guidance for importers.
Get Your FSVP in Order
Send us the foods you import and your foreign suppliers. We will confirm whether FSVP applies, who the FSVP importer should be, what your file needs and the quote for building and maintaining it.
- FSVP for each food and supplier, prepared by qualified individuals.
- Entry data and DUNS checked for every line.
- Optional FSVP importer support where the rule allows.
Contact our specialists, email info@fdaregistrationassistance.com, or call +1 (928) 275-8333. Pricing · FDA food services.
Get FSVP HelpFDA Registration Assistance is a private consulting firm, not FDA or any government agency. FDA registration is not FDA approval, clearance or certification.
Frequently Asked Questions — Foreign Supplier Verification Program (FSVP)
What is a Foreign Supplier Verification Program (FSVP) plan?
An FSVP plan is the written program a U.S. importer keeps to show that each imported food is produced in a way that meets U.S. food safety standards and is not adulterated or misbranded for allergen labeling. It documents the hazard analysis for the food, the evaluation and approval of the foreign supplier, the verification activities chosen, corrective actions and periodic reevaluation, under 21 CFR Part 1, Subpart L.
Who is required to have a Foreign Supplier Verification Program (FSVP) plan?
The FSVP importer must have one. That is the U.S. owner or consignee of the food at entry: the person in the United States who owns the food, has purchased it or has agreed in writing to purchase it. If there is no U.S. owner or consignee at entry, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee, confirmed in a signed statement of consent (21 CFR 1.500). The rule applies unless an exemption or modified requirement fits.
Is a separate Foreign Supplier Verification Program (FSVP) plan required for each product?
FSVP is organized by food and foreign supplier. You need a documented hazard analysis for each food and an evaluation and verification approach for each supplier of that food (21 CFR 1.504, 21 CFR 1.505). Several foods and suppliers can sit in one managed FSVP file, but each food and supplier pairing has to be covered on its own terms.
How quickly can a Foreign Supplier Verification Program (FSVP) plan be created?
Once we have your product details and the supplier's food safety documents, we can usually prepare an FSVP within 7 to 10 business days. Timing depends on how many foods and suppliers are involved, the hazards in each food and how quickly the foreign supplier shares records. We confirm the timeline during intake.
What happens if I don't have a Foreign Supplier Verification Program (FSVP) plan?
Importing food without a required FSVP is a prohibited act under the FD&C Act. FDA can cite the importer after an FSVP inspection (often a Form 483 or a Warning Letter), refuse admission of the food, and place the importer and food on an import alert, such as Import Alert 99-41, for detention without physical examination. See our import alert help page if this has already happened.
How much does Foreign Supplier Verification Program (FSVP) compliance assistance cost?
FDA charges no fee for FSVP. Our professional fee is a custom quote, because the work depends on the number of foods and suppliers, the hazards involved, the verification activities needed, whether we serve as the FSVP importer and how much ongoing maintenance you want. Send your product and supplier list for a written quote.
Can FDA Registration Assistance provide FSVP Agent or FSVP importer support?
Yes. "FSVP Agent" is a common industry term; FDA's rule defines the legal role as the FSVP importer. We prepare and maintain FSVP documentation for importers, and where there is no U.S. owner or consignee at entry, we can discuss serving as the U.S. agent or representative FSVP importer of the foreign owner or consignee with the signed consent the rule requires (21 CFR 1.500).
What information is needed to create a Foreign Supplier Verification Program (FSVP) plan?
We need your company details and your role in the import, a description and ingredient list for each food, foreign supplier names, addresses and contacts, the supplier's food safety documents (such as its food safety plan, HACCP or preventive controls records, audit reports, certificates of analysis and test results), its FDA registration number and any FDA compliance history. We give you a checklist at intake.
How often must a Foreign Supplier Verification Program (FSVP) plan be updated?
Reevaluate promptly whenever you learn new information about a food's hazards or the supplier's performance, and at least every three years if nothing has prompted a reevaluation sooner (21 CFR 1.505). Changing suppliers, a new hazard, a recall or a failed test should trigger a review. Our maintenance service tracks these dates for you.
What is the legal basis for the Foreign Supplier Verification Program (FSVP)?
FSVP comes from Section 301 of the FDA Food Safety Modernization Act (FSMA), which added section 805 to the FD&C Act. FDA's final rule was published November 27, 2015, took effect January 26, 2016 and is codified at 21 CFR Part 1, Subpart L. The first compliance dates began May 30, 2017.
Are there any Foreign Supplier Verification Program (FSVP) exemptions?
Yes. Exempt categories include certain juice and seafood covered by FDA's HACCP rules, food for research or evaluation, food for personal consumption, certain alcoholic beverages, food transshipped or imported for processing and export, U.S. food returned without further processing, and meat, poultry and egg products regulated by USDA at import (21 CFR 1.501). Modified requirements apply to low-acid canned foods, dietary supplements, very small importers and food from countries whose systems FDA recognizes as comparable or equivalent.
What is a DUNS number and why is it required for the Foreign Supplier Verification Program (FSVP)?
A DUNS number is a nine-digit identifier from Dun & Bradstreet. For each line entry of food, the FSVP importer's name, email address and an FDA-recognized unique facility identifier must be sent to CBP at entry (21 CFR 1.509), and FDA currently recognizes the DUNS number for this (FDA UFI guidance for FSVP importers). We can help you get or correct one through DUNS request assistance.
What verification activities are required under the Foreign Supplier Verification Program (FSVP)?
Options include onsite audits, sampling and testing, review of the supplier's relevant food safety records, or other appropriate activities (21 CFR 1.506). For a hazard controlled by the supplier that could cause serious adverse health consequences or death (SAHCODHA), an onsite audit is required before first import and at least annually, unless you document that another approach gives adequate assurance. Onsite audits matter again now that FDA withdrew its temporary COVID-19 onsite audit policy as of June 16, 2026.
Do dietary supplement importers need a Foreign Supplier Verification Program (FSVP)?
Yes, under modified rules in 21 CFR 1.511. If you, or your customer, are required to set and verify component specifications under 21 CFR 111.70(b) or (d) and follow 111.73 and 111.75, most FSVP requirements do not apply beyond entry identification and, where relevant, records. For other imported dietary supplements, including most finished products, you approve suppliers and verify that they follow the supplement CGMP in 21 CFR Part 111. See our dietary supplement compliance page.
What is a hazard analysis under the Foreign Supplier Verification Program (FSVP)?
It is the written evaluation of known or reasonably foreseeable biological, chemical (including radiological) and physical hazards for each food, considering how it is made, its ingredients, the supplier's practices and the intended use (21 CFR 1.504). It decides which hazards need a control and therefore what the supplier must control and what you must verify.
Can FDA Registration Assistance manage my entire Foreign Supplier Verification Program (FSVP)?
Yes. We can run the whole program: hazard analysis, supplier evaluation and approval, verification planning and scheduling, review of audit and test results, corrective action support, three-year reevaluations, records ready for an FDA request, and help with entry data. Where the rule allows, we can also discuss acting as the FSVP importer (21 CFR 1.500).
How much does a Foreign Supplier Verification Program (FSVP) plan cost and what is included?
Fees are custom quoted, because scope varies with the foods, suppliers, hazards, verification activities and support you need. A typical engagement includes intake and a gap review, the hazard analysis and supplier evaluation for each food and supplier, verification procedures and a schedule, a records file ready for FDA, and optional maintenance, reevaluation and FSVP importer support. Your proposal lists exactly what is included.
Can my Foreign Supplier Verification Program (FSVP) Agent be a friend or unrelated party?
Anyone who meets the rule's definition can be the FSVP importer, including a U.S. agent or representative with signed consent when there is no U.S. owner or consignee (21 CFR 1.500). The role carries real legal responsibilities, though: hazard analysis, supplier verification, records and answering FDA. A friend who does not understand those duties creates risk for your shipments.
What happens if my Foreign Supplier Verification Program (FSVP) Agent doesn't respond to the FDA?
FDA expects the FSVP importer to produce records promptly when asked (21 CFR 1.510). If the importer cannot be reached or cannot produce an adequate FSVP, FDA can treat it as out of compliance. That can lead to refusal of admission and placement on an FSVP import alert for detention without physical examination until the issue is fixed.
How do I change my Foreign Supplier Verification Program (FSVP) Agent on an existing registration?
FSVP is not filed or registered with FDA, so there is nothing to amend at FDA. Update your FSVP records to name the new FSVP importer, make sure it has the files and signed consent where needed, and have your customs broker send the new importer's name, email and DUNS number on every line entry from then on (21 CFR 1.509).
Do I need a Foreign Supplier Verification Program (FSVP) if I only import food samples for trade shows?
Possibly not, but only if the shipment meets the research or evaluation conditions in 21 CFR 1.501. The food must not be for retail sale or distributed to the public, must be labeled "Food for research or evaluation use," must be imported in a small quantity used only for that purpose, and the entry must include a declaration saying so. Samples handed out to the public at a trade show do not meet that exemption automatically.
Does the Foreign Supplier Verification Program (FSVP) apply if I sell imported food on Amazon, Shopify, or eBay?
Yes. If you are the U.S. owner or consignee of the imported food at entry, you are the FSVP importer whether you sell through Amazon, Shopify, eBay, Walmart or your own website. Selling online does not change the rule. See FSVP for Amazon sellers.
Is the Foreign Supplier Verification Program (FSVP) required for cosmetics or supplements that are not food?
FSVP covers food, so it does not apply to cosmetics or other non-food products. Dietary supplements are food under the FD&C Act, so imported supplements are covered, but under modified requirements focused on the supplement CGMP in 21 CFR Part 111 (21 CFR 1.511).
Can one Foreign Supplier Verification Program (FSVP) plan cover multiple products from the same supplier?
Yes, if the program covers each food on its own terms. One FSVP file can include several products from the same supplier, but each food needs its own hazard analysis, and the verification activities have to match the hazards in that food. Similar foods with the same hazards can share analysis where that is justified and documented.
What is the difference between the Foreign Supplier Verification Program (FSVP) and Foreign Food Facility Registration?
FSVP is an importer duty: the U.S. importer verifies that the foreign supplier's food is safe. Food facility registration is a facility duty: the foreign plant that makes, packs or holds the food registers with FDA and names a U.S. Agent. Most imports need both, plus Prior Notice filing for each shipment. See foreign food facility registration.
Can the Foreign Supplier Verification Program (FSVP) importer be located outside the United States?
The FSVP importer is the person in the United States who owns or has agreed to buy the food at entry, or, if there is none, the U.S. agent or representative of the foreign owner (21 CFR 1.500). A foreign company with no U.S. presence cannot serve as its own FSVP importer and needs a U.S. party in that role.
How does the FDA verify that an importer has a Foreign Supplier Verification Program (FSVP) plan in place?
FDA checks entry data, including the FSVP importer's name, email and DUNS number on each line (21 CFR 1.509), and inspects importers. Many FSVP inspections are done remotely: FDA asks in writing for records to be sent electronically, which the importer must do promptly (21 CFR 1.510). FDA can also inspect at the importer's U.S. location.
Does the Foreign Supplier Verification Program (FSVP) apply to private-label or co-manufactured imported food?
Yes. If you own or have agreed to buy private-label or contract-manufactured food at entry, you are normally the FSVP importer. You must analyze the hazards and verify the foreign contract manufacturer as your supplier, even if the product carries your brand.
What is the address requirement for a Foreign Supplier Verification Program (FSVP) importer?
At entry, the rule asks for the FSVP importer's name, email address and DUNS number on each line entry (21 CFR 1.509). The importer also has to be a person in the United States, and FDA needs to reach it for records requests and inspections, so the DUNS should be tied to the importer's real U.S. business address and contact details.
What is the penalty for repeated Foreign Supplier Verification Program (FSVP) violations?
Repeat FSVP violations usually escalate. They can lead to Form 483 observations, a Warning Letter, refusal of admission and placement on an FSVP import alert, with detention without physical examination until FDA is satisfied. Under the FD&C Act, serious cases can also bring injunctions or prosecution.
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