The FSVP importer is a food’s U.S. owner or consignee at entry or, absent one, a U.S. agent or representative who signed a consent statement. You make sure each food line reaches U.S. Customs and Border Protection (CBP) with that importer’s name, email address and DUNS number. You also decide what goes in each food and supplier file and what your supplier contracts cover.
FDA’s guidance says others may help under your review, but you stay responsible for the program, so I’d settle these choices before FDA asks. At OFW Law, which has a food and agriculture practice, we review who is named as FSVP importer and how complete each FSVP file is. FSVP is one part of what FDA compliance requires of a food importer.
What FSVP Means and What It Asks of the Importer
FSVP stands for Foreign Supplier Verification Programs, FDA’s rule for imported human and animal food at 21 CFR Part 1, Subpart L. It rests on section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA Food Safety Modernization Act added that section.
FDA published the final rule on November 27, 2015, and says every compliance date has passed. The importer must develop, maintain and follow an FSVP for each food it imports, and for each foreign supplier of that food. The program must give adequate assurances about the supplier and the food.
Where FDA’s preventive controls or produce safety rules apply, supplier processes must give at least the same public health protection those rules require. The food also can’t be adulterated or misbranded for major food allergen labeling.
Supplier documents can feed that file, but the importer can’t rely on the supplier or its staff for verification beyond sampling and testing. FDA’s January 2023 guidance is nonbinding. Still, it shows how the agency reads its rule, so treat guidance points below as FDA’s stated position.
Who the FSVP Importer Is, and Whose Name Belongs on the Entry
Ownership at the Time of Entry Decides It
The regulation defines the importer as the U.S. owner or consignee of the food. At the time of U.S. entry, that person owns the food, has bought it, or has agreed in writing to buy it. FDA has said the time of entry is when the entry goes to CBP.
FDA’s guidance says the importer must be based in the United States. If there’s no U.S. owner or consignee at entry, the foreign owner or consignee must name a U.S. agent or representative before import. The designee becomes the FSVP importer, and the designation is valid only once that person signs a statement agreeing to serve as the FSVP importer.
The FSVP Importer and the Importer of Record Can Differ
FDA’s guidance says the FSVP importer may be the CBP importer of record, but isn’t necessarily. FDA reasoned that the U.S. owner or consignee “is more likely to have knowledge of food safety practices and control over the supply chain of an imported food than a customs broker, who often is the importer of record of a food for CBP purposes.”
Here’s how FDA describes each role.
| Role | What FDA says about it |
|---|---|
| FSVP importer | The U.S. owner or consignee at entry or, absent one, a U.S. agent who signed a consent statement. FDA holds it responsible for the FSVP. |
| CBP importer of record | Per FDA, CBP doesn't require it to verify the food was produced under U.S. food safety requirements. FDA also notifies it of detained entries. |
| Customs broker | FDA says brokers often serve as the importer of record and may transmit the importer's DUNS number to CBP on the importer's behalf. |
Check the Identifiers on Every Line
Each food line must carry the importer’s name, email address and an FDA-recognized unique facility identifier. The importer must see that CBP gets these electronically at filing. FDA recognizes the DUNS number for this, and its guidance says CBP has rejected FSVP lines missing it since July 24, 2022.
The guidance adds that the number must match the importer’s U.S. location. Each food line should name the owner or consignee at entry, or where there’s none, a U.S. agent who signed a consent statement. Pull a sample of recent entries and fix any line that doesn’t.
Route the email address to someone who reads it. FDA’s guidance says it may email that address to tell a company it’s been named as FSVP importer and ask it to confirm. Our guide to importing human food into the U.S. walks through the other FDA import steps.
FSVP Requirements for Each Food and Supplier, and What Is Exempt
A qualified individual, who needn’t be your employee, must develop the program and perform each required activity. The person needs the education, training or experience for the work. They must also read and understand the language of the records they review.
The file starts with a hazard analysis for each type of food, and it must be in writing whatever it finds. Your analysis must cover known or reasonably foreseeable biological, chemical (including radiological) and physical hazards. The regulation expressly includes hazards that “may be intentionally introduced for purposes of economic gain.”
A supplier’s analysis counts if a qualified individual did it and you document your review.
You approve each supplier in writing after a documented review of the hazard analysis, who controls each hazard, and how the supplier performs. Performance covers the supplier’s food safety procedures, history and any FDA warning letter, import alert or other FDA food safety action. Reevaluate promptly on new facts, and at least every 3 years.
Before importing, you pick your verification steps and how often to do them, in writing. The options are onsite audits, sampling and testing, a review of the supplier’s food safety records, and other suitable checks. When a supplier falls short, you promptly take and document corrective action.
Some hazards the supplier controls carry a reasonable probability of serious adverse health consequences or death. For those, you conduct an onsite audit or obtain documentation of an onsite audit before first import and at least annually after. An adequate written determination that other steps or fewer audits give adequate assurances can replace that schedule.
Section 1.507 drops supplier evaluation and verification in two cases. One is food that can’t be consumed without application of a control, such as cocoa beans and coffee beans. The other is where you rely on your customer or a later entity to control the hazard.
The hazard analysis and the rest of the program still apply. In those reliance cases, documents accompanying the food must disclose that it is “not processed to control [identified hazard]”.
Exemptions and Modified Routes
Each one below comes with a condition worth checking.
| Category | What applies, and on what condition |
|---|---|
| Exemptions | |
| Juice and seafood | Outside Subpart L when the supplier must follow, and is following, FDA's juice or seafood HACCP rules. You meet 120.14 or 123.12 instead. |
| Food for research or evaluation | Exempt only if all four conditions are met, including a "Food for research or evaluation use" label |
| Personal consumption | Exempt only for a small, non-commercial quantity not sold or distributed to the public |
| Alcoholic beverages | Exempt when the supplier would need a Treasury permit or registration if domestic and must register with FDA as a maker of alcoholic beverages |
| Transshipment, or import for processing and export | Exempt if not sold or distributed to the public in the United States |
| U.S. food exported and returned | Exempt if not further manufactured or processed abroad |
| Meat, poultry and egg products | Exempt when subject to USDA requirements at the time of importation |
| Modified routes | |
| Low-acid canned food | You verify and document production under part 113 for its microbiological hazards. An FSVP covers every other matter. |
| Receiving facilities under the preventive controls rules | Deemed in compliance when the listed part 117 or 507 requirements are met, except identification at entry, which still applies |
| Dietary supplements (1.511) | Most FSVP elements don't apply when you or your customer set and verify part 111 specifications. Other importers skip hazard analysis, verifying against part 111. |
| Very small importers, certain small foreign suppliers (1.512) | Preventive controls qualified facilities, farms outside the produce safety rule and shell egg producers under 3,000 laying hens qualify. Get written supplier assurance before importing each food and at least every 2 years, and 1.502, 1.503 and 1.509 still apply. |
| Food from comparable or equivalent systems (1.513) | Only food not meant for further manufacturing or processing qualifies. Sections 1.503, 1.509 and 1.510 still apply, plus yearly documentation and a supplier compliance check. |
The very small importer test counts sales plus the U.S. market value of food imported, manufactured, processed, packed or held without sale. FDA’s current inflation-adjusted cutoffs for the 2023 to 2025 average are $1,372,952 for human food and $3,432,379 for animal food. Subsidiaries and affiliates are included, and FDA updates the cutoffs each April.
How an FDA Inspection and Records Request Unfold
FDA said it would enforce overall FSVP compliance by inspecting U.S. importers and reviewing their records, rather than shipment by shipment at the port. The agency’s inspection fact sheet says routine surveillance and a prior violative inspection can each lead to one. So can a recall, foodborne outbreak investigation or complaint involving your products.
- To set up a first inspection, the investigator emails or calls the person or entity identified at entry as the FSVP importer. If those attempts fail, FDA still plans to inspect at the address transmitted at entry.
- The investigator then requests records in writing on Form FDA 482d.
- You provide records at your place of business. If FDA asks in writing, you send them electronically or by another means that delivers them promptly. You can upload them through FDA's FSVP Importer Portal.
- Significant observations are given to you in writing on Form FDA 483a.
| Situation | What applies |
|---|---|
| FDA asks to see your records | Make them available promptly. Form FDA 482d and the regulation set no number of hours or days. |
| Records held offsite, including by other entities | They must be retrievable and provided onsite within 24 hours of a request for official review. |
| FDA asks in writing that you send records | FDA's guidance says it "will generally expect" them within 72 hours. FDA counts from 12 a.m. on the next business day after delivery is signed for or the email is opened. |
| Records in another language | An English translation within a reasonable time, which FDA's guidance ties to the records' number, length and complexity |
| How long to keep records | At least 2 years after they are created or obtained. Procedures and evaluations stay at least 2 years after their use ends, such as after you stop using a supplier. |
Without a read receipt, FDA’s guidance says it generally assumes an emailed request was read within one business day. Importers who need more time should contact FDA, the guidance adds. The same guidance treats a failure to respond to a records request as a violation in itself.
When FDA Finds the Program Falls Short
Your response to a 483a is the next decision you control. FDA’s fact sheet says the agency “highly encourages” a written response within 15 business days after the inspection. The fact sheet also encourages new and updated records and evidence of corrections.
FDA’s guidance says the agency weighs your corrections when deciding on further steps, such as a warning letter or an import alert. FDA’s FSVP compliance program also tells its divisions when to escalate. They should consider recommending a warning letter when an importer didn’t respond to a 483a or fix significant violations.
If the fixes after that notice still fall short, they should consider putting the importer on the Red List of Import Alert 99-41. The listing lets FDA detain the named importer’s listed food without physical examination. Food is also subject to refusal of admission if it appears the importer isn’t complying with Subpart L.
Refused food must be exported or destroyed. Importing or offering food for import without a compliant FSVP is a prohibited act under section 301(zz) of the FD&C Act. If FDA detains an entry, its guidance says the Notice of FDA Action goes to the importer of record and the entry filer.
The importer of record may or may not be the FSVP importer. Our articles on dealing with FDA warning letters and goods detained by U.S. Customs cover those stages in more depth.
What We Advise Doing Before FDA Asks
Supplier Contract Terms We Recommend
FDA doesn’t prescribe supplier contract terms. Several FSVP duties depend on records your supplier holds or access it controls, so we advise building the following terms into your supplier agreements.
- Access to the supplier’s food safety records fast enough for the 24-hour offsite rule and FDA’s 72-hour expectation for written requests. You needn’t keep records of verification others perform if you can get them and make them available to FDA.
- Cooperation with onsite audits by a qualified auditor, or copies of qualifying inspection results. Written results of an appropriate inspection by FDA or another qualifying authority within a year of the audit’s due date can stand in.
- Timely notice of any FDA warning letter, import alert or other FDA action against the supplier. You must weigh those actions when you approve and reevaluate the supplier.
- Help with English translations when FDA requests them.
- Support for corrective action, including your right to stop buying until a problem is fixed.
- On the very small importer route, the supplier’s written assurance before you import each food and at least every 2 years after.
No contract guarantees that FDA will find a program adequate.
A Short Checklist to Run Now
Start by confirming that the records you believe are on file are in fact there.
- Whose name, email address and DUNS number appear on each food line, and whether the DUNS number matches your U.S. location
- That company's role as U.S. owner or consignee at entry, or as a U.S. agent with a signed consent statement
- A separate FSVP for each food and each foreign supplier, with a qualified individual behind it
- A signed, dated hazard analysis, supplier approval and verification plan
- Offsite records, including those suppliers hold, that you can retrieve and provide onsite within 24 hours of a request
- A plan for translating any records not kept in English
- Supplier contracts with the access, audit, notice and cooperation terms above
How We Work With Importers From File Review to Enforcement
I’m J. Mason Weeda, a Managing Principal at OFW Law and Chair of its FDA Food Practice. Our work can start before FDA calls, with a review of who is named as FSVP importer and whether each file is complete. Brian Ravitch, our Senior Regulatory Advisor, brings his FDA import compliance background to that review.
During a 39-year federal career, he served with FDA in Import Field Operations, including eight years as an Import Compliance Officer. At FDA, he was instrumental in developing and implementing the Foreign Supplier Verification Program. He did that work as a Subject Matter Expert for the agency.
When FDA requests records, we work through the request with you and help assemble what FDA asked for. After a Form FDA 483a or warning letter, we help prepare the response. My own practice includes FDA inspections and enforcement matters such as warning letters, import alerts, holds, detentions and refusals.
Denise Calle, a Principal Attorney, chairs our customs and trade practice. She has practiced only customs and international trade law since 2017 and represents importers, exporters and customs brokers. Her work includes requesting Import Alert removals and the release of detained cargo.
If you're checking your FSVP program before FDA asks, or you're already answering an FDA records request, we can work through it with you. Call OFW Law at 1-202-933-5394 to discuss your program with our team.
Frequently Asked Questions About FSVP
What does FSVP stand for?
Foreign Supplier Verification Programs, FDA’s rule for imported human and animal food.
Is FSVP a certification my supplier can provide?
No. The duty sits with the importer, who can’t rely on the supplier for verification beyond sampling and testing.
Who is eligible to be an FSVP importer?
The U.S. owner or consignee at entry. If there’s none, it’s a U.S. agent of the foreign owner or consignee. The agent must sign a statement agreeing to serve.
Is the FSVP importer the same as the importer of record?
Not necessarily. FDA built its definition around the food’s owner or consignee rather than CBP’s importer of record.
How quickly must we produce FSVP records?
The regulation says promptly, with 24 hours for offsite records. If FDA asks in writing for records to be sent, its guidance says it “will generally expect” them within 72 hours. The 72-hour figure is FDA’s stated expectation rather than a legal deadline.
Do FSVP records have to be in English?
The regulation doesn’t require it. On request, though, you must give FDA an English translation within a reasonable time.
