If you are asking what is FSVP, the answer depends partly on which side of the transaction you are on. For a U.S. importer, FSVP can create direct compliance responsibilities. For a foreign food supplier, it usually means being ready to provide information your U.S. importer needs to evaluate your company and food.
The most important distinction is this: FSVP is not another FDA registration for the foreign manufacturer. It is an importer verification program. Understanding that difference prevents one of the most common sources of confusion in international food shipments.
Quick answer
FSVP, or Foreign Supplier Verification Programs, is an FDA rule under FSMA requiring covered U.S. importers to verify that foreign suppliers produce food according to applicable U.S. safety standards. The FSVP Importer is responsible for the program; foreign suppliers support that process by providing relevant information and records.
What is FSVP in practical terms?
FSVP is a risk-based food safety verification requirement for companies importing food into the United States.
The initials stand for Foreign Supplier Verification Programs. FDA established the rule under the Food Safety Modernization Act, commonly known as FSMA.
The basic concept is straightforward: when a covered importer brings food into the United States, the importer must have an appropriate program for evaluating the food and foreign supplier and for verifying that applicable hazards are being controlled.
FDA describes the objective as providing assurance that imported food is produced with the applicable level of public health protection required by U.S. food safety rules and that the food is not adulterated or misbranded with respect to allergen labeling.
FSVP therefore creates responsibilities on the U.S. side of the transaction, while requiring cooperation from the foreign supplier.
That distinction matters whether you are reading this article from Miami, Mexico, Colombia, Turkey, India, Europe, Asia, or anywhere else supplying food to the United States.
This article is for two different readers
FSVP often creates confusion because the importer and foreign supplier receive different responsibilities from the same commercial relationship.
If you are a U.S. importer
You may have just learned that your company is being identified as the FSVP Importer for food purchased from a foreign manufacturer.
If so, FDA may expect your company to meet applicable FSVP requirements for that food and supplier.
This is more than asking the manufacturer for an FDA registration number or collecting several certificates and placing them in a file.
The importer has its own compliance responsibilities.
If you are a foreign food supplier
Your U.S. customer may have sent you a message such as:
“We need your FSVP documents.”
“Please send the documents required for FSVP.”
“Our compliance department needs your FSVP.”
That wording can make it sound as though your factory should already possess a single document called an “FSVP.”
That is not the right way to understand the rule.
FDA states that FSVP applies to U.S. importers. However, an importer may request information from its foreign supplier or other parties to satisfy its FSVP responsibilities.
Your role as the foreign supplier is therefore usually to provide relevant information about your company, product, food safety practices, processes, and compliance history when your importer needs it.
Who is the FSVP Importer?
The FSVP Importer is the party responsible for meeting the applicable importer requirements under the FSVP rule.
In general, FDA defines the FSVP Importer as the U.S. owner or consignee of the food offered for import into the United States. That means the person that owns the food, has purchased it, or has agreed in writing to purchase it at the time of U.S. entry.
If there is no U.S. owner or consignee at the time of entry, a U.S. agent or representative of the foreign owner or consignee may serve as the FSVP Importer under the conditions established by the rule, including the required consent to perform that role.
This definition is important because the FSVP Importer is not automatically:
- the foreign manufacturer;
- the exporter;
- the customs broker;
- the FDA U.S. Agent listed for the foreign food facility;
- or necessarily the same entity acting as importer of record for customs purposes.
The actual commercial structure matters.
Before REGISTRO-FDA.US reviews an FSVP case, one of the first things we clarify is who is actually assuming the FSVP Importer role for the food entering the United States.
What must an FSVP Importer do?
At a high level, a covered FSVP Importer must evaluate the food and foreign supplier and perform appropriate verification activities based on the risks involved.
This is not a universal checklist where every importer requests exactly the same documents from every manufacturer.
FDA’s standard FSVP framework includes areas such as hazard analysis, evaluation of food risk and supplier performance, supplier verification, corrective actions when necessary, importer identification at entry, and recordkeeping.
Evaluating hazards associated with the food
The FSVP framework considers known or reasonably foreseeable biological, chemical, and physical hazards associated with the food.
Which hazards matter depends on the product and how it is produced, processed, packed, stored, transported, and intended to be used.
This is one reason a generic FSVP package is not appropriate for every importer and supplier relationship.
Evaluating the foreign supplier
The importer must also consider the foreign supplier’s performance.
Relevant factors can include the supplier’s food safety practices, procedures, applicable FDA compliance information, food safety history, audit or testing information when relevant, and how the supplier has responded to previous problems.
The goal is not simply to confirm that the foreign company exists. The importer must evaluate whether the supplier is appropriate for the food being imported.
Determining appropriate verification
Supplier verification can take different forms depending on the risks and circumstances.
FDA identifies potential activities such as reviewing relevant food safety records, sampling and testing, onsite audits, or other appropriate verification activities.
That does not mean every supplier needs every activity.
The appropriate approach depends on the food, identified hazards, who controls those hazards, and supplier performance.
Maintaining the compliance relationship
FSVP is not simply a collection of documents obtained from the foreign supplier.
The importer must maintain the applicable program and records and address problems when circumstances indicate that corrective action is necessary.
For that reason, we recommend determining the correct FSVP structure for the actual food and supplier relationship instead of trying to build compliance around a generic document list.
What will a foreign supplier be asked to provide?
A foreign supplier should expect its importer to request information that helps evaluate the company, the food, and the controls relevant to food safety.
There is no single document package that applies to every supplier and every food.
At REGISTRO-FDA.US, we first review what the U.S. importer is asking for and what product is being imported before determining which information is relevant.
Company and product information
The importer needs to understand who is producing the food and which specific food is being evaluated.
That can require identifying information about the foreign supplier and product and enough information to connect the manufacturer with the food being imported.
Information about processes and food safety controls
Depending on the product, the importer may need information that helps it understand how relevant hazards are being controlled.
That may involve existing records concerning manufacturing practices, food safety controls, production processes, testing, audits, or other relevant information.
The correct documentation varies considerably by product.
Compliance and performance history
Supplier performance is also part of the FSVP framework.
The importer may need information concerning the supplier’s food safety history and other relevant compliance information when evaluating the relationship.
The key point for the foreign supplier is simple: do not assume you need to create an FSVP yourself because your buyer asked for “FSVP documents.”
Let us review what they requested and determine what belongs to your side of the transaction.
FSVP vs FDA registration vs U.S. Agent
FSVP vs FDA registration is one of the most important distinctions for companies involved in imported food.
A foreign manufacturer may need an FDA food facility registration and a U.S. Agent while its U.S. importer separately has FSVP responsibilities.
FDA facility registration
Who complies: The foreign food facility when its activities are subject to the applicable registration requirement.
What it is for: Identifies the food facility to FDA under the applicable registration requirements.
Who requires it: FDA.
The registration belongs to the foreign facility side of the compliance structure.
See also: FDA facility registration.
U.S. Agent
Who designates one: A foreign food facility subject to the applicable FDA registration requirement.
What it is for: Provides a contact in the United States for communications associated with the foreign facility.
Who requires it: FDA under the applicable foreign food facility registration requirements.
A U.S. Agent is not automatically the FSVP Importer.
See also: U.S. Agent service.
FSVP
Who complies: The FSVP Importer when the food and transaction are subject to FSVP.
What it is for: Provides a risk-based system for evaluating foreign suppliers and verifying imported food against applicable U.S. food safety requirements.
Who requires it: FDA under FSMA.
The easiest way to remember the difference is:
FDA registration identifies the foreign facility. The U.S. Agent provides a U.S. contact for that foreign facility. FSVP places verification responsibilities on the applicable U.S. importer.
One does not automatically replace another.
What happens if no FSVP Importer is identified?
When identification of an FSVP Importer is required at entry and that information is not provided, the food can face an admissibility problem.
FDA states that it may refuse admission of food when required FSVP Importer identification is not provided. FDA may also refuse admission where no U.S. owner or consignee exists and the foreign owner or consignee has not appropriately designated a U.S. representative to serve as the FSVP Importer when required.
This should be handled factually, not dramatically.
It does not mean every FSVP question produces the same outcome. It does mean that importers and foreign suppliers should not wait until the shipment is at entry to discover that nobody has clearly assumed the FSVP role.
If the parties are unclear about who is responsible, REGISTRO-FDA.US can review the structure before the shipment moves forward.
What is the DUNS or UFI for FSVP?
The FSVP Importer must be properly identified when covered food is offered for entry.
FDA requires the importer’s name, electronic mail address, and a Unique Facility Identifier recognized by FDA for the applicable entry line.
FDA currently recognizes a DUNS number as an acceptable UFI for FSVP Importer identification.
This identifier belongs to the FSVP Importer being identified for FSVP purposes.
Foreign suppliers should not assume that their own company identifier is automatically the one that belongs in the FSVP Importer position.
If there is uncertainty over which company should be identified, we review the transaction structure first.
Does FSVP apply to every imported food?
FSVP applies broadly to food imported or offered for import into the United States, but FDA provides exemptions and modified requirements for specified situations.
For example, qualifying circumstances can involve certain foods subject to seafood or juice HACCP requirements, certain alcoholic beverages, some foods regulated by USDA at import, and other situations specifically addressed by the rule. Modified requirements can also apply to certain importers and suppliers.
This is why REGISTRO-FDA.US does not tell every company that imports food to prepare the exact same FSVP package.
We review the food, supplier, importer, and transaction before determining what requirements appear relevant.
How REGISTRO-FDA.US helps U.S. importers
If you are the U.S. importer and recently learned that your company may be the FSVP Importer, the first priority is understanding what responsibility you are assuming.
We can review the product, foreign supplier, transaction structure, and information already available.
From there, we can identify the compliance areas that need attention and explain what information will be needed from the foreign supplier.
You do not need to guess which documents to request or try to build an FSVP from unrelated templates.
We review the case around the actual food and supplier relationship.
How REGISTRO-FDA.US helps foreign suppliers
If you are outside the United States and your buyer suddenly asked for FSVP documentation, you do not need to interpret that request alone.
Send us the request you received and basic information about your product and company.
We review what your importer is asking for, separate your responsibilities from the importer’s responsibilities, and identify what information from your company is relevant to the case.
If your situation also involves FDA facility registration or U.S. Agent service, we can identify those as separate requirements instead of mixing them into the FSVP request.
That distinction can save considerable confusion when a buyer uses “FDA documents” as a general term for several different compliance issues.
If FSVP is causing confusion, define the roles before the shipment
The most common FSVP problem is not necessarily a missing document. It is often a misunderstanding over who is responsible for what.
A U.S. importer may assume the foreign manufacturer is handling FSVP.
A foreign manufacturer may assume its FDA registration already covers FSVP.
A broker may request an importer identifier without the parties understanding why it is needed.
Those assumptions can be corrected when the transaction is reviewed before the product reaches the entry stage.
REGISTRO-FDA.US can review your situation from either side: as the U.S. importer trying to understand its FSVP responsibilities or as the foreign supplier trying to respond correctly to a buyer’s request.
Private FDA compliance consulting firm. We are not affiliated with or endorsed by the U.S. Food and Drug Administration.
Educational information only; not legal advice.
Frequently Asked Questions
Is FSVP the same as FDA facility registration?
No. FDA facility registration and FSVP address different responsibilities. Facility registration relates to the foreign food facility when the applicable registration requirement applies. FSVP places verification responsibilities on the FSVP Importer for covered imported food. A foreign facility having an FDA registration does not automatically satisfy the U.S. importer’s FSVP obligations.
Does a foreign food supplier need its own FSVP?
A foreign supplier is not the FSVP Importer simply because it manufactures the food. FSVP applies to the importer defined under the rule. The foreign supplier does, however, need to cooperate by providing relevant information its importer requires to evaluate the food, supplier performance, and applicable food safety controls.
Who is the FSVP Importer?
In general, the FSVP Importer is the U.S. owner or consignee of the food at entry. If there is no U.S. owner or consignee, a U.S. agent or representative of the foreign owner or consignee can assume that role under the conditions established by the rule.
What documents will the U.S. importer ask the foreign supplier for?
There is no universal document list for every food. The importer may need information concerning the supplier, product, manufacturing and food safety practices, relevant controls, testing or audit information, and compliance history. REGISTRO-FDA.US can review the specific request and determine what information is relevant instead of giving you a generic checklist.
Does FSVP apply to all foods imported into the United States?
FSVP applies broadly, but there are exemptions and modified requirements for specified products, importers, suppliers, and transactions. Examples include certain foods subject to other food safety regimes and other situations defined by FDA. We review the particular product and transaction before determining how FSVP applies.
Does FSVP replace the FDA U.S. Agent?
No. They are different roles. A foreign food facility may designate a U.S. Agent as part of its FDA registration requirements. The FSVP Importer is responsible for the applicable foreign supplier verification requirements. A company may sometimes perform more than one role, but one role does not automatically replace the other.
What happens if my company is identified as the FSVP Importer but is not prepared?
If your company is being identified as the FSVP Importer, it is important to understand the responsibilities attached to that role. FDA can review FSVP records and take regulatory action for noncompliance, and required importer identification problems can affect admission of the food. REGISTRO-FDA.US can review the case and identify the areas that need attention.
What do you need to review our FSVP situation?
Very little to begin. Tell us what food is being imported, the country of the foreign supplier, the U.S. company involved, and whether you are contacting us as the importer or foreign supplier. If you received an FSVP request from a buyer or another party, provide that information as well. We review the situation and tell you what else is needed.