With approximately 32% of the fresh vegetables, 55% of the fresh fruit, and an overall 15% of the food consumed in the United States being imported from other countries, the Foreign Supplier Verification Program (FSVP) is one of the most important rules established under the Food and Drug Administration’s FSMA.

The purpose of the Food Safety Modernization Act (FSMA) is the prevention of food safety hazards throughout the supply chain and to provide the FDA with the resources and authority to take actions necessary for protecting US consumers — regardless of where the food was produced.

As part of that mission, the FSVP Rule mandates importers to assure all imported foods meet the same stringent food safety standards as those required for food products produced in the US.

Jump to One of These Sections:

• What is the FSVP Rule
• Who is Subject to FSVP Compliance
• The FSVP Checklist for Success
• Top FSVP Violations in FY2023
• FSVP Modified Requirements & FSVP Exemptions
• Required Documents for FSVP Compliance
• Is FSVP Certification Required?
• How to Simplify FSVP Compliance

What is the FSVP Rule?

FSVP stands for Foreign Supplier Verification Program. With this rule, the US Importer is defined as the entity and/or person responsible for the safety of the food that they are importing.

Every importer subject to this rule must implement and maintain FSVPs in which they evaluated and approved each of their food and beverage suppliers.

It also mandates that these Importers have conducted supplier verification activities to assure the food is both safe and in compliance with FDA food safety requirements, as applicable.

An importer’s FSVP must make sure that:

• All food is produced in a manner that meets the same level of public health protection as with established preventive controls for human food or animal food, and/or the produce safety rule, as applicable
• Imported food is not considered adulterated as defined under section 402 (§342) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
• Food products intended for human consumption are not misbranded concerning food allergen labeling as defined under section 403(w) of the FD&C Act

Who is Subject to FSVP Compliance?

Under the Foreign Supplier Verification Program, US importers are required to evaluate and approve suppliers and to conduct supplier verification activities.

An importer is defined as the US owner or consignee of the food offered for import at time of entry. This is someone who either:

• Owns the food
• Has purchased the food
• Has agreed in writing to purchase the food at the time of US entry

If there isn’t a US owner or consignee at time of entry, the foreign owner must designate a US agent or representative to fulfill FSVP responsibilities. This must be confirmed in a signed statement of consent.

An FSVP importer must be located and conduct business in the United States meaning they must have personnel physically present in the United States.

Essentially, if there is a written agreement, paid invoice, or a purchase order for food for a specific US entity at the time of US entry, then that US entity meets the definition of owner and is therefore responsible for and subject to FSVP.

FDA is not looking at the intermediaries, but at the consignee, owner, or US Agent designated for FSVP purposes.

The FSVP Checklist for Success

FDA has made FSVP requirements quite clear and for each category of food you import, there must be a written FSVP for each supplier which must be developed and implemented by a Qualified Individual.

The FSVP must detail all the necessary verification activities and documentation to demonstrate compliance for each of your suppliers. This includes the creation of documented processes for confirming the compliance of the foreign supplier, maintaining records, and conducting other essential tasks like taking corrective actions when issues are discovered.

FSVP requirements are as follows:

• An FSVP importer must evaluate any food risk by checking each supplier’s food safety history and performing a hazard analysis by reviewing the process for any foreseeable hazards.
• An FSVP importer must verify each supplier by either an annual on-site audit of each supplier’s facility, sampling and testing, a review of food safety records, or the use of a third party to verify and provide proper documentation.

Though the requirements seem straightforward enough, there can be many steps and considerations that can complicate FSVP compliance. We’ve put together a simple checklist of actionable steps that help take the complexity out of the process:

1. Designate your FSVP Qualified Individual

The FSVP qualified individual (QI) is a person who has the education, training, or experience necessary to perform FSVP activities and can read and understand the language of records that they must review. It is important to know that in order to conduct supplier evaluations and FSVP activities, the QI must understand the FDA regulations applicable to the food. The QI is not required to be an employee of the importer.

2. Identify Suppliers and Food Products to Be Imported

The first step to FSVP compliance is to have a complete list of the food products you import and who the foreign suppliers are for those products. You will also want to take note of which foods are subject to or are exempt from FSVP.

This identification is essential for evaluating and approving the correct supplier, identifying the applicable FDA food safety regulations, conducting an adequate hazard analysis, and determining and performing proper verification activities to ensure food safety.

What Is A Foreign Supplier Under FSVP?

It’s the entity that manufactures or processes the food, grows the food or raises the animal. In other words, it’s the manufacturer or processor of the food — or the farm in the case of fresh agricultural commodities and live animals for use in food (outside of those regulated by USDA).

Some examples FDA gives are boar, elk and bison.

3. Evaluate Supplier’s Compliance According to Regulations

You must evaluate the foreign supplier’s FDA compliance history and their food safety practices to determine their adequacy and if corrective actions are needed for approval. This includes evaluating if the supplier has had any import refusals, import alerts, recalls, failed inspections or other FDA actions issued against them.

You must also evaluate the food safety related procedures, processes, and practices. Reviewing their food safety plan, procedures for implementing controls measures, sanitation practices, third-party audit reports, etc. are examples of records you may review to reach compliance determinations. It is critical to take corrective actions when issues are discovered.

4. Determine Associated Hazards

After evaluating the supplier’s compliance and food safety practices, it’s important to assess the risks associated with the products.

This encompasses the possible biological, chemical, and physical hazards that are likely to occur in the food, the ingredients, within the production environment, and the packaging. It also encompasses many other factors including everything from farming practices and environmental contaminants to the equipment used and natural disasters, etc.

It also considers the supplier’s food safety history in determining the likelihood of a hazard.

5. Identify Your Verification Activities

Based on the results of your compliance evaluations and the hazard analysis, you must then identify appropriate supplier verification activities and the frequency that you will conduct them in to assure that the hazards in the food have been controlled and your supplier maintains compliance.

This can include, alone or in combination, conducting onsite audits, sampling and testing of the food, and reviewing food safety monitoring records.

6. Monitor & Reevaluate Suppliers

Once your FSVP is in place for each foreign supplier, you must continue to monitor and reevaluate the supplier’s compliance over time.

Maintaining regular communication with the supplier and closely following their compliance history is key. You’ll want to pay special attention to any import alerts, refusals, or detentions that may arise between them and yourself or other importers.

When becoming aware of a compliance concern, you must evaluate if corrective actions are needed and act accordingly.

7. Update & Reassess Your FSVP

As you continue to monitor and reevaluate each supplier you may become aware of new information such as changes in your supplier’s food safety plan, product formulation, processing steps, or food safety concerns.

You must update and reassess the FSVP as necessary to ensure that your FSVP reflects the changes and the current state of your supplier/product to assure they remain compliant and your assessments and verification activities are still adequate.

These changes can affect any and all parts of your FSVP.

8. Maintain all FSVP Documentation & Supplier Records

Finally, to demonstrate your continued compliance during an FSVP inspection, it is necessary to maintain both accurate and complete records of all FSVP activities and other pertinent information. The FDA requires you to keep records readily available from the past 2 years.

These documents may include supplier agreements, shipping documents, product labels, food safety plans, audit reports, laboratory test results, written assurances, and other documents that you reviewed to determine and verify your supplier’s compliance. All documents must be provided in English during an inspection.

Top FSVP Violations in Fiscal Year 2023

Out of over 1700 inspections, 44.2% earned a 483 citation for failure to even develop an FSVP. According to the FDA Data Dashboard for Inspections, 930 FSVP importers were caught without the necessary requirements in place and received either voluntary or official actions indicated, a failure rate of 54%.

FSVP Modified Requirements & FSVP Exemptions

As with any other regulation, there are certain exemptions and modifications to be considered when determining if or how FSVP affects your business:

FSVP Modified Requirements

There are various scenarios for which FSVP modified requirements may apply. These may depend on the type of foods offered for import, the country in which the foreign supplier is located, the financial status of the importer and supplier, or even the food’s intended use. For example:

• If you import dietary supplements, your FSVP must evaluate compliance with Current Good Manufacturing Practices (CGMPs) for dietary supplements as outlined in 21 CFR 111; not the FSMA rules like Preventive Controls or Produce Safety.
• If you import food from a country under a food safety system recognition agreement (FSSRA) with FDA, you must document that the food is within the scope of the agreement, that it was was processed or grown in that country, and that the supplier is under the oversight of — and in good compliance standing with — that food safety system.
• If you import food for which hazards are controlled by a food processing facility in the United States, then written assurances for control of those hazards by that food processing facility can satisfy verification requirements.
• If you are a very small importer or your supplier is a small supplier, then your FSVP verification activities simply consist of obtaining written assurances from the supplier and other basic information.

Very small businesses are defined by FDA as having an annual sales and market value of the food they imported, manufactured, processed, packed or held (for example, held for a fee) for the past 3 years — including their subsidiaries and affiliates — that equals an average of less than $1 million for human food, or in the case of animal food, less than $2.5 million.

The list above is not all inclusive but gives an idea of different types of modified requirements that the food you import may be subject to. Some FSVP modified requirements make approval and verification simpler, while others may require a more detailed approach and evaluating other food safety regulations applicable to the food.

FSVP Exemptions

Exemptions under FSVP also apply due to existent regulations, other jurisdictions with oversight on the safety of those products, or due to its intended use or destination, for example:

• Juice & seafood are subject to FDA’s Hazard Analysis Critical Control Points (HACCP)
• Meat and poultry are under the purview of USDA regulations at import
• Alcoholic beverages remain under TTB jurisdiction
• Foods for research and evaluation purposes only
• Foods solely for individual use
• Foods imported for processing and overseas shipment
• Transshipped foods

List of Possible Required Documents for FSVP Compliance

Recordkeeping is the most crucial part for demonstrating FSVP compliance. If you do not document your activities and maintain proper records, FDA determines the activities did not happen. Here’s a general list of information that may be requested of you during an FDA inspection in the form of records:

Business Details

The FDA initiates their inspections with a questionnaire in which they ask general information about your business operations such as:

• Who the person in charge is
• Who your FSVP qualified individual for is
• The list of products you import
• Your top suppliers and top customers
• Your financial status and other information

However, it is important to know that FDA started their investigation before they contacted you for the FSVP inspection and they already have certain information about your operation. Understanding the details of your operations and having basic information readily available, makes initial interactions smoother and lets FDA know how prepared and aware you are about the business you run.

Supplier & Product List

The FDA uses Customs’ data in identifying the suppliers and products they want to inspect so they already know who you import from and what you are importing. You do not want to be caught off guard when it comes to this list.

You should know with certainty who your active suppliers from the past 2 years are. You will also want to identify who may have been listing you as an FSVP importer without your knowledge or for foods that you don’t import from them.

Not knowing this information puts you at substantial risk of receiving citations for suppliers you didn’t even conduct business with. Or, it may reveal suppliers you didn’t know you had and should have had FSVPs for.

Product Descriptions & Labels

One of the first things you should request from your suppliers is the product descriptions or specifications and their corresponding labels.

Keeping this information accurate will not only help you identify the foods you import, but it will also allow you to conduct initial assessments. These assessments include identifying whether FSVP applies to the food in question and which FSVP requirements might apply.

You’ll be looking at which food safety regulations you need to verify such as Preventive Controls vs Produce Safety, dietary supplements, low acid canned foods, infant formula, and others.

You will also be identifying ingredient related hazards such as unapproved colors and additives and undeclared allergens, and other details that will help you identify controls and verification activities.

Purchasing, Shipment, & Receiving Records

You are required to verify that the foods you import are from approved suppliers.

Purchasing records such as agreements, invoices, and purchase orders indicate products requiring verification of shipment records. This is especially necessary when the food products are received at your facility, a third-party warehouse or another destination you’ve arranged delivery to.

This information helps to ensure the imported food is from the supplier you approved and that it is the food you actually purchased.

Written FSVP Procedures

This includes written steps or SOPs for conducting the various FSVP-related activities such as supplier evaluations and approvals, verification activities, taking corrective actions, managing FDA inspections, listing the FSVP importer at entry, maintaining records, training, among other processes and assigning responsibility for those tasks to a qualified individual.

Qualified Individual Qualifications

All FSVP activities must be conducted by a qualified individual. The FDA may request the qualifications, evidence of education, training, or experience of personnel responsible for the different tasks required under FSVP.

The qualifications required of an individual will vary according to the FSVP requirements that apply to the importer — Standard vs Modified — and the food safety regulations applicable to the food.

Verification Activities

Importers must perform verification activities to ensure a supplier is compliant at time of approval and that they maintain compliance over time. FSVP verification activities vary according to the requirements the importer and/or supplier and food are subject to.

Modified requirements for small businesses require obtaining written assurances as a form of this verification. However, importers subject to the full requirements must conduct more complex activities.

All verifications occur at an established frequency and this frequency depends on the individual requirement, the level of risk associated, the type of food or process, how much you import from that supplier, and other factors.

These activities also encompass the review of sampling and testing results, food safety records, and onsite audits. When issues are found you must verify that the supplier took corrective actions to resolve those issues.

You must then keep evidence that these verification activities were conducted and maintain all the records you reviewed.

Reanalysis & FSVP Updates

This pertains to all records associated with the revisions made to an FSVP and maintaining the different versions that have been developed over time.

Changes to the products imported, supplier food safety procedures, labels, or a supplier’s compliance standing may require a reanalysis of the FSVP.

Any modifications made to the FSVP procedures, the FSVP for a supplier such as hazard analysis, verification activities, etc. must be documented and previous versions kept on file for no less than 2 years.

Foreign Supplier Compliance Evaluations

The evaluations and determinations on foreign supplier compliance must be documented.

As the FSVP importer, you must check whether the supplier had warning letters, refusals at the port of entry, import alerts, or other actions regarding food safety violations and determine if corrective actions are needed.

This evaluation includes reviewing their general food safety procedures and may even include review of third-party audit reports and/or FDA Inspection reports. You will also need to review the qualifications of the person in charge of food safety or quality control to ensure they are qualified.

Some suppliers are hesitant to share their food safety practices, however, you cannot demonstrate compliance without reviewing their procedures, corrective action measures, and their food safety history.

Hazard Analysis & Entities Controlling the Hazards

If applicable, you must have a written hazard analysis, including the determination of potential food safety hazards and the evaluation of their likelihood and severity.

Based on your determinations, you then compare your evaluation with your supplier’s food safety plan or procedures to ensure they’ve addressed the hazards and have appropriate controls in place.

You must also identify any hazards that may not be controlled by your supplier and identify the entity responsible for controlling the hazard. A written hazard analysis does not apply an FSVP for dietary supplements.

Is FSVP Certification Required?

A quick search online will populate thousands of results that speak to FSVP certification courses. These certification courses cover the necessary information for individuals looking to learn how to develop an FSVP on their own.

Certification, however, is not required to develop and implement FSVPs for each of your foreign suppliers as you only need a Qualified Individual on staff — or an out-sourced professional — to perform the necessary tasks and to establish each of the components for the FSVP.

How to Simplify FSVP Compliance

With so much of the US food supply imported from foreign sources, FDA requires exhaustive compliance and verification activities from FSVP importers.

Attempting to evaluate your foreign suppliers and the foods you import on your own is certainly an option, though if you’re unfamiliar with the FSVP landscape and the numerous food safety requirements that may apply to the foods you import, it can be a lengthy and difficult endeavor that can eat away at resources better spent elsewhere.

You can easily achieve full FSVP compliance by leveraging the world’s largest FDA compliance company in the industry. Registrar Corp has spent the last two decades helping over 30,000 companies each year across 180+ countries navigate the complexities of FDA regulations.

We can help you, too.

Discover how you can easily manage FSVP compliance 24/7 with Registrar Corp’s industry leading FSVP solutions.