When mentioning the United States Food and Drug Administration (FDA), people are often familiar with terms such as “FDA approved,” “FDA cleared,” “FDA 510k,” “PMA,” etc. In contrast, the Foreign Supplier Verification Programs (FSVP) are less known but play an extremely important role. In this article, GOL will provide detailed information about FSVP, specifically for those involved in the export of food to the United States and anyone interested in this topic in general. This will help you gain a better understanding of FSVP and its significance in the context of international food safety.

1. What is FSVP?

FSVP stands for Foreign Supplier Verification Programs, which is a program by the FDA for food importers for both human and animal consumption in the United States. The FSVP program is mandatory and applies to food importers into the United States. In other words, FSVP meaning Foreign Supplier Verification Program, is considered the passport for food to be permitted into this country. Under the FSVP program, a food importer is defined as the owner or consignee in the United States of the food being offered for import.

Every year, the United States imports billions of tons of food from over 200 countries and territories. Imported food accounts for approximately 15% of the total food consumed in the United States. To ensure the safety of imported food, the U.S. Food and Drug Administration (FDA) enacted the Food Safety Modernization Act (FSMA) in 2011. One of the most significant programs under FSMA is the Foreign Supplier Verification Programs (FSVP). This program requires food importers to take steps to verify their foreign suppliers, assessing whether the suppliers adhere to U.S. food safety standards.

Furthermore, according to FSVP regulations, importers or their agents must have a comprehensive FSVP plan to ensure that foreign food suppliers meet safety standards similar to the requirements imposed by the FDA on domestic food manufacturers.

2. The main requirements of FSVP

2.1 Scope of application

The scope of application of FSVP primarily focuses on businesses importing food into the United States. According to the FDA’s definition, the FSVP importer is typically the entity responsible for the customs entry. The FSVP importer can be:

• The owner or consignee in the United States of the food offered for import into the U.S.
• A U.S. agency or representative of the foreign owner of the consignee at the time of entry.

2.2 The primary goal of FSVP

The primary goal of the Foreign Supplier Verification Program (FSVP) is to ensure the safety of food from international suppliers and is part of the framework established by the Food Safety Modernization Act (FSMA). Enacted in 2011, the FSMA marked a significant step in the U.S. Food and Drug Administration’s (FDA) efforts to modernize and strengthen the food safety system.

FSVP establishes specific requirements and procedures for importers to help them address unique challenges related to food safety from foreign supply sources. The specific objectives of FSVP include:

• Control and Risk Assessment: FSVP mandates that import businesses must undergo the process of identifying and assessing risks related to food safety from foreign supply sources. This includes evaluating production processes, storage, transportation, and other aspects of the supply chain.
• Maintaining Detailed Records: Import businesses are required to establish and maintain detailed records of their foreign suppliers. These records should include information about production processes, quality control, and other risk management measures.
• Implementing Risk Control Measures: Based on risk assessments, import businesses must implement control measures to minimize or eliminate food safety risks. This may involve implementing controls at international checkpoints or even at U.S. ports of entry.
• Compliance with FDA Food Safety Standards: FSVP ensures that imported food meets FDA food safety standards. This includes controlling additives, oils, pesticides, and other factors that may impact food safety.

Read more: Why is food safety important to the Food Business?

2.3 Specific Requirements of FSVP

The FDA has provided clear guidelines regarding FSVP requirements, stipulating that for every food category imported, a written FSVP must be established and executed for each supplier, overseen by a Qualified Individual.

The FSVP documentation should outline all necessary verification activities and documentation to ensure compliance for each supplier. This involves developing documented procedures for confirming the compliance of foreign suppliers, maintaining records, and undertaking corrective actions as needed.

FSVP requirements entail the following:

• Evaluating food risk by examining each supplier’s food safety track record and conducting a hazard analysis to identify potential hazards.
• Verifying each supplier through methods such as an annual on-site audit of their facilities, sampling and testing, reviewing food safety records, or employing a third party for verification and documentation.

While the requirements may appear straightforward, the process of FSVP compliance can involve numerous steps and considerations. To simplify this process, we have compiled a straightforward checklist of actionable steps.

Appoint your FSVP Qualified Individual

The FSVP qualified individual (QI) is an individual possessing the requisite education, training, or experience to carry out FSVP activities and comprehend the language of the records they must review. It’s crucial to note that the QI must have a grasp of FDA regulations relevant to the food in order to conduct supplier evaluations and FSVP activities. Importantly, the QI doesn’t necessarily have to be an employee of the importer.

Identify Suppliers and Food Products for Importation

The initial step towards FSVP compliance involves compiling a comprehensive list of the food products being imported and identifying the foreign suppliers associated with those products. Additionally, it’s important to distinguish between foods that fall under FSVP requirements and those that are exempt.

This identification process is fundamental for evaluating and approving the appropriate supplier, understanding the applicable FDA food safety regulations, conducting a thorough hazard analysis, and determining and executing proper verification activities to uphold food safety standards.

Assessing Supplier Compliance

It is imperative to evaluate the FDA compliance history of foreign suppliers along with their food safety protocols to gauge their suitability and determine any necessary corrective actions for approval. This entails examining whether suppliers have encountered import refusals, import alerts, recalls, failed inspections, or faced other regulatory actions from the FDA.

Additionally, scrutinizing the procedures, processes, and practices related to food safety is essential. This involves reviewing their food safety plans, procedures for implementing control measures, sanitation practices, third-party audit reports, and similar records to make compliance assessments. Prompt corrective actions must be taken upon identifying any issues.

Identifying Associated Risks

Following the evaluation of supplier compliance and food safety practices, it’s crucial to identify potential hazards associated with the products.

This encompasses assessing the likelihood of biological, chemical, and physical hazards occurring in the food, ingredients, production environment, and packaging. It also considers various factors such as agricultural practices, environmental contaminants, equipment usage, natural disasters, and more.
Supplier food safety history is also taken into account to determine the probability of hazards.

Determining Verification Activities

Based on compliance evaluations and hazard analyses, appropriate supplier verification activities and their frequency must be identified to ensure effective hazard control and ongoing supplier compliance.
These activities may include onsite audits, food sampling and testing, and review of food safety monitoring records, either individually or in combination.

Monitoring & Reassessing Suppliers

Following the implementation of FSVP for each foreign supplier, continuous monitoring and reassessment of supplier compliance are essential.

Regular communication with suppliers and close monitoring of their compliance history are crucial. Any import alerts, refusals, or detentions involving the supplier should be closely monitored and addressed promptly.
Upon identifying compliance concerns, corrective actions must be evaluated and implemented as necessary.

Updating & Reviewing Your FSVP

As ongoing monitoring and reassessment reveal new information such as changes in supplier food safety plans, product formulations, processing procedures, or safety concerns, the FSVP must be updated and reviewed accordingly.

This ensures that the FSVP reflects current supplier and product status, maintaining compliance and adequacy of assessments and verification activities.
These updates can impact all aspects of the FSVP.

Maintaining FSVP Documentation & Supplier Records

To demonstrate continued compliance during FSVP inspections, meticulous maintenance of comprehensive records of all FSVP activities and relevant information is essential. The FDA mandates that records covering the past 2 years must be readily available.

These records may include supplier agreements, shipping documents, product labels, food safety plans, audit reports, laboratory test results, written assurances, and any other documents used to determine and verify supplier compliance. All documentation must be provided in English during inspections.

What will U.S. importers require from exporters?

When U.S. importers collaborate with exporters, especially within the context of the Foreign Supplier Verification Program (FSVP) under the framework of the Food Safety Modernization Act (FSMA), there are specific requirements that exporters need to meet to ensure that their products are imported into the United States safely and in compliance with food safety regulations.

• Unique Facility Identifier (UFI): To comply with FSVP requirements, exporters need to provide their Unique Facility Identifier (UFI). This is a specific code assigned to identify a particular manufacturing facility. This code aids importers and the U.S. Food and Drug Administration (FDA) in tracking and verifying information about foreign supply sources.
• Detailed Product Information: Exporters need to provide detailed information about their products, including ingredients, manufacturing processes, packaging details, and any information related to food safety. This helps importers clearly identify potential risk factors that may arise from the production and processing of the products.
• Food Safety Certificates and Certifications: Exporters need to provide certificates and certifications related to the food safety of their products. This may include inspection certificates, export certificates, or any other documents confirming that the product complies with food safety standards.

The above requirements are intended to enhance the ability to monitor, assess, and manage food safety risks from foreign supply sources, aiding importers and regulatory authorities in ensuring that products imported into the United States comply with food safety standards.

You can find more detailed information on: FDA Import Holds and Detentions

2.4 Electronic Customs Declaration

For all imported food shipments adhering to either the Preventive Controls or the Standards for the Safety of Imported Products regulations, at the time of entry, the FDA requires food importers to declare the following information through the Customs and FDA’s electronic entry filing system:

• Name
• Address of the facility
• Unique Identifier (DUNS number) of the entity designated as the “FSVP importer” for the shipment

Food importers (not exempted) are required to have an FSVP, meaning they must possess the following documents:

1. Hazard analysis for food safety
2. Food Safety Plan
3. Various procedures demonstrating that their foreign suppliers comply with FDA food safety regulations
4. Verification of evidence of compliance of their foreign suppliers with FDA food safety regulations
5. Documentation proving they are using a qualified individual capable of conducting and overseeing these steps (FSMA-trained internal assessor)
6. A corrective action plan
7. Good Manufacturing Practices (GMP) system

All food importers are required to have documentation proving that the steps mentioned above have been completed, or provide reasons why the food importer and their food shipments are exempt from the regulations.

3. How to comply with FSVP quickly and conveniently

To comply with FSVP quickly and conveniently, importers into the United States need to follow food import license through these steps:

3.1 Understand the Requirements of FSVP

The first step is to understand the requirements of FSVP. You can familiarize yourself with these requirements on the GOL website to review specific regulations provided by the FDA.

3.2 Developing the FSVP Plan

After understanding the requirements of FSVP, you need to develop the FSVP plan. This plan should include the following elements:

• Objectives of the Plan
• Scope of the Plan
• Identified or Predicted Hazards
• Risk Assessment Methods
• Approaches to Approving Foreign Suppliers
• Verification Methods for Suppliers
• Methods for Implementing Corrective Actions
• Approaches to Reviewing the Plan

3.3 Implementing the FSVP Plan

Once the FSVP plan has been established, it’s time to initiate its implementation. This involves:

• Identifying or predicting hazards
• Assessing risks
• Approving foreign suppliers
• Designing verification methods for suppliers
• Implementing corrective actions
• Reviewing the FSVP plan

The above information is provided by GOL regarding FSVP – the Foreign Supplier Verification Program when exporting goods to the U.S. market. Hopefully, this article has provided enough information to help answer the question of what FSVP is and has offered useful insights into the program.

If you encounter difficulties in planning or implementing FSVP, seeking advice from experts is recommended. GOL is one of the reputable organizations providing FDA registration services. GOL has a team of experienced experts with in-depth knowledge of FSVP, ready to assist importers in achieving quick and convenient FSVP compliance.

Related articles:

12 Frequently Asked Questions on FSMA regulations

Exporting food to the United States – Things to keep in mind