FSVP 101: What Every Food Importer Should Know

For many imported foods, there is another critical consideration: Foreign Supplier Verification Programs (FSVP).

If your organization imports food into the United States, understanding what FSVP is, why it matters, who is responsible, and how the program will be managed should be part of your import strategy.

Some businesses manage FSVP internally. Others use compliance-management software to organize their programs. Some engage qualified professionals to perform or support applicable FSVP activities.

The important first step is understanding the requirement.

What Is FSVP?

The Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, commonly referred to as FSVP, are requirements administered by the U.S. Food and Drug Administration under the FDA Food Safety Modernization Act.

FSVP is intended to provide assurance that imported foods are produced in a manner that provides the same level of public-health protection as applicable U.S. preventive-controls or produce-safety requirements, and that applicable foods are not adulterated or misbranded with respect to allergen labeling.

In practical terms, FSVP asks importers to look beyond the shipment itself. An importer may need to understand:

• Who produced the food?
• What hazards are associated with the food?
• How has the foreign supplier been evaluated?
• What supplier verification is appropriate?
• Who performed the required FSVP activities?
• Where are the supporting records?
• Can those records be produced when needed?

FSVP Is Not Just a Certificate

One of the most important concepts to understand is that FSVP is not simply a certificate, registration, or one-time document. For importers subject to the standard requirements, FSVP can involve activities such as:

1. Hazard Analysis
2. Supplier Evaluation
3. Supplier Approval
4. Verification Activities
5. Corrective Actions
6. Reevaluation
7. Recordkeeping

Who Is the FSVP Importer?

One of the first questions every food-importing organization should answer is:

Who will be responsible for FSVP?

For purposes of the FSVP regulation, FDA generally defines the importer as the U.S. owner or consignee of the food at the time of entry.

If there is no U.S. owner or consignee at the time of entry, the FSVP Importer may instead be the U.S. agent or representative of the foreign owner or consignee, as confirmed in a signed statement of consent.

This is particularly important for:

• Foreign food manufacturers
• Foreign exporters
• International e-commerce businesses
• Amazon sellers
• Foreign brands without a U.S. subsidiary
• Businesses shipping inventory to U.S. fulfillment centers
• Foreign companies that do not have a U.S. purchaser at the time of entry

What Does an FSVP Importer Have to Do?

For importers subject to the applicable standard FSVP requirements, FDA identifies several core areas of responsibility.

1. Use Qualified Individuals

   Applicable FSVP activities must be performed by individuals with the education, training, or experience necessary to perform their assigned activities.

2. Conduct a Hazard Analysis

   Known or reasonably foreseeable hazards associated with the food must be identified and evaluated as applicable. Depending on the product, potential hazards may include:

   • Biological hazards
   • Chemical hazards
   • Physical hazards
   • Food allergens
   • Natural toxins
   • Pesticide or drug residues
   • Other applicable food-safety hazards

3. Evaluate the Food and Foreign Supplier

   The importer evaluates relevant information concerning the food being imported and the performance of the foreign supplier. This may include applicable food-safety practices, compliance information, previous performance, and other relevant factors.

4. Approve Foreign Suppliers

   Applicable procedures should be established for approving suppliers and determining the circumstances under which food will be imported from those suppliers.

5. Establish Supplier Verification Activities

   Depending on the food, identified hazards, and supplier evaluation, verification activities may include:

   • On-site audits
   • Sampling and testing
   • Review of supplier food-safety records
   • Other appropriate verification measures

   FSVP is risk-based, so the appropriate verification approach can differ among foods and suppliers.

6. Take Corrective Action When Necessary

   When information indicates that a foreign supplier is not producing food in accordance with applicable requirements, appropriate corrective action may be required.

7. Reevaluate When Appropriate

   FSVP should not be treated as a file created once and forgotten. Changes involving the supplier, product, manufacturing process, food-safety information, compliance history, or other relevant circumstances may affect previous determinations.

8. Maintain Records

   Applicable analyses, evaluations, verification activities, decisions, and corrective actions must be appropriately documented.

Good FSVP compliance depends not only on performing the activity, but also on maintaining evidence showing what was done.

Think About FSVP at Five Levels

FSVP becomes easier to understand when you view the import process through five connected levels.

1. Importer

   Who is taking FSVP responsibility in the United States?

   Determine the appropriate FSVP Importer and applicable compliance structure.

2. Exporter

   Who is selling or arranging the export of the food?

   The exporter may not be the same company that actually manufactures, processes, raises, or grows the food.

3. Foreign Supplier

   Who actually produces the food?

   FSVP verification is connected to the foreign supplier responsible for manufacturing, processing, raising, or growing the food.

4. Product

   What food is being imported?

   Different products can involve different ingredients, hazards, processing methods, controls, and regulatory considerations.

5. Shipment

   Does the shipment connect back to the correct supplier, product, importer, and compliance documentation?

   The objective is to connect the compliance program with actual import activity.

When these relationships are clearly established and organized, maintaining FSVP becomes much more manageable.

FSVP Importer and Importer of Record Are Not the Same Thing

Another major source of confusion is the difference between the FSVP Importer and the Importer of Record (IOR). Although both roles may be involved with the same shipment, they serve different functions.

FDA specifically notes that entities identified as FSVP importers may not be the same entities serving as Importers of Record for U.S. Customs and Border Protection purposes. A food shipment may therefore involve separate answers to these questions:

• Who is the FSVP Importer?
• Who is the Importer of Record?
• Who is the customs broker?
• Who is the foreign supplier?
• Who files or coordinates applicable FDA entry information?
• Who maintains the regulatory records?

The same organization may perform more than one role, but one role should not automatically be assumed to include another.

How Should Your Organization Manage FSVP?

Once you understand the requirement and identify the responsible party, the next question is how the compliance program will be managed. There are three practical approaches.

DIY, Software, or Professional Support?

There is no single operational model that works for every food importer. The right approach depends on your:

• Internal expertise
• Number of suppliers
• Number of products
• Shipment frequency
• Available personnel
• Compliance infrastructure
• Desired level of outside support

Some organizations may use a combination of all three. For example:

Internal team + SystemsBuilder.pro + CIG Qualified Individual support

The objective is to establish a practical compliance structure that can be maintained as your import activities grow.

Five Questions to Ask Before Your Next Food Shipment

Before importing food into the United States, your organization should be able to answer:

1. Who is our FSVP Importer?

   Has the appropriate party been identified?

2. Who is the actual foreign supplier?

   Do you know who manufactures, processes, raises, or grows the food?

3. What food are we importing?

   Has the product been appropriately evaluated?

4. What supplier verification is applicable?

   Do you know what verification activities should be performed and documented?

5. Where are our FSVP records?

   Can your organization locate and retrieve the supporting documentation when needed?

Build the Compliance System Before You Need It

FSVP compliance should not begin when:

• The shipment is already in transit;
• Your customs broker requests FSVP importer information; or
• FDA requests your records.

The objective is not simply to move one shipment through the border.

The objective is to establish a repeatable and documented U.S. food-import compliance system.