Who Is Your FSVP Importer?

When food is imported into the United States, businesses usually know who their manufacturer, freight forwarder, customs broker, warehouse, and customer will be.

But one important question is often left until the shipment is already approaching the United States:

Who is the FSVP Importer?

For foods subject to the Foreign Supplier Verification Programs requirements, identifying the appropriate FSVP Importer is an important part of establishing the U.S. import structure.

The answer should not be based simply on:

• Who receives the shipment;
• Who clears Customs;
• Who owns the warehouse;
• Who arranged the transportation; or
• Where the products will ultimately be sold.

Instead, the commercial arrangement and FDA's definition of the FSVP Importer need to be considered.

In general, the FSVP Importer is the U.S. owner or consignee of the food at the time of entry.

If there is no qualifying U.S. owner or consignee, the FSVP Importer may instead be the U.S. agent or representative of the foreign owner or consignee, with that role confirmed through a signed statement of consent.

The important first step is understanding who is actually taking FSVP responsibility.

Why Does the FSVP Importer Matter?

FSVP is not simply an entry-data requirement.

The FSVP Importer is associated with responsibility for meeting applicable Foreign Supplier Verification Programs requirements for the imported food.

Depending on the circumstances, applicable FSVP responsibilities may involve activities such as:

• Using qualified individuals;
• Conducting or reviewing hazard analyses;
• Evaluating the food and foreign supplier;
• Approving foreign suppliers;
• Determining supplier verification activities;
• Conducting or reviewing verification activities;
• Taking corrective actions when appropriate;
• Reevaluating the supplier or program when required; and
• Maintaining supporting FSVP records.

The role therefore involves more than placing a company name on import documentation.

Start With the U.S. Owner or Consignee

When determining who may serve as the FSVP Importer, an important starting point is the commercial relationship that exists when the food enters the United States.

This definition is important because the FSVP Importer should not be determined simply by asking:

“Who receives the shipment?”

Physical delivery and FSVP responsibility are not necessarily the same thing.

Example: Foreign Manufacturer Sells to a U.S. Distributor

If the U.S. distributor owns the food, has purchased the food, or has agreed in writing to purchase it at the time of entry, that relationship should be evaluated under the U.S. owner or consignee definition.

Another company may still perform functions such as:

• Customs brokerage;
• Freight forwarding;
• Transportation;
• Warehousing; or
• Delivery.

What If the Foreign Company Retains Ownership?

A different structure is common among international brands and e-commerce businesses.

In this structure, the foreign company may continue to own the food at the time of entry.

There may therefore be no qualifying U.S. owner or consignee.

Who will serve as the FSVP Importer?

Where there is no U.S. owner or consignee, the FSVP framework provides for a U.S. agent or representative of the foreign owner or consignee.

The role must be appropriately established and confirmed through a signed statement of consent.

This structure may be relevant to:

• Foreign food manufacturers;
• Foreign exporters;
• International Amazon sellers;
• Shopify or direct-to-consumer businesses;
• Foreign brands using a U.S. 3PL;
• Businesses entering the U.S. market without a U.S. subsidiary; and
• Foreign companies retaining ownership of inventory at entry.

A U.S. Representative Is More Than an Address

One common misunderstanding is that a foreign company simply needs:

“A U.S. address for FSVP.”

That does not fully describe the role.

Where a U.S. agent or representative serves as the FSVP Importer, the relationship should address the actual compliance structure.

Important considerations may include:

• Which foreign suppliers are covered;
• Which products are covered;
• Which shipments are covered;
• Who performs applicable FSVP activities;
• What supplier documentation must be provided;
• Where records are maintained;
• How new suppliers or products are handled; and
• How importer information will be used for shipments.

Who Is Not Automatically Your FSVP Importer?

Several parties may be involved in moving food into the United States. Their involvement does not automatically make them the FSVP Importer.

Customs Broker

A customs broker may:

• Prepare or transmit customs entry information;
• Coordinate with U.S. Customs and Border Protection;
• Support entry documentation;
• Transmit applicable FDA entry information; and
• Coordinate with the Importer of Record.

Freight Forwarder or Carrier

A freight forwarder or carrier may:

• Arrange transportation;
• Move the shipment internationally;
• Coordinate delivery; or
• Communicate shipment information.

Transportation responsibility does not automatically create FSVP responsibility.

Warehouse or 3PL

A warehouse or third-party logistics provider may:

• Receive inventory;
• Store products;
• Pick and pack orders;
• Manage fulfillment; and
• Arrange domestic shipments.

Physical possession of the products does not necessarily mean the warehouse owns the food or has taken FSVP responsibility.

Amazon FBA

Amazon may receive and fulfill inventory for sellers.

But sending food to an Amazon fulfillment center does not, by itself, determine:

• Who owns the food at entry;
• Who purchased the food;
• Who serves as FSVP Importer;
• Who performs supplier verification; or
• Who maintains the FSVP records.

The sales and fulfillment platform should therefore be distinguished from the regulatory importer structure.

Do Not Determine the FSVP Importer Based Only on the Delivery Address

That information answers:

Where is the shipment going?

It does not necessarily answer:

• Who owns the food?
• Who purchased it?
• Who is the FSVP Importer?
• Who is the Importer of Record?
• Who is responsible for supplier verification?

The delivery destination is only one part of the overall transaction.

FSVP Importer and Importer of Record Are Different Roles

This distinction is one of the most important concepts for food importers.

FSVP Importer Responsibilities May Include

• Hazard analysis;
• Supplier evaluation;
• Supplier approval;
• Verification activities;
• Corrective actions;
• Reevaluation; and
• FSVP recordkeeping.

Importer of Record Responsibilities May Include

• Customs entry;
• Import documentation;
• Importer identification;
• Duties and applicable charges;
• Customs broker authorization; and
• Import records.

A food shipment may therefore require separate answers to:

The same organization may potentially perform more than one role where appropriate, but one role should not automatically be assumed to include the other.

Think About the Import Structure in Layers

Instead of asking only:

“Who is the importer?”

Break the transaction into several questions.

1. Owner or Purchaser

   Who owns, purchased, or agreed to purchase the food at the time of entry?

   Understand the underlying commercial arrangement.

2. FSVP Importer

   Who is responsible for applicable foreign supplier verification requirements?

   Identify the party taking applicable FSVP responsibility.

3. Importer of Record

   Who is responsible for the applicable Customs import structure?

   This may or may not be the same organization as the FSVP Importer.

4. Customs Broker

   Who facilitates the entry?

   The broker performs entry-related functions within its authorized role.

5. Foreign Supplier

   Who actually manufactures, processes, raises, or grows the food?

   Supplier verification should connect to the appropriate foreign supplier.

6. Exporter

   Who sells or arranges the export?

   The exporter may be different from the manufacturer or foreign supplier.

7. Receiving Location

   Who physically receives or stores the products?

   A warehouse or fulfillment location may perform only logistics functions.

These may be different organizations.

Understanding those differences makes the import structure much clearer.

The Exporter Is Not Always the Foreign Supplier

Another important distinction is between:

A trading company may sell and export a food without manufacturing it.

The trading company may appear on commercial documents as the seller or exporter.

But FSVP supplier verification is connected to the applicable foreign supplier responsible for producing the food.

Being Identified at Entry Is Only One Part of FSVP

The FSVP Importer is relevant to the actual U.S. entry.

Applicable importer identification information must be provided during entry filing for food subject to FSVP.

But providing importer information at entry does not, by itself, establish a complete FSVP program.

Depending on the applicable requirements, that program may include:

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

The entry information should connect back to the underlying compliance program.

The FSVP Importer Needs Information From the Foreign Supplier

FSVP depends heavily on supplier cooperation.

Depending on the product and applicable verification approach, the importer may need information such as:

• Product specifications;
• Ingredient information;
• Process-flow information;
• Hazard analyses;
• HACCP plans;
• Food-safety plans;
• Audit reports;
• Laboratory reports;
• Certificates of analysis;
• Allergen information;
• Regulatory records;
• Corrective-action documentation; and
• Other supporting food-safety information.

Importer ↔ Foreign Supplier

The importer cannot effectively evaluate and verify a supplier if necessary information is unavailable.

What Happens When Products or Suppliers Change?

FSVP should not be treated as a one-time importer designation.

1. A new supplier is added.

   Has the supplier been appropriately evaluated?

2. A new product is introduced.

   Does the current FSVP documentation cover it?

3. The formulation changes.

   Does the hazard analysis need review?

4. The manufacturing process changes.

   Could the change affect food-safety hazards or controls?

5. Supplier performance changes.

   Should verification activities be reconsidered?

6. Regulatory information changes.

   Does the supplier evaluation need updating?

The FSVP structure should be capable of evolving with the business.

Three Ways to Manage the Program

Once the appropriate FSVP Importer has been identified, another question follows:

How will the FSVP program be managed?

There are three practical approaches.

DIY, Software, or Professional Support?

There is no single operating model that works for every food importer.

The appropriate model depends on factors such as:

• Internal expertise;
• Number of suppliers;
• Number of products;
• Shipment frequency;
• Available personnel;
• Existing compliance infrastructure; and
• Desired level of outside support.

Some organizations may use a combination.

Internal Team + SystemsBuilder.pro + CIG Qualified Individual Support

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

Seven Questions to Ask Before Your Next Shipment

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

1. Who owns or purchased the food at entry?

   Understand the commercial arrangement.

2. Who is the FSVP Importer?

   Identify the appropriate U.S. party before shipment.

3. Who is the actual foreign supplier?

   Know who manufactures, processes, raises, or grows the food.

4. Who is the Importer of Record?

   Do not automatically assume this is the same party as the FSVP Importer.

5. What products are covered by the FSVP program?

   Make sure the imported food connects to the correct documentation.

6. What supplier verification has been established?

   Know what supporting activities and evidence apply.

7. Where are the records?

   Can the organization locate and retrieve applicable FSVP documentation when needed?

Common FSVP Importer Mistakes

1. Waiting Until the Shipment Is Already in Transit

   The importer structure should ideally be established before cargo moves.

2. Assuming the Broker Is the FSVP Importer

   Entry facilitation does not automatically create FSVP responsibility.

3. Using a Warehouse Because It Has a U.S. Address

   A receiving address is not the same as an FSVP importer determination.

4. Assuming Amazon FBA Takes the Role

   A fulfillment platform does not automatically determine FSVP responsibility.

5. Providing an Importer Name Without Establishing the Program

   Importer identification should connect to an underlying FSVP compliance structure.

Build the Structure Before You Need It

A more organized approach is:

1. Determine FSVP Applicability
2. Identify Ownership Structure
3. Determine FSVP Importer
4. Identify Foreign Supplier
5. Identify Product
6. Establish Verification
7. Organize Records
8. Connect to Shipment

The objective is not simply to provide an importer name for one shipment.

The objective is to establish a repeatable U.S. food-import compliance structure.