Do I need an FSVP Agent?

An FSVP Agent is a U.S.-based representative designated by certain FSVP importers when required under FDA regulations.

The FSVP Agent serves as the U.S. point of contact identified by the FSVP importer.

The designation of an FSVP Agent does not transfer the importer's regulatory responsibilities under the FSVP regulation.

An FSVP Agent is generally required when:

• The FSVP importer is not a U.S. resident
• The FSVP importer does not maintain a U.S. place of business

In these situations, the importer is generally required to designate a U.S. agent who resides or maintains a place of business in the United States and is physically present in the United States.

Every import arrangement is unique. Businesses should evaluate their specific circumstances to determine whether this requirement applies.

An FSVP Agent may not be required if the FSVP importer already:

• Resides in the United States
• Maintains a place of business in the United States

Whether an FSVP Agent is required should always be determined based on the facts of the import transaction and applicable FDA regulations.

These two roles are often confused but serve different purposes.

• FSVP Importer: Responsible for developing and maintaining the Foreign Supplier Verification Program.
• FSVP Agent: Serves as the designated U.S. representative for certain non-U.S. FSVP importers.
• FSVP Importer: Has primary responsibility for complying with the FSVP regulation.
• FSVP Agent: Does not assume the importer's regulatory responsibilities solely by acting as the FSVP Agent.
• FSVP Importer: Must ensure foreign suppliers meet applicable food safety requirements.
• FSVP Agent: Acts as the designated U.S. contact identified by the importer.

Understanding the distinction is important when developing an import compliance program.

The FSVP importer remains responsible for complying with applicable FSVP requirements, which may include:

• Conducting or obtaining a hazard analysis
• Evaluating foreign suppliers
• Approving suppliers
• Performing appropriate supplier verification activities
• Taking corrective actions when necessary
• Maintaining required records
• Reassessing the FSVP program as required

Designating an FSVP Agent does not transfer these obligations.

The FSVP regulation generally applies to many food products imported into the United States for human or animal consumption.

The applicability of FSVP depends on factors such as:

• Product type
• Regulatory exemptions
• Supplier location
• Import arrangement
• Intended use of the product

Because exemptions and modified requirements may apply in certain situations, each product should be evaluated individually.

Understanding FSVP requirements can be challenging, particularly for organizations entering the U.S. market for the first time.

Our team assists businesses by providing:

• FSVP compliance support
• FSVP Agent services, when required
• Import Readiness Assessments
• Supplier Qualification
• Regulatory Gap Assessments
• Importer of Record (IOR) Services
• FDA Import Compliance Support
• Product Documentation Reviews
• Shipment Compliance Support

As part of Consultare Inc. Group, we integrate Governance, Risk, and Compliance (GRC) principles into every engagement, helping clients build practical and sustainable import compliance programs.

No. These are different roles with different regulatory purposes.

Depending on the import transaction, the FSVP importer, the FSVP Agent, and the Importer of Record may be different entities.

A customs broker and an FSVP Agent perform different functions.

Whether a broker is willing or able to serve in that role is a separate business decision.

Importers should ensure any designated FSVP Agent meets applicable regulatory requirements.

Depending on the business arrangement, a U.S. distributor may be able to serve in that role if the applicable regulatory requirements are met and the parties agree.

The appropriate arrangement should be evaluated based on the specific facts of the transaction.

No. Designating an FSVP Agent does not, by itself, transfer the importer's responsibility for complying with the FSVP regulation.

Yes. Where appropriate, IORServices.pro offers FSVP Agent services together with broader import compliance support to help businesses establish effective import programs for FDA-regulated food products.

Every import transaction is unique.

If you are unsure whether your business requires an FSVP Agent or would like to better understand your responsibilities under the Foreign Supplier Verification Program, our team can help evaluate your situation and recommend an appropriate compliance strategy.

Contact IORServices.pro today to schedule a complimentary consultation and learn how we can help support your U.S. food import compliance program.