Why Importers and Exporters Need an FSVP Agent

The Foreign Supplier Verification Program (FSVP) rule was issued by FDA as part of the Food Safety Modernization Act in 2011. The FSVP rule requires importers to perform “risk-based activities” to verify that the food or dietary supplements brought into the United States have been produced in a manner that meets U.S. food safety standards.

The FSVP rule requires food or dietary supplement importers to do the following:

• Conduct a hazard analysis to determine known or reasonably foreseeable hazards for each product requiring a preventive control
• Evaluate the foreign supplier’s performance and the risk posed by products requiring a preventive control 
• Use the evaluation to approve suppliers and determine appropriate supplier verification activities
• Conduct foreign supplier verification and related activities
• Take corrective actions (if necessary), and
• Maintain records of these FSVP activities

A key provision of the FSVP rule for foreign importers with no employees located in the U.S. is that they must designate an “agent” to carry out FSVP responsibilities on their behalf. An FSVP Agent must be a “qualified individual” physically located in the U.S. A qualified individual is “a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under FSVP, and can read and understand the language of any records that the person must review in performing this activity.”

The FSVP Agent is not the same as a US Agent for a foreign food facility. If a foreign exporter or importer does not have a “consignee” that is qualified to fulfill FSVP duties, they must hire an FVSP Agent.

What do FSVP Agents do?

FSVP Agents develop an FSVP plan for a foreign importer or exporter. FSVP Agents can also identify any hazards associated with the food, beverages, or dietary supplements, review an importer’s compliance history, update an existing FSVP plan, execute the appropriate verification activities, and more. Whenever the manufacturing process of a food, beverage, or dietary supplement changes, such as an ingredient modification, the FSVP plan must be updated accordingly. The FSVP agent must also reevaluate the existing plan every three years. Finally, the FDA requires that each imported product have its own FSVP plan, all of which the FSVP Agent develops and maintains.

Conclusion

FSVP regulations are complex and a qualified individual needs to draft an FSVP. Not designating an FSVP Agent as a foreign importer or exporter can result in disciplinary actions from the FDA. These include product detentions, warning letters, and refusals at port. Warning letters can be accessed by the public and thus negatively impact your brand. It’s best to save valuable time and money by hiring an FSVP Agent. To that end, US Imports can serve as your U.S.-based FSVP Agent.