FSVP vs. U.S. Agent: What's the Difference?
Both relate to FDA compliance for imported food, but they serve very different purposes.
Foreign food facilities exporting to the United States and U.S. importers both have FDA obligations, but the requirements differ significantly. This guide breaks down the two most commonly confused concepts: the U.S. Agent requirement and the Foreign Supplier Verification Program (FSVP).
What is a U.S. Agent?
A U.S. Agent is required for all foreign food facilities that are registered with the FDA under 21 CFR 1.227. The U.S. Agent serves as the FDA's point of contact in the United States for the foreign facility. The agent must be a person or business located in the United States that is available to the FDA during normal business hours.
The U.S. Agent's role includes receiving and responding to FDA communications on behalf of the foreign facility, assisting FDA during inspections, and acting as a liaison between the facility and the agency.
What is FSVP?
The Foreign Supplier Verification Program (FSVP) is a requirement under the Food Safety Modernization Act (FSMA). It applies to U.S. importers, not foreign facilities. Under FSVP, the U.S. importer must verify that their foreign suppliers meet U.S. food safety standards.
FSVP requires importers to conduct hazard analyses, evaluate supplier performance, and take corrective actions when necessary. The regulation is found in 21 CFR Part 1, Subpart L.
Key Differences
| U.S. Agent | FSVP | |
|---|---|---|
| Who needs it | Foreign facilities | US importers |
| Regulation | 21 CFR 1.227 | 21 CFR Part 1, Subpart L |
| Purpose | FDA communication link | Supplier safety verification |
| Responsibility | Foreign facility appoints | US importer implements |
Can One Entity Serve Both Roles?
No. The U.S. Agent role and the FSVP importer role are legally separate requirements under different FDA regulations. They serve different parties (foreign facility vs. U.S. importer) and involve fundamentally different responsibilities.
Assurentry can serve as your U.S. Agent under 21 CFR 1.227, but we do not provide FSVP importer services. If you are a U.S. importer needing FSVP compliance, you will need to work with a qualified FSVP consultant or handle verification activities in-house.
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