FSVP vs U.S. Agent: Different Requirements, Different Roles

FSVP: The Importer's Obligation

The Foreign Supplier Verification Program (FSVP), codified at 21 CFR Part 1, Subpart L, is an FSMA rule that applies to U.S. importers of food. The FSVP importer is the U.S. owner or consignee of food at the time of entry, and their primary obligation is to verify that their foreign suppliers produce food that meets U.S. safety standards.

FSVP activities include conducting hazard analyses, evaluating suppliers, performing risk-based verification activities (such as on-site audits or sampling), and taking corrective actions when suppliers fall short. The importer must also identify themselves at entry by providing their DUNS number to CBP.

The FSVP obligation rests entirely with the U.S. importer. The foreign facility has no FSVP obligation — though they may need to cooperate with supplier audits and provide documentation.

U.S. Agent: The Foreign Facility's Obligation

The U.S. Agent requirement under 21 CFR §1.227 applies to foreign food facilities that register with FDA. Every foreign establishment that manufactures, processes, packs, or holds food for U.S. export must designate a U.S. Agent — an individual or organization in the United States that serves as the point of contact for FDA.

The U.S. Agent's responsibilities include receiving FDA communications on behalf of the foreign facility, assisting with inspection scheduling, and forwarding urgent notifications. The U.S. Agent does not conduct hazard analyses, evaluate suppliers, or perform any FSVP-related activities.

The U.S. Agent obligation rests entirely with the foreign facility. The U.S. importer has no role in the foreign facility's U.S. Agent designation (though they should verify that their supplier has a valid FDA registration with an active U.S. Agent).

Side-by-Side Comparison

How They Work Together

When a foreign food facility exports to the United States, the compliance framework involves both parties:

1. The foreign facility registers with FDA and designates a U.S. Agent. This is the facility's obligation and ensures FDA can communicate with them.
2. The U.S. importer develops and maintains an FSVP for that foreign facility. This is the importer's obligation and ensures the imported food meets U.S. safety standards.
3. At entry, the importer files Prior Notice and identifies themselves as the FSVP importer. The foreign facility's FDA registration number (which includes the U.S. Agent) is referenced in the entry.

If either component is missing — no U.S. Agent or no FSVP — the food shipment is at risk of detention or refusal.

Common Misconceptions

• "My U.S. Agent handles FSVP." — No. The U.S. Agent handles FDA communications for the foreign facility. FSVP is the importer's separate obligation.
• "My FSVP covers my facility registration."— No. FSVP is an importer program. The foreign facility must still independently register with FDA and designate a U.S. Agent.
• "I only need one or the other." — For food imports, both are required. The foreign facility needs a U.S. Agent for registration, and the U.S. importer needs an FSVP for each food they import.

Understanding these distinctions is critical for both foreign manufacturers and U.S. importers. Assurentry can help foreign facilities with U.S. Agent services and guide importers to reliable FSVP resources.