FDA Food Facility Registration: U.S. Agent Requirements for Foreign Food Exporters

Published by US Compliance Agent LLC

If your company makes, packs, or stores food outside the United States and that food is sold here, your facility must be registered with FDA, and the registration must name a U.S. Agent. FDA will not issue a registration number until that agent has confirmed the role.

The timing matters right now. Every food facility registration has to be renewed between October 1 and December 31, 2026. A registration that isn't renewed in that window expires.

This guide covers who has to register, what the U.S. Agent does, what FDA checks before it confirms your registration, and how this role differs from the FSVP importer.

Who has to register

Under 21 CFR 1.225, the owner, operator, or agent in charge of a foreign facility must register if the facility manufactures, processes, packs, or holds food for consumption in the United States.

"Food" is broad. FDA's definition includes beverages (including alcoholic beverages and bottled water), dietary supplements, food ingredients and additives, animal feed and pet food, snack foods, candy, bakery goods, and canned foods.

21 CFR 1.226 lists the facilities that don't have to register. The ones that matter most for exporters:

• Food that is further processed by another foreign facility before export. Only the last facility that processes or packages the food needs to register. This exemption does not apply if the later facility only adds labels or does something similarly minor.

• Farms, retail food establishments, restaurants, and certain nonprofit food establishments.

• Facilities regulated only by USDA for meat, poultry, or egg products.

What the U.S. Agent is

21 CFR 1.227 defines the U.S. Agent as a person who lives in the United States or has a place of business here, and whom the foreign facility designates as its agent for registration. Three points from that definition:

• It has to be a real person or business. The regulation rules out a mailbox, an answering machine or answering service, or any place where nobody acting as your agent is physically present.

• It is FDA's communications link to you. The agent handles both routine and emergency communications. FDA will contact the agent in an emergency unless your registration names a separate emergency contact.

• What FDA sends the agent counts as sent to you. FDA treats the agent's statements as the facility's own and treats documents given to the agent as delivered to the facility. That is why an agent who forwards mail late is a real risk.

The agent can see the information in your registration. The regulation also makes clear that your commercial business in the U.S. does not have to run through the agent. Your importer, distributor, or customers can be completely separate.

What the registration asks for

Under 21 CFR 1.232, a foreign facility's registration must include:

• The facility's name, address, and phone number

• A Unique Facility Identifier (UFI). FDA currently accepts the DUNS number as the UFI, and the address in the DUNS record must match the address in the registration

• The owner, operator, or agent in charge, with email address

• Food product categories and the activities performed for each (for example manufacturer/processor, packer, or warehouse)

• The U.S. Agent's name, full address, phone number, and email address

• An emergency contact phone number and email address

• An assurance that FDA will be allowed to inspect the facility

Registration is done online through FDA's Unified Registration and Listing System (FURLS). FDA charges no registration fee (21 CFR 1.231(c)).

All information must be in English, except names of people, companies, and streets, and everything must use the Latin alphabet.

FDA checks your U.S. Agent before it confirms

This step catches many first-time registrants. Under 21 CFR 1.231(a)(5), after a foreign facility submits its registration, FDA contacts the person named as U.S. Agent to confirm they agreed to serve. FDA will not confirm the registration or issue a registration number until the agent confirms.

The same check applies when you change your U.S. Agent during a renewal or an update. So have your agent in place, and make sure they expect FDA's request, before you submit.

The 2026 renewal window

21 CFR 1.230(b) requires every registered facility to renew between October 1 and December 31 of each even-numbered year. This year that means October 1 to December 31, 2026.

For a step-by-step walkthrough of this year's renewal, read our FDA Food Facility Registration Renewal 2026 guide.

If nothing in your registration has changed, you can use the shorter abbreviated renewal.

If you miss the window, FDA considers the registration expired and treats the facility as unregistered (21 CFR 1.241(b)), and it will cancel expired registrations (21 CFR 1.241(c)).

Food from an unregistered foreign facility that is offered for import can be held at the port under 21 CFR Part 1, Subpart I.

Between renewals, you must update the registration within 60 calendar days of any change, including a change of U.S. Agent (21 CFR 1.234(a)).

U.S. Agent vs. FSVP importer

These two roles are often confused, and they are not the same.

• The food facility U.S. Agent is named in your facility's FDA registration. It is FDA's point of contact for the facility.

• The FSVP importer is responsible for verifying that imported food meets U.S. safety standards under the Foreign Supplier Verification Program. Under 21 CFR 1.500, the importer is the U.S. owner or consignee of the food at entry. Only if there is no U.S. owner or consignee does the role fall to the foreign owner's U.S. agent or representative, and only if that person signs a statement agreeing to serve as importer.

Naming a U.S. Agent on your facility registration does not make that agent your FSVP importer. In most shipments, your U.S. buyer or distributor is the FSVP importer. Our service covers the food facility U.S. Agent role only.

If you export food and cosmetics

A company that makes both food and cosmetics, such as tea and a skincare line, needs two separate FDA registrations: a food facility registration in FURLS and a cosmetic facility registration under MoCRA. Each one names a U.S. Agent. The same agent can serve for both.

Our FDA Food Facility U.S. Agent service

Our FDA Food Facility U.S. Agent service is $349 per year. It includes:

• U.S. Agent designation for your FDA food facility registration

• A U.S. business address, phone number, and email for the registration

• Confirmation of FDA's U.S. Agent verification request

• Same-business-day forwarding of FDA correspondence

• 12 months of coverage

We don't file your registration, review your labels, or act as your FSVP importer. If you need those services, you will need a regulatory consultant or your U.S. importer.

If your facility is renewing this quarter or registering for the first time, visit our FDA U.S. Agent page or see our pricing page.

US Compliance Agent LLC is a private company. We are not affiliated with, endorsed by, or connected to the FDA or any U.S. government agency. We do not provide legal advice, regulatory consulting, product testing, or certification services.