FDA registration and US Agent: what it takes to sell food in the United States

Key points

• Registration is required under the Bioterrorism Act rules in 21 CFR Part 1, Subpart H, and there is no registration fee.

• Foreign facilities must designate a US Agent. A mailbox, answering machine or answering service does not qualify.

• Renewal runs from October 1 to December 31 of each even-numbered year. The 2026 window is open now.

• A registration that is not renewed is treated as expired, and FDA will cancel it.

• Prior notice must be submitted for each imported shipment, with minimum lead times by transport mode.

Which facilities must register

Under 21 CFR 1.225, owners, operators or agents in charge of domestic or foreign facilities that manufacture, process, pack or hold food for US consumption must register, unless an exemption applies. A foreign facility is exempt if its food is further manufactured or processed by another foreign facility before export, but not if that further step is only labeling or a similar de minimis activity. Farms, restaurants and retail food establishments are exempt, as are facilities regulated exclusively by USDA for certain meat, poultry and egg products.

You must register before the facility begins to make, pack or hold food for the US market. Since January 2020, registrations, renewals, updates and cancellations must be submitted electronically unless FDA grants a waiver.

The role of the US Agent

The regulation defines the US Agent as a person residing or maintaining a place of business in the United States who is physically present there. The agent acts as the communication link between FDA and the foreign facility, including in emergencies. The registration must include the agent’s name, address, phone number and email, plus an emergency contact. Through FDA’s voluntary identification system, the agent confirms the appointment before FDA confirms the registration.

If the agent’s details change, the registration must be updated within 60 calendar days. Choose someone reliable and reachable, because an outdated agent makes the registration out of date.

What the registration contains

• Facility name, address and phone number.

• A unique facility identifier recognized by FDA. FDA accepts the DUNS number.

• US Agent and emergency contact details.

• An assurance that FDA will be permitted to inspect the facility.

Prior notice for each shipment

Prior notice is a separate obligation from registration. Under 21 CFR 1.279, it must be submitted at least 2 hours before arrival by road, 4 hours by air or rail and 8 hours by water, and no earlier than 15 days before arrival through FDA’s PNSI system or 30 days through CBP’s ACE. Food with missing, inaccurate or late prior notice can be refused and held at the port.

Importers and supplier verification

Under FSMA’s Foreign Supplier Verification Programs rule, the US owner or consignee at entry is generally the FSVP importer. If there is none, the importer is the US agent or representative of the foreign owner, with signed consent. The FSVP importer must verify that each foreign supplier produces food with the same level of public health protection required in the US.

Labeling basics

Packaged food sold in the US must follow FDA labeling rules in 21 CFR Part 101 and the Fair Packaging and Labeling Act, including Nutrition Facts. FDA recognizes nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame, which became the ninth on January 1, 2023. European labels almost always need to be redesigned.

Steps to get ready

1. Confirm whether each facility in your supply chain needs to register.

2. Obtain a DUNS number for each facility.

3. Appoint a US Agent and have them set up their FDA account.

4. Register through FDA’s Food Facility Registration Module and put the next even-year renewal on the calendar.

5. Agree on who files prior notice and who acts as FSVP importer.

6. Review your labels against US rules before printing.

How Devolus can help

Devolus coordinates FDA registration, US Agent arrangements and import setup for food companies entering the US, together with specialist partners. The Readiness Check is a quick way to see where you stand, or you can write to us.

What we handle and our starting fees are on the FDA & Import page.