FDA Food Facility Registration: The Questions First-Time Registrants Ask Before Filing

FDA food facility registration is mandatory for every foreign food facility that manufactures, processes, packs, or holds food intended for US consumption — with limited exceptions. For manufacturers doing this for the first time, the process raises practical questions that are not always easy to find clear answers to. Here are the questions we hear most from first-time registrants.

Who exactly must register?

Any facility outside the United States where food is manufactured, processed, packed, or held for consumption in the United States must register. This includes factories, processing plants, bottling plants, packing facilities, and warehouses if the food in the warehouse is intended for the US market. Farms in their primary activity — growing crops, raising livestock — are exempt. Restaurants, retail stores, fishing vessels, and non-profit facilities that provide food directly to consumers are also exempt. But a facility that packages raw agricultural commodities or performs any processing step — even minimal processing like sorting, grading, or labeling — is not a farm and is generally required to register.

Does the registration expire?

Yes. FDA food facility registrations must be renewed between October 1 and December 31 of every even-numbered year (2024, 2026, 2028, and so on). A facility that does not renew within this window is considered unregistered. There is no grace period. If you miss the renewal window, you must re-register, which generates a new FEI number and requires notifying your US importers of the change. Missing the renewal is one of the most common compliance failures among foreign food exporters and it has immediate consequences at the US border.

What is a US Agent and do I need one?

Yes, a US Agent is required for all foreign food facility registrants. The US Agent is a person or company with a physical address in the United States who agrees to receive FDA communications on behalf of the foreign facility. This includes inspection notices, Warning Letters, and requests for information. The US Agent cannot be a P.O. box. The US Agent's name and contact information are entered as part of the FURLS registration and must be kept current. If your US Agent changes, you must update the registration. FDABridge serves as US Agent for foreign food facilities and maintains communication with FDA throughout the registration lifecycle.

How do I know if my registration was successful?

After a successful FURLS submission, FDA assigns a Food Establishment Identifier (FEI) number to the facility. This is FDA's permanent identifier for that registered facility. You can verify registration status using FDA's online facility search tool. Some third-party registration services issue their own 'FDA registration certificates' — FDABridge issues a registration confirmation document — but the legally relevant proof of registration is the FEI number assigned by FDA and the active status of that FEI in FDA's public database.

What do I need to have in place before shipping to the US?

Before your first food shipment arrives at a US port of entry, you must have: an active FDA food facility registration with a valid FEI number, a designated US Agent, a DUNS number associated with your facility address, a labeling review (to confirm your labels meet FDA requirements including allergen declarations, nutrition facts panels, and net content statements), and a prior notice submission for each shipment (required by FDA before food arrives in the US). US importers also typically require evidence of your FSMA food safety plan and may conduct FSVP audits. FDABridge can help you prepare all of these elements before your first export.

What happens if I ship food to the US without registering?

Food from an unregistered foreign facility is subject to refusal of admission at the US border under Section 801 of the Federal Food, Drug, and Cosmetic Act. CBP and FDA coordinate to check registration status at ports of entry. An unregistered shipment will be detained, and the importer bears the cost of storage, re-export, or destruction. The foreign manufacturer's relationship with the US importer is also at risk — most commercial contracts require active FDA registration as a precondition of purchase. FDABridge handles the full registration process from DUNS number acquisition through FEI issuance. Visit fdabridge.com/food-facility-registration for pricing and process details.