How a Foreign Company Can Export Food to the United States: The FDA Requirements

Before the first US food shipment, identify the product, each facility that makes, packs or holds it, the US buyer or consignee, and who will submit shipment information. Registration, importer verification, labeling and Prior Notice are different tasks. Their applicability depends on the activity and product; no single filing or number covers them all.

Which facility needs FDA food registration?

A foreign facility that manufactures, processes, packs or holds food for US consumption generally registers with FDA before shipping, unless an exemption applies. Farms, restaurants, retail food establishments and certain other operations have specific exemptions; assess the actual activity rather than treating every exporter or trader as a registrable facility. A required registration identifies the physical facility and its food categories, and a foreign facility designates a US Agent. Registration is free with FDA; professional preparation and Agent coverage are separate services. https://www.fda.gov/food/food-industry/how-start-food-business

UFI, DUNS, registration number and FEI are different

A facility submitting food registration needs an FDA-accepted unique facility identifier (UFI); FDA currently recognizes the D&B DUNS number for that purpose. Check whether the facility already has a usable DUNS record before requesting one. D&B issues and updates it; the FDA food registration number is produced through FDA's registration process. FEI is a different FDA establishment identifier, not a universal prerequisite or proof that a food registration is active. https://www.fda.gov/food/online-registration-food-facilities/food-facility-registration-user-guide-summary-fields

The facility's US Agent and the FSVP importer

A registered foreign food facility designates a US Agent as its FDA communications contact. The FSVP importer is a separate role: generally the US owner or consignee at entry, or, if there is none, a US agent or representative of the foreign owner or consignee who has agreed in a signed statement to serve as FSVP importer. The importer owns applicable supplier verification duties; a foreign supplier can provide hazard, process and verification evidence. Naming a facility US Agent does not by itself make that party the FSVP importer. Confirm any FSVP exemption or modified requirement for the product and transaction. https://www.fda.gov/food/food-safety-modernization-act-fsma/final-rule-foreign-supplier-verification-programs-fsvp-glance

Label compliance before the first shipment

Check the actual product's US labeling rules before printing: identity, net quantity, ingredients, major allergens, nutrition information where required, and other category-specific statements. Some products qualify for particular nutrition-label exemptions; country-of-origin marking is generally a CBP issue. A professional label review helps identify gaps but is not an FDA filing or a guarantee of entry. https://www.fda.gov/food/food-labeling-nutrition

Prior Notice and what happens at the border

Prior Notice is a separate shipment/article task for food imported or offered for import, subject to specified exemptions. FDA must receive and confirm it before arrival: generally at least 2 hours before road arrival, 4 hours before rail or air, and 8 hours before water arrival; international mail requires notice before sending. Check the actual mode, article and exemption. A confirmation acknowledges receipt for review, not admission or clearance. FDABridge's Prior Notice service is US$99 per shipment subject to agreed article scope; it does not include facility registration or importer FSVP duties. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-what-you-need-know-about-prior-notice-imported-food-shipments

Choose the relevant food service

Compare food facility registration, DUNS acquisition or update, US Agent coverage, food label review and shipment-specific Prior Notice at https://fdabridge.com/food. If you process shelf-stable acidified or low-acid canned food, check whether separate FCE registration and scheduled-process filings apply: https://fdabridge.com/blog/low-acid-acidified-canned-food-fda-fce-sid-registration. For importer-owned FSVP work and supplier evidence, see https://fdabridge.com/blog/fsvp-gap-analysis-what-foreign-food-suppliers-must-document-for-us-importers. Ask for a scoped recommendation before selecting a service if your product, facility or importer role is uncertain.