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

Selling food products in the United States is one of the most commercially significant decisions a foreign manufacturer can make — and one of the most heavily regulated. The US market is governed by the Federal Food, Drug, and Cosmetic Act, extensively updated by the Food Safety Modernization Act of 2011, and enforced by the FDA through a combination of facility registration requirements, import controls, labeling rules, and inspection authority. A foreign company that starts shipping food to the US without completing the required filings will face import refusals, holds, and potential FDA action against its registration. Getting the foundation right before the first shipment is far less expensive than correcting it under pressure at a US port.

FDA food facility registration is the legal starting point

Any foreign establishment that manufactures, processes, packs, or holds food for consumption in the United States must register with the FDA under the Bioterrorism Act before shipping. This requirement applies regardless of whether the food is imported directly or sold through a US distributor, and regardless of whether the company has any other US regulatory relationship. The registration must include the facility's full legal name and address, the food categories handled at the facility, and the name and contact information of the facility's designated US Agent. Without a current, active registration, a shipment from the facility can be refused at the US border.

The DUNS number must come before the registration

The FDA requires a DUNS number — issued by Dun & Bradstreet — as the Unique Facility Identifier in food facility registration submissions. The DUNS number must be obtained before the FDA filing is started, because the name and address in the DUNS record must match the name and address on the FDA registration form exactly. A mismatch — even a minor difference in abbreviation, punctuation, or address format — creates a discrepancy in the FDA's verification process that can delay or invalidate the registration. The DUNS application is free of charge when applied for directly with Dun & Bradstreet, and standard processing typically takes five to ten business days.

The US Agent requirement and what it means in practice

Every foreign food facility registered with the FDA must designate a US Agent. The US Agent must be a person or entity physically located in the United States, and must be available to the FDA at all times — including for inspection scheduling, compliance correspondence, and import hold notifications. The FDA communicates with foreign registered facilities through the US Agent, not directly with the overseas facility. If the FDA cannot reach the US Agent, the facility's compliance position is functionally impaired regardless of how well the physical facility operates. The US Agent is not a formality; it is the regulatory communications channel between the FDA and the registered foreign facility.

Label compliance before the first shipment

US food labeling requirements are detailed and format-specific. The Nutrition Facts panel must follow the FDA's updated format introduced in 2016. The ingredient list must appear in descending order by weight using common or usual names, with all nine major allergens declared by name including sesame, which was added in January 2023. The principal display panel must show an accurate statement of identity and net quantity of contents in both metric and US customary units. Country of origin must be marked clearly. Products that arrive with labels that do not comply with these requirements can be detained at the port of entry. Label review before the first shipment is one of the most effective ways to avoid an initial refusal.

Prior Notice and what happens at the border

The FDA requires Prior Notice — advance notification submitted through the FDA's electronic system before each food shipment arrives at a US port — for all food imported into the United States. Prior Notice must include information about the shipper, the product, the manufacturing facility, the carrier, the port of entry, and the US recipient. It must be submitted at least two hours before arrival for shipments arriving by land or two hours before unloading for air shipments, and four hours for ocean vessels. If Prior Notice is not submitted, or if the information submitted does not match the actual shipment, the cargo can be held at the port. A facility registration that is not current or accurate compounds the Prior Notice problem, because the FDA cross-checks the registration against the Prior Notice data.

How FDABridge handles this for foreign food exporters

FDABridge manages FDA food facility registration, DUNS acquisition, US Agent appointment, label review, and ongoing registration maintenance for foreign food manufacturers. Our service covers the full filing path from the first document to the FEI number confirmation. Visit fdabridge.com/food to see our food export services or fdabridge.com/apply/food to begin.