FDA Packaged Food Export Checklist: What Foreign Manufacturers Must Have Ready

An FDA packaged food export checklist is the difference between a shipment that clears US customs on arrival and one that sits in a bonded warehouse accumulating demurrage charges. The FDA does not publish a single consolidated checklist for foreign food exporters — the requirements are spread across the Bioterrorism Act, the Food Safety Modernization Act (FSMA), the Federal Food, Drug, and Cosmetic Act, and multiple regulations in 21 CFR. The result is that most first-time exporters discover a missing requirement only when a shipment is refused. This guide walks through the filings, registrations, and documents that must be in place before the first container leaves the factory.

Core FDA registrations and numbers required before the first shipment

Every foreign food manufacturer shipping packaged food to the United States must hold a valid FDA food facility registration under the Bioterrorism Act. The registration is filed through the FDA Industry Systems portal and must include the facility's full address, trade names, product categories, and the designated US Agent. The registration has no government fee but requires a DUNS number as the official facility identifier. The DUNS number is issued by Dun & Bradstreet and must match the exact legal entity name and address used in the FDA registration — a mismatch between DUNS records and FDA records is one of the most common causes of rejected registrations.

In addition to the facility registration, foreign manufacturers must designate a US Agent with a US physical address, as required under 21 CFR 1.227. The US Agent must be available during US business hours to receive FDA communications on behalf of the facility. If a facility ships products in specific categories — shell eggs, infant formula, low-acid canned foods, acidified foods, juice, or seafood — additional registrations and filings apply beyond the standard facility record. For example, low-acid canned food facilities must also hold a Food Canning Establishment (FCE) number and submit Scheduled Process (SID) filings for each product.

Shipment-level requirements: Prior Notice and the FSVP

A valid facility registration does not, by itself, allow a shipment to enter the United States. Every inbound food shipment must also have a Prior Notice filed with the FDA, submitted electronically no more than 30 days and no less than 2 hours (for truck), 4 hours (for air/rail), or 8 hours (for ocean) before the shipment arrives at the US port. The Prior Notice includes the identity of the submitter, the article of food, the manufacturer, the shipper, the grower (if applicable), the country of production, the anticipated arrival information, and the FDA registration number of the manufacturer. A missing or inaccurate Prior Notice will cause the shipment to be refused entry.

Separate from Prior Notice, the Foreign Supplier Verification Program (FSVP) places obligations on the US importer — not the foreign manufacturer directly. But the foreign manufacturer's compliance record is what makes FSVP verification possible. The US importer must document that the foreign supplier produces food consistent with US food safety requirements, which means the manufacturer must be able to provide hazard analysis records, preventive controls documentation, and third-party audit results when the importer requests them. Foreign manufacturers without these records in a US-ready format often lose US importer relationships after the first FSVP audit cycle.

Label compliance: what must be on every package

US food label requirements differ significantly from labeling rules in the EU, UK, and most Asian markets. A label that is fully compliant in the European Union will almost never satisfy FDA requirements without modification. The mandatory elements include: the statement of identity (product name) in the principal display panel, the net quantity of contents in both US customary and metric units, the ingredient list in descending order by weight, the Nutrition Facts panel in the FDA-mandated format, the name and address of the manufacturer or distributor, country of origin marking, and allergen declarations using the specific language required under the Food Allergen Labeling and Consumer Protection Act.

Nutrition Facts formatting is a frequent source of non-compliance. The FDA format has specific rules about font sizes, line spacing, the order of nutrients, the reference amount customarily consumed (RACC), and the calculation of serving size. A Nutrition Facts panel copied from another market — or even an older US format from before the 2016 label update — will fail compliance review. Allergen declarations must call out the nine major allergens by name, and since the FASTER Act added sesame as the ninth major allergen in January 2023, any label formatted before that date needs review.

Documentation the shipment itself must carry

Beyond the FDA filings, the physical shipment must be accompanied by a specific document set for customs and FDA entry review. The commercial invoice must identify the manufacturer, the importer of record, the country of origin, the FDA registration number, and the harmonized tariff schedule (HTS) codes for each product. The bill of lading must match the Prior Notice data exactly — discrepancies trigger automatic holds. Certificates of analysis are not mandatory for most food categories but are increasingly requested during FSMA inspections, particularly for products with microbiological risk profiles.

For products subject to specific program requirements — seafood (HACCP), juice (HACCP), acidified or low-acid canned foods (21 CFR 108, 113, 114) — the shipment documentation must also include references to the relevant HACCP plan, Scheduled Process filings, or process authority letters. Missing program-specific documentation is a major cause of first-shipment refusals for facilities that are otherwise properly registered.

Common gaps in an FDA packaged food export checklist

The most frequent gap is assuming that a registration valid a year ago is still valid today. Registration status can change for reasons unrelated to the facility's own actions — the US Agent relationship may have lapsed, a required renewal window may have been missed, or FDA may have flagged the registration after a contact attempt failed. Before every new shipping cycle, the registration status should be verified against the FDA Industry Systems portal, not assumed.

Another common gap is treating the checklist as a first-shipment exercise only. Registrations require renewal, US Agent appointments need to remain active, labels must be re-reviewed when ingredients or claims change, and Prior Notice must be filed for every shipment — not just the first. Facilities that shipped successfully five years ago and are now returning to the US market often find that their registration has lapsed, their US Agent has moved on, and their label no longer complies with current FDA rules.

How FDABridge handles the full FDA packaged food export checklist

FDABridge manages every item on the FDA packaged food export checklist as a single service. Facility registration, DUNS number acquisition, US Agent appointment, label review against current FDA requirements, and ongoing compliance monitoring are all handled by our team. Visit fdabridge.com/food to see our food export services or fdabridge.com/apply/food to start your filing with documents ready for review.