Exporting Food to the US: FDA Registration, Prior Notice and FSVP

Food facility registration

Facilities in the US or abroad that manufacture, process, pack or hold food for US consumption must register with FDA. A foreign facility is exempt only if another foreign facility further processes or packs the food before export, beyond minor steps such as labeling.

Foreign facilities need a US agent based in the US and a unique facility identifier, for which FDA accepts the DUNS number. Registrations must be renewed from 1 October to 31 December of every even-numbered year, or they expire and are cancelled.

Registration is confidential, and FDA does not certify products, labels or shipments.

Prior notice for every shipment

FDA must receive prior notice of each shipment, commercial samples included, usually filed by the customs broker in CBP's ACE system or in FDA's PNSI portal. It lists the product, the manufacturer's registration number, shipper, importer and arrival details.

• Road: at least 2 hours before arrival
• Air or rail: at least 4 hours before arrival
• Sea: at least 8 hours before arrival
• International mail: before sending, with the confirmation number on the customs declaration
• Earliest: 30 days before arrival through ACE, 15 days through PNSI

FSVP and preventive controls

The FSVP importer is the US owner or consignee at entry or, if there is none, a US agent of the foreign owner with signed consent. Its DUNS number must be sent on each entry line of covered food; entries without one are rejected.

The importer analyzes hazards, approves suppliers and verifies them by audits, testing or record review. If the supplier controls a hazard that can cause serious illness or death, an onsite audit is due before the first import and yearly unless another method is justified in writing.

Registered facilities, foreign ones included, generally need a written food safety plan under FSMA's preventive controls rule. Firms with under USD 1 million in yearly food sales have lighter duties.

Canned and acidified foods, supplements

Low-acid canned foods (LACF) and acidified foods (AF) need more. The processor registers the plant (FCE number) and files a process for each product (SID number), and FDA checks both at entry. If a sauce or drink might be covered, ask a process authority early.

Dietary supplements have added rules of their own, such as new dietary ingredient notifications.

Labels, allergens, additives and colors

Required label information must be in English, and imported food must show its country of origin.

• Front panel: name of the food and net quantity in metric and US units
• Ingredient list, and the manufacturer's, packer's or distributor's name and address
• Nutrition Facts panel, unless exempt
• Nine major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame (since 1 January 2023), declared in the ingredient list or a "Contains" statement naming the specific nut, fish or shellfish
• Colors need FDA authorization for their use. FD&C Red No. 3 may not be used in food from 15 January 2027, and FDA is pushing a shift away from other petroleum-based dyes.
• Other ingredients must be approved food additives or generally recognized as safe (GRAS).

Changes to watch

• Food Traceability Rule (FSMA 204): extra records for US and foreign firms handling foods on FDA's Food Traceability List; FDA will not enforce it before 20 July 2028.
• Front-of-package nutrition label: proposed in 2025 and still under review in 2026; not yet required.
• "Healthy" claim: FDA is implementing updated criteria and said in 2026 it may revise them and add a symbol.
• GRAS: an August 2026 proposal would make GRAS notices mandatory; comments close 9 December 2026.

At the border and US customs

FDA's PREDICT tool checks entry data against FDA records such as registrations, canning filings and import alerts; mismatches go to manual review, examination or sampling. Products on an import alert are detained without physical examination (DWPE).

After detention the importer normally has 10 business days to show compliance or apply on Form FDA 766 to relabel. Refused goods must be exported or destroyed within 90 days.

Duty-free de minimis entry (USD 800 or less) has been suspended since 29 August 2025, indefinitely under a CBP rule effective 24 June 2026, and by law ends on 1 July 2027. The 2026 Supreme Court tariff ruling did not restore it.

Rules change. Confirm current requirements with FDA, CBP and a licensed customs broker or food regulatory consultant.