Taiwan Food Export to the USA: FDA Registration, Prior Notice, and FSMA Compliance

Selling food in the US requires satisfying three FDA regulatory obligations: (1) FDA Food Facility Registration — the Taiwan manufacturing facility must be registered with FDA before exporting food to the US. (2) Prior Notice — FDA must be notified of each food shipment before it arrives in the US. (3) FSMA Compliance — the US importer must verify that you (the foreign supplier) are producing food in a manner that meets US food safety standards.

These requirements stem from the Food Safety Modernization Act (FSMA), signed in 2011 and implemented through the 2010s. FSMA shifted the US food safety system from reactive (responding to outbreaks) to preventive (requiring documented safety controls). Taiwan food exporters targeting the US market must understand these requirements regardless of product category.

Failure to comply can result in: FDA refusing admission of your food shipment at the US port of entry, import alert (automatic detention of all shipments from your facility), and CBP seizure. None of these outcomes are recoverable quickly — getting back on track after an import alert can take months.

Any facility that manufactures, processes, packs, or holds food intended for US consumption must register with FDA under 21 CFR Part 1, Subpart H. This includes Taiwan-based factories, contract manufacturers, co-packers, and storage facilities.

Registration is done through FDA's Unified Registration and Listing System (FURLS), accessible at access.fda.gov. You will need: facility name and address, parent company information (if applicable), all food product categories handled, and contact information for a US Agent (a US-based individual or company that FDA can contact regarding the facility).

US Agent requirement: every foreign food facility registered with FDA must designate a US Agent — a person or company resident in the US who agrees to act on your facility's behalf for FDA communications. US Agent services are available from regulatory consultants and industry associations for fees ranging from $200–1,000/year. Some larger Taiwan-based export consultancies offer US Agent services.

Biennial renewal: FDA food facility registration must be renewed every two years during the October–December renewal period of even-numbered years (e.g., October–December 2024, 2026). Failure to renew results in registration suspension and inability to legally export food to the US until renewed.

FDA's Prior Notice system requires that FDA be notified of every food article imported or offered for import into the US. Prior Notice must be submitted electronically and received by FDA no more than 10 days before arrival (for ocean freight) and no earlier than 4 hours before arrival (for air cargo).

Who submits Prior Notice: typically the US importer or their customs broker via FDA's Prior Notice System Interface (PNSI) at pnsi.fda.hhs.gov, or through the CBP ABI (Automated Broker Interface) system. As the Taiwan exporter, you provide the required information to your US importer or their customs broker: your FDA facility registration number, product description, quantity, shipper information, and anticipated arrival details.

If Prior Notice is not submitted before arrival, FDA can refuse admission of the shipment and require it to be held, exported, or destroyed. There is no grace period — this is a hard requirement. Ensure your US importer understands their obligation to file Prior Notice and confirm it is filed for every shipment.

Inadequate Prior Notice (missing, late, or inaccurate filing) can also result in your facility being placed on the Priority Review list, meaning every shipment from your facility receives additional FDA scrutiny.

FSMA's Foreign Supplier Verification Program (FSVP) requires US importers of food to verify that their foreign suppliers produce food in compliance with US food safety preventive controls. This obligation falls on your US importer — not directly on you — but you must cooperate.

What FSVP requires from your US importer: conducting a hazard analysis for each food they import, establishing a supplier verification program (which may include audits, testing, or review of your food safety records), maintaining records for at least 2 years, and ensuring their foreign suppliers are registered with FDA.

What Taiwan exporters should do: prepare food safety documentation that satisfies FSVP verification. This includes your HACCP plan (Hazard Analysis and Critical Control Points) or equivalent food safety management system documentation, your FDA facility registration number, recent third-party food safety audit reports (SQF, BRC, FSSC 22000, or equivalent), and any certificate of analysis (COA) for relevant products.

Practical tip: many Taiwan food manufacturers are already certified to FSSC 22000 or BRC because major international retail buyers require it. If your facility has one of these certifications, share the audit report with your US importer — it substantially satisfies their FSVP verification obligation and makes selling to US buyers far easier.