FDA Prior Notice and Food Facility Registration for Taiwan Food Exporters

The US Food and Drug Administration (FDA) has broad authority over imported food products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Every Taiwan food manufacturer or exporter sending food products to the United States must comply with FDA's food import requirements.

The FDA's food import framework for Taiwan exporters has four key components: Food Facility Registration (the manufacturing facility must be registered with FDA), Prior Notice (FDA must be notified before food shipments arrive in the US), Foreign Supplier Verification Program compliance (US importers must verify that foreign suppliers meet US food safety standards), and the Food Safety Modernization Act (FSMA) standards covering preventive controls and hazard analysis.

Non-compliance consequences: the FDA can refuse entry of non-compliant food shipments at the US border. An import alert (also called a "Red List") places your company on an automatic detention list — every future shipment is held and tested until the alert is lifted. Import alerts can take months to years to resolve and effectively block you from the US market.

Scope of "food" under FDA jurisdiction: FDA regulates almost all food except meat, poultry, and egg products (which are regulated by the USDA). For Taiwan exporters, FDA food products include: packaged foods and snacks, beverages (non-alcoholic), dietary supplements (under a different regulatory framework from food, but still FDA), tea and coffee, condiments and sauces, dried fruit and nuts, seafood, and processed dairy products.

Any facility — including facilities in Taiwan — that manufactures, processes, packs, or holds food for consumption in the United States must register with the FDA under the Bioterrorism Act. This includes: food manufacturing plants, contract manufacturers, co-packers, repackers, and cold storage facilities.

Who is exempt: farms, restaurants, retail food establishments, non-profit food establishments, and fishing vessels are generally exempt from facility registration.

How to register: register online for free at the FDA's Food Facility Registration portal (the FURLS system at registration.fda.gov). You will need: facility name and address, facility type, a description of the food categories handled, the owner/operator/agent contact information, and a US Agent designation (required for foreign facilities).

US Agent: every foreign food facility must designate a US Agent — a person or company physically located in the United States who is available to receive FDA communications on the facility's behalf. The US Agent can be a distributor, a compliance consultant, or a professional agent service. US Agent services are available for approximately $200–$600/year.

Registration renewal: food facility registrations must be renewed every two years (during the October–December window of even-numbered years: 2026, 2028, etc.). The FDA deactivates registrations that are not renewed. A facility with a deactivated registration cannot legally export food to the US until reregistered.

Registration number: upon registration, the FDA issues a 10-digit registration number. This number must be included in your prior notice submissions and may be requested by Amazon or US distributors as proof of compliance.

Prior Notice is an advance notification to the FDA that a food shipment is coming to the US. The FDA requires prior notice for all imported food, including food carried by individuals and food imported for research or trade show purposes.

Who submits prior notice: the submitter can be the foreign exporter, the US importer, a customs broker, or any other party with knowledge of the shipment. For Taiwan food exporters using a US customs broker (which is standard practice), the broker typically submits prior notice as part of their customs clearance service.

Submission timing: prior notice must be submitted no more than 30 days before arrival in the US and no less than: 2 hours before arrival by land, 4 hours before arrival by air, and 8 hours before arrival by sea. For Taiwan-to-US sea freight (which takes 14–21 days), submit prior notice 3–5 days before estimated port arrival.

Required information for prior notice: submitter's name and contact information, the FDA food facility registration number of the manufacturing facility, article of food (product name, quantity, and lot or code numbers), manufacturer, shipper, carrier, arrival information (port, estimated date and time), country of origin, country where the article was packed, intended US recipient.

Prior notice submission system: submit through the FDA PNSI (Prior Notice System Interface) at www.access.fda.gov. The FDA issues a confirmation number (PN confirmation) that must be presented to US Customs upon arrival. Shipments without a valid PN confirmation number are refused entry.

The FSVP is an FSMA requirement that places legal responsibility on US importers — not foreign exporters — to verify that their foreign suppliers produce food meeting US safety standards. If you sell to a US importer (a distributor or food company that handles your US customs entry), they are your FSVP importer.

What your US importer must do under FSVP: conduct a hazard analysis of your food product, establish and follow procedures to verify that you (the foreign supplier) are producing food in compliance with US food safety standards, review your facility records and audit results, and maintain FSVP records for at least 2 years.

How this affects Taiwan food exporters: your US importer will likely ask you to provide: your FDA facility registration number, records of your food safety plan (under FSMA's Preventive Controls for Human Food rule), Certificate of Analysis (CoA) for each production lot, and potentially a food safety audit report (conducted by an approved third-party auditor).

FSMA Preventive Controls for Human Food: under this rule, your Taiwan food facility must have a written food safety plan covering hazard analysis, preventive controls, monitoring procedures, and corrective actions. This is similar to HACCP (Hazard Analysis and Critical Control Points) but with additional elements. Most export-oriented Taiwan food manufacturers already have HACCP certification — ensure it meets FSMA Preventive Controls requirements.

Importer of Record vs. FSVP importer: the importer of record (who handles customs) and the FSVP importer (who is responsible for supplier verification) are often the same entity, but not always. Clarify with your US business partner who bears FSVP responsibility.

Pitfall 1 — Expired facility registration: registration that was not renewed during the October–December biennial window is automatically deactivated. Shipments from a facility with a deactivated registration are refused at the US border. Set a calendar reminder for registration renewal — the consequences of missing the window are severe.

Pitfall 2 — Prior notice submitted too early: prior notice submitted more than 30 days before arrival is invalid. For orders placed far in advance, submit prior notice within the 30-day window. Your customs broker's system should handle this timing automatically.

Pitfall 3 — Incomplete prior notice: a missing lot number, incorrect FDA registration number, or vague product description triggers FDA review and holds. Provide your customs broker with complete and accurate shipment documentation for every export.

Pitfall 4 — Non-compliant labeling: even compliant food that is correctly registered and prior-noticed can be refused entry if the product label violates FDA food labeling requirements. Common violations: missing nutrition facts panel, unauthorized health claims, allergen labeling errors, or inadequate net quantity declaration. Have US market labels reviewed before production.

Pitfall 5 — Underestimating import alert risk: once your company or facility is placed on an import alert, every shipment is detained for examination. The process of lifting an import alert requires demonstrating sustained compliance and can take 6–24 months. Prevention through meticulous compliance is far less costly than remediation.