How to Complete FDA Food Facility Registration Biennial Renewal for Taiwan Exporters

The FDA Food Safety Modernization Act (FSMA), signed into law in January 2011, amended Section 415 of the Federal Food, Drug, and Cosmetic Act to require food facilities to renew their registration with the FDA during the biennial renewal period, which runs from October 1 through December 31 of each even-numbered year. The next renewal window is October 1, 2026 through December 31, 2026. All domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must complete this renewal. Taiwan food and beverage exporters, supplement manufacturers, and ingredient suppliers with existing FDA registrations must renew during this window or risk having their registration cancelled.

Registration renewal is not optional. If a facility fails to renew its registration during the biennial period, the FDA will consider the registration lapsed and will cancel it. A cancelled registration means the facility is no longer in compliance with Section 415 of the FD&C Act, and any food products shipped from that facility to the United States will be subject to FDA refusal of entry under Section 801(l). US Customs and Border Protection (CBP) will flag shipments from unregistered facilities during automated screening, resulting in import holds that can last weeks or months while the facility scrambles to re-register.

The biennial renewal requirement applies to all food facility registrations regardless of when the initial registration was submitted. Even if a Taiwan facility registered for the first time in September 2026, it must still complete the biennial renewal in October through December 2026. The FDA estimates that approximately 287,000 food facilities worldwide hold active registrations, and a significant percentage fail to renew on time during each cycle. The FDA sends email reminders to registered facilities approximately 60 days before the renewal window opens, but these reminders go to the email address on file, which may be outdated if the facility has not maintained its contact information.

Taiwan exporters should mark October 1 of even-numbered years on their compliance calendars and begin the renewal process within the first two weeks of the window. Waiting until December risks encountering system outages, US Agent delays, and holiday staffing shortages that could prevent timely completion. LNH31 Global recommends completing the renewal by November 15 at the latest to allow a buffer for resolving any technical issues with the FDA's online system.

Every food facility registering or renewing with the FDA must provide a Data Universal Numbering System (DUNS) number, which is a unique nine-digit identifier assigned by Dun and Bradstreet (D&B). Taiwan facilities that do not already have a DUNS number must request one from D&B before beginning the renewal process. Obtaining a DUNS number is free of charge and can be done through the D&B website or by contacting D&B's Taiwan office. Processing time is typically 5 to 10 business days for a new DUNS number, though expedited processing is available for a fee of approximately $229. Ensure you request the DUNS number well in advance of the renewal window to avoid delays.

Foreign food facilities, including all Taiwan-based facilities, are required to designate a US Agent as part of their FDA registration. The US Agent must be a person or entity residing or maintaining a place of business in the United States. The US Agent acts as a communication link between the FDA and the foreign facility: the FDA will direct all correspondence, including inspection notices, warning letters, and recall communications, to the US Agent rather than to the facility directly. The US Agent must be available 24 hours a day, 7 days a week to respond to FDA inquiries, making this a critical operational role.

US Agent services are offered by numerous companies specializing in FDA regulatory compliance. Typical annual fees for US Agent services range from $300 to $1,500 depending on the scope of services provided. Basic US Agent services include only the receipt and forwarding of FDA communications, while premium services may include regulatory consulting, registration assistance, prior notice filing, and label review. Companies such as Registrar Corp, FDA Import Solutions, and IntraEdge offer US Agent services tailored to Asian food exporters. When selecting a US Agent, verify that the company has been in operation for at least five years and maintains a physical US address, not merely a virtual mailbox.

During the biennial renewal, you must confirm or update your US Agent information. If your US Agent has changed since your initial registration or last renewal, you must update this information through the FDA's FURLS system. Failure to maintain a current US Agent designation is a violation of Section 415 of the FD&C Act and can result in the FDA cancelling your facility registration. Taiwan exporters should maintain a written agreement with their US Agent that specifies the agent's responsibilities, response time commitments, and the process for notifying the facility of FDA communications. Review this agreement annually and ensure your US Agent's contact information in the FURLS system matches the current agreement.

The FDA Unified Registration and Listing System (FURLS) is the online platform used for food facility registration and renewal, accessible at furls.fda.gov. To begin the renewal process, log in to your existing FURLS account using your FDA Industry Systems (FIS) credentials. If you have forgotten your login credentials or if the person who originally registered the facility is no longer with the company, you will need to contact the FDA's FURLS help desk at 1-800-216-7331 or by email at furaboratory@fda.hhs.gov to recover access. Allow at least 5 business days for account recovery.

Once logged in, navigate to the Food Facility Registration module and select the renewal option. The system will display your current registration information, including facility name, address, DUNS number, product categories, and US Agent details. Review every field carefully and update any information that has changed since your last registration or renewal. Common updates include changes to the facility's physical address, email contacts, product categories (if you have added or discontinued product lines), and US Agent information. After reviewing and updating all fields, submit the renewal electronically. The system will generate a confirmation page with a unique submission number. Print or save this confirmation as proof of timely renewal.

The FURLS system assigns a unique 11-digit FDA Establishment Identifier (FEI) to each registered facility. This FEI number is used by US Customs and Border Protection to verify facility registration status when food products arrive at US ports. Include your FEI number on all commercial invoices, packing lists, and prior notice filings to ensure smooth customs processing. If your shipment arrives at a US port and CBP cannot verify your facility registration through the FEI number, the shipment will be held until registration status is confirmed, which can take 3 to 15 business days and result in demurrage charges of $100 to $500 per day.

After submitting the renewal, the FDA does not issue a formal renewal certificate or approval letter. The confirmation page generated at the time of submission is your only documentation that the renewal was completed. Unlike many regulatory systems, the FDA does not mail physical certificates for food facility registration. Taiwan exporters should save the confirmation page in multiple formats (PDF, screenshot) and distribute copies to their logistics team, customs broker, and US Agent. If a customs broker or importer of record requests proof of FDA registration, provide the confirmation page along with your FEI number and the FDA's public verification tool, which customs brokers can access through the FURLS public query system.

If you encounter technical difficulties with the FURLS system during the renewal process, contact the FDA help desk immediately rather than waiting. Common issues include browser compatibility problems (the FURLS system works best with Google Chrome or Microsoft Edge), expired digital certificates, and session timeouts for slow internet connections. The FDA help desk is available Monday through Friday from 8:00 AM to 6:00 PM Eastern Time and can often resolve access issues within 24 to 48 hours. Document all help desk interactions with ticket numbers in case you need to demonstrate good-faith efforts to renew on time if the process extends past the December 31 deadline due to technical issues.

The consequences of failing to renew FDA food facility registration are severe and immediate. Once the biennial renewal window closes on December 31, the FDA begins cancelling registrations for facilities that did not renew. The cancellation process typically completes within 30 to 60 days after the window closes, during which time the FDA may send a final notice to the facility's email address on file. After cancellation, any food products from the facility that arrive at US ports will be refused entry under Section 801(l) of the FD&C Act, which states that food from an unregistered facility is deemed adulterated and shall be refused admission.

Import refusals due to lapsed registration create cascading problems for Taiwan exporters. CBP will issue a notice of FDA refusal to the importer of record, who must then either re-export the goods, destroy them under FDA supervision, or petition for release after the facility re-registers. Re-exporting a container from a US port typically costs $3,000 to $8,000 including drayage, ocean freight, and customs fees. Destruction under FDA supervision costs $500 to $2,000 depending on the product volume and the destruction method required. These costs are borne by the importer or exporter, not by the FDA.

Re-registering a facility after its registration has lapsed is possible but introduces delays. The facility must submit a new initial registration through FURLS, which typically takes 3 to 10 business days to process. During this period, no shipments from the facility can clear US customs. If the facility had products in transit when the registration lapsed, those shipments will be held at the port until registration is restored. Amazon FBA sellers face additional complications: Amazon requires active FDA food facility registration for food and dietary supplement listings, and a lapsed registration can trigger listing deactivation, inventory stranding at FBA warehouses, and potential account health warnings.

LNH31 Global strongly recommends implementing a dual-reminder system for biennial renewal deadlines. Set calendar reminders for both September 1 (to begin preparation) and October 1 (to submit renewal) of each even-numbered year. Additionally, designate a backup person within your organization who has FURLS login credentials and can complete the renewal if the primary contact is unavailable. Companies that rely on a single individual for FDA registration management are vulnerable to missed deadlines if that person leaves the company, goes on leave, or is otherwise unreachable during the renewal window.