FDA Food Facility Registration: 2026 Biennial Renewal Guide

Who Must Register a Food Facility?

Under Section 415 of the FD&C Act and 21 CFR Part 1 (Subpart H), domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with FDA. This requirement was established by the Bioterrorism Act of 2002 and strengthened by the FDA Food Safety Modernization Act (FSMA) in 2011.

Covered facilities include food manufacturers, processors, warehouses, cold storage facilities, and any establishment that handles food products. Exemptions exist for farms, retail food establishments, restaurants, and nonprofit food establishments that prepare or serve food directly to consumers.

Foreign facilities that export food to the United States must also register and designate a U.S. Agent. Without a valid registration and U.S. Agent, food shipments will be refused entry at U.S. ports under Section 801(l) of the FD&C Act.

The 2026 Biennial Renewal Window

FDA requires biennial (every two years) renewal of food facility registrations during the period October 1 through December 31 of even-numbered years, per 21 CFR §1.230. The next renewal window is:

If you do not renew by December 31, 2026, your registration will be considered expired. For foreign facilities, this means your products can no longer legally enter the United States. For domestic facilities, FDA may consider your facility in violation of Section 415 of the FD&C Act.

Step-by-Step Renewal Process

1. Log in to FDA's FURLS system: Access the Food Facility Registration Module (FFRM) at access.fda.gov. You will need your facility's FDA registration number and your FURLS account credentials.
2. Review facility information: Verify your facility name, address, type of activity (manufacturer, processor, packer, holder), and product categories. Update any information that has changed since your last registration.
3. Verify U.S. Agent information (foreign facilities): Confirm that your U.S. Agent's name, address, phone, and email are current. If you need to change your U.S. Agent, do so during renewal.
4. Update food product categories: Ensure the product categories listed match the food products currently manufactured or held at the facility.
5. Submit the renewal: Complete the renewal submission. FDA does not charge a fee for food facility registration or renewal.
6. Save confirmation: Keep a copy of your renewal confirmation for your records.

Common Renewal Mistakes

• Forgetting to renew: The most common mistake. Set calendar reminders for October 1, 2026.
• Outdated U.S. Agent information: If your U.S. Agent changed and you didn't update FDA, the renewal will reflect incorrect information.
• Wrong product categories: Not updating product categories to reflect new products or discontinued lines.
• Expired FURLS credentials: If you haven't logged into FURLS in two years, your account may require reactivation. Test your login well before October.
• Confusing registration with Prior Notice:Registration is a facility-level requirement; Prior Notice is a shipment-level requirement. Both are needed for food imports.

What Happens if You Miss the Deadline?

If your registration lapses after December 31, 2026:

• Your facility will no longer have a valid FDA registration number
• Food products from your facility may be detained or refused at U.S. ports under Section 801(l)
• U.S. importers may be unable to file Prior Notice for your shipments
• You may face FDA enforcement action for operating an unregistered facility

You can re-register after the renewal window closes, but there may be a gap during which your products cannot legally enter the U.S. market. This gap can result in shipment delays, additional storage costs, and lost business.