Food Facility Biennial Renewal 2026: Step-by-Step Walkthrough

What Is Biennial Renewal?

Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 1, Subpart H, all food facilities that manufacture, process, pack, or hold food for consumption in the United States must register with FDA. This registration is not permanent — it must be renewed every two years during the designated biennial renewal window.

The biennial renewal requirement was introduced by the FDA Food Safety Modernization Act (FSMA) in 2011. Prior to FSMA, food facility registrations did not expire. Now, registrations must be actively renewed during each even-year renewal period (2024, 2026, 2028, etc.) or they will lapse.

The 2026 renewal window is the fourth biennial renewal cycle since FSMA implementation. FDA has steadily increased enforcement around missed renewals, making it critical for facilities to act within the window.

Note: Biennial renewal is separate from the obligation to update your registration within 60 days of any changes (21 CFR §1.234). Even if you updated your registration in July 2026, you must still renew during the October–December window.

Who Must Renew in 2026?

Every facility that is currently registered with FDA as a food facility must renew. This includes:

• Domestic facilities — U.S.-based manufacturers, processors, packers, and holders of food, animal food, and dietary supplements
• Foreign facilities — Any facility outside the U.S. that manufactures, processes, packs, or holds food for export to the U.S. (these facilities must also maintain a U.S. Agent designation)
• Private labelers — Facilities that do not manufacture but whose labels appear on food products
• Pet food and animal feed facilities — Including manufacturers of pet treats, animal feed, and livestock supplements

Facilities exempted from registration under 21 CFR §1.226 (farms, retail food establishments, restaurants, nonprofit food establishments, fishing vessels, and facilities regulated exclusively by USDA) are not subject to biennial renewal because they are not registered in the first place.

The 2026 Renewal Window: Key Dates

The 2026 biennial renewal window runs from October 1, 2026 through December 31, 2026. These dates are set by statute and will not be extended.

FDA typically experiences heavy FFRM traffic in the final two weeks of December. System slowdowns and timeouts are common during this period. We strongly recommend completing your renewal by mid-November to avoid technical issues.

Step-by-Step FFRM Portal Walkthrough

Biennial renewal is completed through FDA's Food Facility Registration Module (FFRM), accessible at furls.fda.gov/xt/. Here is the step-by-step process:

1. Log in to your FDA Industry Systems (FIS) account. You will need your FIS credentials. If you've lost access, contact the FDA help desk well in advance — account recovery can take several days.
2. Navigate to FFRM. From the FIS dashboard, select "Food Facility Registration Module." You should see your existing registration(s) listed.
3. Select "Renew" for each facility. Click the renewal option next to each facility registration. If you have multiple facilities, each must be renewed individually.
4. Verify all information. Review every field: facility name, address, type of activity (manufacturer, processor, packer, holder), food product categories, and contact information. Update any information that has changed.
5. Confirm U.S. Agent information (foreign facilities). Foreign facilities must verify their U.S. Agent's name, address, phone number, and email. Your U.S. Agent must separately confirm the designation in FFRM.
6. Submit and save your confirmation. After submitting, FFRM will display a confirmation page with your renewed registration number. Save or print this confirmation — it serves as proof of timely renewal.

The entire process typically takes 15–30 minutes per facility if all information is up to date. If you need to update your U.S. Agent or facility details, plan for additional time.

Common Renewal Mistakes to Avoid

Based on FDA guidance and industry experience, these are the most common mistakes that delay or invalidate biennial renewals:

• Waiting until the last week of December. FFRM traffic spikes in late December. System slowdowns, timeouts, and maintenance windows can prevent you from completing your renewal. In 2024, multiple facilities reported being unable to access FFRM on December 30–31.
• Expired FIS account credentials. FDA deactivates FIS accounts after extended inactivity. If you haven't logged in since 2024, your account may require reactivation. Start this process by October.
• Outdated U.S. Agent information. Foreign facilities that changed their U.S. Agent since 2024 but did not update FFRM will encounter mismatches. The U.S. Agent listed in FFRM must match the agent who confirms the designation.
• Not renewing every facility separately. Companies with multiple registered facilities sometimes renew only their primary facility. Each facility has its own registration and must be renewed individually.
• Confusing renewal with initial registration. New facilities registered in 2025 or 2026 still need to renew during the October–December 2026 window if their registration was submitted before October 1, 2026.
• Not saving the confirmation page. FFRM does not always send email confirmations. The confirmation page displayed after submission is your proof of renewal. Always save or screenshot it.

What Happens If You Miss the Deadline?

If you do not renew by December 31, 2026, your food facility registration will be marked as expired by FDA on January 1, 2027. The consequences are significant:

• Import holds for foreign facilities. FDA checks registration status during import entry review. An expired registration will result in your food shipments being refused at the border under DWPE (detention without physical examination).
• Prior Notice rejections. Prior Notice filings (required under 21 CFR Part 1, Subpart I) must reference a valid registration number. An expired registration will cause Prior Notice failures, halting your imports.
• Warning letters. FDA has issued warning letters to domestic facilities operating with expired registrations. These become public record and can affect your business relationships.
• Re-registration required. Once expired, you cannot simply "renew" — you must submit a new initial registration, which may take additional time and requires fresh U.S. Agent confirmation for foreign facilities.

For foreign facilities, a lapsed registration can halt all U.S. food imports from your facility for weeks or months. The financial impact of detained shipments, diverted cargo, and lost contracts far exceeds the time required for timely renewal.

If you've already missed the window, contact Assurentry immediately to expedite re-registration and restore your compliance status.