FDA Food Facility Renewal 2026: Everything You Need to Know

What Is Biennial Renewal?

Section 415(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 USC 350d), as amended by the FDA Food Safety Modernization Act (FSMA), requires food facilities to renew their FDA registration every two years during even-numbered years. This process is called biennial renewal.

Biennial renewal applies to both domestic and foreign food facilities that manufacture, process, pack, or hold food for consumption in the United States. The requirement is codified in 21 CFR 1.230. A facility that fails to renew is deemed to have an expired registration, which means it is no longer considered registered with FDA.

The renewal window always runs from October 1 through December 31 of even-numbered years. Since 2026 is an even-numbered year, all registered food facilities must renew during this period.

2026 Renewal Window: Oct 1 – Dec 31

FDA does not send individual reminders to every registered facility. While FDA may send courtesy email notices, the legal obligation to renew rests entirely with the facility owner, operator, or agent in charge. This is why many facilities use services like Assurentry to ensure they do not miss the window.

Required Information for Renewal

During biennial renewal, you must verify and update the following information per 21 CFR 1.232:

• Facility name and address: Must match the physical location where food is manufactured, processed, packed, or held
• FDA Establishment Identifier (FEI): Your unique facility identifier assigned by FDA
• DUNS number: The Data Universal Numbering System identifier for your facility (required for foreign facilities)
• Owner, operator, or agent in charge: Current contact information including name, title, phone, and email
• US Agent information (foreign facilities): Name, address, phone, and email of the US-based agent designated under 21 CFR 1.227
• Product categories: The general food product categories manufactured or processed at the facility (using FDA's standardized category list)
• Attestation: The individual submitting the renewal must certify that the information is truthful and accurate

Step-by-Step Renewal Process

1. Verify your FDA account access: Log into the FDA Industry Systems (FIS) portal at https://www.access.fda.gov. If you have forgotten your credentials, allow extra time for account recovery.
2. Access FFRM: Navigate to the Food Facility Registration Module within FIS. Select the biennial renewal option.
3. Review pre-populated information: FDA will display your current registration data. Review each field carefully for accuracy.
4. Update any changed information: If your facility address, ownership, product categories, or US Agent have changed, update those fields now.
5. Submit the renewal: After verifying all information, submit the renewal electronically. You will receive a confirmation with your renewed registration number.
6. Save your confirmation: Download or print the renewal confirmation. This serves as proof that your registration is active.

The renewal process is free from FDA. There are no fees to renew your food facility registration.

Common Renewal Mistakes

• Waiting until the last week: FDA systems can experience high traffic in late December. Start your renewal in October or early November.
• Expired FDA account credentials: If you have not logged into FIS since your last renewal, your account may be locked. Reset credentials well before October.
• Outdated US Agent information: If your US Agent changed since your last renewal, update their information during the renewal process.
• Wrong product categories: If you added new product lines since 2024, make sure to add those categories to your renewal.
• Assuming renewal is automatic: Renewal is NOT automatic. Even if nothing has changed, you must affirmatively submit the renewal through FFRM.

What Happens If You Miss the Deadline

If a facility fails to renew by December 31, 2026, the consequences are significant:

• Registration expires: FDA considers the registration inactive as of January 1, 2027. The facility is no longer legally registered.
• Food imports blocked: For foreign facilities, food shipments to the US will be refused at the port. CBP and FDA systems check registration status for Prior Notice filings.
• Must re-register: To restore registration, the facility must submit a new initial registration through FFRM, which may take longer than a simple renewal.
• Potential FSVP issues: US importers whose foreign suppliers lose registration may face Foreign Supplier Verification Program (FSVP) compliance problems (21 CFR Part 1, Subpart L).
• Supply chain disruption: Customers and distributors may require proof of active registration. An expired registration can disrupt existing supply agreements.

Prepare Now with Assurentry

Even though the renewal window does not open until October, there are steps you can take now to ensure a smooth process:

1. Verify your FDA account access: Log into FIS today to confirm your credentials work. Reset if needed.
2. Audit your current registration: Review your facility name, address, product categories, and US Agent (if applicable) for accuracy.
3. Set calendar reminders: Mark October 1 and November 15 (safety reminder) on your calendar.
4. Engage Assurentry: Our service includes 90-day advance reminders, guided renewal processing, and confirmation verification at $199 one-time.