FDA Food Facility Registration Basics (See 2026 Renewal Guide) | Axentra

For 2026 biennial renewal dates, rules, and traps, see our updated guide: 2026 food facility renewal dates, rules, and traps.

FDA food facility registration must be renewed between October 1 and December 31, 2026. Every registered domestic and foreign facility must renew, even if nothing has changed. FDA treats a registration not renewed by December 31 as expired and cancels it, and failure to renew is a prohibited act under federal law. FDA charges no fee to renew.

What Is FDA Food Facility Registration?

FDA food facility registration creates an official record with the FDA, assigns an FEI number, and designates a US Agent for foreign facilities. The FDA uses this registry to track the food supply chain, conduct risk-based inspections, and respond to food safety emergencies.

Which Facilities Must Register?

• Food and beverage manufacturers — packaged foods, beverages, condiments, and processed foods

• Dietary supplement manufacturers — vitamins, minerals, botanicals, and functional food products

• Infant formula and pet food manufacturers

• Food ingredient and food additive manufacturers

• Contract food manufacturers producing products for US-branded companies

The Role of the US Agent

Foreign food facilities must designate a US Agent as part of registration. The agent must be US-located, available during US business hours, and receive all FDA communications including inspection notices and import alert notifications. If the FDA cannot reach your agent, your registration may be suspended — causing automatic import holds on all your products.

DUNS Number Requirement

Foreign manufacturers must obtain a DUNS number — a nine-digit identifier from Dun & Bradstreet — before completing FDA food facility registration. The process typically takes three to five business days for international applicants.

How to Register a Food Facility

Step 1: Create an FDA Account

Food facility registration is completed through FDA's FURLS portal. You must first create an FDA Industry Systems account.

Step 2: Complete the Registration Form

The form requires: legal name and address, trade names, facility owner and operator information, type of activities, food product categories, emergency contact, and US Agent details for foreign facilities.

Step 3: Biennial Renewal

FDA food facility registration must be renewed every two years. 21 CFR 1.230(b) requires a renewal "every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year." 2026 is an even-numbered year, so the 2026 renewal window runs from October 1, 2026 to December 31, 2026. FDA considers a registration expired if it is not renewed by December 31 and cancels expired registrations; a facility whose registration has expired must register again before it may manufacture, process, pack or hold food for consumption in the United States. If none of your previously submitted information has changed, 21 CFR 1.230(c) allows an abbreviated renewal using Form FDA 3537. There is no FDA fee for registration or renewal.

Prior Notice Requirement for Food Imports

In addition to registration, Prior Notice must be filed before every food shipment enters the US — no earlier than 15 days before arrival and no later than two hours before air arrival or four hours before land or sea arrival. Shipments without valid Prior Notice are subject to refusal of admission.

Common FDA Food Facility Registration Mistakes

• Registering the corporate headquarters rather than the manufacturing facility

• Using an incorrect DUNS number — must match the exact legal entity name

• Appointing a US Agent unavailable during US business hours

• Missing the biennial renewal window — no grace period exists

• Failing to update registration when product categories or activities change

2026 Renewal Checklist

Work through these six items before the window opens on October 1, 2026.

• Confirm your DUNS number is active and matches the facility's legal name and address exactly. 21 CFR 1.232 requires a unique facility identifier (UFI) recognized as acceptable by FDA, and FDA currently accepts the DUNS number as an acceptable UFI.

• Confirm your U.S. Agent has agreed to serve. Under 21 CFR 1.231 the designated U.S. agent must confirm agreement before FDA confirms the registration.

• Check FURLS account access now, not in December. Renewals are submitted electronically through FDA's FURLS Food Facility Registration Module.

• Review facility legal name, address, trade names, owner and operator details, and food product categories for anything that changed since the 2024 renewal.

• Submit between October 1 and December 31, 2026. If nothing has changed you may use the abbreviated renewal process under 21 CFR 1.230(c).

• Save the renewal confirmation and your registration number once FDA confirms the submission.

FDA Food Facility Registration Renewal 2026: FAQs

When is the FDA food facility registration renewal deadline for 2026?

The 2026 renewal window opens October 1, 2026 and closes December 31, 2026. 21 CFR 1.230(b) requires renewal "every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year."

What happens if I miss the 2026 renewal deadline?

FDA considers a registration expired if it is not renewed by December 31 and cancels expired registrations. Failure to register, renew, update or cancel a registration is a prohibited act under 21 CFR 1.241. A facility whose registration has expired must register again before it may manufacture, process, pack or hold food for consumption in the United States.

Does FDA charge a fee to renew a food facility registration?

No. FDA states there is no fee associated with registration or renewal. Any cost you pay is for a service provider or U.S. Agent, not to FDA.

Do I need a DUNS number to renew my food facility registration?

Yes. 21 CFR 1.232 requires each registration to include "the facility's UFI recognized as acceptable by FDA," and FDA currently accepts the DUNS number as an acceptable UFI. The DUNS record must match the facility name and address on the registration.

Does a foreign facility need a U.S. Agent to renew?

Yes. 21 CFR 1.232 requires a foreign facility to supply "the name, full address, phone number, and email address of the foreign facility's U.S. agent," and 21 CFR 1.231 requires that U.S. agent to confirm they agreed to serve before FDA confirms the registration.

Do I still have to renew if nothing at my facility has changed?

Yes. Renewal is required in every even-numbered year regardless of whether anything changed. If none of your previously submitted information has changed, 21 CFR 1.230(c) allows you to use the abbreviated renewal process on Form FDA 3537.

How Axentra Helps

Axentra manages FDA food facility registration for foreign manufacturers across all food categories. Services include DUNS acquisition, FDA account setup, facility registration, US Agent designation, and biennial renewal management. Contact us for a free expert assessment.