FDA Food Facility Registration for Food & Dietary Supplements

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Who Must Register as Food Facility?

FDA food facility registration is required for domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States. This includes food, supplement, and beverage manufacturers, processors, packers, warehouses, dietary supplement facilities, food ingredient suppliers, and certain pet food and animal feed facilities. Moreover, traders, importers, and distributors may also need to register if they operate a facility or warehouse that holds food products.

Once FDA registration is completed, the facility is assigned an 11-digit Food Facility Registration (FFR) number. This number identifies the facility in the FDA registration system. However, having an FFR number does not replace other import requirements, such as FDA Prior Notice, when applicable.

In addition, FDA food facility registration information is confidential and is not available to the public. The registration or renewal confirmation email issued by FDA serves as the official confirmation that the facility’s registration has been completed or renewed.

2026 Update: What is a Unique Facility Identifier/ DUNS number, and how to get one?

What Facility Information is Required ?

When applying for a food facility registration number, the following information is required:

● Unique Facility Identifier (9-digit DUNS number)

● Facility name, address, and emergency contact

● Information on the owner, operator, or agent in charge

● General product categories and types of activities conducted

● Any trade names (brand names)

● U.S. Agent who has accepted the designation (for international facilities)

What are the FDA Food Facility Registration Steps ?

Obtain a Unique Facility Identifier (UFI), currently a DUNS number.
Provide the facility information required for FDA food facility registration.
Designate a U.S. agent if the facility is located outside the United States.
Submit the registration to the FDA and receive the Food Facility Registration (FFR) number.

The FDA registration is generally completed within 1-2 days if all information, including the DUNS number (UFI), is adequately provided.

How about Food Facility Renewal?

FDA food facility registrations must be renewed every even-numbered year between October 1 and December 31, regardless of the facility’s original registration date. Therefore, the next FDA food facility registration renewal period begins on October 1, 2026, and ends on December 31, 2026.

During renewal, facilities should review and confirm that their registration information is accurate and up to date, including the facility address, product categories, contact information, Unique Facility Identifier (UFI), and U.S. agent information for foreign facilities. If a facility does not renew its registration during the required period, FDA may cancel the registration, and the facility may need to submit a new registration before continuing operations.

What is the Role of U.S. FDA Agent ?

Foreign companies must appoint a U.S. agent to complete FDA registration. This agent acts as the primary contact for all FDA communications and must be knowledgeable about FDA compliance requirements. Even small errors in the registration process can cause delays or problems at U.S. ports. Using an independent FDA agent, rather than a trade partner, also reduces the risk of conflicts of interest.

The FDA does not approve or disapprove U.S. agent firms. During registration, renewal, and updates, the FDA only verifies that the designated agent has accepted the role. Once confirmed and reviewed, the company is issued an 11-digit Food Facility Registration (FFR) number, provided the submitted Unique Facility Identifier (UFI) is accurate.

FDA Registration Certificate

Although the FDA does not issue certificates, FDA Listing Inc. provides an FDA registration certificate, valid for one year, upon completion of the registration process. This certificate serves as proof of registration and can be shared with U.S. customs, importers, distributors, and other commercial partners.

What is FDA Prior Notice ?

Before any food shipments enter the United States, a Prior Notice shall be filed with the FDA. This requirement applies to all food items, including samples intended for trade shows or personal use. After filing the Prior Notice, the submitter will receive a confirmation number, which will be used during the shipment process. Firms can access the FDA Prior Notice portal, follow the instructions to create an account, and submit their shipment prior notices. Alternatively, the company’s customs broker or international shipping firms (e.g., DHL, FedEx, TNT) can file the Prior Notice on behalf of the company.

How can FDA Listing Inc Assist ?

FDA food facility registration requires accurate information and timely renewal. FDA Listing Inc services help facilities meet applicable FDA food facility registration requirements by:

Food facility registration with the FDA
Biennial renewal and registration updates
Acting as a U.S. Agent for foreign food facilities

For assistance with U.S. agent designation, FDA renewal, FDA certificate, or any FDA food facility compliance matter, please contact us by email or phone.

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