Registration of Food Facility in the U.S.

Food facility registration is an essential prerequisite to sell foods to the United States (U.S.). It helps the Food and Drug Administration (FDA) to quickly identify and inspect food facilities to enhance food safety through the registered facility information. According to the authority, food products from an unregistered or suspended overseas facility cannot be delivered to the U.S. importer, until the foreign facility is registered.

The registration of food facility is easy but sometimes may confound enterprises without experience in the U.S. market. In this context, ChemLinked compiles the key points to help figure out the critical points of food facility registration in the U.S. 

For the whole procedure of food export to U.S., please refer to Selling Food to the U.S.: Decoding Food Import Procedure and Product Compliance.

1. Overview of Food Facility Registration

As per the Food Safety Modernization Act (FSMA)¹ enacted on January 4, 2011, the facilities that manufacture, process, pack, receive, or hold food must register with the FDA before trade and renew the registration every two years. FDA will compare the application information to FDA’s internal data. If the information matches, then compliance is verified; if not, FDA may need to gather additional information or detain the product.

Generally, if compliance is achieved, the FDA will issue an11-digit registration number to the applicant soon. The 11-digit registration number is a unique identifier of the facility to track products and check the compliance statutes. For enterprises with multiple facilities manufacturing foods for the U.S. market, each facility should have a separate 11-digit FDA food facility registration number.

It is worth noting that the FDA can cancel the facility registration if it is not renewed by December 31 of the biannual period. After that, all food exported to the US port will be kept on hold and cannot be released to the importer, owner, or consignee until the facility is re-registered with a new 11-digit registration number. 

FSMA¹also requires food facilities to give assurance to the FDA to inspect the facility at all times. FDA can suspend the registration of a food facility when food safety concerns are found, especially when the foods were found with risks to cause serious adverse health consequences or death to humans or animals.

Please note that there are some exceptions from the registration requirements, including farms, retail food establishments, restaurants, nonprofit food establishments, fishing vessels not engaged in processing, and facilities that only store packaged food not exposed to the environment.

2. Online Registration of Food Facility

On October 16, 2003, the FDA launched an online system, FDA Industry Systems (FIS)², to make it easier for companies to submit various documents, such as product listings and other notifications. The submission of food facility registration documents can also be done through this online system.

According to the FDA, the owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for human or animal consumption in the U.S. can register the facility with the FDA. Besides, an owner, operator, and agent in charge of a facility can authorize an individual to register the facility on their behalf. Please note that a non-U.S. food facility must have a U.S. agent who acts as the domestic communications representative to register the facility. In general, registrants need to provide the contact person’s information, appropriate additional food categories, and an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug, and Cosmetic Act (FD&C Act)³.

Detailed steps for the online registration of food facility are as follows:

(1) Create an account on FIS

(2) Login and choose "Food Facility Registration” from the list of available systems on the FDA Unified Registration and Listing System (FURLS) Account Management Home Page:

Once in the Food Facility Registration system, choose the “Register a Food Facility” main menu option to register a food facility as shown below. From this main menu enterprises may also:

• Complete a draft registration

• Update a facility registration

• Cancel a facility registration

• Link a registration(s) to your account

• Search for one of the facility registrations

• Manage registrations among all the applicant's accounts

• Confirm receipt of a mailed notification

• Retrieve the registration's unique PIN if it is ever lost or forgotten

• Renew the registration(s) during biennial renewal periods every two years

(3) Complete the registration process online

• Necessary items need to be filed for online registration, including:

• Type of Registration

• Facility Name / Address Information

• Preferred Mailing Address Information (Optional)

• Parent Company Name/Address Information

• Facility Emergency Contact Information

• Trade Names

• U.S. Agent (Required for the successful registration of foreign facilities)

• Seasonal Facility Dates of Operation (Optional)

• General Product Categories—Human/Animal/Both

• Information of the Owner, Operator, or Agent in Charge

• Inspection Statement

• Certification Statement

(4) Record the necessary information

Once the registration is finished, a message with the registration number, PIN, and registration expiration date will be displayed below. It is recommended that these numbers be recorded for future reference.

Additionally, this system allows the applicant to save a partially completed registration as a draft and return later to complete it. Please note that the registration will be saved up to 7 days after the initial draft is completed, which means the registration should be completed and submitted within 7 days, otherwise the draft will be deleted.

3. U.S. Agent Voluntary Identification System 

FDA has established the U.S. Agent Voluntary Identification System (VIS) in conjunction with the food facility registration database to ensure the accuracy of U.S. agent information and enable U.S. agents to independently identify the information of overseas facilities. 

The VIS allows a U.S. agent to directly provide the FDA with their contact information and the name of the facility or facilities for which the agent agrees to serve. FDA will then provide the U.S. agent with an identification number that the agent can provide to the relevant facilities. Foreign food facilities can now provide the identification number of their U.S. agent during food facilities registration. 

The VIS provides a streamlined U.S. agent verification process. Generally, after a foreign facility submits registration, FDA will verify that the person identified as the U.S. agent for the foreign facility has agreed to serve as the U.S. agent. FDA will not confirm registration or provide the foreign facility with a registration number until the U.S. agent has confirmed the agent’s consent to serve as the U.S. agent for the relevant facility. When a foreign facility uses a U.S. agent identification number in accordance with the VIS, the FDA will consider that verification and provide the facility with a registration number without taking any additional steps to verify the U.S. agent.

The information that needs to be provided for registering with VIS includes the agent's name, complete address, phone number, email address, and emergency contact phone number. To enter the information in the VIS, the U.S. agent shall also obtain an account for FURLS to obtain access to FFRM. Upon entering FFRM, the U.S. agent can access the VIS from the main menu, where they can enter their information, verify the information provided, and obtain their unique U.S. agent ID number. 

4. FDA Guidelines

Official guidelines related to the online registration of food facility are also published by the authority, including: