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The United States Food and Drug Administration (FDA) continues to receive questions from food facilities regarding whether such facilities are required to pay registration fees or use third-party businesses to register with FDA. In response to these questions, FDA clarifies that there is no fee required to register a food facility with FDA and food facility registrants are not required to use a third-party business or “registrar” to register their facilities with FDA. Additionally, FDA is aware that private businesses are offering services (such as U.S. agent listing and registration renewal services) to food facilities. U.S. Agents may charge a fee for their services, which is solely an issue to be decided between the food facility and the person who agrees to serve as the food facility's U.S. Agent. FDA would like to remind registrants that FDA is not affiliated with these private businesses, nor do they act on FDA’s behalf.

1. FSMA amended section 415 of the Federal Food, Drug, and Cosmetics Act (FD&C Act) [21 U.S.C. § 350d], which requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with FDA unless an exemption applies (see 21 CFR 1.226). Food facilities that are required to register with FDA must register directly with FDA electronically or by mail or fax. There is no fee to register with FDA (21 C.F.R. 1.231(c)). A food facility may register, update, or cancel its registration itself (or authorize another person to do so on its behalf) using the Internet at http://www.access.fda.gov. Alternatively, a food facility may register, update, or cancel a registration by mail by requesting the appropriate form from U.S.FDA at 1-800-216-7331 or 240-247-8804 outside the United States, or by e-mail at furls@fda.gov. FDA issues a registration number to registered food facilities. Any registered food facility may obtain its registration number by contacting FDA. Note: Traders/brokers, in accordance with Section 415 of the Federal Food, Drug, and Cosmetic act, are not required to register.

2. Food facilities do not need a certificate of registration. FDA does not issue a certificate of registration or product status (e.g., low acid canned food), nor does FDA recognize a certificate of registration or product status issued by a private business. If such a certificate of registration is issued by a private business, FDA reminds issuers that the FDA logo is for the official use of FDA and not for use on private sector materials. To the public, such use would send a message that FDA favors or endorses a private sector organization or the organization’s activities, products, services, and/or personnel (either overtly or tacitly), which FDA does not and cannot do. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability. For more information of the use of the FDA logo, please see the complete policy at FDA Logo Policy. 

3. Food facilities that have registered and do not have their FURLS information or PIN should not re-register. Instead, a food facility can contact FDA for help at 1-800-216-7331 or 240-247-8804, or by e-mail at furls@fda.gov. 

A food facility will be asked to provide information on its company's letterhead signed by the owner, operator, or agent-in-charge of the facility to verify the information. Once FDA verifies the identity of the food facility, FDA will provide the facility access to its account. 

Additional Information 

• FDA food facility registration requirements, including FDA’s food facility registration regulation, can be found on Registration of Food Facilities and Other Submissions. 
• FDA Food Safety Modernization Act (FSMA) frequently asked questions section
• Small Entity Compliance Guide: Registration of Food Facilities
• Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)

For more information about these requirements, please refer to the guidance documents and frequently asked questions referenced in this update or contact the FURLS.