Dear Valued Customer,
Food facilities that are required to register with the U.S. Food and Drug Administration (FDA) must renew their registration in the year 2020 between October 1 and December 31. If you are the owner, operator, or agent in charge of either a domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States, you are required to register with the FDA, unless an exemption applies. Establishments that meet the definition of a primary production farm, secondary activities farm, retail food establishment, restaurant, or nonprofit food establishment are not required to register. For other exemptions, please see 21 CFR 1.226.
Food facility registration requirements were initially brought about by The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. The FDA Food Safety Modernization Act (FSMA) then amended the FD&C Act to require domestic and foreign facilities to submit certain additional new information to FDA and to renew registrations every other year during the period beginning on October 1 and ending on December 31 of each even-number year.
FDA will consider a food facility with an expired registration as having failed to meet their registration requirements, and failure to register a food facility is a prohibited act under the FD&C Act. FDA will cancel a registration if the facility’s registration has expired because the facility has failed to renew its registration as required. There is no cost involved to register or to renew registration.
Owners and operators of facilities can renew their registration through their FDA Industry Systems account. As of January 4, 2020 all submissions must be electronic unless the facility has received a waiver. If you need guidance on how to navigate the FDA registration system, please review the Food Facility Registration User Guide: Biennial Registration Renewal page on the FDA website.
If you have any questions for the FDA related to facility registrations, you may reach them at: Email: Furls@fda.gov Telephone: 1-800-216-7331 or 240-247-8804
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