The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, enables FDA to better protect public health by strengthening the food safety system. Among many other changes, 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. Under FSMA, all food facilities that are required to register with FDA under Section 415 of the FD&C Act must renew their registrations with FDA, every other year, during the period of time beginning on October 1 and ending on December 31 of each even-numbered year.
Beginning on January 1, 2017, if a foreign food facility is required to register with FDA, but fails to do so, food from that facility that is being imported or offered for import into the U.S. is subject to be held under Section 801(l) of the FD&C Act. Food Facility Registrations (FFR) that are not renewed by December 31, 2016 will be subject to invalidation of registration and could result in food shipments manufactured by those facilities without valid registrations to be held at the port upon arrival in the U.S. As a result, FDA encourages import brokers who file prior notices for food shipments take proactive action and contact clients with high-volume food shipments, inquire about the FSMA food facility registration renewal status of foreign manufacturing facilities associated to their shipment, and confirm any new registration numbers. Doing so could greatly mitigate any prior notice shipment delays related to registration on or after January 1, 2017. There is no planned extension for this renewal time period.
As a reminder, if you serve as a U.S. agent, you must confirm that you have agreed to serve as the U.S agent for the facility. In accordance with 21 CFR 1.231(a)(5) and (b)(7), FDA will not confirm a registration or provide a registration number until the person identified as the U.S. agent for a foreign facility confirms that person has agreed to serve as the U.S. agent. If we do not receive confirmation from the U.S. agent within 30 days of the renewal submission, a new submission will be required.
For more information on the FDA food facility registration requirement, see FDA’s website at: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm.
For assistance with registration issues contact FDA Industry Systems Help Desk at 800-216-7331 or 301-575-0156.
For assistance via email, utilize the form on FDA’s website http://www.accessdata.fda.gov/scripts/email/cfsan/bioterrorismact/helpf2.cfm