CSMS Message: 15-000002

From: Food & Drug Administration

“If you have already renewed, thank you and disregard this notice.”

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, 2015 any foreign food facility that failed to renew their registration by December 31, 2014 is subject to be held under Section 801(l) (21 USC 381(l)) of the FD&C Act.

FDA encourages import brokers who file prior notices for food shipments after January 1, 2015 take proactive action and contact clients with high-volume food shipments, inquire about the renewal status of foreign manufacturing facilities associated to their shipment, and confirm any new registration numbers. Prior notices after January 1, 2015 must have a valid facility registration number. Doing so could greatly mitigate any prior notice shipment delays related to invalid or canceled registration.

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.