Industry News

FDA Delays Enforcement of Food Facility Registration Renewal to February 1, 2013

January 17, 2013


As previously reported, effective October 1, 2012, domestic and foreign food facilities that sell into the U.S. market are required to comply with new registration requirements established by the Food Safety Modernization Act (FSMA).  The FSMA, which was signed into law on January 4, 2011, among various changes, amended Section 415 of the Federal Food, Drug and Cosmetics Act (FFDCA), to require that all food facilities that are required to register with the Food and Drug Administration (FDA) renew their registrations with FDA every other year, between October 1 and December 31 of each even-numbered year. 

FDA has recently issued guidance indicating that due to the delay in its implementation of the biennial registration renewal for the 2012 cycle, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after the December 31, 2012 deadline.  Registration renewal for the 2012 cycle did not become available until October 22, 2012.  Thus, FDA will allow registration renewals to be submitted for an additional period of 31 days, until January 31, 2013.

Beginning on February 1, 2013, if a foreign food facility is required to register with FDA and fails to do so as required by Section 415(a)(3) of the FFDCA, food from that foreign facility if imported or offered for import into the United States may be held at the port of entry or refused upon arrival in the United States.  FDA is encouraging import filers who file prior notices for food shipments to take proactive steps to contact any clients with high volume shipments to inquire about the FSMA food facility registration renewal status of any foreign manufacturing facilities associated with their shipments and confirm any new registration numbers.  Taking such steps may mitigate any prior notice shipment delays associated with registration on or after February 1, 2013.

Should you have any questions concerning these registration requirements, please contact a Barnes/Richardson attorney.