The Food, Drug and Cosmetic Act, as amended by FSMA, requires food facilities to register with the U.S. Food and Drug Administration (FDA) and to renew their registrations during the period of October 1 and December 31 of each even-numbered year. However, in December 2012, FDA issued guidance stating that because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.
On Tuesday, January 8, 2013, FDA posted the following update on its website: “Due to the high volume, processing Registration PIN requests has been suspended and will resume on Monday, February 4, 2013.” FDA, however, did not extend its enforcement discretion beyond the January 31, 2013 deadline. Food facilities should note that it is a “prohibited act” with potential criminal and civil penalties if you fail to renew by the deadline.
Food facilities needing assistance with their U.S. FDA Food Facility Registration or any other U.S. FDA regulatory requirements can contact Registrar Corp for immediate assistance. Registrar Corp’s global team of Regulatory Specialists is available by phone: +1-757-224-0177 or via Live Help: https://www.registrarcorp.com/LiveHelp