Last night (12/21/2016) the U.S. Food and Drug Administration (FDA) provided a second chance at registration renewal for food facilities who failed to secure a confirmation from the U.S. agent listed on the registration. The agency has not yet announced this publicly. Tomorrow the agency will be releasing revised guidance on food facility registration but it is unclear if this matter will be addressed.
Under the Bioterrorism Act (21 USC 350d), all U.S. and foreign facilities that process, pack and hold human or animal food for consumption in the U.S. are required to register with FDA. Facilities that register receive a food facility registration number. The food facility registration number of foreign facilities is required to be submitted to FDA in prior notice filings. Prior notice must be provided for food imports in advance of arrival of shipments in the U.S. All foreign facilities must have a U.S. agent listed in their registration to serve as a point of contact for FDA among other things. The Food Safety Modernization Act (FSMA) required food facilities to renew their registration between October 1 and December 31 on every even-numbered year. As part of this renewal process, FDA sends an email to the address of the U.S. agent listed in the registration. This email contains a unique receipt code that the U.S. agent must use to confirm that it agrees to serve as the agent for the facility for the upcoming 2017-2018 cycle. The confirmation is done through FDA’s FURLS system. If the agent failed to provide a confirmation within 30 days, FDA canceled the registration. This process had created some confusion because facilities received a confirmation that their registration status was “Valid” and “Expiring 12/31/2018” before the agent confirmed the registration. If the agent failed to confirm the registration within 30 days of the renewal submission, the registration status was changed to “Unconfirmed” and the registration was locked in the FURLS system (i.e. it could be viewed but not edited, canceled or renewed).
Beginning last night FDA has reopened the opportunity for facilities to secure confirmation from agents that failed to confirm with 30 days of receiving the initial notice. Registrations that were locked/cancelled because of this reason have been unlocked/restored for an additional period. Please note that FDA does not allow for duplicate registrations. For facilities that now have two registrations (and thus two numbers) it is advisable to cancel one of them so you can be certain of which number is valid. If you do not cancel one duplicate registration yourself, FDA will do it for you (and you may not know which number is cancelled until you have a problem with a prior notice filing).
U.S. Food Imports LLC provides registration and agent services to foreign facilities around the world. If you need assistance with the renewal process do not hesitate to contact us at 202.765.1800 or firstname.lastname@example.org.