Hampton, VA – This year marked the first time the U.S. Food and Drug Administration (FDA) required food facilities to submit Unique Facility Identifiers (UFIs) in order to renew their FDA registrations. In response to delays surrounding facilities being able to obtain UFIs before the deadline, FDA announced on December 1, 2020 that FDA will exercise “enforcement discretion” regarding the mandatory UFI requirement.
Under FDA’s enforcement discretion, facilities may submit new registrations and registration renewals without a UFI. Facilities that do this will have 90 calendar days from the date of their submission to update their registration with a valid UFI number. According to FDA, facilities that fail to update their registration with a valid UFI within 90 calendar days of submitting a registration or renewal will have their registrations canceled.
D-U-N-S® numbers are currently the only UFIs recognized by FDA. Around 200,000 food facilities worldwide are registered with FDA, many of which did not have a D-U-N-S® number before this year’s renewal period. As such, thousands of facilities are requesting D-U-N-S® numbers to use as their UFI, which has led to delays in fulfilling these requests. If FDA continued to require the UFI, it is likely that many companies could not obtain a D-U-N-S® number in time to renew by the December 31 deadline.
Industry has expressed that the process to obtain a D-U-N-S® number can be lengthy and tedious, so it is prudent that facilities apply for a D-U-N-S® number now to ensure they obtain it in time to update their registrations.
Only One Month Left to Renew
Despite the enforcement discretion, food facilities must still renew their FDA registrations by December 31, 2020. Because so many companies have not been able to obtain a UFI, many companies will attempt to renew at once during this last available month. Facilities should submit their renewal as soon as possible to avoid potential delays. Registrations that are not renewed by the deadline will be cancelled. In 2019, FDA removed 20% of registered food facilities from its database because they did not properly renew during the 2018 renewal period. Marketing food products in the United States without a valid registration is a prohibited act that can lead to fines as well as civil and criminal penalties.
Registrar Corp’s Regulatory Specialists can quickly and properly renew facilities’ FDA registrations to assure they are completed prior to the deadline. As part of their registration renewal service, Registrar Corp will request a D-U-N-S® number on your behalf and update your registration with your D-U-N-S® number when they receive it to assure your registration remains valid after the 90 day grace period.
Given the uncertainty regarding UFI submissions to FDA, it is prudent for facilities that already submitted their FDA registration renewal to verify their renewal was successfully completed. Registrar Corp can verify your registration at no cost.
Facilities can contact Registrar Corp to get help obtaining a D-U-N-S® number for their facility. You can reach them by email at [email protected] or by phone at +1-757-224-0177. You can also chat online with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat
Media Contact
Devon McClellan, Director of Marketing, Registrar Corp
(757) 224-0177 | [email protected]
