Food Facilities Must Renew FDA Registration or Risk Cancellation
Any facility that produces food or dietary supplements intended for sale in the United States is required to renew their FDA registration between October 1 and December 31, 2020. This requirement applies to both U.S.-based facilities and foreign food facilities.
Foreign facilities located outside of the United States are also required to appoint an Agent physically located in the U.S. to act as a liaison with the FDA. The FDA will not approve the facility registration until the U.S. Agent accepts the designation to communicate with the FDA on behalf of the facility.
What happens if registration is not renewed?
FDA may cancel registrations for facilities that fail to renew prior to the December 31 deadline. Any facility that markets food or dietary supplements in the U.S. without a valid registration may be subject to civil action and/or criminal penalties and fines.
Once an FDA registration expires, there is no way to reinstate the facility. In this case, the facility will lose it's original registration number and its only option is to file a new registration and receive a new registration number.
For foreign facilities, failure to maintain an active FDA facility registration can disrupt exporting activities. For example, food or dietary supplements offered for import into the United States manufactured or processed in a foreign facility that failed to renew its registration can result in products being detained at the port of entry or refused entry.
New requirement for 2020 renewals
New for 2020, the FDA is requiring all U.S. and foreign food facilities to designate a Unique Facility Identifier (UFI) as part of the renewal registration process. While the FDA has not designated a specific UFI format, it stated that Data Universal Numbering System (D-U-N-SĀ©) numbers are acceptable as a UFI. This is a service administered by a private firm, Dun and Bradstreet.
Securing a UFI can be a lengthy process, so it is important to start prior to applying for the FDA registration renewal which will help accelerate the process.
Since the UFI requirement is new, it may lead to a backlog of requests. A delay in obtaining your UFI could result in missing the registration deadline and put your facility's registration at risk.
It is also important to make sure you talk to your suppliers to make sure they renew their FDA registration so there are no delays in clearing your shipments through U.S. Customs.
US Imports can assist with your food or dietary supplement business FDA facility registration process.
For further information on FDA registration renewal, see the FDA guidance document here.
