Under the Food Safety Modernization Act (FSMA), all food and dietary supplement facilities are required to renew their registrations with FDA between Oct. 1 and Dec. 31, 2014.
Who: Domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register and renew. This is true for both conventional food and dietary supplement facilities.
What: Food facilities have been required to register with FDA since 2003, but until recently, once a facility completed its initial registration, the information was never updated. So, in 2011, FSMA updated the Food, Drug, and Cosmetic Act (FD&C) to require biennial registration renewals so FDA would have access to current information.
When: FDA registrations must be renewed between Oct. 1 and Dec. 31 of every even numbered year. It does not matter when a food facility completed its initial registration. Even if a facility registers the day before a renewal period begins, the facility will need to renew its registration.
Where: Facilities can renew their registrations directly with FDA by mail, fax or online, or they can renew through a third party like Registrar Corp.
Why: Facility registrations that are not renewed on time are considered by FDA to be expired. Failing to renew a food facility registration is a prohibited act and can lead to prosecution by FDA. As for foreign facilities that do not renew, FDA will hold any food shipped to the U.S. by the facility at its port of entry until the facility is compliant.
There are two recent changes to FDA’s Food Facility Registration Module (FFRM) that facilities should be aware of before renewing their FDA registrations. First, foreign facilities are no longer able to enter the same email address for the facility contact and its U.S. Agent. Second, the FFRM now prevents registrants from entering a P.O. Box as their physical address. Any facility that currently lists the same e-mail for the facility and U.S. Agent or has a P.O. Box as its physical address will be required to change these aspects before submitting its renewal.
To read more about FDA requirements and the laws that shape today’s supplement and functional foods industry, visit INSIDER’s Regulatory Content Library.
David Lennarz is vice president of Registrar Corp. He served as a Technical Expert for FDA’s Foreign Facility Registration Verification Program operated by FDA’s Division of Field Investigations. Lennarz is based in Registrar Corp’s head office in Hampton, Virginia.