The US Food and Drug Administration is reminding all food facilities that manufacture, process, pack or store food to renew their FDA registrations during the period of October 1 through December 31, 2018. This is true even for food facilities that registered with FDA as recently as September 2018.
The 2018 biennial registration renewal is required under section 415 of the Federal Food, Drug and Cosmetic Act (FD&C Act), which requires food facilities that are required to register with FDA to renew such registrations during the period beginning on October 1 and ending December 31 of each even-numbered year.
If a registration is not renewed during this period, FDA considers it expired and removes the facility’s registration. During the last biennial registration renewal period in 2016, failure to renew FDA registrations contributed to a 28 percent drop in the number of registered food facilities in early 2017.
Also, facilities should be aware that renewing a registration is distinct from updating a registration. To keep their FDA registrations valid for 2019, facilities need to ensure they properly renew during this period.
For facilities located outside of the US, these companies must designate and be accepted by a US agent for FDA communications to renew registrations. Failure to complete the renewing of the registration can result in food exported to the US being detained or refused at the US port of entry.
To get more details, PFW interviewed Mary Hancock, food facility registration manager for Registrar Corp, a consulting firm specializing in FDA regulatory compliance:
PFW: What types of food manufacturing facilities need to renew their FDA registration?
Hancock: Nearly every facility that manufactures, processes, packs or stores food, beverages or dietary supplements that may be consumed in the United States must register with FDA and complete the biennial renewal. This includes facilities bringing in samples of products that may be consumed at trade shows in the United States.
There are some exemptions to the registration requirement: private residences of individuals, farms that do not engage in additional processing activities, retail food establishments, restaurants, nonprofit food establishments in which food is served direct to the consumer, fishing vessels that do not engage in additional processing onboard the vessel, facilities that are regulated exclusively by USDA.
PFW: Do they all need to renew their registrations, even if they recently registered?
Hancock: Yes. A facility that registers with FDA as late as September 30 will still need to renew the registration between October 1 and December 31. This is true for facilities that update their existing registrations before October 1 as well.
PFW: What is the FDA’s intended purpose of the biennial registration renewal?
Hancock:Biennial registration renewal was mandated in 2011 by the Food Safety Modernization Act (FSMA). The purpose of the registration renewal requirement is to ensure that FDA has access to current information on facilities supplying food for US consumers. Before this requirement, facilities would shut down, move or change their points of contact and without notifying FDA. This resulted in the agency wasting resources by sending inspectors to non-food facilities.
PFW: What happens if facilities don’t renew their registrations by the deadline?
Hancock: Registrations that are not renewed are removed from FDA’s registration database, and it’s a prohibited act to manufacture, process, pack, or store food that may be consumed in the US without a valid registration. For facilities located outside the United States that failed to renew in a timely fashion, their food shipments may be stopped at the US border until they are re-registered.
If a facility’s registration is cancelled due to failure to renew, it will lose its current registration number. There is no way to reinstate the original registration number. The facility will need to file a brand new registration and be assigned a new number.
PFW: Anything that facilities should keep in mind when renewing?
Hancock: Food facilities located outside of the United States will be required to designate a “US Agent” during their registration renewal. The listed U.S. Agent will receive an e-mail from FDA and will need to accept their designation. If the US Agent does not accept the designation, FDA will not consider the non-US facility’s registration renewal complete and its registration will be cancelled after the renewal period. Facilities outside the United States should ensure they are designating a reliable U.S. Agent. Navigating FDA’s Unified Registration and Listing System can be a confusing and lengthy process for users who are unfamiliar with the database.