Once every two years, food manufacturers must undergo the US Food and Drug Administration (FDA) registration renewal process to ensure and uphold food safety. The window for renewal will be open from October 1 until December 31, 2022, but it is recommended that all importers renew early to avoid any disruption to shipments.
Agents, owners or operators of food manufacturing facilities must go through the FDA registration renewal process before the deadline. If a company fails to submit a timely renewal, the regulatory authority may consider the company’s products misbranded and this may lead to FDA detention of certain products. To encourage timely submission, there is no cost associated with the renewal process.
Facilities that are engaged in manufacturing, packaging, processing, or holding foods, beverages, or dietary supplements that are consumed in the US must register with the FDA. Any facilities located outside of the US must also register their facilities and employ a US agent to communicate with the FDA.
To go through the FDA registration renewal process, the food manufacturing facility must have a unique facility identifier (UFI) accepted by the agency. Currently, the FDA accepts the Data Universal Numbering System (DUNS), which can be accessed at DNB.com, as a UFI. However, the FDA has issued specific guidance advising that a DUNS number for a company’s corporate headquarters is not sufficient. A DUNS number associated with the physical location of the food facility must be provided during renewal.
The name and contact information on the FDA food manufacturing facility registration must exactly match the DUNS number contact information. If not, the registration will be rejected. For example, if the FDA registration identifies “ABC Manufacturing” at “123 Main Street,” while the DUNS number information is listed as “ABC Manufacturing LLC” at 123 Main St.,” the registration will be denied.
Due to the specificity of the requirements, registering or renewing a food facility with the FDA can be a confusing and lengthy process. In total, there are five steps required to complete the FDA registration renewal process:
- Acquiring a DUNS number
- Filling out an online application
- US agent appointment authorization
- Submitting an application for FDA registration
- Getting an 11-digit food facility registration number from the FDA
The FDA registration renewal process is required to help identify the location and potential sources of foodborne illness outbreaks and bioterrorism incidents. Registration requirements were initiated by the 2002 Public Health Security and Bioterrorism Preparedness and Response Act and were later amended by the FDA’s Food Safety Modernization Act (FSMA) in 2011.
The Bioterrorism Act includes a “one step forward, one step back” traceability requirement, meaning that each facility along the food supply chain is required to show where a product is going as well as where it has been. The FSMA supports and expands the Bioterrorism Act by requiring facilities to establish and implement a food safety system that includes preventive controls and a recall plan.
Implementing a food safety and traceability program should satisfy FDA and industry compliance requirements as well as provide food and beverage companies with better visibility and control while minimizing risks to the public.