As part of the Food Safety Modernization Act (FSMA), all US facilities that manufacture, process, pack, or hold food for human consumption must register with the US Food and Drug Administration (FDA) every two years. An easy way to remember is that re-registration opens during a specific window in every even-numbered year. Facilities are required to register and re-register in this way to help address food safety threats and provide a backbone for tracing food-borne issues. 

If the current year ends in an even number (zero is even), the registration window opens on October 1 and closes on December 31. If you don’t know how to proceed with , you have come to the right place. 

What is the Biennial Renewal Requirement? 

Essentially, every business that needs to register or re-register must do so between October 1 and December 31 every even-numbered year. 

Those businesses that are just beginning operations are legally required to register with the FDA before handling food that is destined for the US market. However, if you register in an odd year or outside the mandated date range, you will be required to renew the registration again at the next even-numbered October 1 - December 31 window. 

Businesses that fail to re-register before December 31 will have their registration considered expired and will need to start the registration process again from the beginning. 

Who Has to Register with the FDA? 

All domestic and foreign facilities that manufacture, pack, or store food or food ingredients intended for the US market must register with the FDA. Domestic facilities proceed with the registration process as it is detailed below, but foreign facilities must designate a US agent to serve as their touchpoint with the FDA.

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This agent must reside or maintain a place of business in the US, and will act as the primary point of contact for the FDA on behalf of the foreign company. You must have a US agent before you can attempt the registration/re-registration process. 

How to Renew Your FDA Food Facility Registration/Re-Registration 

The process is entirely free and handled through the FDA Industry Systems (FIS) portal. You will need to have a Unique Facility Identifier (UFI) when you register; at present, the FDA accepts the Data Universal Numbering System (DUNS) as an acceptable UFI. This number, if you don’t have it, is provided by Dun & Bradstreet. 

Once you have the required number and, if applicable, a U.S. agent, you can complete the registration entirely through the FIS portal. The FDA’s website also provides comprehensive guidance on the registration process. 

How Can PCB Help? 

PCB can help with this process in a number of ways, including: 

• Acting as your US agent. 
• Assisting with FSMA re-registration
• Answering questions regarding FDA Requirements. 

Notably, PCB does not have to be your US customs broker to assist your company with FDA re-registration. For any and all issues with FDA facility registration/re-registration or anything at all, be sure to get in contact with our team for assistance.