Mandatory biennial renewal of your FDA registration opens on October 1 and is due prior to December 31

As you may be aware, If you are the owner, operator, or agent in charge of either a domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the US, you are required to register with the FDA, unless an exemption applies. The Food Safety Modernization Act (FSMA) expands the registration mandate under the Bioterrorism Act of 2002, to state that all facilities must re-register every two (2) years between October 1 and December 31, beginning in 2012. 

This is a friendly reminder that your current registration will expire on January 1st, 2023.

Steps to Renewal 

Renewing or Newly Assigning PCB as Your US FDA Agent:

We are pleased to assist you with your biennial registration renewal process, or can act as your assigned US FDA Agent by following the steps below:

1. Download either the renewal or agent forms below
2. Complete the forms
3. Email the completed form to tcg@pcbusa.com

‍

*Please note, that if you have assigned PCB as your US agent with the FDA directly, but have not completed an Agency Agreement with us, we are forced to decline the registration. Please ensure that you complete a PCB FDA Agency Agreement prior to your first shipment release request.

Renewing if PCB Is NOT your Agent:

1. Advise your Customs Broker(s) that you have completed your FDA renewal
2. If your Food Facility Registration number has changed, advise your Customs Broker(s) to avoid delay in processing your shipment release requests.

To learn more about the FDA Food Facility Registration program click here.

Important Reminders

1. Foreign (non-US domiciled) food facilities must appoint a US domiciled agent for the Food Facility Registration. This US agent will act as the domestic representative for the foreign facility through which all communication with FDA takes place.
2. Re-register your food facility soon after the October 1, 2022 opening to avoid delays in processing your renewal.
3. Note that DUNS numbers are now required as part of your registration. Click here for DUNS Number Acquisition instructions.
4. The FDA will terminate any Food Facility Registrations that are not renewed by December 31, 2022.
5. Although PCB will still be able to assist you, please be aware that allowing your food facility registration to expire creates additional delays and expenses.
6. If re-registration is not completed prior to December 31, 2022, your current registration will be considered invalid and you will be required to register anew. This will create a new FDA registration number for your facility, and will impact all FDA regulated products that you import into the US, and may create a delay in shipping your products until a new food facility registration is obtained.
7. When you first registered with FDA you may have appointed one of your customers, or Pacific Customs Brokers Inc., as your agent. At the time the Bioterrorism Act took effect in 2003, there were very limited responsibilities placed on the agent. The Food Safety Modernization Act greatly expanded these requirements to include the financial liability of payment to FDA for all re-inspection fees. Your current agent (if not us) may not be willing to accept the liabilities involved under these requirements, and will be given an opportunity by FDA to decline that role, which will render your re-registration invalid.
8. As a non-domestic food facility importing FDA regulated food products into the US, your firm is directly affected by the Food Safety Modernization Act (FSMA). Failing to renew your food facility registration is a prohibited act.

As always, we appreciate the confidence that you place in us and we look forward to effectively and successfully completing this required activity together.