Mandatory Re-Registration With FDA Due Dec 31, 2012

Mandatory Re-Registration With FDA Due Dec 31, 2012

As customs brokers for many importers who ship U.S. Food and Drug Administration (FDA) regulated products, Pacific Customs Brokers has been actively monitoring and informing companies of the changes in U.S. FDA regulations.

As a non-domestic food facility importing FDA regulated food products into the United States, your firm is directly affected by the Food Safety Modernization Act (FSMA), which was enacted in January 2011.

New Biannual Registration Requirements

The new act requires that all food facilities, foreign and domestic, must re-register with FDA. This act EXPANDS the registration mandate under the Bioterrorism Act of 2003, to state that all facilities must re-register every two (2) years between October 1 and December 31, beginning in 2012. The re-registration module of FDA became available on October 22, 2012.

Your current registration will expire on January 1, 2013. If re-registration is not completed prior to that date, 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 all products that you import into the U.S. In order to complete your re-registration, you will need to have the original FDA facility registration account number, your password, and your PIN.

Food Modernization Safety Act | Re-Registering Your Facility With The FDA

U.S. Agent Required For Foreign (Non-U.S. Domiciled) Food Facilities

One of the requirements for registration of a foreign (non-U.S. domiciled) food facility is that a U.S. domiciled agent be appointed. The U.S. agent plays the role of the domestic representative for the foreign facility through which all communication takes place.

Note: When you first registered, you may have appointed one of your customers, or a custom broker, as your agent. At the time the Bioterrorism Act took effect in 2003, there were very limited responsibilities placed on the agent. The FSMA greatly expands these requirements, to include the financial liability of payment to FDA for all re-inspection fees. Your current agent may not be willing to accept the liabilities involved under the new requirements, and will be given an opportunity to decline that role, which will render your re-registration invalid.

Pacific Customs Brokers can assist you with food facility registration or renewal and U.S. Agent services. Our 24 hour, 7 days a week operation is available to provide immediate answers to your regulatory questions. Please address your comments and questions to the team at Pacific Customs Brokers at or call us at 877-332-8534. To stay current on this topic, you may also want to subscribe to Pacific Customs Brokers' weekly trade newsletter.

U.S. Food Safety Modernization Act - Does It Affect Me?
Good To Know | FDA Food Facility Re-Registration Now Open
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About Author
April Collier

April Collier is a Trade Compliance Specialist with Pacific Customs Brokers Inc. with over 36 years of experience in international trade. April has been a valued member of the PCB team for 18 years, having taking the lead in implementing the Compliance department for US imports. Her current responsibilities include advising and coaching clients on a variety of regulatory compliance matters, and include expertise in Antidumping & Countervailing matters. In addition to her regular duties, April is also the CTPAT coordinator for PCB.

While we strive for accuracy in all our communications, as the Importer of Record it is incumbent upon your company to ensure that you are aware of the requirements under the new regulations so that you maintain compliance as always.
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