Foreign and domestic food facilities now have one more month, until Jan. 31, to make sure they are properly registered with the Food and Drug Administration. The FDA had formerly fixed a Dec. 31 deadline for food facilities that manufacture, process, pack or hold food for human or animal consumption to register or renew their existing registrations, a process which must be completed every other year. However, the FDA announced today that it is now extending that deadline for one month due to registration process delays and substantive changes to the Food Safety Modernization Act, which caused slight setback.
Specifically, until Jan. 31, FDA intends to exercise enforcement discretion with respect to registration renewals submitted after Dec. 31. Consequently, FDA will not suspend the registration number for facilities that submit a registration or renewal during this one-month period. However, the agency is strongly encouraging facilities to renew their registrations as early as possible to avoid any further issues.
Those affected by the new registration requirements are reminded that FSMA also creates new burdens and potential liabilities on entities elected as U.S. agents to foreign food facilities. One of these liabilities stems from FSMA §107 concerning re-inspection fees. It is suspected that in 2013, FDA will begin charging $289 per hour for the time it dedicates foreign re-inspections, resulting in the potential for invoices to reach several thousands of dollars per re-inspection. FDA will hold the U.S. agent responsible for paying these invoices. As a result, brokers, forwarders and importers of record will likely want to find alternatives to becoming U.S. agents themselves and foreign food facilities will need to seek out entities to become U.S. agents.
FDA Solutions Group LLC, a consulting company affiliated with the customs and international trade law firm Sandler, Travis & Rosenberg, assists foreign and domestic clients with the registration and compliance requirements affecting FDA-regulated industry. FDA Solutions Group makes it easy for food facilities to protect against suspension and costly business interruptions through its turn-key registration and U.S. agent services. To learn more about these services or submit your registration renewal today, please visit our Web site at http://www.fdasolutionsgroup.com or send us an e-mail at email@example.com.