Print PDF

Only 4 Weeks Left: Renew Food Facility Registrations with FDA or Face Suspension

Thursday, December 06, 2012

December 6, 2012

Only 4 Weeks Left: Renew Food Facility Registrations with FDA or Face Suspension

All foreign and domestic food facilities must renew their food facility registration with the Food and Drug Administration (FDA) before December 31, 2012. The FDA may suspend the registration number of any facility that fails to comply, resulting in a prohibition on the importation, distribution or sale of food from the suspended facility. Food importers are urged to take immediate action to prevent import refusals or detentions come January 1, 2013.

The 2002 Bioterrorism Act (BTA) requires all facilities that manufacture, process, pack or hold food or beverages for consumption in the United States to register as a food facility with the FDA. Under the Food Safety Modernization Act (FSMA) enacted in 2011 those registrations must be updated on or before Dec. 31, 2012, and every two years thereafter. Facilities that fail to renew may have their registration number suspended as early as Jan. 1, 2013, as permitted under Section 102 of FSMA.

Any doubts over the FDA’s intentions to exercise its suspension power were dispelled last month when the Agency suspended the registration of Sunland Inc., a producer of nuts, and nut and seed spreads, after noting several deficiencies during a facility inspection. As a result of this suspension neither Sunland Inc. nor any other person can introduce into U.S. commerce, offer to import, or export any food made at the suspended facility. The warning was reiterated by Amy Barringer, a director in the FDA’s Office of Compliance, who asserted during a webcast sponsored by the United Fresh Produce Association that shipments may be refused if foreign food facilities do not submit their registration renewals by Dec. 31.

Barringer also emphasized the impact of the new financial responsibilities imposed on U.S. Agents. The U.S. Agent is a person or entity located within, or that maintains an office in, the United States who will be the domestic communications representative for a foreign food facility. Since many entities that previously served as U.S. Agent are no longer providing this service due to the increased liability imposed by FSMA, foreign food facilities are advised to immediately re-evaluate who to designate as their U.S. Agent in order to renew their registration before the end of the year.

Sandler, Travis and Rosenberg P.A. has established FDA Solutions Group, LLC, an affiliated consulting company that provides U.S. Agent and registration services. FDA Solutions Group, LLC assists foreign and domestic clients with the registration and compliance requirements affecting FDA regulated industry.

FDA Solutions Group, LLC 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 our services or submit your registration renewal today, please visit our web site at or send us an e-mail at

Customs & International Headlines