Food facilities required to register with the Food and Drug Administration must renew their registrations between Oct. 1 and Dec. 31. Food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted or renewed must be held at the port of entry for and may not be delivered to the importer, owner, or consignee until the foreign facility is registered. Failure to register or renew a registration can also expose facilities to civil or criminal action.

Under section 102 of the Food Safety Modernization Act, all domestic and foreign facilities that manufacture, process, pack, or store food, food ingredients, pet foods, or dietary supplements are required to renew their registration with the FDA every even-numbered year. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located within, or maintains an office in, the United States and acts as the domestic representative for the foreign facility through which all communication with the FDA takes place.

FDA states that it is continuing to use the version of the food facility registration form (Form FDA 3537) that was in use prior to a July 17 final rule making various amendments to the registration requirements and that this version does not include all of the data elements required by that rule. FDA plans to implement a revised version of the form shortly.

Facilities can register online, via mail, or by fax (though FDA encourages online registration) or may authorize third parties to register for them. Sandler, Travis & Rosenberg's FDA Practice Group offers food facility registration services, including identifying a company's registration obligations, potential exemptions, and registering a foreign or domestic company, as well as service as a U.S. agent for foreign facilities. To learn more about U.S. food regulatory compliance requirements and to ensure your company is registered during the renewal period this year, please contact Shelly Garg at (305) 894-1043.


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