Background

Food facilities required to register with the Food and Drug Administration must register or renew their registrations by Dec. 31. U.S. Customs and Border Protection states that beginning Jan. 1, 2017, food being imported or offered for import into the U.S. from a foreign facility that has failed to register or renew its registration is subject to being held at the port of entry. 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. In addition, U.S. agents must confirm that they have agreed to serve as such, and the FDA will not confirm a registration or provide a registration number until the U.S. agent has provided such confirmation.

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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