FDA Issues Revised Q&A Document on Food Facility Registration
The Food and Drug Administration has issued a revised seventh edition of its guidance for industry with questions and answers on the food facility registration requirements. The revised draft guidance contains the 15 sections that were included in the previous version as well as an additional section with definitions and another section detailing who is exempt from registration. The draft guidance, which is intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act, also includes an additional question and answer related to mobile facilities in the section discussing the information required in the registration. Interested parties may submit comments on this document by March 27.
As previously reported, food facilities required to register with the FDA must renew their registrations by 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.
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.