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FDA Updates Food Facility Registration Guidance

The Food and Drug Administration has issued the seventh edition of a guidance to help facility owners and operators understand their registration requirements as well as supplemental draft guidance clarifying the agency’s thinking about the registration requirements in situations in which multiple entities are involved in the use of shared physical space (e.g., when manufacturers lease their facility, store food at self-storage warehouses, or use commercial communal kitchens that are also used by other manufacturers to process food).

Under 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 registrations 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 or maintains an office in the United States and acts as the facility’s domestic representative through which all communication with the FDA takes place. The current biennial registration renewal period will run from 1 October through 31 December 2018.

Failure to register can result in the facility being prohibited from importing or exporting food into or from the United States, offering to import or export food into or from the United States, or otherwise introducing food into interstate or intrastate commerce. Failure to submit, renew, update or cancel a registration can also result in civil or criminal action.

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