Updated FDA Guidance Documents for Food Facility Registrations

The Food and Drug Administration has issued two guidance documents to help food facilities meet their registration requirements. The biennial registration renewal period runs from Oct. 1 through Dec. 31. U.S. and foreign food facilities that do not properly renew their registrations can be locked out of the U.S. market.

[Click here for ST&R’s upcoming free webinar on food facility registration.]

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 U.S. and acts as the facility’s domestic representative through which all communication with the FDA takes place.

Failure to register can result in the facility being prohibited from importing or exporting food into or from the U.S., offering to import or export food into or from the U.S., 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.

The FDA has now issued (a) the seventh edition of a guidance to help facility owners and operators understand the registration requirements and (b) a supplemental draft guidance clarifying the agency’s thinking about the registration requirements in situations in which multiple entities are involved in the use of shared physical space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).

ST&R’s FDA Solutions Group can register facilities, serve as U.S. agent for foreign facilities, and assist with the full range of related functions. Visit our food & beverage page or contact info@fdasolutionsgroup.com for more information.

This article was originally published in the Sandler, Travis & Rosenberg Trade Report on August 20, 2018

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