Background

Foreign and domestic food facilities that do not properly renew their registrations with the Food and Drug Administration can be locked out of the U.S. market. Renewals for these registrations are due this month.

Under the Food Safety Modernization Act, all foreign and domestic 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. 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 this confirmation.

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.

Foreign and domestic food facilities, as well as the companies that source from them, should ensure those facilities renew their registrations on time. Renewals are mandatory regardless of when the initial registration occurred.

FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered, please contact Domenic Veneziano at (202) 734-3939.

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