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FDA Issues Additional Food Facility Registration Guidance

Nov 16, 2016

The Food and Drug Administration last week issued a new question-and-answer guidance document to assist facilities in complying with the food facility registration requirements. The guidance incorporates changes made to the facility registration requirements and addresses questions raised with the agency since the last version was released in 2014.

The guidance provides clarity on several issues not fully addressed in the revised registration requirements, including:

  • how FDA will verify information involving U.S. agents for foreign facilities
  • how facilities can obtain a unique facility identifier
  • steps FDA will take to verify a facility’s registration when it is submitted by a third party
  • how registrations must be submitted; starting in 2020, registrations, renewals, updates and cancellations of registrations must be submitted to FDA electronically

FDA has not completed the sections on exemptions from registration and definitions, but the agency intends to reissue the guidance with those additions when completed.

For more details, visit Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry

Reminder to Renew Registration

The Food Safety Modernization Act requires U.S. and foreign food facilities to renew their registration with FDA every even-numbered year between Oct. 1 and Dec. 31, and to indicate the types of foods produced or held at each facility. IDFA encourages members to register early to avoid any system issues due to a last-minute registration rush.

Members with questions can contact Emily Lyons, IDFA director of regulatory affairs and counsel, at

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