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FDA to Enforce Mandatory Re-registration of Food Facilities on January 31 – Failure to Comply Could Mean Import Suspension and Delay.

Last month, the Food and Drug Administration (FDA) announced that it had extended an enforcement discretionary period for the submission of facility registration renewals, required every two years under the Food Safety Modernization Act (FSMA). NCA has learned that the FDA plans to cancel all facility registrations that have not been renewed by January 31, 2013.

The FDA’s plans would mean that any facility that fails by January 31 to renew its registration, as mandated by the Bioterrorism Act of 2002, will be unable to import food until a new registration is secured. Moreover, since all imports from foreign facilities require prior notice bearing a valid registration number, any lapse in registration could cause cascading delays. Since the FDA has not issued a formal statement, however, the plans are not binding and may change.

Recommended Action

The FDA’s putative course of action requires the immediate attention of all companies that manufacture, process, pack or hold food for consumption in the U.S. NCA strongly suggests the following immediate actions:

  • Ensure that you have renewed the registrations for all of your facilities currently registered under the Bioterrorism Act.
  • Contact your manufacturers, co-packers and private label distributors to verify that they have renewed their registrations in a timely manner.
  • Contact your domestic and foreign suppliers to ensure that they have renewed their registrations on a timely basis.

Facility Registration

Under FSMA, all domestic and foreign facilities that manufacture, process, pack or hold food must submit a registration renewal every two years. Beyond potential import disruptions for lapsed registrations, failure to register or to renew, update or cancel a registration is a “prohibited act” under the federal Food, Drug and Cosmetic Act, punishable by a civil or criminal action.

For further information and to register online, please go to the FDA’s food facility registration website.

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