• FDA issued a final rule more than two years ago, on July 14, 2016, to amend and update the Agency’s food facility registration requirements and implement revisions that were mandated by the Food Safety Modernization Act (FSMA). FDA’s compliance guidance for the updated food facility registration requirements was issued in draft on November 7, 2016 and was updated – again in draft – on December 27, 2016. (See previous blog coverage here.)
  • On August 17, 2018, FDA informally announced the availability of the finalized guidance document titled Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry. (See also 83 Fed. Reg. 42024, August 20, 2018.) FDA concurrently announced the release of a new draft document titled Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration addressing registration requirements when multiple entities are involved in the use of shared physical space, such as where one entity owns a building and lessees manufacture/process, pack or hold food in the building. (See 83 Fed. Reg. 42062, August 20, 2018.) All comments on the new supplement that are received by October 19, 2018 will be considered when FDA incorporates it into a future edition of the Q&A Guidance on Food Facility Registration.
  • FDA states that the August 2018 Q&A Guidance on Food Facility Registration has been modified in response to numerous comments received on the draft guidance document. Changes to the document, however, are not highlighted for easy comparison to the draft guidance. We are reviewing the August 2018 Q&A Guidance to identify all differences as compared to the draft guidance and determine whether FDA has changed its views on any food facility registration requirements as opposed to merely clarified the Agency’s position.