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FSMA Update: FDA Revises Q&A Draft Guidance on Food Facility Registration

  • By way of background, on July 14, 2016, FDA issued a final rule to amend and update the Agency’s food facility registration requirements and implement revisions mandated by the Food Safety Modernization Act (FSMA). To support industry compliance with the updated food facility registration requirements, on November 7, 2016, FDA issued a Draft Guidance for Industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” (See previous blog coverage here).  The Draft Guidance contains 15 sections of a multi-section guidance which sets forth the Agency’s current thinking on FDA’s registration requirements.

  • On December 27, 2016, FDA announced the availability of an updated version of the draft guidance, “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” This updated Draft Guidance supersedes the November 2016 version.

  • The December 2016 version of the seventh edition of the Draft Guidance includes 15 sections that were in the November 2016 version, along with two additional sections, namely, “Who is Exempt from Registration?” and “Definitions.” FDA has also revised some of the existing questions and answers and made other editorial changes. A Federal Register notice about the December 2016 version can be found here.

  • All comments submitted by March 27, 2017—for both the November 2016 and December 2016 draft guidance documents—will be considered in the drafting of the final version of the Guidance.

© 2020 Keller and Heckman LLPNational Law Review, Volume VII, Number 3


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...