• FDA Releases Updated Guidance on the Reportable Food Registry
  • June 4, 2010 | Authors: Miriam J. Guggenheim; Eugene I. Lambert; Jeannie M. Perron
  • Law Firm: Covington & Burling LLP - Washington Office
  • On May 24, 2010, the United States Food and Drug Administration (“FDA”) released a revised Guidance on the Reportable Food Registry (the “Registry”). FDA refers to this Guidance as a “Draft Guidance,” although it updates a September 2009 “Final Guidance.” The new Draft Guidance adds and revises questions and answers regarding the Registry and the new Safety Reporting Portal...Despite anticipation that the Draft Guidance would address specific topics on which questions have arisen repeatedly since the issuance of the September 2009 Guidance, such as when FDA deems transfer of food to take place, the Draft Guidance does not significantly change the previous Guidance in many respects. This alert highlights those policy changes that do appear in the Guidance and discusses areas that are still in need of clarification.