• On August 17, 2016, FDA finalized the rule – codified at 21 CFR Parts 170 and 570 for human food and animal feed respectively – that was originally proposed on April 17, 1997 permitting manufacturers to reach a Generally Recognized as Safe (GRAS) determination with the option of notifying FDA. Prior to 1997, companies were able to submit a GRAS affirmation petition to seek FDA’s approval for a GRAS determination. GRAS status is important because the safety of additives in food must be reviewed by FDA unless the additive is GRAS.
  • On May 22, 2017, a group of nonprofit organizations (the Center for Food Safety (CFS), Breast Cancer Prevention Partners (CPP), Center for Science in the Public Interest (CPI), Environmental Defense Fund (EDF), and Environmental Working Group (EWG)) sued FDA seeking a declaratory judgement that the GRAS Rule: “(1) violates fundamental principles of separation of powers, (2) exceeds FDA’s statutory authority, (3) does not accord with the law, (4) is arbitrary and capricious, and (5) is an abuse of discretion” and they are seeking vacation of the rule and that FDA reissue a rule consistent with the law.
  • FDA made a motion to dismiss the suit on the basis that the organizations lack standing to sue. The Court filed its opinion on September 12, 2018 holding that CFS and EDF do have standing to sue and it dismissed the case, without prejudice, as to the other plaintiffs. The case will proceed to discovery and the dismissed plaintiffs will have the option to reformulate their complaint and refile with the Court. Thus, it is possible that the Court will eventually rule on the substantive issues raised by the plaintiffs as discussed above.
  • Keller and Heckman will continue to monitor the case. Given the current procedural posture of the lawsuit, be believe that industry should look for opportunities to file amicus briefs in support of the GRAS regulation and potentially meeting with FDA Commissioner Gottlieb to emphasize the importance of GRAS and to encourage the Agency to vigorously defend the lawsuit.