• 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, we believe that industry should look for opportunities to file amicus briefs in support of the GRAS regulation and potentially meet with FDA Commissioner Gottlieb to emphasize the importance of GRAS and to encourage the Agency to vigorously defend the lawsuit.
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Photo of Benjamin Wolf Benjamin Wolf

Benjamin Wolf practices in the area of food and drug law. Mr. Wolf provides state and federal legislative counsel to tobacco and e-vapor suppliers and manufacturers. His practice also includes providing advice to food, dietary supplement, medical device, consumer product, and pharmaceutical clients regarding compliance with domestic and foreign regulations.

Prior to joining Keller and Heckman, Mr. Wolf worked for the Food and Drug Administration (FDA) as a regulatory counsel in the Center for Tobacco Products (CTP) and Office of Regulatory Affairs (ORA). In his role as a regulatory counsel, Mr. Wolf worked closely with CTP, ORA, the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) to develop and implement policies including tobacco compliance and enforcement, tobacco premarket review, medical device compliance and enforcement, device premarket, and device and combination products good manufacturing practice. This work touched upon areas including tobacco substantial equivalence (SE), premarket tobacco product applications (PMTAs), modified risk tobacco product applications (MRTPAs), investigational tobacco product applications (ITPAs), data integrity, medical device quality metrics, utilization of benefit and risk factors in determining appropriate FDA engagement for devices being marketed, laboratory developed tests (LDTs), and good manufacturing practice (GMPs) for medical devices and combination products.

Also while at the FDA, Mr. Wolf served as a reviewer of certain tobacco premarket applications and submissions; responded to Congressional, Government Accountability Office (GAO) and Office of Inspector General (OIG) inquiries; and trained in bioresearch monitoring for field investigators.

Mr. Wolf’s practice is benefited by his extensive background as a research and development engineer at a medical device company in Boston, Massachusetts. In that role, he gained experience in GMP compliance, preparing regulatory submissions and addressing FDA questions. He has executed numerous bench and animal studies to support regulatory filings.

Prior to law school Mr. Wolf completed graduate-level coursework in Aerospace and Mechanical Engineering at Boston University. While at George Washington University Law School, Mr. Wolf worked as a student attorney assisting clients with proceedings in the Vaccine Injury Compensation Program (VICP). His Student Note, written while serving as a member of the Federal Circuit Bar Journal (FCBJ) and regarding the VICP, was selected for publication as the best Student Note written for the FCBJ during the 2011-2012 academic year. Mr. Wolf was the recipient of the Henry R. Berger Award, awarded to one graduate annually for excellence in tort law.