Overview
Last summer, the Reagan-Udall Foundation convened an independent expert panel to panel to conduct an evaluation of the FDA’s human foods program with the goal of strengthening FDA’s role in food regulation. The panel spent several months receiving input from key stakeholders and assessing the program’s culture, structure and leadership, resources, and authorities. Their work culminated in the December 6th release of a final report entitled “Operational Evaluation of the FDA Human Foods Program.” Join leading experts–including former FDA officials–who will address the report’s key findings and recommendations as well as discuss opportunities and challenges for agency implementation and the potential impact on industry, food safety, and public health.
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Speakers
Sharon Lindan Mayl, Partner, DLA Piper LLP
Stephen Ostroff, Public Health and Regulatory Consultant, S. Ostroff Consulting and Medical Science Trustee, US Pharmacopeia (USP)
Sarah Sorscher, Director of Regulatory Affairs, Center for Science in the Public Interest (CSPI)
Moderated by Ricardo Carvajal, Director, Hyman, Phelps & McNamara, P.C. and Member, FDLI Board of Directors
STEPHEN OSTROFF has dedicated his career to promoting and protecting public health. After graduating from the University of Pennsylvania School of Medicine, his distinguished career has included multiple leadership positions. As Deputy Commissioner for Foods and Veterinary Medicine at FDA, he oversaw the food and animal health activities of FDA, including FDA’s responsibilities in the areas of food safety and nutrition, food labeling, food and color additives, cosmetics, dietary supplements, animal drugs and animal feed, and research to support the food and veterinary medicine mission of FDA. Dr. Ostroff has also served as the acting FDA Commissioner on two occasions, from April 2015 to late February 2016 and again from January to May 2017. During his time as FDA’s Chief Scientist, his office worked closely with FDA’s product centers, providing strategic leadership and support for FDA’s regulatory science and innovation initiatives. Dr. Ostroff left the FDA in 2019. While earlier serving as Deputy Director of the National Center for Infectious Diseases at CDC, Dr. Ostroff focused on emerging infectious diseases, food safety, and coordination of complex outbreak response. Dr. Ostroff currently serves on the Board of Trustees of USP as a Medical Sciences Trustee, helping shape USP’s direction going into the future to ensure that USP can continue to fulfill its public health mission.
SARAH SORSCHER is Deputy Director of Regulatory Affairs at Center for Science in the Public Interest, where she works to improve consumers’ access to information about the food they eat, stop deceptive food advertising, and reduce or remove pathogens and other harmful contaminants in our food supply. Prior to joining CSPI she worked on health and safety issues at Public Citizen’s Health Research Group and served as a law clerk for the Court of Appeals for the District of Columbia. She holds a JD from the Harvard Law School, an MPH from Harvard School of Public Health, and a BA from Amherst College.
RICARDO CARVAJAL is a director at Hyman, Phelps & McNamara, PC. From 2002 to 2007, he served as an associate chief counsel at FDA, where he counseled the agency on a variety of food-related enforcement and rulemaking activities. Drawing on that expertise, he now counsels’ clients on managing inspections, responding to warning letters and other enforcement actions, resolving import detentions, and conducting product recalls. He advises clients on the regulatory status of ingredients and finished products and provides guidance on compliance with labeling and advertising requirements, as well as representation in advertising-related disputes. He also helps clients interpret and comment on the implementation of new requirements, such as those arising under the Food Safety Modernization Act. He applies his subject matter expertise to corporate transactions, issuing opinions and conducting due diligence for acquisitions and initial public offerings. He is a member of the Food and Drug Law Institute, the American Bar Association, and the European Food Law Association, and a professional member of the Institute of Food Technologists.Virtual Learning FAQ
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