Evaluation of FDA’s Human Foods Program
Independent Expert Panel submitted report to FDA Commissioner
Evaluation of FDA’s Human Foods Program
Independent Expert Panel submitted report to FDA Commissioner
On December 6, 2022, the Independent Expert Panel for Foods submitted its report on the Operational Evaluation of FDA’s Human Foods Program to FDA Commissioner Dr. Robert Califf. The evaluation and report were facilitated by the Reagan-Udall Foundation at Dr. Califf’s request.
The evaluation of FDA’s Human Foods Program launched on September 8, 2022. The evaluation focused on structure/leadership, authorities, resources, and culture, expecting to provide recommendations that would equip FDA to carry out its regulatory responsibilities, strengthen its relationships with state and local governments, and secure the nation’s food supply for the future. (The review excludes cosmetic and dietary supplement responsibilities.)
The Foundation convened a food-focused Independent Expert Panel comprised of researchers, former regulators, and process improvement specialists with disciplinary expertise and experience in epidemiology, food science and safety, microbiology, nutrition, and regulatory operations.
Jane Henney, MD (Chair), was the 19th Commissioner of Food and Drugs serving from November 1998-2001. She previously served as the Agency’s Deputy Commissioner for Operations, and held multiple posts, including Deputy Director, at the National Cancer Institute of the National Institutes of Health.
Francisco Diez-Gonzalez, PhD, a food safety microbiologist, is Director of the Center for Food Safety and a Professor in the Department of Food Science and Technology at the University of Georgia’s College of Agricultural and Environmental Sciences. He conducts research aimed to control foodborne pathogens and is a member of the USDA’s National Advisory Committee on Microbiological Criteria for Foods.
James Jones is President of JJones Environmental, following a 30-year career at the U.S. Environmental Protection Agency. His posts at EPA included five years as the Assistant Administrator, and his accomplishments include leading the agency’s effort to significantly reduce pesticides in food and navigating a years-long backlog of pesticide registrations and tolerances as well as leading the Obama Administration’s efforts to reform the Toxic Substances Control Act.
Barbara Kowalcyk, PhD, directs the Center for Foodborne Illness Research and Prevention at The Ohio State University’s College of Food, Agricultural, and Environmental Sciences and is Associate Professor of Food Safety and Public Health in the Department of Food Science and Technology. She is a well-respected epidemiologist and biostatistician, and a nearly ten-year member of the FDA Science Board, which she currently chairs.
Shiriki Kumanyika, PhD, MS, MPH, is Research Professor in the Department of Community Health and Prevention at Drexel University’s Dornsife School of Public Health. She has applied her interdisciplinary background and extensive research experience in numerous roles, and currently chairs the National Academies Food and Nutrition Board. She is also Emeritus Professor of Epidemiology at the Perelman School of Medicine, University of Pennsylvania.
John Taylor, JD, is President and Principal, Compliance and Regulatory Affairs, at Greenleaf Health. He spent more than 20 years at FDA, holding posts that included Counselor to the Commissioner, Acting Deputy Principal Commissioner, Acting Deputy Commissioner for Global Regulatory Operations and Policy, and Associate Commissioner for Regulatory Affairs.
On September 29-30, the Foundation facilitated a public meeting of the Independent Expert Panel on food. The Panel heard from invited stakeholders on a variety of topics to inform its review of the structure/leadership, authority, resources, and culture of FDA’s human foods program.