Douglas Stearn is the acting deputy associate commissioner for regulatory affairs in the FDA Office of Regulatory Affairs (ORA), overseeing inspections, compliance, enforcement, field laboratory operations, import operations, and strategic planning, among other areas.
Mr. Stearn’s usual position is deputy director for regulatory affairs for the FDA Center for Food Safety and Applied Nutrition. In this role, he directs oversight and responsibility for regulatory programs overseeing the food supply under FDA jurisdiction, including compliance functions and regulatory programs involving food safety, outbreak response, and dietary supplements for over five years.
Previous roles include director of the FDA Office of Enforcement and Import Operations between 2013 and 2018, where he oversaw the execution of the agency’s import operations and compliance activities. Between 2009 and 2013, he was the assistant director and then deputy director of the Office of Compliance in the FDA Center for Drug Evaluation and Research (CDER).
Prior to joining CDER, Mr. Stearn directed the ORA Division of Compliance Policy for almost two years. Before joining the FDA, Mr. Stearn was a trial attorney in the U.S. Department of Justice’s Office of Consumer Litigation for more than fifteen years. In this role, he litigated numerous civil and criminal cases referred by the FDA and other consumer protection agencies.