Douglas Stearn, J.D., served for more than 17 years at the FDA, leading regulatory, compliance, enforcement, and policy activities across a broad range of products.
Most recently, Mr. Stearn was the Principal Deputy Associate Commissioner for Inspections and Investigations in the FDA Office of Inspections and Investigations (OII), serving as the primary advisor to and surrogate for the Associate Commissioner for OII on all organizational decisions and actions involving food, drugs, medical devices, biologics, and tobacco products. He directly oversaw emergency operations, inspectional policy, recalls, debarment, internet investigations, tobacco product inspections, and other cross-cutting functions. Mr. Stearn held similar responsibilities as Deputy Associate Commissioner in the Office of Regulatory Affairs (ORA) before the 2024 FDA reorganization.
Between 2018 and 2024, Mr. Stearn was the Deputy Director of Regulatory Affairs of the Center for Food Safety and Applied Nutrition (CFSAN), where he led regulatory and compliance activities and programs involving food safety and outbreak response. He provided executive and technical leadership on efforts to modernize food safety and the regulation of dietary supplements and cosmetics, in addition to leading precedent-setting enforcement actions.
Prior to that, Mr. Stearn was Director of ORA’s Office of Enforcement and Import Operations, overseeing major initiatives to improve import and recall processes and operational efficiency. In this position, he led a reorganization of all personnel working in import operations and FDA’s integration into a new government-wide import entry system. He also served as a Deputy Director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER) and as the Director of ORA’s Division of Compliance Policy.
Mr. Stearn was a trial attorney in the U.S. Department of Justice’s Office of Consumer Litigation for more than 15 years, litigating civil and criminal cases referred by the FDA and other consumer protection agencies.
Mr. Stearn received his law degree from Cornell University and his bachelor’s degree from Brown University.