Stuart Pape helps clients understand and face challenges presented by regulations imposed by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and similar health and safety regulatory bodies worldwide. He currently serves as chair of the firm's FDA practice and focuses on:
- Assisting clients on the regulation of food ingredients and novel foods
- Advising clients whether food ingredients are generally recognized as safe (GRAS) or whether dietary ingredients require a new dietary ingredient notification (NDI)
- Advising on labeling and promotion of regulated products and claims substantiation and helping clients address challenges to their labeling and promotion
- Assisting clients in obtaining approval of pharmaceuticals and medical devices and complying with post approval requirements
- Assisting in enforcement proceedings initiated by regulatory bodies
- Helping clients develop sound strategies in the face of challenges from NGOs.
- Lobbying in connection with legislative consideration of statutory changes to the laws governing FDA regulated products
Stuart regularly appears before the FDA, USDA, Consumer Product Safety Commission, U.S. Customs and Border Protection, Federal Trade Commission, numerous other federal and state regulatory bodies, and the Congress of the United States, Stuart serves clients across the U.S. and around the world in many capacities. Previously, he served in various positions in the Office of the Chief of Counsel at the FDA, including as associate chief counsel for food. He also served as executive assistant to FDA Commissioner Donald Kennedy.
Education
- University of Virginia School of Law (J.D., 1973)
- University of Virginia (B.A., 1970)
Bar Admission
- District of Columbia, 1980
Court Admissions
- United States Supreme Court, 1976
Professional Affiliations
- District of Columbia Bar
- Elizabeth Glaser Pediatric AIDS Foundation
- Vice Chair, Board of Directors, 2004-2020
- World Food Regulation Review, Advisory Board
- Guide to U.S. Food Labeling Law
- Editorial Advisory Board
Recognition
- Selected for inclusion in Best Lawyers in America® for:
- FDA Law, 2016-2026
- Health Care Law, 2023-2024
- Ranked in Chambers USA: America’s Leading Lawyers for Business, Food & Beverages: Regulatory & Litigation, Band 1, Nationwide, 2014-2025
- Service to FDLI Award, The Food and Drug Law Institute (FDLI), 2022
- Selected for inclusion in Super Lawyers
- Who’s Who in America
- Who’s Who in the World
- FDA Commendable Service Award, 1978
- Judge Learned Hand Award, American Jewish Committee, 2012
- Natural Products Association,President’s Award, 2015
