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
      Publications
      FDA Signals it Has No Appetite to Add Popular GLP-1 Drug Substances to the 503B Bulks List
      Key Takeaways FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list. The proposal would materially limit 503B bulk compounding of these GLP-1 products. Comments on the proposal are due June 29, 2026. Bulk compounders should consider submitting comments that directly address FDA’s clinical-need framework, including patient safety considerations and any specific medical necessity for compounding these products from bulk drug substances. On April 30, 2026, FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list via a Federal Register notice published on May 1, a move that, if finalized, would limit mass compounding of these substances by outsourcing facilities. FDA explained that, after reviewing nominations for semaglutide, tirzepatide and liraglutide, it found no demonstrated clinical need for outsourcing
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      Tiny Chains, Big Changes? What FDA’s Latest Actions Mean for Peptide Compounding
      Key Takeaways: FDA will convene the Pharmacy Compounding Advisory Committee (PCAC) on July 23-24, 2026, to discuss seven peptides for potential inclusion on the 503A bulks list. An additional five peptides will be considered at a PCAC meeting to be held before the end of Feb. 2027. FDA separately announced on April 15, 2026, that these same substances will be removed from 503A Category 2 after seven calendar days because the nominations were withdrawn, although the agency confirmed it was still planning to bring them to PCAC. That procedural removal should not be read as a go-ahead to compound these peptides. Under FDA's current policy, removal of a bulk drug substance from Category 2 does not, on its own, authorize use of that
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