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.
