The Food and Drug
Law Institute
The Food and Drug Law Institute (FDLI) is a nonprofit 501(c)(3) organization committed to providing high quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy, and regulatory communities. FDLI does not engage in advocacy activities.
FDLI pursues two major priorities: 1) to present conferences and publications for comprehensive discussion of major policy, legislative, regulatory, and enforcement actions and judicial decisions; and 2) to provide education and training in the practice of food and drug law and regulation. FDLI's mission relates to the regulatory programs of the Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture, (especially the Food Safety and Inspection Service), Federal Trade Commission, Department of Justice, Environmental Protection Agency, and other federal and state government agencies as they pertain to human and veterinary drugs, biologics and biotechnology products, medical devices, food, and cosmetics.
FDLI is an organization of more than 10,000 members and affiliates, manufacturers and suppliers (pharmaceuticals, biologics, and biotechnologies), medical devices, food, and cosmetics subject to FDA regulation; law and consulting firms; associations; and individuals.
Each year, FDLI sponsors more than 20 conferences and workshops, which focus on a variety of issues affecting FDA-regulated industries (e.g., new statutes or regulations, promotion, enforcement initiatives, etc.).
FDLI produces the award-winning peer-reviewed Food and Drug Law Journal, the bimonthly magazine Update, and a selection of publications that, together, provide a comprehensive set of resources related to food and drug law and regulation.
Located in Washington, D.C., FDLI is governed by a Board of Directors that meets four times per year. Other bodies include the following committees: Academic, Drug/Biologics, Executive, Finance, Food/Dietary Supplement, Governance, H. Thomas Austern Writing Awards Committee Long/Short Papers, Journal Editorial Advisory Board, Medical Device, Audit, Legal, Membership, Strategic and Update Editorial Advisory Board.
FDLI was founded in 1949 as "The Food Law Institute." The name and scope were changed in 1966 to "The Food and Drug Law Institute" to recognize growing interest in FDA's regulatory authority over other products affecting human and animal health in the United States. The organization now uses the acronym, FDLI. One of FDLI's goals has been to encourage development of a cadre of attorneys specifically trained in food and drug law. That goal has been expanded to include persons in other disciplines involved in the regulatory aspects of FDA regulated products. FDLI programs are intended for attorneys, regulatory affairs practitioners, scientists and healthcare professionals, government employees, marketers and other professionals who need to understand the laws, regulations, and policies affecting the development, approval, manufacture, promotion, and marketing of regulated food, cosmetics or healthcare technology products.