Health Affairs March 22, 2023
Gregory D. Curfman, Nicole Huberfeld

Twenty-five years ago, the Food and Drug Administration (FDA) attempted-for the first time-to use its statutory authority to regulate tobacco products. Commissioner David Kessler contended that nicotine was a drug and cigarettes were a delivery system (a device), and both could be regulated by the agency with existing authority. In FDA v. Brown & Williamson (2000), the US Supreme Court disagreed, ruling that the FDA did not have implied power to regulate tobacco because Congress would not “delegate a decision of such economic and political significance to an agency in so cryptic a fashion.” This opinion was among the first to explore the “major questions” theory, which the US Supreme Court elevated to doctrine in West Virginia v. EPA (2022).


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