Authored by: Cody P. Csulak
Abstract
This article discusses the United States Supreme Court’s recent decision in FDA v. Wages & White Lion Investments, LLC. Justice Samuel Alito authored the unanimous opinion for the court, which was followed by a concurrence from Justice Sonia Sotomayor. The opinion focused on whether the FDA acted in an arbitrary and capricious manner when it denied Wages & White Lion Investment, LLC’s Premarket Tobacco Authorization (“PMTA”) under the authority delegated to it under the U.S. Family Smoking Prevention and Tobacco Control Act (“TCA”). The article discusses the relevant historical background of the FDA and its eventual ability to regulate tobacco products under the TCA. The article also dives into the circuit split that occurred as a result of the FDA’s denial of PMTAs, and the ambiguity that previously surrounded the standard of “Appropriate for the Protection of the Public Health.” Overall, this article provides a view of current administrative law principles in the post-Loper Bright Enters. v. Raimando era.