Food and Drug Administration v. Wages and White Lion Investments, LLC, No. 23-1038 [Arg: 12.2.2024]

The Sidebar: Supreme Court of the United States

In a case of FDA's denial of applications for flavored e-cigarettes. The core issue is whether the FDA provided fair notice to the applicants regarding the required evidence for approval, specifically concerning the need to demonstrate sufficient benefits for adult smokers to outweigh the risks to youth. The petitioner, representing the FDA, argues that the agency’s actions were consistent with the law and that any guidance provided was not misleading. The respondents, the e-cigarette companies, contend that the FDA changed its requirements unexpectedly, violating fair notice principles. The justices explore the nuances of the Administrative Procedure Act and the concept of harmless error.