FDA v. Wages and White Lion Investments, LLC

Questions presented

SCOTUS records, cert granted 2 Jul 2024

The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, Div. A, 123 Stat. 1776, requires a person to obtain authorization from the Food and Drug Administration (FDA) before introducing a new tobacco product into interstate commerce. The agency may grant such authorization only if the applicant shows, among other things, that the marketing of the product would be "appropriate for the protection of the public health." 21 U.S.C. 387j(c)(2)(A). In this case, the agency denied respondents' applications for authorization to market new e-cigarette products because they had failed to show that marketing the products would be appropriate for the protection of the public health. The Fifth Circuit set aside FDA's denial orders as arbitrary and capricious, relying on legal theories that have been rejected by other courts of appeals that have reviewed materially similar FDA denial orders. The question presented is: Whether the court of appeals erred in setting aside FDA's denial orders as arbitrary and capricious.

Opinion summary

Etalia.ai summary of the majority opinion

The case involves the U.S. Food and Drug Administration (FDA) and its regulatory authority over e-cigarettes, specifically focusing on Wages and White Lion Investments, LLC's challenge to FDA's denial of their premarket tobacco product applications. The company argued that the FDA acted arbitrarily in denying their application for flavored e-cigarette products without adequately considering scientific evidence they provided about potential benefits for adult smokers seeking alternatives to traditional cigarettes. The Supreme Court upheld the FDA’s decision, emphasizing that the agency has broad discretion under the Tobacco Control Act to evaluate public health impacts when approving new tobacco products. The Court found that while there might be some benefit in aiding smoking cessation among adults, it was outweighed by concerns about youth addiction due to flavored options appealing more strongly to younger demographics.

Dissent summary

Etalia.ai summary of the dissenting opinions

In dissenting opinion, Justice Alito argued that the FDA failed to properly balance its mandate between protecting minors from nicotine addiction and providing potentially less harmful alternatives for adult smokers trying to quit conventional cigarettes. He criticized what he saw as an overly rigid approach by not sufficiently weighing submitted scientific data indicating reduced harm potential compared with combustible tobacco use among adults who switch entirely or partially replace cigarette consumption with these products.