Supreme Court Justices Press Sides Over Who May Challenge FDA Tobacco Denials and Where

The Supreme Court heard oral argument in case No. 231187, Food and Drug Administration v. RJ Reynolds Vapor Company, over whether retailers may challenge FDA marketing-denial orders and whether multiple petitioners may establish venue in a single circuit.

At issue were two related legal questions: whether the Tobacco Control Act’s phrase “any person adversely affected” allows retailers to seek judicial review of FDA denials of premarket tobacco applications, and whether a manufacturer may join a retailer’s petition to establish venue in a circuit where the manufacturer does not reside. Counsel for the FDA argued that only applicants may challenge denials, while counsel for the respondents defended retailers’ ability to sue and argued joinder and long-standing venue practices allow consolidating review in a single circuit.

The case matters because the Court’s decision will determine who can bring federal challenges to FDA marketing decisions under the Tobacco Control Act and whether litigants can effectively choose the forum in which those challenges proceed. Lawyers and the justices considered the statutory text, the so-called APA “zone of interests” inquiry, and the…