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 practicality of enforcement and joinder rules.

Counsel for the FDA, Mr. Suri, told the justices that under the Act the “only person entitled to challenge the denial of an application is the applicant itself,” characterizing retailers as “bystanders to the application process” who do not receive the agency’s order or the administrative record. He argued retailers are “simply a prop being used by the manufacturer to enable them to get into the circuit they prefer” and that “the judgment of the fifth circuit should be reversed.”

Responding, counsel for the respondents, Mr. Watson, said the TCA “plainly intended to extend review beyond the applicant” and that retailers are harmed because a marketing-denial order “prohibits retailers from selling the products” and exposes them to enforcement penalties. Watson emphasized the statute’s separate provisions for withdrawals (limited to applicants) and for marketing denials (allowing “any person adversely affected”), and he urged the Court to read those provisions to permit retailer challenges.

Justices pressed both sides on textual and practical points. Justice Kagan asked how the government’s reading fits with the statute’s use of the identical phrase “any person adversely affected” for distinct types of agency action; Suri replied that the court must infer the appropriate plaintiffs from the statute’s structure and that denials were designed to be challenged by applicants. Justice Jackson and others explored whether retailers’ interests differ depending on whether a product is premarket or already on store shelves; counsel acknowledged the distinction but disagreed about its legal significance.

On venue, the FDA’s counsel warned of forum shopping if manufacturers can “ride in on” retailers’ residence to file petitions in circuits of choice, citing multiple petitions filed in the Fifth Circuit in 2024. The respondents’ counsel pointed to joinder under Federal Rule of Appellate Procedure 15 and to 28 U.S.C. §2112’s multi-circuit consolidation mechanism (the “multi-circuit” process), arguing that mandatory consolidation and transfer processes would limit any practical venue problem in this case.

The justices also queried precedent the parties invoked. The government relied on Block v. Community Nutrition Institute and related decisions to argue that indirectly affected parties are outside the statutory zone; respondents invoked Bank of America and other cases to support a broader zone-of-interests approach in agency-review provisions. The Court explored whether its ruling could be narrowly confined to the Tobacco Control Act’s text or would sweep more broadly into other federal venue statutes such as 28 U.S.C. §1391 or statutes cited by amici (Investment Advisers Act, Natural Gas Act).

Both sides acknowledged practical complications. Counsel for the respondents pointed out that retailers face criminal and civil penalties for selling products lacking authorization and said that immediate stays are often sought to prevent irreparable harm to retailers that claim they could go out of business. The government warned that permitting manufacturers to rely on retailers’ residences to establish venue would undercut the statute’s deliberate channeling of review to petitioners’ home circuits or the D.C. Circuit.

The argument concluded after rebuttal. The Court’s decision will resolve whether retailers may be treated as “adversely affected” persons under the TCA’s judicial-review provision, and how venue rules apply when multiple parties jointly file petitions challenging the same marketing-denial order.