Caseflicks

Supreme Court of the United States • 2025

FDA v. R. J. Reynolds Vapor Co.

606 U.S. 226

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Takeaway

In short, this case holds that tobacco retailers directly barred from selling a product by an FDA marketing denial are "adversely affected" under the Tobacco Control Act and may use their own location to obtain judicial review in an otherwise unavailable circuit.

Background

The Tobacco Control Act requires FDA authorization before a manufacturer may market a new tobacco product. In 2016, the FDA deemed e-cigarettes subject to that regime, while temporarily deferring enforcement as manufacturers pursued premarket authorization. R. J. Reynolds Vapor Co. applied to market its menthol- and mixed-berry-flavored Vuse Alto products, but the FDA denied its applications because RJR Vapor had not shown that marketing the products would be appropriate for the protection of public health.

The Act permits "any person adversely affected" by an FDA denial order to seek review in the D.C. Circuit or in the circuit where that person resides or has its principal place of business. RJR Vapor, a North Carolina company, joined with a Texas Vuse retailer, a Mississippi retail trade association, and a North Carolina affiliate to petition in the Fifth Circuit. The FDA sought dismissal or transfer, contending that only the applicant manufacturer—not retailers—was adversely affected and that venue therefore lay only in the D.C. or Fourth Circuit. A divided Fifth Circuit denied the motion. The Supreme Court affirmed that ruling and remanded.

Issues

Issue #1

Whether the Supreme Court had appellate jurisdiction to review the Fifth Circuit's interlocutory order denying the FDA's motion to dismiss or transfer.

Holding

Yes. The Court was exercising appellate jurisdiction over the Fifth Circuit's venue order, not original jurisdiction over the underlying challenge to the FDA's denial.

Reasoning

The respondents argued that review was premature because the Fifth Circuit had not yet decided the merits of their petition. The Court rejected that characterization. It reviewed a lower-court order denying a motion to transfer venue, which is an exercise of appellate jurisdiction even though the merits remain unresolved.

Issue #2

Whether retailers that would sell a tobacco product absent the FDA's denial of the manufacturer's marketing application are "person[s] adversely affected" entitled to seek review under 21 U.S.C. §387l(a)(1).

Holding

Yes. Retailers directly harmed by an FDA denial order fall within the Tobacco Control Act's cause of action and may petition for judicial review.

Reasoning

The Court treated "adversely affected" as a familiar administrative-law term tied to the zone-of-interests inquiry: whether the plaintiff has an interest arguably protected or regulated by the relevant statute. Drawing on APA and non-APA cases alike, including Data Processing, Thompson, and Bank of America, the Court rejected the FDA's proposed distinction between the APA's broad formulation and supposedly narrower uses of similar language in other statutes.

The retailers had a direct and substantial stake in the FDA's denial. They lost the opportunity to profit from selling Vuse Alto products, and selling those products without authorization would expose them to statutory sanctions, including potential criminal penalties. Their interests therefore were not merely marginally related to the Tobacco Control Act's operation.

The Act's text reinforced that conclusion. Section 387l(a)(1) grants review to "any person adversely affected," language naturally broad enough to cover more than the applicant manufacturer. Had Congress meant to limit review to an applicant, it could have used that term instead.

Congress used narrower language elsewhere in the same statutory scheme. When the FDA withdraws a prior marketing authorization, §387j(d)(2) permits review only by the "holder" of the application. The contrast between that express limitation and §387l(a)(1)'s broader language supported reading the latter to include retailers.

The FDA's arguments about the application process did not alter the result. Although manufacturers submit the scientific materials, receive notices, and are usually best positioned to challenge a denial, §387l(a)(1) asks whether a petitioner is adversely affected, not whether it participated in the application process or possesses the most information.

Issue #3

Whether the Court should decide the FDA's newly raised argument that every petitioner in a joint petition must independently satisfy the Tobacco Control Act's venue requirements.

Holding

No. The Court declined to consider the argument because the FDA had not raised it in the Fifth Circuit.

Reasoning

The FDA argued for the first time in the Supreme Court that even if the Texas and Mississippi retailers could establish Fifth Circuit venue, RJR Vapor and its North Carolina affiliate had to establish venue separately. The Court ordinarily does not resolve issues first raised before it, especially where lower courts have not developed the competing arguments or analyzed the issue.

Prudence was particularly appropriate because an interpretation of the Act's joint-petition venue rules could affect comparable venue statutes, including the general federal-officer venue statute. The Court therefore left that question for another case and affirmed the Fifth Circuit's ruling that at least one proper petitioner had venue in the Fifth Circuit.

Dissents

Justice Jackson

Reasoning

Justice Jackson, joined by Justice Sotomayor, agreed that the zone-of-interests test governs but maintained that the majority applied it at the wrong level of generality. In her view, the Court should have examined §387j(c), the provision governing the FDA's decision on a manufacturer's application, rather than relying chiefly on the broad wording of the judicial-review provision.

The premarket-authorization scheme, she explained, creates an adjudicatory process solely between the FDA and the manufacturer. Manufacturers submit the product's scientific, manufacturing, and health-risk information; retailers have no right to participate, receive notice, supplement an application, or access confidential application materials. That design indicates that Congress did not intend retailers to be parties who could challenge a denial.

A retailer's commercial disappointment did not, in the dissent's view, make it an intended beneficiary of the statutory scheme. Retailers have no legal right to sell an unauthorized product either before or after an application is denied. In contrast, manufacturers have already invested in developing and applying to market the product, and they are the parties Congress reasonably could have expected to seek judicial review.

The withdrawal provision confirmed that reading for Justice Jackson. When the FDA withdraws a previously granted authorization—a point at which retailers may have inventory and reliance interests—Congress expressly permits suit only by the application holder. It would be illogical, she reasoned, to allow retailers to challenge an initial denial, when they generally have fewer concrete interests, but not a withdrawal of existing approval.

Justice Jackson also viewed Block v. Community Nutrition Institute as closely analogous. Just as milk consumers could not challenge regulatory orders in a scheme that involved only the agency, producers, and handlers, tobacco retailers should not challenge marketing denials in a scheme that involves only the FDA and manufacturers. Manufacturers' incentives to contest unlawful denials adequately protect the statutory program's objectives.

Finally, the dissent stressed the practical consequence of the majority's rule: it enables a manufacturer to join a retailer located in a favorable circuit and evade the venue choices Congress prescribed for the manufacturer. In Justice Jackson's view, the statute did not authorize retailers to serve as proxies for manufacturers seeking a different forum.