SCOTUS Rules E-Cigarette Retailers Can Challenge FDA Order in Fifth Circuit

In FDA v. R. J. Reynolds Vapor Co., 606 U.S. ____ (2025), the U.S. Supreme Court held that e-cigarette retailers who would sell the products if not for the FDA’s denial order may seek judicial review of that order in the Fifth Circuit Court of Appeals.

Facts of the Case

The Family Smoking Prevention and Tobacco Control Act (TCA) (21 U.S.C. §387j) requires manufacturers to apply for and receive approval from the Food and Drug Administration (FDA) before marketing any “new tobacco product.” 

In 2016, the FDA decided that e-cigarettes and related products were new tobacco products subject to the TCA. Given the size of the existing e-cigarette market, the FDA announced that it would defer enforcement of the TCA against e-cigarette manufacturers and retailers while the manufacturers sought FDA approval.

R.J. Reynolds Vapor Co. (RJR Vapor)—a manufacturer of e-cigarettes—sought FDA approval to continue marketing its popular Vuse Alto products. The FDA denied the applications, finding that RJR Vapor had failed to demonstrate that marketing Vuse Alto products would be “appropriate for the protection of the public health” as required by the TCA.

RJR Vapor sought to challenge order under the TCA, which provides that “any person adversely affected” by an FDA denial order can petition for judicial review in either the D.C. Circuit or “the circuit in which such person resides or has their principal place of business.” Had RJR Vapor sought judicial review on its own, it could have filed a petition in the D. C. Circuit (the statutory default) or the Fourth Circuit (which includes North Carolina, RJR Vapor’s state of incorporation and principal place of business). RJR Vapor instead combined forces with a Texas-based retailer and a Mississippi-based trade association of retailers to challenge the FDA’s denial order in the Fifth Circuit (which includes both Texas and Mississippi).

In response, the FDA asked the court to either dismiss the joint petition for lack of venue or transfer it to the D. C. Circuit or Fourth Circuit. The FDA argued that only a disappointed applicant—in this case, RJR Vapor—is “adversely affected” by an FDA denial order within the meaning of the TCA. Because the retailers had no right to seek review, the FDA argued, the petition had no basis for being in the Fifth Circuit. A divided Fifth Circuit panel concluded venue was proper and denied the FDA’s motion.

Supreme Court’s Decision

The Supreme Court affirmed by a vote of 7-2. It held that retailers who would sell a new tobacco product if not for the FDA’s denial order may seek judicial review of that order under §387l(a)(1).

As Justice Amy Coney Barrett explained, to invoke a statutory cause of action, a plaintiff must be within the “zone of interests” that the statute protects. That means a plaintiff must belong to the class of persons to which the statute grants a right to sue, which under the TCA is “any person adversely affected” by the FDA’s “denial.”

Justice Barrett went on to emphasize that the Court has interpreted “adversely affected” broadly, as covering anyone even “arguably within the zone of interests to be protected or regulated by the statute . . . in question,” citing Association of Data Processing Service Organizations, Inc. v. Camp, 397 U.S. 150 (1970) (emphasis added). Accordingly, the Court rejected the FDA’s argument that, under the TCA, the only person actually aggrieved by the denial of permission to market a tobacco product is the one with the closest relationship to the application—the applicant. Justice Barrett wrote:

If the FDA denies an application, the retailers, like the manufacturer, lose the opportunity to profit from the sale of the new tobacco product—or, if they sell the product anyway, risk imprisonment and other sanctions. Given this significant, direct impact on retailers, their interests are not “so marginally related to or inconsistent with the purposes implicit in the statute that it cannot reasonably be assumed that Congress intended to permit the suit.”

Accordingly, the retailers are “adversely affected” by a denial order and are therefore proper petitioners under §387l(a)(1).

The Court also rejected the FDA’s argument that the TCA’s text and structure reflect Congress’s choice to offer judicial review only to manufacturers denied permission to market a tobacco product, concluding that the argument can’t be squared with §387l(a)(1)—the provision that creates the cause of action.

Finally, the Court declined to decide whether RJR Vapor must be able to file in the 5th Circuit independently even if the retailers have a right to file there.As the Court noted, the FDA did not raise the argument in the lower courts, and the Court generally avoids addressing an argument raised first to the Court.