FDA v. R. J. Reynolds Vapor Co.

Background

The FDA denied premarket authorization for R.J. Reynolds Vapor’s Vuse Alto e-cigarette products under the Tobacco Control Act (TCA). RJR Vapor joined with a Texas retailer and a Mississippi trade association to file a joint petition in the Fifth Circuit. The FDA moved to dismiss or transfer, arguing only the manufacturer (the applicant) could seek review under the TCA’s phrase “any person adversely affected.” The Fifth Circuit denied the FDA’s motion and stayed the denial order; the FDA then asked this Court to review the venue ruling.

Reasoning

The Court framed the key question simply: who counts as “adversely affected” under the TCA? Looking to prior cases that interpret similar language, the Court adopted a broad “zone of interests” approach. It concluded retailers who would have sold the product lose the chance to profit and risk penalties if they sell unauthorized products, so their interests fall within the statute’s protection. The Court rejected the FDA’s argument that the phrase must mean only the applicant manufacturer, noting Congress used “any person adversely affected” and contrasted that wording with other TCA provisions that expressly limit review to an application holder.

Real world impact

The ruling lets retailers who would have sold a denied product join suit to challenge FDA denials and to file in circuits where they are based. The Court affirmed the Fifth Circuit’s denial of the FDA’s motion and remanded for further proceedings. The opinion did not resolve a separate FDA argument—raised late—that each co-petitioner must independently establish venue, which the Court declined to decide.

Dissents or concurrances

Justice Jackson (joined by Justice Sotomayor) dissented, arguing Congress designed the approval process to protect manufacturers’ interests and that retailers have no role in the application process; she warned this decision could encourage venue-shopping.