Cases & Deals

R.J. Reynolds Vapor Company and e-cigarette retailers successfully move to stay FDA's marketing denial order for menthol-flavored e-cigarette

Client(s) Reynolds American Inc.

At the request of Jones Day clients including R.J. Reynolds Vapor Company, the U.S. Court of Appeals for the Fifth Circuit stayed the U.S. Food and Drug Administration's marketing denial order for the menthol-flavored Vuse Vibe e-cigarette. The decision allows Reynolds and retailers to continue selling menthol-flavored Vuse Vibe e-cigarettes while the case is pending or upon further order of the court.

The Fifth Circuit found that Reynolds had demonstrated that, in issuing the marketing denial order, FDA violated the Administrative Procedure Act in numerous ways. For example, FDA failed to reasonably consider Reynolds' reliance interests before changing its position on what sort of studies and marketing plans were required in applications. In addition, FDA failed to adequately address the evidence in Reynolds' application. Third, FDA created a de facto rule banning all non-tobacco-flavored e-cigarettes without following the APA's notice-and-comment rulemaking procedures.

The Fifth Circuit also found that the other factors favor a stay. Specifically, it found that Reynolds faces irreparable harm in the form of non-compensable financial losses. And it concluded that the balance of harms and public interest favor a stay because maintenance of the status quo is an important consideration in granting a stay, and it is of the highest public importance that federal agencies follow the law.

R.J. Reynolds Vapor Co., et al. v. U.S. Food and Drug Administration, et al., No. 23-60037 (5th Cir.)