In January, the Food & Drug Administration denied R.J. Reynolds Vapor (RJRV) Company's application to market menthol-flavored electronic cigarettes. This is no surprise as the FDA has denied most e-cigarette applications and has yet to approve a non-tobacco-flavored e-cig application. RJRV sued, and sought a stay of the FDA's order (so that RJRV could continue to market its products pending the outcome of litigation). Yesterday, the U.S. Court of Appeals for the Fifth Circuit granted RJRV's petition for a stay and, in the process, provided further evidence that the FDA has a serious vaping problem.
In R.J. Reynolds Vapor Co. v. FDA, a unanimous panel concluded that the RJRV made a strong showing that it would prevail on the merits of its challenge to the FDA's denial, and satisfied the other requirements of a stay. As Judge Edith Jones summarized for the panel:
RJRV demonstrates that the FDA failed to reasonably consider the company's legitimate reliance interests concerning the need for longitudinal studies and marketing plans; failed to consider relevant evidence, inter alia, that youthful users do not like menthol-flavored e-cigarettes; and has created a de facto rule banning all non-tobacco-flavored e-cigarettes without following APA notice and comment requirements.
