On Friday, the Supreme Court denied vaping product manufacturer Breeze Smoke’s emergency application for a stay of the Food & Drug Administration’s denial of its product applications. Breeze Smoke cannot sell electronic cigarettes or any other electronic nicotine delivery system (ENDS) without approval.
This is not surprising. These types of applications are rarely granted by the Supreme Court, especially when they’re filed privately (aside from occasional emergency relief for death row inmates and religious institutions). The Court’s denial of this request does not mean the justices aren’t interested in reviewing FDA’s alleged inconsistent or arbitrary approach to ENDS regulations. This simply indicates that justices prefer to address such questions in the normal course after having made decisions in lower courts on merits.
An eventual Supreme Court review is possible because the FDA ENDS regulations are subject to different interpretations by different appellate courts. Particularly, the U.S. Court of Appeals, Fifth Circuit has been much more critical of FDA’s conduct that the U.S. Court of Appeals, Sixth Circuit. However, both courts have not yet issued judgments on the merits of FDA’s handling of ENDS product application applications. This will impact whether the Supreme Court decides to address these matters.
Manufacturers of ENDS products will be interested in whether the Supreme Court decides to review the FDA’s actions. Public health is equally important. As I’ve already mentioned, it is not clear whether FDA’s approach to public health (in part driven by federal statutes text and structure) promotes public safety. This amicus brief by public health professionals, which was filed in the FDA vs. Wages and White Lion Investments case before the U.S. Court of Appeals for the Fifth Circuit.