Supreme Court

Supreme Court Denies Breeze Smoke Stay Application

The justices show little interest in vaping regulation on the shadow docket, but may yet review the FDA's behavior in the regular course.

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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. Without approval of its applications, Breeze Smoke may not sell e-cigarettes or other electronic nicotine delivery systems (ENDS).

The Court's denial is not much of a surprise. The Supreme Court rarely grants such applications, particularly when filed by private parties (save the occasional offer of emergency relief to death row inmates or religious institutions). That the Court denied this application also does not mean that the justices have no interest in reviewing the FDA's allegedly arbitrary or inconsistent approach to ENDS regulation. It simply means that the justices would prefer to consider such questions (if at all) in the regular course, after there have been decisions on the merits in lower courts.

Eventual Supreme Court review of FDA ENDS regulation is somewhat likely because different appellate courts have reached somewhat different conclusions about the FDA's conduct. The U.S. Court of Appeals for the Fifth Circuit, in particular, has been far more critical of the FDA's conduct than has the U.S. Court of Appeals for the Sixth Circuit. Both courts, however, have yet to issue judgments on merits reviewing the FDA's treatment of ENDS manufacturer product applications, so whether these issues come before the Supreme Court will depend, in part, on whether these disagreements persist.

Whether the Supreme Court eventually reviews the FDA's actions is certainly important for ENDS manufacturers. It is also significant for public health. As I have noted before, there are serious questions as to whether the FDA's approach (driven, in part, by the text and structure of the relevant federal statutes) advances public health. For more on this point, I recommend this public health experts amicus brief, filed in the Wages and White Lion Investments v. FDA case before the U.S. Court of Appeals for the Fifth Circuit.