On November 12, the U.S. Court of Appeals for the Sixth Circuit rejected an electronic cigarette manufacturer’s application of a stay of the Food and Drug Administration’s order rejecting its application seeking approval of some of its vaping products. Now that e-cigarette company, Breeze Smoke, has filed an emergency application for a stay with Justice Kavanaugh.
As Breeze Smoke’s application points out, the Sixth Circuit’s decision conflicts with one from the U.S. Court of Appeals for the Fifth Circuit, which granted a similar stay application to another manufacturer of vaping products (often called electronic nicotine delivery systems or “ENDS”), and harshly criticized the FDA’s arbitrary and inconsistent decision-making. Indeed, the Sixth Circuit acknowledged that it disagreed with the Fifth Circuit’s assessment of the FDA’s conduct.
While it is possible that there are substantive differences between the relevant product applications, the FDA did not engage in the sort of review expected of a regulatory agency. (Indeed, the Sixth Circuit faulted the FDA, but just did not find the deficiencies to be great enough to justify a stay.) Thus, Breeze Smoke is able to argue, with some justification, that whether individual e-cigarette manufacturers were able to obtain a stay of their FDA denials was a function of which circuit they filed in. (Another manufacturer obtained a stay in the U.S. Court of Appeals for the Seventh Circuit, while a similar stay application was also denied by the Ninth Circuit.) Further, as I noted here, the FDA has also rescinded its rejection of applications from some other manufacturers, magnifying the inconsistent treatment manufacturers are receiving.
It is understandable why Breeze Smoke has gone to the Supreme Court. The FDA’s rejection of e-cigarette product applications is a big deal for e-cigarette companies. Without FDA approval, they cannot market their products to consumers. For major tobacco companies, on the other hand, such denials are less significant, as they can continue to sell their other tobacco products, such as combustible cigarettes, which are significantly more dangerous.
The question for the Supreme Court is whether the arbitrary and inconsistent treatment of e-cigarette manufacturers by the FDA, and the inconsistent rulings on stay applications by different circuits, justify emergency relief on the shadow docket. There is already a circuit split on the remedial question of whether a stay is justified, and this could well foreshadow a substantive circuit split over the FDA’s underlying conduct. The question for the Court (or, in the first instance, for Justice Kavanaugh) is whether this justifies intervention now.