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. Breeze Smoke is now requesting a temporary stay from Justice Kavanaugh.
Breeze Smoke’s appeal points out that the Sixth Circuit’s decision is in conflict with one of the U.S. Court of Appeals (Fifth Circuit), which granted a similar stay request to another manufacturer of electronic nicotine delivery systems (“ENDS”) and sharply criticised the FDA for its inconsistent and arbitrary decisions-making. In fact, the Sixth Circuit stated that it did not agree with the Fifth Circuit’s evaluation of FDA’s conduct.
It is possible to find substantive differences in product applications. However, FDA failed to engage with the kind of review one would expect from a regulatory agency. The Sixth Circuit did fault the FDA but didn’t find that the FDA had sufficient deficiencies to warrant a stay. Breeze Smoke can argue with some merit that the circuit in which e-cigarette makers were filed was what determined whether they could obtain a stay on FDA denials. The U.S. Court of Appeals of the Seventh Circuit granted a stay to another manufacturer, while a similar application for a stay was rejected by the Ninth Circuit. As I have already mentioned, FDA also reversed rejections of other manufacturer applications, thereby enhancing the inconsistent treatment that manufacturers receive.
Breeze Smoke is now before the Supreme Court. E-cigarette manufacturers are very disappointed by the FDA’s refusal to approve e-cigarette products. E-cigarette companies cannot market their products to the public without FDA approval. These denials for major tobacco companies are not as significant as they are able to continue selling their other tobacco products like combustible cigarettes which can be significantly more hazardous.
It is now up to the Supreme Court to decide whether the FDA’s arbitrarily and inconsistent treatment for e-cigarette makers and inconsistencies regarding stay applications made by various circuits are sufficient justifications for emergency relief. Circuit splits exist already on the question of the remedy to whether stay should be granted. This could lead to a substantive circuit split regarding the FDA’s conduct. It is up to Justice Kavanaugh (or the Court) whether intervention can be justified now.