Justice Kavanaugh Asks FDA to Respond to Breeze Smoke Emergency Stay Application

Justice Brett Kavanaugh asked yesterday that the federal government respond to Breeze Smoke LLC’s emergency stay application to stop the Food and Drug Administration’s denial of approval for the manufacturer’s flavored vaping product. In this last post, I mentioned Breeze smoke’s application. December 6th is the deadline for the government to respond. Here is the case docket.

Breeze Smoke has applied for an emergency stay to the Supreme Court following a split panel of U.S. Court of Appeals, Sixth Circuit that denied its stay request. As I explained here, the Sixth Circuit panel expressly disagreed with a panel of the U.S. Court of Appeals for the Fifth Circuit, which granted another company’s stay application due to the FDA’s arbitrary and inconsistent approach to reviewing product applications for flavored  vaping products (often called electronic nicotine delivery systems or “ENDS”). One manufacturer was granted a stay by The Seventh Circuit while another company was rejected by The Ninth Circuit. The FDA has rescinded the rejections of other ENDS manufacturer product application who had raised the same substantive objections to its decision.

It is clear that the case raises the type of administrative law issue the justices prefer to address in the regular order. This would be after several courts of appeals have considered all the merits of the case and only then after extensive argumentation and briefing. However, for many ENDS manufacturer, denial by the FDA of their application amounts to a death sentence. Without such approval, they can no longer sell their products. As noted, circuit courts already have different opinions about the FDA’s egregious behavior. The Sixth Circuit refused to grant the stay but acknowledged some Breeze Smoke’s claims. The justices will have to decide if this case raises enough concerns to justify intervention.