Appeals Court Rejects Breeze Smoke’s Plea for MDO Stay

A divided panel of the U.S. Court of Appeals for the Sixth Circuit rejected Breeze Smoke LLC’s application of a stay of the U.S. Food and Drug Administration’s order Friday, denying the company’s premarket tobacco product application (PMTA) for some of its vaping products.

In Breeze Smoke LLC v. FDA, the Sixth Circuit rejected the Fifth Circuit’s conclusion that the FDA had orchestrated a “surprise switcheroo” in the PMTA review process. This creates an interesting circuit split that might attract Supreme Court interest, according to Reason’s Jonathan Hadler.

The Sixth Circuit’s order, on behalf of Judges Moore and Gilman, concluded that the FDA had never committed itself to accepting PMTA applications for flavored vaping products that lacked long-term studies. Rather, the FDA had merely indicated that “it might accept evidence other than long-term studies, if that evidence had sufficient scientific underpinnings to meet the [Tobacco Control Act’s] statutory mandate of demonstrating that flavored ENDS devices are appropriate for the protection of public health” (emphasis in original).

Thus the court concluded that Breeze Smoke had failed to demonstrate the strong likelihood of success on the merits necessary to support a stay. Judge Kethledge dissented, noting his agreement with the Fifth Circuit’s decision in Wages and White Lion Investments LLC v USFDA.

While rejecting Breeze Smoke’s stay request, the Sixth Circuit panel did note some concern with the FDA’s handling of the company’s application, particularly its “formulaic consideration” of Breeze Smoke’s plans to prevent marketing to youth. This failing, and the impact of a PMTA denial on Breeze Smoke’s business were still not enough to convince a majority of the panel to enter a stay however.