For the first time since vape companies began challenging the FDA’s Marketing Denial Orders (MDOs), a federal court has denied a motion to stay an MDO pending completion of a review.
Michigan-based Breeze Smoke submitted PMTAs for 10 prefilled disposable devices with five percent-strength e-liquid—nine in flavors other than tobacco. The company filed a petition for review Oct. 4 in the 6th Circuit Court of Appeals, and a motion for a stay Oct. 13.
Last Friday, Nov. 12, a panel of three judges ruled 2-1 against Breeze Smoke on the motion for a stay. Two of the judges agreed Breeze Smoke “has not shown a strong likelihood of success on the merits.” The third judge, Raymond Kethledge, dissented, citing the 5th Circuit Court’s reasoning in its decision to grant a stay to Triton Distribution.
The judges who voted to deny Breeze Smoke’s motion ignored the FDA’s questionable cookie-cutter process in denying PMTAs for flavored products. They noted that in its PMTA guidance the agency didn’t promise that evidence other than long-term studies would be sufficient for a successful application, but merely suggested it was possible.
“The FDA said that, in light of the accelerated court-ordered deadline for submission of applications for new tobacco products, it might accept evidence other than long-term studies, if that evidence had sufficient scientific underpinnings to meet the TCA’s statutory mandate of demonstrating that flavored ENDS devices are appropriate for the protection of public health,” wrote the judges.
“The FDA found Breeze Smoke’s evidence lacking against this standard….Breeze Smoke argues that the FDA’s willingness to consider some forms of evidence, explicitly phrased as such, required the FDA to accept that evidence as meeting a statutory requirement even where the FDA found the evidence unsatisfactory. We decline to embrace that claim.” The judges also suggested the company’s customer survey—which was given to customers in stores—was biased.
The judges did acknowledge that the FDA’s refusal to consider Breeze Smoke’s marketing plan was probably a mistake—meaning it could be a factor in the court’s MDO review. The agency announced in August that it would not fully consider applications lacking the scientific evidence it said was needed for authorization of flavored products. However, the fact that the FDA refused to fully review applications once it found the scientific evidence lacking wasn’t enough to convince the court panel to grant a stay to Breeze Smoke.
“Because Breeze Smoke bears the burden of showing a strong likelihood of success on the merits,” they wrote, “and because the FDA likely properly concluded that Breeze Smoke failed to show that its products adequately protected the public health, described above, we still deny Breeze Smoke’s motion for stay, even in light of the FDA’s possibly insufficient consideration of Breeze Smoke’s marketing plan.”
The court also granted several anti-vaping organizations—the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Parents Against Vaping E-Cigarettes, and Truth Initiative— permission to submit an amicus curiae brief supporting the FDA.
The MDO will now move to a full review by the court. But with its stay denied, Breeze Smoke cannot continue to sell the products that received MDOs without risking FDA enforcement.
Be sure to read Jonathan Adler's excellent analysis of the Breeze Smoke decision. Adler, a law professor at Case Western Reserve University, raises the possibility that conflicting decisions by the 5th and 6th Circuit Courts could lead to Supreme Court interest in the PMTA process.