Federal Court Rejects Vaping Industry Appeal of PMTA Decision

A federal appeals court has denied a vapor industry coalition’s appeal of last year’s district court decision that moved the PMTA submission deadline for vaping manufacturers up from 2022 to 2020. The deadline imposed in that July 2019 order by federal district court Judge Paul Grimm was May 12, 2020.

Judge Grimm recently allowed the FDA to delay the deadline until September because of logistical problems created by the coronavirus pandemic. That postponement will not be affected by the denied appeal. The PMTA deadline remains Sept. 9, 2020—for now.

A three-judge panel of the Fourth Circuit Court of Appeals, located in Richmond, Virginia, said the vapor industry appeal was moot because the 2017 FDA guidance the appeal was based on had been superseded by January 2020 FDA guidance that reshuffled FDA enforcement priorities.

Because the circuit court judges ruled against the vapor industry appellants based on procedural grounds (arguing the 2017 guidance that is no longer relevant), and not on the merits of the case, the vaping industry group could file a new lawsuit challenging the 2020 FDA guidance if it chooses to. They could also request a rehearing before the full appeals court, or attempt to appeal the case to the Supreme Court—a long shot.

The FDA had already announced it would not change the PMTA deadline even if the vaping industry won its appeal.

“We hold that the 2020 Guidance moots the Vapor Appellants’ appeal because it supersedes the August 2017 Guidance,” wrote the appeals court, “leaving no possible meaningful relief that this court could grant.”

“Of course, the Vapor Appellants may challenge the 2020 Guidance, if they so choose, in a separate action brought in the appropriate district court,” the judges added in a footnote.

The appellants, a group of vapor industry associations sometimes designated as the Right to be Smoke-Free Coalition, were represented by Eric Gotting of Washington, D.C.-based law firm Keller and Heckman. Keller attorney Azim Chowdhury announced the industry groups’ intention to intervene and appeal the decision last August.

The panel also rejected appeals by the cigar industry and by the FDA itself, which the court said requested dismissal of its appeal if the other two were denied. The FDA had already announced it would not change the PMTA deadline even if the vaping industry won its appeal.

It is unknown if the vaping coalition will file a new lawsuit in district court, or attempt to appeal. A vaping industry win in a new lawsuit could force the FDA to replace its informal guidance with rules made through Administrative Procedure Act procedures, including a mandatory public comment period.

Article Author: Jim McDonald