No. 5:19-cv-00330 (E.D. Ky.)
No. 20-05199 (6th Cir. Feb 21, 2020)
On August 14, 2019, Vapor Technology Association, and Vapor Stockroom, LLC, an e-cigarette trade group and an e-cigarette manufacturer, filed suit in the Eastern District of Kentucky. The lawsuit alleged that:
- the FDA failed to use the notice and comment process to establish new premarket review compliance deadlines, a violation of the APA;
- the FDA’s action amounts to a deprivation of property without due process of law, a violation of the Fifth Amendment.
The plaintiffs requested that that the court issue a preliminary and permanent injunction as well as declaratory judgment that the FDA’s May 12, 2020 deadline to file marketing applications violates the Administrative Procedure Act. On September 2, 2019, the plaintiffs filed a motion for a preliminary injunction. On October 11, 2019, the FDA filed a response to the motion for a preliminary injunction along with a motion to dismiss, and a motion to transfer the case to the District of Maryland. On October 18, public health groups filed a motion to file an amicus brief. The plaintiffs filed their opposition to the motion made by the amici on November 7, 2019, and their opposition to the government’s motions shortly thereafter.
The FDA filed its reply on November 25, 2019. On December 12, 2019, FDA filed a notice of supplemental authority, notifying the court of the D.C. Circuit’s decision in Nicopure Labs.
On January 7, 2020, FDA filed notice of its updated Guidance document detailing its enforcement priorities for ENDS and other deemed products, in support of its motion to dismiss. On January 16, 2020, the court granted FDA’s motion to dismiss, and denied the remaining pending motions as moot.
On February 15, 2020, Vapor Stockroom LLC filed a notice of appeal in the case, and on February 21, 2020, the appeal was docketed with the 6th Circuit Court of Appeals. A briefing schedule was set on February 26, 2020, setting early April and May deadlines for the industry appellants and government appellee to file their respective briefs. On February 27, 2020, the industry filed a motion for an injunction pending appeal, or in the alternative, to expedite the briefing schedule, oral argument, and decision. The government filed its response to that motion on March 9, 2020, and the industry filed its reply on March 12, 2020. The industry appellants filed their brief on the merits of the appeal on March 21, 2020, and on April 2, 2020, the court denied the request for an injunction or expedited briefing schedule. The FDA filed its response brief on May 5, 2020. Vapor Stockroom’s reply brief was filed on May 26, 2020. Oral arguments will take place on August 5, 2020.