Docket No. 5:19-cv-00330 (E.D. Ky.)
Appeal: Docket No. 20-05199 (6th Cir. Feb 21, 2020)


E-cigarette manufacturers and trade group challenged the deeming rule under the Administrative Procedure Act and on Constitutional grounds.


On May 5, 2016, the FDA issued the final rule deeming all existing and future tobacco products to be subject to the agency’s jurisdiction, including e-cigarettes. Among the requirements applicable to e-cigarettes is the requirement that they go through the Tobacco Control Act’s premarket review process.

District Court Proceedings

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:

  1. the FDA failed to use the notice and comment process to establish new premarket review compliance deadlines, a violation of the APA;
  2. 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.

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.

Proceedings in the Court of Appeals for the Sixth Circuit

On February 15, 2020, Vapor Stockroom LLC filed a notice of appeal in the Court of Appeals for the Sixth Circuit. 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, which the court denied on April 2, 2020. Briefing took place between March and May of 2020, and oral arguments were held on August 5, 2020.

On October 6, 2020, the Sixth Circuit Court of Appeals issued its opinion upholding the district court’s dismissal of the case. The opinion stated that the industry plaintiffs did not have standing to challenge the premarket review deadlines because they had been set by a court in the AAP v. FDA District of Maryland case, not by the FDA. Therefore, the plaintiffs had suffered no injury as a result of FDA’s actions and the case was dismissed.

Litigation Status

The case was dismissed and is now closed.