Hoban, et al. v. U.S. Food and Drug Administration

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No. 0:18-cv-00269 (D. Minn.)
No. 18-2592 (8th Cir.)
No. 1:19-cv-00372 (D.D.C.)
No. 1:18-cv-00203 (D.D.C.)

On January 30, 2018, Jen Hoban, The Plume Room LLC, J.H.T. Vape LLC, Lakes Vape Supply, LLC, and Tobacco Harm Reduction 4 Life, e-cigarette manufacturers and retailers, filed suit in the District of Minnesota. The plaintiffs requested that the court issue a preliminary injunction barring enforcement of the rule while the litigation proceeds and asked the court to permanently strike down the rule. The FDA filed its answer on April 13, 2018 along with a motion to transfer the litigation to the District of Columbia where an identical case had been filed by the same attorneys representing different parties. The plaintiffs responded to the motion on May 4, 2018. The FDA filed its reply on May 18, 2018.

On June 26, 2018, the court granted the motion to stay. On June 27, 2018, the plaintiffs filed a motion to stay the transfer order until plaintiffs filed an appeal of the decision. On July 5, 2018, the FDA filed its response to the plaintiffs' motion and on July 6, 2018, the court granted the motion, staying the order until July 26, 2018.

On July 26, 2018, the plaintiffs filed a writ of mandamus to the U.S. Court of Appeals for the 8th Circuit, requesting that the court reverse the district court’s transfer order. The FDA filed its response on August 24, 2019 and oral arguments were held on October 16, 2018. On November 23, 2018, the parties filed supplemental briefs requested by the court on the issue of whether the transfer should be denied and the case stayed pending the outcome of Nicopure. On November 28, 2019 the court denied the writ of mandamus.

On February 8, 2019, the district court lifted the stay and transferred the case to the District of Columbia and on March 1, 2019 it was consolidated into Moose Jooce.

The lawsuit alleges that:

  1. the FDA employee whose name appears in the Federal Register notice for the deeming regulation is not a principal officer or inferior officer, a violation of the Appointments Clause of the Constitution;
  2. the prohibition on making unauthorized modified risk claims unconstitutionally restricts speech, a violation of the First Amendment.