E-cigarette manufacturers and retailers challenged the deeming rule on Constitutional grounds.
Why It Matters for Public Health
This case is yet another challenge to the FDA’s deeming rule that gave it regulatory authority over tobacco products, including e-cigarettes. It was consolidated with another case, Moose Jooce v. FDA , which is ongoing. The multi-district litigation illustrates the resistance of e-cigarette manufacturers and retailers to regulatory oversight over their products.
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 a prohibition on making claims that a product is less harmful or presents a “modified risk.”
District Court Proceedings
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, raising the same First Amendment and Appointments clause arguments made in the Moose Jooce and Hoban cases, which had been filed by the same attorneys representing different parties. The plaintiffs requested that the court issue a preliminary injunction barring enforcement of the rule while the litigation proceeded 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.
On June 26, 2018, the court granted the motion to transfer the case to the District of Columbia. On June 27, 2018, the plaintiffs filed a motion to stay the transfer order until plaintiffs filed an appeal of the decision. On July 6, 2018, the court granted the motion, staying the order until July 26, 2018.
On July 26, 2018, the plaintiffs filed a petition for a writ of mandamus in 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 petition for a writ of mandamus.
On February 8, 2019, the district court lifted the stay and transferred the case to the District of Columbia. On March 1, 2019, the case was consolidated into Moose Jooce.
The case was consolidated with Moose Jooce v. FDA. Please see that case entry for updates.