E-cigarette manufacturers and retailers challenged the deeming rule under the U.S. Constitution.
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. While the legal issue in this case is quite specific and has to do with a specific procedural aspect of the deeming rule, the ongoing litigation represents the continued litigiousness of the e-cigarette industry.
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, Moose Jooce, Mountain Vapors, Rustic Vapors, and Dutchman Vapors, e-cigarette manufacturers and retailers, filed suit against the FDA in the District Court of the District of Columbia.
The lawsuit alleged that:
- 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;
- the prohibition on making unauthorized modified risk claims unconstitutionally restricts speech, a violation of the First Amendment.
The plaintiffs requested that the court issue a preliminary injunction preventing enforcement of the deeming rule while the litigation proceeded and asked the court to permanently strike down the rule. The FDA filed its answer on April 23, 2018 along with a notice informing the court that it was seeking to transfer Rave Salon and Hoban to the District of Columbia so that the three cases could be consolidated. On July 17, 2018, the court ordered that the proceedings in this case be stayed until the expiration of the transfer order in Hoban.
On March 1, 2019, the court consolidated the Rave Salon Inc., Hoban, and Moose Jooce cases. On May 2, 2019, the plaintiffs filed a motion for partial summary judgment. On June 6, 2019, the FDA filed its opposition to the plaintiffs’ motion along with a cross-motion for partial summary judgment. Oral arguments were held on October 22, 2019. On December 17, 2019, the parties filed a status report notifying the court of the D.C. Circuit’s decision in Nicopure, which impacted the First Amendment claim in this case. On February 11, 2020, the court issued an order denying the plaintiffs’ motion for partial summary judgment and granting the FDA’s motion for partial summary judgment on the plaintiffs’ Appointments Clause claim. Because the D.C. Circuit’s decision in Nicopure governed the First Amendment claim, the court also granted summary judgment in favor of the government on that claim.
Proceedings in the Court of Appeals for the D.C. Circuit and Petition for Review by U.S. Supreme Court
On March 10, 2020 Moose Jooce filed a notice of appeal with the D.C. Circuit Court of Appeals, and on March 11, filed an emergency motion to expedite the case. The court denied that motion and briefing occurred in the Spring of 2020. Oral arguments were held on September 23, 2020. On December 2, 2020, the Court of Appeals for the D.C. Circuit upheld the lower court’s ruling in favor of the FDA. Moose Jooce filed a Petition for Certiorari in the U.S. Supreme Court on March 3, 2021 requesting review of the Court of Appeals’ decision. On June 28, 2021, the petition was denied by the U.S. Supreme Court.
Moose Jooce submitted a petition to the U.S. Supreme Court for review of the Court of Appeals’ decision. The U.S. Supreme Court declined to hear the case, meaning the decision of the Court of Appeals is final.