The U.S. Court of Appeals for the D.C. Circuit will hear another challenge to the FDA’s rule Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule”). The challenges are based on the Constitution’s Appointments Clause and First Amendment. The cases are Moose Jooce, et al. v. FDA, et al., Nos. 20‑5048, -5049, & -5050 (D.C. Cir.).

On March 9, 2020, the challengers filed notices of appeal, after the U.S. District for the District of Columbia rejected their challenges. In an emergency motion filed on March 11, the challengers asked the D.C. Circuit to expedite its consideration of the appeal. The challengers forward several bases for expedition, and these include the FDA’s May 12 deadline for the filing of premarket tobacco applications.

While the D.C. Circuit rejected several other challenges to the Deeming Rule in Nicopure Labs, LLC, et al. v. FDA, et al., No. 17-5196 (D.C. Cir.), this will be the first time the Court addresses the Appointments Clause challenge to the Deeming Rule. The challengers also contend that the First Amendment issues resolved in Nicopure Labs, LLC are not controlling in their case.

We will monitor for further developments. Meanwhile, be on the lookout for the Troutman Sanders Tobacco Team’s forthcoming article in SMOKESHOP Magazine discussing the District Court’s decision in the case.