The FDA’s July 28, 2017, announcement has spurred the parties and would-be intervenors to address the issue to the Court in Cyclops Vapor 2, LLC, et al. v. FDA, et al., No. 2:16-cv-556 (M.D. Ala.). A hearing will be held in the morning of August 10, 2017, in this case challenging the FDA’s Deeming Regulations.
On July 28, the FDA specially announced a new comprehensive plan for focusing its regulatory efforts regarding nicotine, including extending the deadline for premarket review of electronic nicotine delivery systems.
On the heels of the announcement, the parties in Cyclops Vapor 2 jointly moved the Court to vacate the existing briefing schedule and to stay the case. Their July 31 Motion states that the FDA’s announcement “affords Plaintiffs much of the relief they seek.” As another basis for their Motion, they raised the prospective appeal of “an analogous case”—Nicopure Labs, LLC, et al. v. FDA, et al., No.1:16-cv-00878 (D.D.C. July 21, 2017)—“that would, at a minimum, significantly inform the resolution of the issues presented here.”
The would-be intervenors had already filed their Motion to Intervene on July 24. On August 2, they supplemented it to cite the existing parties’ Joint Motion as additional justification for their intervention in the case. To be sure, the would-be intervenors’ participation in August 10’s hearing will be limited. The Court has ordered that they “may participate in oral argument on the motion to intervene but the court will not hear from them on any other issue.”
Stay tuned for further developments.