Activity on Motions for Summary Judgment seems to suggest different paths ahead for remaining trial litigation in Deeming Regulations challenges. This activity comes after delays owing to the need for new leadership in the Department of Health and Human Services to review the cases and, more recently, for the existing plaintiffs and defendants to reconsider the claims in light of the FDA’s July 28, 2017, announcement of a new comprehensive plan for focusing its regulatory efforts regarding nicotine. The cases are Cigar Association of America v. FDA, No. 1:16-cv-01460 (D.D.C.), and Cyclops Vapor 2, LLC v. FDA, No. 2:16-cv-00556 (M.D. Ala.).

In the Cigar Association of America case, the plaintiffs filed a Motion for Preliminary Injunction and a Motion for Partial Summary Judgment, with a consolidated Brief in support of each, on October 3, 2017. Raising issues under the First Amendment, Tobacco Control Act, and Administrative Procedure Act, the plaintiffs seek “a preliminary injunction restraining the FDA from implementing or enforcing the warning requirements as imposed on cigars and pipe tobacco in the Deeming Rule . . . and the other labeling requirements set to take effect.” Among other things, in seeking partial summary judgment, the plaintiffs ask the Court to

  • vacate and set aside aspects of the Deeming Regulations imposing warning and other labeling requirements on cigars and pipe tobacco, determining retailers who blend pipe tobacco to be regulated manufacturers, and including tobacco pipes as regulated components or parts of tobacco products;
  • vacate and set aside the User Fee Rule;
  • declare the Deeming Regulations in violation of the First Amendment;
  • permanently enjoin the FDA from implementing or enforcing the warning and other labeling requirements on cigars and pipe tobacco;
  • permanently enjoin the FDA from implementing or enforcing other challenged aspects of the Deeming Regulations; and
  • permanently enjoin the FDA from implementing or enforcing the User Fee Rule.

Per a previous Order of the Court, Defendants are anticipated to file a Cross Motion for Summary Judgment. Filings with respect to these Motions are anticipated into early December, and counsel are scheduled to argue their positions before the Court on December 14, 2017.

Meanwhile, in Cyclops Vapor 2, LLC, the plaintiffs’ pending Motion for Summary Judgment (filed on February 1, 2017) has been “denied with leave to renew.” So ruled the Court on September 25, 2017, without further explanation. Of note, the parties’ Joint Motion to Vacate Briefing Schedule and Stay Case is still pending before the Court. Having earlier anticipated its possibility as support for the requested delay, on September 28 the parties notified the Court of the pending appeal in Nicopure Labs, LLC, v. FDA, No. 17-5196 (D.C. Cir.). According to the parties, “the pendency of these now-certain appellate proceedings provides further support for the[] motion to stay,” and the D.C. Circuit’s decision “would, at a minimum, significantly inform the resolution of this case.”

Stay tuned for further developments.