Delays in Cigar Industry Challenge to Deeming Regulations After the FDA’s July 28 Announcement

Several delays have come in a cigar industry challenge to the FDA’s Deeming Regulations. The case is Cigar Association of America, et al. v. U.S. Food & Drug Administration, et al., No. 1:16-cv-01460 (D.D.C.).

During the spring of 2017, there were several extensions of pending deadlines to “allow new leadership personnel at the Department of Health and Human Services to more fully consider the issues raised in this case and determine how best to proceed.” Another delay has come after the FDA’s most recent announcement of July 28, 2017, declaring a new comprehensive plan for focusing the FDA’s regulatory efforts regarding nicotine.

Shortly after the July 28 announcement, the parties filed a Joint Motion to Amend the Scheduling Order. On August 1, they asked the Court for “a 30-day extension of briefing deadlines in view of the U.S. Food and Drug Administration’s announcement of a new comprehensive plan for the regulation of tobacco products.” Among other things, the parties represented to the Court that “[t]he approach outlined in the FDA’s new comprehensive plan may affect several claims raised in this case.”

The day after the parties’ Joint Motion, a group of health organizations and anti-tobacco advocacy groups, which had earlier filed a Motion to Intervene as Codefendants, supplemented their Motion to cite the existing parties’ Joint Motion as an additional justification for their intervention in the case.

The Court held a conference on August 7 and granted the existing parties’ Joint Motion. In addition to staying the deadlines for briefing a pending Motion for Summary Judgment and for filing and briefing an anticipated Cross-Motion for Summary Judgment, the Court ordered that “on or before September 4, 2017, the parties shall file a Joint Status Report, which addresses whether the parties have narrowed any disputed issues and proposes a revised briefing schedule.” Briefing will continue, without delay, on the pending Motion to Intervene.

Stay tuned for further developments.