In a pending vapor industry challenge to the FDA’s Deeming Regulations, on March 22, 2018, the Court permitted several anti-tobacco advocacy and public health groups to intervene in the litigation as Codefendants and, at the same time, stayed the case pending the decision of the U.S. Court of Appeals for the D.C. Circuit in Nicopure Labs, LLC, et al. v. FDA, et al., No. 17-5196 (D.C. Cir.). The case is Cyclops Vapor 2, LLC, et al. v. FDA, et al., No. 2:16-cv-00556 (M.D. Ala.).

Permitted Intervention of Anti-Tobacco Advocacy and Public-Health Groups

The motion to intervene was filed by the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, and the Truth Initiative (the “Intervenors”). The Court ruled that the Intervenors’ “motion was timely and none of the parties have been or will be prejudiced by permitting intervention.”

Although the Court acknowledged that the Intervenors’ motion was premised on merely a “speculative” fear that the FDA would not adequately defend the Deeming Regulations, the Court found that this speculation “in no way minimize[d] the fact that the Intervenors would be practically and substantially affected by rescission of the [Deeming Regulations].”

Stay Pending D.C. Circuit’s Decision in Nicopure Labs

Separate from the intervention issue, the existing parties had filed a joint motion to vacate the briefing schedule and stay the case. Notifying the Court of the pendency of Nicopure Labs, the parties advised that the D.C. Circuit’s decision “would, at a minimum, significantly inform the resolution of this case.”

The Court has “conclude[d] that it is appropriate to stay resolution of this matter pending a decision in Nicopure Labs.”


The Court’s intervention decision is interesting, as the Intervenors have moved for, and been denied, intervention in Cigar Association of America, et al. v. FDA, et al., No. 1:16-cv-01460 (D.D.C.) (cigar-industry challenge to Deeming Regulations), previously noted by this blog. And, as also reported by this blog, an intervention decision remains pending in Nicopure Labs.

As far as the stay and the reasons for it, they only confirm the anticipation of the D.C. Circuit’s decision in Nicopure Labs and the significance it could have in other cases.

We will monitor for further updates.