Cyclops Vapor 2, et al. v. U.S. Food and Drug Administration

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No. 2:16-cv-556 (M.D. Ala. 2016)

On July 8, 2016, Cyclops Vapor 2, LLC, Tiger Vapor, LLC, and Karma S Clouds, LLC, Alabama-based manufacturers and distributors of e-cigarette devices and liquid nicotine, filed suit in the Middle District of Alabama. The plaintiffs have requested that the court permanently strike down the rule. The FDA filed its answer on November 28, 2016.10 The plaintiffs filed a motion for summary judgment on February 1, 2017.

The lawsuit alleges that:

  1. the FDA’s interpretation of the term, “tobacco product” is “in excess of statutory jurisdiction,” a violation of the APA;
  2. the enforcement of premarket review against e-cigarette companies will be costly, stifle innovation, and does not account for the possibility that e-cigarettes are less harmful than combustible cigarettes, rendering the FDA’s action “arbitrary and capricious,” a violation of the APA;
  3. the FDA’s cost-benefit analysis for the rule overstates the benefits and understates the costs, a violation of the APA11 and the RFA; and
  4. e-cigarette manufacturers will be prohibited from making truthful and non-misleading statements and other forms of protected expression, including distributing free samples, an action that is “contrary to [the] constitutional right” to free speech protected by the First Amendment, a violation of the APA.

On July 24, 2017, the American Academy of Pediatrics, the American Lung Association, the American Heart Association, the American Cancer Society Cancer Action Network, the Campaign for Tobacco-Free Kids, and the Truth Initiative filed a motion to intervene as defendants to ensure that the deeming rule is adequately defended, after the government had filed several requests to delay motions in this and other cases, as well as delaying some of the enforcement dates implementing the deeming rule. The parties filed responses to this motion on August 10, 2017, and the potential intervenors filed their reply on August 18, 2017.

On July 31, the parties filed a joint motion to stay the proceedings because the FDA’s newly announced regulatory plan for tobacco products “affords Plaintiffs much of the relief they seek.” If granted the motion would administratively close the case but it could be reopened by a motion of one of the parties.

On August 10, 2017, the court held a hearing on both the motion to intervene and the motion to stay the proceedings. On March 22, 2018, the court granted the public health groups’ motion to intervene and also granted the motion to stay the case pending the outcome of NicoPure Labs LLC et al. v. FDA.