Synopsis
E-Cigarette manufacturers and distributors challenge the deeming rule under the Administrative Procedure Act (APA) and the First Amendment.
Why It Matters for Public Health
This case was yet another challenge to the FDA’s deeming rule by the e-cigarette industry. While this case’s outcome was determined by a ruling in a different case, it shows how bold regulations are often subject to many different legal challenges raising the same claims.
Background
On May 5, 2016, the FDA issued the final rule deeming all existing and future tobacco products to be subject to the agency’s jurisdiction, including e-cigarettes and their components and parts.
District Court Proceedings
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 requested that the court permanently strike down the deeming rule.
The lawsuit alleges that:
- the FDA’s interpretation of the term, “tobacco product” is “in excess of statutory jurisdiction,” a violation of the APA;
- 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;
- the FDA’s cost-benefit analysis for the rule overstates the benefits and understates the costs, a violation of the APA and the RFA; and
- 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.
The FDA filed its answer on November 28, 2016. The plaintiffs filed a motion for summary judgment on February 1, 2017. 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 was adequately defended, after the government raised concerns by filing 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, 2017, the parties filed a joint motion to stay the proceedings because NicoPure Labs LLC et al. v. FDA, 266 F. Supp. 3d 360, raised identical issues and was pending before the District Court of the District of Columbia. On September 28, 2017, the parties informed the Court that the case was on appeal, and requested a stay of the case pending a decision in Nicopure. A hearing was held on August 10, 2017, and on March 22, 2018, the Court granted the public health groups’ motion to intervene, and issued an order staying the case pending a decision in Nicopure Labs. On February 24, 2020, the parties stipulated to the dismissal of the case after the decision in Nicopure was issued by the D.C. Circuit Court of Appeals.
Litigation Status
The case was dismissed on February 26, 2020.