E-cigarette manufacturers and trade group challenged the premarket review deadlines set by a federal district court in Maryland under the Administrative Procedure Act and on Constitutional grounds.
Why It Matters for Public Health
This case challenged the deadlines initially set by a federal district court in Maryland which required new tobacco products to submit applications for marketing products by May 12, 2020. While the challenge was unsuccessful, it nonetheless illustrates the pattern of industry-led challenge to nearly every aspect of what is ultimately a regulatory process created to protect public health.
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. Among the requirements applicable to e-cigarettes is the requirement that they go through the Tobacco Control Act’s premarket review process. After a delay of the premarket review requirements to e-cigarettes, a court in Maryland required the FDA to begin requiring industry groups to file applications by May 12, 2020 (which was later changed to September 9, 2020).
District Court Proceedings
On August 14, 2019, Vapor Technology Association, and Vapor Stockroom, LLC, an e-cigarette trade group and an e-cigarette manufacturer, filed suit in the Eastern District of Kentucky.
The lawsuit alleged that:
- the FDA failed to use the notice and comment process to establish new premarket review compliance deadlines, a violation of the APA;
- the FDA’s action amounts to a deprivation of property without due process of law, a violation of the Fifth Amendment.
The plaintiffs requested that that the court declare the May 12, 2020 deadline to file marketing applications unlawful under the Administrative Procedure Act. On September 2, 2019, the plaintiffs filed a motion for a preliminary injunction. On October 11, 2019, the FDA filed a response to the motion for a preliminary injunction along with a motion to dismiss, and a motion to transfer the case to the District of Maryland. On October 18, public health groups filed a motion to file an amicus brief. The plaintiffs filed their opposition to the motion made by the amici on November 7, 2019, and their opposition to the government’s motions shortly thereafter.
On December 12, 2019, FDA filed a notice of supplemental authority, notifying the court of the D.C. Circuit’s decision in Nicopure Labs.
On January 7, 2020, FDA filed notice of its updated Guidance document detailing its enforcement priorities for Electronic Nicotine Delivery Services (ENDS) and other deemed products, in support of its motion to dismiss. On January 16, 2020, the court granted FDA’s motion to dismiss, and denied the remaining pending motions as moot.
Proceedings in the Court of Appeals for the Sixth Circuit
On February 15, 2020, Vapor Stockroom LLC filed a notice of appeal in the Court of Appeals for the Sixth Circuit. On February 27, 2020, the industry filed a motion for an injunction pending appeal, or in the alternative, to expedite the briefing schedule, oral argument, and decision, which the court denied on April 2, 2020. Briefing took place between March and May of 2020, and oral arguments were held on August 5, 2020.
On October 6, 2020, the Sixth Circuit Court of Appeals issued its opinion upholding the district court’s dismissal of the case. The opinion stated that the industry plaintiffs did not have standing to challenge the premarket review deadlines because they had been set by a court in the American Academy of Pediatrics v. FDA District of Maryland case, not by the FDA. Therefore, the plaintiffs had suffered no injury as a result of FDA’s actions and the case was dismissed.
The case was dismissed and is now closed.