Health Law Daily Manufacturer of e-liquids for e-cigarettes lacks standing to obtain judicial review of FDA’s litigation documents
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Wednesday, October 7, 2020

Manufacturer of e-liquids for e-cigarettes lacks standing to obtain judicial review of FDA’s litigation documents

By Elena Eyber, J.D.

Manufacturer of e-liquids for e-cigarettes lacked standing to obtain judicial review of FDA’s brief and declaration in Maryland district court because the threat to manufacturer of enforcement proceedings against it could not be traced back to the submission of litigation documents.

The Sixth Circuit affirmed the Maryland district court’s judgment holding that the manufacturer of e-liquids for e-cigarettes did not have standing to pursue its Administrative Procedure Act (APA) claim for judicial review of the FDA’s litigation submissions. The manufacturer challenged the FDA’s current enforcement guidance timetable for when e-cigarette manufacturers must file premarket tobacco applications to remain on the market. The challenged timetable was set by the Maryland district court in an injunction issued by that court in separate litigation regarding the FDA’s 2017 enforcement guidance. The manufacturer contended that the FDA’s remedial brief and declaration submitted by the FDA to the Maryland district court motivated that court to impose the challenged deadline for application submissions, which significantly accelerated the original FDA deadline. The manufacturer alleged that the FDA’s brief and declaration constituted a final agency action that violated the APA. However, the appellate court held that the Maryland court’s injunction was independent from the FDA’s brief and declaration. The manufacturer therefore lacked standing to obtain judicial review of the remedial brief and declaration because the alleged injury was the result of the Maryland court’s independent action, not the challenged FDA filings (Vapor Technology Association v. FDA, October 5, 2020, per curiam).

Procedural history. In May 2016, the FDA promulgated the "Deeming Rule," which deemed e-cigarettes to be tobacco products subject to the Family Smoking Prevention and Tobacco Control Act (TCA). Thus, the manufacture of nicotine-containing e-liquids for e-cigarettes became subject to the TCA’s premarket authorization requirements pursuant to the Deeming Rule. The FDA issued new guidance in August 2017 that extended the compliance period to August 8, 2022 for most e-cigarettes. The FDA issued the August 2017 guidance without going through notice and comment.

In 2018, several public health organizations filed suit against the FDA in Maryland district court under the APA, alleging that the FDA’s August 2017 guidance was procedurally and substantively invalid. The Maryland district court concluded that the August 2017 guidance was inconsistent with the TCA and unlawful, requiring notice and comments under the APA. Accordingly, the Maryland court granted summary judgment in favor of the plaintiffs and entered an injunction that ordered the FDA to require that premarket applications be filed within ten months of the court’s order. The deadline therefore became May 12, 2020.

The FDA issued new guidance in January 2020, which replaced the August 2017 guidance. The 2020 guidance stated that the FDA intended to prioritize enforcement of the TCA’s premarket-review requirements for e-cigarettes beginning on May 12, 2020. However, due to Covid-19, the district court amended its injunction to require the premarket-review applications to be submitted by September 9, 2020, rather than by May 12, 2020. Following the Maryland court’s extension of the deadline, the FDA revised the 2020 guidance to change its May 12, 2020 deadline to September 9, 2020.

District court decision. The manufacturer filed this suit alleging that the FDA violated the APA by proposing an abbreviated ten-month deadline as an alternative in the government’s remedial brief and declaration to the Maryland district court. The complaint sought an injunction to require the FDA to refrain from taking enforcement action based on the failure of a vapor product manufacturer to submit a completed premarket tobacco application by May 11, 2020.

The district court granted the government’s motion to dismiss concluding that the manufacturer lacked standing because it failed to establish that its alleged injuries were causally connected to the challenged government action. The court determined that it was the Maryland district court, and not the FDA, which set the deadline that gave rise to the manufacturer’s alleged injuries. Thus, the court concluded that the alleged injuries were the result of the Maryland district court’s orders in the litigation, which were independent actions by a third party not before the Kentucky district court. Further, the court rejected the manufacturer’s argument that the FDA motivated the Maryland court to impose the ten-month deadline by proposing this timeline in its remedial brief and declaration.

Appellate court decision. The manufacturer appealed the district court’s decision to dismiss the case. The manufacturer also asked the appellate court to preliminarily enjoin the FDA from taking enforcement action against it because it alleged it faced immediate irreparable harm after the compliance deadline date, which was September 9, 2020. The manufacturer alleged that the FDA’s proposal of a ten-month deadline to the Maryland court caused it to be injured. The manufacturer contended that the FDA’s proposal led the Maryland court to adopt the accelerated ten-month deadline, which Vapor Stockroom asserted that it was unprepared to meet. Thus, the manufacturer contended that the FDA’s conduct caused the company current and impending financial harm because it was unable to submit an application by the compliance deadline.

The appellate court held that the manufacturer’s alleged injuries were the result of the Maryland district court’s injunction, not the FDA’s conduct. The Maryland court is an independent third party that is not part of the present suit. The manufacturer cannot sue the FDA to attack the Maryland court’s decision. Further, the FDA’s remedial brief and declaration were not a motivating factor in the Maryland court’s decision. Finally, the manufacturer’s argument that its injury was traceable to the FDA’s 2020 guidance failed because the manufacturer never challenged the 2020 guidance in its complaint. The manufacturer indicated that it intended to amend its complaint to challenge the 2020 guidance, but it failed to do so before the district court dismissed the case. The appellate court therefore declined to address the manufacturer’s arguments regarding the 2020 guidance. The appellate court held that the district court properly determined that the manufacturer did not have standing to pursue its APA claim for judicial review because the threat to the manufacturer of enforcement proceedings against it could not be fairly traced back to the submission of litigation documents.

The case is No. 20-5199.

Attorneys: Eric N. Heye (Thompson Hine LLP) for Vapor Stockroom, LLC. Lindsey Powell, U.S. Department of Justice, for U.S. Food and Drug Administration and U.S. Department Of Health and Human Services.

Companies: Vapor Stockroom, LLC; Vapor Technology Association

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