Federal Court Rules for FDA in Latest MDO Appeal

For the third time in four decisions, a federal appeals court has denied a vaping manufacturer’s petition for review of an FDA marketing denial order (MDO). So far, seven companies have lost their circuit court MDO challenges and six have prevailed—but all six winners were in one consolidated decision.

Today, a unanimous three-judge panel of the Seventh Circuit Court of Appeals ruled for the FDA, denying the appeal by Illinois-based Gripum LLC, which manufactures bottled e-liquid under several brand names.

Gripum, which is also known as OPMH Project, submitted premarket tobacco applications (PMTAs) in September 2020 for about 200 bottled e-liquid products in non-tobacco flavors. The company received an MDO on Sept. 8, 2021. Gripum filed a petition for review Oct. 8, and was granted a stay of FDA enforcement in November 2021. The company participated in oral arguments before the court on April 20.

Gripum argued the FDA’s marketing denial was arbitrary and capricious because Congress (in the Tobacco Control Act) and the agency (in its Deeming Rule) did not “set forth any ascertainable standards” needed to determine if Gripum’s products are “appropriate for the protection of public health.” The company also argued that the FDA changed the evidentiary standard for a successful PMTA after the application deadline had long since passed, and that the agency failed to conduct an individualized PMTA review, which the Tobacco Control Act requires.

The court rejected all three of Gripum’s arguments, finding the FDA’s “approach to adjudicating the application was both reasoned and consistent with the [Tobacco Control] Act.”

Two previous circuit court appeals by vaping manufacturers—Triton Distribution and Vapetasia in the Fifth Circuit and four companies in the D.C. Circuit—failed on similar reasoning by those courts. The outlier was last week’s decision against the FDA and in favor of six small vape companies in the Eleventh Circuit. There are still multiple challenges to MDOs pending in other federal appeals courts, as well as unresolved internal FDA appeals.

Two of the three judges who decided against Gripum were nominated to the court by Democratic presidents, and the third by a Republican. The Seventh Circuit is based in Chicago, and covers appeals from Illinois, Indiana and Wisconsin.

Gripum could now seek an en banc review of the case (a re-hearing by the full Seventh Circuit). Triton and Vapetasia are pursuing that option in the Fifth Circuit.