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U.S. Court of Appeals Rejects Gripum PMTA Marketing Denial Order Appeal

U.S. Court of Appeals Rejects Gripum PMTA Marketing Denial Order Appeal

2022-08-30

On August 30, according to foreign reports, the U.S. federal appeals court rejected for the third time the petition of the e-cigarette manufacturer to review the FDA marketing denial order (MDO).


So far, seven companies have lost circuit MDO challenges and six have won -- but all six have won in a combined decision.


Today, a three-judge panel on the 7th Circuit Court of Appeals unanimously agreed with the FDA’s decision to dismiss an appeal by Illinois-based Gripum LLC, which makes multiple brands of bottled e-liquids.


Gripum, also known as Project OPMH, filed a Premarket Tobacco Application (PMTA) in September 2020 for approximately 200 non-tobacco flavored bottled e-liquid products. The company received the MDO on September 8, 2021.


Gripum submitted an application for review on October 8 and received a stay of enforcement from the FDA in November 2021. The company participated in oral arguments in court on April 20.


Gripum argues that FDA's marketing denials are arbitrary and capricious because Congress (in the Tobacco Control Act) and the agency (in its presumptive rules) have not established any identifiable criteria for determining whether Gripum's products are suitable to protect the public health.


The company also argued that the FDA changed the standard of evidence for a successful PMTA long after the application deadline and that the agency failed to conduct a personalized PMTA review as required by the Tobacco Control Act.


The court rejected all three of Gripum's arguments, arguing that the FDA's approach to ruling the application was both reasonable and consistent with tobacco control law.


Two previous circuit appeals by the e-cigarette maker — Triton Distribution and Vapetasia in the Fifth Circuit and four companies in the D.C. Circuit — have failed on similar reasoning in those courts. The outlier was last week's decision to the FDA and favored the six small vaping companies on the Eleventh Circuit.


Other federal appeals courts still have multiple challenges to the MDO, as well as an unresolved internal FDA appeal.


Two of the three justices who decided against Gripum were nominated by Democratic presidents and the third was nominated by Republicans. The Seventh Circuit is based in Chicago and handles appeals from Illinois, Indiana and Wisconsin.


Gripum can now seek a full review of the case (rehearing by the Seventh Circuit). Triton and Vapetasia are pursuing the option in the Fifth Circuit.


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