In four separate rulings, the Federal Appeals Court has once again rejected requests from electronic cigarette manufacturers to review the FDA's marketing rejection orders (MDO). Seven companies have now lost their challenges in the circuit courts, while six have emerged victorious.
A three-judge panel in the Seventh Circuit Court of Appeals unanimously ruled against Gripum LLC, an Illinois-based company producing bottled e-cigarette liquid under several brands, and upheld the decision of the FDA.
The company known as Gripum, also referred to as the OPMH project, submitted a pre-market tobacco application (PMTA) in September 2020 for approximately 200 bottled e-liquid products with non-tobacco flavors. The application was received by the FDA's Center for Tobacco Products in September. On August 8th, 2021, Gripum submitted a letter of intent for review and was granted a delay on FDA enforcement in November of the same year. On April 20th of this year, the company participated in an oral argument in court.
Gripum alleges that the FDA's refusal to allow marketing is arbitrary and capricious, as neither Congress (in the Tobacco Control Act) nor the agency (in its guidance documents) have "established any necessary, discernible standards" to determine whether Gripum's products are "appropriate for the protection of public health." The company also argues that the FDA changed the evidence standard for PMTAs after the application deadline had passed and failed to conduct personalized PMTA reviews as required by the Tobacco Control Act.
The Federal Appeals Court still faces multiple challenges on other issues, as well as unresolved internal appeals within the FDA.
The court rejected all three arguments presented by Gripum, stating that the FDA's "method of decision-making was both reasonable and in accordance with the Tobacco Control Act.
Two electronic cigarette manufacturers, Triton Distribution and Vaptasia of the Fifth Circuit Court of Appeals, as well as four companies from Washington, D.C., had previously failed in similar reasoning during two rounds of appeals. However, last week, six small electronic cigarette companies won support for their appeal against the FDA's decision from the Eleventh Circuit Court of Appeals.
Several federal appellate courts still have multiple challenges, and there are unresolved internal appeals within the FDA.
Two of the three judges who opposed Gripum were nominated to the court by the Democratic president, while the third was nominated by a Republican. The headquarters of the Seventh Circuit Court is located in Chicago and covers appeals from Illinois, Indiana, and Wisconsin.
Gripum can now seek an en banc review of the case (a full rehearing by the Seventh Circuit Court of Appeals). Triton and Vaptasia are seeking this option in the Fifth Circuit Court of Appeals.
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