Logic Obtains Temporary Stay of FDA Marketing Denial Order
PHILADELPHIA — Logic Technology Development LLC obtained a court order on Oct. 28 from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stays the U.S. Food and Drug Administration's (FDA) marketing denial order (MDO) for several Logic products, including two already on the market: the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package.
The stay was issued two days after the FDA denied premarket tobacco applications (PMTAs) filed by Logic for several products, as Convenience Store News previously reported.
The MDO issued on Oct. 26 was not limited to the two named Logic products, as the FDA publicly names only products that the applicant is marketing to avoid potential disclosure of confidential commercial information.
According to the Third Circuit Court, both the Logic Pro Menthol e-Liquid Package and the Logic Power Menthol e-Liquid Package can be sold by retailers and wholesalers while the stay is in place and the court considers a further motion by Logic regarding the MDO.
"Within seven days of this order, the petitioner must file its motion for a stay pending the petition. The FDA's response must be filed within ten days thereafter," the court order read. "The panel considering the stay motion may decide it without waiting for a reply, see Fed. R. App. P. 27(a)(3)(A); 3d Cir. I.O.P. 10.2.3, so any reply must be filed as quickly as possible (and no later than three days after the response).
"The temporary administrative stay will remain in effect until a panel of this Court decides the forthcoming stay motion. If no timely stay motion is filed, the Clerk is authorized and directed to vacate this temporary administrative stay," it continued.
The Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package were the first menthol e-cigarette products to receive a marketing decision based on a full scientific review from the FDA. The agency found that the PMTAs lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
"Ensuring new tobacco products undergo premarket evaluation is a critical part of the FDA's work to reduce tobacco-related disease and death," said Brian King, director of the FDA's Center for Tobacco Products. "We remain committed to evaluating new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole."