The agency stated that after reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications “lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health (APPH), the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.” “Lest anyone believe that FDA was hard at work coming up with ways to achieve balance, today they revealed that their big plan for menthol vaping products is to follow the exact same ‘fatal flaw’ review process that has led to dozens of lawsuits being filed against the agency.” For the last year-plus, the FDA has sat back deferred decision making on menthol vaping products,” Conley said. “The dysfunction at the FDA knows no bounds. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process. The term “fatal flaw” was used by the FDA for PMTA submissions that didn’t have specific studies. Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, told Tobacco Reporter that the latest move by the FDA to ban menthol vaping flavors is reminiscent of the agency’s “fatal flaw” review of PMTAs that resulted in millions of denials. “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.” “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 (CTP), in a release. The FDA also isn’t expected to approve any flavored vaping product other than tobacco. The move seems inline with the regulatory agency’s goal to ban menthol flavors from tobacco products. It’s the first time the FDA has issued MDOs for menthol products after receiving a scientific review. The products include the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. Food and Drug Administration has issued marketing denial orders (MDOs) for several menthol-flavored vaping products marketed by Logic Technology Development.
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