FDA Issues First Marketing Decision on Menthol Vapor Products
The agency rejected applications for several Logic products, including two currently on the market.
SILVER SPRING, Md. — The Food and Drug Administration (FDA) issued marketing denial orders (MDOs) for several menthol-flavored electronic cigarette products currently marketed by Logic Technology Development LLC.
The MDOs include the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package, which are currently on the market. As a result, the company must not market or distribute these products in the United States or risk enforcement action by the FDA.
These are the first menthol e-cigarette products to receive a marketing decision based on a full scientific review from the FDA.
“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.”
After reviewing the Logic'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, the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
According to the agency, the evidence provided within PMTAs does not demonstrate that these menthol-flavored e-cigarettes are more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers.
Logic may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
The MDO letter that Logic received on Oct 26 is not limited to the two products named above; in general, the FDA publicly names only products that the applicant is marketing to avoid potential disclosure of confidential commercial information.
In March, the FDA authorized several tobacco-flavored e-cigarette products from the company under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.