Today, FDA issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). These products include the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. 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.
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, the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. The evidence provided within the application 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.