The Food and Drug Administration has issued marketing denial orders to Logic Technology Development LLC to stop selling two of its menthol e-cigarette products because they risk public health. Photo by Vaping 360/Flickr
Oct. 26 (UPI) -- For the first time, the Food and Drug Administration has snuffed out marketing plans for a menthol e-cigarette product, ordering Logic Technology Development LLC to stop selling two of its e-cigarette packages because they risk public health.
The FDA issued marketing denial orders Wednesday for the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. That means Logic cannot market or distribute either product in the United States. These are the first menthol e-cigarette products to receive marketing denials following a scientific review by 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," Dr. Brian King, director of the FDA's Center for Tobacco Products, said in a statement.
"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."
In June, the FDA banned Juul Labs Inc. from selling its e-cigarette products, but temporarily lifted the ban in July to review the company's application that argued its products protect public health.
To date, the FDA has approved 23 tobacco-flavored e-cigarette products and devices.
In its review of Logic's premarket tobacco product applications, the FDA determined there was not enough evidence to prove the e-cigarettes protect public health, as required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Logic argued its menthol-flavored non-tobacco e-cigarettes reduced the use of tobacco products among adult smokers.
According to the 2022 National Youth Tobacco Survey, 85% of youth who use e-cigarettes are using flavored products, including 26.6% using menthol and 29.4% using mint-flavored e-cigarettes.
Since menthol-flavored e-cigarettes are strongly linked to youth appeal, the FDA requires stronger evidence to prove products promote complete switching from tobacco or significantly reduced cigarette use among adults.
"The FDA conducts a rigorous, scientific review of submitted premarket tobacco product applications, evaluating the data for each product to determine if it meets the public health standard," King said.
"In this case the applicant did not provide sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks to youth."
The American Lung Association applauded the FDA for its first marketing denial order to a menthol-flavored e-cigarette, saying scientific review proves "menthol e-cigarettes are not appropriate for the protection of public health."
"E-cigarette flavors, including menthol, are largely responsible for the youth vaping epidemic," Erika Sward, assistant vice president of national advocacy for the American Lung Association, told UPI in an email.
"We acknowledge the importance of this decision, and we urge the FDA to continue its efforts to remove flavored e-cigarettes from the marketplace."
