FDA Denies Marketing of Logic's Menthol E-Cigarettes

The US Food and Drug Administration (FDA) issued marketing denial orders for menthol e-cigarette products manufactured by Logic Technology Development LLC (Logic).

As a result, the company must not market or distribute the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package in the US.

These are the first menthol e-cigarette products to receive a marketing decision based on a full scientific review from the FDA.

According to the agency, the evidence provided in Logic's premarket tobacco product applications 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.

"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, PhD, MPH., 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."

The American Heart Association (AHA) issued a statement supporting the FDA's decision and saying that the agency needs to move forward with final rules to remove menthol cigarettes and flavored cigars from the market.

"These flavored products are also highly appealing to kids and put them on a path toward a lifetime of addiction and put our communities at risk of illness and death," the AHA statement says.

A recent study from the FDA and the Centers for Disease Control and Prevention (CDC) reveals that 14.1% of high school students and 3.3% of middle school students reported smoking e-cigarettes in the past 30 days. Most (85.5%) respondents said they used flavored e-cigarettes.

"Adolescent e-cigarette use in the United States remains at concerning levels and poses a serious public health risk to our nation's youth," Brian King, PhD, MPH, director of the FDA's Center for Tobacco Products, said in a statement.

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