FDA Denies Menthol E-cigarette Product Application
This week, the FDA Center for Tobacco Products rejected the product application from e-cigarette manufacturer Logic, for their menthol e-cigarette products. In rejecting the application, the agency stated, “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.”

The FDA’s decision is the first time the agency has rejected, or more precisely, issued a “marketing denial order” for a menthol e-cigarette product.

“I am glad the FDA is making these sound decisions, backed by evidence, on e-cigarette products that are predominately used by youth,” said ATS Tobacco Action Committee Chair Hasmeena Kathuria MD. “The recent Youth Tobacco Survey showed that nearly 2.5 million kids are active e-cigarette users. By taking action to remove menthol flavored e-cigarettes from the market, FDA is taking important steps to make a dent in US youth e-cigarette use. We continue to urge the FDA to use its regulatory powers to remove all flavored tobacco products-including menthol e-cigarettes from the market.”