The Food and Drug Administration (FDA) issued a marketing denial order (MDO) for the e-cigarette myblu Menthol 2.4%. Due to the order, the company must not market or distribute the product in the United States. Myblu can file a new application to address any deficiencies, but as of now, it was denied based on a failure to prove that the consumption would benefit public health.

“Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, Ph.D., director of the Office of Science within FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweighs the known risks.”

According to the statement from the FDA, the agency evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the impact of the product on the population as a whole, including benefits (i.e., complete transitioning to the product or significant reduction in combustible cigarette use among adults who smoke) and risks (e.g., initiation among youth). After reviewing the company’s PMTA, FDA determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. For example, the application did not present sufficient scientific evidence to show the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.

As of today, the FDA has received 26 million applications for tobacco products, made determinations on 99% and approved 23 tobacco-favored e-cigarette products.