FDA Denies Marketing of myblu Menthol E-Cigarette Product

From FDA

The U.S. Food and Drug Administration (FDA) issued a marketing denial order (MDO) for myblu Menthol 2.4% an e-cigarette product made by Fontem US, LLC (myblu).  As a result, the company must not market or distribute this product in the United States, or they risk enforcement action by FDA.  The company may resubmit a new application to address the deficiencies for the product subject to this MDO.

“Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” sad 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 outweigh the known risks.”

FDA 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, among other deficiencies, 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.

Tobacco products that receive a marketing denial order may not be offered for sale, distributed, or marketed in the U.S. Additionally, such products may not be introduced or delivered for introduction into interstate commerce, and if the product is already on the market, the product must be removed from the market – or risk FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, FDA intends to ensure compliance by distributors and retailers.

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