FDA Issues MDO for 4 blu and 1 myblu E-cigarette Products

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FDA Issues MDO for 4 blu and 1 myblu E-cigarette Products
FDA Issues Marketing Denial Order for Fontem US LLC.’s blu® and myblu® E-Cigarette Products in the US.

On February 5th, the U.S. Food and Drug Administration (FDA) issued a Marketing Denial Order (MDO) to Fontem US LLC., a subsidiary of Imperial Tobacco. The MDO targeted four blu disposable e-cigarette products and one myblu-cigarette product. These rejected products included closed-system mint-flavored e-cigarette liquid and several flavored disposable e-cigarettes. As a result, the company is prohibited from promoting or selling these products in the U.S. market or else they will face enforcement actions from the FDA. However, the company has the option to submit new applications for these MDO-rejected products.


The current products on the market that have been rejected by the MDO include:


The blu® brand offers a range of disposable electronic cigarettes in various flavors and nicotine levels. These include the blu® disposable menthol flavor with a nicotine strength of 2.4%, blu® disposable vanilla flavor with a nicotine strength of 2.4%, blu® disposable icy menthol flavor with a nicotine strength of 2.4%, and blu® disposable cherry flavor with a nicotine strength of 2.4%. Additionally, the myblu product line offers a mint flavor with a lower nicotine strength of 1.2%.


The FDA evaluates premarket tobacco product applications (PMTAs) based on public health standards, considering the risks and benefits of the products for the entire population. Following a review of the company's PMTAs, the FDA has determined that these applications lack sufficient evidence to demonstrate that allowing these products to be marketed is appropriate for public health protection, as required by the 2009 Family Smoking Prevention and Tobacco Control Act.


Specifically, the application lacks sufficient evidence regarding the harmful and potentially harmful constituents in an aerosol product and the battery safety of multiple products. Furthermore, the applicant has not provided sufficient data to demonstrate the potential benefits of the new product for adult smokers, including the risks of complete smoking cessation or significant reduction in smoking, which would outweigh the risks for adolescents. According to the 2023 National Youth Tobacco Survey, currently, 6% of adolescents who use e-cigarettes report using the blu brand e-cigarette.


According to the rigorous scientific review by the FDA, tobacco products that have received marketing denials are prohibited from being introduced or shipped into interstate commerce and must be withdrawn from the market. Manufacturers, distributors, and retailers that violate the law by selling or distributing these products across state lines may face the risk of enforcement actions. The FDA has provided information on MDO on its tobacco product marketing orders webpage.


Today's action is part of the FDA's ongoing effort to ensure that all new tobacco products cannot legally be marketed without undergoing scientific review and obtaining FDA authorization. Since 2020, the FDA has received over 26 million applications for deemed products and has made decisions on 99% of these applications. To date, the FDA has authorized 23 e-cigarette devices and tobacco flavor e-cigarette products. The FDA provides a publicly available list of authorized e-cigarette products and devices, which retailers, consumers, and others can consult to understand which products can be legally marketed.


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