February 5, 2024
On Feb. 5, FDA issued marketing denial orders (MDOs) to Fontem US LLC., for four blu Disposable and one myblu brand e-cigarette products. The denied products include a closed menthol e-liquid and several flavored disposable e-cigarettes. As a result, the company must not market or distribute these products in the United States or they risk FDA enforcement action. However, the company may submit new applications for the products that are subject to these MDOs.
The currently marketed products that received an MDO are:
- blu® Disposable Menthol 2.4%
- blu® Disposable Vanilla 2.4%
- blu® Disposable Polar Mint 2.4%
- blu® Disposable Cherry 2.4%
- myblu Menthol 1.2%
FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product to the population as a whole. After reviewing the company’s PMTAs, FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
More specifically the application lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products. Additionally, the applicant did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth. According to the 2023 National Youth Tobacco Survey, among youth who currently used e-cigarettes, 6% reported using blu brand e-cigarettes.
Following FDA’s rigorous scientific review, tobacco products that receive a marketing denial order may not be introduced or delivered for introduction into interstate commerce and must be removed from the market. Manufacturers, distributors, and retailers who do sell, or distribute, these products in interstate commerce are violating the law and are at risk of enforcement action. FDA posts information about MDOs on the Tobacco Products Marketing Orders webpage.
Today’s actions are part of FDA’s ongoing progress toward making sure that all new tobacco products have undergone science-based review and received marketing authorization by FDA before they can be legally marketed. Since 2020, FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications. To date, FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products. FDA provides a publicly available list of e-cigarette products and devices with marketing granted orders so that retailers, consumers, and others may know which products may be legally marketed.