The Food and Drug Administration (FDA) issued marketing denial orders (MDO) for 65 disposable e-cigarettes to Shenzhen Yibo Technology Co. Ltd. The e-cigarettes, which received the MDOs on April 15, are marketed as “MNGO Disposable Stick.”
The products in the denial orders include flavors such as tobacco, menthol, pink lemonade, strawberry mango, watermelon freeze, iced banana and others, with each flavor offered in a range of nicotine concentrations from 2% to 6%. According to the 2023 National Youth Tobacco Survey, fruit flavors were reported to be the most popular among e-cigarette users.
The MDOs also included several “Clear” flavor products that were described by the applicant as flavorless or unflavored, but according to the FDA based on data submitted in the company’s applications, these products contain ingredients that are flavor enhancers or are known to impart a menthol or mint flavor and are determined to have a characterizing flavor.
“The onus is on tobacco companies to provide the evidence demonstrating that the necessary public health standard has been met, and when they fail to do so, FDA will appropriately deny the marketing authorization of new tobacco products,” said Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products. “In this case, the applicant did not meet the necessary bar.”
The FDA determined the applications did not provide adequate evidence concerning various aspects such as product stability, manufacturing, product design features to prevent product tampering or misuse, and other necessary data. The FDA also noted the applications did not sufficiently demonstrate that the flavored e-cigarettes — relative to tobacco-flavored e-cigarettes —could offer an added benefit to adults who use cigarettes, by either facilitating complete switching or significantly reducing cigarette use, that would outweigh the associated risks to youth.
Tobacco products that receive an MDO may not be introduced or delivered for introduction into interstate commerce and must be removed from the market. Retailers should contact the manufacturer, Shenzhen Yibo Technology, with any questions about MNGO Disposable Stick products in their inventory. Manufacturers, distributors and retailers who do sell, or distribute, these products in interstate commerce are at risk of enforcement action. The company may submit new applications for the products subject to these MDOs.
Since 2020, the agency has received applications for more than 26 million deemed products, the majority of which are e-cigarettes, and has made determinations on 99% of these applications. Among these determinations, FDA has issued MDOs for more than 20,000 flavored e-cigarette products since December 2023, including the MNGO Disposable Stick products.
To date, FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products.