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Multidisciplinary Scientific Review Finds Products Do Not Meet the Necessary Public Health Standard
On April 15, FDA issued marketing denial orders (MDOs) to Shenzhen Yibo Technology Co. Ltd. for 65 disposable e-cigarettes marketed as “MNGO Disposable Stick.” As a result, the company must not market or distribute these products in the United States or they risk FDA enforcement action.
The products in today’s 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 (NYTS), disposable e-cigarettes were the most commonly used device among current e-cigarette users, and almost 9 out of 10 current e-cigarette users reported using flavored e-cigarettes with fruit flavors being the most popular.
The MDOs also include several “Clear” flavor products that were described by the applicant as flavorless or unflavored. However, data submitted in the company’s applications showed these products contained ingredients that are flavor enhancers or are known to impart a menthol or mint flavor. Based on the entirety of evidence, FDA determined that the products 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.”
After a multidisciplinary scientific review, FDA determined that the applications lacked sufficient evidence to show that marketing of the products would be appropriate for the protection of the public health – the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. More specifically, 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. Furthermore, the applications did not sufficiently demonstrate that the flavored e-cigarettes—relative to tobacco-flavor 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 Co. Ltd., 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 violating the law and are at risk of enforcement action. The company may submit new applications for the products subject to these MDOs. 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, 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 described above.
disposable nicotine vape To date, FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products. Further information about legally marketed tobacco products is available in FDA’s new Searchable Tobacco Products Database.