The Food and Drug Administration issued marketing denial orders (MDOs) for 65 disposable e-cigarette products from Shenzhen Yibo Technology Co. Ltd., marketed as MNGO Disposable Stick. The company must not sell these products in the United States, or it risks FDA enforcement action, but the company can submit new premarket tobacco product applications (PMTAs) for these products.
Flavors of denied products includeMenthol, Pink Lemonade, Strawberry Mango, Watermelon Freeze, Iced Banana and others, with each flavor offered in a range of nicotine concentrations from 2% to 6%.
The MDOs also include several “Clear” flavor products that were described by Shenzhen Yibo Technology Co. as flavorless or unflavored. The FDA said the 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.
The applications for the products did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health, the FDA said.
“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, director of the FDA’s Center for Tobacco Products. “In this case, the applicant did not meet the necessary bar.”
The products appeal to youth, the FDA said, citing the 2023 National Youth Tobacco Survey, which found 9 out of 10 current e-cigarette users reported using flavored e-cigarettes with fruit flavors being the most popular.
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, the agency said.
The FDA has received PMTAs for more than 26 million new tobacco products since spring 2020, and has taken action on more than 99% of those applications, the agency said. Among these determinations, the FDA has issued MDOs for more than 20,000 flavored e-cigarette products since last December, including the MNGO Disposable Stick products described above.
To date, the FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products that can be found on the FDA's Tobacco Products Database.
Retailers with any questions about MNGO Disposable Stick products in their inventory should contact the manufacturer, Shenzhen Yibo Technology Co. Ltd., the FDA said.
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