FDA Denies Marketing of 65 MNGO-Branded Vapor Products
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to Shenzhen Yibo Technology Co. Ltd. for 65 disposable e-cigarettes marketed as MNGO Disposable Sticks.
As a result, the company must not market or distribute these products in the United States or they risk FDA enforcement action.
[Read more: Sen. Durbin Questions FDA Over Youth Access to Unauthorized E-Cigarettes]
The products include flavors such as tobacco, menthol, pink lemonade, strawberry mango, watermelon freeze and iced banana, 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 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.
"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."
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 or product design features to prevent product tampering or misuse.
[Read more: FDA Creates Database for Legally Marketed Tobacco Products]
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 with any questions about MNGO Disposable Stick products in their inventory.
Manufacturers, distributors and retailers who continue to sell or distribute these products in interstate commerce are violating the law and are at risk of enforcement action.