FDA Issues MDO on 65 "MNGO Disposable Stick" Vapes of Shenzhen YIBAI Technology
According to an announcement released by the United States FDA on April 15, the FDA has issued a Marketing Denial Order (MDO) to Shenzhen Yibai Technology Co., Ltd., prohibiting the sale of 65 disposable e-cigarettes named "MNGO Disposable Stick" in the United States. Failure to comply could result in legal action by the FDA against the company.
The FDA has announced a ban on flavored disposable e-cigarettes, including tobacco, mint, pink lemonade, strawberry mango, watermelon ice, and ice banana flavors, with nicotine concentrations ranging from 2% to 6% for each flavor. According to the 2023 National Youth Tobacco Survey (NYTS), disposable e-cigarettes are the most commonly used device among e-cigarette users, with nearly 90% of users reporting that they use fruit-flavored e-cigarettes.
Dr. Brian King, Director of the FDA's Center for Tobacco Products, revealed that data submitted by Yibai Technology in their application indicated that products marketed as "Clear" flavor, claiming to be flavorless or odorless, actually contain flavoring agents or present a minty taste. Based on all evidence, the FDA has determined that these products have distinct flavors.
After a multidisciplinary scientific review, the FDA determined that the application materials lacked sufficient evidence to demonstrate that the marketing of the product meets the public health protection standards required by the 2009 Family Smoking Prevention and Tobacco Control Act - especially in terms of product stability, manufacturing processes, design features to prevent product tampering or misuse, and other necessary data. Therefore, the application was not sufficient to prove that flavored e-cigarettes offer additional benefits to adult smokers compared to tobacco-flavored e-cigarettes, such as aiding in quitting smoking completely or significantly reducing cigarette use, thus offsetting the risks they pose to youth.
The FDA has announced that it has received 26 million applications for related products, with the majority being e-cigarettes, and has already made decisions on 99% of the applications. Since December 2023, the FDA has issued market denial orders for over 20,000 flavored e-cigarette products, including Shenzhen Yibo Technology's MNGO disposable e-cigarette product.
As of now, the FDA has authorized the legal sale of 23 e-cigarette devices and tobacco-flavored e-cigarette products. Information on tobacco products allowed for sale by law can be found in the new tobacco product database established by the FDA.
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