FDA issues MDO for 65 MNGO Disposable Sticks Vape – China Vape

The U.S. Food and Drug Administration (FDA) on April 15 announced that it issued a marketing denial order (MDO) to Shenzhen Yibo Technology Co., Ltd. The MDO bans 65 of Yibo’s “MNGO Disposable Sticks”, which are sold in the United States. Otherwise, the company will face legal action from the FDA.

Various vape flavors of Yibo’s “MNGO Disposable Sticks” are banned.

The FDA says the products involved in the ban include various vape flavors. For example, tobacco flavor, mint flavor, pink lemon flavor, strawberry mango flavor, watermelon jelly flavor, and ice banana flavor. The nicotine strength of each flavor vape juice ranges from 2% to 6%.

According to the 2023 National Youth Tobacco Survey (NYTS), disposable vapes are currently the most commonly used device among vape users. And, nearly 90% of vape users reported that they use fruit-flavored vapes.

Dr. Brian King, FDA’s CTP director, revealed some information. The data submitted by Yibo Technology in the application shows that the “Clear” flavor vape products were declared as unflavored or tasteless. Actually, they contain flavorings or have a mint or mint flavor. Based on this evidence, the FDA determines that their products have distinctive flavors.

Therefore, after a multidisciplinary scientific review, the FDA issues an MDO to Shenzhen Yibo.

It determined that the application materials lacked enough evidence to prove that the marketing of this product meets the public health protection standards. The standard is legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. The standard includes product stability, manufacturing, product design features to prevent product tampering or misuse, and other necessary data.

Thus, the application form is not enough. It cannot prove that compared to tobacco vapes, flavored vapes can provide extra benefits to smokers. Such as helping to completely quit or reduce smoking, thus offsetting risks to minors.

The FDA continues to tighten sales applications for vape products.

The FDA announced that it has received 26 million applications for related products. Most of which are vapes. The organization has made judgments on 99% of the applications. Since Dec. 2023, the FDA has issued MDO for more than 20,000 flavored vape products. Such as Shenzhen Yibo Technology’s MNGO disposable vape products.

So far, the FDA has authorized the legal sale of 23 types of vape devices and tobacco-flavored vapes.

Besides, for information on tobacco products permitted by law, visit the FDA’s new tobacco product database.

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