The United States Food and Drug Administration (FDA) issued a marketing Denial order (MDO) for several Myblu electronic Nicotine Delivery System (ENDS) products to Fontem US because their use lacked sufficient evidence that allowing the sale of these products was appropriate to protect public health.
Currently available mDO-accepting products include Myblu device Kit, Myblu Strength Tobacco Chill 2.5% and Myblu Strength Tobacco Chill 4.0%, according to an announcement posted on the FDA website.
In reviewing premarket applications for tobacco products, FDA evaluates the risks and benefits of these products to the entire population, including users and non-users of tobacco products, and considers the possibility that people who do not currently use tobacco products may begin to use these tobacco products.
Based on the information Fontem US submitted for these Myblu products and available evidence, the FDA said the applications lacked sufficient evidence of design characteristics, manufacturing and stability. In addition, the agency said the applications did not show that the potential benefits of the device to completely or significantly reduce smoking among smokers would outweigh the risks to young people.
Tobacco products subject to the MDO may not be sold, distributed, or sold in the United States.