Market access

FDA denies Myblu market access

The United States Food and Drug Administration issued marketing denial orders (MDOs) to Fontem US for several Myblu electronic nicotine delivery system (ENDS) products after determining that their claims lacked sufficient evidence to show that the authorization of the marketing of these products would be appropriate for the protection of public health.

According to a to remark published on the FDA website, currently marketed products receiving MDOs include Myblu Device Kit, Myblu Intense Tobacco Chill 2.5% and Myblu Intense Tobacco Chill 4.0%.

When reviewing premarket applications for tobacco products, the FDA assesses the risks and benefits of those products to the general population, including users and nonusers of the tobacco product, and considers, among other things, the likelihood that those who do not currently use tobacco products will start using those tobacco products.

Based on information submitted by Fontem US for these Myblu products and available evidence, the claims lacked sufficient evidence regarding design features, manufacturing and stability, according to the FDA. Additionally, the applications have not demonstrated that the potential benefits for smokers who completely change or drastically reduce their cigarette consumption would outweigh the risks for young people, the agency said.

Tobacco products subject to an MDO may not be offered for sale, distributed or marketed in the United States