On January 19th, the U.S. Food and Drug Administration (FDA) issued a Market Denial Order (MDO) against two e-cigarette products, Suorin and blu PLUS+, manufactured by Shenzhen Youme Information Technology Co. Ltd. and Fontem US, LLC respectively. This order prohibits the sale or distribution of these products in the American market, and failure to comply may result in enforcement actions by the FDA. Both companies may choose to submit new applications for these products that are subject to the restrictions imposed by the MDO.
The Director of the FDA Center for Tobacco Products, Dr. Brian King, stated, "Thorough scientific scrutiny of tobacco product applications is a crucial pillar of the FDA's comprehensive regulatory approach. Applicants are responsible for ensuring sufficient scientific evidence is included in their applications to meet the necessary public health standards mandated by law. In these cases, such evidence is lacking."
The Food and Drug Administration (FDA) evaluates pre-market tobacco product applications (PMTAs) based on public health standards, which take into account the risks and benefits of the products for the entire population. After reviewing these companies' PMTAs, the FDA has determined that these applications lack sufficient evidence to demonstrate that allowing these products on the market would be beneficial for public health, as required by the 2009 Family Smoking Prevention and Tobacco Control Act.
The rejected Suorin product is a refillable e-cigarette device called the Suorin Air, along with a refillable empty pod. Consumers have the option to fill the purchased e-cigarette liquid into the pod.
The FDA has stated that the application submitted by Niuwo Network Technology Co., Ltd. of Shenzhen lacks sufficient evidence regarding the responsibility for abuse. Abuse responsibility refers to the ability of tobacco products to promote sustained use and develop addictive and dependent behavior.
According to the 2023 National Youth Tobacco Survey (NYTS), 3.8% of middle and high school students who have used e-cigarettes in the past 30 days reported using Suorin brand products during this period.
The rejected blu PLUS+ product includes a battery and several pre-filled e-cigarette liquids.
blu PLUS+ batteries blu PLUS+® Carolina Bold 2.0 blu PLUS+® Classic Tobacco 1.2 blu PLUS+® Classic Tobacco 2.4 blu PLUS+® Gold Leaf 1.2 blu PLUS+® Gold Leaf 2.4 blu PLUS+® Menthol 1.2 blu PLUS+® Menthol 2.4 Apart from other deficiencies in the application, Fontem US, LLC failed to provide sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yields, and misuse liability information.
Furthermore, the applicants have also failed to provide sufficient evidence to prove that the potential benefits of this new flavored product for adult smokers, in terms of complete smoking cessation or significant reduction in tobacco use, outweigh the risks for teenagers. According to a 2023 investigation conducted in New York State, 6.0% of middle and high school students who had used e-cigarettes in the past 30 days reported using blu brand products during this period.
The FDA has also issued a Medical Device Order (MDO) for other blu PLUS+ products that were not mentioned above. The FDA has only disclosed the product names that have been currently approved by either the FDA or the manufacturer, in order to avoid revealing confidential business information.
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