FDA issues marketing denial orders to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products & Fontem US, LLC for their blu PLUS+ brand e-cigarette products

When evaluating premarket tobacco product applications (PMTAs), the FDA considers the risks and benefits of the product to the population as a whole, based on a public health standard. After reviewing the PMTAs from both companies, the FDA concluded that there was insufficient evidence to demonstrate that allowing the marketing of these products would be appropriate for the protection of public health.

The FDA has issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. and Fontem US, LLC for their respective e-cigarette products. These companies are now prohibited from marketing or distributing these products in the United States, as they risk facing FDA enforcement action. However, there is still a possibility for the companies to submit new applications for these products that are subject to the MDOs.

“Thorough scientific review of tobacco products applications is a key pillar of FDA’s comprehensive regulatory approach,” said Brian King., Ph.D., M.P.H., Director of FDA’s Center for Tobacco Products. “It is the applicant’s responsibility to ensure that sufficient scientific evidence is included in an application to meet the necessary public health standard required by law. In these cases, such evidence was lacking.”

When evaluating premarket tobacco product applications (PMTAs), the FDA considers the risks and benefits of the product to the population as a whole, based on a public health standard. After reviewing the PMTAs from both companies, the FDA concluded that there was insufficient evidence to demonstrate that allowing the marketing of these products would be appropriate for the protection of public health. This standard is legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

Specifically, the denied Suorin products include the Suorin Air - Refillable E-Cigarette (available in various colors) and the Suorin Air - Empty Cartridge, which allows consumers to fill it with e-liquid purchased separately. The applications submitted by Shenzhen Youme Information Technology Co. Ltd. lacked sufficient evidence regarding abuse liability, which refers to the ability of a tobacco product to promote continued use, addiction, and dependence.

Explained by FDA, according to the 2023 National Youth Tobacco Survey (NYTS), 3.8% of middle and high school students who used e-cigarettes in the past 30 days reported using Suorin brand products during that period.

Regarding blu PLUS+ products, there are several that have been denied by the FDA. These include the blu PLUS+ Battery, 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%, and blu PLUS+® Menthol 2.4%.

Fontem US, LLC, the manufacturer, failed to provide sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities, and abuse liability information in their applications.

Additionally, they did not provide enough evidence to demonstrate that their flavored products would benefit adult smokers in terms of complete switching or significant reduction in cigarette use, outweighing the risk to youth. According to the 2023 NYTS, 6.0% of middle and high school students who used e-cigarettes in the past 30 days reported using blu brand products during that period.

The FDA is also issuing marketing denial orders (MDOs) for other blu PLUS+ products that have not been listed above. However, the FDA has only publicly named products that have been confirmed by either the FDA or the manufacturer to be currently available in the market, in order to protect confidential commercial information.

Compliance and enforcement are crucial. They further explained that once a tobacco product receives a marketing denial order, it cannot be introduced or delivered for introduction into interstate commerce. If the product is currently being marketed, it must be removed. Manufacturers, distributors, and retailers who continue to sell or distribute these products in interstate commerce are violating the law and may face enforcement action. The FDA provides information about MDOs on the Tobacco Products Marketing Orders webpage.

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