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On Jan 19, 2024, the U.S. FDA issued Marketing Denial Orders(MDO) of two Suorin vape and several blu PLUS+ vape products. Suorin vape belongs to Shenzhen Youme Information Technology Co., Ltd, a vape manufacturer from China. blu Plus+ belongs to Fontem US, LLC, a subsidiary of Imperial Tobacco.
The two vape companies are not allowed to sell or distribute these products in the U.S. market. Otherwise they will face enforcement action from the FDA. Both companies may submit new applications for products subject to these MDOs.
Brian King, MD, director of the FDA’s Center for Tobacco Products (CTP) said:
“Thorough scientific review of tobacco products applications is a key pillar of FDA’s comprehensive regulatory approach. 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.”
FDA evaluates premarket tobacco product applications (PMTAs) based on public health standards. The standards consider the risks and benefits of the product to the entire population. After reviewing the companies’ PMTAs, FDA determines that the applications lacks sufficient evidence. It cannot demonstrate that allowing these products to the market would be beneficial to protect the public health.
The rejected Suorin vapes include a refillable vape device, Suorin Air, and a refillable cartridge. Consumers can fill with separately purchased vape oil.
The application submitted by Shenzhen Youme lacks sufficient evidence about abuse liability. It refers to the ability of a tobacco product to promote continued use and the development of addiction and dependence.
3.8% of middle and high school students who used vapes in the past 30 days reported using a Suorin brand product during that time. (Data according to the 2023 National Youth Tobacco Survey (NYTS).)
The rejected blu PLUS+ vape products include a battery and several prefilled e-liquids:
Among other deficiencies in the application, Fontem US, LLC failed to provide sufficient ingredient information, harmful and potentially harmful ingredient (HPHC) production volumes, and abuse liability information.
In addition, the applicant did not provide sufficient evidence for another thing. That is, to demonstrate that the potential benefits of the new flavored vape to adult smokers, from the perspective of complete cessation or significant reduction in cigarette use, outweigh the risks to youth.
In addition, the applicant did not provide sufficient evidence demonstrating that the flavored new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth.
6.0% of middle and high school students who used vapes in the past 30 days reported using blu-brand products during that time. (Data from the 2023 NYTS.)
The FDA has also issued MDOs for other blu PLUS+ products not listed above. FDA only discloses the names of products that FDA or vape manufacturers confirm are currently on the market. This is to avoid disclosing confidential business information.