January 19, 2024
On Jan. 19, FDA issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products and to Fontem US, LLC for their blu PLUS+ brand e-cigarette products. The companies must not market or distribute these products in the United States or they risk FDA enforcement action. The companies may submit new applications for the products that are subject to these 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.”
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product to the population as a whole. After reviewing the companies’ PMTAs, FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
The denied Suorin products are an e-cigarette device, Suorin Air - Refillable E-Cigarette (various colors), and an empty refillable cartridge, Suorin Air - Empty Cartridge, that would allow a consumer to fill the cartridge with an e-liquid purchased separately. The applications submitted by Shenzhen Youme Information Technology Co. Ltd. lacked sufficient evidence regarding abuse liability, which is the ability of a tobacco product to promote continued use and the development of addiction and dependence.
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.
The denied blu PLUS+ products include a battery and several prefilled e-liquids:
- 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%
- blu PLUS+® Menthol 2.4%
Among other deficiencies in their applications, Fontem US, LLC failed to include sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities, and abuse liability information. 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. 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.
FDA is also issuing MDOs for additional blu PLUS+ products not listed above. However, FDA has only publicly named products that FDA or the manufacturer have confirmed to be currently marketed to avoid the release of confidential commercial information.
Compliance and Enforcement
Following FDA’s rigorous scientific review, tobacco products that receive a marketing denial order may not be introduced or delivered for introduction into interstate commerce, and, if currently marketed, the product must be removed. Manufacturers, distributors, and retailers who do sell or distribute these products in interstate commerce are violating the law and are at risk of enforcement action. FDA posts information about MDOs on the Tobacco Products Marketing Orders webpage.
Today’s issuance of these MDOs is just one of the many actions the FDA has taken to ensure all new tobacco products undergo science-based review and receive marketing determinations by the FDA. Since 2020, the agency has received applications for more than 26 million deemed products and has made determinations on 99% of these applications. To date, FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products. FDA provides this list of e-cigarette products and devices with marketing granted orders so that retailers, consumers, and others may know which products may be legally marketed. FDA has also denied marketing applications for millions of products that did not meet the necessary public health standard required by law.