US FDA Rejects Pre-Market Application of Shenzhen Company Suorin and SMOK Electronic Cigarettes

Release time:

2024-02-05 14:48

Recently, the U.S. Food and Drug Administration FDA issued a marketing refusal order (MDO) to two Suorin brand electronic cigarette products of Shenzhen Beautiful Information Technology Co., Ltd. and 22 SMOK brand electronic cigarette products of Shenzhen IVPS Technology Co., Ltd. These companies must not market or distribute these products in the United States or risk FDA enforcement action. Companies can submit new applications for products subject to these MDOs.

"A thorough scientific review of tobacco product applications is a key pillar of the FDA's comprehensive regulatory approach," said Dr. Brian King, director of the FDA's Tobacco Products. "It is the applicant's responsibility to ensure that the application contains sufficient scientific evidence to meet the necessary public health standards required by law. In these cases, such evidence is lacking."

The FDA evaluates premarket tobacco product applications (PMTAs) based on public health criteria that consider the risks and benefits of the product to the population as a whole. After reviewing the PMTAs of these companies, the FDA determined that these applications lacked sufficient evidence to demonstrate suitability to protect public health.

The rejected Suorin branded products include e-cigarette devices, Suorin Air refillable e-cigarettes (various colors) and empty refill cartridges, and Suorin Air-empty cartridges, where consumers can purchase e-liquid to fill cartridges. The application submitted by Shenzhen Beautiful Information Technology Co., Ltd. lacks sufficient evidence of abuse of liability.
The rejected SMOK e-cigarette products do not contain e-liquids, including smoking sets, smoke bombs (without smoke oil), and combinations of smoking sets and smoke bombs (without smoke oil). Consumers can add e-liquids they purchased separately to the device. Therefore, these SMOK products have the potential to be used with any e-liquids on the market, including tobacco and non-tobacco flavors.
According to the 2023 National Youth Tobacco Survey (NYTS),SMOK is currently the sixth largest brand among youth e-cigarette users. 11.3 percent of teenagers said they had used SMOK products in the past 30 days and 3.8 percent said they had used Suorin brand products during this period.

After the FDA's rigorous scientific review, a tobacco product that receives a marketing refusal order cannot be introduced or delivered into interstate commerce, and if it is currently on the market, the product must be removed from the shelves. These MDOs released today are just one of many actions the FDA is taking to ensure that all new tobacco products undergo science-based review and receive FDA approval.

Since 2020, the FDA has received more than 26 million applications for recognized products and has made decisions on 99% of these applications. To date, the FDA has authorized 23 e-cigarette devices and tobacco-flavored e-cigarette products. The FDA provides lists of e-cigarette products and devices along with marketing approval orders so that retailers, consumers and others can know which products can be legally sold. The FDA has also rejected marketing applications for millions of products that do not meet the necessary public health standards required by law.

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