The Food and Drug Administration issued marketing denial orders (MDOs) for 22 Smok electronic cigarettes from Shenzhen IVPS Technology Co. Ltd. The products include devices, pods, atomizers and cartridges, which are part of an e-cigarette system marketed without an e-liquid.
The company must not sell or distribute these products in the United States, or it risks FDA enforcement action, the agency said Tuesday.
The MDOs were issued because the agency determined the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, the FDA said in a news release.
“Science is a cornerstone of FDA’s tobacco product review process, and CTP remains committed to evaluating applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “It is the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of the public health. In this case, the applicant failed to provide this evidence.”
Smok e-cigarette products are not sold with an e-liquid. Instead a consumer adds their separately purchased e-liquid into the device. The FDA said this has the potential to be used with any e-liquid on the market and available to the consumer, which could include tobacco-flavored and non-tobacco flavored e-liquids.
The 2023 National Youth Tobacco Survey (NYTS) lists Smok as the sixth most commonly reported brand among current youth e-cigarette users. Data from NYTS reveals that 11.3% of middle and high school students report past 30-day use of Smok products.
The issuance of these MDOs means the products that are the subject of the PMTAs may not be introduced into the market or, if the products are already on the market, the products must be removed from the market or risk enforcement action by the FDA.
This includes a requirement that retailers remove these products from store shelves which are the subject of the MDOs issued by the FDA. However, the company may submit new applications for the products that are subject to these MDOs.
Since 2020, FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications. It has authorized 23 tobacco-flavored e-cigarette products and devices.
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