The U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to Shenzhen IVPS Technology Co. Ltd for 22 SMOK brand e-cigarette products. The denied products include devices, pods, atomizers and cartridges, which are part of an e-cigarette system marketed without an e-liquid.
The company must not market or distribute these products in the United States or it risks FDA enforcement action, the agency said. The issuance of the MDOs means that the products that are the subject of the PMTA may not be introduced to the market or must remove the products from the market.
Included in the MDOs is a requirement for retailers to remove the products that are subject to the MDOs from store shelves.
According to a statement from the FDA, the MDOs for the SMOK e-cigarette products were issued after the agency determined the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health.
“Science is a cornerstone of FDA’s tobacco product review process, and the Center of Tobacco Products (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 FDA’s 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.”
The denied SMOK e-cigarette products are not sold with an e-liquid. Instead, a consumer adds their separately purchased e-liquid into the device. The agency said in a statement that the SMOK products have 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.
According to the 2023 National Youth Tobacco Survey (NYTS), SMOK was the sixth most commonly reported brand among current youth e-cigarette users, with 11.3% of middle and high school students reporting past 30-day use of SMOK products.
As of today, the FDA has received 26 million applications for tobacco products, made determinations on 99% and approved 23 tobacco-favored e-cigarette products.
The products that received an MDO are:
- SMOK OSUB ONE Device
- SMOK OSUB ONE RPM Cartridge
- SMOK RPM DC 0.8 Ω MTL Atomizer
- SMOK OSUB ONE RPM Cartridge 3 Pack
- SMOK RPM DC 0.8 Ω MTL Atomizer 5 Pack
- SMOK Nfix Device
- Nfix DC 0.8 Ω MTL Pod
- SMOK POZZ Device
- SMOK POZZ DC 0.8 Ω Pod
- SMOK RPM 40 Device
- SMOK RPM Empty Standard Cartridge
- SMOK RPM Empty Nord Cartridge
- SMOK RPM Mesh 0.4 Ω Atomizer
- SMOK Nord DC 0.8 Ω MTL Atomizer
- SMOK SCAR-P3 Device
- SMOK SCAR-P3 Empty RPM 2 Cartridge
- SMOK SCAR-P3 Empty RPM Cartridge
- SMOK PRM 2 Mesh 0.16 Ω Atomizer
- SMOK RPM Mesh 0.4 Ω Atomizer
- SMOK Nord 2 Device
- SMOK Nord 2 RPM Cartridge
- SMOK Nord 2 Nord Cartridge