January 16, 2024
On Jan. 16, 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 they risk FDA enforcement action.
- 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
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 company’s PMTAs, FDA determined that the applications lacked sufficient evidence to demonstrate that permitting 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. More specifically, the applicant failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.
The denied SMOK e-cigarette products are not sold with an e-liquid. A consumer instead adds their separately purchased e-liquid into the device. Therefore, these 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.
“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, Ph.D., M.P.H., Director of FDA’s Center for Tobacco Products. “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.”
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 products must be removed from the market. 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 the most current information about MDOs, including updates or changes such as a recission or relevant court order, on the Tobacco Products Marketing Orders webpage. However, the company may submit new applications for the products that are subject to these MDOs.
Today’s action is part of FDA’s ongoing progress toward making sure that all new tobacco products have undergone science-based review and received marketing authorization by FDA before they can be legally marketed. Since 2020, FDA 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 tobacco-flavored e-cigarette products and devices. FDA provides this list of e-cigarette products and devices with marketing granted orders (MGOs) 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.