FDA Issues Marketing Denial Order for 22 SMOK E-cigarette Products

On January 16th, the U.S. Food and Drug Administration (FDA) issued Marketing Denial Orders (MDOs) against 22 SMOK brand e-cigarette products from Shenzhen IVPS Technology Co., Ltd, based in Shenzhen, China. The products that were denied marketing approval included devices, e-liquid cartridges, atomizers, and pods, which are marketed as part of the e-cigarette system but do not contain e-cigarette e-liquid.

The FDA explained that the company is prohibited from promoting or distributing these products in the US market, or else they will face enforcement actions by the FDA. After reviewing the company's PMTAs, the FDA concluded that these applications lack sufficient evidence to demonstrate that allowing these products to enter the market would be appropriate for public health, as required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, the applicants failed to provide sufficient data to describe ingredient release, product stability, and product misuse risks.

The rejected SMOK e-cigarette products did not come with e-cigarette liquid. Consumers are required to separately purchase and add their own e-cigarette liquid to the device. Therefore, these SMOK products have the potential to be used with any e-cigarette liquid available on the market, including both tobacco and non-tobacco flavors. According to the 2023 National Youth Tobacco Survey (NYTS), SMOK is reported as the sixth most popular brand among teenage e-cigarette users, with 11.3% of high school students reporting use of SMOK products in the past 30 days.

Dr. Brian King, Director of the Center for Tobacco Products (CTP) at the FDA, stated:

Science serves as the foundation of the FDA tobacco product review process, and CTP remains committed to evaluating tobacco products based on public health standards, taking into consideration the risks and benefits posed by such products to the entire population. It is the responsibility of the applicant to provide sufficient scientific evidence to demonstrate that the introduction of a new tobacco product into the market is appropriate for safeguarding public health. In this particular case, the applicant failed to provide this evidence.

After undergoing rigorous scientific scrutiny by the FDA, tobacco products that receive a Marketing Denial Order (MDO) are prohibited from being introduced or delivered into interstate commerce. If these products are currently being sold on the market, they must be withdrawn. The manufacturers, distributors, and retailers selling or distributing these products in interstate markets will be in violation of the law and may face enforcement actions. The FDA provides the latest information on MDOs, including updates or changes, such as revocations or relevant court rulings, on its Tobacco Product Marketing Orders webpage. However, companies can submit new applications for products that are subject to these MDOs.

The FDA also stated that this action is part of its ongoing efforts to ensure that all new tobacco products cannot be legally marketed until they have undergone science-based evaluation and obtained FDA marketing authorization.

Since 2020, the FDA has received over 26 million applications for products and has made decisions on 99% of these applications. So far, the FDA has authorized 23 e-cigarette products and devices with tobacco flavors. To enable retailers, consumers, and others to know which products can be legally marketed, the FDA has provided a list of e-cigarette products and devices that have obtained marketing authorization orders (MGOs). Additionally, the FDA has rejected the marketing applications for millions of products that failed to meet the necessary public health standards required by law.

The following is a list of products that have been issued MDOs：

• 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