FDA issues marketing denial order to 22 SMOK vape products

The U.S. Food and Drug Administration (FDA) issued Marketing Denial Orders (MDOs) on 22 SMOK vape products. SMOK is a vape brand belonging to Shenzhen IVPS Technology Co., Ltd. The rejected products include vape devices, e-liquid cartridges, atomizers and cartridges. These products are marketed as part of an vape system but do not carry vape liquid.

The FDA explains that the vape company is not allowed to promote or distribute these products in the U.S. market. Otherwise they will face FDA enforcement action.

After reviewing the company’s PMTAs, FDA determines that the applications lacks enough evidence. They cannot prove that allowing these products entering the market would be appropriate to protect the public health. This is required standards under the Family Smoking Prevention and Tobacco Control Act of 2009.

More specifically, the applicant fails to provide sufficient data to describe ingredient release, product stability, and product abuse risk.

The rejected SMOK vape products did not carry vape liquid.

Consumers will need to add their separately purchased vape liquid to the device. Thus, these SMOK vape products can be used with any vape liquid on the market. These may include tobacco-flavor and non-tobacco-flavor vape liquids. According to the 2023 National Youth Tobacco Survey (NYTS), SMOK is the sixth most reported vape brand among teen vape users. 11.3% of middle and high school students reporting using SMOK products in the past 30 days.

Dr. Brian King, director of the FDA’s Center for Tobacco Products (CTP), said:

“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,”

“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.”

After rigorous scientific review by the FDA, tobacco products that receive a marketing denial order may not be introduced or delivered into interstate commerce.

If they are currently on the market, these products must be removed from the market.

Manufacturers, distributors and retailers who sell or distribute these products into interstate markets will be violating the law. And they will face the risk of enforcement action. FDA posts the latest information about MDOs on the Tobacco Product Marketing Orders webpage. These includes updates or changes like rescissions or related court rulings. However, the company can submit new applications for products to which these MDOs apply.

The FDA also states that this action is part of the FDA’s ongoing efforts. It aims to ensure that all new tobacco products are not legally marketed until they have undergone a science-based review. And, at the same time, they will need to receive FDA marketing authorization.

Since 2020, the FDA has received over 26 million applications for product designations. And they have made decisions on 99% of these applications. So far, the FDA has authorized 23 tobacco-flavored vape products and devices. The FDA provides a list of vape products and devices that have received Marketing Authorization Orders (MGOs). So that vape retailers, consumers and others can know which products is legal on the market.

Besides, the FDA has also denied marketing applications for millions of products. Because they have failed to meet necessary public health standards required by law.

List of products to which MDOs have been issued:

SMOK is one of the famous vape brands in the market. It has various types of vape devices on sale in the market. The following is a list of SMOK’s vape products to which MDOs have been issued:

Number	SMOK Vape Product Name
1	SMOK OSUB ONE Device
2	SMOK OSUB ONE RPM Cartridge
3	SMOK RPM DC 0.8 Ω MTL Atomizer
4	SMOK OSUB ONE RPM Cartridge 3 Pack
5	SMOK RPM DC 0.8 Ω MTL Atomizer 5 Pack
6	SMOK Nfix Device
7	Nfix DC 0.8 Ω MTL Pod
8	SMOK POZZ Device
9	SMOK POZZ DC 0.8 Ω Pod
10	SMOK RPM 40 Device
11	SMOK RPM Empty Standard Cartridge
12	SMOK RPM Empty Nord Cartridge
13	SMOK RPM Mesh 0.4 Ω Atomizer
14	SMOK Nord DC 0.8 Ω MTL Atomizer
15	SMOK SCAR-P3 Device
16	SMOK SCAR-P3 Empty RPM 2 Cartridge
17	SMOK SCAR-P3 Empty RPM Cartridge
18	SMOK PRM 2 Mesh 0.16 Ω Atomizer
19	SMOK RPM Mesh 0.4 Ω Atomizer
20	SMOK Nord 2 Device
21	SMOK Nord 2RPM Cartridge
22	SMOK Nord 2 Nord Cartridge