Appeal Filed Against FDA's Marketing Denial Order on SMOK Products

Editor's Note: On January 16th, the US Food and Drug Administration (FDA) issued a Marketing Denial Order (MDO) on 22 e-cigarette products under the SMOK brand by Shenzhen IVPS Technology Co., Ltd. The denied products include devices, pods, atomizers, and pods. 

As a result, the company is prohibited from selling or distributing these products in the United States, otherwise risking enforcement actions by the FDA. In response, on January 18th, Shenzhen IVPS Technology Co., Ltd issued an official statement on their website, stating that they have filed an appeal with the United States Court of Appeals for the Fifth Circuit. The following is a translated version of the statement.

Shenzhen IVPS Technology Co., Ltd., a manufacturer of electronic nicotine delivery systems (ENDS) products, announced today (January 18) that it has filed an appeal with the United States Fifth Circuit Court of Appeals, opposing the MDO imposed by the FDA on its popular SMOK brand open system kit and related components.

A distributor based in Dallas, Texas, has jointly participated in this appeal and has submitted an appeal request to the United States Fifth Circuit Court of Appeals headquartered in New Orleans, Louisiana.

FDA issued a MDO for pre-market tobacco product applications involving the aforementioned open-system SMOK products, on January 16, 2024, according to a press release. The reason cited for this action was the alleged failure of these applications to provide sufficient data regarding ingredient delivery, product stability, and potential for misuse.

Shenzhen IVPS strongly opposes this claim, stating that the company has invested over $30 million in these applications, with a total of over 600,000 pages. IVPS has also conducted robust aerosol testing for harmful components, in vitro toxicology testing and toxicology analysis, accelerated and 24-month storage and stability testing, as well as rigorous clinical pharmacokinetic studies to assess the potential for product abuse.

Welfer Ouyang, CEO of IVPS, expressed concern over the MDO for nicotine-free e-cigarette devices, stating that the FDA is selectively choosing isolated data from testing that contradicts the product labels' clear warnings, while disregarding the positive performance of these products in toxicology and safety aspects.

Shenzhen IVPS also claimed that the statements made by the FDA in the press release announcing the MDO regarding the level of adolescent use of SMOK products were misleading. The FDA stated that the 2023 National Youth Tobacco Survey showed that "11.3% of middle and high school students reported using SMOK products in the past 30 days." However, the actual study revealed that only 7.7% of high school and middle school students reported using ENDS products in the past 30 days. Among these users, only 11.3% reported using SMOK products, accounting for less than 0.88% of the surveyed students, not 11.3% as claimed by the FDA.

The US Court of Appeals for the Fifth Circuit has overturned the FDA's issuance of two additional MDO to two bottled e-liquid manufacturers in 2021. The court ruled that the FDA's decision constituted an "unexpected reversal" as the agency suddenly introduced new research requirements months after the applicants were asked to submit their applications, without prior notification or opportunity to meet the new research requirements.