SMOK’s Legal Challenge Against FDA: Navigating the Complex Intersection of Vaping Innovation and Public Health Regulations
Chinese Vape Brand SMOK Appeals Against US FDA’s Marketing Denial Order
On January 18, Shenzhen IVPS Technology Co., Ltd., the parent company of the SMOK brand, announced that it has filed an appeal with the United States Fifth Circuit Court of Appeals against the US Food and Drug Administration (FDA)’s marketing denial order for its SMOK open system e-cigarette kits and related replacement parts.
Previously, on January 16, the FDA issued a press release stating that it had issued marketing denial orders (MDOs) for 22 SMOK open system products, citing that the premarket tobacco product applications (PMTAs) for these products “failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.”
Shenzhen IVPS Technology strongly questioned the FDA’s assertions. The company disclosed that it had invested over $30 million in its PMTA submission, producing more than 600,000 pages of data. This included extensive testing for harmful and potentially harmful constituents in aerosols, in vitro toxicology tests, toxicological analysis, accelerated and 24-month storage and stability tests, as well as rigorous clinical pharmacokinetic studies, in collaboration with leading global laboratories.
The company also highlighted that the FDA’s press release misleadingly portrayed the expected level of youth usage of SMOK products. While the FDA claimed that the 2023 National Youth Tobacco Survey showed “11.3% of middle and high school students reported using SMOK products in the past 30 days,” Shenzhen IVPS pointed out that, according to The New York Times, only 7.7% of middle and high school students reported using nicotine vaping products for more than 30 days, and of those, only 11.3% reported using SMOK products.
What Happened Previously
On January 16, the FDA issued marketing denial orders to Shenzhen IVPS Technology Co., Ltd for 22 SMOK brand e-cigarette products. These products, including devices, pods, atomizers, and cartridges, are part of an e-cigarette system marketed without an e-liquid, meaning consumers can add their own choice of e-liquid. The FDA determined that the company’s PMTAs lacked sufficient evidence to demonstrate that permitting marketing of these products would be appropriate for the protection of public health, a standard set by the 2009 Family Smoking Prevention and Tobacco Control Act.
Specifically, the applications were found lacking in data to characterize constituent delivery, product stability, and product abuse liability. The denied products are not sold with an e-liquid, which means they can be used with any e-liquid available to consumers, including tobacco-flavored and non-tobacco flavored e-liquids.
Following the FDA’s rigorous scientific review, products receiving an MDO cannot be introduced or delivered for introduction into interstate commerce and must be removed from the market if they are currently marketed. However, the company may submit new applications for the products subject to these MDOs. This action is part of the FDA’s ongoing efforts to ensure that all new tobacco products undergo a science-based review and receive marketing authorization before being legally marketed. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices but has denied marketing applications for millions of products that did not meet the necessary public health standard.
Balancing Innovation and Regulation: A Closer Look at the SMOK vs. FDA Dispute
The clash between Shenzhen IVPS Technology (SMOK) and the FDA represents a significant moment in the vaping industry. The FDA’s strict stance is a clear signal of their commitment to public health and rigorous scientific standards. The denial of SMOK’s products, based on insufficient data regarding safety and abuse potential, underscores the challenges vape companies face in navigating regulatory landscapes.
However, Shenzhen IVPS’s decision to appeal and their substantial investment in research and testing suggest that vape manufacturers are willing to engage deeply with regulatory processes. This could be seen as a positive sign, indicating that companies are taking scientific scrutiny and public health concerns seriously.
The discrepancy in youth usage statistics between the FDA and external sources like The New York Times raises questions about the portrayal and perception of vaping among young people. It’s a complex issue, with the need to balance public health concerns, especially among youth, against the rights of businesses to market their products.
Overall, this situation illustrates the ongoing tension between innovation in the vaping industry and public health priorities. As vaping technology evolves and becomes more popular, especially among younger demographics, the role of regulatory bodies like the FDA becomes increasingly crucial. The outcome of this appeal could set a precedent for how similar cases are handled in the future, potentially shaping the vaping landscape for years to come.
