On Jan. 16th, the FDA issued marketing denial orders (MDOs) to Shenzhen IVPS Technology Co., Ltd for 22 SMOK vape products. The denial orders are directed at devices, pods, atomizers, and cartridges free from (and marketed without) e-liquid, including the SMOK POZZ, SMOK RPM 40, and fan-favorite SMOK Nord 2.
The SMOK products in question are part of open-system vape devices that vapers buy independently of e-liquids. The FDA acknowledges that SMOK e-cigarettes are not sold with e-liquids, but concludes that they “have the potential to be used with any e-liquid on the market […] which could include tobacco-flavored and non-tobacco-flavored e-liquids.”1“FDA Denies Marketing of SMOK E-Cigarette Products,” U.S. Food and Drug Administration, [Online]. Available: https://www.fda.gov/tobacco-products/ctp-newsroom/fda-denies-marketing-smok-e-cigarette-products
This logic sets a dangerous new precedent and opens the floodgates for even harsher anti-vape legislation.
Since 2020, the FDA has received Premarket Tobacco Product Applications (PMTAs) for more than 26 million products. It has authorized just 26, all of which are tobacco-flavored products and devices.
Previously, the FDA has only issued denial orders to disposable vape devices and cartridge-based systems, which are at the center of the moral panic around vape products marketed to young people, despite a decrease in the number of teen vapers. Instead of acknowledging the statistics, the FDA has doubled down on the current anti-vape sentiment in the U.S.
Vape manufacturers are fighting back against the growing anti-vape rhetoric. On Jan. 18th, Shenzhen IVPS Technology petitioned to review its MDOs. This follows a rush of similar appeals from manufacturers and retailers that are being pushed out of the vape market in the U.S. Earlier this month, the same appeals court granted petitions to review to two e-liquid manufacturers.
One of the main contentions in SMOK’s petition refers to the FDA’s misuse of statistics. The FDA stated that 11.3% of all students who took part in the 2023 National Youth Tobacco Survey2“Results from the annual National Youth Tobacco Survey (NYTS),” U.S. Food and Drug Administration, [Online]. Available: https://www.fda.gov/tobacco-products/youth-and-tobacco/results-annual-national-youth-tobacco-survey reported using SMOK products in the last 30 days. In fact, the survey found that 11.3% of all students who vaped named SMOK, which accounts for less than 1% of all middle and high schoolers.
In a press release, SMOK revealed it spent $30 million to conduct tests and create robust PMTAs for the denied products. The PMTAs contained more than 600,000 pages of evidence, which included detailed information on robust and harmful constituent aerosol testing, in vitro toxicology testing, rigorous clinical pharmacokinetic studies, and more.
Brian King, director of the FDA’s Center for Tobacco Products (CTP), shed some light on the issue. “It’s the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of public health,”3“FDA Denies Marketing of SMOK E-Cigarette Products,” U.S. Food and Drug Administration, [Online]. Available: https://www.fda.gov/tobacco-products/ctp-newsroom/fda-denies-marketing-smok-e-cigarette-products. he said. “In this case, the applicant failed to provide the evidence.”
This new precedent joins the list of never-ending blows leveled against vape manufacturers and retailers around the globe. In the last six months, French politicians backed a proposal to ban single-use e-cigarettes and UK legislators announced a plan to increase the tax on e-liquids.
Given the inexplicable logic behind the FDA’s decision to block open-system SMOK products, we would not be surprised to see more unfair, unprecedented rulings in the coming months.
