On Thursday, June 23, the U.S. Food and Drug Administration issued marketing denial orders to JUUL’s e-cigarette products, including their menthol and tobacco-flavored pods. In its statement, the agency claims that JUUL did not provide sufficient data to prove their products were appropriate for the protection of public health.
Specifically, the FDA claims that “there is insufficient evidence to assess the potential toxicological risks of using JUUL products.” The agency is also seemingly blaming JUUL for other companies stealing their product design, with FDA remarking that there “is no way to know the potential harms from using unauthorized third-party e-liquid pods with the JUUL device or using JUUL pods with a non-JUUL device.”
Since 2018, JUUL has been available for sale worldwide, including Canada, Russia, and the UK. In contrast to the States, where fearmongering and alarmism regarding reduced risk tobacco products remains rampant, the UK is leading the world in transitioning people who smoke to e-cigarettes and other less harmful alternatives. In fact, in that country, where JUULs are readily available to adults, the government “provides a subsidy for e-cigarettes licensed as medicinal products” to help low-income persons quit smoking.
In issuing its denial, the FDA is clearly appealing to the misguided efforts of Michael Bloomberg-backed public health groups and politicians. Since 2019, Congress has spent an inordinate amount of time examining JUUL and their role in youth vaping. In 2021, lawmakers doubled down and urged the FDA to deny JUUL’s marketing orders.
While Congress urged the FDA to deny JUUL, youth use of their products was significantly declining. In fact, according to the Monitoring the Future Survey, past 30-day use of JUUL products among 12th graders declined by 46.9% between 2019 and 2021. Moreover, among 10th graders, use of JUUL declined by 75.3% in the same time period. Interestingly, the decline of youth use of JUUL products has been greater than the overall decline of youth vaping. Between 2019 and 2021, among 10th graders, past 30-day use of vapor products declined by only 37.6%.
Given the data, it is incredulous that the FDA claims that removing less harmful tobacco products from the market will protect public health. As evidenced in prior prohibitionist policies, banning products doesn’t work and in absence of a highly regulated product like JUUL, other actors will enter the market place. In fact, one brand claims to be the “leading developer of JUUL-compatible pods,” and a quick search on the internet reveals how easy it is to purchase these products, despite the company not having a marketing order.
The FDA should be ashamed of itself. Not only is the agency bowing down to misguided politicians, but it is opening the door for unregulated products to flourish. Moreover, the entire process to be able to market less harmful tobacco products is an entire sham, and JUUL is correct in asking the courts to block the FDA denial. Ultimately, it seems that judges—not a purported public health agency of the U.S.—will determine if smokers can get access to tobacco harm reduction products.