In a Surprise Move, the FDA Denies Approval for Juul Tobacco and Menthol Vapes
What was once a classic Silicon Valley success story has become the victim of an intensely ideological war on nicotine.
After nearly two years of review, the Food and Drug Administration (FDA) is preparing to deny Juul's application to keep its tobacco- and menthol-flavored vaping products on the market, according to reporting from The Wall Street Journal. The news is surprising; when compared to competitors' applications, Juul's was one of the most detailed and data-heavy, showing just how effective it was at transitioning smokers away from cigarettes, toward a safer alternative.
Research published in Nicotine and Tobacco Research that studied smokers who transitioned to Juuls found that smokers in North America were significantly more likely to switch to vaping than those in the United Kingdom who only had access to lower-strength nicotine products.
The company was founded by Stanford University classmates James Monsees and Adam Bowen, both of whom were smokers. Monsees and Bowen decided they no longer wanted to smoke but found the mix of options available for quitting unsatisfying, so they decided to make their own alternative in 2004.
The result was Juul. After years of finetuning, it turned out to be a hit, with many lifelong smokers switching, saying they'd finally found a product that worked for them. In 2018, Juul was valued more highly than Uber and was considered by many to be a promising prospect that could help make a smoke-free world through choice and innovation rather than prohibition and taxation. (Reason Foundation, the 501(c)(3) that publishes Reason, receives contributions from tobacco manufacturers.)
But what appeared to be a classic Silicon Valley success story soon became a victim of an intensely ideological war on nicotine. Unfortunately, Juul also for a time became the most popular product among minors who were experimenting with vaping. Youth vaping rates rose substantially. Current e-cigarette use, defined as taking a puff or more in the past 30 days, jumped from 11.7 percent in 2017 to 27.5 percent in 2019.
Juul was squarely blamed for the rise of youth vaping, with critics pointing to its initial marketing campaigns showing people in their early twenties enjoying the product. Critics alleged that flavors like mango and cucumber were especially appealing to the younger demographic. But what they forget is that in late 2016, the company switched to exclusively using models who are 35 or older in their advertising campaigns, as well as only using real customers who have switched from smoking to vaping. What anti-vaping campaigners also ignore is that the vast majority of adult vapers quit smoking using sweet or fruity flavors; such products are not just desired by teens.
The claim that Juul's flavors were the underlying cause for the rise in youth vaping is highly dubious, considering there were thousands of different flavors for other e-cigarettes on the market years before Juul took off. Surveys of teenagers by the Centers for Disease Control and Prevention show that just 13.2 percent of young people who use e-cigarettes say they do so for the flavors. Experimentation with e-cigarettes mimics other behaviors like alcohol and illicit drug use, often with the same populations engaging in these types of activities. But to appease critics, Juul voluntarily removed all flavors other than tobacco and menthol from the market in 2019.
The FDA's reasoning for banning Juul will most likely be that it presents a greater threat to nicotine-naive youth than the benefit it presents to adult smokers. This would be an extraordinary conclusion since, according to the 2021 National Youth Tobacco Survey, 89 percent of high schoolers are not using e-cigarettes at all and 95 percent are not using them frequently.
In 2020, the Cochrane Review, widely considered the gold standard for evaluating evidence-based medicine, concluded that e-cigarettes are more effective than traditional nicotine replacement therapies for helping smokers quit. By banning the most effective and popular e-cigarette on the market, there is no doubt that the FDA's choice will force a portion of current Juul users to go back to smoking, and an unknown number of smokers to never make the healthier switch to vaping. What economist Alex Tabarrok calls the FDA's "invisible graveyard" just got a whole lot bigger.