Juul Labs, the popular e-cigarette company once known for its fruity flavors and blamed by federal regulators and public-health groups for sparking a youth vaping epidemic, must pull its currently available products from the U.S. market, the U.S. Food and Drug Administration (FDA) announced.
The FDA’s order means that Juul must stop selling and distributing its device and accompanying menthol- and tobacco-flavored e-liquid pods in the U.S. In a June 23 statement, FDA officials said they did not have enough data about the toxicological risks of Juul’s products to authorize their continued sale.
“To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods,” the statement says. “However, the [decision] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products.”
The controversial move, which comes just days after the FDA announced plans to limit nicotine levels in cigarettes, could reshuffle the U.S. vaping industry. While Juul has lost much of its market share in recent years, its e-cigarettes are some of the most popular nationwide. As of May, Juul reportedly controlled about a third of the U.S. e-cigarette market, based on convenience store data. While Juul products are sold in other countries, the U.S. is its largest market.
Juul could still appeal the decision or challenge it in court, which would potentially allow its products to stay on the market while the issue is litigated. The company could also focus on securing authorization for a high-tech version of its product that would unlock only for legal-aged users. No such product is currently available in the U.S., but versions have been sold in Canada and the U.K. A Juul representative did not immediately provide a comment.
Eric Lindblom, a former official at the FDA’s Center for Tobacco Products and a senior scholar at the O’Neill Institute for National and Global Health Law, was initially surprised after news broke that the FDA was expected to take Juul off the market, given that the agency recently authorized other similar vaping devices. The agency’s concerns about toxicological risks raise serious questions, he says.
“If FDA knew about this possible risky technical problem with Juul’s e-cigs, why didn’t it take action against those currently on the market sooner to protect consumers against leaching harmful chemicals, etc.?” he wrote in an email to TIME. “Are these technical problems unique to Juul—and not shared by any of the e-cigs FDA has allowed on the market?”
For almost two years, the FDA has been reviewing data provided by U.S. e-cigarette manufacturers to determine whether their products can improve public health. That assessment largely hinges on whether a particular product provides enough benefit to smokers—by helping them switch to a less-dangerous alternative to cigarettes—to make up for downsides like underage use or health risks related to vaping.
A former Juul employee with knowledge of the company’s FDA application says there’s “no question” it met that standard with its data—though the FDA evidently disagreed. “Many of these decisions are political,” the former employee says. “They’re not necessarily based on the evidence.”
As of March 2022, the FDA had denied applications covering more than 1 million e-cigarette products, many of which came from small, independent vaping companies. But it has granted marketing authorization to some major manufacturers, including some of Juul’s direct competitors.
In October 2021, the FDA authorized tobacco company R.J. Reynolds’ Vuse Solo and its tobacco-flavored pods, making it the first e-cigarette to be sold in the U.S. with the agency’s clearance. The agency authorized the continued sale of additional Vuse products in May 2022, followed by tobacco-flavored products made by the brand NJOY in June.
“The only difference [between those companies and Juul] is the social phenomenon that’s attached to [Juul],” says the former Juul employee. “There’s no way to divorce that from Juul the brand.”
Juul always faced an uphill battle with the FDA, given its reputation as a favorite product among teens. In 2019, at the height of what the FDA called a youth vaping “epidemic,” 27.5% of high school students said they currently vaped. Juul was widely blamed for that phenomenon, both by independent public-health experts and former FDA Commissioner Dr. Scott Gottlieb. “The dramatic spike of youth [vaping] — that was driven in part, at the very least, if not largely, by Juul,” he told Vox in a 2019 interview.
The device launched with a splash in 2015. Its bright, colorful launch campaign featured young, trendy models and showed off the sleek Juul device, which looks like a flash drive, in a way that made some tobacco-control experts fear it was meant to lure young users.
Juul has repeatedly denied that it intentionally targeted teenagers, but it never shook that perception. As youth vaping rates climbed upward over the years, “juuling” became both a cultural phenomenon and shorthand for underage vaping. Some high schools went so far as to ban flash drives—since they were so easily confused with Juuls—or to remove stall doors in the bathrooms, where students vaped so much they were nicknamed “Juul rooms.” Even after it pulled its fruity and sweet flavors off store shelves, shut down its U.S. social media accounts, stopped most advertising, and invested $30 million in youth vaping prevention, Juul was still known as the brand that sparked a new form of teen nicotine addiction.
Youth vaping inspired a regulatory crackdown not just on Juul, but on the entire vaping industry. In early 2020, the Trump Administration restricted the sale of many flavored e-liquids. Around the same time, the Administration raised the minimum age of tobacco sales to 21.
Youth vaping rates have declined for the past few years. In 2021, about 11% of high school students and 3% of middle school students said they currently vaped, according to federal data. And Juul was no longer the most popular e-cigarette among teenagers who vaped: Less than 6% of high school vapers said Juul was their preferred brand, compared to 26% who favored Puff Bar, a brand of disposable vaporizers.
Before Juul caught on among American kids, federal regulators were cautiously optimistic about the potential of e-cigarettes. In 2017, then-FDA Commissioner Gottlieb announced an ambitious plan to change the way Americans consume nicotine. In addition to limiting nicotine levels in cigarettes, he advocated for the promotion of less-dangerous options like nicotine gum, patches, and e-cigarettes.
“We thought e-cigarettes could provide a less harmful alternative for adult smokers who don’t want to quit nicotine,” Gottlieb said in an interview for my book, Big Vape: The Incendiary Rise of Juul. “Obviously, our worldview and framing pivoted…when we started to get reports that youth use of e-cigarettes was rising. We started to implement a series of enforcement actions against Juul, in particular.”
That new worldview was apparent after news of the FDA’s expected decision broke on Wednesday. “JUUL was [the] fulcrum of the youth vaping crisis; it was driven by their product and marketing practices,” Gottlieb tweeted. “FDA is right to be circumspect.”
Despite Juul’s controversial past, some believe that regulating the product out of existence is a loss for public health. E-cigarettes are also used by adults looking for a less-harmful alternative to cigarettes, and removing one of the country’s top brands from the market could make that more difficult.
There’s plenty of debate over how well e-cigarettes actually work for adults looking to stop smoking, and many questions remain about their long-term health effects. But studies suggest that e-cigarettes help at least some smokers quit and contain fewer known toxins than traditional tobacco cigarettes. Given that smoking-related diseases kill nearly half a million Americans each year, any improvement in that area could be lifesaving.
Under the Biden Administration, the FDA has taken an aggressive approach to tobacco regulation. It has moved forward with plans to ban menthol cigarettes and, more recently, announced its intent to cap the amount of nicotine in all cigarettes. Its decision to order Juul off the market is a continuation of that bold—and polarizing—public-health trend.
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Write to Jamie Ducharme at email@example.com