FDA: Once Dominant E-Cigarette Brand Juul Must Exit US Market

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 withdraw its currently available products from the U.S. market , the US Food and Drug Administration (FDA) announced.

The FDA order means that Juul must stop selling and distributing its device and its accompanying menthol and tobacco-flavored e-liquid pods in the U.S. In a June 23 statement, FDA officials FDA said they did not have enough data on the toxicological risks of Juul products. to authorize its continued sale.

“To date, the FDA has received no clinical information suggesting an immediate hazard associated with the use of the JUUL device or JUULpods,” the statement said. “However the [decision] issued today reflect the FDA’s determination that there is insufficient evidence to evaluate potential toxicological risks from the use of JUUL products.”

The controversial move, which comes just days after the FDA announced plans to limit nicotine levels in cigarettes, could shake up the US vaping industry. While Juul has lost much of its market share in In recent years, their electronic cigarettes are some of the most popular across the country. As of May, Juul reportedly controlled about a third of the US e-cigarette market, according to data from convenience stores. Although Juul products are sold in other countries, the US is its largest market.

Tobacco giant Altria, which owns a 35% stake in Juul Labs, saw its share price fall nearly 10% after Wall Street. Daily reported on the expected FDA decision on June 22.

Juul could still appeal the decision or challenge it in court, potentially allowing its products to remain on the market while the issue is litigated. The company could also focus on getting authorization for a high-tech version of its product that would be unlocked only for users of legal age. No such product is currently available in the US, but versions have been sold in Canada and the UK. A Juul representative did not immediately provide comment.

Eric Lindblom, a former official with 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 pull Juul. from 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 the FDA knew about this potentially risky glitch with Juul’s e-cigarettes, why didn’t they take action sooner against those currently on the market to protect consumers from leaking harmful chemicals, etc.?” he wrote in an email to TIME. “Are these technical issues unique to Juul and not shared by any of the e-cigarettes the FDA has allowed on the market?”

For nearly two years, the FDA has been reviewing data provided by US e-cigarette manufacturers to determine whether their products can improve public health. That assessment depends largely on whether a particular product provides enough benefits to smokers, by helping them switch to a less dangerous alternative to cigarettes, to outweigh disadvantages such as underage use or related health risks. with vaping.

A former Juul employee with knowledge of the company’s FDA request says there is “no question” it met that standard with its data, though the FDA evidently disagreed. “Many of these decisions are political,” says the former employee. “They are not necessarily evidence-based.”

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 of the major manufacturers, including some of Juul’s direct competitors.

In October 2021, the FDA cleared tobacco company RJ Reynolds’ Vuse Solo and its tobacco-flavored pods, making it the first e-cigarette to be sold in the US with agency clearance. The agency authorized the continued sale of additional Vuse products in May 2022, followed by tobacco-flavored products manufactured under the NJOY brand in June.

“The only difference [between those companies and Juul] is the social phenomenon that is linked to [Juul]”, says the former Juul employee. “There’s no way to divorce that from Juul, the brand.”

Juul has always faced an uphill battle with the FDA, given its reputation as a favorite among teens. In 2019, at the height of what the FDA called an “epidemic” of youth vaping, 27.5% of high school students said they currently vaped. Juul was widely blamed for that phenomenon, both by independent public health experts and by former FDA Commissioner Dr. Scott Gottlieb. “The dramatic leap of youth [vaping] – that was fueled in part, at least, if not in large part, by Juul,” he told Vox in a 2019 interview.

The device launched to great fanfare in 2015. Its bright and colorful launch campaign featured young, hip models and showcased the sleek Juul device, which looks like a flash drive, in a way that made some tobacco control experts fear it it was meant to appeal to young users.

Juul has repeatedly denied that it intentionally targeted teenagers, but it never shook that perception. As youth vaping rates increased over the years, “juuling” became both a cultural phenomenon and a shorthand for underage vaping. Some high schools went so far as to ban flash drives, since they were easily mistaken for Juuls, or removed the doors from the bathrooms, where students vaped so much they dubbed them “Juul rooms.” Even after it pulled its fruity and sweet flavors from store shelves, shut down its US social media accounts, stopped most advertising, and spent $30 million on youth vaping prevention, Juul it was still known as the brand that sparked a new form of nicotine addiction in teens.

Youth vaping inspired a regulatory crackdown not just against Juul, but 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 for tobacco sales to 21.

Vaping rates among young people have been declining in recent years. In 2021, about 11% of high school students and 3% of high school students said they currently vape, according to federal data. And Juul was no longer the most popular e-cigarette among teen vapers: Less than 6% of high school vapers said Juul was their brand of choice, compared to 26% who favored Puff Bar, a brand of disposable vapes .

Before Juul caught on among American children, 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 the levels of nicotine in cigarettes, he advocated promoting less dangerous options like nicotine gum, patches and e-cigarettes.

“We think e-cigarettes could provide a less harmful alternative for adult smokers who don’t want to give up nicotine,” Gottlieb said in an interview for my book, Big Vape: The Incendiary Rise of Juul. “Obviously our worldview and framing changed…when we started getting reports that youth e-cigarette use was on the rise. We began to implement a series of enforcement measures against Juul, in particular.”

That new worldview became apparent after news of the long-awaited FDA decision broke Wednesday. “JUL was [the] foothold of youth vaping crisis; was driven by their products and marketing practices,” Gottlieb tweeted. “The FDA is right to be circumspect.”

Despite Juul’s controversial past, some believe regulating the product’s disposal is a public health loss. E-cigarettes are also used by adults looking for a less harmful alternative to cigarettes, and removing one of the country’s leading brands from the market could make that task more difficult.

There is much debate about how well e-cigarettes work for adults looking to quit 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. With smoking-related illnesses killing nearly half a million Americans each year, any improvement in that area could save lives.

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 intention to limit the amount of nicotine in all cigarettes. His 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 protected]

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