FDA orders all Juul electronic cigarettes removed from US market

WASHINGTON (AP) — Federal health officials on Thursday ordered Juul to pull its e-cigarettes from the U.S. market, the latest blow to the embattled company widely blamed for sparking a national surge in teen vaping.

The action is part of a broader effort by the Food and Drug Administration to bring scientific scrutiny to the multi-billion dollar vaping industry after years of regulatory delays.

The FDA said Juul must stop selling its tobacco- and menthol-flavored vaping device and cartridges. Those already on the market should be removed. Consumers are not barred from having or using Juul’s products, the agency said.

To stay on the market, companies must demonstrate that their e-cigarettes benefit public health. In practice, this means proving that adult smokers who use them are likely to quit or cut down, while teenagers are unlikely to become addicted.

The FDA noted that some of the biggest sellers like Juul may have played a “disproportionate” role in the rise in teen vaping. The agency said Thursday that Juul’s application did not have enough evidence to show that the marketing of its products “would be appropriate for the protection of public health.”

Juul said it disagrees with the FDA’s findings and will seek to suspend the ban while the company considers its options, including a possible appeal and discussions with regulators.

In a statement, the FDA said Juul’s application left regulators with important questions and did not include enough information to assess potential risks. The agency said the company’s research included “insufficient and conflicting data” on things like potentially harmful chemicals leaking from Juul’s cartridges.

“Without the data necessary to determine the relevant health risks, the FDA is issuing these marketing denial orders.” Michele Mital, acting director of the FDA’s Tobacco Center, said in the statement.

The agency has granted some e-cigarette requests. Since last fall, the agency has given its approval to tobacco-flavored e-cigarettes from RJ Reynolds, Logic and other companies.

But industry players and anti-tobacco advocates have complained that these products make up only a tiny percent of the $6 billion vaping market in the United States.

Regulators have repeatedly delayed decisions on devices from market leaders, including Juul, which remains the top-selling vaping brand despite sales falling.

Last year, the agency rejected applications for more than a million other e-cigarettes and related products, mostly because of their potential appeal to underage teenagers.

The American Lung Association called Thursday’s decision “long overdue and welcome” and cited Juul for encouraging youth vaping.

Electronic cigarettes first appeared in the United States over a decade ago with the promise of providing smokers with a less harmful alternative. The devices heat a nicotine solution into a vapor that is inhaled, bypassing many toxic chemicals produced by burning tobacco.

But studies have come up with conflicting results about whether they really help smokers quit. And the FDA’s efforts to rule on vaping products and their claims have been repeatedly slowed by lobbying from industry and competing political interests.

The vaping market has grown to include hundreds of companies selling a range of devices and nicotine solutions in different flavors and strengths.

The vaping problem took on new urgency in 2018 when Juul’s high-nicotine, fruity-tasting cartridges quickly became a national craze among middle and high school students. The company faces a slew of federal and state investigations into its early marketing practices, which included handing out free Juul products at concerts and parties hosted by young influencers.

In 2019, the company was forced to stop all advertising and phase out its fruit and dessert flavors. The following year, the FDA limited the flavors of small vaping devices to tobacco and menthol. Separately, Congress has raised the age of purchase for all tobacco and vaping products to 21.

But the question of whether e-cigarettes should stay on the market remains.

The FDA worked under a court order to make its decisions; anti-tobacco groups successfully sued the agency to expedite its review.

FDA regulators have warned companies for years that they should submit rigorous, long-term data showing a clear benefit for smokers switching to vaping. But all but the biggest e-cigarette manufacturers have resisted this kind of expensive and time-consuming research.

Although Juul remains a top seller, a recent federal survey shows teens are turning away from the company. Last year’s survey showed Juul to be the fourth most popular e-cigarette among high school students who vape regularly. The most popular brand was a disposable e-cigarette called the Puff Bar that comes in flavors like pink lemonade, strawberry, and mango. This company’s disposable e-cigarettes have been able to circumvent regulations because they use synthetic nicotine, which until recently was outside the jurisdiction of the FDA. Congress recently closed this loophole.

Overall, the survey showed an almost 40% drop in vaping rates among teens, as many children were forced to learn at home during the pandemic. Still, federal officials cautioned against interpreting the results given that they were collected online for the first time, rather than in classrooms.

The brainchild of two Stanford University students, Juul was launched in 2015 and within two years has risen to the top of the vaping market. Juul, which is part-owned by tobacco giant Altria, still accounts for nearly 50% of the US e-cigarette market. He once controlled more than 75%.

On Tuesday, the FDA also outlined plans to set maximum nicotine levels for certain tobacco products to reduce addiction. In the announcement, the agency also noted that it had invested in a multimedia public education campaign aimed at warning young people of the potential risks of e-cigarette use.

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AP Health Writer Tom Murphy contributed to this report.

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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.

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