FDA bans Juul e-cigarettes linked to rise in teen vaping

By MATTHEW PERRONE

WASHINGTON (AP) — Juul was ordered Thursday by federal health officials to withdraw its e-cigarettes from the U.S. market, the latest blow to the beleaguered company widely blamed for sparking a national surge in teen vaping.

The action is part of a larger effort by the Food and Drug Administration to bring scientific scrutiny to the multibillion-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 that are already on the market must be eliminated. Consumers are not restricted from owning or using Juul products, the agency said.

To stay on the market, companies must show that their e-cigarettes benefit public health. In practice, that means showing that adult smokers who use them are likely to quit or cut down, while adolescents are unlikely to get hooked on them.

The FDA noted that some of the larger vendors like Juul may have played a “disproportionate” role in the rise of teen vaping. The agency said Thursday that Juul’s application had insufficient evidence to show that marketing its products “would be appropriate for the protection of public health.”

A Juul representative did not immediately respond to an Associated Press request for comment.

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 investigation included “insufficient and conflicting data” about things like the leaching of potentially harmful chemicals from Juul 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, in the statement.

The agency has granted some e-cigarette applications. 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 those products make up only a small percentage of the $6 billion vaping market in the US.

Regulators have repeatedly delayed making decisions on devices from market leaders, including Juul, which remains the best-selling vaping brand even though sales have fallen.

Last year, the agency turned down applications for more than a million other e-cigarettes and related products, primarily because of their potential appeal to underage teens.

The American Lung Association called Thursday’s decision “very overdue and very welcome,” citing Juul for encouraging young people to vape.

E-cigarettes first appeared in the US more than 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 of the toxic chemicals produced by burning tobacco.

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

The vaping market grew to include hundreds of companies selling a variety of nicotine devices and solutions in various flavors and strengths.

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

In 2019, the company was pressured to stop all advertising and remove its fruit and dessert flavors. The following year, the FDA limited the flavors in small vaping devices to just tobacco and menthol. Separately, Congress raised the purchase age for all tobacco and vaping products to 21.

But the question remained whether e-cigarettes should remain on the market.

The FDA has been working under a court order to issue its decisions; anti-tobacco groups successfully sued the agency to expedite its review.

FDA regulators warned companies for years that they would have to submit rigorous long-term data showing a clear benefit to smokers who switch to vaping. But all but the biggest e-cigarette makers have resisted doing that kind of costly and time-consuming research.

While Juul remains a top seller, a recent federal survey shows that teenagers have been drifting away from the company. Last year’s survey showed that Juul was 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. That company’s disposable e-cigarettes had been able to evade regulation because they use synthetic nicotine, which until recently was outside the FDA’s jurisdiction. Congress recently closed that loophole.

Overall, the survey showed a nearly 40% drop in teen vaping rates, as many kids were forced to learn from 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 launched in 2015 and within two years had shot 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, once controlling more than 75%.

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

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AP Health reporter Tom Murphy contributed to this report.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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