FDA bans Juul e-cigarettes linked to increased vaping in teens

US health regulators on Thursday ordered Juul to withdraw its e-cigarettes from the market, the latest blow to the ailing company widely blamed for sparking a national wave of teen vaping.

The action is part of a sweeping effort by the Food and Drug Administration to force a scientific examination of the multibillion-dollar e-cigarette industry after years of regulatory delays.

The U.S. Food and Drug Administration said Juul should stop selling vaping device, tobacco flavor cartridges, and menthol. Those already on the market should be removed. The agency said consumers are not restricted from owning or using Juul products.

To survive in the market, companies must show that e-cigarettes benefit public health. In practice, this means demonstrating that adult smokers who use them are more likely to quit or reduce smoking, while adolescents are less likely to get involved.

The FDA has suggested that some of the biggest sellers such as Juul may have played a “disproportionate” role in the high rate of teen vaping. The agency said Thursday that Juul’s app does not contain sufficient evidence to show that marketing of its products “would be appropriate to protect 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 speaking with regulators.

The Food and Drug Administration, in a statement, said Jules’ request left regulators important questions and did not include enough information to assess any potential risks. The agency said the company’s research included “inadequate and conflicting data” about things like leakage of harmful chemicals from Joule cartridges.

“Without the data necessary to determine the relevant health risks, the Food and Drug Administration issues these marketing denial orders.” Michelle Mittal, acting director of the Food and Drug Administration’s Tobacco Center, said in the statement.

Joe Murillo, Juul’s chief regulatory officer, said in the company statement that Juul has provided sufficient information and data to address all of the issues raised by regulators. He noted that the company’s application, which it submitted more than two years ago, included comparisons to combustible cigarettes and other products.

It also included information about the potential adverse effects of the company’s products, he said.

Since last fall, the Food and Drug Administration has granted approval for tobacco-flavored e-cigarettes from RJ Reynolds, Logic, and other companies. But industry players and tobacco control advocates have complained that these products represent only a small percentage of the $6 billion vaping market in the United States.

The agency said Thursday that people who use Juul products or smokers who want to stay away from cigarettes and cigars can switch to FDA-approved e-cigarettes.

Regulators have repeatedly postponed decisions on devices from market leaders, including Juul, which remains the best-selling vaping brand despite declining sales.

Last year, the agency denied applications for more than 1 million other e-cigarettes and related products, mainly because of their potential appeal to underage teens.

Anti-tobacco groups praised the FDA’s move, with the American Lung Association calling it “long overdue and most welcome.” The American Vapor Manufacturers Association said it was a “shameful decision”.

E-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 of the toxic chemicals from burning tobacco.

But studies have come up with conflicting results about whether they actually help smokers quit. Efforts by the FDA to judge e-cigarette products and claims have repeatedly been slowed by industry pressure and competing political interests.

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

The issue of vaping gained new prominence in 2018 when Juul’s high-nicotine, fruity cartridges quickly became a nationwide craze among middle and high school students. The company is facing a slew 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 came under pressure to stop all advertising and phase out fruit and sweet flavors. The following year, the U.S. Food and Drug Administration (FDA) limited the flavors in small vaping devices to tobacco and menthol only. Separately, Congress raised the age to buy all tobacco and vaping products to 21.

But the question is whether e-cigarettes should remain on the market at all.

The Food and Drug Administration operates under a court order to make its decisions; Anti-tobacco groups successfully sued the agency to speed up its review.

Kenneth Warner, a tobacco expert at the University of Michigan School of Public Health, suspects that political pressure from those groups played a role in the FDA’s decision.

“I think they would have had a hard time coming up with any other conclusion,” said Warner, who was not familiar with Juul’s request. He added that he does not take tobacco money.

In response, an FDA spokesperson said the company had not provided enough information to conduct a full risk assessment of its products, and that alone would prevent the agency from finding Juul’s favour.

While Juul remains a top seller, a recent federal survey showed that teens are turning away from the company.

Overall, the survey showed a nearly 40% reduction in the rate of teen vaping, as many children were forced to learn from home during the pandemic. However, federal officials cautioned against interpreting the results because they were collected online for the first time, rather than in the classroom.

The brainchild of two Stanford University students, Juul launched in 2015 and within two years climbed to the top of the vaping market. Juul still accounts for nearly 50% of the US e-cigarette market. It once dominated over 75%.

Tobacco giant Altria, which makes Marlboro cigarettes, paid nearly $13 billion for a 35% stake in Juul in 2018.

On Tuesday, the US Food and Drug Administration also made plans to set a maximum nicotine level for some tobacco products to reduce their addiction. In that announcement, the agency also indicated that it had invested in a multimedia public awareness campaign to warn young people about the potential risks of e-cigarette use.

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Murphy reported from Indianapolis.

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

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