WASHINGTON (AP) – U.S. health regulators on Thursday ordered Juul to withdraw its e-cigarettes from the market, the latest blow to the troubled company, widely accused of causing a nationwide increase in vaporization. teenagers.
The action is part of a comprehensive effort by the Food and Drug Administration to bring scientific scrutiny to the multimillion-dollar vaping industry after years of regulatory delays.
The FDA said Juul should stop selling its spray device and its tobacco and menthol-flavored cartridges. Those already on the market should be withdrawn. Consumers have no restrictions on owning or using Juul products, the agency said.
To stay in the market, companies must demonstrate that their e-cigarettes benefit public health. In practice, this means showing that adult smokers who use them are likely to quit smoking or reduce their consumption, while teenagers are unlikely to stick to them.
The FDA noted that some of the larger vendors like Juul may have played a “disproportionate” role in increasing 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 adequate for the protection of public health.”
Juul said he disagrees with the FDA’s findings and will try to suspend the ban while the company considers its options, including a possible appeal and talk to regulators.
In a statement, the FDA said the Juul application left regulators with important questions and did not include enough information to assess any potential risk. The agency said the company’s investigation included “insufficient and conflicting data” on things such as potentially harmful chemicals that were leaching from Juul’s cartridges.
“Without the data needed to determine the relevant health risks, the FDA issues these marketing denial orders.” Michele Mital, acting director of the FDA tobacco center, said in the statement.
Joe Murillo, Juul’s regulatory director, said in the company’s statement that Juul presented enough information and data to address all the issues raised by regulators. He noted that the company’s application, filed more than two years ago, included comparisons to combustible cigarettes and other products.
He said it also included information on the possible harmful effects of the company’s products.
Since last fall, the FDA has given permission to tobacco-flavored e-cigarettes from RJ Reynolds, Logic, and other companies. But industry players and tobacco advocates have complained that these products account for only a small percentage of the $ 6 billion vaporization market in the U.S.
The agency said Thursday that people who use Juul products or smokers who want to get away from cigarettes and cigars could switch to FDA-approved e-cigarettes.
Regulators have repeatedly delayed decision-making on devices from market leaders, including Juul, which remains the best-selling vaporization brand even though sales have fallen.
Last year, the agency rejected applications for more than a million e-cigarettes and related products, primarily because of their potential to appeal to underage teens.
Tobacco groups applauded the FDA’s move, and the American Lung Association called it “very backward and welcome.” The American Steam Manufacturers Association said it was a “shameful decision.”
Electronic cigarettes first appeared in the U.S. more than a decade ago with the promise of providing smokers with a less harmful alternative. The devices heat a solution of nicotine in an inhaled vapor, avoiding many of the toxic chemicals produced by tobacco burning.
But studies have come to contradictory results on whether they really help smokers quit. And FDA efforts to rule on vaporization products and their claims have been repeatedly slowed by industry lobbying and competitive political interests.
The vaporization market grew to include hundreds of companies selling a wide variety of nicotine devices and solutions in various flavors and strengths.
The vaping problem took on a new urgency in 2018, when Juul’s high nicotine and fruity-flavored cartridges quickly became a nationwide craze among high school and high school students. The company faces a series of federal and state research on its early marketing practices, which include distributing free Juul products at concerts and parties organized by young influencers.
In 2019, the company was pressured to stop all advertising and eliminate its fruit and dessert flavors. The following year, the FDA limited the flavors of small vaporizers to tobacco and menthol only. Separately, Congress raised the age of purchase of all tobacco and vaporization products to 21 years.
But the question remained as to whether e-cigarettes should remain on the market.
The FDA has been working under a court order to make its decisions; anti-tobacco groups successfully sued the agency to expedite its review.
Kenneth Warner, a tobacco expert at the University of Michigan School of Public Health, suspects that political pressure from these groups played a role in the FDA’s decision.
“I think they would have had a hard time coming to any other conclusion,” said Warner, who had not seen Juul’s request. He added that he does not take money from tobacco.
In response, an FDA spokesman said the company did not provide enough information for a full risk assessment of its products, and that alone would prevent the agency from being in favor of Juul.
While Juul remains one of the best sellers, a recent federal survey shows teens have moved away from the company.
Overall, the survey showed a nearly 40% drop in the vaporization rate of teens, as many children were forced to learn from home during the pandemic. Still, federal officials warned about interpreting the results, as they were collected online for the first time, rather than in classrooms.
The creation of two Stanford University students, Juul was launched in 2015 and in two years reached the top of the vaporization market. Juul still accounts for nearly 50% of the U.S. e-cigarette market. He once controlled more than 75%.
Tobacco giant Altria, which makes Marlboro cigarettes, paid close to $ 13 billion for a 35% stake in Juul in 2018.
On Tuesday, the FDA also unveiled plans to set a maximum nicotine level for certain tobacco products to reduce its addiction. In this 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 using e-cigarettes.
___
Murphy reported from Indianapolis.
___
The Associated Press Department of Health and Science is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.