WASHINGTON — U.S. health regulators on Thursday ordered Juul to withdraw its e-cigarettes from the market, in the latest blow to an embattled company widely blamed for sparking a surge in teen vaping in the country.
The action is part of a wide-ranging effort by the Food and Drug Administration to put the multi-billion dollar vaping industry under scientific scrutiny after years of regulatory delays.
The FDA said Juul should stop selling its tobacco and menthol flavored vaping device and cartridges. Those that are already on the market should be removed. The agency said that consumers are not prohibited from owning or using Juul products.
To stay in the market, companies must show that their e-cigarettes benefit public health. In practice, this means proving that adult smokers who use them are more likely to quit or reduce their smoking, while teenagers are less likely to become addicted.
The FDA noted that some of the biggest sellers, such as Juul, may have played a “disproportionate” role in the rise in vaping among teenagers. On Thursday, the agency said there was not enough evidence in Juul’s statement to show that marketing of its products is “fit to protect public health.”
Juul said he disagreed with the FDA’s findings and would seek to delay the ban while the company considers its options, including possible appeal and negotiations with regulators.
The FDA said in a statement that Juul’s filing left serious questions for regulators and did not provide enough information to assess any potential risks. The agency said the company’s research included “insufficient and conflicting data” about things like potentially harmful chemicals released from Juul cartridges.
“Without the data needed to determine the relevant health risks, the FDA issues these do not market orders.” This is stated in a statement by Michelle Mital, Acting Director of the FDA Tobacco Center.
Joe Murillo, Juul’s director of regulation, said in a company statement that Juul has provided sufficient information and data to resolve all issues raised by regulators. He noted that the company’s application, filed more than two years ago, included comparisons with combustible cigarettes and other products.
He said it also contained information about the potential harmful effects of the company’s products.
Since last fall, the FDA has given the go-ahead for tobacco-flavored e-cigarettes from RJ Reynolds, Logic, and others. But industry players and tobacco advocates complain that these products account for only a tiny percentage of the US $6 billion vaping market.
The agency said Thursday that people who use Juul products or smokers who want to quit cigarettes and cigars can switch to FDA-approved e-cigarettes.
Regulators have repeatedly delayed decisions on devices from market leaders, including Juul, which remains the top-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, largely due to their potential appeal to underage teens.
Anti-tobacco groups hailed the FDA’s move, with the American Lung Association calling it “long overdue and long overdue.” The American Vapor Manufacturers Association said it was a “shameful decision”.
E-cigarettes first appeared in the US over a decade ago with the promise of providing smokers with a less harmful alternative. The devices convert the nicotine solution into vapor that is inhaled, bypassing many of the toxic chemicals produced when tobacco is burned.
But studies have reached conflicting results as to whether they actually help quit smoking. And the FDA’s efforts to rule on vaping products and their claims have been repeatedly slowed down by industry lobbying and competing political interests.
The vaping market has grown to hundreds of companies selling many devices and nicotine solutions in various flavors and strengths.
Vaping took on new urgency in 2018, when Juul’s high-nicotine, fruit-flavoured cartridges quickly became a nationwide craze among middle and high school students. The company is facing multiple 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 forced to stop all advertising and abandon its fruit and dessert flavors. The following year, the Food and Drug Administration (FDA) limited flavors in small vaping devices to tobacco and menthol only. Separately, Congress raised the age to purchase all tobacco and vaping products to 21.
But the question of whether e-cigarettes should remain on the market at all remains.
The FDA worked by 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 political pressure from these groups played a role in the FDA’s decision.
“I think it would be difficult for them to come to any other conclusion,” said Warner, who did not see Yule’s statement. He added that he does not take money for tobacco.
In response, an FDA spokesman said the company did not provide enough information to fully assess the risk of its products, and that alone would prevent the agency from inferring in favor of Juul.
While Juul remains a top seller, a recent federal survey shows teens are leaving the company.
Overall, the survey showed a nearly 40% drop in teen vaping as many children were forced to homeschool during the pandemic. However, federal officials caution against interpreting the results given that they were collected online for the first time and not in classrooms.
The brainchild of two students from Stanford University, Juul was launched in 2015 and within two years has skyrocketed to the top of the vaping market. Juul still accounts for almost 50% of the e-cigarette market in the US. It once controlled over 75%.
Tobacco giant Altria, which makes Marlboro cigarettes, paid almost $13 billion for a 35% stake in Juul in 2018.
On Tuesday, the FDA also laid out plans to set maximum levels of nicotine for certain tobacco products to reduce addiction. In the announcement, the agency also noted that it has invested in a multimedia education campaign to warn young people about the potential risks of e-cigarette use.