On Thursday, federal health officials ordered Juul to withdraw e-cigarettes from the US market.
This action is part of a radical effort by the Food and Drug Administration to bring scientific scrutiny to the multi-billion dollar e-cigarette industry after years of regulatory lag.
The FDA has stated that Juul must stop selling its vaping device and its tobacco and menthol-flavored cartridges. Those that are already on the market should be removed. Consumers are not restricted from owning or using Juul's products, the agency said.
To stay in the market, businesses must show that their e-cigarettes benefit public health. In fact, that means that adult smokers who use them may quit or reduce smoking, and teens are less likely to get hooked on them.
The FDA pointed out that the biggest sellers like Juul could have played a "disproportionate" role in the growth of teenage e-cigarettes. The agency said Thursday that Juul's application did not have enough evidence to show that marketing of its product was "appropriate for public health protection."
Juul disagreed with the FDA's findings and said it would put the ban on hold while the company was considering options such as possible appeals and discussions with regulatory agencies.
In a statement, Juul's application left serious questions to regulators and did not contain enough information to assess potential risks. The agency said the company's investigation contained "insufficient and inconsistent data," such as potentially harmful chemicals leaching out of Juul's cartridges.
"If we don't have the data needed to determine the associated health risks, the FDA has issued these marketing denial orders," Michele Mital, acting director of the FDA's Tobacco Center, said in a statement. Said in.
The agency has approved some e-cigarette applications. Since last fall, distributors have given R.J.'s tobacco-flavored e-cigarettes OK. Reynolds, Logic and other companies.
However, industry insiders and anti-tobacco advocates complain that these products make up a small percentage of the US $ 6 billion e-cigarette market.
Regulators have soaked sales.
Last year, the agency refused to apply for more than a million other e-cigarettes and related products, primarily because it could appeal to underage teens. ..
The American Lung Association called Thursday's decision "long postponed and most welcomed," citing Jur for smoking e-cigarettes for young people.
E-cigarettes first appeared in the United States over a decade ago, promising to provide smokers with a less harmful alternative. The device heats the nicotine solution into inhaled vapor, bypassing many of the toxic chemicals produced by burning cigarettes.
However, studies have reached conflicting results as to whether it really helps smokers quit smoking. And the FDA's efforts to control vaping products and their claims have been repeatedly slowed down by political interests competing with industry lobbying.
The vaping market has grown to include hundreds of companies selling an array of devices and nicotine solutions with different flavors and strengths. The
Vaping issue took on a new urgency in 2018, when Juul's high nicotine and fruity flavored cartridges quickly became a national epidemic among middle school and high school students. The company faces numerous federal and state investigations into early marketing practices, including distributing free Juul products at concerts and parties hosted by young influencers.
In 2019, the company stopped all advertising and was pressured to eliminate 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 vapor-breathing products to 21.
However, the question of whether e-cigarettes should be left on the market remains.
The FDA is working under a court order to make that decision. The Anti-Tobacco Group has successfully sued the agency to speed up its review.
For years, FDA regulators have warned companies that they need to provide rigorous, long-term data that show clear benefits for smokers switching to e-cigarettes. However, with the exception of the largest e-cigarette makers, they have resisted conducting such costly and time-consuming research.
Juul is still a top seller, but a recent federal survey shows that teens are moving away from the company. According to last year's survey, Juul was the fourth most popular e-cigarette among high school students who smoke regularly. The most popular brands were disposable e-cigarettes called puff bars with flavors such as pink lemonade, strawberry and mango. The company's disposable e-cigarettes used synthetic nicotine, which until recently was not under the jurisdiction of the FDA, allowing them to circumvent the regulation. Congress recently closed the loophole.
Overall, a study showed that the incidence of teenage e-cigarettes dropped by nearly 40% as many children were forced to learn from home during a pandemic. Still, federal officials warned about the interpretation of the results, as the results were first collected online rather than in the classroom.
Inspired by two students from Stanford University, Juul was launched in 2015 and has risen to the top of the vaping market within two years. Partially owned by tobacco giant Altria, Juul still occupies almost 50% of the US e-cigarette market. It used to control more than 75%.
On Tuesday, the FDA also announced plans to establish maximum nicotine levels to reduce addiction to certain tobacco products. In its announcement, the agency also mentioned that it had invested in a multimedia public education campaign aimed at alerting young people about the potential risks of using e-cigarettes.
