US federal health officials have asked Juul to withdraw its electronic cigarettes from the US market. The order is the final blow to the embattled company, which has been accused of driving a national increase in e-cigarette use among youth.
The action is part of the Food and Drug Administration’s (FDA) effort to bring scientific scrutiny and regulation to the billion-dollar vape industry after years of delays.
“Should be withdrawn from the market”
The FDA said Juul should stop selling its electronic cigarette device and tobacco and menthol flavored cartridges. Noting that those already on the market should be removed, the FDA noted that consumers are not restricted from owning or using Juul’s products.
To stay on the market, companies must demonstrate that e-cigarettes benefit public health. That means adults using these products prove they are more likely to quit or cut down on traditional smoking, while teenagers are less likely to become addicted to e-cigarettes.
The FDA noted that some of the biggest vendors, such as Juul, may have played a “disproportionate” role in the increase in young vape users. The FDA said in a statement that Juul’s application did not provide sufficient evidence to show that marketing its products would be “suitable for the protection of public health.”
Juul has yet to respond to requests for comment.
In the FDA’s written statement, it was stated that Juul’s application raises important questions for auditors and does not contain sufficient information to assess potential risks. The FDA reported that the company’s research contained “insufficient and conflicting data” on issues such as the potentially harmful chemicals in Juul’s cartridges.
“Without the data needed to identify the relevant health risks, the FDA is issuing marketing disclaimer orders,” said Michele Mital, acting director of the FDA tobacco center.
The FDA has accepted some electronic cigarette applications. Since last fall, tobacco-flavored e-cigarettes from RJ Reynolds, Logic and several other companies have been approved.
But industry players and anti-tobacco advocates complain that these products only make up a small percentage of the six billion dollar e-cigarette market in the US.
Auditors have repeatedly delayed making decisions on devices from market leaders, including Juul, which remains the top-selling vape brand despite falling sales.
Last year, the FDA rejected applications for more than one million e-cigarettes and related products because of their potential appeal to underage youth.
The American Lung Association described the decision as “overdue and unwelcome” and accused Juul of promoting e-cigarettes to youth.
E-cigarettes first appeared in the US over a decade ago with the promise of providing a less harmful alternative to smokers. The devices turn the nicotine solution into an inhaled vapor, destroying many of the toxic chemicals produced by burning tobacco.
But studies have shown conflicting results about whether the devices actually help smokers quit. The FDA’s efforts to control e-cigarette products and these claims have been repeatedly slowed by industry lobbying and competing political interests.
The e-cigarette market has grown thanks to a range of devices and hundreds of companies selling nicotine solutions in a variety of flavors and strengths.
In 2018, when Juul’s high-nicotine, fruit-flavored cartridges quickly became a nationwide passion among middle and high school students, the issue of vaping took on new urgency. The company is facing a series of federal and state investigations into early marketing practices, including distributing free Juul products at concerts and parties hosted by prominent youth.
Pressure was put on the company to stop all its ads in 2019 and eliminate those that taste fruity and sweet. The following year, the FDA restricted flavors in small e-cigarette devices to tobacco and menthol only. In addition, Congress increased the purchase age for all tobacco and electronic cigarette products to 21.
But the question remains whether e-cigarettes should stay on the market.
While Juul remains a bestseller, a recent federal survey shows that teens are turning away from the brand. Last year’s survey showed Juul was the fourth most popular brand among high school students who regularly use vaping.
The most popular brand has been a disposable e-cigarette called Puff Bar, which comes in flavors like pink lemonade, strawberry, and mango. This company’s disposable e-cigarettes were exempt from regulation because they used synthetic nicotine, which until recently was outside the FDA’s jurisdiction. Congress recently changed that.
As a result, the survey showed a nearly 40 percent decrease in the rate of young people using e-cigarettes as they switched to homeschooling during the pandemic. Still, federal officials have cautioned against interpretation, as this is the first time the results have been collected online rather than in classrooms.
Founded by two students from Stanford University, Juul was launched in 2015 and climbed to the top of the electronic cigarette market in two years.
Partly owned by tobacco giant Altria, Juul currently holds about half of the US e-cigarette market. The company once dominated more than 75 percent of the market.
The FDA also this week announced plans to set maximum nicotine levels to reduce addictions to certain tobacco products. The FDA also noted that it has invested in a multimedia public education campaign aimed at warning young people of the potential risks of e-cigarette use.