The agency ruled against the company’s application to stay on the market, a decisive blow to a once-popular vaping brand.
Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes on the United States market, a devastating blow to a once-popular company whose brand was blamed for the teenage vaping epidemic.
All Juul products on the U.S. market, which accounts for most of the company’s revenue, are affected by the order. Juul’s sleek vaping cartridges and sweet-flavored pods helped usher in an era of alternative nicotine products that are exceptionally attractive to young people. As a result of its initial dominance, the company was closely scrutinized by antismoking groups and regulators who feared they would do more harm than good to cigarette smokers who were trying to quit.
Although teenage vaping rates have declined during the Coronavirus pandemic, lawmakers and public health experts continue to express concerns about the additive nicotine in some e-cigarettes that remain on the market, including brands like Puff Bar, whose fruity flavors appeal to young people.
The F.D.A.’s decision did not address Juul’s relationship to youth vaping. Juul’s e-liquid pods could leach potentially harmful chemicals based on insufficient and conflicting information from the company, according to the agency. F.D.A. said there was no imminent health threat to consumers, but it did not have enough evidence to evaluate the risks.
It is important for the FDA to ensure that all e-cigarettes and electronic nicotine delivery systems currently being marketed to consumers meet our public health standards, said Doctor, commissioner of the agency. In addition, he acknowledged that many e-cigarette products contributed to the rise in teenage vaping.
F.D.A.’s move is part of a wide-ranging initiative to rewrite the rules for smoking and vaping products and to prevent illnesses and deaths caused by inhalable nicotine products.
To discourage use of the most deadly of legal consumer products, the agency announced plans on Tuesday to reduce nicotine levels in traditional cigarettes. The Food and Drug Administration announced in April that it would ban menthol-flavored cigarettes.
Juul’s action is part of a new regulatory mission for the FDA, which must determine which electronic cigarettes currently for sale, or proposed for sale, will be allowed to stay on shelves permanently. Other companies’ e-cigarettes have already been granted permission to remain on the market.
In spite of this, some of the agency’s new initiatives may not take effect for years – if they can withstand fierce resistance from the tobacco lobby, antiregulatory groups, and the vaping industry.
Juul said it would appeal the F.D.A.’s findings. It could request a stay from the agency or from a court pending an appeal to the FDA. The company hasn’t indicated which path it will take, but it will keep its products on the market.
“Jul intends to seek a stay, and we are exploring all our options under the F.D.A.’s regulations and law, including appealing the decision and engaging with our regulator.”
The ruling was hailed by public health groups.
According to Erika Sward, national assistant vice president of advocacy for the American Lung Association, the FDA’s decision to remove Juul products from the marketplace is both welcome and long overdue. Juul has been targeting and hooking kids on tobacco for far too long.
American Vapor Manufacturers Association, an industry trade group, hinted at the fight to come.
“Taking into account the lives lost and potential destroyed, the F.D.A.’s staggering indifference towards ordinary Americans and their right to switch to vaping, a safer alternative to tobacco, will surely be remembered as one of the greatest regulatory malpractice episodes in American history, according to Amanda Wheeler, the association’s president.
F.D.A. is treading a fine line in remaking the landscape for nicotine products. Efforts are being made to wean the public off traditional cigarettes while allowing less harmful vaping products that won’t attract a new generation of users: The new devices must be appealing to smokers, but not so appealing that they lure young people in the thousands.
The agency’s decision against Juul ends a nearly two-year review of data that the company submitted to continue selling its tobacco and menthol-flavored products in the country. The F.D.A. rejected a Juul vaping device along with four different pods, including tobacco pods with nicotine concentrations of 3 percent and 5 percent and menthol-flavored pods with the same levels.
“It is clear that the company was given the opportunity to address questions and concerns regarding safety, toxicology, and potential genotoxicity, but for whatever reason the company was unable to meet its burden, which resulted in a negative marketing order, said Mitch Zeller, who retired in April as director of the agency’s tobacco center.
In response to the agency’s concerns about chemical leaching, Juul could submit an entirely new application for a revamped product.
Four years ago, the F.D.A. began investigating Juul’s marketing efforts. In the past, Juul advertised its product using attractive young models and flavors such as cool cucumber and creme brulee, which critics said attracted underage users.
A crackdown on the sale of such products, including Juul’s, to people under 21 was announced by the FDA in April 2018.
The number of young people using the drug had soared. According to Monitoring the Future, an annual survey conducted for the National Institute on Drug Abuse, 19 percent of 12th graders, 16 percent of 10th graders, and 8 percent of eighth graders reported vaping nicotine in 2017.
While Juul routinely denied targeting young people, it was sued and investigated by state attorneys general, with some cases resulting in millions of dollars in damages. Juul agreed to pay $40 million to North Carolina in 2021 after the state asserted the company lured underage vapers to vaping. There are still lawsuits and investigations pending in more than a dozen other states.
Since Juul’s market share has plummeted, the news is less significant now than it would have been in Juul’s heyday. Juul was once the dominant player with 75 percent of the market, but now it has a considerably smaller share.
In December 2018, Altria, formerly Philip Morris and maker of Marlboro, bought 35 percent of Juul for $12.8 billion.
While Juul looked to Altria for support as it navigated increased regulatory scrutiny, Altria made the investment to counteract slowing tobacco sales.
Neither of those strategies seems to have worked.
The value of Altria’s investment in Juul has been written down by more than $11 billion to $1.7 billion. The company’s revenue dropped slightly last year as smokable products accounted for 90 percent of its revenue. In the past five years, the stock has declined by more than 40 percent, and by 20 percent just in the past month. In 2021, Juul’s revenue fell to $1.3 billion from $2 billion in 2019, with 95 percent coming from the United States.
“Altria is disappointed in today’s decision and continues to believe that e-vapor can play an important role in harm reduction for adult smokers,” the company said in a statement.
Juul employed more than 4,000 people at its peak. As of now, it has over 1,000 members, mostly in the United States, but also in Canada, Great Britain, and other countries.
Despite not falling under the FDA’s regulatory purview for several years, e-cigarettes have been sold on the U.S. market for more than a decade without formal FDA approval.
The Food and Drug Administration issued a warning letter to Juul in 2019, stating that the company violated federal regulations by not obtaining approval to promote and sell its products as healthier alternatives to smoking.
Recently, the FDA reported it had rejected more than a million applications for products it considered more of a health risk than a benefit. R.J. Reynolds was authorized in October to continue marketing Vuse. It was the first time the agency granted approval to a vaping product made by a big cigarette company
In March, the agency approved several tobacco-flavored products from Logic Technology Development, saying the company was able to demonstrate that its products were likely to help adults make the transition from traditional cigarettes while posing a low risk of attracting young, new users.
Juul’s ban from the U.S. market could be counterproductive, according to some tobacco control experts.
Several experts have come to see Juul and other e-cigarettes as valuable tools for helping adult smokers quit conventional cigarettes, according to Clifford Douglas, director of the University of Michigan Tobacco Research Network.
He said they can provide smokers with an alternative to combustibles, which are responsible for virtually every tobacco-related death. Now that off ramp is being narrowed and paved over, putting millions of adult lives at risk. Juul should respond effectively to the request for more scientific analysis, make any necessary product adjustments, and once again offer its products to adults in need.”