The San Juan Daily Star
FDA orders Juul to stop selling e-cigarettes
By Matt Richtel and Andrew Jacobs
The Food and Drug Administration late last week ordered Juul to stop selling e-cigarettes on the U.S. market, a profoundly damaging blow to a once-popular company whose brand was blamed for the teenage vaping crisis.
The order affects all of Juul’s products on the U.S. market, the overwhelming source of the company’s sales. Juul’s sleek vaping cartridges and sweet-flavored pods helped usher in an era of alternative nicotine products that were exceptionally attractive to young people. The company’s initial dominance invited intense scrutiny from anti-smoking groups and regulators who feared the products would do more harm to young people than good to cigarette smokers trying to quit.
Although teenage vaping rates have declined during the coronavirus pandemic, public health experts and lawmakers 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 FDA’s decision did not deal with Juul’s relationship to youth vaping. Instead it was based on what the agency said was insufficient and conflicting data from the company about potentially harmful chemicals that could leach out of Juul’s e-liquid pods. There was not an imminent health threat to consumers, the FDA said, but it did not have enough evidence to assess the potential risks.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” Dr. Robert M. Califf, the agency commissioner, said in a statement. And he acknowledged that many of the e-cigarette products had played a role in the rise in teenage vaping.
The move by the FDA is part of a wide-ranging effort to remake the rules for smoking and vaping products and to reduce illnesses and deaths caused by inhalable products containing highly addictive nicotine.
On Tuesday, the agency announced plans to slash nicotine levels in traditional cigarettes as a way to discourage use of the most deadly of legal consumer products. In April, the FDA said it would move toward a ban on menthol-flavored cigarettes.
The FDA’s action against Juul in particular is part of a newer regulatory mission for the agency, which must determine which electronic cigarettes currently for sale, or proposed for sale, will be allowed to permanently remain on shelves. It has already granted permission for other companies’ e-cigarettes to stay on the market.
But it could take years before some of the agency’s new initiatives take effect — if they can withstand fierce resistance from the powerful tobacco lobby, antiregulatory groups and the vaping industry.
Juul said it disagreed with the FDA’s findings and planned to appeal. The company could seek a stay from the agency or from a court pending an appeal to the FDA. The company has not said which path it will seek but it will try to keep its products on the market during any proceedings.
“We intend to seek a stay,” Juul’s statement concluded, “and are exploring all of our options under the F.D.A.’s regulations and the law, including appealing the decision and engaging with our regulator.”
Public health groups hailed the ruling.
“The FDA’s decision to remove all Juul products from the marketplace is both most welcomed and long overdue,” said Erika Sward, national assistant vice president of advocacy for the American Lung Association. “Juul’s campaign to target and hook kids on tobacco has gone on for far too long.”
A statement from the American Vapor Manufacturers Association, an industry trade group, hinted at the fight ahead.
“Measured in lives lost and potential destroyed, F.D.A.’s staggering indifference to ordinary Americans and their right to switch to the vastly safer alternative of vaping will surely rank as one of the greatest episodes of regulatory malpractice in American history,” Amanda Wheeler, the association’s president, said in a statement.
Broadly, the FDA is walking a fine line in remaking the landscape for nicotine products. It is trying to wean the public off traditional cigarettes while permitting less harmful vaping products that do not attract a new generation of users: The new devices must be appealing for smoking cessation but not so appealing that they lure young people en masse.
The agency’s ruling against Juul capped a nearly two-year review of data that the company had submitted to try to win authorization to continue selling its tobacco- and menthol-flavored products in the United States.
Specifically, Juul sought approval for — and the FDA rejected — a Juul vaping device and four different pods, including tobacco pods with nicotine concentrations of 3% and 5% and menthol-flavored pods with the same levels.
“It’s clear that the company was given an opportunity to address questions and concerns related to safety, toxicology and potential genotoxicity, and for whatever reason the company was unable to meet its burden and that led to a negative marketing order,” said Mitch Zeller, a former director of the agency’s tobacco center who retired in April.
He said Juul could submit an entirely new application for a revamped product — one that presumably addressed the agency’s concerns about the leaching of chemicals.
The FDA began an investigation into Juul’s marketing efforts four years ago. Before that time, Juul had advertised its product using attractive young models and flavors such as cool cucumber and creme brulee that critics said attracted underage users.
By April 2018, the FDA announced a crackdown on the sale of such products, including Juul’s, to people younger than 21.
Use among young people had soared. In 2017, 19% of 12th graders, 16% of 10th graders and 8% of eighth graders reported vaping nicotine in the previous year, according to Monitoring the Future, an annual survey done for the National Institute on Drug Abuse.
For its part, Juul routinely denied that it targeted young people, but it was pursued in lawsuits and by state attorneys general, with some cases resulting in millions of dollars in damages against the company. In one settlement in 2021, Juul agreed to pay $40 million to North Carolina, which represented various parties in the state who asserted the company had helped lure underage users to vaping. More than a dozen other states have lawsuits and investigations that are still pending.
The news is somewhat less weighty for the industry now than it would have been in Juul’s heyday, given the company’s plummeting market share. Once the dominant player with 75% of the market, Juul now has a considerably smaller share of the market.
But the news delivers a significant blow to Altria, formerly known as Philip Morris and the maker of Marlboro, which in December 2018 bought 35% of Juul for $12.8 billion.
Altria made the investment to counteract slowing tobacco sales, while Juul looked to Altria as an ally to help it navigate increased regulatory scrutiny.
Neither of those strategies appear to have worked out.
Altria has written down the value of its investment in Juul by more than $11 billion, to $1.7 billion. Altria, which gets about 90% of its revenue from smokable products, saw revenue fall slightly last year. Its stock is down more than 40% over the past five years, and 20% just in the past month. Juul, for its part, saw its revenue fall to $1.3 billion in 2021, from $2 billion in 2019, with about 95% in U.S. sales.