The reviews are part of a sweeping effort, years in the making, to regulate tobacco products other than cigarettes to ensure they are “appropriate for the protection of public health” — the federal standard for staying on the market or entering it. That means a product, on balance, must be more likely to help adults quit smoking cigarettes than to entice young people to start vaping and potentially get addicted to nicotine.
The review process kicked off last September, when manufacturers of e-cigarettes and other items were required to apply to the FDA for permission to continue selling their products. If the agency doesn’t authorize the products by this September, the companies are supposed to stop selling their wares or face possible FDA enforcement action, which could include fines or seizure.
Juul, which began as a Silicon Valley start-up, wants the nod to continue marketing its vaping device and pre-filled pods in menthol and tobacco flavors. In recent years, after receiving widespread criticism, it halted sales of its popular mint and fruity flavors. The company denies it has ever targeted young people and says its products offer a much safer alternative than cigarettes for adult smokers addicted to nicotine.
But many health groups, and Democratic lawmakers and parents, say Juul caused the spike in teen vaping between 2017 and 2019 and argue there is scant evidence its products help smokers quit.
If the FDA doesn’t toss Juul off the market, “there will be an epic storm from Capitol Hill and the public health community,” said Erika Sward, assistant vice president of national advocacy for the American Lung Association.
The FDA has regulated cigarettes since the enactment of the 2009 Family Smoking Prevention and Tobacco Control Act, which outlawed flavors in cigarettes except for menthol. But the agency didn’t get authority over e-cigarettes, pipes, cigars and hookahs until 2016. Since then, it has been working on a process to review those products but the effort has been repeatedly delayed by industry opposition and political machinations.
Juul officials, whose company has faced a deluge of lawsuits and investigations in recent years, argue that they have orchestrated a sweeping “reset” to show their commitment to working with regulators and helping adult smokers.
“I think the reset was essential to the future of Juul and, to some extent, the entire category, in order to take advantage of the enormous opportunity we have to really make progress against smoking,” said Joe Murillo, Juul’s chief regulatory officer and a former executive with Altria Group, the tobacco giant that bought a 35 percent chunk of Juul in 2018.
Juul critics scoff at the notion of reform.
“Reset? Give me a break,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes, a nonprofit. “They sell addiction. If you wanted to do the right thing, you would close up shop.”
Some tobacco-control experts disagree. Clifford E. Douglas, director of the University of Michigan Tobacco Research Network and former vice president for tobacco control at the American Cancer Society, said Juul should not be punished retroactively for past behavior. Its products, he said, should be considered “on the scientific merits,” like those of other manufacturers.
“We need to be able to walk and chew gum at the same time,” protecting young people while helping adult smokers, he added, noting that 480,000 people in the United States die annually from smoking. Other tobacco-control advocates who share his views argue that many health organizations and the media have focused too much on the risks to young people of flavored e-cigarettes while not considering potential benefits to smokers.
For the FDA, the decisions on Juul and other manufacturers could represent a milestone as it tries to execute an ambitious tobacco-regulation agenda. The FDA in April said it was taking steps to ban menthol cigarettes. And it continues to work on a potential requirement that nicotine levels in cigarettes be set at minimally addictive levels — a possible game-changer that the White House would need to approve.
The FDA’s Sept. 9 deadline for reviewing marketing applications for about 2 million vapes and other products is the result of a lawsuit brought by public health groups trying to accelerate the schedule. The number of applications is high because bottled e-liquids sold in adult vape shops come in a vast array of flavors and nicotine strengths, each of which must be reviewed.
The FDA said in a recent statement that the “unprecedented number of applications” will make it difficult to complete the reviews by Sept. 9. But it has created a separate queue for products with the biggest market share — which puts Juul at the top of the list.
On Thursday, the agency released its first substantive decisions on applications, ordering three small e-cigarette manufacturers not to sell their flavored products. Under the FDA’s orders, the manufacturers — JD Nova Group LLC, Great American Vapes and VaporSalon — must pull 55,000 existing or planned flavored products from the market or risk FDA enforcement action.
Regulators said the companies’ applications failed to provide “sufficient evidence” that their products provide a net public health benefit for adult smokers compared with the “threat posed by the well-documented, alarming levels of youth use” of flavored vapes. Representatives of Great American Vapes and VaporSalon declined to comment. The owners of JD Nova Group did not immediately respond to a request for comment.
Steven A. Schroeder, former president and chief executive officer of the Robert Wood Johnson Foundation and head of the Smoking Cessation Leadership Center at the University of California at San Francisco, said ideally he would retain flavored vaping options for adult smokers while keeping them away from young people.
But he conceded that the balance is hard to strike: “Kids are attracted to the flavors, but so are adults.”
Many health groups, including the American Heart Association and the American Academy of Pediatrics, are adamantly opposed to almost all flavored e-cigarettes — both the cartridge-based variety sold by Juul and other big companies, such as Reynolds American Inc., and the e-liquids used in refillable tank systems found in adult vape shops.
In particular, the health advocates and a group of bipartisan attorneys general have strongly urged the FDA to reject menthol-flavored vapes, which became more popular with teens after sweet and fruity pods were voluntarily withdrawn or banned.
The health groups say they are less worried about tobacco-flavored e-cigarettes, which are not popular among young people. But they say Juul is an exception. They want all Juul products, including the tobacco-flavored cartridges, off the market because they say the pods’ nicotine levels are too high and the company can’t be trusted based on its past behavior.
“We won’t end the youth e-cigarette epidemic as long as flavored and high-nicotine products, including Juul’s, continue to be sold,” said Matthew L. Myers, president of Campaign for Tobacco-Free Kids, a nonprofit tobacco-control group.
Juul’s menthol- and tobacco-flavored pods come in nicotine concentrations by weight of 3 and 5 percent. The 5 percent cartridge contains the nicotine equivalent of about one pack of cigarettes.
During a House hearing in June, Democratic lawmakers prodded FDA acting commissioner Janet Woodcock to take aggressive action against flavored e-cigarettes, including Juul’s. She said she could not “prejudge” decisions by the agency’s Center for Tobacco Products, but added she believes menthol makes “it harder to stop either vaping or smoking. It’s, to my mind, like actually having a higher concentration of nicotine in whatever delivery system.”
After surging in popularity among young people after its 2015 launch, Juul was publicly pilloried in 2018, when Scott Gottlieb, who was FDA commissioner at the time, accused the company of igniting the youth vaping epidemic. In the months that followed, Juul pulled most flavored products from retail locations and shut down its social media accounts.
A year later, K.C. Crosthwaite, another Altria veteran, became chairman and chief executive. The company suspended sales of e-cigarettes other than those in tobacco and menthol flavors, months ahead of a Trump administration partial ban on cartridge-based e-cigarettes. And the company moved its headquarters to D.C. from San Francisco.
Teen vaping, meanwhile, increased sharply in recent years, then declined — though to levels still worrisome to public health advocates. The percentage of high-schoolers who vaped shot up from 11.7 percent in 2017 to 27.5 percent in 2019, according to the National Youth Tobacco Survey. The proportion fell to 19.6 percent last year, in part because Congress banned the sale of tobacco products to people under 21.
Juul’s revenues in recent years have reflected the ups and downs of the vaping battle, totaling $1.3 billion in 2018, $2 billion in 2019 and just under $1.5 billion in 2020. Juul’s Murillo said his company will be able to help adult smokers only “if we continue to combat underage use.”
Meanwhile, lawsuits involving the company have proliferated.
The Federal Trade Commission is suing Altria, alleging the company violated antitrust laws in investing in Juul. Recently, Juul agreed to pay North Carolina $40 million to settle allegations that the company aggressively marketed products to young people; the company did not admit wrongdoing. Another 13 states and D.C. also have sued the company, and many more cases, filed by governments and individuals, have been combined in a federal court in California.
The FDA, as it rules on different products, might find itself ensnared in a lawsuit.
“There is no way they are going to make everyone happy,” said Desmond Jenson, a senior staff attorney at the Public Health Law Center at the Mitchell Hamline School of Law. “They are going to make one side or the other mad.”
Dan Diamond contributed to this report.
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