In less than two months, the U.S. Food and Drug Administration is supposed to decide, at long last, whether the company most responsible for the teenage vaping epidemic should be stopped, or at least restrained, from marketing its e-cigarettes.
The decision will hinge on whether scientific research shows that Juul's sleek nicotine-delivery device has public health benefits. Does it enable smokers to break or reduce their addiction to cigarettes? Or does it primarily lead to dual use of e-cigs and traditional cigarettes, while luring nonsmokers - especially young people - into nicotine addiction?
Juul, which is partly owned by tobacco giant Altria, decided to add to that scientific evidence.
Juul paid more than $50,000 to a scholarly journal so it would devote the entire May-June issue to 11 studies that Juul funded, all showing vaping is a public health boon. The availability of e-cigs could "avert millions of premature deaths in the U.S.," one Juul study concluded.
But Juul's gambit may have backfired.
Three members of the editorial board of the 45-year-old American Journal of Health Behavior resigned in protest, while editor and publisher Elbert D. Glover retired shortly after the "Special Issue on JUUL Use" was published, according to the New York Times.
A tobacco regulatory scientist who reviewed and critiqued two studies for the special issue said she and other reviewers were kept in the dark about Juul's role until they asked questions about "fishy" aspects of the studies.
"We've been hoping the truth would come out," said the scientist, who shared with The Philadelphia Inquirer an email Glover sent to reviewers that said nothing about Juul's sponsorship.
"I don't want to be named, because I'm not sure of the implications," she said. "I don't want to take a career hit" for being a reviewer.
Battery-operated gizmos that convert liquid nicotine into an inhalable mist were invented in China and came to the U.S. around 2007. A decade later, the U.S. vaping industry was vast, largely unregulated, and dominated by Juul. Teenage use exploded, fueled by fruit and candy flavors that Juul and other e-cig makers added to the liquid nicotine. Juul's early marketing campaigns blatantly targeted the young.
By 2019, more than a quarter of high school students reported vaping in the previous month. That year, the debate over the safety of vaping hit a crescendo as more than 2,000 young people were hospitalized with a mysterious vaping-related lung illness. That led regulators to investigate Juul's youth-oriented marketing, and prompted Juul to discontinue sales of flavored vape pods. The company still faces thousands of lawsuits, including from 14 states that want money to fight youth vaping.
The lung illness has not gone away, but amid the COVID-19 pandemic, attention has dwindled. The Centers for Disease Control and Prevention hasn't updated data on the illness since February 2020.
Congress gave the FDA authority to regulate any new tobacco-derived products, including e-cigs, in 2009. But it wasn't until seven years later, in 2016, that the agency began cracking down, making new products subject to the same rules as cigarettes. Suddenly, e-cig makers and vendors weren't supposed to sell to anyone under 18. They also couldn't advertise the products as safer than smoking, or as a way to quit smoking.
Even though e-cigs were already on the market, the FDA also ordered makers to submit applications for marketing approval. By law, that meant the companies had to provide scientific evidence that their addictive products were sufficiently beneficial to the public health to keep selling them.
The vaping industry fought this extension of the FDA's power all the way to the U.S. Supreme Court — and lost early last month.
Meanwhile, pre-eminent public health organizations, including the American Academy of Pediatrics and the American Cancer Society, have been pressuring the FDA to snuff out Juul.
Why the focus on Juul?
The FDA says its "finite resources" have been overwhelmed by marketing applications, so it decided to prioritize review of the products that account for most of the current market. Juul remains dominant, even though its market share has shrunk from 70% to about 40% as stores such as Walmart have stopped selling e-cigs.
"Juul's products have been largely responsible for the extraordinary growth in the percentage of youth who have become addicted to e-cigarettes - an epidemic which continues to this day — with no measurable public health benefit," the health organizations wrote in April to Janet Woodcock, the FDA's acting commissioner.
Over the past three years, numerous comprehensive reviews of e-cig research around the world have found the same thing.
"Strong and consistent evidence finds that children and adolescents who use e-cigarettes are significantly more likely to go on to use traditional cigarettes - a product that kills half its long-term users," the American Academy of Pediatrics wrote in a 2019 statement.
There is also evidence that e-cigs help some smokers quit or cut back, at least temporarily. For example, in the United Kingdom, where national health insurance covers e-cigs as part of smoking cessation programs, a study found that e-cigarettes worked better than nicotine-replacement therapies such as patches. But better is not to say great: The smoking abstinence rate at one year was 18% in the e-cigarette group, compared with about 10% in the nicotine-replacement group.
Many tobacco policy scientists are so convinced that e-cigs do more harm than good that they refuse to serve as pre-publication reviewers of e-cig research. Vaping studies are often tied to companies or researchers with financial conflicts - a problem that has undermined the integrity of academic publications in general.
But the reviewer who agreed in November to critique two articles in the special issue on Juul tried to keep an open mind.
She was not aware that the American Journal of Health Behavior is unusual in that it charges authors hefty fees for publication. But she respected Glover, who was also the editor of Tobacco Regulatory Science, where she had been on the editorial board.
"Reviewing articles has become a divisive thing," she said. "I felt someone needs to be objectively evaluating the science. But this experience burned me."
She shared with the Inquirer the email from Glover to scores of potential reviewers. "Peer reviewers" are usually not paid, but Glover offered $75 per review if it could be turned in quickly - one week. He said the special issue was on "e-cigarettes" in general and did not mention that the authors of the 12 studies were on Juul's payroll. The actual manuscripts redacted the name of the sponsor.
The design of one study she reviewed seemed so biased that she recommended rejecting it. "I thought, 'No way it wasn't funded by Juul.' " She questioned Glover about it. Soon, he sent another email to the group.
"It has been brought to my attention that some reviewers were unaware that the special issue on e-cigarettes is being funded by JUUL," Glover wrote. "My apologies for not alerting everyone. ... I honestly did not believe it to be a concern as the comprehensive reviews always purge weak or biased manuscripts."
Of the 12 manuscripts submitted by Juul, apparently one was "purged" because 11 appear in the issue. The reviewer does not know if that means her rejection recommendation was taken, because "I was so disgusted with how it went that I didn't look at what ran."