E-cigarette makers face an existential threat. By May, they must submit applications to the U.S. Food and Drug Administration proving that their products provide a net benefit to public health. If a company fails to make its case, the FDA has the power to order its products off the market.
The agency will judge that benefit with a two-part test: Are e-cigarettes effective in getting smokers to quit? And, if so, does that benefit outweigh the health damage to new e-cigarette users — including teenagers — who never smoked in the first place?
That’s a particularly high hurdle for the largest e-cigarette maker, Juul Labs Inc, according to a Reuters analysis of the latest available data on trends in cigarette and e-cigarette use from the U.S. Centers for Disease Control and Prevention.
The data show that e-cigarettes are having little impact in reducing U.S. cigarette smoking, while growth in vaping since 2015 has come entirely from users under 25 years old, including teenagers. Those trends present a special problem for Juul because of its dominance of the U.S. market and its enormous popularity among teenagers, according to more than a half dozen tobacco researchers and medical experts who assessed the data at Reuters' request.
"I don't see it as a surmountable hurdle," Suzanne Colby, a tobacco researcher at Brown University, said of the FDA standard for public health benefits. "The data look like their product differentially attracts youth instead of adults, in such great numbers."
Between 2017 and 2018 — the period when Juul rapidly grew to become the U.S. market leader — e-cigarette use among U.S. adults grew from 2.8 percent of the population to 3.2 percent, according to the CDC. But rates of cigarette smoking among adults barely budged, dropping from 14 percent to 13.7 percent — not enough to be statistically significant, according to the CDC. (For a graphic showing vaping trends for various age groups, see: here.)
Use of e-cigarettes by high-school students, by contrast, shot up by 78 percent over the same period – from 11.7 percent to 20.8 percent of students, data from the CDC and the FDA show. Juul is by far the most popular e-cigarette among teens, with more than half of high school and middle school students naming it as their favorite brand in surveys by the CDC and the FDA.
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Moreover, the biggest growth in adult e-cigarette use came among the youngest age cohort of adults, people aged 18 to 24. E-cigarette use among young adults is nearly four times more common than among those aged 45 to 64, the CDC numbers show.
Another dynamic that undermines the public-health case for e-cigarettes is the large proportion of "dual users." The most recent federal data show that 41 percent of adult e-cigarette users continue to also smoke cigarettes.
Some studies show dual use could be more harmful than smoking alone. A study last December found people who used both products tested higher than cigarette smokers for a range of volatile organic compounds and other toxins associated with tobacco-related disease. A separate study last year of heart disease risk among e-cigarette users found that dual use was "more dangerous than using either product alone."
For the industry as a whole, the usage data cast serious doubts on whether e-cigarettes are providing a clear benefit among adult smokers, said Brian King, a deputy director at the CDC's Office on Smoking and Health.
"When it comes to net public health impact, you have to consider both ends of the scale," King said. "Right now it does appear the youth initiation is outweighing the adult use."
Juul declined a request for an interview with executives including CEO K.C. Crosthwaite, a veteran of Marlboro maker Altria Group Inc who took the helm in September, on how it plans to pass the FDA's regulatory test. As pressure on the company has mounted, Crosthwaite has made the FDA application process a central goal, laying off 650 employees, including many in marketing, last month in an effort to restructure the company to focus on regulatory approval.
In written responses to questions from Reuters, Juul said it believes its products "already are playing a critical role in transitioning adult smokers from combustible cigarettes and have the potential to convert tens of millions of smokers in the U.S." The company cited studies it has commissioned showing that between 30 percent to 50 percent of adult smokers who use Juul "switch completely from smoking cigarettes within six months."
Juul has said its customers are “the world’s 1 billion smokers,” but the company did not directly address questions about the disparity in youth and adult uptake in the United States. Juul acknowledged it must address any potential impact on nonsmokers who start using e-cigarettes. It said it is "committed to working cooperatively with regulators, public health officials and other stakeholders to combat underage use and convert adult smokers."
In October, Crosthwaite brought on another Altria executive, Joe Murillo, who helped navigate a successful FDA application for IQOS, a Phillip Morris International Inc product that heats up but doesn't burn packages of ground-up tobacco. Altria has an agreement with Philip Morris to market IQOS in the United States. The IQOS device is one of only two tobacco products that have successfully made it through the FDA process.
Juul’s competitors in the U.S. market face the same regulatory challenge. One rival, Japan Tobacco International, says it is confident in the FDA application it filed in August for its Logic products because it contains company data showing the brand — unlike Juul — is used overwhelmingly by older adults.
Anthony Hemsley, an executive for Japan Tobacco International's U.S. division, acknowledged the population-wide trends in e-cigarette and cigarette use. But he pointed out that the FDA's decision on net public health benefit will be made on a product-by-product basis — not across the entire industry. He added that Juul has "a significant challenge ahead of them, in overcoming the concerns that exist out there."
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The FDA declined requests for an interview with Mitch Zeller, who heads tobacco regulation at the agency, about its oversight of e-cigarettes. In written answers to questions, the agency did not directly address the population-level data on smoking and vaping trends but said it is “tasked with threading a public health needle” in crafting regulations on e-cigarette firms.
