FDA Investigation Into Juul Could Vaporize E-Cigarette Giant

In the course of just a few years, the electronic cigarette company, Juul, has possibly gone from a ubiquitous fixture among American high schoolers to contraband prohibited by the full strength of the federal government.

Amid the company’s meteoric rise, eyebrows began raising at the U.S. Food and Drug Administration (FDA) — triggering a multi-year investigation that recently ended in the complete removal of the product from the marketplace.

However, the battle does not appear to be over. A federal appeals court approved a request from Juul to halt the agency’s order.

How did the upstart vaping brand become a regulatory pariah in such a short time?

Crown Juul

Juul Labs spun off from a cannabis company, Pax Labs, in 2017 and almost immediately became a business and cultural phenomenon. Like other e-cigarette companies, rather than producing tobacco products, Juul focused on isolating nicotine — the addictive compound in tobacco — and delivering it through water vapor.

The product and others in its category were quickly replacing cigarettes as the contraband of choice for American teenagers. In 2007, over 46% of 12th graders had tried cigarettes; by 2017, 36% had tried vaping, while only 27% had tried cigarettes, according to University of Michigan data published in The Wall Street Journal.

Rather than swiping cigarettes, high school teachers and administrators found themselves confiscating slim devices that looked like flash drives to the untrained eye.

“We go for a walk. We stop in the bathroom. It’s not uncommon to see a circle of kids passing it around,” Steve Lehman, the principal of Northern High School in Pennsylvania, told The Wall Street Journal in 2018. “That’s where we confiscate.”

By the summer of that year, Juul sales had surged nearly 800% — granting the company a 68% market share in the e-cigarette category. A $1.2 billion fundraising round valued Juul at a stunning $15 billion — a figure that was upgraded to $38 billion months later, once Altria, the company formerly known as Philip Morris and the manufacturer of Marlboro cigarettes, snagged a 35% stake in the company.

Around the same time, the FDA — a federal agency under the fold of the U.S. Department of Health and Human Services — reported “clear signs” that use of the e-cigarettes had reached “an epidemic proportion.”

“While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids,” former FDA Commissioner Scott Gottlieb said in 2018. “We cannot allow a whole new generation to become addicted to nicotine.”

At the same time, state governments began slamming Juul with lawsuits over its marketing practices, alleging that the company was intentionally peddling its devices to young people.

The state of North Carolina sued the company in 2019 for “designing, marketing, and selling its e-cigarettes to attract young people and for misrepresenting the potency and danger of nicotine in its products.” One year later, a complaint from the commonwealth of Massachusetts argued that the company “engaged in unfair and deceptive acts and practices” by “selling nicotine products to children, adolescents, and other consumers younger than the minimum legal sales age.”

Juul filed a permanent tobacco product application with the FDA — only for the agency to decide in June 2022 that the documents “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” Accordingly, Juul devices and four types of pods have been served marketing denial orders and will receive the FDA’s “highest enforcement priorities.”

Shortly thereafter, the U.S. Court of Appeals for the D.C. Circuit approved a halt on the FDA’s order — rendering the fate of Juul uncertain.

Smoked Out

Curiously, the regulatory treatment of e-cigarettes varies drastically across the pond.

The United Kingdom’s National Health Service concluded that although “nicotine is a very addictive substance,” it is “relatively harmless” — because it is truly the “carbon monoxide, tar and other toxic chemicals in tobacco smoke that will cause serious damage” to one’s health. Nevertheless, the proportion of American adults that believe e-cigarettes are more harmful than conventional cigarettes rose substantially from 2012 to 2017, according to research from Georgia State University and other entities.

It is understandable for regulators to target products that could produce addiction in young people — but why do they oppose the e-cigarette category as a whole? Heritage Foundation research fellow Daren Bakst postulated in 2019 that some “irrationally justify their dislike for the products based on a dislike of big tobacco companies” — and thereby leverage “concern over youth usage of e-cigarettes as a way to demonize the products.”

Indeed, the Biden administration’s health apparatus has by no means been clear-headed on its drug policies. The FDA’s prohibition of Juul comes months after the Department of Health and Human Services planned a $30 million grant program, which would have allegedly involved handing out crack pipes to drug addicts as part of safe smoking kits.

As most Americans are surely aware, the federal health infrastructure and its leaders neither engage in outright deception nor seek their own political gain — especially when it comes to regulating what Americans decide to put in their bodies. In any case, as alternatives disappear, young people may even find themselves returning to cigarettes.

“I have often said that Democrats think government prohibition works when it comes to cigarettes but not other drugs, while Republicans think government prohibition works for other drugs but not cigarettes. Sadly, the war on tobacco harm ​reduction has been bipartisan, spanning Democratic and Republican administrations,” Cato Institute senior fellow Jeffrey Singer wrote. “We should not be surprised to see teen and adult smoking rates start back up, after years of decline.”