On June 23, the FDA denied the marketing applications for Juul, which would pull one of the most popular e-cigarettes off the US market. (The Wall Street Journal first reported the impending decision.)
The Food and Drug Administration (FDA) stated that there was “insufficient evidence to asses the potential toxicological risks of using Juul products,” yet there was no “clinical information to suggest an immediate hazard.”
“After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications 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,” an FDA press release reads. “In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” Joe Murillo, the chief regulatory officer at Juul Labs, said in a press statement. “In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health.’”
“We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” he continued.
Mitch Zeller, the former director of the Food and Drug Administration’s Center for Tobacco Products (CTP), declined to comment over email.
Like all other vapor companies, Juul had to submit a PMTA by September 2020, and had to prove to the Food and Drug Administration, which regulates nicotine products through CTP, that its products would be “appropriate for the protection of public health.” The manufacturer had to show, in short, that its products were more likely to help adult smokers switch to a safer alternative than introduce a new generation to nicotine dependence. Juul submitted applications for both its tobacco and menthol-flavored pods.
The news has sent shock waves through the vaping community.
But Juul is no ordinary vape company. It’s by far the biggest name in the US market.
Above all, to most outside the insular world of tobacco control, the company is best known for its early ad campaigns after it came on the US market in 2015. Those were heavily criticized for targeting youth, inspiring reams of sensationalized media coverage about a supposed youth vaping “epidemic.”
In the years since, youth vaping—never high on a daily basis among youth who have never smoked—has declined, and youth who do vape seem to prefer disposables like Puff Bar. Yet Juul has mostly been in a defensive crouch.
At the end of 2018, the company sold a 35 percent stake to the tobacco giant Altria. Some observers saw this as a bid to harness the latter’s expertise in handling PR crises. Since then, Juul has seemingly been doing everything possible to please the regulator: In October 2019, for example, before the Trump administration eventually announced a ban on flavored pods, Juul pulled its flavors in a preemptive move. (Altria’s stock fell following the news.)
Meanwhile, misinformation around “EVALI”—the string of mysterious lung illnesses misattributed to nicotine vapes and eventually subscribed to vitamin E acetate found in some illicit THC cartridges—swirled, further damaging the manufacturer’s image. The false narrative was simple: Juul addicted a swarm of teenagers to nicotine, and now it was making them sick.
The news about the apparent FDA denial, so far only reported by anonymous sources to the Journal, has sent shock waves through the vaping community, with many consumer advocates and smaller producers—normally hostile to what they see as Juul’s role in tainting the reputation of e-cigarettes—in the position of defending a company they have frequently criticized.
“FDA’s apparent intention to outlaw Juul is the latest sorry example of the agency’s campaign of regulatory arson against the nicotine vaping products that millions of Americans rely on as an alternative to cigarettes,” Amanda Wheeler, a vape shop owner in Arizona and president of American Vapor Manufacturers, said in a press statement. “Measured in lives lost and potential destroyed,” she continued, “FDA’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.”
“If this reported denial by the FDA is intended to punish past bad behavior, which appears to no longer be taking place, then it is hard to understand,” Cliff Douglas, the director of the University of Michigan Tobacco Research Network and the former vice president for tobacco control at the American Cancer Society, told Filter. “Juul appears to have the potential to be an effective and much less harmful substitute for cigarettes for addicted adult smokers. Youth no longer like the product.”
Nonetheless, the dominant tale up until this point—cheer-leaded by many public health lobbying groups funded by Michael Bloomberg—has been one of a youth vaping “epidemic” often blamed on Juul. The forgotten story, though, has been on the adult vapers and smokers who remain, now left with just a handful of FDA-authorized products that few actually use.
“The sad irony is that this product would be banned from the market while billions of combustible cigarettes, which kill half of all long-term users, enjoy ‘grandfather’ status and continue to be aggressively marketed to and used by tens of millions of Americans,” Douglas said.
“Here we have Juul, the most successful anti-smoking product ever seen, and the FDA’s decision is to try to kill it.”
On top of that, the Biden administration has recently advanced plans to ban menthol combustible cigarettes (with no menthol vaping products currently authorized by the FDA) and to lower the nicotine levels in cigarettes to effectively zero—an embrace, no doubt, of a War-on-Drugs mentality that could trigger numerous illicit markets and leave many adults in the US still smoking cigarettes. (Cigarette smoking remains the number one cause of preventable death in the US.)
The Juul decision “marks an extraordinary failure of objectivity and competence by the FDA,” Clive Bates, the former director of the United Kingdom’s Action on Smoking and Health, told Filter. “Under FDA’s jurisdiction, 3,000 cigarettes are allowed on the market almost untouched by any sort of regulatory inconvenience. The FDA has even come out and declared one cigarette appropriate for the protection of public health. Yet here we have Juul, the most successful anti-smoking product ever seen, and the FDA’s decision is to try to kill it. This can only be a political move, driven by the political pressure from well-funded elitist activists, their billionaire backer and grandstanders in Congress. It’s a dark day for science, regulation and public health.”
“The silver lining is that Juul has the money to fight the FDA, and this could potentially benefit some of the smaller businesses without a voice.”
It seems almost inevitable that the decision to deny Juul will result in a major lawsuit against the FDA. Smaller companies that received FDA denials have in some cases won victories in the courts. Yet the overwhelming sense in the tobacco harm reduction community is one of shock that a company with a well-resourced PMTA application, which gives millions of people an option to replace smoking, could face oblivion.
“The Juul product has helped millions of smokers switch to a reduced risk alternative,” said Matt Culley, a content creator on the board of CASAA, a consumer advocacy nonprofit. “That alone should be enough for an FDA authorization. That being said, Juul has made some mistakes along the way, and they’re being forced into a group full of small businesses who are on the outside looking in.”
“The silver lining is that Juul has the money to fight the FDA, and this could potentially benefit some of the smaller businesses without a voice,” he told Filter. “The news has also clearly put vaping back in the national discussion.”
Update, June 23: This article has been updated to reflect the FDA’s confirmation that it would deny Juul’s marketing applications, and the response from Juul Labs.
Photograph by Vaping360 via Flickr/Creative Commons 2.0
The Influence Foundation, which operates Filter, has received grants from Juul Labs and Altria. Filter’s Editorial Independence Policy applies.