After the US Food and Drug Administration (FDA) announced last week that it would instruct e-cigarette giant Juul Labs to stop selling its products in the US, my inbox flooded with emails from public health groups applauding the decision. The CEO of the Truth Initiative, an anti-smoking gr” up, called it a “huge public health victory.” The CEO of the American Lung Association called it” long ago and very welcome.”
These celebratory statements revolve around Juul’s starring role in what federal regulators have termed an epidemic of teenaJuul’sotine addiction, one that many experts feared could undo decades of progress in smoking prevention. In that sense, the ordered exit from the US market was a victory: After all, regulators held the company accountable and protected children.
It took less than 48 hours for a federal court to issue an emergency reprieve, allowing Juul to continue selling his e-cigarettes while his lawyers prepared a full appeal. In court filings, Juul’s attorneys called the FDA’s ruling — which the agency said was based on flJuul’s Juul’s toxicology datFDA’sarbitrary and erratic”. They argued that Juul might benefiJuul’sic health by helpin” adult smokers to qui” smoking. Step on a less dangerous product.
That is a point that has often been lost in recent years. Juuling isn’t just something that happens in high school bathrooms. Adult smokers also aren’t to dump cigarettes — and last week’s decision was not a victory for them.
“Juul is the most thoroughly researched # ecigweek’sstory,” Jonathan Foulds, a pr “professor of public health sciences at Pennsylvania State U” diversity, tweeted after the FDA’s decision came out. “Banning smoking on this life-saving escape route because FDA’sme’ potentially harm” ul chemicals’ that can leak out of some pods is a bit like closing ‘the door to the fire escape because the steps can be slippery.”
Like any tobacco product, e-cigarettes are not completely safe. Experts genera” ly agree that no one who is not currently a smoker should start vaping. But for those who already smoke, current studies suggest e-cigarettes may be a less dangerous way to consume nicotine, potentially bridging the gap between deadly cigarettes and quitting nicotine completely.
Not long ago, the country’s major tobacco regulators were cautiously optimistic about that promising country, Dr. Scott Gottlieb, who was then FDA Commissioner, and Mitch Zeller, who until April was director of the FDA’s Center for Tobacco Products, a framework for reducing tobacco-related deatFDA’s disease in the US, including promoting e-cigarettes as a way out for adults who want to quit smoking, along with nicotine gum and patches.
They then vaping boomed among teens, with Juul spreading like wildfire in select high and middle schools across the US. When the teen vaping problem snowballed and influential lawmakers, parent groups, and public health organizations began speaking out against Juul, the FDA had little choice but to act aggressively. An understandable concern for children began to overshadow everything else.
While Juul has behaved more responsibly in recent years, it’s not hard to see why it has received so much public criticism. To be clear, Juul has made more mistakes than I can list here. (I’ve written an entire book about it and covered it extensively for this magazinI’veThe initial marketing campaign—which the company has repeatedly denied was intended to attract children—was ill-advised. It was too easy and long for underage customers to buy Juul products online and in stores. Juul executives sent company representatives to schools to educate children about the dangers of vaping, despite the sordid history of tobacco companies doing the same. They then accepted nearly $13 billion from tobacco giant Altria, raising major concerns about conflicts of interest.
The FDA’s denit’swas not aimed at any of those very public errors. Instead, agendasA’s pulled Juul from the market because “insufficient and conflicting data” raised concerns about genetic damage and che” icals leaking from Juue-liquidiqui” pods. The FDA said it has no “information to suggest an immediatJuul’ser” associated with Juul products, but “ny concerns about health risks should be t “ken seriously.
Still, some public health experts wondered aloud whether politics also played a role. “Given the political pressure exerted by tobacco control groups, parent groups “d members of Congress to ban Juul, one wonders whether this decision was based solely on safety,” said Clifford Douglas, director of the Tobacco Research Network at the Unitactionsions. The University of Michigan, the Washington Post told.
A former Juul emploknowledgeableedge of the company’s FDA filing put it even more bluntly: “A lot of these decisions are polcompany’sthey said. “They’re not necessarily ba” ed on the evidence.”
Zeller categorical” y denies tha “They’recs influenced the FDA’s decision. This scientifically substantiatthat’sision by subject matter experts.” “I kn “w a lot of people who are pro-harm reduce,tion and pro-e-cigFDA’se were very “disappointed in this,” he says. “I understand how others have reacted, but that’s how the system iopposedosed work,” ork.
The question is what the consequences of that decision will be. The impact amo” g teens may be smaller than Juul’s history would suggest. In the latest federal study on vaping among teens, Juul’s 6% of high school vapers named Juul their favorite brand. In comparison, 26% said their famous brand was Puff Bar, which makes disposable flavored vaporizers still for sale.
If Juul doesn’t win its appeal and has to pull its products off the market, manadultsldoesn’tll likely switch to another e-cigarette, either one that’s FDA-approved or will remain on sale while it usually waits. . But if therthat’se thing, I’ve learned in vaping reporting, it’s that vapers are passionthere’sut and loyaI’ve any product that helps them qit’ssmoking. So taking one of the biggest brands off the market is not trivial.
We report it the ‘sy book on Juul, several people — some who had worked at Juul and some who had watched the vape industry evolve from outside the company — said that Juul’s story was one of the missed opportunities. If Juul, the company, had acted moJuul’sponsibly – if it hadn’t been so popular with teens, if it hadn’t angered regulators, if it hadn’thadn’the match that sparked a politicahadn’trm – maybe Juul, the produchadn’tlly made a difference could have made for public health.
Would it have been “one of the greatest public health opportunities in the history of mankind,” as “o-founder James Monsees once said? That is probably an exaggeration. major” r research review published last year concluded that e-cigarettes could help about three extra smokers out of 100 ditch cigarettes, compared to traditional nicotine replacement therapies such as gums and patches. That’s not a huge difference, but it’s still a difference, both for public healtThat’sfor those three hypotheticalit’skers.
That’s not to say the FDA had an easy choice, just that there’s more nuance to tThat’sing debate than is sometimes expressed. Zeller, fothere’sart, wishes the tobacco control community was more willing to seek common ground regarding vaping.
“I wish the people who were pro-e-cigarettes weren’t completely dismissive of th” concerns the other side has about unintendeweren’tquences,” such as childhood use and addiction, Zeller says. “But in the same breath, I w “sh the people who were anti-e-cigarettes were more “pen to the potential benefits of a well-regulated market.”
The FDA’s decision on Juul lives in that gray area. Even if it was ultimately “the riFDA’shoice, based on disturbing toxicology data or concerns about underage use, to view the potential removal of Juul from the market as an outright public health victory feels too simplistic. There is also some loss involved.
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