The FDA’s Juul Ban May Not be a Pure Public Health Triumph

After the U.S. Food and Drug Administration announced that Juul Labs would be banned from selling e-cigarettes in America, my email inbox was flooded by emails from groups supporting the move. The CEO of the American Lung Association called it “long overdue and most welcome.” The CEO of the Truth Initiative, an anti-smoking group, called it a “huge public health victory.”

These celebratory statements center around Juul’s starring role in what federal regulators have called an epidemic of teenage nicotine addiction, one that many experts feared could undo decades of progress on smoking prevention. The company’s orderly exit from U.S. markets was in this sense a win: Finally, regulators had made the company responsible and were protecting children.

A federal court issued an emergency stay in less than 48 hours, which allowed Juul to continue selling its ecigarettes while it prepares a full appeal. In court filings, Juul’s lawyers called the FDA’s ruling—which the agency said was based on inadequacies in Juul’s toxicology data—”arbitrary and capricious” and argued that Juul can benefit public health by helping adult smokers switch to a less-dangerous product.

That’s a point that has often gotten lost over the past few years. Juuling isn’t only something that happens in high school bathrooms. Adult smokers also use Juul to ditch cigarettes—and for them, last week’s decision was not a victory.

“Juul is the most thoroughly researched #ecig in history,” Jonathan Foulds, a professor of public health sciences at Pennsylvania State University, tweeted after the FDA’s decision came out. “Banning this lifesaving escape route from smoking because some ‘potentially harmful chemicals’ may leach from some pods is a bit like locking the door to the fire escape because the steps may be slippery.”

E-cigarettes, like any other tobacco product are safe. Experts are unanimous in their belief that anyone not already smoking shouldn’t start vaping. For those who smoke already, however, current research suggests that e-cigarettes are a safer way to use nicotine. It can also be used as a bridge between smoking and quitting.

Not long ago, the country’s top tobacco regulators were cautiously optimistic about that promise. In 2017, Dr. Scott Gottlieb, who was then FDA commissioner, and Mitch Zeller, who until April was director of the FDA’s Center for Tobacco Products, described a framework for reducing tobacco-related death and disease in the U.S., including promoting e-cigarettes as an off-ramp for adults who want to stop smoking, along with nicotine gums and patches.

Vaping became a popular pastime among teens, and Juul was especially well-received in U.S. high school middle schools. The concern of kids overtook all other concerns. When the problem of teen vaping grew, influential legislators, parent groups and public-health organisations began to speak out against Juul. The FDA couldn’t help but take action.

Juul has committed more serious mistakes than I am able to mention here. They were the subject of a book I wrote and extensive coverage for this magazine. Its first marketing campaign—which the company has repeatedly denied was meant to attract kids—was, at the very least, ill-advised. For too long it was easy for minors to purchase Juul products both online and at stores. Juul’s executives went to schools and educated children about vaping, in spite of the history of other tobacco companies doing so. The company received $13 billion in donations from Altria tobacco, which raised serious conflict-of-interest concerns. Though Juul has behaved more responsibly in recent years, it’s not hard to understand why it earned so much public scrutiny.

The FDA’s denial didn’t focus on any of those very public mistakes. Instead, the agency ordered Juul off the market because “insufficient and conflicting data” raised concerns about genetic damage and chemicals leaching out of Juul’s e-liquid pods. The FDA said it does not have “information to suggest an immediate hazard” linked to Juul products, but any concern about health risks needs to be taken seriously.

Some public-health specialists wondered aloud if politics played any role. “Given the political pressure brought to bear by tobacco-control groups, parent groups, and members of Congress to ban Juul, one wonders whether this decision was solely based on safety,” Clifford Douglas, director of the University of Michigan’s Tobacco Research Network, told the Washington Post.

A former Juul employee with knowledge of the company’s FDA application put it to me more bluntly: “Many of these decisions are political,” they said. “They’re not necessarily based on the evidence.”

Zeller categorically denies that politics influenced the FDA’s decision. “I know that a lot of people who are pro-harm-reduction and pro-e-cigarette were very disappointed in this,” he says. “I understand how others have reacted, but this is the way the system is supposed to work. This was a science-based decision by subject-matter experts.”

What will the consequences of this decision be? The impact among teenagers might be smaller than Juul’s history would suggest. In the latest federal study on teen vaping, about 6% of high school vapers listed Juul as their preferred brand, while 26% said their go-to brand was Puff Bar—which makes flavored, disposable vaporizers that are still for sale.

If Juul doesn’t win its appeal and must remove its products from the market, many adult users will probably switch to another e-cigarette, either one that has been authorized by the FDA or remains for sale as it waits in regulatory limbo. But if I’ve learned anything in reporting on vaping, it’s that vapers are passionate about and loyal to whatever product helps them stop smoking. It’s possible to take one of the most popular brands from the market.

When I was reporting my book on Juul, multiple people—some who had worked at Juul and some who had watched the vaping industry evolve from outside the company—said Juul’s story was one of missed opportunities. If Juul, the company, had acted more responsibly—if it hadn’t been so popular with teenagers, if it hadn’t angered regulators, if it hadn’t lit the match that started a political firestorm—perhaps Juul, the product, could have made a real difference for public health.

Would it have been “one of the greatest opportunities for public health in the history of mankind,” as co-founder James Monsees once said? That’s probably an overstatement. According to a major review, the e-cigarette could be used as a substitute for traditional nicotine-replacement therapy like patches or gums by three extra smokers. That’s not a massive difference—but it is still a difference, both for public health and for those three hypothetical smokers.

That’s not to say the FDA had an easy choice on its hands, only that there is more nuance to the vaping debate than is sometimes expressed. Zeller for his part wishes that the vaping community would be more open to finding common ground in relation to tobacco control.

“I wish that the pro-e-cigarette people were not completely dismissive of the concerns the other side has about unintended consequences” like youth use and addiction, Zeller says. “But in the same breath, I wish that the anti-e-cigarette people were more open-minded on the potential upside of a properly regulated marketplace.”

The FDA’s decision on Juul lives in that gray area. Even if it was ultimately the right choice, based on troubling toxicology data or concerns about underage use, to cast Juul’s potential removal from the market as an unmitigated win for public health feels overly simplistic. You also have to consider the loss.

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