Health

FDA’s Juul ban may not be a victory for pure public health


OneFter The US Food and Drug Administration (FDA) announced last week that it will place an order E-cigarette giant Juul Labs stops selling its products In the US, my inbox is flooded with emails from public health groups welcoming the decision. The executive director of the American Lung Association called it “the longest-running and most welcome overdue.” The CEO of the Truth Initiative, an anti-smoking group, called it a “huge victory in public health”.

These celebratory statements revolve around Juul’s key role in what federal regulators have called nicotine addiction in adolescents, something that many experts fear could set back decades of progress on smoking prevention. In that sense, their withdrawal from the US market was a victory: in the end, regulators held the company accountable and protected the children.

It takes less than 48 hours for a Federal court orders emergency stay, allowing Juul to continue selling its e-cigarettes while attorneys prepare a full appeal. In the court filing, Juul’s lawyers called the FDA’s ruling – which it said was based on inadequacies in Juul’s toxicology data – as “arbitrary and capricious” and argued that Juul had can benefit public health by helping adult smokers switch to a less hazardous product.

It’s a point often lost over the past few years. Juuling doesn’t just happen in high school bathrooms. Adult smokers also use Juul to quit — and for them, last week’s decision wasn’t a win.

“Juul is the most well-studied #ecig in history,” says Jonathan Foulds, professor of public health sciences at Pennsylvania State University, tweeted after the FDA’s decision is made. “Prohibit smoking on this life-saving exit because some ‘potentially harmful chemicals’ can leak from some pods a bit like locking an exit door because the steps can be slippery.”

Like any tobacco product, e-cigarettes are not completely safe. Experts widely agree that no one who doesn’t currently smoke should start vaping. But for people who already smoke, current studies show that e-cigarettes can a less dangerous way to consume nicotinecould potentially provide a bridge between lethal tobacco and quitting nicotine altogether.

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 to reduce tobacco-related deaths and illnesses in the United States, including promoting e-cigarettes as a shortcut for adults wanting to stop smoking, along with nicotine gum and patches.

After that, vaping boomed among teenagers, especially Juul, spreading like wildfire in several US middle and high schools. Concerns understandable to children begin to overshadow all else. When the problem of teen vaping emerges and becomes influential legislatorsAs mother groups and public health organizations began to speak out against Juul, the FDA was left with only strong action.

Just to be clear, Juul has made more mistakes than I have room to list here. (I wrote a whole book about them and yes cover them widely for this magazine.) Their first marketing campaign — which the company has repeatedly denied was aimed at attracting children—at least not. It has been easy for underage customers to buy Juul products online and in stores for a long time. Juul executives have sent company representatives to schools to educate children about the dangers of vaping, though bad history of tobacco companies doing the same. They then accepted nearly 13 billion dollars from tobacco giant Altria, raising concerns of significant conflicts of interest. Although Juul has behaved more responsibly in recent years, it is not difficult to see why it has received so much public scrutiny.

The FDA’s denial doesn’t focus on any public wrongdoing. Instead, the agency ordered Juul out of the market because “insufficient and conflicting data” have raised concerns about genetic damage and chemicals leaching out of Juul’s e-liquid enclosures. The FDA said it has no “immediate hazard information” associated with Juul products, but any concerns about health risks need to be taken seriously.

However, some public health experts wonder if politics plays a role. “Given the political pressure that tobacco control groups, parent groups and members of Congress are under to ban Juul, one wonders if the decision is based solely on safety.” Clifford Douglas, Director of the University of Michigan Tobacco Research Network, told Washington Parcel.

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

Zeller categorically denied that politics influenced the FDA’s decision. “I know that a lot of harm reduction advocates and advocates of e-cigarettes are very disappointed about this,” he said. “I understand how others have reacted, but this is how the system should work. This is a science-based decision by subject matter experts. “

The question is what the effects of that decision will be. The impact on teenagers may be smaller than in Juul’s history. inside Latest federal study on teen vapingabout 6% of high school students listed Juul as their preferred brand, while 26% said the brand they used was Puff Bar – which produces flavored, disposable aerosols that are still sold .

If Juul fails to gain traction and has to remove its product from the market, many adult users will likely switch to another e-cigarette, or a different type of cigarette. FDA approved or still for sale as it waits in regulatory limbo. But if I’ve learned anything from reporting on vaping, it’s that vapers are passionate and loyal to any product that helps them stop smoking. So, the possibility of removing one of the biggest brands from the market is not small.

When I reported my book on Juul, many people — some who had worked at Juul and some who watched the vaping industry grow from outside the company — said that Juul’s story is One of those 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 ignited the match that started a firestorm. political – perhaps Juul, the product, could have made a real difference to public health.

Is it “one of the greatest public health opportunities in human history,” as co-founder James Monsees puts it. used to say? That is probably an overstatement. A large research review published last year concluded that e-cigarettes can help about 3 more smokers out of 100 discarded cigarettes, compared with traditional nicotine replacement therapies such as gum and patches. It’s not a huge difference – but it’s still a difference, both for public health and for those three hypothetical smokers.

That’s not to say the FDA had an easy choice, just that the vaping debate is more nuanced than it is sometimes expressed. For her part, Zeller wants the tobacco control community to be more willing to find common ground when it comes to vaping.

“I wish e-cigarette advocates didn’t completely dismiss the concerns raised by the other side about unwanted consequences” like youth tobacco use and addiction, Zeller said. “But in the same breath, I wish the anti-e-cigarettes were more open-minded about the potential of a properly regulated market.”

The FDA’s decision on Juul is in that gray area. Even if it’s ultimately the right choice, based on troubling toxicology data or concerns about underage use, removing Juul’s potential from the market as a The inevitable victory for public health feels too simple. There is also some loss attached to it.

Other must-read stories from TIME


Write letter for Jamie Ducharme at jamie.ducharme@time.com.





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