The FDA Is Banning Juul

Juul, the e-cigarette brand as controversial as it was once wildly popular, may finally be meeting its end in the US.

On Thursday, the FDA announced that it is ordering Juul off the market. The agency said that Juul “must stop selling and distributing” its e-cigarettes in the US and that its current products for sale must be removed from shelves.

The FDA also denied authorization to market Juul in the US but added that its order does not stop individual consumers from possessing or using Juul products.

The agency denied the company’s premarket tobacco product application to keep selling its Juul device, as well as its tobacco- and menthol-flavored nicotine pods, after determining it “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,” according to a press release. In particular, the FDA said that Juul had failed to address its concerns about “insufficient and conflicting data,” including unspecified “potentially harmful chemicals leaching” from Juul pods.

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert M. Califf said in the press release. The decision was first reported by the Wall Street Journal.

The FDA is also separately proposing to slash the amount of nicotine in traditional cigarettes to reduce their addictiveness as well as lessen youth use and smoking-related deaths, according to a statement released Tuesday.

Since Juul launched in 2015, experts have raised questions about its safety and practices. Though the company claims its mission is to offer adult smokers an alternative to standard cigarettes, it’s also been accused of marketing to children.

The FDA declared vaping among youth an “epidemic” in 2018, and numerous teens have been hospitalized or even, according to one lawsuit, died from Juul use. Despite marketing that portrays the company’s products as a healthier alternative to cigarettes, Juul pods contain large amounts of nicotine and are highly addictive — often hooking young people who were never previously addicted to smoking and didn’t know the products contained nicotine. On the other hand, vaping advocates contend that the FDA’s decision doesn’t consider the potential benefits it may offer to current and ex-smokers. It is estimated that nearly 31 million adults in the US currently smoke cigarettes.

Juul peaked in late 2018, when its dominance over the e-cigarette market compelled the tobacco giant Altria to acquire a 35% stake that valued it at $38 billion. But Juul stopped selling flavored pods in 2019, following warnings from the federal government that a ban was imminent. It also stopped advertising in the US and later scaled back sales in Europe and Asia.

In the years since, it’s been hard times for what was once the nation’s leading e-cigarette brand. Its valuation has plummeted (Altria now values its investment at $1.6 billion, down from $12.8 billion), hundreds of employees have been laid off, and it has faced numerous lawsuits — including ones from hundreds of schools alleging that the company deliberately marketed to minors, and from former employees accusing their employer of knowingly selling contaminated pods (though internal documents cast doubt on that claim) and of retaliating for reporting sexual harassment.

The FDA’s decision was the result of a review process that started nearly two years ago, when Juul and other e-cigarette manufacturers submitted applications to argue that their devices were a net benefit to public health. A handful of e-cigarettes, like the Vuse from tobacco manufacturer R.J. Reynolds, have since been authorized. Before the agency began regulating the industry in 2016, e-cigarettes operated in a gray area.

As Juul scaled back during the pandemic, teens craving a nicotine fix have turned to disposable flavored e-cigarettes, like Puff Bars, that circumvent federal standards. At the same time, sales of traditional cigarettes climbed for the first time in over two decades.

The FDA’s decision technically means that Juul will no longer be allowed to sell its products in the US. But that’s not likely.

What’s likely to happen, according to Gregory Conley, president of the American Vaping Association, an industry group, is that Juul will take advantage of the administrative appeals process to keep its products on American shelves. It’s unclear how long it would take the FDA to review an appeal if Juul files one. It’s also unclear whether Juul will pursue this option. The company has yet to respond to BuzzFeed News’ request for comment.

Conley said the FDA’s denial of Juul’s applications “is a terrible sign of the things to come” because it ignores the potential benefits these products provide for current and former adult smokers. He also mentioned that the number of young people who vape nicotine is on a “big decline” anyway.

“The FDA has already banned hundreds of thousands of vaping products,” Conley told BuzzFeed News. “With this move, the FDA is making crystal clear how low the health of adult smokers and ex-smokers is on their priority list.”

Research is limited, but some studies suggest e-cigarettes with nicotine can help adult smokers quit smoking. There are other options for adults to break their nicotine addiction, including nicotine gum and patches and the FDA-approved medications bupropion and varenicline. However, studies show they aren’t too effective in the long term.

A former Juul employee speaking on the condition of anonymity told BuzzFeed News that in retrospect, the company assumed — incorrectly — that the FDA would cater to it because of its large customer base, instead of trying to work with regulators from the start. “Years from now we’re going to see this as a huge missed chance to do good,” the ex-employee said, adding, “This could have saved lives. Leadership fucked that up.”

Still in the works, however, is an application for another version of Juul not currently sold in the US that includes age verification technology. Conley suspects that regardless of what happens, the FDA’s latest announcement “weaves a pathway” for these other products to enter the US market.

The device works by pairing to smartphones via Bluetooth, providing data on what and how often someone is vaping, and can automatically lock when it moves away from the phone it’s connected to.

Anyone who buys this product has to pass an age verification and facial recognition process that confirms they’re at least 21 years old. The company claims this technology could “combat underage use and support a more responsible marketplace,” but some health experts couldn’t disagree more.

“Juul ruthlessly and aggressively targeted kids, and worked to addict them to their products,” Erika Sward, national assistant vice president of advocacy for the American Lung Association, told BuzzFeed News. “We have urged the FDA to deny all marketing orders to Juul, and we certainly don’t think that the company should be allowed to collect any data about kids, which is exactly what would happen with an age verification product.” (The FDA does not approve tobacco products, but it can grant or deny them marketing orders, Sward noted.)

Sward said this decision “should mean the end of Juul,” but that’s not to say the company can’t come back and submit a new application for another product at some point.

“We are obviously quite troubled by all of this and all of Juul’s products,” Sward said, “and we certainly welcome the FDA’s announcement, as long overdue as it is.”

Studies have shown that e-cigarettes are more addictive among young adults than traditional cigarettes. What’s more, research has found that one Juul pod contains about 40 milligrams of nicotine, which is equal to about one pack of cigarettes.

“Unfortunately, we have fewer tools for kids to quit, and so it’s extra important that any parent with a kid who became addicted or any young adult speak with their doctors about the best ways to quit smoking,” Sward said. “The FDA must act swiftly to ensure that no one can buy a Juul product in the US and that it is enforcing its decision entirely.”

Source link