Experts are divided on whether efforts to block Juul’s product withdrawal from the market will dent the popularity of vaping among young people.
Late last month, the U.S. Food and Drug Administration made international headlines when it stripped e-cigarette giant Juul’s products from the e-cigarette market, drawing praise from anti-tobacco advocates and lawmakers. The agency said Juul had not demonstrated that keeping its products on the market was “appropriate to protect public health.”
But less than two weeks later, after Juul filed a lawsuit, the FDA backed down. The agency said it would temporarily allow Juul products to remain on the market while the company’s apps were revisited.
The FDA warned that the additional review should not be misinterpreted as overturning its original decision, and that the Juul device could still end up being banned. But even if that happens, it’s unclear whether there will be a significant impact on teen vaping.
In a statement to The Hill, Juul’s chief regulatory officer, Joe Murillo, said the company clearly met the FDA’s criteria for being “fit to protect the public health.”
“We have full confidence in the quality and substance of our application,” Murillo said.
Juul has been heavily criticized for targeting teens since its first product hit shelves in 2015.
Juul, whose e-cigarettes are similar to USB drives, originally sold fruit flavors like mango, which its founders say is designed to help people quit smoking.
But these flavors have been widely blamed for attracting teens and young children to vaping.
Juul has since pulled all flavors except tobacco and menthol, and suspended its marketing. The company believes that the e-cigarette landscape is very different now that Juul products no longer pose a threat to public health.
Other vaping products are now more popular than Juul, including disposable e-cigarettes made by Puff Bar and Vuse.
If Juul is pulled from the market, it’s unclear how much of an impact it will have in stemming the tide of underage smokers. According to the National Youth Tobacco Survey, 26 percent of high school students said their usual brand was Puff Bar, and about 11 percent used Vuse.
Fewer than 6 percent of high school-age youth currently say they prefer Juul.
Clifford Douglas, director of the University of Michigan’s Tobacco Research Network and a professor at the university’s School of Public Health, said Juul should not be viewed as an “evil example” of the teen vaping epidemic.
“Clearly, Juul played a big role, especially in 2018, driving an increase in youth experimentation with vaping products. For the same reason…and in the years since then, partly at the coercion of the FDA , they significantly changed their behavior,” Douglas said.
However, Parents Against Vaping (PAVE) said that JUUL “created” the epidemic by marketing it to children and removing it from the market would send a strong message to the industry. It also criticized the company for ignoring evidence that its menthol products are popular with young people.
“Kids are using your menthol products. If you really don’t want youth users, based on your own public statements and logic, it will be removed,” said Meredith Berkman, co-founder of the group . “Their predation is basically continuing.”
Juul launched its sleek, disposable e-cigarettes in 2015 as an alternative to bulky traditional e-cigarettes that require users to fill canisters of “e-liquids.” By the end of 2017, it was the hottest e-cigarette on the market.
U.S. Surgeons warned in 2018 that teen vaping had become an “epidemic” as they found that more than 20 percent of high school students reported vaping that year, a 78 percent increase from 2017.
Juul pulled its fruity flavors that same year under pressure from the FDA and Congress. Currently, only JUUL’s menthol and tobacco-flavored pods are still in stores. The company, which was worth $38 billion at its peak, is now only worth around $1.6 billion.
In 2019, Congress found that JUUL “deployed a sophisticated program” to target children in schools and summer camps. The company has also been accused of targeting young people in advertisements and commercials.
The FDA has spent two years reviewing requirements for Juul to sell tobacco and menthol-flavored e-cigarettes. While advocates praised the move, the agency’s abrupt reversal raised questions.
Robin Koval, chief executive and president of anti-tobacco group The Truth Initiative, said keeping Juul on the market “sends mixed signals about its bold decision to deny JUUL marketing authorization.”
“We are in a situation where nearly a year ago, millions of teens were at risk of lifelong nicotine addiction, and the FDA failed to take action on products that make up the bulk of the e-cigarette market,” Koval said in a statement. . ” What seemed like progress just a few weeks ago now seems like a mirage in the summer sun, a failure for our nation’s youth and public health.”
Douglas, director of the Tobacco Research Network, told The Hill that the FDA’s decision to suspend its marketing denial order was “puzzling.”
“The fact that they had to crunch and go back to the drawing board almost immediately shows that they did blunder, asking more questions than answering,” he said.
The FDA said it would not comment on pending litigation.
In response to questions about how to review applications from other companies, including Vuse and Puff Bar, the federal agency said it evaluates each application individually and that all manufacturers must demonstrate that the new product is “fit for protecting public health.”
“The standard requires us to consider the risks and benefits to the entire population,” the statement read.
As the legal battle continues, experts are divided on whether the teen vaping epidemic is worsening or improving. About 11 percent of high school students and about 3 percent of middle school students reported vaping in 2021, according to the latest FDA data.
That’s down from 2020, when the FDA found 3.6 million teen e-cigarette users, with 26.5 percent of high school students using the products.
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The agency cautioned against making comparisons to previous years because the survey was conducted at the height of the pandemic last year.
Still, health officials say the survey provides an important snapshot of vaping trends among young people in the country.
Nathaniel Weixel contributed.