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The Food and Drug Administration on Thursday postponed a long-awaited decision on whether Juul Labs and other major e-cigarette companies could continue to sell their products in the United States.
The companies are at the center of a review of the vaping industry the agency has been conducting for the past year. The FDA said Thursday it has so far denied applications for 946,000 flavored e-cigarette products to remain on the market, mostly made by small companies.
No e-cigarettes were approved through the application process, an agency official said.
“The FDA is committed to completing the review of the remaining products as quickly as possible,” the agency said in a statement Thursday afternoon.
The FDA had earlier signaled that it would vote on large companies by Thursday, a year after the deadline for filing maintain-to-market applications. Many public health experts had hoped that a decision on market leaders would clarify the conditions under which companies could operate.
“They still haven’t made the tough decisions,” said Eric Lindblom, an expert on tobacco control policy at Georgetown University Law Center. “I expected a little more, and I’m not optimistic.”
In response to the agency’s decision, Juul said in a statement that it “respects the central role of the FDA” in concluding a “thorough” review of its applications.
Proponents of e-cigarettes see the products as a way to wean smokers off traditional cigarettes, which are more toxic, while critics say it is just another nicotine delivery system and one that attracts young people into drugs.
Juul, the market leader, whose sleek devices have led to a wave of vaping among never-smoker teens, has been at the center of the debate. By pushing back its decision on the company, the FDA appears to be delaying a broader decision on whether the agency views these devices as creating more harm than good.
The FDA reviews e-cigarette product applications from about 500 companies, many of which are small. Companies need to show that their vaping products are less harmful than traditional cigarettes and that their usefulness in helping smokers quit outweighs the risk that some people will start using nicotine through the products.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said the FDA’s denial of thousands of products was “significant” progress, but much more was needed, such as action against Juul and the ban. all flavored electronic cigarettes, including menthol.
“The decisions the FDA still has to make are more important than those it has already made,” Myers said. “If they don’t commit to getting them done quickly, then we have no choice but to ask a court to intervene.”
While overall smoking rates have fallen sharply since the mid-1960s, smoking remains the leading cause of preventable death in the United States, contributing to the deaths of nearly half a million Americans each year. Electronic cigarettes, which provide vaporized nicotine without many of the carcinogens inhaled with combustible cigarettes, have been marketed as a safer alternative despite uncertain science as to their wider impact on public health.
Ever since e-cigarettes hit the US market in the mid-2000s, vaping among young people has steadily increased. In 2019, over 27% of high school students reported in surveys that they vaped. That figure fell to less than 20% during the coronavirus pandemic, which experts say may in part reflect the fact that teens were isolated and less likely to use social drugs.
The fate of Juul and other market leaders is also part of a larger conversation about how best to further discourage cigarette smoking. Some experts believe that the most effective measure would be to limit the amount of nicotine in traditional cigarettes, making them less attractive.
Juul initially presented himself as an enemy of Big Tobacco. But in December 2018, the company sold a 35% stake to Altria, one of the world’s largest cigarette companies, for $ 12.8 billion.
Critics have argued that Juul’s early marketing campaigns and flavors like fresh cucumber and creme brulee drew a new generation of young people into nicotine, many of whom have become addicted to it.
The company recently agreed to pay $ 40 million to settle a lawsuit with the state of North Carolina over its marketing practices, allowing Juul to avoid public testimony from aggrieved teens and families. The company still faces thousands of other lawsuits.
Juul officials have long said the company never looked for a youth market. They argued that Juul has taken aggressive steps to discourage use by young people, including suspending its advertising in the United States.
Under pressure from the FDA, the company withdrew almost all of its flavors from the market in 2019. Since then, it has only filed applications for products flavored with menthol and tobacco. He is seeking approval for his nicotine pods in two strengths: 5%, which is equivalent to the nicotine in an average pack of cigarettes, and 3%.
As part of its application for approval for its nicotine pods, Juul has filed a 125,000-page application with the FDA, claiming that its products have public health benefits. Company-funded research suggests the devices may be effective in helping smokers quit. A study that began with 55,000 adult Juul users found that 58% of the 17,000 smokers who stayed in the study had quit by 12 months. Another 22% continued to smoke both e-cigarettes and traditional cigarettes, but cut their cigarette consumption by at least half.
Several major health organizations – the American Heart Association, the American Lung Association, the American Academy of Pediatrics, and the American Cancer Society Cancer Action Network – have asked the FDA to deny Juul’s request.
On Thursday, the American Heart Association said it was disappointed with the FDA’s inaction on big companies like Juul, which the Heart Association said “has been targeting teens in our country for decades. years and contributed to the epidemic of smoking among young people ”.
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