F.D.A. Delays Decision on Juul’s E-Cigarettes but Orders Others Off the Market
The agency had faced a Sept. 9 deadline to decide whether the products could stay on the market but said it needed more time to review evidence.,
The Food and Drug Administration on Thursday put off a long-anticipated ruling 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 that the agency has been conducting for the past year. The F.D.A. said on Thursday that it had so far denied the applications of 946,000 flavored e-cigarette products to remain on the market, mostly made by small companies.
No e-cigarettes have been approved through the application process, an agency official said.
“The F.D.A. is committed to completing the review of the remaining products as quickly as possible,” the agency said in a statement Thursday afternoon.
The F.D.A. had earlier signaled that it would rule on the larger companies by Thursday, one year after applications to stay on the market were due. Many public health experts had hoped a ruling on the market leaders would clarify the conditions under which companies could operate.
“They still haven’t made any of the tough decisions,” said Eric Lindblom, a tobacco policy expert at the Georgetown University Law Center. “I expected a little bit more, and I’m not an optimist.”
In a response to the agency’s move, Juul said in a statement that it “respects the central role of the F.D.A.” in concluding a “thorough” review of its applications.
Advocates of e-cigarettes see the products as a way to wean smokers from traditional cigarettes, which are more toxic, while critics say they are just another nicotine delivery system and one that is luring young people to the drug.
Juul, the market leader, whose sleek devices led to a surge in vaping among teenagers who had never smoked, has been at the center of the debate. By pushing back its decision on the company, the F.D.A. appears to be delaying a larger decision about whether the agency sees these devices as creating more harm than good.
The F.D.A. is considering applications for e-cigarette products from around 500 companies, many of them small. Companies have 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 that the F.D.A.’s inaction on Juul and other companies could bring additional court action. “The decisions the F.D.A. still has to make are more important than the ones they’ve made already,” Mr. Myers said. “If they don’t commit to making them promptly, 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. E-cigarettes, which deliver vaporized nicotine without many of the carcinogens inhaled with combustible cigarettes, have been marketed as a safer alternative despite unsettled science about their broader public health impact.
Since e-cigarettes came on the market in the United States in the mid-2000s, youth vaping has increased steadily. By 2019, more than 27 percent of high school students reported in surveys that they vaped. That figure dropped to less than 20 percent during the coronavirus pandemic, which experts said could partly reflect the fact that teenagers were isolated and less likely to use social drugs.
The fate of Juul and other market leaders also is part of a larger conversation about the best way to further discourage cigarette use. Some experts believe the most effective step would be to limit the amount of nicotine levels in traditional cigarettes, making them less appealing.
Juul initially pitched itself as a foe of Big Tobacco. But in December 2018, the company sold a 35 percent stake to Altria, one of the world’s largest cigarette companies, for $12.8 billion.
Critics have argued that Juul’s initial marketing campaigns and flavors like cool cucumber and creme brulee lured a new generation of young people to nicotine, many of whom became addicted.
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 teenagers and families. The company still faces thousands of other lawsuits.
Juul officials have long said that the company never sought a youth market. They have argued that Juul has taken aggressive steps to discourage youth use, including suspending its advertising in the United States.
Under pressure from the F.D.A., the company pulled almost all its flavors from the market in 2019. It has since submitted applications for only menthol- and tobacco-flavored products. It is seeking approval for its nicotine pods in two strengths: 5 percent, which is equivalent to the nicotine in an average pack of cigarettes, and 3 percent.
As part of its request to gain approval for its nicotine pods, Juul filed a 125,000-page application to the F.D.A., making the case that its products have public health benefits. Research that the company funded has suggested that the devices can be effective at helping smokers quit. A study that began with 55,000 adult Juul users found that 58 percent of the 17,000 smokers who stayed in the study had stopped smoking at 12 months. Another 22 percent continued to smoke both e-cigarettes and traditional ones but cut their cigarette smoking 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 F.D.A. to reject Juul’s application.
On Thursday, the American Heart Association said that it was disappointed by the F.D.A.’s inaction on big companies like Juul, which the heart association said “has targeted our nation’s teens for years and contributed to the epidemic of tobacco use among youth.”