FDA Postpones Long-Awaited Decision On Juul's Vaping Products
More than 500 companies submitted applications for 6.5 million vaping products to the FDA. The agency ruled on some of them but did not yet make a decision on products made by Juul.
Updated September 10, 2021 at 8:28 AM ET
The Food and Drug Administration said it has ruled on whether some electronic cigarette products can remain on the market, but that it's also delaying action on products made by Juul, which accounts for 40% of the e-cigarette market.
The FDA said Thursday it has issued marketing denial orders for more than 946,000 flavored vaping products because their applications "lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products."
The decisions encompass 93% of the applications companies submitted for approval – but Juul, the largest vape company, was not included in Thursday's action.
A federal judge had given the FDA one year to act on a flood of applications submitted by vape companies in a decision stemming from a lawsuit brought by anti-tobacco groups. The agency said it's made progress but needs more time.
"We continue to work expeditiously on the remaining applications that were submitted by the court's Sept. 9, 2020, deadline, many of which are in the final stages of review," the FDA said.
The news comes after years in which critics have urged tighter federal controls on vaping to combat a new surge of nicotine use by minors.
One in five high school students — and more than 6% of American adults overall — now say they vape. The industry has ballooned to more than $6 billion, led by Juul.
The FDA has long regulated the marketing and sale of traditional tobacco products such as cigarettes. But until now, the agency hasn't required the same scrutiny for vapes, allowing the market to flourish.
Decisions are pending on many vaping products
E-cigarette companies, including Juul, argue that their products are safer than traditional tobacco products such as cigarettes. But the FDA has been evaluating about 6.5 million products made by more than 500 companies to determine whether they are "appropriate for the protection of public health."
The products under FDA review range from rechargeable vape pens and the liquids that fill them to disposable e-cigarettes. Each of them requires a Premarket Tobacco Product Application, or PMTA, to be filed with the government — and those applications are what the FDA has been considering.
In the most serious instances, some products would be required to be pulled from the market.
Last month, the FDA issued its first marketing denials for some 55,000 flavored vape products from three companies, ordering them to withdraw their products from stores. It has also denied applications for companies marketing flavors designed to appeal to kids, such as Apple Crumble and Cinnamon Toast Cereal.
Regulators said the applications in the FDA's first set of denials "lacked sufficient evidence" that any benefit to adult smokers outweighed "the public health threat posed by the well-documented, alarming levels of youth use of such products."
The FDA weighs vaping's health effects
Though vaping allows users to avoid some of the harmful carcinogens caused by smoking traditional cigarettes, studies have found that e-cigarettes are still harmful.
Inhaling vapors from the products can introduce harmful chemicals into the lungs, including, in some cases, vitamin E acetate. Dozens of people have died in recent years from vaping complications in the U.S., and thousands more have been hospitalized. Most of those vaping injury cases were linked to products containing THC, not nicotine.
Virtually all e-cigarette products contain nicotine, some in high levels — including Juul's 5% pods, each of which contains as much nicotine as an entire pack of cigarettes. Nicotine also affects prenatal and adolescent brain development, making it dangerous for both teenagers and pregnant people to vape.
"If any e-cigarette could actually help a smoker quit, they would apply to be a drug through other pathways that the FDA [has], and they would demonstrate that they are safe and effective in helping smokers quit," said Erika Sward of the American Lung Association, which has advocated for the denial of all applications to the FDA for any flavored tobacco product.
"Instead, what we've seen is another generation of kids addicted and a whole situation where we have millions of smokers — who might otherwise try to end their addiction — try to use this product," she said.
Why the FDA was expected to announce decisions Thursday
In 2019, a federal judge ordered e-cigarette manufacturers to submit applications to the FDA by 2020. Their products would be allowed to remain on the market for one year while the agency reviewed them. That year-long deadline arrived on Thursday.
The agency was not expected to respond to every product application by Thursday's deadline. It has said it will prioritize companies based on their market share, meaning Juul, along with British American Tobacco and Imperial Brands — which respectively own the brands Vuse (formerly Vype) and blu — would have been expected to be the first to face decisions.
"We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications, which is key to advancing harm reduction and earning a license to operate," a company spokesman for Juul Labs said in a statement. "We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use."
Thursday's deadline left many industry watchers wondering if the FDA might impose a major crackdown on virtually all vape products or if it might take a more targeted approach, such as blocking the sale of flavored products or disposable e-cigarettes — or creating marketing rules similar to those for traditional cigarettes.
Restrictions on marketing and package designs are meant "to reduce youth initiation and use," said Kathleen Hoke, a professor of public health law at the University of Maryland.
Some worry vaping limits will lead teens to cigarettes
Some researchers worry that a major crackdown on Juul and other manufacturers would simply send teenagers reaching for traditional cigarettes instead.
"I think it would be a public health disaster," said Dr. Michael Siegel, a researcher at Tufts University who studies youth tobacco and alcohol use. "Vaping is not causing a culture of smoking. It's actually replacing that culture."
Youth smoking rates have fallen dramatically in recent years as vaping has exploded in popularity. But other researchers are skeptical the trend would reverse.
"Whether those people chose to choose to go back to a cigarette that tastes like a cigarette or a vape product that tastes like a cigarette, I think is anyone's guess," the University of Maryland's Hoke said.
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