The US Food and Drug Administration said on Thursday it will need more time to decide whether the biggest-selling e-cigarette products may remain on the market — a delay that infuriated pediatricians and anti-tobacco advocates.
The FDA said it has taken action on about 93% of the submitted applications, something it called “significant progress.” The agency did not announce a decision yet on products from the leading e-cigarette company Juul Labs.
E-cigarette products have been allowed to remain on the market for years, even though none have been given the official green light by the FDA. Manufacturers were given until September 9 of last year to submit applications for the agency’s authorization to remain on the market.
The FDA had a year to review those applications. Now, the agency says it needs to do more.
A long, regulatory road
“However, there’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States,” acting FDA Commissioner Dr. Janet Woodcock and Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a joint statement on Thursday.
Advocacy groups slammed the delay.
The American Cancer Society Cancer Action Network, the lobbying arm of the American Cancer Society, had joined a lawsuit to force the September 9 deadline.
“The FDA’s failure today to act on applications by JUUL, the manufacturer with the single biggest e-cigarette market share, is extremely disappointing and will allow the industry to further endanger public health and hook more kids on their highly addictive products,” Lisa Lacasse, president of ACS CAN, said in a statement.
“The FDA has had ample time to review the applications and allowing additional delays is unconscionable. There is overwhelming data to demonstrate the negative impact these kinds of flavored products have had on public health and their role in the youth e-cigarette epidemic. The time to act is now,” Lacasse added.
Dr. Lee Savio Beers, president of the American Academy of Pediatrics, said the FDA was in essence giving companies such as Juul a pass.
“Even though products like JUUL are technically being marketed illegally, FDA signaled that it will not take imminent action to remove them. This is a reckless decision that will allow products proven to addict and endanger young people to continue being sold,” Beers said.
“The AAP, along with our public health partners, will be looking closely at our legal options to compel FDA to do the right thing and once and for all get dangerous e-cigarette products off the market. We must do everything we can to protect young people from nicotine addiction. We have not a moment more to waste when it comes to keeping children and teens safe.”
Robin Koval, president and CEO of the Truth Initiative, said millions of teens have become addicted to nicotine.
“Postponing decisions on those with the lion’s share of the market further empowers the big, rich, tobacco companies to continue to grow their business and profits on the backs of young people putting millions at risk for a lifetime of nicotine addiction,” Koval said in a statement.
Woodcock and Zeller said that, as of Thursday, the FDA has taken action on applications for more than 6 million products known as electronic nicotine delivery systems — rejecting most of them, including refusing to file one company’s applications for about 4.5 million products because required contents were missing. The FDA also issued 132 marketing denial orders for more than 946,000 flavored products, “including flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal,” the statement said.
“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 statement said.
“We are committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review by the FDA and met the statutory standard.”
While many products under review have been on the market, “all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion,” the statement said. “The FDA is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress.”
Even though e-cigarette products have been sold for years — and are often marketed as tools to help adults quit smoking traditional cigarettes — none have officially been authorized by the FDA. That means e-cigarettes have been on the market illegally, the FDA says.
Prior to August 8, 2016, e-cigarettes, cigars and hookah products were not regulated by FDA. That’s because, as the FDA notes, “the original grant of authority from Congress in 2009 only covered cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.”
Then, e-cigarettes and other vape products became subject to the FDA’s tobacco authority and have been somewhat in regulatory limbo since August 2016, according to the FDA. The products on the market at that time needed to have FDA authorization to be legally marketed, but the agency had deferred enforcement of the authorization requirements and no products had been authorized.
A July 2019 court decision placed a 10-month deadline on e-cigarette companies to apply to the FDA for public health review. Any products that missed the May 2020 application deadline could have been pulled from the market by the FDA, while those that did apply could stay on the market for up to a year while under review.
Then came Covid-19 — and a four-month extension of that deadline to September 9, 2020.
So for e-cigarette products and others deemed as a “new tobacco product,” the FDA issued a policy allowing manufacturers to submit applications for authorization by September 9 of last year. That gave the FDA one year — until Thursday — to review applications for products and decide to approve or reject the sale of each product.
In the meantime, such products have stayed on the market, pending review.
“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. We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use,” a Juul spokesman told CNN in an email.
‘A winnowing of the market’
Large vape companies, such as Juul, likely have limited concerns around the FDA’s review — whereas, smaller manufacturers could be worried, Kathleen Hoke, professor of law at the University of Maryland, said on NPR’s “All Things Considered” on Wednesday.
“I suspect the large players, the big market players like Juul Labs, are less worried. They have submitted substantial applications with likely a significant amount of science base, but there are many other manufacturers that probably submitted applications with a less strong science base,” Hoke said.
“Whether they get to bootstrap on some of the data presented by the other manufacturers or not is a question,” she said. “So, I think we’re going to see a winnowing of the market — and so our major players will probably stay in the business and some of our smaller manufacturers will likely be out.”
As of late July, companies had submitted more than 6.9 million tobacco products to the FDA for review, all but a sliver related to e-cigarettes. In late August, the FDA denied marketing applications for about 55,000 flavored e-cigarettes, saying the products posed a public health threat to youth in the US.
In deciding whether to greenlight certain vaping products, the FDA must decide their public health merit. Does the likelihood of smokers switching over to vapes outweigh the likelihood that others — especially young people — will start getting hooked on nicotine?
A ‘free-for-all market’
In the past several years, while e-cigarette products have been on the market without authorization, they have grown in popularity among young people, leading to a vaping epidemic in high schools nationwide.
Health advocates have been urging the FDA to act more quickly to limit e-cigarette sales.
“We are encouraged that the FDA appears to be recognizing that flavors have to be taken off the market in the interest of protecting youth and public health, and menthol should absolutely be included. But we are very concerned that they did not prioritize and complete the reviews of the companies with over 75% of the e-cigarette market as they promised to do, especially category leader JUUL who started the e-cigarette epidemic in the first place followed by Vuse, blu and NJOY who round out the top brands,” said Koval, whose group was formed out of the 1998 Master Settlement Agreement between states and the major tobacco companies.
“Moreover, we believe adult smokers who might possibly benefit from a carefully regulated market with products that have proved they are safe and do what they promise are not well served by the continuation of a free-for-all commercial market.”
The use of e-cigarettes among high schoolers and middle school students declined significantly from 2019 to 2020 but remains high. A study published in June in the journal JAMA Network Open found that early 20% of high schoolers and almost 5% of middle schoolers reported last year that they currently vaped — down from 27.5% and 10.5% in 2019. Most of the young students reported commonly using fruit-flavored products.
Leading e-cigarette company Juul Labs stopped selling several flavored products in the United States in 2019. Only tobacco and menthol flavors have remained for sale.
The long-term safety of vaping products is not yet known, said Marielle Brinkman, a senior research scientist at The Ohio State University Comprehensive Cancer Center.
“At the Center for Tobacco Research, we have measured short-term effects in lung and heart health; we have measured harmful and potentially harmful constituents in the vapor that user’s inhale from these products,” Brinkman told CNN.
“It is already established that there is no safe way for people under the age of 25 years to use nicotine,” she wrote. “However, if you are a smoker, and you have failed at using FDA-approved cessation such as nicotine gum, lozenge, patch, etc., transitioning from combustible tobacco product use (meaning cigarettes, cigars, cigarillos, hookah) to ONLY using e-cigarettes may be result in an unknown reduction of harm.”
But Matthew Myers, president of the Campaign for Tobacco-Free Kids, said the evidence is clear.
“There is no public health justification for the FDA to allow the continued sale of any flavored e-cigarettes, including menthol-flavored products,” Myers said in a statement.
“There is overwhelming evidence that flavored e-cigarettes — including menthol products — appeal to kids and have fueled the youth e-cigarette epidemic, while there is a lack of evidence that flavored e-cigarettes are effective at helping smokers quit,” Myers added.
“It would be particularly harmful for the FDA to authorize the continued sale of Juul’s menthol e-cigarettes given the fact that Juul was the main cause of the youth e-cigarette epidemic with its appealing flavors, massive doses of nicotine and slick, youth-oriented marketing campaigns. The Juul products pending before the FDA put kids doubly at risk. Not only do they come in menthol flavor attractive to kids, these products also have high nicotine levels — equivalent to a whole pack of cigarettes — that can rapidly addict kids.”
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