By Matthew Perrone -
The Associated Press
For the first time, the Food and Drug Administration authorized an e-cigarette on Tuesday, saying RJ Reynolds' vaping device
can help smokers cut back on conventional cigarettes.
E-cigarettes have been sold in the US for more than a decade with minimal government oversight or investigation.
Heading into a judicial deadline, the FDA has been conducting a comprehensive review of vaping products to determine which ones should remain on the market.
The agency said in September that it
had rejected applications for more than a million e-cigarettes and related products
, primarily because of their potential appeal to underage teens.
But regulators delayed decision-making on most of the major vaping companies, including market leader
Juul
, which is still pending.
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Tuesday's decision only applies to the
Solo
de Vuse
e-cigarette
and its tobacco-flavored nicotine cartridges.
The agency said the company's data showed that the e-cigarette helped smokers significantly reduce cigarette use.
While the products can now be legally sold in the US,
the FDA emphasized that they are not safe or "FDA approved" and that non-smokers should not use them
.
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Launched in 2013,
Vuse Solo
is a rechargeable metal device that is shaped like a traditional cigarette.
The FDA said it
rejected 10 other requests from the company for other flavored products
, but did not release details.
The agency is still reviewing the company's application to sell a menthol-flavored nicotine formula.
"Today's authorizations are an important step in ensuring that all new tobacco products undergo robust scientific and premarket evaluation by the FDA," said Mitch Zeller, director of the FDA's tobacco center, in a release.
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"The manufacturer's data shows that its tobacco-flavored products could benefit addicted adult smokers who switch to these products, either completely or with a significant reduction in cigarette use."
E-cigarettes first appeared in the US around 2007 with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes.
The devices heat a solution of nicotine in a vapor that is inhaled.
But there have been few rigorous studies on whether e-cigarettes really help you quit smoking.
And the FDA's efforts to begin scrutinizing vaping products and their claims were repeatedly held back by lobbying from industry and competing political interests.
In recent years, the vaping market has grown to include hundreds of companies
selling a variety of nicotine devices and solutions in various flavors and strengths
.
But the vast majority of the market is controlled by a few companies, including Juul Labs, which is partially owned by Altria, and Vuse.
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To stay in the market,
companies must demonstrate that their products benefit public health
.
In practice, that means showing that adult smokers who use the products are likely to quit or cut back, while teens are unlikely to hook up.
Kenneth Warner, a tobacco expert at the University of Michigan School of Public Health, said the news was a positive step in reducing the harms of smoking.
But he regretted that only a vaping device endorsed by a large tobacco company was able to gain FDA endorsement.
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"The demands that the FDA places on companies that file these applications are so extraordinarily difficult to meet that only those with enormous resources and staff, in terms of scientists, lawyers, researchers, can successfully file," Warner said.
He said smaller companies and vape shops should have a separate path to getting their products cleared from regulators.
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The FDA declared underage vaping an “epidemic” in 2018
and has taken a series of actions targeting the small cartridge-based devices that first caused the problem, including limiting their flavors to tobacco. and menthol.
Separately, Congress raised the purchase age for all tobacco and vaping products to 21.
Survey data collected earlier this year showed that
Vuse was the second most popular e-cigarette among high school students using vaporizers
, preferred by 10%.
Juul was the fourth most popular e-cigarette, used by less than 6%.
In 2018, the FDA declared underage vaping an “epidemic.” Getty Images / Bloomberg
The FDA said it was aware of the data on Vuse's popularity, but decided to license its tobacco flavor "because
these products are less attractive to young people and licensing them may be beneficial" to adult smokers.
The most popular brand among teens was a disposable e-cigarette called Puff Bar that comes in flavors like pink lemonade, strawberry, and mango.
Disposable e-cigarettes are not subject to the strict taste restrictions of products like Juul.
Overall,
the survey showed a nearly 40% drop in the teen vaping rate
, as many children were forced to learn at home during the pandemic.
Still, federal officials cautioned against interpreting the results because they were collected online for the first time, rather than in classrooms.