First e-cigarette authorized in the U.S., FDA cites benefit for smokers

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For the first time ever, the Food and Drug Administration authorized an electronic cigarette on Tuesday, saying RJ Reynolds’ vaping device could help smokers wean away from traditional cigarettes.

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E-cigarettes have been sold in the US for more than a decade with minimal government oversight or research. Facing a court deadline, the FDA is conducting a comprehensive review of vaping products to determine which products should be allowed to remain on the market.

The agency said in September it had rejected applications for more than one million e-cigarettes and related products, primarily because of their potential appeal to underage teens. But regulators delayed a decision on most major vaping companies, including market leader Juul, which is still pending.

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Tuesday’s ruling applies only to Vuse’s solo e-cigarettes and its tobacco-flavored nicotine cartridges. The agency said the company’s data showed that e-cigarettes helped smokers reduce their exposure to the harmful chemicals in traditional cigarettes.

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While the products can now be sold legally in the US, the FDA insists that they are neither safe nor “FDA approved,” and that people who do not smoke should not use them.

Launched in 2013, the Vuse Solo is a rechargeable metal device shaped like a traditional cigarette. The FDA said it rejected 10 other requests from the company for other flavored products. The agency is still reviewing the company’s request to sell the menthol-flavored nicotine formula.

“Today’s authorization is an important step toward ensuring that all new tobacco products undergo the FDA’s robust, scientific pre-market evaluation,” Mitch Zeller, director of the FDA’s Tobacco Center, said in a statement.

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“The manufacturer’s data suggest that its tobacco-flavored products may benefit addictive adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption.”

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 nicotine solution into vapor that is inhaled.

But little has been studied about whether e-cigarettes actually help smokers quit. And efforts by the FDA to launch an investigation into vaping products and their claims were repeatedly slowed by industry lobbying and competing political interests.

In recent years, hundreds of companies have joined the vaping market, selling a range of devices and nicotine solutions in various flavors and strengths. But the majority of the market is controlled by a few companies, including Juul Labs, which is partly owned by Altria and Vuse.

Vuse is the number 2 vaping brand in the US after Juul, accounting for about a third of all retail sales. Its parent company RJ Reynolds sells Newport, Camel and other major cigarettes.

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A spokesperson for the company said in a statement that the FDA’s decision confirms that “Vuss Solo products are suitable for protecting public health, underscoring years of scientific study and research.”

The company said it is still awaiting the FDA’s decision on its more popular vaping device, the Vus Alto.

To remain in the market, companies must demonstrate that their products benefit public health. In practice, this means proving that adult smokers who use the products are less likely to quit or reduce smoking, while adolescents are unlikely to become addicted to them.

Kenneth Warner, a tobacco expert at the University of Michigan School of Public Health, said the news is a positive step in reducing the harms of smoking. But he lamented that only a vaping device backed by a Big Tobacco company was able to win the backing of the FDA.

“The FDA’s demands on companies filing these applications are so extraordinarily difficult that only scientists, lawyers, researchers _ with vast resources and personnel are able to file successfully,” Warner said.

He added that smaller companies and vape shops should have a different route to authorize their products.

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The FDA declared underage vaping an “epidemic” in 2018 and has taken a number of measures aimed at the small cartridge-based devices that first caused the problem, including limiting the flavor of tobacco and menthol. Separately, Congress raised the purchase age to 21 for all tobacco and vaping products.

Survey data collected earlier this year showed that Vues was the second most popular e-cigarette brand among high school students, preferred by 10%. Juul was the fourth most popular e-cigarette, cited by less than 6%.

The FDA said it was aware of Vus’s popularity figures, but decided to authorize its tobacco flavor “because these products are less attractive to youth and it is advantageous to authorize these products for adult smokers.” It is possible”.

The most popular brand among teenagers 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 stringent taste restrictions of products like Juul.

Overall, the survey showed a nearly 40% drop in teen vaping rates as many children were forced to learn from home during the pandemic. Still, federal officials cautioned about interpreting the results as they were first collected online rather than through classes.


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