For the first time, the Food and Drug Administration on Tuesday allowed e-cigarettes to be smoked, saying a vaping device from RJ Reynolds could help smokers cut back on traditional cigarettes.
E-cigarettes have been sold in the United States for more than a decade with minimal government oversight or research. Facing a court deadline, the Food and Drug Administration conducted a comprehensive review of e-cigarette products to determine which products should be allowed to remain on the market.
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The agency said in September that it had rejected orders for more than 1 million e-cigarettes and related products, mainly because they were potentially attractive to underage teens. But regulators have delayed decisions on most major vaping companies, including market leader Juul, which is still pending.
Tuesday’s decision applies only to Vuse’s Solo e-cigarettes and tobacco-flavored nicotine cartridges. The agency said data from the company showed that e-cigarettes helped smokers significantly reduce their exposure to harmful chemicals in traditional cigarettes.
While the products can now be sold legally in the United States, the Food and Drug Administration has stressed that they are neither safe nor “FDA approved,” and that people who do not smoke should not use them.
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Launched in 2013, Vuse Solo is a rechargeable metallic device in the shape of a traditional cigarette. The Food and Drug Administration said it had rejected 10 more requests from the company for products with other flavors. The agency is still reviewing the company’s request to sell a menthol-flavored nicotine formulation.
“The licenses issued today are an important step toward ensuring that all new tobacco products undergo robust, scientific premarket evaluation from the FDA,” Mitch Zeller, director of the FDA’s Center for Tobacco, said in a statement.
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“Manufacturer data show that their tobacco-flavored products can benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption.”
E-cigarettes first appeared in the United States around 2007 with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes. The devices heat the nicotine solution into a vapor that is inhaled.
But there have been few rigorous studies on whether e-cigarettes help smokers quit. Efforts by the U.S. Food and Drug Administration (FDA) to begin frequently examining e-cigarette products and claims have been slowed by industry pressure and competing political interests.
In recent years, the vaping market has grown to include hundreds of companies selling a range 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 partly owned by Altria and Vuse.
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Vuse is the No. 2 vaping brand in the United States after Juul, and accounts for about a third of retail sales. Parent company RJ Reynolds sells Newport, Camel and other flagship cigarettes.
A company spokesperson said in a statement that the FDA’s decision confirms “that Vuse Solo products are appropriate to protect public health, confirming years of study and scientific research.”
The company said it is still waiting for the Food and Drug Administration’s decision on its most popular vaping device, the Vuse Alto.
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To survive in the market, companies must show that their products benefit public health. In practice, this means demonstrating that adult smokers who use the products are more likely to quit or reduce smoking, while adolescents are less likely to engage in them.
Kenneth Warner, a tobacco expert at the University of Michigan School of Public Health, said the news was a positive step to reduce the harms of smoking. But he lamented that only a Big Tobacco-backed vaping device could win the FDA’s endorsement.
“The demands the FDA places on companies that file these requests are so difficult that only those with huge resources and employees — in terms of scientists, lawyers, researchers — can file successfully,” Warner said.
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He said small businesses and e-cigarette stores should have a separate path to obtaining a license for their products.
The US Food and Drug Administration (FDA) declared underage vaping an “epidemic” in 2018 and took a series of actions targeting the small cartridge-based devices that first sparked the problem, including limiting their flavors to tobacco and menthol. Separately, Congress raised the age to buy all tobacco and vaping products to 21.
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Survey data collected earlier this year showed that Vuse was the second most popular e-cigarette brand among high school students who preferred e-cigarettes, favored by 10%. Juul was the fourth most popular e-cigarette, with a score of less than 6%.
The Food and Drug Administration said it was aware of the data on Vuse’s popularity but decided to allow flavored tobacco “because these products are less attractive to young adults and allowing these products may be beneficial” for adult smokers.
The brand most popular with teens was the single-use e-cigarette called Puff Bar which comes in flavors like pink lemonade, strawberry, and mango. Disposable e-cigarettes are not subject to the strict flavor restrictions of products like Juul.
Overall, the survey showed a nearly 40% reduction in the rate of teen vaping, as many children were forced to learn from home during the pandemic. However, federal officials cautioned against interpreting the results because they were collected online for the first time, rather than in the classroom.
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