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FDA clears first electronic cigarette, cites quitting benefit for smokers

For the first time, the Food and Drug Administration authorized the sale of an electronic cigarette on Tuesday, saying RJ Reynolds’ vaping device can help smokers reduce their consumption of conventional cigarettes.

Electronic cigarettes have been sold in the United States for over a decade with minimal government surveillance or research. Facing a legal deadline, the FDA has conducted a thorough review of vaping products to determine which ones should be allowed to remain in the market.

The agency said in September it had rejected applications for more than one million electronic cigarettes and related products, mainly because of their potential appeal to underage adolescents. But regulators have delayed making decisions on most major vaping companies, including Juul market leader, which is still pending.

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

Although the products can now be sold legally in the United States, the FDA has pointed out that they are neither safe nor “FDA approved” and that people who do not smoke should not start using them.

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

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

“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 consumption.”

A 14-year debate

Electronic 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 a nicotine solution into a vapor that is inhaled.

But there have been few rigorous studies to find out whether e-cigarettes really help smokers quit. And the FDA’s efforts to begin controlling vaping products and their claims have been repeatedly hampered by lobbying from industry and competing political interests.

Over the past few 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.

Vuse is the # 2 vaping brand in the United States behind Juul, accounting for about a third of all retail sales. Its parent company RJ Reynolds sells Newport, Camel and other major brands of cigarettes.

A spokesperson for RJ Reynolds said in a statement that the FDA decision confirms “that Vuse Solo products are appropriate for the protection of public health, highlighting years of study and scientific research.”

The company said it is still awaiting a decision from the FDA on its most popular vaping device, Vuse Alto.

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

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 lamented that only a vaping device backed by a major tobacco company could win FDA approval.

“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 – are able to successfully file. “said Warner.

He said small businesses and vape shops should have a separate path to get their products cleared.

A vaping “epidemic” among minors

The FDA declared underage vaping an “epidemic” in 2018 and imposed measures on the small cartridge devices that triggered the problem, including limiting their flavors to tobacco and menthol. In addition, Congress raised the purchase age of all tobacco and vaping products to 21.

Survey data collected earlier this year showed Vuse to be the second most popular e-cigarette brand among high school students who vape, 10% preferred. Juul was the fourth most popular electronic cigarette, cited as a favorite by less than 6%.

The FDA said it was aware of the data on the popularity of Vuse, but decided to authorize its tobacco flavor “because these products are less appealing to young people and authorization of these products may be beneficial. “for adult smokers.

The most popular brand among teens was a disposable electronic cigarette called Puff Bar, available in flavors such as pink lemonade, strawberry, and mango. Disposable electronic cigarettes are not subject to the strict flavor restrictions on products like Juul.

Overall, the survey showed an almost 40% drop in teen vaping rates, as many children were forced to learn at home during the pandemic. Still, federal officials have cautioned against interpreting the results because they were first collected online, rather than in classrooms.