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A Big First for FDA on E-Cigarettes

Agency authorizes one to stay on the market
By Newser Editors and Wire Services
Posted Oct 13, 2021 2:19 AM CUT

(Newser) – For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette, saying the vaping device from RJ Reynolds 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 research. Facing a court deadline, the FDA has been conducting a sweeping review of vaping products to determine which ones should be allowed to remain on the market, the AP reports. The Vuse Solo is the first one to be approved to do so, the New York Times reports. "The authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data," the FDA said in a statement.

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The agency said in September it had rejected applications for more than a million e-cigarettes and related products, mainly due to their potential appeal to underage teens. But regulators delayed making decisions on most of the major vaping companies, including market leader Juul, which is still pending. Tuesday's decision only applies to Vuse’s Solo e-cigarette and its tobacco-flavored nicotine cartridges. The agency said data from the company showed the e-cigarette helped smokers significantly reduce their exposure to the harmful chemicals in traditional cigarettes. While the products can now be legally sold in the US, the FDA stressed they are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.

Vuse is the No. 2 vaping brand in the US behind Juul, accounting for about a third of all retail sales. Its parent company RJ Reynolds is one of the biggest cigarette companies in the world, selling Newport, Camel, and other leading cigarettes. The FDA said it rejected 10 other requests from the company for other flavored products, which are more popular with teens than tobacco-flavored products. The agency is still reviewing the company's request to sell a menthol-flavored nicotine formula. “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation," said Mitch Zeller, director of the FDA’s tobacco center, in a statement. (Read more e-cigarettes stories.)

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