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FDA clears first electronic cigarette but only allows tobacco flavoring

After rejecting more than a million e-cigarette-related products, the Food and Drug Administration announced today that it is authorizing its first e-cigarette: the Vuse Solo, manufactured by RJ Reynolds Vapor Company. The agency clears the company’s tobacco-flavored e-liquid pods for sale, but has rejected its flavored pods.

It’s been over a month since the FDA deadline for its review of vapes and e-cigarettes. Early September marked the end of a one-year period in which companies were allowed to continue selling their products, even though agency regulations stipulated that any new tobacco product had to be cleared before it could be marketed. Now all that sells without authorization is marketed illegally.

The companies submitted applications for 6.5 million vaping and e-cigarette products, and the agency denied or said the applications were overwhelmingly incomplete. The FDA says its decisions focus on whether the benefits of an e-cigarette product for adult smokers – who can use it to quit – outweigh the risk of hooking children and teenagers on nicotine for the first time.

Vuse tobacco flavored electronic cigarettes are the first that the FDA has found to meet this bar. According to the 2021 National Youth Tobacco Survey, about 10% of high school students who vape use Vuse products. But teens are less likely to use tobacco flavors, the agency said in a statement. The FDA has rejected 10 of Vuse’s flavored e-liquid pods and is still reviewing its mint flavor claim.

The agency said in its statement that it is also restricting RJ Reynolds Vapor Company’s advertising around its e-cigarettes to reduce the chances that teens will see the ads.

The FDA has yet to rule on 2% of vaping and e-cigarette applications submitted. This includes apps from Juul, a market leader and the company that has been most criticized and blamed for luring children and teens to vaping.

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