FDA authorizes first e-cigarette but only allows tobacco flavors

After rejecting over one million e-cigarette related products, the Food and Drug Administration announced today that it authorized its first e-cigarette: the Vuse Solo, made by R.J. Reynolds Vapor Company. The agency is allowing the company’s tobacco-flavored e-liquid pods on the market but rejected its flavored pods.

It’s been over a month since the FDA’s deadline for its review of vapes and e-cigarettes. Early September marked the end of a yearlong period where companies were allowed to keep selling their products, even though agency regulations said that any new tobacco products need authorization before they can be marketed. Now, anything sold without authorization is being marketed illegally.

Companies submitted applications for 6.5 million vaping and e-cigarette products, and the agency has rejected or said the applications were incomplete for the vast majority. The FDA says its decisions center on whether the benefits of an e-cigarette product to adult smokers — who may use it to quit smoking — outweigh the risk of hooking kids and teenagers on nicotine for the first time.

The tobacco-flavored Vuse e-cigarettes are the first that the FDA says meet that bar. Around 10 percent of high school students who vape use Vuse products, according to the 2021 National Youth Tobacco Survey. But teens are less likely to use tobacco flavors, the agency said in a statement. The FDA rejected 10 of Vuse’s flavored e-liquid pods and is still reviewing its application for a menthol flavor.

The agency said in its statement that it’s also restricting R.J. Reynolds Vapor Company’s advertising around its e-cigarettes to make it less likely teens will see the ads.

The FDA still hasn’t ruled on 2 percent of the submitted vaping and e-cigarette applications. That includes applications from Juul, a market leader and the company that’s been most heavily criticized and blamed for attracting kids and teenagers to vaping.