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The First FDA-Authorized E-Cigarette Is Here

Three Vuse vaping products were authorized for sale, the FDA's first major move in a controversial public health battle.

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A photo of Vuse’s Solo Digital Vapor Cigarette brand, the e-cigarette product that won FDA authorization Tuesday, taken at a product launch event in June 2013.
A photo of Vuse’s Solo Digital Vapor Cigarette brand, the e-cigarette product that won FDA authorization Tuesday, taken at a product launch event in June 2013.
Photo: Brian Ach/AP Images for R.J. Reynolds Vapor Company (AP)

The Food and Drug Administration has formally authorized the first vaping products to be sold in the U.S. On late Tuesday night, the agency announced it would permit the marketing of three products, all sold under the Vuse brand. In doing so, the FDA stated that the benefits of vaping in helping smokers quit traditional tobacco products will likely outweigh the potential harms of teens becoming new users.

Up until recently, the vaping industry had been largely unregulated, and thousands of brands were able to be sold at supermarkets, grocery stores, and head shops. Over the years, the FDA has been pressured to finalize its planned regulations that would decide which products could remain on the market. But the deadline was moved up to September 2021 when a federal court sided with public health organizations suing the FDA over its scheduled timeline, which would have started in 2022. Despite the mandate, the FDA blew past the deadline last month, though it claimed that it had “taken action” on the vast majority of applications.


Prior to the September deadline, the FDA did reject large batches of vaping products, particularly flavored e-cigarette brands. But this batch of products is the first of any to be allowed to stay on the market. The three products are the Vuse’s refillable Solo Power device along with two tobacco-flavored cartridges.

The FDA determined Vuse’s products to be a safer alternative to tobacco cigarettes, one that could sway current smokers away from cigarettes. At the same time, it concluded that the risk of teens and young people turning to these products was low enough to not outweigh the benefits of smokers switching to them. Notably, Vuse products are sold by the RJ Reynolds Vapor Company, a subsidiary of RJ Reynolds, the notorious tobacco company.


“The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals,” said Mitch Zeller, head of the FDA’s Center for Tobacco Products, in a statement by the agency.

In authorizing these products, the FDA also rejected 10 of Vuse’s applications for flavored vaping products, though a menthol-flavored application remains up in the air. The agency promised that it would remain vigilant and re-evaluate the decision if Vuse’s vapes proved to be more popular among teens. But some public health organizations were nonetheless not pleased by the move. For instance, the American Lung Association bashed the decision, pointing to data showing that Vuse is the second most popular brand among high-schoolers. The organization also highlighted the fact that some of these products contain relatively high levels of nicotine, at 5%.

“The harm these products cause to youth shows that they fail to meet the Tobacco Control Act’s public health standard,” the American Lung Association said in a statement Tuesday. “Completely removing high-nicotine products like Vuse from the market and ending the sale of all flavored e-cigarettes products, including menthol, is the clear path to ending the youth vaping epidemic.”

Teen vaping does seem to be on the downswing as of late. And so far, the FDA hasn’t indicated that it will authorize any of the most elaborately flavored products once available on the market (in early 2020, the FDA banned most flavored products following a rise in teen vaping). But one looming question is whether other major companies, particularly the once-ascendant Juul, will be allowed to keep selling their wares as well.