Home News FDA authorizes first e-cigarette, cites benefit for smokers

FDA authorizes first e-cigarette, cites benefit for smokers


The Food and Drug Administration on Tuesday for the first time authorized an electronic cigarette that the regulator says may help smokers cut back on traditional tobacco cigarettes.

The authorization applies to Vuse’s Solo e-cigarette and its tobacco-flavored nicotine cartridges — which are manufactured by R.J. Reynolds.

Data from the company showed that the authorized model of e-cigarette helped smokers lower their exposure to harmful chemicals in conventional cigarettes.

“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.

“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,” said Zeller.

Tuesday’s authorization comes over a decade after e-cigarettes first appeared in the US.

By court order, the FDA has been conducting a wide-ranging review of scores of e-cigarettes and other vaping products — already rejecting over a million applications for other vaping products.

The agency’s vetting process has been hampered by lobbying and political interests.

The FDA said it rejected 10 other requests from Vuse for other flavored products. The agency is still reviewing the company’s request to sell a menthol-flavored nicotine formula.

Vuse is the No. 2 vaping brand in the U.S. behind Juul, accounting for about a third of all retail sales. Juul’s application with the FDA is still pending.

While authorizing its first e-cigarette, the FDA stressed Tuesday that products are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.

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