The Food and Drug Administration on Tuesday for the first time approved an digital cigarette that the regulator says could assist smokers reduce on conventional tobacco cigarettes.
The authorization applies to Vuse’s Solo e-cigarette and its tobacco-flavored nicotine cartridges — that are manufactured by R.J. Reynolds.
Data from the corporate confirmed that the approved mannequin of e-cigarette helped smokers decrease their publicity to dangerous chemical compounds in typical cigarettes.
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” stated Mitch Zeller, director of the FDA’s tobacco middle, in an announcement.
“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,” stated Zeller.
Tuesday’s authorization comes over a decade after e-cigarettes first appeared within the US.
By court docket order, the FDA has been conducting a wide-ranging evaluation of scores of e-cigarettes and different vaping merchandise — already rejecting over one million purposes for different vaping merchandise.
The company’s vetting course of has been hampered by lobbying and political pursuits.
The FDA stated it rejected 10 different requests from Vuse for different flavored merchandise. The company continues to be reviewing the corporate’s request to promote a menthol-flavored nicotine system.
Vuse is the No. 2 vaping model within the U.S. behind Juul, accounting for a couple of third of all retail gross sales. Juul’s software with the FDA continues to be pending.
While authorizing its first e-cigarette, the FDA careworn Tuesday that merchandise are neither protected nor “FDA approved,” and that individuals who don’t smoke shouldn’t use them.