FDA Approves Marketing Of E-Cigarettes Citing Benefit For Addicted Smokers
The U.S. Food and Drug Administration, for the first time, has authorized the marketing of e-cigarette products, saying the approved ones could help addicted smokers to quit or to reduce smoking, but cautioned cigarettes of all types are “harmful,” the agency said in a statement on Tuesday.
The FDA approved the three tobacco-flavored e-cigarette products made by R.J. Reynolds Vapor Company, saying they could “benefit addicted” smokers quit or cut down on cigarette use after looking into R.J. Reynolds’ data, the agency said in a statement.
The FDA rejected 10 flavored e-cigarette products made by R.J. Reynolds Vapor Company, but did not disclose which one were denied, the statement said, adding it is aware teenagers are more likely to use flavored e-cigarette products.
The approval was made after examining “risks and benefits” to the population and reviewing the likelihood of youth using the e-cigarette products.
The FDA noted its authorization “does not mean these products are safe” or “FDA approved,” adding that cigarette products of all types are “harmful and addictive.”
The approved products included Vuse Solo closed ENDS device, Vuse Solo Power Unit and Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.
“We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement.
R.J. Reynolds Vapor Company is subject to digital, radio and television advertising restrictions to reduce exposure of the products to teenagers, the FDA’s statement said. Around one in 10 high school students who use e-cigarettes use Vuse’s products, the FDA said, citing the 2021 National Youth Tobacco Survey. According to the Associated Press, more than a million applications for e-cigarettes and related products had been turned down by the FDA over concerns they could appeal to teenagers. The FDA had temporarily suspended sales of flavored e-cigarette products last year to reduce teenagers from using e-cigarettes.
FDA authorizes first e-cigarettes, cites benefit for smokers (Associated Press)