BRITISH AMERICAN TOBACCO P.L.C. By Dean Seal
The U.S. Food and Drug Administration has denied a British American Tobacco PLC unit's marketing applications for two menthol e-cigarette replacement cartridges.
The agency said Friday that it has ordered the R.J. Reynolds Vapor Co. to stop marketing the e-cigarette products, which are sold under the Vuse Solo brand.
R.J. Reynolds Vapor, a subsidiary of British American Tobacco's Reynolds American Inc., submitted premarket applications that "lacked sufficient evidence" showing that marketing the e-cigarette products would be appropriate for the protection of public health, the FDA said.
"Specifically, evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes," according to the FDA.
The FDA said menthol-flavored e-cigarettes have a higher risk "with regard to youth appeal, uptake and use" than their tobacco-flavored counterparts. Because of that, applicants have to provide robust evidence that their menthol-flavored vape products do a better job than tobacco-flavored e-cigarettes at promoting a switch from, or reduction in use of, traditional cigarettes in adult smokers, according to the regulator.
Retailers of the unauthorized e-cigarette products should contact R.J. Reynolds Vapor with any questions about products in their inventory, the FDA said.
A spokesman for R.J. Reynolds Vapor didn't immediately respond to a request for comment.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
03-17-23 1154ET
