This week, FDA Center for Tobacco Products issued a marketing denial order, effectively rejecting two menthol flavored e-cigarette products made by R.J. Reynolds Vapor Products. The FDA action covers two products: the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. R.J. Reynolds must remove these products from the U.S. market or risk enforcement action by FDA.
In announcing the decision, FDA Center for Tobacco Products Director Brian King PhD, MPH, stated, “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”
To date, FDA has approved several tobacco-flavored e-cigarette products and rejected all flavored tobacco products except menthol, but until recently, had not issued decisions on menthol flavored e-cigarettes. In October 2021, FDA issued its first decision on a menthol-flavored e-cigarette product, issuing a market denial order for Logic menthol flavored e-cigarettes. This week’s action marks only the second time FDA has taken action on a menthol flavored e-cigarette product.
“FDA’s decision to reject two menthol flavored R.J. Reynolds e-cigarette products is welcome news! This decision, coupled with FDA’s earlier decision to reject menthol-flavored Logic e-cigarette products, hints that FDA has reached the conclusion that due to the risk of youth initiation, menthol-flavored product do not belong in the U.S. market,” says ATS Tobacco Action Committee chair Hasmeena Kathuria, MD. “Hopefully marketing denial decision on other menthol e-cigarette products and enforcement action to remove these products from the market will soon follow.”