The US Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) for two of R.J. Reynolds Vapor Company menthol e-cigarette products, according to an FDA press release.

The products in question are marketed under the Vuse Solo brand and include the Vuse Replacement Cartridge Menthol 4.8 per cent G1 and the Vuse Replacement Cartridge Menthol 4.8 per cent G2. R.J. Reynolds Vapor Company may no longer market or distribute these products in the US but can resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs, according to the press release. If the company continues to sell or market the products it risks FDA enforcement action.
After reviewing the premarket tobacco product applications (PMTAs) for both products, the FDA came to the conclusion that, the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health and specifically that evidence submitted by the applicant did not demonstrate that its menthol-flavoured e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavoured e-cigarettes, according to the FDA press release.
“The FDA is a data driven agency and science remains the cornerstone of our tobacco product regulatory activities,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “The science has guided – and will always guide – the FDA’s decision making on premarket tobacco product applications, including today’s marketing denial orders.”
“We are disappointed in FDA’s decision to issue an MDO for Vuse Solo’s 4.8% Menthol product. Reynolds intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products to adult nicotine consumers age 21+ without interruption,” said a BAT spokesperson.
“We believe that menthol vapour products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health. Reynolds will challenge the denials. We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health,” they concluded.