The Food and Drug Administration (FDA) has issued marketing denial orders for 2 menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company.

The marketed products include the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. Under these orders, the Company may not market or distribute these products in the US without risking FDA enforcement.

The Agency denied the Company’s premarket tobacco product applications (PMTA) because the application lacked sufficient evidence to show that permitting the marketing of these products would provide a benefit to adult smokers that would outweigh the potential appeal to youth. Because of the increased risk of youth initiation, applicants must provide robust evidence showing that use of menthol flavored e-cigarette products would result in a complete switch or a significant reduction in the use of combustible cigarettes in adult smokers beyond that observed with tobacco-flavored e-cigarettes.

“Today’s decision pertains to the specific application submitted for review by FDA,” said Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”

Only 23 tobacco-flavored e-cigarette products and devices are currently authorized by the FDA for sale in the US.

Reference

FDA denies marketing of two vuse menthol e-cigarette products following determination they do not meet public health standard. News release. US Food and Drug Administration. Accessed January 24, 2023. https://www.prnewswire.com/news-releases/fda-denies-marketing-of-two-vuse-menthol-e-cigarette-products-following-determination-they-do-not-meet-public-health-standard-301729373.html.