FDA’s Latest Marketing Denial Order for Menthol E-Cigarette Products Underscores Its Continued Commitment to Sound Science

Statement by CEO and President Robin Koval

Truth Initiative applauds the Food and Drug Administration’s (FDA) latest announcement issuing market denial orders (MDOs) for two menthol e-cigarette products, requiring their immediate removal from the U.S. consumer market. Menthol and all flavored tobacco products play an indisputable role in youth tobacco initiation. The order against Big Tobacco’s R.J. Reynolds Vapor Company’s Vuse Solo brand, specifically the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2, shows that sound science leads the way in protecting young people from these highly addictive products.

This latest action – the second against R.J. Reynolds Vapor Company in the past several months – demonstrates that Dr. Brian King and the FDA are committed to consistent action regarding all flavored e-cigarettes, and in particular menthol e-cigarettes that protects public health. Menthol, both on its own and in combination with nicotine, alters the nicotine receptors in the brain and can contribute to nicotine dependence. It has also been shown to increase the intensity of nicotine’s reinforcing effects and withdrawal symptoms, making it easier to start and harder to quit.

The most recent data from the 2022 National Youth Tobacco Survey indicated that 26.6% of middle and high school students who use flavored e-cigarettes use menthol. Findings published in Tobacco Control in July 2022 by CDC Foundation in collaboration with Truth Initiative show that sales of e-cigarettes in “cooling” flavors like menthol, ice, cool, frost, chill, or freeze rose by nearly 700%, and their U.S. market share doubled to 55% between 2017 and 2021, making the FDA’s decision ever more critical and timely given the on-going youth e-cigarette crisis. 

We encourage the agency to accelerate and complete their review of all remaining e-cigarettes, especially those with the largest market share – including Vuse Alto, which is now the #1 e-cigarette brand and one young people list as a product they use – in order to keep these addictive products out of the hands of young people moving forward.