The Food and Drug Administration (FDA) has taken a significant step in its efforts to combat the popularity of vaping among young people by banning the sale of Vuse Alto menthol and fruit-flavored electronic cigarettes. Vuse, produced by R.J. Reynolds Vapor Co., is the leading e-cigarette brand in the United States, and its sub-brand, Vuse Alto, is particularly popular among kids.
The FDA has targeted three different menthol-flavored and three mixed-berry-flavored vaping products, each available in three nicotine strengths. As a result, Reynolds is now prohibited from marketing or distributing these products in the U.S., although they do have the option to submit a new regulatory application.
The decision was reached after the FDA determined that Reynolds had not provided sufficient evidence to demonstrate that the benefits of their menthol and mixed-berry-flavored products for adults outweigh the known risks to youth. Recent data from the 2022 National Youth Tobacco Survey revealed that Vuse was the second most commonly used brand of e-cigarettes among children and teenagers who had vaped within the past 30 days.
It is important to note that the FDA has not yet decided whether the tobacco flavors of Vuse Alto will be allowed to remain on the market. In response to the FDA’s ban, British American Tobacco, the parent company of Reynolds, has expressed its intention to challenge the agency’s Marketing Denial Orders and seek a stay of enforcement.
Kingsley Wheaton, British American Tobacco’s chief strategy and growth officer, criticized the FDA’s decision, stating that it contradicts proven scientific evidence and undermines the agency’s goal of reducing the health effects of tobacco use. Wheaton believes that appropriately regulated flavored vaping products, including menthol, are crucial in helping adult smokers transition away from traditional combustible cigarettes.
Initially marketed as a “healthier” alternative to cigarettes, electronic cigarettes quickly gained popularity among young people due to their availability in enticing flavors. Since 2014, e-cigarettes have been the most commonly used tobacco product among U.S. youth.
The FDA has faced criticism for its handling of e-cigarette products, which require agency authorization to remain on the market. In 2016, the FDA determined that e-cigarettes should be subject to the same regulations as traditional tobacco products. Companies were given until September 2020 to submit applications for FDA approval, even if their products were already on the market. Failure to do so rendered the products illegal.
To date, the FDA has received applications for over 26 million vaping products and has made determinations on 99 percent of them. The agency has denied numerous applications, but critics argue that the process has been too slow, allowing companies to circumvent regulations. In a significant move, the FDA ordered all Juul e-cigarette products off the market in 2022. Juul appealed the decision, leading the FDA to suspend enforcement and initiate an internal review of scientific issues related to Juul’s application.
The review is ongoing, and Juul is currently pursuing its administrative appeal. As the FDA continues its efforts to combat the rise of vaping among young people, it aims to strike a balance between protecting public health and providing potential harm reduction options for adults.
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