The Food and Drug Administration (FDA) on Thursday banned the sale of Vuse Alto menthol and fruit-flavored electronic cigarettes as part of its larger crackdown on vaping products marketed at young people.
Vuse, made by R.J. Reynolds Vapor Co., is the most commonly sold e-cigarette brand in the country, the FDA said, and it has become increasingly popular among kids. Vuse Alto is the most popular sub-brand.
The agency took action against three menthol-flavored and three mixed-berry-flavored products, with each flavor being offered in three nicotine strengths. The company must not market or distribute the products in the U.S., but they can submit a new regulatory application.
The FDA said Reynolds failed to show evidence that keeping its products on the market would be appropriate for the protection of public health. Specifically, the company didn’t demonstrate that the benefits to adults from the menthol and mixed-berry-flavored products outweighed the known risks to youth.
According to federal data in the 2022 National Youth Tobacco Survey, Vuse was the second most common brand of e-cigarettes among children and teens who said they had vaped in the past 30 days.
The order came following the FDA’s review of Reynolds’s application to sell products in the U.S. The FDA has not yet said whether it would allow Vuse Alto’s tobacco flavors to remain on the market.
Reynold’s parent company, British American Tobacco, said in a statement it would immediately challenge the agency’s Marketing Denial Orders and seek a stay of enforcement.
“This decision flies in the face of proven science and is contrary to the FDA’s stated goal of reducing the health effects of tobacco use,” said Kingsley Wheaton, British American Tobacco’s chief strategy and growth officer.
“This disappointing decision would harm, not benefit, public health. We believe appropriately regulated flavoured vaping products—including menthol—are critical in supporting adult smokers migrate from combustible cigarettes.”
Electronic cigarettes were first introduced on the market as a “healthier” alternative to traditional tobacco cigarettes, but they began to spread to young people, who were drawn in by sweet and fruit-flavored e-cigarette pods easily accessible in stores. Since 2014, e-cigarettes have been the most commonly used tobacco product among U.S. youth.
The FDA is facing intense scrutiny for its handling of e-cigarette products, which need agency authorization to stay on the market. The FDA in 2016 determined that e-cigarettes were subject to its regulation, like traditional tobacco products.
The agency gave companies until September 2020 to submit applications for approval of each of their vape products, even if they were already on the market. Otherwise, they would be considered illegal.
The FDA said it has received applications for more than 26 million products and has made determinations on 99 percent of them. The agency has denied millions of the applications, but critics say the process has been too slow and is allowing companies to skirt the rules.
In its most high-profile action, the FDA last year ordered all Juul e-cigarette products off the market. Juul appealed, and the FDA then suspended the decision to conduct an internal review of “scientific issues” in the company’s application.
The review is still ongoing, and Juul has said it is continuing to pursue its administrative appeal.
