October 13, 2023
The US health regulator on Thursday blocked the sale of six flavors of British American Tobacco’s (BAT) main vape brand, Vuse Alto, in the market including the menthol flavor that makes up a large portion of its sales.
The US Food and Drug Administration’s (FDA) marketing denial orders for R.J. Reynolds, owned by BAT, include three menthol-flavored and three mixed berry-flavored e-cigarette products, with each flavor being offered in three nicotine strengths.
“R.J. Reynolds Vapor company intends to challenge denials and will seek a stay of enforcement of menthol denial immediately,” BAT said.
The FDA said evidence submitted by R.J. Reynolds failed to prove that menthol- and mixed berry-flavored products offered an added benefit for adult cigarette smokers compared to tobacco-flavored products that is sufficient to outweigh the known risks to youth.
But the company may submit new applications for the products that are subject to these orders, it said.
“We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, director of the FDA’s Center for Tobacco Product’s Office of Science.
“If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorise the product. But such evidence was lacking in this case.”
Vuse is the most commonly sold e-cigarette brand in the US, with Vuse Alto being its most popular sub-brand. Further, findings from the National Youth Tobacco Survey show that Vuse e-cigarettes have been the second most commonly reported e-cigarette brand used by youth in the US since 2021.