US FDA bans 6 flavors of vape brand Vuse Alto

Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland | File photo by Andrew Kelly/Reuters

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 (MDOs) 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 MDOs, it said.

In the past, companies have challenged FDA decisions in court, with some success.

A subsidiary of rival Imperial Brands had disputed the FDA’s decision to ban its flavored and unflavored vape products. A US appeals court in August agreed that its unflavored products should be reviewed again by the FDA.

Vuse Alto makes up the vast majority of BAT’s vape volumes in the United States, with menthol flavors accounting for around 75 percent of that, according to Jefferies.

Jefferies analyst Owen Bennett noted that BAT may succeed in securing a stay, which could prevent the product being removed from the market.

A rise in disposable vapes has dented BAT’s business in the world’s largest market for such products. Its US vape volumes were down 6.5 percent in the first half of 2023.

BAT bought out R.J. Reynolds for $49.4 billion in 2017, gaining access to the lucrative and highly regulated US market after a long absence since 2004.