The US federal drug regulator told British American Tobacco PLC (LSE:BATS) to halt sales of its menthol-flavoured Vuse Alto vape, the most popular e-cigarette in the US, following a jump in popularity of the product among underage users.
BAT has said it will challenge the decision in court.
The Food and Drug Administration (FDA) said it had issued marketing denial orders (MDO) for six vaping products sold by BAT-owned RJ Reynolds Vapor under its Vuse Alto brand. Three of the refillable products were menthol-flavoured and three "mixed berry", the FDA added.
The company must not market or distribute these products in the US or they risk FDA enforcement action. However, the company may submit new applications for the products that are subject to these MDOs.
Product applications from the company lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, the regulator said.
"Specifically, evidence submitted by the applicant did not demonstrate that the menthol and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes - in terms of complete switching or significant smoking reduction," a statement from the FDA said.
The FDA said Vuse is the most commonly sold e-cigarette brand in the US, with Vuse Alto being its most popular sub-brand.
Vuse e-cigarettes, which are cartridge-based products, have been the second most commonly reported e-cigarette brand used by youth in the US since 2021, it said, based on findings from the National Youth Tobacco Survey.
BAT shares fell 2% to 2,485.80p in early Thursday trade.