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US FDA calls on BAT to halt sales of some flavoured vape products

ALN

The US federal drug regulator has told British American Tobacco PLC‘s US subsidiary 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.

The Food & Drug Administration said on Thursday that it had issued marketing denial orders for six vaping products sold by BAT-owned RJ Reynolds Vapor Co under its Vuse Alto brand. Three of the 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.

The FDA said the company’s premarket tobacco product applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

‘Specifically, evidence submitted by the applicant did not demonstrate that the menthol and mixed berry-flavoured 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. Further, findings from the National Youth Tobacco Survey show that 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.

To date, the FDA has authorized 23 tobacco-flavoured e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the US, it said.

Shares in BAT closed up 0.5% at 2,554.17p in London on Thursday.

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