FDA issues ban on RJ Reynolds menthol-flavoured vapes in US

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The US federal drug regulator has told British American Tobacco’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 and Drug Administration said on Thursday that it had issued marketing denial orders for six vaping products sold by BAT-owned RJ Reynolds Vapor Company under its Vuse Alto brand. Three of the products were menthol-flavoured and three “mixed berry”, the FDA added.

Evidence submitted by Reynolds to the FDA “did not demonstrate” that the products “provided an added benefit for adults who smoke cigarettes . . . relative to that of tobacco-flavoured products that is sufficient to outweigh the known risks to youth”, the agency explained.

RJ Reynolds said in a statement that it planned to immediately challenge in court the FDA decision to ban the menthol-flavoured Vuse Alto and seek a stay of enforcement, which would allow the products to remain on shelves.

Kingsley Wheaton, chief strategy and growth officer at Reynolds’ parent company BAT, said the FDA’s logic in determining to ban the products because there was insufficient long-term data to show adult users switching from cigarettes amounted to a “capricious decision”. “This decision flies in the face of proven science,” he added.

The block would represent a huge blow for BAT’s push into reduced-risk nicotine products in the US. In the year to September 23, the Vuse product line generated $2.2bn in sales, accounting for 40 per cent of the total vaping market, according to a Goldman Sachs analysis of Nielsen IQ sales data from convenience stores. The menthol variety accounts for about three-quarters of Vuse’s total sales

Last year, Vuse overtook Juul as the most popular vaping brand in the US after Juul came under mounting pressure from regulators as it was blamed for sparking a “vaping epidemic” among US adolescents.

Juul’s products were banned by the FDA last year but the DC Circuit Court of Appeals placed a stay on the marketing denial order and the FDA launched an additional review into its decision, allowing Juul to keep its products on the shelves. The conclusion of the review has yet to be announced.

In its decision, the FDA cited data from its national youth tobacco survey that showed that the Vuse brand was the second most popular among underage users, reaching 12.5 per cent of those who vape.

Shares in the London-listed BAT, which are also tradeable on the New York Stock Exchange in the form of American depositary shares, fell by 4.3 per cent to just under $30 following the announcement.

In 2022, 2.5mn students in middle and high school, or 9.4 per cent of the total, reported using a vape in the previous 30 days, according to the FDA survey, carried out in collaboration with the Centers for Disease Control and Prevention.

The FDA has granted approval for just 23 new tobacco-flavoured vaping devices under its rolling review of 26mn e-cigarettes. This commenced in 2020 and has yet to approve a single flavoured vape.

“If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavoured product, we’d authorise the product,” said Matthew Farrelly, director of the FDA’s Center for Tobacco Products’ Office of Science.

But BAT’s Wheaton took aim at the FDA for “[continuing] to allow the proliferation of youth-appealing vapour products [flavours] like cotton candy and peanut butter cookie which are flooding US retail shelves”.

Earlier this year, the FDA issued enforcement orders allowing customs officials to seize shipments of Elf Bar/EB Design, Esco Bar and Breeze vaping products. It later sent warning letters to 189 retailers continuing to sell them and issued fines.

But despite the FDA import ban, sales of Elf Bars, which have since been rebranded as EB Design vapes, were 18 per cent higher in the four-week period to September 23, compared with the same period last year.