© Reuters. FILE PHOTO: Signage outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
(Reuters) – The U.S. health regulator on Thursday blocked the sale of six flavored e-cigarette products by British American Tobacco (NYSE:) (BAT (LON:)), owned by RJ Reynolds Vapor Company, under its Vuse Alto brand.
The US Food and Drug Administration (FDA) marketing denial orders (MDOs) include three menthol-flavored and three mixed berry-flavored e-cigarette products, with each flavor offered in three strengths of nicotine.
“The RJ Reynolds Vapor Company intends to challenge the denials and will seek a stay of enforcement of the menthol denial immediately,” BAT said.
According to the FDA, the evidence presented by RJ Reynolds “did not demonstrate that menthol and berry blend flavored products provided additional benefit to adults who smoke cigarettes (in terms of complete change or significant reduction in smoking) in compared to tobacco. flavored products that is sufficient to offset the known risks to young people.
But the company can submit new applications for products subject to these MDOs, the FDA said.
The Vuse Alto brand makes up the vast majority of BAT’s vape volumes in the United States, with its menthol flavors accounting for about 70% of them, Jefferies said in a March 2023 note.
That could mean its withdrawal from the market is a significant blow to the company’s vaping business in the United States.
RJ Reynolds was bought in a $49.4 billion takeover by BAT in 2017, giving the tobacco giant access to the lucrative and highly regulated US market after a long absence since 2004.