US FDA blocks sale of some R.J. Reynolds flavored e-cigarette products

(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 R.J. Reynolds Vapor Company under its Vuse Alto brand.

The U.S. Food and Drug Administration’s (FDA) marketing denial orders (MDOs) 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.

According to the FDA, evidence submitted by R.J. Reynolds “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 — relative to that of 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, 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 around 70% of that, Jefferies said in a March 2023 note.

That could mean its withdrawal from the market is a significant blow to the company’s U.S. vape business.

R.J. Reynolds was bought out in a $49.4 billion takeover by BAT in 2017, which gave the tobacco giant access to the lucrative and highly regulated U.S. market after a long absence since 2004.