The U.S. Food and Drug Administration (FDA) on Thursday approved the sale of RJ Reynolds’ tobacco-flavored e-cigarette product, Vuse Alto, allowing the company to keep the product on the market.
Vuse is the country’s best-selling e-cigarette brand, accounting for more than 40% of the market, according to Nielsen data.
The FDA’s marketing authorization applies to six varieties of sealed, prefilled, non-refillable tobacco-flavored pods. The FDA determined that the products are “appropriate for the protection of the public health,” but emphasized that marketing them does not mean they are safe or “FDA approved.”
“All tobacco products are harmful and potentially addictive. People who do not use tobacco products, especially young people, should not start smoking,” the FDA said.
But the FDA said it had determined that there would be benefits for adults who smoke traditional cigarettes if they switched completely to the new products or significantly reduced the amount of traditional cigarettes they smoked — benefits that outweigh the potential risks to young people, especially given data showing that young people do not use tobacco flavors.
The FDA last year banned the sale of Vuse Alto menthol and fruit-flavored e-cigarettes because of their growing popularity among children. Reynold’s parent company, British American Tobacco, is challenging the order in court.
The FDA has faced increased scrutiny over its handling of e-cigarette products, which require agency approval to remain on the market.
The FDA has been slow to review premarket tobacco product applications, which are required for new tobacco products to be legally sold in the U.S. The agency previously said it would finish reviewing the applications by the end of 2023, but has missed the deadline.
Like other brands, Vuse is on store shelves pending action from the FDA, which has rejected more than 26 million product applications it has received from e-cigarette companies, leaving only a handful approved to help smokers.
In a statement, British American Tobacco CEO Tadeu Marocco said the company welcomed the FDA’s decision, but stressed that “the success of these legal products depends on the FDA doing more to address the thriving illicit market in e-cigarette products that are knowingly and systematically marketed to young people.”
