The Food and Drug Administration (FDA) on Thursday authorized sales of certain tobacco-flavored Vuse Alto electronic cigarette products from R.J. Reynolds, allowing the company to keep the products on the market.
Vuse is the top-selling e-cigarette brand in the country, according to Nielsen data, comprising more than 40 percent of the market.
The FDA’s marketing authorization applies to six tobacco-flavored pods, which are sealed, prefilled and nonrefillable. The agency found the product is “appropriate for the protection of public health” but stressed that allowing it on the market does not mean it’s safe or “FDA approved.”
“All tobacco products are harmful and potentially addictive. Those who do not use tobacco products, especially young people, should not start,” the FDA said.
However, the FDA said it determined there is a benefit for adults who smoke traditional cigarettes and completely switch to the new product or significantly reduce their smoking of traditional cigarettes. That benefit outweighs potential risk to youth, the FDA said, especially since data shows young people don’t use tobacco flavors.
Last year, the FDA banned the sale of Vuse Alto menthol and fruit-flavored electronic cigarettes, citing its increasing popularity among kids. Reynolds’s parent company British American Tobacco is challenging the order in court.
The FDA is facing intense scrutiny for its handling of e-cigarette products, which need agency authorization to stay on the market.
The agency is overdue in its task of reviewing premarket tobacco product applications, which are required for new tobacco products to be legally marketed in the U.S. The FDA previously said it would finish reviewing applications by the end of 2023 but missed that deadline.
Like other brands, Vuse has remained in stores while awaiting FDA action. The agency has rejected more than 26 million applications for products it received from vaping companies. Only a handful of products have been authorized to help smokers.
Chief Executive of British American Tobacco Tadeu Marroco said in a statement that the company welcomed the FDA’s decision, but stressed that “the success of these legal products is dependent on the FDA doing more to tackle a thriving illicit marketplace of vapour products, which are intentionally and systematically marketed to youth.”