(Reuters) – The U.S. Food and Drug Administration (FDA) on Tuesday authorized British American Tobacco Plc (BAT) to market its Vuse Solo e-cigarettes and tobacco-flavored pods, health regulator.
The FDA said the approval came after an analysis of the manufacturer’s data showing that using Vuse’s tobacco-flavored products could help users reduce exposure to harmful chemicals emitted by flammable cigarettes.
“Today’s order is an important moment for Reynolds,” said a spokesman for British American Tobacco, referring to RJ Reynolds Vapor Co, the US entity that sought marketing authorization for Vuse.
The FDA has given RJ Reynolds permission to commercialize its closed-loop electronic nicotine delivery device, Vuse Solo, and two accompanying tobacco-flavored e-liquid pods that have a nicotine strength of 4.8%, which is roughly the equivalent of a pack of cigarettes.
Nicotine is a chemical released when tobacco is burned and is the addictive stimulant that makes smokers in a hurry. It is not immediately clear what diseases it causes.
The agency denied the company’s request to sell flavored products because it had failed to demonstrate that they would adequately protect public health. However, an application to resell a menthol version will still be considered.
The FDA’s decision follows a survey conducted by the CDC in 2021 that found that an estimated 2.06 million American middle and high school students are still using e-cigarettes, with Vuse and Juul among the most popular brands. Most of the users reported using flavored products, with fruits, sweets, and desserts being the most common.
A more comprehensive US study published in JAMA Network Open in 2019, which followed adolescents between the ages of 12 and 15 for three years, found that adolescents who used e-cigarettes before trying other tobacco products were more than four times more likely to smoke traditional cigarettes within a few years compared to those who tried any vapes.
The BAT Group spokesman said the FDA’s “denial-of-market orders” related to five flavored products that are not currently being sold in the market, and said that it was carefully investigating the “limited concerns of the FDA” with those requests.
BAT announced last month that Vuse is now the # 1 global vaping brand by retail sales in the United States, Canada, France, the United Kingdom and Germany, which represent an estimated 77% of the closed system vaping market.
BAT said it is now awaiting approvals for its other e-cigarette products, including Vuse Alto, whose marketing authorization application was filed almost a year after Vuse Solo, and Vuse Vibe and Ciro, whose applications “share a fundamental science” similar like Vuse Solo.
“We are still convinced of the quality of our applications,” said the spokesman.
In September, the FDA delayed its decision on whether BAT rival Juul and other major manufacturers, including BAT, could sell their e-cigarette products in the United States as it weighed the products’ public health effects.
The FDA also imposed strict restrictions on RJ Reynolds on digital, radio and television advertising Tuesday.
Juul did not immediately respond to a Reuters request for comment.