A person uses a Juul Labs electronic cigarette maker in San Francisco on Monday, June 24, 2019.
David Paul Morris | Bloomberg | Getty Images
The Food and Drug Administration announced Tuesday that it would allow a unit of British American Tobacco to resell its Vuse Solo e-cigarettes in the United States.
The decision is part of the agency’s broader review of the steam industry after years of pressuring politicians and public health groups to regulate the segment as strictly as other tobacco products.
The decision marks the first time the agency has approved an e-cigarette brand for sale in the United States. However, the approval does not cover some of the flavored products submitted by RJ Reynolds Vapor Co. under the Vuse Solo trademark.
“The manufacturer’s data shows that its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either entirely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller. Director of the FDA Center for Tobacco Products in a statement announcing their decision.
The FDA was given authority to regulate new tobacco products in 2009. Over the past decade, thousands of e-cigarettes have appeared on store shelves without agency approval, allowing these products to be sold as standards for the emerging industry gradually rolled out.
E-cigarettes deliver nicotine to the user by vaporizing liquid in cartridges or pods. Nicotine is the ingredient that is addictive to tobacco and can have other negative health effects. However, e-cigarette makers have argued that their products can deliver nicotine to addicted adult smokers without the health risks associated with smoking tobacco.
The FDA is currently reviewing around 6.5 million applications from around 500 companies and has yet to make decisions on all of these products. Tens of thousands of requests have been turned down by smaller vendors like JD Nova Group and Great American Vapes, especially for flavored vaping products.
A decision has yet to be made for the once dominant brand Juul. Juul had sold fruity flavors like mango, but stopped selling these products in October 2019. It currently sells a tobacco and menthol flavor. (Marlboro owner Altria has a 35% stake in Juul.)
In its decision on Tuesday, the FDA said it was aware that 10% of high school students who used e-cigarettes named Vuse as their usual brand in the 2021 National Youth Tobacco Survey.
In 2019, federal data found that more than 1 in 4 high school students had used an e-cigarette in the past 30 days, up from 11.7% just two years earlier. By last year, that number had dropped to 19.6% of high school students due to tighter government controls and the coronavirus pandemic.
“The agency takes this data very seriously and considered risks for young people when reviewing these products,” it said. However, it believes the data suggests that many teenage e-cigarette users start out with products that are flavored like candy, fruit, or mint.
“These data reinforce the FDA’s decision to approve tobacco-flavored products because these products are less attractive to teenagers and approval of these products can be beneficial to adult burned cigarette users,” it said.
Vuse Solo’s endorsement met with criticism from anti-tobacco groups. The American Lung Association said it was “upset” by the FDA’s decision.
In a statement, the group said youth vaping is still at critical levels. “The complete removal from the market of nicotine-rich products like Vuse and the cessation of sales of all flavored e-cigarette products, including menthol, is the clear path to ending the youth vaping epidemic,” the ALA said.
