FDA approves Vuse vaping products for sale, marking a first for the e-cigarette industry

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A person uses a Juul Labs electronic cigarette device in San Francisco, on Monday, June 24, 2019.
David Paul Morris | Bloomberg | Getty Images

The Food and Drug Administration announced Tuesday that it will allow a unit of British American Tobacco to keep selling its Vuse Solo e-cigarettes in the United States.

The decision is part of the agency’s broader review of the vaping industry, following years of pressure from 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 U.S. However, the approval doesn’t include some of the flavored products submitted by R.J. Reynolds Vapor Co. under the Vuse Solo brand.

“The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement announcing its decision.

The FDA gained the power to regulate new tobacco products in 2009. Over the last decade, thousands of e-cigarettes appeared on store shelves without any approval from the agency, which allowed the sale of those products as it phased in standards for the burgeoning industry.

E-cigarettes deliver nicotine to users by vaporizing liquid in cartridges or pods. Nicotine is the ingredient that makes tobacco addictive, and it may have other negative health effects. However, e-cigarette manufacturers have argued that their products can deliver nicotine to addicted adult smokers without the health risks that come along with burning tobacco.

A court decision eventually created a timeline for the FDA’s approval process of e-cigarette company’s premarket tobacco product applications. The agency received roughly 6.5 million applications from about 500 companies by its September deadline, but the agency has yet to rule on all of these products.

It has denied approval to tens of thousands of applications from smaller players like JD Nova Group and Great American Vapes for their flavored vape products. A decision is still pending for the brand Juul, which at one time had dominated the market.

The agency’s decision seems to suggest that the FDA is concerned about flavored vaping products, which have been favored by teen users.

The approval of Vuse Solo is sure to be met with criticism by anti-tobacco groups. 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 prior. By last year, that number fell to 19.6% of high school students amid greater regulatory scrutiny and the coronavirus pandemic. An outbreak of vaping-related lung disease only heightened concerns about e-cigarettes.

Juul had once sold fruity flavors like mango, but suspended the sale of these products in October 2019. It currently sells a tobacco and menthol flavor. (Marlboro owner Altria owns a 35% stake in Juul.)


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