For the first time, the FDA has authorized an e-cigarette to help addicted adult smokers

• The Food and Drug Administration said the e-cigarette reduces exposure to harmful chemicals.
• E-cigarettes’ aerosols are “significantly less toxic” than its alternatives, the FDA found.
• The manufacturer must follow requirements to reduce youth exposure to the product.

History was made Tuesday when the US Food and Drug Administration granted its first-ever authorization of an e-cigarette, Vuse Solo by R.J. Reynolds Vapor Company, and two accompanying tobacco-flavored e-liquid pods.

“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,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a press release.

While assessing the products, the FDA found aerosols in e-cigarettes are “significantly less toxic” than those of combustible cigarettes, according to the agency’s press release. Additionally, the agency determined that the potential benefit of the e-cigarette to smokers would outweigh the risk to youth if its manufacturer, R.J. Reynolds Vapor Company, follows requirements to reduce youth exposure and access to the products.

The agency also acknowledged the 2021 National Youth Tobacco Survey, which found approximately 10% of high school students who used e-cigarettes named Vuse as their usual brand. In the press release, the FDA cited data that found most youth and young adults who use e-cigarettes start by using flavors like fruit, candy, and mint, which reinforced its decision to authorize the tobacco-flavored products.

“These data reinforce the FDA’s decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for adult combusted cigarette users who completely switch to electronic nicotine delivery systems or significantly reduce their cigarette consumption,” the FDA said in a press release.