FDA Authorizes An E-Cigarette To Help Addicted Adult Smokers

• The Food and Drug Administration said the e-cigarette reduces exposure to dangerous chemicals.
• E-cigarettes’ aerosols are “considerably less toxic” than its alternatives, the FDA found.
• The manufacturer must comply with 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 may benefit addicted adult smokers who change to those products — either completely or with a significant reduction in cigarette consumption — by decreasing 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 discovered aerosols in e-cigarettes are “considerably less toxic” than those of combustible cigarettes, according to the agency’s press release. Additionally, the agency determined that the potential advantage of the e-cigarette to people who smoke would outweigh the risk to youth if its manufacturer, R.J. Reynolds Vapor Company, follows requirements to cut back youth exposure and access to the products.

The agency also acknowledged the 2021 National Youth Tobacco Survey, which found roughly 10% of high school students who used e-cigarettes named Vuse as their regular brand. In the press release, the FDA cited data that found most youth and young adults who use e-cigarettes begin 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 as a result of these products are less appealing to youth and authorizing these products could also be helpful for adult combusted cigarette users who completely change to electronic nicotine delivery systems or considerably cut back their cigarette consumption,” the FDA said in a press release.