In a First, FDA Permits Marketing of E-Cigarette Products in the US

WASHINGTON  — The Food and Drug Administration late Tuesday authorized the marketing of an electronic cigarette in the United States. A groundbreaking development in a long running debate over the healthfulness of such products.

Specifically, the FDA granted the R.J. Reynolds Vapor Company the right to sell its Vuse Solo closed ENDS device as well as the tobacco-flavored e-liquid pods that are used with it.

In a press release announcing the decision, the agency said study participants who used only the approved products were exposed to fewer harmful and potentially harmful constituents from aerosols compared to users of combusted cigarettes.

The FDA also said it determined the potential benefit to smokers who switch completely or significantly reduce their cigarette use outweighed the risk to youth so long as R.J. Reynolds adhered to specific requirements related to reducing youth exposure and access to the products.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller,, director of the FDA’s Center for Tobacco Products, in a written statement. 

“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,” Zeller said. 

“We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization,” he said.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue.