The FDA has authorized the marketing of three Vuse vaping devices, marking the first ever electronic nicotine delivery system (ENDS) products authorized by the FDA through the Premarket Tobacco Product Application (PMTA) pathway.

The FDA issued marketing granted orders to RJ Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.

“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, JD, director of the FDA’s Center for Tobacco Products.

While today’s action permits the tobacco products to be sold in the US, it does not mean these products are safe or “FDA approved,” the agency emphasized. “All tobacco products are harmful and addictive and those who do not use tobacco products should not start,” the FDA said in a statement.

“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.”

In addition to the three authorizations, the FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR.

In September, the FDA reported that it has denied marketing authorization to over one million flavored ENDS products that lacked sufficient evidence that the benefit to adult smokers who used the flavor products would overcome the public health concern posed by the well-documented and considerable appeal of the products to youth.