FDA Authorizes First Vapor Products Through PMTA Pathway

R.J. Reynolds Vapor Co.’s Vuse receives the greenlight to be marketed in the U.S.

THE FOOD AND DRUG ADMINISTRATION (FDA) gave the greenlight to R.J. Reynolds Vapor Co. (RJR Vapor), an operating company of Reynolds American Inc., to market its Vuse Solo electronic nicotine delivery system (ENDS) in the United States.

The agency on Oct. 12 issued marketing granted orders to RJR Vapor for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods. This move marked the first time that the FDA authorized an electronic cigarette or vapor product under its premarket tobacco product application (PMTA) pathway.

Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the tobacco product would be appropriate for the protection of public health. The FDA must approve PMTA bids for e-cigarette and vapor products to stay on the market.

“[These] authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said when announcing the approval. “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.

“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,” Zeller continued. “We will take action as appropriate, including withdrawing the authorization.”

The marketing granted orders cover the Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.

On the same day it approved these products, the FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand. The FDA is still evaluating the application for menthol-flavored products under the Vuse Solo brand.

“[The] order represents an important moment for Reynolds,” said a spokesperson for British American Tobacco (BAT) Group, of which WinstonSalem, N.C.-based Reynolds American Inc. is a member. “FDA is required to evaluate vapor product PMTAs against a rigorous, science-driven standard to determine that sales of these transformational products are appropriate for the protection of the public health. BAT is committed to reducing the health impact of its business through a multi-category approach, and [the] marketing orders for Reynolds Premarket Tobacco Product Applications are a significant regulatory accomplishment.”