FDA Authorizes First Vapor Products for U.S. Market

SILVER SPRING, Md. — The Food and Drug Administration gave the greenlight for R.J. Reynolds Vapor Co. (RJR Vapor), an operating company of Reynolds American Inc., to market its Vuse Solo electronic nicotine delivery system (ENDS).

The move is the first time the FDA authorized an electronic cigarette or vapor product under the premarket tobacco product application (PMTA) pathway. It also covers the Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.

With the nod, RJR Vapor can legally sell the products in the United States.

"Today's authorizations are an important step toward ensuring all new tobacco products undergo the FDA's robust, scientific premarket evaluation. 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, director of the FDA's Center for Tobacco Products.

"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 added.

Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health.

Tobacco companies and manufacturers had to submit the applications by Sept. 9, 2020 and the agency faced a Sept. 9. 2021 deadline to review the submissions. As of Oct. 13, the FDA has taken action on 98 percent of the applications.

The same day it approved RJR Vapor's PMTA for these Vuse products, the FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products.

These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. The agency is still evaluating the company's application for menthol-flavored products under the Vuse Solo brand.  

According to the FDA, the Oct. 12 authorization imposes strict marketing restrictions on the company, including digital advertising restrictions as well as radio and TV advertising restrictions. RJR Vapor is also required to report regularly to the agency with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.

"We are pleased that, today, Vuse Solo received the first of its kind U.S. Food and Drug Administration marketing authorization for vapor products, authorizing the sale of our U.S. subsidiary Reynold's Vuse Solo product in Original flavor," said spokesperson for British American Tobacco (BAT).

Winston-Salem, N.C.-based Reynolds American is a member of the British American Tobacco Group.

"In addition to our PMTA authorizations, FDA also issued [MDOs] for five flavors that are not currently on the market. Menthol remains under review. Regarding FDA's limited concerns on those applications not currently on the market, we are carefully studying the agency analysis and decision," the BAT spokesperson added.

The FDA is still reviewing RJR Vapor's premarket application for Vuse Alto.

"Today's order represents an important moment for Reynolds; 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," the BAT spokesperson said. "BAT is committed to reducing the health impact of its business through a multi-category approach, and today's marketing orders for Reynolds [PMTAs] are a significant regulatory accomplishment."

The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer "appropriate for the protection of the public health," such as if there is a significant increase in youth initiation.

While today's action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or "FDA approved."