FDA Grants Marketing Order for Vuse Solo

R.J. Reynolds Vapor’s application for menthol-flavored products under the brand remains under review
Photograph courtesy of R.J. Reynolds Vapor Co.

WINSTON-SALEM, N.C. — Retailers can continue to sell R.J. Reynolds Vapor Co.’s Vuse Solo closed electronic nicotine delivery system (ENDS) and accompanying tobacco-flavored e-liquid pods. Menthol-flavored products under the brand are still in limbo, though, and several flavored products were denied. The marketing granted order marks the first for e-cigarette products under the premarket tobacco product application (PMTA) pathway, the U.S. Food and Drug Administration (FDA) said.

This means the company can legally sell its Vuse Solo device and the Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1 and Vuse Replacement Cartridge Original 4.8% G2, the FDA said.

R.J. Reynolds Vapor submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health, the FDA said.; however, the action does not mean these products are safe or FDA approved, the agency said, noting all tobacco products are harmful and addictive and those who do not use tobacco products should not start.

The FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR, but due to potential confidential commercial information issues, the FDA would not publicly disclose 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 FDA said. “Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory.”

Applications for menthol-flavored products under the Vuse Solo brand are still being evaluated, the FDA said.

The company is pleased that Vuse Solo received the first of its kind FDA marketing authorization for vapor products, Kaelan Hollon, senior director of communications for RAI Services Co., told CSP.

“FDA’s orders confirm that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers (ANCs) age 21 and up have access to innovative and potentially less harmful alternatives to traditional tobacco products,” Hollon said.

While R.J. Reynolds Vapor Co.’s Alto product awaits further review from the FDA, and until the FDA directs otherwise, the company can lawfully sell products for which it has submitted PMTAs, she said.

“FDA has stated it is focusing resources on reviewing products with the largest market share, though it has limited the number of applications any one manufacturer may have under review at one time. Vuse Alto PMTA was submitted nearly a year after Vuse Solo, and five months after Vuse Vibe and Ciro, and those applications share foundational science. We remain confident in the quality of our applications,” Hollon said.

Vuse products are marketed in the U.S. by Winston-Salem, N.C.-based R.J. Reynolds Vapor, an operating company of Reynolds American Inc., which is a member of the British American Tobacco Group. R.J. Reynolds sells variations of Vuse including Vuse Alto, Ciro, Vibe and Solo. It also sells Velo Nicotine Pouches and Velo Nicotine Lozenges.

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