SILVER SPRING, Md. — The list of electronic nicotine delivery system (ENDS) products R.J. Reynolds Vapor Co. can legally sell in the United States is growing. The U.S. Food and Drug Administration (FDA) authorized six new tobacco products on May 12 through the premarket tobacco product application (PMTA) pathway for the company’s Vuse Vibe and Vuse Ciro e-cigarette brands.
Products that received marketing granted orders (MGOs) are:
- Two Vuse Vibe Power Units
- Vuse Vibe Tank Original 3.0%
- Two Vuse Ciro Power Units
- Vuse Ciro Cartridge Original 1.5%
Vuse Vibe is a large capacity, closed-tank system e-cigarette, and Vuse Ciro is a clear cartridge-based system with an innovative ceramic wick, according to R.J. Reynolds Vapor Co., Winston-Salem, N.C.
Only tobacco-flavored pods were authorized, while menthol flavors are pending and can remain on the market pending a decision from the agency, according to British American Tobacco (BAT), of which R.J. Reynolds Vapor Co. is an indirect subsidiary. The FDA denied the other flavors, BAT said, but those flavored products are not currently sold or marketed in the United States.
In October 2021, the FDA issued MGOs to the R.J. Reynolds Vapor Co.’s Vuse Solo ENDS product and accompanying tobacco-flavored e-liquid pods, making it the first marketing granted order for e-cigarettes under the PMTA pathway. Vuse Solo is a cartridge-based system for a simple-to-use alternative to cigarettes, according to the company. The PMTA for Vuse Alto, a large capacity pod-based system with a ceramic wick and alloy heating element, is still pending.
“These authorizations represent the broadest portfolio of market authorizations provided to any company in the U.S for PMTA,” said David O'Reilly, director of scientific research at London-based BAT. “Continued focus on science and innovation has supported the robust submissions, which have enabled FDA to evaluate and authorize the marketing of these products. We are proud of the work undertaken by the team to achieve this significant regulatory milestone and are confident in the quality of our applications.”
Under the PMTA pathway, the applicant must demonstrate to the agency, among other things, the marketing of the new tobacco product would be appropriate for the protection of public health. The authorized Vuse products were found to meet this standard because, among other considerations, chemical testing was sufficient to determine that overall harmful levels in the aerosol of these products is lower than in combusted cigarette smoke, the FDA said. The products have the potential to benefit adult smokers who switch completely to Vuse Vibe or Ciro from combustible cigarettes or significantly reduce their cigarette consumption, the agency said.
The FDA also determined the potential benefit to adult smokers who switch would outweigh the risk to youth. The agency will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any requirements.
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