![]() ![]() “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. 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’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. 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. 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.Īpplications for menthol-flavored products under the Vuse Solo brand are still being evaluated, the FDA said. 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. 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. The marketing granted order marks the first for e-cigarette products under the premarket tobacco product application (PMTA) pathway, the U.S. Menthol-flavored products under the brand are still in limbo, though, and several flavored products were denied. Reynolds Vapor Co.’s Vuse Solo closed electronic nicotine delivery system (ENDS) and accompanying tobacco-flavored e-liquid pods.
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