“Reynolds announced its final submission of a group of Premarket Tobacco Product Applications (PMTAs) to the Food and Drug Administration (FDA) through R.J. Reynolds Vapor Company (RJRV), seeking orders authorizing the marketing of Vuse Alto electronic nicotine delivery systems (ENDS) under Section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. The group of applications concludes a multi-year application process launched in advance of FDA’s Sept. 9 deadline for PMTAs. Reynolds first submitted a PMTA application in October of 2019 for Vuse Solo, and submitted additional applications for its Vuse Ciro and Vuse Vibe vapor products in April of 2020. Applications for VELO lozenge and pouch products submitted in August of this year. The VELO product PMTAs have been accepted by the FDA after their August filing, while the Vuse products are currently in substantive scientific review by the FDA. Thirteen Vuse Alto ENDS products are included in the Vuse Alto PMTAs, comprised of an ENDS component (the Vuse Alto Power Unit) and 12 closed e-liquid cartridges. Vuse Alto Cartridges are available in four flavors, each in three nicotine levels.”
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Reynolds Completes PMTA Submissions With Vuse Alto E-Cigarette Applications
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