Reynolds American, a subsidiary of British American Tobacco (BAT), filed its final round of premarket tobacco product application (PMTA) submissions with the U.S. Food and Drug Administration (FDA) on Friday.
The move will allow its Vuse and Velo brands to remain on the market in the United States for at least one year while the applications are reviewed. The process allows the FDA to evaluate whether the products should remain on the market as part of the FDA’s public health mission.
The filing concludes an 11-month process for Reynolds which has the industry’s broadest portfolio of alternative nicotine products, according to a press release. Reynolds has filed six applications for its Vuse Solo, Vuse Ciro and Vuse Vibe vapor products, as well as for its Velo nicotine lozenge and modern oral pouch products. The Vuse Alto-branded device PMTA includes 12 cartridges in various flavors and nicotine strengths in menthol, two tobacco-flavored products and mixed berry.
Across the six applications, over 530,000 pages of scientific data and more than 8,600 scientific documents have been submitted as part of the filings.
“The U.S. is the world’s largest vaping market and so the completion of our PMTA filings is a really important step for us as we transform our organisation, drive a step change in our New Categories business, and increase our non-combustible consumer base and revenues. Our transformation is progressing very well and in the first six months of 2020 we attracted an additional 2.7million new non-combustible consumers compared to the same time last year,” Kingsley Wheaton, chief marketing officer for BAT said. “Globally, we now have nearly 12 million regular non-combustible consumers and the U.S. will play a large part of our ambition to grow this number to at least 50 million by 2030.”