RAI Concludes PMTA filings for 2020

Reynolds American Inc. (RAI), has filed its final premarket tobacco product application (PMTA) submissions with the U.S. Food and Drug Administration (FDA) to allow its Vuse and Velo brands to remain on the market in the United States.

Submitted Sept. 4, the filing concludes an 11-month process for RAI. The company 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. Across the six applications, more than 530,000 pages of scientific data and more than 8,600 scientific documents have been submitted as part of the filings.

RAI parent company BAT says it is committed to reducing the health impact of its business with a multicategory approach that offers consumers a wide range of enjoyable and lower-risk alternatives to cigarettes. With noncombustible nicotine products now available in more than 40 countries, the group’s ambition is to exceed 50 million noncombustible consumers by 2030.

“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 organization, drive a step change in our ‘new categories’ business, and increase our non-combustible consumer base and revenues,” said Kingsley Wheaton, chief marketing officer of BAT.

“Our transformation is progressing very well and in the first six months of 2020 we attracted an additional 2.7 million new noncombustible consumers compared to the same time last year. Globally, we now have nearly 12 million regular noncombustible consumers and the U.S. will play a large part of our ambition to grow this number to at least 50 million by 2030.

“We remain fully committed to building a better tomorrow and reducing the health impact of our business by offering consumers a range of enjoyable and lower risk products including vapor, tobacco heating and modern oral nicotine products.”

The FDA’s PMTA deadline is Sept. 9.