BAT completes PMTA submissions for the broadest portfolio in the U.S.
04 September 2020
BAT’s U.S. subsidiary, Reynolds American Inc. (Reynolds), has today filed its final Pre-Market 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.
Any new-to-market tobacco product must file a PMTA before it can be sold in the United States. For products already available to consumers, the FDA set a deadline of 9th September 2020 for PMTAs to be submitted. This process allows the FDA to evaluate whether these existing products should remain on the market as part of the FDA’s public health mission.
Today’s filing concludes an 11-month process for Reynolds which has the industry’s broadest portfolio of alternative nicotine products. Reynolds has filed six applications for its Vuse Solo, Vuse Ciro and Vuse Vibe vapour products, as well as for its VELO nicotine lozenge and modern oral pouch products. 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.
Globally, BAT is committed to reducing the health impact of its business with a multi-category approach that offers consumers a wide range of enjoyable and lower-risk alternatives to cigarettes. With non-combustible nicotine products now available in over 40 countries, the Group’s ambition is to exceed 50 million non-combustible consumers by 2030.
Kingsley Wheaton, Chief Marketing Officer, BAT, said:
“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. Globally, we now have nearly 12million 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.
“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 vapour, tobacco heating and modern oral nicotine products.”
This is a release by British American Tobacco p.l.c. References to ‘British American Tobacco’, ‘BAT’, ‘we’, ‘us’ and ‘our’ when denoting opinion refer to British American Tobacco p.l.c. (the Company, and together with its subsidiaries, the “Group”), and when denoting tobacco business activity refer to Group operating companies, collectively or individually as the case may be. This release contains certain forward-looking statements, including those made within the meaning of Section 21E of the United States Securities Exchange Act of 1934, regarding our intentions, beliefs or current expectations reflecting knowledge and information available at the time of preparation and concerning, amongst other things, prospects, growth, strategies, compliance with regulatory guidelines, our ability to submit further regulatory applications, the success of our regulatory applications and the economic and business circumstances occurring from time to time in the countries and markets in which the Group operates. BAT undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Readers are cautioned not to place undue reliance on such forward-looking statements.
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