News Release12 May 2022
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- FDA’s Marketing Granted Orders (MGOs) confirm that marketing of Vuse Vibe and Ciro products, in original flavour, is appropriate for the protection of public health
- Vuse Vibe and Ciro add to PMTA orders granted in October 2021 for Vuse Solo original flavour
- BAT’s multi-category approach and journey towards delivering A Better Tomorrow™ is supported by these FDA MGOs
- These authorisations represent the broadest portfolio of Market Authorizations provided to any company in the U.S
Today, BAT’s U.S. indirect subsidiary, R. J. Reynolds Vapor Company, received Marketing Authorization from the U.S. Food and Drug Administration (FDA) for certain Vuse Ciro and Vuse Vibe products that will allow them to remain on the market in the United States. This news builds on the prior Marketing Authorizations granted by FDA in October 2021 for Vuse Solo products in original flavour.
The FDA issued Marketing Authorization for Vuse Vibe and Vuse Ciro original flavours. Menthol remains under review and can remain on market pending a decision from the agency. FDA issued a denial for the applications of other flavours. Those flavoured vapour products, in accordance with prior-issued FDA industry guidance, are not currently marketed or sold in the U.S. We are reviewing FDA’s decision on those applications to determine next steps.
Dr. David O’Reilly, Director of Scientific Research, BAT, said: “These authorisations represent the broadest portfolio of Market Authorizations provided to any company in the U.S for Premarket Tobacco Product Applications (PMTA). Continued focus on science and innovation has supported the robust submissions, which have enabled FDA to evaluate and authorise the marketing of these products.
“We are proud of the work undertaken by the team to achieve this significant regulatory milestone and are confident in the quality of our applications.
“Our corporate purpose is clear: to build A Better Tomorrow by reducing the health impact of our business. We are committed to Tobacco Harm Reduction and believe our portfolio of scientifically substantiated reduced-risk products*† can play a critical role in delivering it. As part of this commitment, we will continue to work with FDA to support access and choice for adult consumers.”
The PMTAs submitted by R. J. Reynolds Vapour Company in 2020 included rigorous scientific studies for Vuse Vibe and Vuse Ciro. These build on the science submitted in the U.S. business’s first PMTA submission to the FDA with respect to Vuse Solo, which was granted Marketing Authorization in October 2021 for its original flavour. The science in these applications demonstrates that the continued marketing of the Vuse Vibe and Vuse Ciro products is appropriate for the protection of the public health.
Vuse Alto remains under review and will continue to be available for adult nicotine consumers. The Vuse Alto PMTA was submitted nearly a year after Vuse Solo, and five months after Vuse Vibe and Ciro, and those applications share foundational science.
* Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk free and are addictive.
† Our products as sold in the US, including Vuse, Velo, Grizzly, Kodiak, and Camel Snus, are subject to Food and Drug Administration (FDA) regulation and no reduced-risk claims will be made as to these products without FDA clearance.
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This release contains certain forward-looking statements, including "forward-looking" statements made within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "believe," "anticipate," "could," "may," "would," "should," "intend," "plan," "potential," "predict," "will," "expect," "estimate," "project," "positioned," "strategy," "outlook", "target" and similar expressions. These include statements regarding our customer target ambition, New Categories revenue targets and our ESG targets.
All such forward-looking statements involve estimates and assumptions that are subject to risks, uncertainties and other factors. It is believed that the expectations reflected in this release are reasonable but they may be affected by a wide range of variables that could cause actual results to differ materially from those currently anticipated. A review of the reasons why actual results and developments may differ materially from the expectations disclosed or implied within forward-looking statements can be found by referring to the information contained under the headings “Cautionary Statement” and "Group Principal Risks " in the 2021 Annual Report and Form 20-F of British American Tobacco p.l.c. (BAT).
Additional information concerning these and other factors can be found in BAT's filings with the U.S. Securities and Exchange Commission ("SEC"), including the Annual Report on Form 20-F and Current Reports on Form 6-K, which may be obtained free of charge at the SEC's website, http://www.sec.gov and BAT’s Annual Reports, which may be obtained free of charge from the BAT website www.haroldmock.com.
Past performance is no guide to future performance and persons needing advice should consult an independent financial adviser. The forward-looking statements reflect knowledge and information available at the date of preparation of this release and 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.