British American Tobacco - Vuse Solo first to receive US FDA vapour marketing authorisation

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News Release

Vuse Solo first to receive US FDA vapour marketing authorisation

13 October 2021

  • Key regulatory milestone in BAT’s journey towards delivering A Better Tomorrow™
  • FDA’s orders confirm that Vuse Solo products are appropriate for the protection of the public health
  • Important moment for Reynolds American Inc. and the wider BAT Group

A BAT Group spokesman said:

“We are pleased that, today, Vuse Solo received the first of its kind U.S. Food and Drug Administration (“FDA”) marketing authorisation for vapour products, authorising the sale of our U.S. subsidiary Reynolds' Vuse Solo product in Original flavour.  FDA’s orders confirm that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers (ANCs) aged 21+ have access to innovative and potentially less harmful alternatives*† to traditional tobacco products.

“In addition to our PMTA authorisations, FDA also issued Marketing Denial Orders for five flavours that are not currently on the market. Menthol remains under review.  Regarding FDA’s limited concerns on those applications not currently on the market, we are carefully studying the agency analysis and decision. 

“While Alto awaits further review from FDA unless and until FDA directs otherwise, Reynolds can lawfully sell products for which it has submitted PMTAs, subject to FDA’s ongoing enforcement discretion. FDA has stated it is focusing resources on reviewing products with the largest market share, though it has limited the number of applications any one manufacturer may have under review at one time. 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. We remain confident in the quality of our applications.

“Today’s order represents an important moment for Reynolds; FDA is required to evaluate vapour product PMTAs against a rigorous, science-driven standard to determine that sales of these transformational products are appropriate for the protection of the public health.

“BAT is committed to reducing the health impact of its business through a multi-category approach, and today’s marketing orders for Reynolds Premarket Tobacco Product Applications are a significant regulatory accomplishment.”

* 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.

Forward-looking statements

References to ‘BAT’, ‘BAT Group’, ‘we’, ‘us’ and ‘our’ refer to BAT Group operating companies, collectively or individually as the case may be. This release contains certain forward-looking statements, including “forward-looking” statements made within the meaning of the US 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 intentions, beliefs or current expectations reflecting knowledge and information available at the time of preparation, and concerning our results of operations, financial condition, liquidity, prospects, growth, strategies and the economic and business circumstances occurring from time to time in the countries and markets in which BAT Group companies operate, including the projected future financial and operating impacts of the COVID-19 pandemic.

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.

Among the key factors that could cause actual results to differ materially from those projected in the forward-looking statements are uncertainties related to the following: the impact of adverse domestic or international legislation and regulation; the inability to develop, commercialise and deliver BAT’s New Categories strategy; the impact of significant increases or structural changes in tobacco, nicotine and New Categories-related taxes; changes or differences in domestic or international economic or political conditions; the impact of serious injury, illness or death in the workplace; adverse decisions by domestic or international regulatory bodies; and the inability to lead the development and roll-out of BAT innovations (New Category products and combustibles), including as a result of unsuccessful research and development or a failure to develop robust scientific risk assessment frameworks. The forward-looking statements reflect knowledge and information available at the date of preparation of these materials, 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.

The material in this release is provided for the purpose of giving information about BAT to stakeholders only and is not intended for general consumers. BAT, its directors, officers, employees, agents or advisers do not accept or assume responsibility to any other person to whom this material is shown or into whose hands it may come and any such responsibility or liability is expressly disclaimed. The material in this release is not provided for product advertising, promotional or marketing purposes. This material does not constitute and should not be construed as constituting an offer to sell, or a solicitation of an offer to buy, any of our products. Our products are sold only in compliance with the laws of the particular jurisdictions in which they are sold.

Additional information concerning these and other factors can be found in British American Tobacco p.l.c.’s filings with the US 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.

Enquiries

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