British American Tobacco - BAT expresses disappointment at FDA Marketing Denial Order for Vuse Alto Menthol and Mixed Berry and will immediately seek a stay of enforcement

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News Release

12 October 2023

BAT expresses disappointment at FDA Marketing Denial Order for Vuse Alto Menthol and Mixed Berry and will immediately seek a stay of enforcement

  • The company will immediately challenge the FDA issued Marketing Denial Orders (MDOs) seeking a stay of enforcement
  • FDA decision will serve to deny US adult smokers access to reduced risk*† products
  • This decision flies in the face of proven science and is contrary to FDA goal of reducing health effects of tobacco use
  • A quarter-million page scientific submission for PMTA arbitrarily dismissed
  • Vuse Alto Rich Tobacco and Golden Tobacco remain under FDA PMTA review

Today, BAT’s U.S. indirect subsidiary, R. J. Reynolds Vapor Company, received Marketing Denial Orders (MDOs) for Vuse Alto’s Menthol and Mixed Berry products. Vuse Alto Rich Tobacco and Golden Tobacco products remain under review with FDA.

Kingsley Wheaton, Chief Strategy & Growth Officer, BAT, said: “According to the FDA, the sole ground for this arbitrary decision was the absence of long-term consumer switching data for these products. This is a capricious decision, considering a year-long data package was presented at the Food & Drug Law Institute Tobacco & Nicotine Regulatory Product Science Symposium on 30 March 2023 with FDA in attendance. We will publish a summary of these data on our website in the coming days.

“This decision flies in the face of proven science and is contrary to the FDA’s stated goal of reducing the health effects of tobacco use. This disappointing decision would harm, not benefit, public health. We believe appropriately regulated flavoured vaping products—including menthol—are critical in supporting adult smokers migrate from combustible cigarettes.

“Central to the efficacy of any regulated market is the rule of law - where good behaviour is encouraged, and bad behaviour punished. Without a properly functioning regulatory regime, illicit markets grow that endanger the public, irresponsible players flourish, responsible players are penalised, the purposes of the underlying regulations are undermined, and consequently adult smokers who would like to transition to reduced risk*† products are let down.

“We also remain deeply concerned that the FDA continues to allow the proliferation of youth-appealing vapor products like Cotton Candy and Peanut Butter Cookie which are flooding US retail shelves.  Companies in open defiance of the Agency must be held accountable. BAT believes FDA should be employing its most powerful enforcement tools on the worst offenders without delay.”

R. J. Reynolds Vapor Company intends to challenge the denials and will seek a stay of enforcement of the Menthol denial immediately.

The PMTAs submitted by R. J. Reynolds Vapor Company in 2020 included rigorous scientific studies for Vuse Alto.  These build on the science submitted in the earlier PMTA submissions to FDA with respect to Vuse Solo, Vuse Vibe and Vuse Ciro, which were granted Marketing Authorisation in original flavours in October 2021 and May 2022 respectively. The science in these applications demonstrates that the continued marketing of the Vuse Alto, Vuse Vibe, Vuse Ciro and Vuse Solo products is appropriate for the protection of the public health.


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Victoria Buxton: +44 (0)20 7845 2012
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Jane Henderson: +44 (0)20 7845 1117

* Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk free and are addictive.

† Our vapour product Vuse (including Alto, Solo, Ciro and Vibe), and certain products, including Velo, Grizzly, Kodiak, and Camel Snus, which are sold in the U.S., are subject to FDA regulation and no reduced-risk claims will be made as to these products without agency clearance.

Forward-looking statements

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, and BAT’s Annual Reports, which may be obtained free of charge from the BAT website

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.