News Release12 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.
* 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.
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