Vuse Alto receives U.S. FDA Marketing Authorisation

• FDA’s Marketing Granted Orders (MGOs) confirm that the continued marketing of Vuse Alto device as well as the Golden Tobacco and Rich Tobacco flavour pods at 1.8%, 2.4%, and 5% nicotine levels is appropriate for the protection of public health
• Vuse Alto decision follows Vuse Vibe, Ciro and Solo original flavour Marketing Granted Orders in May 2022 and October 2021
• BAT’s multi-category approach and journey towards delivering A Better Tomorrow is supported by these FDA MGOs
• These authorisations represent the largest vapour portfolio of Market Authorisations provided to any U.S. organisation
   

Today, BAT’s U.S. indirect subsidiary, R. J. Reynolds Vapor Company, received Marketing Authorisation from the U.S. Food and Drug Administration (FDA) that authorises the marketing of Vuse Alto device and Golden Tobacco and Rich Tobacco flavours in the United States.

This news builds on the prior Marketing Authorisations issued by FDA for Vuse Vibe and Ciro and Solo in original flavour in May 2022 and October 2021 respectively.

Tadeu Marroco, Chief Executive, BAT, said: “We welcome the FDA’s decision to authorise RJR Vapor’s Vuse Alto device, as well as Golden Tobacco and Rich Tobacco flavours. With authorisations for Alto, Vibe, Ciro and Solo, all in tobacco flavours, BAT now has the largest portfolio of vapour Market Authorisations provided to any U.S. organisation for Premarket Tobacco Product Applications (PMTAs).

“However, the success of these legal products is dependent on the FDA doing more to tackle a thriving illicit marketplace of vapour products, which are intentionally and systematically marketed to youth.

“By creating a future where a wide range of potentially reduced-risk^*† products is accessible to adult smokers, we are taking a meaningful step towards Building a Smokeless World.”

While this decision now means the Vuse Alto device and Golden Tobacco and Rich Tobacco flavours have now been authorised, the company continues to challenge the FDA’s Marketing Denial Orders for Alto’s Menthol and Mixed Berry flavours which were issued in October 2023. Per court order, FDA’s Denial Order for Alto Menthol products is stayed, meaning they remain available for adult nicotine consumers.

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 U.S. business’s earlier PMTA submission 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 tobacco-flavoured 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.