U.S.: Our Vapour Products Story

Public Health Impact of Vapour Products vs. Smoking

The Food and Drug Administration (FDA) has acknowledged that “No tobacco product is safe. However, the health risks for different tobacco products exist on a spectrum, which is sometimes referred to as a ‘continuum of risk.’ Combusted, or smoked, tobacco products – such as cigarettes – are the most harmful type of tobacco product. Non-combusted products – such as e-cigarettes and other smokeless tobacco products – generally have lower health risks than cigarettes and other combustible tobacco products.”^[4] The National Academies of Sciences, Engineering, and Medicine also found that there is “substantial evidence that except for nicotine, under typical conditions of use, exposure to potentially toxic substances from e-cigarettes is significantly lower compared with conventional cigarettes” and “conclusive evidence that completely substituting combustible tobacco cigarettes for e-cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes”^[5].

In 2016, the FDA began to regulate Vapour Products as tobacco products, requiring regulatory authorisation for new products to be legally marketed in the U.S. and banning sales to anyone under 18 years old (later increased to 21 years old in 2019). Manufacturers are required to submit a Premarket Tobacco Product Application (PMTA). Each PMTA needs to demonstrate that the product meets all the regulatory requirements and has sufficient scientific evidence to conclude it is “appropriate for the protection of the public health” (APPH). The FDA is required to conduct a thorough scientific review of all scientific evidence to determine if a product is APPH. Successful applications are granted a marketing granted order (MGO) by the FDA, allowing those products to be sold in the U.S.

Vuse and the PMTA Process

Under the brand name Vuse, BAT’s affiliate RJ Reynolds Vapor Company launched its first Vapour Products in June 2013. Through the release of Vuse Solo, Vuse Ciro, Vuse Vibe, and Vuse Alto, we have contributed to the decline in smoking prevalence through offering adult smokers these Vapour Products.

FDA’s “deeming regulation,” which deemed Smokeless Products – including Vapour Products and Oral Nicotine Pouches – to be under the agency’s authority and subject to the same regulatory and statutory requirements of cigarettes and other traditional tobacco products, took effect 8th August 2016. The newly applied provisions included a requirement that all “deemed” products must receive premarket authorization from the FDA to be legally marketed. Manufacturers of products on the market as of the effective date were required to submit PMTAs by 9th September 2020.

RJ Reynolds Vapor Company successfully advanced several PMTAs for the broad portfolio of Vuse Solo, Ciro, Vibe, and Alto Vapour Products. Through the PMTA process, our US affiliate has submitted comprehensive scientific data packages, including hundreds of thousands of pages of data and thousands of scientific documents. These PMTAs were designed to help the FDA determine that the marketing of Vuse Vapour Products is APPH.

The FDA issued the first Vapour Product MGOs for Vuse Solo in October 2021. Additional MGOs followed for Vuse Ciro and Vuse Vibe in May 2022. In July 2024, the FDA issued MGOs for the Vuse Alto device and its Golden Tobacco and Rich Tobacco flavoured pods. The current FDA-authorised Vuse Vapour Products represent one of the broadest portfolios of authorised Vapour Products on the U.S. market, with 16 MGOs.