Back to the homepage

An important milestone

A significant milestone for Tobacco Harm Reduction was achieved in October, when the US Food and Drug Administration (FDA) made an historic decision by granting the first ever marketing authorisation for a vapour product under its Premarket Tobacco Product Application (PMTA) process for Vuse Solo product in Original flavour.  The authorisation confirms FDA’s conclusion that the marketing of Vuse Solo is appropriate for the protection of the public health in the US and demonstrates how BAT is making progress towards building A Better TomorrowTM.

a male scientist in a lab

In the US, the FDA is the body responsible for regulating all tobacco and nicotine products. In 2019, it announced that a PMTA must be filed for certain tobacco products, including vapour products, in order to remain on the market.

What is a PMTA?

A Premarket Tobacco Product Application (PMTA) is submitted to the US regulatory authority, the FDA, when a company wants to sell a new tobacco product in the US. The application must provide scientific data that shows that the marketing of the product is appropriate for the protection of the public health. Applications are often thousands of pages long, contain huge quantities of data, and can take several years to prepare.

The introduction of the PMTA process in the US plays an important role in the scientific evaluation of products against a rigorous, science-driven standard requiring a finding that the marketing of any product granted authorisation is “appropriate for the protection of the public health” and establishes a high regulatory bar for these transformational products.

We were the first company to have our PMTA authorised for a vapour product.  This important decision underscores years of scientific study and research dedicated to ensuring that adult nicotine consumers have access to innovative and less risky alternatives*† to traditional tobacco products.

We were the first company to have our PMTA authorised for a vapour product. This important decision underscores years of scientific study and research

At the time of the PMTA authorisation, Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, commented:

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavoured products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals.”

liquid being poured into test tubes

Commenting on this milestone, BAT said:

“The 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.”

BAT is committed to reducing the health impact of its business through a multi-category approach

We are awaiting review of our Vuse Alto application which was submitted nearly a year after our now-authorised Vuse Solo application. These applications, along with Vuse Vibe and Ciro, share foundational science and we remain confident in the quality of our applications.

a female scientist in the lab

* 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.