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.
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.
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.
“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.”
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.
* 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.