News Release13 October 2021
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- Key regulatory milestone in BAT’s journey towards delivering A Better Tomorrow™
- FDA’s orders confirm that Vuse Solo products are appropriate for the protection of the public health
- Important moment for Reynolds American Inc. and the wider BAT Group
A BAT Group spokesman said:
“We are pleased that, today, Vuse Solo received the first of its kind U.S. Food and Drug Administration (“FDA”) marketing authorisation for vapour products, authorising the sale of our U.S. subsidiary Reynolds' Vuse Solo product in Original flavour. FDA’s orders confirm that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers (ANCs) aged 21+ have access to innovative and potentially less harmful alternatives*† to traditional tobacco products.
“In addition to our PMTA authorisations, FDA also issued Marketing Denial Orders for five flavours that are not currently on the market. Menthol remains under review. Regarding FDA’s limited concerns on those applications not currently on the market, we are carefully studying the agency analysis and decision.
“While Alto awaits further review from FDA unless and until FDA directs otherwise, Reynolds can lawfully sell products for which it has submitted PMTAs, subject to FDA’s ongoing enforcement discretion. FDA has stated it is focusing resources on reviewing products with the largest market share, though it has limited the number of applications any one manufacturer may have under review at one time. The Vuse Alto PMTA was submitted nearly a year after Vuse Solo, and five months after Vuse Vibe and Ciro, and those applications share foundational science. We remain confident in the quality of our applications.
“Today’s 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.”
* 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.
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