Vuse Solo announced that it received the first of its kind U.S. Food and Drug Administration (FDA) marketing authorization for vapor products, authorizing the sale of its U.S. subsidiary Reynold’s Vuse Solo product in Original flavor.
FDA’s orders confirm that Vuse Solo products are appropriate for the protection of the public health, the company said, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers (ANCs) aged 21-plus have access to innovative and potentially less harmful alternatives to traditional tobacco products.
In addition to its PMTA authorizations, FDA also issued Marketing Denial Orders for five flavors that are not currently on the market. Menthol remains under review. Regarding FDA’s limited concerns on those applications not currently on the market, Vuse Solo is 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,” said a spokesperson for the company.
FDA is required to evaluate vapor product PMTAs against a rigorous, science-driven standard to determine that sales of these 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,” said a spokesperson for the company.