Reynolds American Inc. (Reynolds) has announced the submission of a group of Premarket Tobacco Product Applications (PMTAs) to the FDA seeking orders authorising the marketing of VELO dissolvable nicotine lozenges.
A grant of these marketing orders would allow these products to remain on the market after the FDA’s September 9, 2020 deadline for PMTAs.
VELO Lozenges – formerly sold under the REVEL brand – were reintroduced under the VELO brand in 2020 by Reynolds subsidiary R.J. Reynolds Vapor Company. VELO is the group’s brand for modern oral products. According to Reynolds, VELO Lozenges are designed to provide adult tobacco consumers with innovative alternatives to traditional combustible and smokeless tobacco products. VELO’s dissolvable oral nicotine lozenge products are available in hard and soft forms and four flavour variants Dark Mint, Mint, Berry, and Crema. They are manufactured using tobacco-derived nicotine.
Although the applications contain confidential commercial information, broadly, the PMTAs for VELO Lozenges highlight key evidence demonstrating that the continued marketing of these products is appropriate for the protection of the public health, Reynolds said in a press release.
“VELO is an award-winning brand bringing consistently innovative products to adult tobacco users, and a potential marketing order for PMTA submission would help to ensure adult tobacco consumers have access to FDA-regulated, consumer-acceptable product alternatives to combustible tobacco,” noted Reynolds’ Executive Vice President and Head of Scientific and Regulatory Affairs, Dr. James Figlar.
The PMTAs for VELO lozenges are part of Reynolds’ ongoing submissions to the FDA seeking marketing orders, following applications for Vuse Vibe, Ciro and Solo electronic nicotine delivery devices. The PMTA process allows the FDA to evaluate whether these products should remain on the market as part of the FDA’s public health mission.