Reynolds American Inc. submitted a group of premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking orders authorizing 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 Sept. 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’s dissolvable oral nicotine lozenge products are available in hard and soft forms and four flavor variants, dark mint, mint, berry and crema. Velo Lozenges are manufactured using tobacco-derived nicotine.
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. The applications include a range of scientific studies using established methodologies for the comparative assessment of tobacco products and associated health risks, including product analyses, information on human health risks and assessments showing the impact of Velo Lozenges on the health of the population as a whole—including users and nonusers of tobacco products.
“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,” said James Figlar, Reynolds’ executive vice president and head of scientific and regulatory affairs.