Reynolds American Inc. (RAI) has 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 pouches. A grant of these marketing orders would allow these products to remain on the market after FDA review.
Velo is the group’s brand for modern oral products, designed to provide adult tobacco consumers with innovative alternatives to traditional combustible and smokeless tobacco products. A small, white pouch made with nicotine derived from tobacco but containing no tobacco leaf, Velo is placed between an adult tobacco consumer’s gum and lip. Unlike traditional dip, there is no need to spit the product and no lingering smell. The submitted group of applications includes varying nicotine strength levels and two flavors for Velo pouch products.
As with prior PMTA submissions, these commercially-proprietary applications provide the FDA with product analyses, information on human health risks, and assessments showing that these Velo pouches are appropriate for the protection of public health—including assessments on users and nonusers of tobacco products.
“Velo represents an innovative space for us to identify what adult tobacco consumers want next—thus submitting the final group of Velo brand PMTAs was a great next step to help ensure adult tobacco consumers have consumer-acceptable products available that provide them with lifestyle choices and varying nicotine levels that make sense,” said James Figlar, RAI’s executive vice president and head of scientific and regulatory affairs, in a statement. “As the FDA begins evaluation of our industry’s collective PMTAs after the Sept. 9 deadline, it is critical that our chief regulatory agency continues to enforce against illegally marketed tobacco products introduced after Aug. 8, 2016.”
The PMTAs for Velo pouches are part of Reynolds’ ongoing submissions to the FDA seeking marketing orders following applications for Velo lozenges and Vuse Vibe, Ciro and Solo electronic nicotine delivery systems. 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. While these applications include relative risk information, the marketing orders sought make no claims of modified risk.