BAT's latest research study initiative focus on oral nicotine product Velo

Reynolds is trying to attract consumer demand for Velo, an oral tobacco product, in the U.S.

British American Tobacco Plc released Thursday the preliminary results of its latest research study, this time evaluating its oral nicotine product Velo of R.J. Reynolds Tobacco Co.

In this instance, the study aimed "to identify differences in important early indicators associated with smoking-related disease between Velo users and smokers."

Details have been published in the journal JMIR Research Protocols. The goal is publishing additional results by year's end.

Participants were based in Denmark and Sweden between ages 19 and 55 years old, and in good general health.

The dissolvable Velo contains no tobacco leaf or other tobacco-plant matter apart from the nicotine extracted from the tobacco plant, Reynolds said.

The product is a small, white pouch that is placed between the adult user's gum and lip. Unlike traditional dip, there is no need to spit the product and no lingering smell.

The Velo study is part of BAT's A Better Tomorrow initiative that's focused on reducing the health impact of its business through non-combustible nicotine and tobacco products.

The study evaluates exposure to certain toxicants and early indicators associated with smoking-related disease in people who have been exclusively using Velo for more than six months.

Those users are compared with groups of smokers, former smokers and never-smokers.

The biomarkers selected are important indicators that include: a person's exposure to certain toxicants or chemicals; and potential harm related to several smoking-related diseases, such as respiratory or cardiovascular disease

"It is hoped that the results ... will provide further supportive evidence that using Velo may reduce relative risk for certain diseases among adult consumers compared to smoking," BAT said.

"These data would add to the growing body of evidence demonstrating Velo's potential as a reduced-risk product."

Dr. Sharon Goodall, BAT's group head of Regulatory Sciences, said previous research has shown Velo "has a toxicant profile better than snus and is comparable to nicotine replacement therapy.

"However, we wanted to generate further evidence to demonstrate the important contribution it can make to tobacco harm reduction."

In September 2020, Reynolds submitted to the Food and Drug Administration another round of premarket tobacco-product applications for Velo, this time for pouches. The applications include two nicotine strength levels and two flavors.

The premarket standard requires the FDA to consider products’ risks and benefits to the population as a whole, including users and non-users.

"A potential marketing order for (premarket) submission would help to ensure adult tobacco consumers have access to FDA-regulated, consumer-acceptable product alternatives to combustible tobacco," said James Figlar, Reynolds American Inc.'s head of scientific and regulatory affairs.

Reynolds debuted Velo products in July 2019 with nicotine pouches. Since then, Velo pouches have been distributed nationwide and globally.

Dissolvable tobacco products have drawn criticism from the Campaign for Tobacco-Free Kids, which has protested most Reynolds tobacco innovations in recent years.

The FDA's Tobacco Products Scientific Advisory Committee has said dissolvable products could provide a societal benefit in reducing disease from tobacco use by decreasing the number of smokers through cessation or preventing the first use of cigarettes.

It cautioned that increased use of dissolvable products also could lead to more smokers by serving as a bridge to cigarettes and/or reducing societal concern about the potential health risks of tobacco products.

"We are confident in the quality of our Velo application and cannot comment on FDA's timeline," Reynolds Vapor said in a statement.

"We will continue working alongside FDA to support our goal of providing adult nicotine consumers age 21-plus with new category tobacco products that are deemed appropriate for the protection of public health."

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