Tag: Velo

  • BAT to Launch Synthetic Nicotine Pouch in the U.S.

    BAT to Launch Synthetic Nicotine Pouch in the U.S.

    Photo: Andrii

    BAT will launch a new version of its Velo pouches using synthetic nicotine in the United States next year, reports Reuters.

    Made in a laboratory rather than derived from tobacco leaves, synthetic nicotine has gained popularity among manufacturers recently as a means to avoid the Food and Drug Administration’s lengthy and cumbersome tobacco product authorization process.

    While the FDA initially had authority only over naturally occurring nicotine, President Joe Biden in March 2022 signed into law a bill that extended the agency remit to synthetic nicotine. BAT’s launch would mark the first time a major tobacco company introduces a synthetic nicotine product in the U.S., according to Reuters. To date, synthetic nicotine has been used primarily by smaller manufacturers of vapes or pouches.

    David Waterfield, president of BAT’s Reynolds American subsidiary, said that the product’s previous owner submitted a premarket tobacco product application before the May 2022 deadline, meaning it can stay on the market while its application is pending, Waterfield said.

    The FDA, however, told Reuters that a pending application is insufficient for a synthetic nicotine product to be sold in the U.S. Products on the market without FDA authorization, the agency added, may be subject to enforcement.

    BAT expects U.S. nicotine pouch industry revenues to grow from £1.7 billion ($2.21 billion) today to up to £7 billion by 2030.

  • Kenya Wants to Ban BAT Nicotine Pouches

    Kenya Wants to Ban BAT Nicotine Pouches

    Image: Tobacco Reporter archive

    Kenyan legislators are urging the government to ban the sale of BAT’s nicotine pouches Velo and Lyft, reports 2Firsts.

    Health Minister Susan Nakhumicha was questioned about the products during a parliamentary address.

    The Kenyan Tobacco Control Act (KTCA) states that all packaging of nicotine pouches and tobacco products must contain warnings in English and Kiswahili. Sabina Chege, Member of Parliament, showed two boxes of Velo nicotine pouches, which only displayed a reminder that Velo contains nicotine, which can be addictive. The argument by experts is that nicotine also poses serious health risks.

    Allowing import and sale of the pouches could jeopardize the well-being of Kenyan youth, according to Chege. In response, Nakhumicha suggested the formation of a technical team to investigate the KTCA and make recommendations.

  • Study Shows Velo Offers Reduced Risk

    Study Shows Velo Offers Reduced Risk

    Photo: BAT

    Users of BAT’s Velo modern nicotine pouch showed significant reduced risk of smoking-related diseases compared to smokers, according to a new cross-sectional clinical study published in Biomarkers.

    The study included participants who had been using Velo exclusively for over six months as well as current smokers, former smokers and never-smokers. For the Velo consumers and current cigarette smokers, usage patterns and overall consumption were not controlled under the study protocol as the aim was to assess the impact among people using the products in their “normal” way rather than in a controlled way. Four different groups were enrolled and studied.

    The results showed that the levels for the biomarkers of exposure, based on priority toxicants as defined by the World Health Organization, were substantially lower in Velo consumers compared with smokers. The data also showed favorable differences between the Velo consumers and smokers in the majority of the biomarkers of potential harm, with four achieving statistical significance and the others having similar levels across the Velo consumers, former and never smoker groups.

    A single set of samples of blood, urine and other clinical measurements was tested for certain toxicants and a range of biomarkers thought to be linked to the development of diseases such as cancer and cardiovascular disease.

    “These results add further evidence that supports the important contribution Velo can make to tobacco harm reduction.”

    “These results are very important for Velo and the modern oral nicotine product category,” said David O’Reilly, director of scientific research at BAT, in a statement.

    “They build on the extensive scientific evidence, including epidemiological data, that already exists for oral tobacco and add to the weight of evidence that supports our belief that Velo is a reduced-risk product for smokers who completely switch from cigarettes as compared to continued smoking. We have already generated data that shows Velo has a toxicant profile better than snus and comparable to nicotine-replacement therapy. These results add further evidence that supports the important contribution Velo can make to tobacco harm reduction.”

    Based on the biomarkers measured, compared to smokers, Velo consumers who had been using the product exclusively showed significantly lower levels in biomarkers of exposure to priority tobacco toxicants; significant favorable differences in a biomarker of potential harm relevant to lung cancer risk; significant favorable differences in a number of biomarkers of potential harm relevant to cardiovascular disease; and significant favorable differences in a biomarker of potential harm relevant to general inflammation.

    For the biomarkers that showed no significant difference between the Velo consumers and smokers, similar levels were observed between the Velo and former and never-smoker groups.

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

  • BAT Conducts New Study of Velo

    BAT Conducts New Study of Velo

    Photo: BAT

    BAT has conducted a cross-sectional clinical study of Velo, which is designed to provide new insights into the real-world health impact of its modern oral nicotine pouch product compared to smoking. Protocol details explaining the design have been published in the journal JMIR Research Protocols.

    The study evaluates exposure to certain toxicants and early indicators associated with smoking-related disease in people who have been exclusively using Velo for over six months and compares them with groups of smokers, former smokers and never-smokers.

    The results are currently being analyzed and will be published by the end of the year.

    “Modern oral nicotine pouches are an exciting product category, which build upon the extensive scientific evidence available for snus but are designed to offer adult consumers an improved tobacco-free, reduced-risk alternative,” said Sharon Goodall, BAT’s group head of regulatory sciences, in a statement.

    “We have already generated data that shows 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. I believe the results of this study will provide important new information, and we look forward to sharing them once available.”

  • Modern Oral Less Toxic Than Other Products

    Modern Oral Less Toxic Than Other Products

    Emma Cheung (Photo: BAT)

    British American Tobacco (BAT) has published a new study in Food and Chemical Toxicology showing that modern oral products (MOPs) elicit lower toxicity responses than traditional tobacco products.
     
    Velo, one of BAT’s nicotine pouch products, was compared with a traditional cigarette as well as a Swedish-style snus pouch and found to be “less biologically active than cigarette smoke and snus, even at greater concentrations of nicotine, across a range of tests,” according to a company press release. “In many cases, Velo failed to elicit a biological response at all, supporting the view that MOPs are likely to be less risky than traditional cigarettes and Swedish-style snus for users who switch completely.”
     
    “Velo was found to be less biologically active than cigarette smoke in certain assays, which is very encouraging,” said Emma Cheung, a preclinical scientist at BAT, in a statement. “This study helps to support the reduced-risk potential of MOPs. Our scientists will continue to build evidence to support our new category products.”

  • RAI Concludes PMTA filings for 2020

    RAI Concludes PMTA filings for 2020

    PHoto: RAI

    Reynolds American Inc. (RAI), has filed its final premarket tobacco product application (PMTA) submissions with the U.S. Food and Drug Administration (FDA) to allow its Vuse and Velo brands to remain on the market in the United States.

    Submitted Sept. 4, the filing concludes an 11-month process for RAI. The company has filed six applications for its Vuse Solo, Vuse Ciro and Vuse Vibe vapor products, as well as for its Velo nicotine lozenge and modern oral pouch products. Across the six applications, more than 530,000 pages of scientific data and more than 8,600 scientific documents have been submitted as part of the filings.

    RAI parent company BAT says it is committed to reducing the health impact of its business with a multicategory approach that offers consumers a wide range of enjoyable and lower-risk alternatives to cigarettes. With noncombustible nicotine products now available in more than 40 countries, the group’s ambition is to exceed 50 million noncombustible consumers by 2030.

    Kingsley Wheaton

    “The U.S. is the world’s largest vaping market and so the completion of our PMTA filings is a really important step for us as we transform our organization, drive a step change in our ‘new categories’ business, and increase our non-combustible consumer base and revenues,” said Kingsley Wheaton, chief marketing officer of BAT.

    “Our transformation is progressing very well and in the first six months of 2020 we attracted an additional 2.7 million new noncombustible consumers compared to the same time last year. Globally, we now have nearly 12 million regular noncombustible consumers and the U.S. will play a large part of our ambition to grow this number to at least 50 million by 2030.

    “We remain fully committed to building a better tomorrow and reducing the health impact of our business by offering consumers a range of enjoyable and lower risk products including vapor, tobacco heating and modern oral nicotine products.”

    The FDA’s PMTA deadline is Sept. 9.

  • Reynolds Submits First Velo PMTA

    Reynolds Submits First Velo PMTA

    Photo: RAI

    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.

  • R.J. Reynolds Launches Velo Nicotine Lozenges

    R.J. Reynolds Launches Velo Nicotine Lozenges

    Photo: RJRVC

    R.J. Reynolds Vapor Company (RJRVC) is expanding its modern oral portfolio with Velo dissolvable nicotine lozenges.

    A leading modern oral nicotine brand globally, Velo-branded products in the United States are designed to provide adult tobacco consumers with innovative, enjoyable alternatives to traditional combustible and smokeless tobacco.

    RJRVC says the decision to offer Velo nicotine lozenges reflects the company’s commitment to meeting adult nicotine consumers’ changing preferences and desire for convenience, simplicity and choice.

    “We are pleased to expand the Velo product portfolio to better provide adult nicotine consumers with a range of sensorial, modern oral nicotine options,” said Shay Mustafa, senior vice president for modern oral at RJRVC. “Bringing Velo nicotine lozenges to our portfolio reiterates our commitment to empower consumer choice and to provide adult nicotine consumers with products that fit modern lifestyles.”

    Velo-branded dissolvable nicotine lozenges are currently available for adult nicotine consumers to responsibly purchase at select retailers in Atlanta, Charlotte, Columbus, Houston, Las Vegas, Philadelphia and online at www.velo.com.

    In addition to dissolvable hard and soft format lozenges in four flavors, Velo offers adult nicotine consumers disposable nicotine pouches in varying strengths and flavors.