Category: News This Week

  • Juul Ban Reversal Welcomed

    Juul Ban Reversal Welcomed

    Photo: Juul Labs

    The potential return of Juul to U.S. store shelves would represent a win for consumers and tobacco harm reduction, according to the Consumer Choice Center (CCC).

    On June 6, the U.S. Food and Drug Administration rescinded its 2022 marketing denial order. While the move is neither an authorization nor a denial, it places the company’s premarket tobacco product application back into scientific review, meaning it could potentially be authorized at some point.

    “This is a step in the right direction for consumers who want more nicotine alternatives to combustible tobacco,” said CCC U.S. Policy Analyst Elizabeth Hicks.

    The FDA said in its June 6 statement that it had “conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science and clinical pharmacology” and that their change of course is based on a “review of information provided by the applicant” plus new case law based on court decisions involving MDOs for e-cigarette products.

    “With over 26 million applications submitted to the FDA, less than 10 e-cigarette devices have been approved by the agency. Vaping is 95 percent less harmful than smoking combustible tobacco, and the FDA has an opportunity to help drastically improve public health by allowing consumers a choice when it comes to alternatives to combustible cigarettes,” said Hicks.

    The FDA decision opens the door for Juul to return to the market in the future and allow U.S. consumers the same choice as those in the U.K. and Canada.

    “We hope the FDA provides a clear and transparent pathway for Juul Labs and the thousands of other companies who submitted product applications to finally gain authorization to offer their products to consumers in a regulated market,” concluded Hicks.

  • COP11 and MOP4 Meetings Announced

    COP11 and MOP4 Meetings Announced

    Photo: Olrat

    The World Health Organization has announced the approximate dates of the 11th session of the conference of the parties to the Framework Convention on Tobacco Control (COP11) and the fourth session of the meeting of the parties to the Protocol to Eliminate Illicit Trade in Tobacco Products (MOP4).

    COP11 will take place in the week of Nov. 17, 2025, at the Geneva International Conference Centre.

    MOP4 will take place in the week of Nov. 24, 2025, at the WHO headquarters.

    The specific dates will be communicated later.

  • Policies May Perpetuate Health Disparities

    Policies May Perpetuate Health Disparities

    A Fralin Biomedical Research Institute study published in Nicotine and Tobacco Research was the first to use data from the Experimental Tobacco Marketplace to examine how policies restricting flavors of nicotine and tobacco products influence health equity. (Photo: clayton metz/Virginia Tech)

    Restricting menthol flavor in cigarettes while making nicotine replacement therapy more available and affordable has the potential to reduce socioeconomic disparities in tobacco use.

    That was one of the findings in a study published in May in Nicotine and Tobacco Research that marks a new use of existing data from the Fralin Biomedical Research Institute at VTC’s Addiction Recovery Research Center. Researchers analyzed data from their Experimental Tobacco Marketplace to look beyond broad effects of tax and regulatory policies for the journal’s special issue on the health equity effects of restricting flavored nicotine.

    Smoking also accounts for more than 30 percent of the difference in life expectancy among socioeconomic groups, according to the study’s lead author, Assistant Professor Roberta Freitas-Lemos.

    Freitas-Lemos said the team saw an opportunity to use the marketplace to extend the Fralin Biomedical Research Institute’s work in addressing equity and inclusion in health research.

    “We realized we could use an existing data set, split the sample in two based on socioeconomic status, and compare how policies implemented affected purchase behaviors of different groups,” she said in a statement. “The study has shown us that flavor restrictions may decrease tobacco-related disease and death rates.”

    According to the researchers, it also points to the need to evaluate tobacco restrictions in a broader context, as cigarette substitution is highly dependent on what other products are available.

    In the Experimental Tobacco Marketplace, study participants use an online account to purchase tobacco and nicotine products based on their reported use. Researchers adjust the product mix and pricing to predict their effects on purchase behavior. The marketplace applies the economic concept of substitution effect, in which decreased sales of a product can be attributed to purchasers switching to alternatives as prices rise.

    “We came up with a methodology, endowed it with an Amazon-like interface, and we give study participants an amount to spend based on their reported use,” said Warren Bickel, professor with the Fralin Biomedical Research Institute and director of the Addiction Recovery Research Center. “In the process, we’re understanding how new policies may change consumers’ behavior.”

    What’s critical, he said, is understanding the interplay of policies. “We’ve shown there’s a policy that ameliorates disparity, but if you implement a second, different policy simultaneously, it destroys that effect,” Bickel said. “We think this is an exciting outcome. If we can actually start addressing and forecasting the impact of policy on health disparity, that’s a game-changer.” 

    Bickel also is director of the institute’s Center for Health Behaviors Research and a psychology professor with Virginia Tech’s College of Science. Freitas-Lemos also is assistant professor in the College of Science and is part of the Fralin Biomedical Research Institute’s Center for Health Behaviors Research and Cancer Research Center.

    In addition to Freitas-Lemos and Bickel, Fralin Biomedical Research Institute authors on the study include Research Assistant Professor Allison Tegge and Assistant Professor Jeffrey Stein.

    The research is supported by the National Cancer Institute of the National Institutes of Health. “This elegant work by Dr. Freitas-Lemos, Dr. Bickel, and their colleagues spans behavioral neuroscience and tax policy. It represents an emerging area of importance in cancer research that is becoming a major area of emphasis at the National Cancer Institute,” said Michael Friedlander, Virginia Tech’s vice president for health sciences and technology and executive director of the Fralin Biomedical Research Institute. “We are very fortunate to have such an array of talent among our research community that is poised to move the needle in this important new focus for both initial cancer prevention and relapse.”

    The team focused on data that simulated the effects of a menthol cigarette ban and a flavored electronic cigarette ban on study subjects based on education and income levels. The analysis examined four conditions: one that mirrored the current market environment, one that imposed only menthol cigarette ban, one that imposed only e-cigarette flavor restrictions, and one that restricted both menthol cigarettes and flavored e-cigarettes.

    Researchers saw significant differences under the one that mirrored the current market: Participants in the high socioeconomic status group purchased fewer cigarettes, more e-cigarettes, and more nicotine replacement therapy. The lower-status group purchased more cigarettes, fewer e-cigarettes, and fewer replacement-therapy products. Researchers speculate that menthol allows users to inhale more deeply, potentially allowing smokers with restricted resources to optimize their nicotine intake.

    The main finding was that a menthol cigarette flavor ban only significantly decreased disparities with the group with lower socioeconomic status purchasing fewer cigarettes and more nicotine replacement therapy than the group with higher socioeconomic status.

    They also found that flavor restrictions lessened differences between the groups’ purchases of nicotine replacement therapy.

    The journal’s special issue inspired the current research, but the team has been looking for opportunities to extend a health equity lens to the experimental marketplace.

    “We see the prevalence of cigarette use decreasing in the United States, but the disparities are increasing,” Lemos said. “Having an experimental model that can investigate that is important to the field of tobacco research.”

  • FDA Accepts Application for CLEW Pouches

    FDA Accepts Application for CLEW Pouches

    Image: Nevcore Innovations

    The U.S. Food and Drug Administration has accepted a premarket tobacco product application for Nevcore Innovations’ CLEW modern oral nicotine pouches.

    According to the manufacturer, CLEW pouches are manufactured in state-of-the-art cGMP- and HAACP-certified facilities that comply with strict quality protocols and ensure products meet the highest safety standards.

    “At the core of CLEW lies our unwavering commitment to delivering an unparalleled experience, by blending cutting-edge technology with the finest ingredients,” said Nevcore Innovations’ founder and chairman, Nutesh Singla, in a statement.

    “Crafted with precision and passion, CLEW nicotine pouches are formulated at the top laboratories in the USA and contain pharmaceutical-grade nicotine and carefully selected flavorings, ensuring a gratifying sensation with every use.”

    “CLEW nicotine pouches herald a new era in nicotine indulgence, and we are confident they will set the new global benchmark for white nicotine pouches the world over,” said Nevcore Innovations’ global CEO, Waqas Khan.

    “We have listened to the needs and desires of consumers and have developed a product that not only meets but exceeds their expectations and are confident that they will play a significant role in global harm reduction efforts. With CLEW, we are reimagining what it means to enjoy nicotine, providing a solution that is both convenient and satisfying.”

    CLEW nicotine pouches will be available in flavors such as mint, fruit and tobacco, and in strengths of 3 mg, 5 mg, 6 mg, 9 mg, 10 mg, 12 mg, 15 mg and 20 mg.

  • Malawi Prices Up a Quarter Over Last Year

    Malawi Prices Up a Quarter Over Last Year

    Photo: Taco Tuinstra

    Malawi tobacco growers have sold 64.7 million kg of tobacco for $182 million in the seven weeks since the marketing season opened, reports The Nyasa Times.

    Tobacco Commission spokesperson Telephorus Chingwenembe said the average price, at $2.81 per kg, was 26 percent above that fetched during the same period during last year’s selling season.

    “We are happy to note that the progress of the selling season underway has triggered people’s interest to grow the crop,” he was quoted as saying. “This aligns very well with our goal to increase our annual production to 200 million kg by 2028 because in the recent years, we have been failing to meet the trade demand. The demand is higher than what we are currently producing.”

    Chingwenembe also praised the high quality of leaf being brought to the sales floors.

  • Hong Kong Mulls New Anti-Smoking Measures

    Hong Kong Mulls New Anti-Smoking Measures

    Photo: ChenPG

    Hong Kong announced several new anti-tobacco policies on June 6, reports The Standard.

    Among other measures, the city plans to introduce a new duty-paid labeling system, ban “smoke-and-queue” behavior in public, and prohibit all flavored cigarettes and alternative products including vapes and heated cigarettes.

    The rules are meant to help the government lower smoking prevalence to 7.8 percent by 2025 and ultimately achieve a “Tobacco-free Hong Kong” after the completion of a public consultation exercise launched last year.

    Other measures include raising the maximum penalty for evading tobacco duty to a HKD2 million ($256,082) fine and seven years’ imprisonment; a ban on providing cigarettes to underage teens and children; and continuous reviews on the adjustment of tobacco duty.

    The government will also maximize the area reserved for health warnings on cigarette packaging to 100 percent; expand non-smoking areas and increase fines for violations.

    Secretary for Health Lo Chung-mau said the government strives to table the new policies to the Legislative Council before the end of this year and expects they will be passed within this legislative year.

    More than 90 percent of respondents to the public consultation agreed with further lowering the smoking prevalence.

    There are more than 570,000 daily smokers in Hong Kong and the latest prevalence stands at 9.1 percent, according to Director of Health Ronald Lam Man-kin.

  • Pyxus Completes Strong Fiscal 2024

    Pyxus Completes Strong Fiscal 2024

    Photo: Pyxus International

    Pyxus International reported sales and other revenue of $2 billion in fiscal year 2024, up 6.1 percent over its 2023 results. The company attributed this growth to “consistent execution” and an increase in average pricing of 10.5 percent, partially offset by slightly lower volume of 4.4 percent compared to fiscal 2023. Operating income increased 46.3 percent to $137.2 million, reflecting a more favorable business mix as well as improved operating efficiencies.

    “We achieved strong fiscal year 2024 results through our continued identification and capture of opportunities for growth, acceleration of our operating cycle times, improved working capital efficiency and increased availability of our total liquidity,” said Pyxus’ President and CEO Pieter Sikkel in a statement.

    “Our discipline is enabling a significant reduction of long-term debt that strengthens our capital structure and demonstrates our ability to achieve near-term operating and financial objectives while ensuring that the business remains positioned for long-term success.”

    For fiscal 2025, Pyxus anticipates sales to range between $2.1 billion and $2.3 billion and adjusted EBITDA to range between $165 million and $185 million. The company believes it is well positioned to successfully navigate an industry operating environment for fiscal 2025 that, due to the El Niño weather phenomenon, is generally expected to have a short-term negative impact on margins. 

  • Shareholders Approve Hotels Demerger

    Shareholders Approve Hotels Demerger

    Timon Schneider/Wirestock

    Shareholders on May 6 approved ITC’s plan to demerge its hotels business, reports Reuters.

    The company, which has a substantial cigarette business, announced the demerger plan in July last year and later said that the new entity would be tentatively listed.

    In May, proxy advisory firms Stakeholders Empowerment Services and InGovern Research Services asked shareholders to support the proposal, while Institutional Investor Advisory Services opposed the move.

    The hotels business contributed 4 percent to ITC’s fiscal year 2024 revenue, while its mainstay consumer staples business made up 71 percent of the topline.

  • Leaf Sales Down

    Leaf Sales Down

    Photo: Taco Tuinstra

    Contracted and self-financing growers had earned more than US$600 million by Day 56 of Zimbabwe’s 2024 tobacco selling season, down from $722 million earned by the same day last year, reports The Herald.

    The most recent season was impacted by an El Nino-induced drought, which caused the season to start late and end early.

    Tobacco Industry and Marketing Board statistics revealed that farmers had cumulatively sold 173.76 million kilograms of tobacco worth $607.08 million by Day 56 under both the auction and contract systems. This represents a 16 percent decline in earnings from the comparable 2023 period.

     In volume terms, the leaf sold was 27 percent below the 239.56 million kg sold last season. The average auction price was $0.12 higher than that at the contract floors.

    Some stakeholders remained positive about the remainder of the season. “On the back of an El Niño-ravaged season, we need to celebrate the 174 million kilograms achieved to date,” said Paul Zakariya, secretary general of the Zimbabwe Farmers Union. “The marketing season is still underway and we expect more tobacco to come through. We may not necessarily reach the desired target, but we will not totally be out of range .”

    Others were less optimistic. Tobacco Farmers Union Trust Vice President Edward Dune said it was highly unlikely that the 240 million kilogram target would be reached in the wake of the drought.

    “Deliveries should definitely be declining now that the marketing season is almost coming to an end. Firewood cutting and nursery preparations are the major farmer activities currently taking place on farms,” he said.

  • Swedish Match MRTP Comments Due July 5

    Swedish Match MRTP Comments Due July 5

    The U.S. Food and Drug Administration posted the final set of application materials related to renewing existing modified-risk tobacco product (MRTP) orders for Swedish Match U.S.A.’s General Snus products.

    The agency announced a deadline for public comments. To ensure they receive consideration by FDA, the applications must be submitted to the docket by 11:59 p.m. EDT on July 5, 2024.

    The application materials, redacted in accordance with applicable laws, can be found on the FDA’s website. “Before making a final determination on an MRTP application, FDA considers all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC),” a release states.

    The FDA recently announced a TPSAC meeting to discuss these renewal applications, scheduled for June 26, 2024, which the public is able to attend in person at the FDA White Oak Campus or virtually. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

    Written submissions may be made to the contact person on or before June 20, 2024.