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  • FDA Urged to Act on Remaining Applications

    FDA Urged to Act on Remaining Applications

    Photo: New Africa

    Several anti-tobacco groups have sent a letter to the U.S. Food and Drug Administration urging the agency to act on the outstanding premarket tobacco product applications (PMTAs) and pushing for the denial of all flavored e-cigarette products.

    It’s been more than four months since the FDA was supposed to decide which e-cigarette products can remain on the market, but the agency still hasn’t completed some of the reviews, including some of the bestselling e-cigarettes.

    “We write to urge the U.S. Food and Drug Administration (FDA) to expedite decisions on the premarket tobacco product applications (PMTAs) still pending before the agency involving the flavored e-cigarette products, including those with menthol flavoring and, based on the best available scientific evidence, deny the pending applications for all nontobacco flavored e-cigarettes in order to protect the nation’s young people from the health harms of these products,” the letter said.

    The letter was signed by the American Academy of Pediatrics, the American Heart Association and the Campaign for Tobacco-Free Kids, among others.

    “Every day that FDA delays action, more of our kids remain at risk,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “While the FDA has ruled on applications from a lot of small companies, it hasn’t ruled on the applications from the large companies whose products are being used by a majority of kids.”

    American Vaping Association President Gregory Conley pointed to data showing that youth vaping has been declining. According to the Centers for Disease Control and Prevention (CDC), use of e-cigarettes went down among middle school and high school students from 2019 to 2020.

    But even with the drop, the CDC said it “estimated that more than 2 million U.S. middle [school] and high school students reported currently using e-cigarettes in 2021.”

  • Lithuania Bans Flavored E-Cigarettes

    Lithuania Bans Flavored E-Cigarettes

    Photo: MNStudio

    Lithuania will ban the sale of flavored e-cigarettes and e-liquid cartridges starting in July, reports LRT. Tobacco flavors will remain legal.

    The move is aimed at reducing sales of e-cigarettes that are growing increasingly popular in Lithuania.

    On Jan. 18, Lithuanian lawmakers adopted amendments to the Law on Control of Tobacco, Tobacco Products and Related Products with 92 votes in favor, nine against and nine abstentions.

    Lithuania already bans e-cigarettes and e-liquid cartridges containing vitamins and other additives that create an impression that they are good or do less damage to health.

    The country also prohibits imports of e-cigarettes and e-liquid cartridges containing caffeine and other stimulating compounds linked to energy and vitality.

  • P&K Presents New Brand Strategy

    P&K Presents New Brand Strategy

    Phillips & King International has announced a new brand identity and wholesale e-commerce platform.

    A contemporary refinement of the company’s “shield and knight” badge, the new logo signifies Phillips & King’s mission to modernize the business while paying homage to its 116-year history.

    Phillips & King has embarked on a complete digital transformation of its business to better serve the evolving needs of its retail customers and brand partners. Over the course of this year, the company will be launching a host of enhancements to its business, including a new web platform expected to launch in the second quarter that will make it easier for stores to discover and stock products. Phillips & King will also be expanding its product and category assortment to give emerging brands the ability to reach more buyers.

    “The future of B2B wholesale commerce is both digital and highly personalized,” says Jason Carignan, president of Phillips & King. “Our new web platform will enable us to more easily connect buyers and sellers across the industry and offer a more expansive array of products and categories—all while improving the personal connection our sales teams have with customers.

    “We believe that retailers should be able to manage their entire business with ease from their mobile device and have access to business intelligence—and expert guidance—that helps drive inventory-buying decisions. This new platform is the first step in our quest to helping stores thrive in the new retail reality.”

    Phillips & King is a subsidiary of Kretek International.

  • BAT Launches Virtual R&D Visitor Experience

    BAT Launches Virtual R&D Visitor Experience

    Image: BAT

    BAT has created a virtual R&D visitor experience, an online tour of its global research and development hub in Southampton, U.K., that allows people to explore its cutting-edge science and innovation.

    BAT says the experience builds on the company’s open and transparent approach to the science underpinning its reduced-risk product portfolio and beyond nicotine activities. The company regularly welcomes visitors in person to its global R&D hub, with more than 3,500 people viewing the facilities firsthand since 2011. However, with travel significantly reduced, the virtual experience allows people from across the globe to access and understand BAT’s scientific research and tobacco harm reduction activities and gain perspectives and insights from experts.

    “At BAT, R&D is fundamental to what we do,” said David O’Reilly, director of scientific research at BAT, in a statement. “Our focus on science and research has enabled us to make significant progress in developing and evolving our New Category products, which are rigorously tested and scientifically substantiated as reduced-risk alternatives to cigarettes. Our R&D is based around consumer preferences as well as applying evolving science and innovation to our products. This allows us to offer a range of enjoyable reduced-risk alternatives to cigarettes while ensuring we maintain very high safety and quality standards.

    “Our new R&D virtual visitor experience demonstrates the breadth of science we are undertaking and the robust scientific framework we use to evaluate and support the role our products play in delivering tobacco harm reduction.”

    With 360-degree lab tours, animations, videos, scientist profiles, podcasts and more, the R&D virtual visitor experience is the one-stop hub for those looking to find out about BAT’s science. The tour illuminates BAT’s purpose to build “A Better Tomorrow” and mission to reduce the health impact of its business. BAT invests almost £350 million [$477.18 million] a year to find innovative ways to reduce its effects on public health and aims to have 50 million consumers of its noncombustible products by 2030.

  • Malaysia Mulls Age-Based Tobacco Ban

    Malaysia Mulls Age-Based Tobacco Ban

    Photo: sezerozger

    Malaysian Health Minister Khairy Jamaluddin wants to ban smoking for the next generation of Malaysians, according to reports by Lowyat and Code Blue. The plan comes in the wake of New Zealand’s announcement that it would prohibit the sale of cigarettes to anyone born after 2008.

    Jamaluddin plans to table a new Tobacco and Smoking Control Act at the upcoming Parliament meeting from Feb. 28 to March 24, which will replace the current tobacco product control legislation under the Food Act 1983.

    The bill will also regulate e-cigarettes and vape products, according to Jamaluddin, who called the bill a “generation endgame.”

    “For too long, our healthcare system has been burdened with healthcare issues resulting from smoking,” said Jamaluddin. “This allocation will enable smoking to be phased out in stages until one day in [the] future, Malaysia will be a smoke-free country.”

    A date for the proposed legislation has not been specified nor has a cutoff year of birth for the cohort smoking ban.

  • New Habanos Website

    New Habanos Website

    Photo: Tobacco Reporter archive

    Corporacion Habano has redesigned its website with the input from distributors and cigar aficionados. The new website allows users to easily find information about brands, events and new developments. The site’s popular authenticity check function has been improved.

    The site also features a section that allows aficionados to easily locate places where Habanos cigars can be purchased or smoked.

    “Habanos has opted for a much more visual style, faithful to its elegant and exquisite essence, trying the Habanos aficionados to find everything they need and enjoy browsing and learning more about the rich culture surrounding this exclusive product,” said Habanos Deputy Director of Operational Marketing Alex Fernandez Blanco Barrero.

    A global leader in the commercialization of premium cigars, Corporacion Habano has an exclusive distribution network spread over five continents and more than 150 countries.

  • Respira Creates Science Advisory Board

    Respira Creates Science Advisory Board

    Respira Technologies has created a scientific advisory board and appointed Jasjit S. Ahluwalia as its chair.

    According to Respira, the scientific advisory board plans to strengthen the company’s connection to the constantly evolving body of scientific evidence on the issues of tobacco use, harm reduction, nicotine and smoking cessation being generated by public health to guide the development of its technology and pipeline for current and future new drug applications.

    “As a biotechnology company whose goal is to end the death and disease caused by smoking through the development of a breakthrough smoking cessation therapy, we must be guided by and have a deep understanding of the constantly evolving data and science generated by public health on issues important to our business,” said Respira Technologies CEO Mario Danek in a statement.

    “We are thrilled to name Dr. Ahluwalia as chair and the founding member of our scientific advisory board. He represents one of the best and brightest scientific minds with decades of experience in studying nicotine addiction and cessation. Having guidance and perspective from the most distinguished researchers in this space will be critical to Respira achieving its goal of contributing to eliminating preventable morbidity and mortality and achieving health equity.”

    Ahluwalia is a leader in academic research and public health focused on studying tobacco use, nicotine addiction and smoking cessation. He is a physician and public health scientist at Brown University.

    Through his research, he has also investigated issues of health disparities and minority health broadly across multiple areas of substance use, cancer prevention and public health.

    At Brown University, he is a professor, associate director of the Legoretta Cancer Center and deputy director of the Center for Addiction and Disease Risk Exacerbation, a NIH-funded Center of Biomedical Research Excellence. Ahluwalia’s work has generated over 350 publications in leading scientific journals, and he has received over $100 million in research funding as a principal and co-investigator.

    As chair of Respira’s Scientific Advisory Board, Ahluwalia will be engaged in the company’s scientific strategy, development of clinical research and leading engagement within the nicotine, addiction and cessation public health community. His broad healthcare research background will guide Respira’s current application and inform the company’s development pipeline to expand application of its proprietary drug delivery platform across a diverse spectrum of indications and patient populations.

    “I have dedicated the last 30 years of my career to understanding nicotine addiction, cessation and the complex issues they create in our society, especially among ethnic minority and other vulnerable populations,” said Ahluwalia. “Respira has the potential to create a very significant impact on this important public health crisis.  I am thrilled to be leading Respira’s scientific advisory board and look forward to assisting the company in its efforts to improve the lives of hundreds of millions of smokers looking to quit around the world.”

    Respira Technologies is preparing to submit an investigative new drug application to the U.S. Food and Drug Administration in 2022, which will allow the company to begin human clinical studies. The company is pursuing a prescription designation for its portable handheld combination drug device for the indication of smoking cessation therapy.

  • 22nd Century to Launch VLN Cigarettes in U.S.

    22nd Century to Launch VLN Cigarettes in U.S.

    Photo: 22nd Century

    22nd Century Group plans to launch its VLN reduced-nicotine cigarettes in a major U.S. metropolitan market by March 2022. The debut will be followed by a nationwide launch.

    On Dec. 23, 2021, the U.S. Food and Drug Administration authorized 22nd Century Group’s VLN King and VLN Menthol King as the first reduced-nicotine content cigarettes under the agency’s modified-risk tobacco product designation. Scientific studies show the company’s VLN reduced-nicotine content cigarettes “help you smoke less.”  

    “The FDA’s MRTP authorization of VLN ushered in a new reality—a combustible cigarette carrying an authorized harm reduction claim supported by extensive scientific and clinical studies, most of which were funded by federal health agencies,” said James A. Mish, CEO of 22nd Century, in a statement.

    “VLN is the only reduced harm product of its kind, and we are confident based on the research that it can absolutely be successful on its own or in combination with other harm reduction products. With an estimated 1,300 deaths per day associated with U.S. smoking, our products that can help people smoke less offer a truly game-changing prospect for millions of American adults who currently smoke.”  

    During the pilot phase, 22nd Century Group will test and optimize its marketing mix. The pilot will help the company better understand how adult smokers will use this product prior to advancing to national distribution, providing an unmatched tool for helping adult smokers find an off-ramp from nicotine addiction.

    “22nd Century has secured a well-known national retail partner for VLN’s pilot market launch phase,” said Mish. “We intend to deploy and test a wide array of marketing materials aimed at adult smokers looking for ways to help them smoke less. These will include marketing at the point of sale, direct materials sent to self-identified adult smokers interested in VLN and online resources, such as our new product site at tryvln.com.”

    While 22nd Century owns or controls the intellectual property that makes VLN tobacco possible, the company has reiterated its willingness and expectation to license the technology to strategic partners.

  • RAI Heating Technology Declared ‘Unpatentable’

    RAI Heating Technology Declared ‘Unpatentable’

    Photo: tashatuvango

    The U.S. Patent Trial and Appeal Board (PTAB) has determined as unpatentable several claims by RAI Strategic Holdings relating to tobacco-heating technology, reports The Winston-Salem Journal.

    According to federal law, a claim is unpatentable if “the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.”

    The board’s rulings are the latest developments involving several patent infringement lawsuits between RAI and Philip Morris International.

    In November, the U.S. Trade Representative affirmed a legal victory by RAI’s parent company, British American Tobacco, against rival Philip Morris International and its U.S. partner, Philip Morris USA.

    On Sept. 29, the U.S. International Trade Commission issued a final determination of a violation of the Tariff Act of 1930 by Philip Morris USA and Altria Client Services as it related to two BAT product patents.

    Altria Group, parent of PM USA, asked trade representative Katherine Tai to overturn the ban. The U.S. Trade Representative’s office confirmed no action was taken by Tai.

    As a result of the ITC ruling, PM USA is barred from importing PMI’s IQOS 2.4, IQOS 3 and IQOS 3 Duo heat-not-burn cigarette products into the United States.

    PMI welcomed the PTAB ruling. “We are extremely pleased with the well-reasoned PTAB decisions, which further demonstrate the futility of RJR/BAT’s efforts to litigate this patent family,” a PMI spokesperson said.

    Reynolds said in a statement that “we disagree with the decision finding (the ‘915’ ruling) invalid partially contradicting the International Trade Commission’s ruling, which was based on a highly developed evidentiary record, including a six-day trial with live witnesses.”

    Reynolds said an ITC panel and the full commission “agreed with Reynolds’ position regarding the patent.”

    PTAB decisions can be appealed for review to the U.S. Court of Appeals for the Federal Circuit, which Reynolds has indicated it will pursue.

    Another option for Reynolds, according to the patent board’s ruling, is for Reynolds to amend its patents in dispute or request a reexamination of the challenged patent.

  • Institute Warns Against Overregulation of Vapor

    Institute Warns Against Overregulation of Vapor

    Photo: iQoncept

    A new study by the American Consumer Institute highlights the dangers of overregulating e-cigarettes and vaping products. Co-authored by Steve Pociask and Liam Sigaud, the report investigates the empirical evidence surrounding the consumer risks and benefits of using e-cigarettes and vaping products compared to using combustible tobacco products.

    The reports assets that vapor products are significantly safer than smoking and more effective than other nicotine-based smoking cessation treatments in getting smokers to quit cigarettes.

    The authors contend that excessive regulation of e-cigarettes not only ignores the prevailing scientific consensus on health risks, but also deters smokers from switching to safer alternatives while pushing vapers back to smoking.

    Therefore, the authors argue, overregulating vapor products will have serious health consequences for consumers who smoke.

    “This report provides much-needed clarity on an issue of profound importance for public health,” the publishers wrote in a press release accompanying the report. “As the authors note, ‘informed by rigorous research, the U.S. can better chart a responsible course that encourages smokers to seek safer substitutes and quit, while protecting our youth from the dangers of tobacco products.’”