Category: Nicotine

  • Korea to Treat Synthetic Nicotine as Tobacco

    Korea to Treat Synthetic Nicotine as Tobacco

    Photo: Purilum

    The government of South Korea aims to regulate synthetic nicotine as tobacco, reports the Yonhap News Agency.

    The Ministry of Health and Welfare and the Ministry of Economy and Finance want to revise the Tobacco Business Act to include synthetic nicotine in the definition of tobacco.

    Tobacco in South Korea is governed by the National Health Promotion Act, under the jurisdiction of the health ministry, and the Tobacco Business Act governed by the finance ministry.

    The current rules define tobacco as a product “manufactured in a state suitable for smoking, sucking, inhaling steam, chewing or smelling, by using tobacco leaves as all or any part of the raw materials.”

    That language fails to capture the e-cigarette liquids made with synthetic nicotine, which is created in a laboratory rather than from tobacco leaves. As a result, vapes are not subject to product requirements, such as health warning labels, age restrictions and tobacco taxes, in South Korea.

    The push for new legislation follows an announcement by BAT that it is mulling the launch of a new synthetic nicotine product in the country. South Korea is reportedly the only nation where the tobacco giant is considering a synthetic nicotine product.

    “We have decided to push for the revision of the Tobacco Business Act when the 22nd National Assembly opens,” an official at the health ministry was quoted as saying. “We will provide necessary materials to the finance ministry, and there is already an abundance of evidence proving that synthetic nicotine is tobacco.”

    The consumption of e-cigarettes has been rising steadily in South Korea, reaching 16.9 percent of tobacco sales in 2023.

  • Patent Filed for Pouch Technology

    Patent Filed for Pouch Technology

    Photo: ir1ska

    TJP Labs has filed for patent protection of a novel nicotine particulate that dramatically increases the speed of nicotine release.

    According to the company, the new technology releases nicotine significantly faster than polacrilex, a resin complex commonly used in nicotine replacement therapy products.

    Other features of the nicotine particulate include:

    • Versatile particulate size customization; from ultra-fine to several hundred microns for precise product design.
    • Precision-targeted binding, which improves nicotine release rate, which enhances effectiveness.
    • Broad spectrum of adaptable core materials, which expands product versatility and application possibilities.
    • Efficient raw material use, allowing for nicotine loading several orders of magnitude over Polacrilex.
    • Eco-friendly and versatile composition. The product is optimized for organic and inorganic forms, including biodegradable resins, enabling diverse, innovative applications.
    • Streamlined manufacturing, which accelerates product development.
    • Seamless integration: The technology is designed for easy incorporation into nicotine pouch formats and related products.

    “This landmark initiative powerfully showcases TJP Labs’ commitment to redefining nicotine consumption through innovation,” said TJP Labs Chief Relationship Officer David Richmond-Peck in a statement. “With other innovations in our pipeline, safeguarding our intellectual property remains integral to our strategy, matching our innovative efforts with consumers’ evolving preferences.”

    TJP Labs anticipates initial evaluation data for these particulates to be available toward the end of the second quarter of 2024

    TJP Labs is a wholly owned subsidiary of KIK ASS Products, a full-service contract manufacturer of next-generation products focusing on modern oral nicotine.

  • Estrogen May Drive Nicotine Addiction

    Estrogen May Drive Nicotine Addiction

    Researchers discovered that estrogen induces the expression of olfactomedins, proteins that are suppressed by nicotine in key areas of the brain involved in reward and addiction. The research could lead to new targeted therapies that help women control nicotine consumption. (Image: Sally Paus)

    A newly discovered feedback loop involving estrogen may explain why women might become dependent on nicotine more quickly and with less nicotine exposure than men, according to recently published research.

    “Studies show that women have a higher propensity to develop addiction to nicotine than men and are less successful at quitting,” said project lead Sally Pauss, a doctoral student at the University of Kentucky College of Medicine in Lexington, in a statement. “Our work aims to understand what makes women more susceptible to nicotine use disorder to reduce the gender disparity in treating nicotine addiction.”

    The researchers found that the sex hormone estrogen induces the expression of olfactomedins, proteins that are suppressed by nicotine in key areas of the brain involved in reward and addiction. The findings suggest that estrogen–nicotine–olfactomedin interactions could be targeted with therapies to help control nicotine consumption.

    “Our research has the potential to better the lives and health of women struggling with substance use,” she said. “If we can confirm that estrogen drives nicotine seeking and consumption through olfactomedins, we can design drugs that might block that effect by targeting the altered pathways. These drugs would hopefully make it easier for women to quit nicotine.”

    Pauss will present the research at Discover BMB, the annual meeting of the American Society for Biochemistry and Molecular Biology, which will be held March 23–26 in San Antonio, Texas, USA.

  • Russian Scientists Create Reduced-Nicotine Tobacco

    Russian Scientists Create Reduced-Nicotine Tobacco

    Image: Elyena Grigorova

    Scientists from Russia’s Institute of Cytology and Genetics have created a reduced-nicotine content tobacco.

    “Tobacco synthesis genes are associated with key life processes of the plant,” said Sofya Gerasimova, senior researcher at the Institute of Cytology and Genetics at the Siberian Branch of the Russian Academy of Sciences. “We modified tobacco into a plant with an inherited reduced-nicotine content.”

    The two “most promising methods” for reducing the nicotine content were patented, according to nsk.kp. The scientists believe modified tobacco could serve as a food source for insects and that it will have a positive effect on the human body. 

  • Freebase Nicotine Safer than Salts: Study

    Freebase Nicotine Safer than Salts: Study

    A new University of Louisville study shows the nicotine in certain types of electronic cigarettes can increase the risk for an irregular heartbeat, according to a press release.

    Tests in mice showed that nicotine salts used in pod-based e-cigarettes led to heart arrhythmias and could trigger a fight-or-flight response in higher doses.

    “This suggests the nicotine is harmful to the heart and counters popular claims that the nicotine itself is harmless,” Alex Carll, an assistant professor in UofL’s Department of Physiology who led the study, said in a news release Thursday. “Our findings provide new evidence that nicotine type and concentration modify the adverse cardiovascular effects of e-cigarette aerosols, which may have important regulatory implications.”

    Researchers state that regulating nicotine salts could help mitigate the health risks of vaping.

    The research also suggests choosing e-cigarettes with freebase nicotine instead of nicotine salts, or using e-cigarettes with a lower nicotine content could reduce the risk of harm.

  • Pouches Do little to Curb Cravings: Study

    Pouches Do little to Curb Cravings: Study

    Photo: Ohio State University

    Nicotine pouches do little to curb smokers’ nicotine cravings, according to a study by scientists at the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

    The researchers evaluated whether nicotine pouches with different levels of nicotine concentration were more or less appealing to smokers.

    They found that current smokers had a much greater spike of nicotine in their blood levels and much sharper relief from craving symptoms when smoking than when using both the low-dose and higher dose nicotine pouches. That spike of nicotine measurable in the blood occurs about five minutes after smoking, explained lead author Brittney Keller-Hamilton.

    With nicotine pouches, it typically takes 30 minutes to an hour to hit peak effectiveness. The same is true for the decline in nicotine levels; it is a much more gradual decline as well for oral pouches.

    Because of this, says Keller-Hamilton, it is reasonable to see how the craving for instant gratification of cigarette smoking is more appealing than oral nicotine pouches for individuals who are already experiencing nicotine addiction.

    “Our challenge is to approach regulation of nicotine pouches to limit their appeal among young people while making them more appealing to adult smokers who would see health benefits by switching from cigarettes—which have the most severe health impacts with long-term use—to nicotine pouches,” said Keller-Hamilton in a statement.

  • Health Groups Target Zonnic Pouch

    Health Groups Target Zonnic Pouch

    Photo: Imperial Tobacco Canada

    Anti-smoking advocates in Canada are calling for the federal government to restrict sales of Zonnic, a product of Imperial Tobacco Canada (ITCAN), stating that it is aimed at youth. Health Canada recently approved the product, which is a nicotine-replacement therapy (NRT) oral pouch containing up to 4 mg of nicotine.

    Despite the criticism, Imperial Tobacco Canada has defended its product. ITCAN “believes that Zonnic, a nicotine-replacement therapy (NRT) product authorized for sale by Health Canada, will help adult Canadian smokers quit,” the company wrote in a press release. “In addition to the youth access prevention measures ITCAN has already taken, ITCAN would support regulations that limit the sale [of the] NRT category to adults 18 years old and over.”

    “I want to be absolutely clear: Zonnic is not a tobacco product,” said Eric Gagno, vice president of legal and external affairs at ITCAN. “It is licensed, regulated and advertised in the same way as any other smoking cessation product on the market. There should be no reason why ITCAN is singled out for adding another innovative choice to the market to help adult smokers quit.”

    Zonnic is marketed as an NRT for adults, but it is available for sale at convenience stores and gas stations with no legal restrictions on who can purchase it, according to public health groups. The groups also stated that ITCAN’s social media posts feature young people and highlight Zonnic’s flavors, including Berry Frost and Tropic Breeze.

    “It really is incomprehensible that this could have happened, but it has,” Rob Cunningham, senior policy analyst with the Canadian Cancer Society, told The Globe and Mail. “And now it has to be fixed.”

    ITCAN’s press release states that “Zonnic is not promoted any differently than any other competing smoking cessation product in Canada. ITCAN’s marketing guidelines require that all material be targeted at adults. Everyone appearing in Zonnic advertising is 25 years old and older. In addition, the company has gone above and beyond the regulatory requirements in the terms of its market authorization by instructing retailers to require proof of age to purchase Zonnic at convenience stores. Zonnic is also sold behind the counter, which means the retailer must hand the product to the consumer. Furthermore, Zonnic will be available in pharmacies before the end of the month.”

    The public health groups, including the Canadian Cancer Society, the Canadian Lung Association, Physicians for a Smoke-Free Canada and the Heart and Stroke Foundation, are calling on the Canadian government to make nicotine pouches prescription only or suspend the sale until changes can be made to prevent sales to minors. The groups are also calling for a moratorium on approval for any other nicotine pouches unless they are prescription only.

    “As for all of our products,” Gagnon said, “our position has been consistent and strong on this point. Nicotine products are for adult consumers only. We believe that if we truly want to reduce the health risks of tobacco products, we need to introduce products that will be appealing to adult smokers and have them available where people traditionally buy their cigarettes. Health groups should be on our side with this rather than putting up roadblocks.”

    “We are aligned to Health Canada’s goal of reducing smoking rates to below 5 percent by 2035,” Gagnon said. “But to get there, we need to change the conversation to bring about impactful outcomes. Governments, health groups and industry must work together in a meaningful manner to bring effective solutions to the market. Our door is always open to have those discussions.”

  • 22nd Century Continues VLN Expansion

    22nd Century Continues VLN Expansion

    Photo: 22nd Century Group

    22nd Century Group has expanded its VLN retail presence with more than 500 additional locations across 11 U.S. states.

    With these latest additions, 22nd Century Group’s FDA-authorized VLN reduced nicotine content cigarettes can now be found at more than 5,100 store locations spanning 23 states, including the addition of Washington, Oregon, Kentucky and Louisiana.

    “The addition of over 500 new VLN sales locations has propelled us beyond the noteworthy milestone of 5,100 stores. Our VLN sales presence now extends to 23 states, making VLN available in many of the top markets where smokers reside,” said 22nd Century Group interim CEO John Miller in a statement.

    “VLN is purposefully crafted to offer adult smokers a clinically documented tool to gradually reduce their smoking frequency and mitigate the associated health risks over time. We are pleased that an increasing number of adult smokers now have access to this important product if they are seeking new ways to reduce their smoking habit,” said Miller.

  • 22nd Century Expands Nicotine-Reduction IP

    22nd Century Expands Nicotine-Reduction IP

    Photo: Tobacco Reporter archive

    22nd Century Group has signed a reduced nicotine content technology license with North Carolina State University. The latest license provides additional modes of efficiently producing reduced nicotine content tobacco plants, extending 22nd Century’s IP portfolio. The license will provide 22nd Century Group exclusive rights to the technology until 2042.

    “Our reduced nicotine content technologies support the first and only FDA MRTP [modified-risk tobacco product] authorized combustible smoking harm reduction products that meet adult smokers where they are today, providing a new solution to help them smoke less and achieve their health goals,” said 22nd Century Group interim CEO John Miller in a statement.

    “This latest license further enhances and expands on our capabilities to produce reduced nicotine content tobacco plants as we work to bring these innovative products to market for the betterment of public health, including by enhancing our capability to produce reduced nicotine content tobacco plants suitable for international markets that are opposed to genetically modified plants.”

    This latest license further enhances and expands on our capabilities to produce reduced nicotine content tobacco plants.

    John Miller, interim CEO, 22nd Century Group

    Under terms of the exclusive license, 22nd Century will have full use of the patent rights and plant materials to develop and commercialize reduced nicotine content tobacco using this latest non-GMO technology, which further enables worldwide marketability of the company’s VLN reduced nicotine content products.

    “22nd Century is pioneering a new pathway in the global fight to end the health and economic harms of smoking, offering both GMO and non-GMO solutions suitable worldwide,” said Miller. “Extensive clinical research, much of it funded by national government health agencies, has consistently documented the benefit of reduced nicotine content tobacco products in helping adult smokers to break the bonds of nicotine addiction and smoke less over time. Reduced nicotine content solutions, such as our VLN products, provide a new solution to adult smokers who want to quit, but have not found success with traditional cessation products.”

  • Correcting The Record

    Correcting The Record

    Photo: Yeti Studio

    Targeting tobacco risk communications

    By Cheryl Olson

    On August 22, the U.S. Food and Drug Administration’s Center for Tobacco Products will take live comments from the public to help develop its five-year strategic plan. One of the strategic goal areas involves improving public health via knowledge: “timely, clear and accessible health communications and education to diverse public audiences.” Along with discouraging youth initiation, the CTP wants to “encourage cessation and to inform adults who smoke about the relative risks of tobacco products.”

    This is welcome news. Misinformation is killing people. For example, U.S. cigarette users who believe nicotine is harmful to health are less likely to try nicotine-replacement therapies (NRTs) or e-cigarettes to help them quit and (no surprise) are less likely to quit successfully.

    “If someone believes that using reduced-risk products is just as bad as smoking, why bother switching?” says Jeffrey S. Smith, a senior fellow in harm reduction at R Street Institute in Washington, D.C.

    Let’s help the CTP get rolling. What tobacco-related misconceptions deserve immediate attention? And which groups are in particularly dire need of lifesaving actionable knowledge due to persistently high smoking rates and low quit rates? I asked several colleagues for their nominations.

    Dangerous Misinformation

    Confusion about tobacco product relative risks is a huge concern. Clifford Douglas, who directs the Tobacco Research Network at the University of Michigan, alerted me to an article he and six distinguished experts wrote recently for the journal Addiction. It responds to the U.S. Surgeon General, who called stopping the spread of trust-destroying health misinformation “a moral and civic imperative.” The article targets two huge myths about e-cigarette risks that federal authorities unfortunately helped promote and failed to correct.

    First is misinformation about e-cigarette or vaping product use-associated lung injury (EVALI), which turned out to be linked instead to vaping illicit THC products. The authors contrast the CDC’s approach to EVALI to its handling of food-related illness outbreaks. With lettuce-linked listeria, authorities are quick to share brands, dates and locations of concern, which products are probably safe and when to stop worrying. That hasn’t happened with EVALI. Not even the name has been corrected, perpetuating confusion among researchers, clinicians and the public.

    The second myth is the persistent insistence that youth e-cigarette use is a gateway to smoking. Not only is evidence lacking for a causal link, but studies support the reverse: that vaping reduces youth smoking rates. This information has not been shared by health authorities.

    “I’ve heard researchers tell me that we still don’t know the relative harm of e-cigarettes compared to smoking,” says Bethea (Annie) Kleykamp, assistant professor in psychiatry at the University of Maryland School of Medicine. “I’ve seen [healthcare] providers very nervous about talking about harm reduction at all. I don’t know if that’s because they’re misinformed or they’re reading information that is different from what I’m reading.”

    Smith, a brain researcher with deep experience in both academia and industry, shares these concerns. “I could understand this error if it was coming from nonscientists,” he says. “But it is in the messaging from academics, policymakers and national health organizations.”

    He is frustrated by the way the link between smoking and nicotine is used to tar all reduced-risk products. “If cigarettes contain nicotine, then any nicotine-containing product must be equally bad,” is how he sums up that mistaken theme.

    As a neuroscientist, Smith sees an additional overlooked benefit from correcting misperceptions of nicotine. “The potential of nicotine to improve health in nonsmokers has really lagged behind due to its association to smoking,” he says. If nicotine could be destigmatized, research may lead to treatments for traumatic brain injury, Alzheimer’s disease and age-related memory loss.

    The Greatest Need

    “Diverse public audiences” who smoke and die at unacceptably high rates should get top priority attention from the FDA. These include people in custody and persons with serious mental illnesses.

    At the University of Maryland, Kleykamp works with a long-established Baltimore addiction clinic. Smoking rates are at 70 percent or higher among people with opioid use disorder (OUD).

    “A little over half of people in addiction treatment will actually die of tobacco-related disease, not other addictions,” she says. People with OUD seldom quit smoking with prescription medicines or NRTs. Preliminary evidence suggests that e-cigarettes may be a more acceptable substitute.

    Kleykamp notes that addiction professionals typically focus on immediate risks: stabilizing patients and making sure they don’t overdose. And for younger patients who smoke, the biggest tobacco dangers are decades down the line. But the pattern is changing.

    “A lot of patients in opioid treatment are aging,” Kleykamp notes. “In our clinic, over 50 percent are over 55 and above. So tobacco harm reduction is becoming equally urgent.”

    Kleykamp’s other research focus is on longtime adult cigarette users. Among Americans over age 65 who smoke, quit rates have been stagnant since the turn of the century.

    “Older adults who smoke are the least informed on relative harms and more likely to think that nicotine is a cause of cancer,” says Kleykamp. “Yet they are the most likely to get the cancer and heart disease.”

    There is little research on how to change the minds and behaviors of longtime smokers. Kleykamp is working to fill that gap. She’s preparing to publish research based on the Population Assessment of Tobacco and Health study data from adults aged 55-plus who have smoked for decades. In this sample, more people had tried e-cigarettes than had tried NRT. Based on such findings, Kleykamp speculates that longtime smokers “don’t want to use these medicines. They want something that’s more the look and feel of a cigarette.”

    “It seems to me that if you smoke that long and have difficulty quitting and don’t want to quit, then a product that replaces the nicotine and is pleasurable is your best hope,” she says.

    Wanted: Consistency and Trust

    From studies and expert opinions, one message is clear: We need consistent, clear messaging on the relative risk of smoking. Kleykamp thinks that the FDA is a trusted source of information for researchers and healthcare providers. She would like to see educational interventions geared toward providers on the basics: nicotine’s non-role in cancer, and the tobacco product continuum of risk.

    For the larger public, the FDA may need to work through other avenues. Surveys suggest that many Americans, and particularly people who smoke, don’t trust information from the FDA or the Centers for Disease Control.

    “Aging and tobacco use is correlated with being not white and low socioeconomic status, so you also have a correlation with historic mistrust of providers,” Kleykamp says. “An interaction with a clinician that they trust could help. Maybe in the context of a relationship that’s already been built.”

    Smith also advocates one-to-one education. “I think the medical and public health community could be the source of credible information, but on the local level, not large and expensive national campaigns,” he says. “I feel that there is mistrust everywhere. And without personal connection, it will be hard to drive change.”

    Smith would like to see this consistent message coming from all sources: “Combustion is the problem, not nicotine. Stop smoking—through any means, quit or switch—and your health will improve.”

    Finally, he calls for more communication among researchers. “I would argue today that regardless of source—academic, regulatory or industry—the only way to solve the health problems that exist around smoking is to listen, argue, discuss, agree and disagree as a single scientific community,” says Smith. “Science is what will drive change.”

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.