Author: Staff Writer

  • NJoy Daily Disposable Gets FDA Marketing Approval

    NJoy Daily Disposable Gets FDA Marketing Approval

    Credit: NJOY

    NJOY now has two devices that have received marketing approval from the U.S. Food and Drug Administration. The regulatory agency today issued marketing granted orders (MGOs) under the premarket tobacco product application (PMTA) process for NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.

    “It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the MGO states. “The issuance of these marketing granted orders confirms that you have met the requirements of section 910(c) of the FD&C Act and authorizes marketing of your new tobacco products.”

    The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the company to legally market them in the United States.

    “Our finding that permitting the marketing of the new products is APPH does not mean FDA has ‘approved’ the new tobacco products specified in Appendix A,” the MGO states. “Therefore, you may not make any express or implied statement or representation in a label, labeling, or through the media or advertising, that the new tobacco products specified in Appendix A are approved by FDA.”

    The FDA also issued marketing denial orders (MDOs) to NJOY for multiple other Daily e-cigarette products. These are presumed to be for flavored products other than tobacco. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.

    Additionally, this authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.

  • US FDA Campaign to Focus on E-Cig Use by Native Youth

    US FDA Campaign to Focus on E-Cig Use by Native Youth

    The U.S. Food and Drug Administration announced the launch of its “Next Legends” youth vaping prevention campaign. The regulatory agency stated that the program is part of the FDA’s ongoing efforts to protect youth from the dangers of tobacco use.

    The campaign will educate American Indian/Alaska Native (AI/AN) youth, ages 12-17, about the harms of vaping through unique branding and tailored messaging created to inspire a new generation to live Native strong and vape-free, according to a statement.

    There are approximately 400,000 Native teens in the U.S., and more than half of them are at-risk of using tobacco products, including e-cigarettes, according to FDA. Studies show that Native youth are more susceptible to e-cigarette use than their non-Native peers, and they demonstrate disproportionately high experimentation and current use of e-cigarettes.

    “The Next Legends campaign is an important and creative way to educate Native youth about the harms of vaping,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “E-cigarettes are the most used tobacco product among youth, and they pose serious health risks if used during adolescence, when the brain is still developing. Next Legends builds on the success of previous youth e-cigarette prevention campaigns while also addressing health disparities among Native Americans and Alaska Natives associated with tobacco use. Communicating with Native youth through culturally-aligned messages will help these young people make informed decisions about healthy behavior, including being vape-free.”

  • EVALI, Covid-19 Boosted Misinformation on Vaping

    EVALI, Covid-19 Boosted Misinformation on Vaping

    A new study led by researchers at the American Cancer Society (ACS) shows perceptions of e-cigarettes as being “more harmful” than cigarettes by adults in the United States more than doubled between 2019-2020 and perceptions of e-cigarettes as “less harmful” declined between 2018-2020.

    The study also found that an increase in cigarette smoking prevalence (2019-2020) was restricted to those who perceived e-cigarettes as “more harmful” than cigarettes, while increases in prevalence of e-cigarette use was restricted to those who perceived e-cigarettes as “less harmful” than cigarettes, according to a press release.

    Prevalence of dual use of both products increased only among those who perceived these products as equally or “as harmful”. The results coincide with the e-cigarette or vaping use-associated lung injury outbreak (EVALI) and the COVID-19 pandemic. The data was published today in the American Journal of Preventive Medicine (AJPM).

    “While all tobacco products, including e-cigarettes, pose a risk to the health of the user, major health events, such as the EVALI epidemic in late-2019 and the COVID-19 pandemic in 2020, paved the way to new smoking/e-cigarette health risks,” the release states. “During this time, the quality and type of information individuals were exposed to may have shaped how they compare the potential harms of tobacco products, which in turn, may have altered tobacco use behaviors.”

    How individuals perceive the harm of e-cigarettes vs. traditional cigarettes can predict their individual decision to use tobacco products, but according to the study authors, this is the first study to provide evidence this relationship translates to population-based prevalence changes. 

    “While this study showed sharp changes in public perceptions of e-cigarette vs. cigarette harms during EVALI and COVID-19, the more relevant finding for public health is that increases in cigarette smoking and e-cigarette use prevalence occurred primarily in individuals who perceived their preferred product as relatively less harmful,” said Priti Bandi, principal scientist, risk factors & screening surveillance research at the American Cancer Society and lead author of the study. “This suggests that public perceptions of e-cigarettes vs. cigarettes harms influences population tobacco use patterns.”

    In this study, researchers analyzed data from the National Cancer Institute sponsored Health Information National Trends Survey collected from more than ten-thousand U.S. adults from 2018 – 2020. The results showed perceptions of e-cigarettes as “more harmful” than cigarettes doubled each year, increasing most between 2019-2020 (2018: 6.8%, 2019: 12.8%, 2020: 28.3%), while uncertainty (responses of “don’t know”) in relative harm declined (2018: 38.2%, 2019: 34.2%, 2020: 24.7%). “Less harmful” relative perceptions declined (2018: 17.6%, 2019: 15.3%, 2020: 11.4%), while “as harmful” perceptions remained steady (2018: 37.4%, 2019: 37.7%, 2020: 35.6%).

    Exclusive cigarette smoking increased between 2019-2020 among those who perceived e-cigarettes as relatively “more harmful” (2018: 18.5%; 2019: 8.4%; 2020: 16.3%), exclusive e-cigarette use increased linearly among those who perceived them as relatively “less harmful” (7.9%; 15.3%, 26.7%), and dual use increased linearly in those who perceived them “as harmful” (0.1%, 1.4%; 2.9%).

    “It is challenging for individuals to make conclusions about the short- and long-term health effects of tobacco products without clear, effective, and ongoing communication from public health authorities, especially when new contextual events that change health harms happen,” said Bandi. “There is a need for behavioral interventions to encourage individuals to be informed consumers of available scientific findings and appreciate that while no tobacco products is safe, there are inherent differences between relative and absolute harms between tobacco products that can influence behavior. In turn, public health education campaigns must facilitate informed decision making by translating emerging scientific evidence accurately to appropriate audiences.”

  • Vaping May Lead to Healthier Choices for Former Smokers

    Vaping May Lead to Healthier Choices for Former Smokers

    Credit: Adrian_ilie825

    A new University of Washington study shows smokers who switch to e-cigarettes may have more opportunities for healthier choices. That does not mean vaping is safe, researchers say, but for people who smoke combustible tobacco and are trying to quit, vaping can be associated with healthy routines.

    The study was funded by the National Cancer Institute, the National Institute on Aging and the National Institute on Drug Abuse.

    The co-authors of the study stressed e-cigarettes have substantial public health downsides, including popularity among young people, particularly those not previously addicted to nicotine. The study, however, focused on asking whether vaping can be beneficial to existing smokers unable to to quit.

    For the study, Kosterman and his co-authors, Marina Epstein, Jennifer Bailey and David Hawkins, connected with a group of 800 Seattleites who are part of a landmark study that began in 1985 when they were elementary school students.

    The UW study focused on 156 of those participants. This subsample reported smoking combustible cigarettes at age 30 and smoking or vaping at age 39.

    The research team surveyed participants, when they were 30 and 39, about nine measures of healthy aging and well-being and how often they engaged in certain activities, according to Seattle Times.

    Of the 156 participants, 64 percent smoked only combustible cigarettes at age 39, 28 percent smoked and vaped, and 8 percent only vaped. The roughly one third of the group that shifted to vaping some or all the time by age 39 reported better physical health, exercised more and had more active social engagement, the study found.

    “Although the study cannot show a causal relationship, we think that because e-cigarettes have less stigma, less odor and are less physically harmful, they may increase health-promoting opportunities among smokers.” Kosterman said. People who use e-cigarettes may be more likely to be in settings that promote physical activity and to interact more with nonsmokers, he said.

    “What we’re saying is that e-cigs do have a positive role to play for existing adult smokers who continue to use nicotine,” he said.

  • QR Joy Launches ‘Fume Unlimited’ Disposable Device

    QR Joy Launches ‘Fume Unlimited’ Disposable Device

    QR Joy, the retail manufacturer of Fume disposable vaping hardware, has introduced its “most powerful, longest-lasting vape” device, according to a press release.

    The Fume Unlimited comes pre-loaded with 14mL of e-liquid in 17 classic and exotic flavors, including icy, fruity, sweet, and more. Its 400mAh rechargeable battery ensures that vape enthusiasts will be able to enjoy every one of the 7,000 puffs Fume Unlimited has to offer, a release states.

    The new Fume Unlimited offers 7,000 puffs of e-liquid and a USB-C charger.

    “Vape enthusiasts love unique flavors and want to be able to enjoy every last drop of e-liquid in their devices,” said the president of QR Joy in a release. “Packed with loads of flavor and a handy USB-C charging port, Fume Unlimited offers virtually endless vape satisfaction in a sleek, pocket-sized package.

    QR Joy teased Fume Unlimited at the 2022 Alternative Products Expo in Medellin, Colombia, in late May, and will officially unveil the new device at the CHAMPS Chicago Show June 7-9.

  • Thailand: Decriminalized Cannabis to Begin Thursday

    Thailand: Decriminalized Cannabis to Begin Thursday

    Credit: Art Proximo

    Thailand’s Courts of Justice announced that suspects and prisoners on charges related to cannabis use and possession would be freed after cannabis and hemp are removed from the Public Health Ministry’s Category 5 drug list beginning June 9.

    The cultivation and smoking of recreational marijuana, even for personal use, will still not be legalized, according to The Haiger.

    On Saturday, spokesperson of the Courts of Justice, Sorrawit Limparangsi, confirmed that all suspects and prisoners charged with production, import, export, distribution, use and possession of cannabis even before June 9 would be released.

    The Ministry of Public Health is working to decriminalise the use and possession of cannabis in Thailand in a bid to develop medical tourism and the economy in Thailand. Starting Thursday, people are allowed to grow cannabis at home for medical use without asking for government permission. The only requirement, those said people have to download an app called Plook Ganja and register.

    Every part of cannabis and hemp, including leaves, stems, fibers, branches, seeds, inflorescences, and roots, can be legally used at home for medical purposes if the amount of THC, tetrahydrocannabinol, or CBD, cannabidiol, is less than 0.2%. That means you are not legally allowed to get high in Thailand, for now anyway.

    Smoking cannabis is considered a public nuisance. People can file a complaint against cannabis smokers and those users face a 3-month jail sentence and a fine of up to 25,000 baht if they are found guilty of a public nuisance charge.

    The Public Health Ministry says this would help prevent the recreational use and other abuses of cannabis that are currently in conflict with existing Thai laws.

  • New U.K. Study on Public Health Effects of Vuse

    New U.K. Study on Public Health Effects of Vuse

    The “real world” public-health effects of BAT’s Vuse e-cigarette is the subject of a new study.

    The study is “designed to assess and provide insights” into the growing role of the e-cigarette brand. Vuse has been market momentum in since some of its branded products received marketing approval from the U.S Food and Drug Administration.

    The study involves a cross-sectional confinement study of exclusive Vuse users in the United Kingdom over at least a six-month period, according to a press release.

    “This innovative study demonstrates our commitment to researching the reduced-risk potential of our New Category products. What makes it particularly relevant and exciting is that the results generated will be from people who have been using Vuse as they normally would for more than six months prior to testing,” Sharon Goodall, BAT’s Group Head of Regulatory Sciences, said. “The results will provide important new insights and show us the differences between Vuse users, smokers and former smokers across a range of important biomarkers thought to be predictive of disease development. We look forward to sharing the data once available.”

    Also participating were current or former smokers of traditional cigarettes and people who have never smoked. Former smokers would have had to quit for at least six months to qualify. Study participants were between 19 and 55 years old, and in good general health.

    “It is hoped that the results, which are currently being analyzed and will be published later this year, will provide further supportive evidence that using Vuse can reduce relative risk for certain diseases among adult consumers compared to smoking,” BAT said in a news release.

    Unlike longitudinal studies where participants attend multiple clinic visits over an extended period of time, participants in this study made a single clinic visit where samples of blood, urine and other measurements were collected. These samples were then tested for “biomarkers of exposure” (to selected cigarette smoke toxicants) and “biomarkers of potential harm”. Differences between the groups were assessed, rather than changes from baseline.

    In addition, to ensure compliance, the Vuse and former smoker groups were tested for the biomarker, CEVal, which indicates if they have recently smoked cigarettes.

    Results from the completed study will be published in due course.

  • Aquavape to Distribute IQOS Devices in U.K. Vape Shops

    Aquavape to Distribute IQOS Devices in U.K. Vape Shops

    The U.K.-based next-generation nicotine distributor Aquavape has partnered with Philip Morris Limited (PML), the supplier behind IQOS, to offer heated tobacco products for the first time. Philip Morris Ltd. (PML), the U.K. affiliate of Philip Morris International

    This year, vape retailers have been challenged by the needs of their consumers, which are changing rapidly, according to Better Retailing. While over a quarter of adult smokers will explore smoke-free products in 2022, 58 percent haven’t yet found a satisfying alternative to cigarettes.

    The challenge for vape retailers, said PML, is twofold: meeting the growing consumer demand for smoke-free products, while matching individual preferences based on taste, satisfaction, ritual and other potentially complex needs.

    “It’s fair to say that no one single product can achieve this which is why retail outlets of all sizes have evolved as vape specialists, to become multicategory operators. Aquavape is one supplier which has made the move to multicategory, both for the benefit of its retailers’ customers and to the revenues generated by its business,” a spokesperson for PML told betterRetailing.com.

    Ebrahim Kathrada, managing director at Aquavape, said historically, the company did not list multiple smoke-free categories: “We now supply a range of smoking alternatives that meet market demands and trends.”

    Ebrahim believes a complete smoke-free product offering is essential to diversifying sales and increasing chances of satisfying more customers. “If you don’t have a category in the store, you can’t sell it and explore its potential. If you do, you become the one-stop shop conveniently catering to all the customer’s needs which increases overall takings, basket spend and retention,” he explained.

  • UAE Bans Vaping Inside Offices and Public Spaces

    UAE Bans Vaping Inside Offices and Public Spaces

    Credit: Adobe Photo

    Vaping e-cigarettes is prohibited inside offices and closed spaces across the UAE, the health ministry has confirmed. The use of e-cigarettes are now subject to the federal law on tobacco control in the country.

    This came as the Ministry of Health and Prevention (MoHAP) highlighted the dangers of consuming tobacco products, including e-cigarettes, according to Khaleej Times.

    According to the UAE government website, the federal law also forbids and penalizes:

    • The sale of tobacco products to those under 18
    • Smoking in private cars when a child under the age of 12 is present
    • Smoking in houses of worship, educational institutions (such as universities and schools), health and sports facilities
    • Automatic vending equipment and devices for tobacco distribution inside the country
    • Tobacco advertisement

    The MoHAP said it has collaborated with the Telecommunications Regulatory Authority (TRA) to block websites that advertise and promote electronic nicotine-delivery systems (ENDS).

    The UAE had originally planned to ban vaping products because UAE-based doctors had said that e-cigarettes would create a whole new generation of smokers. However, the country changed course after advocacy groups pushed for the harm reduction products.

    Meanwhile, citing the National Health Survey, the ministry said the prevalence of adult tobacco smoking has declined from 11.1 per cent in 2010 to 9.1 per cent in 2018.

    The latest edition of the Tobacco Atlas suggests that the UAE has among the lowest cigarette consumption rates. A graphic shared as part of the report shows that an adult smoker consumes 438 cigarettes a year in the country.

  • Vuse Continues to Expand U.S. Market Share Over Juul

    Vuse Continues to Expand U.S. Market Share Over Juul

    Credit: Syda Productions

    The Vuse e-cigarette brand has expanded its U.S. market share to two full percentage points over Juul.

    Vuse, a product of of R.J. Reynolds Vapor Co., held 35.1 percent of the market share, compared with Juul at 33.1 percent, according to the latest Nielsen analysis of convenience store data that covers the four-week period ending May 21.

    For the latest report, NJoy dropped from 3.1 percent to 3 percent, while Fontem Ventures’ blu eCigs slipped from 2.1 percent to 1.9 percent, according to the Winston-Salem Journal.

    By comparison, Vuse was ahead 34.8 percent to Juul’s 34.4 percent for the four-week period ending April 23. That was the first time Vuse held the top market share in the Nielsen report since November 2017.

    However, for the past 52 weeks, Juul remains ahead 35.9 percent to 30.8 percent.

    According to Barclays, Nielsen largely covers the big chains. For the smaller chains, the group extrapolates trends, which is why trend changes don’t appear immediately in Nielsen.

    As recently as May 2019, Juul held a 74.6 percent U.S. e-cig market share. That’s which is when a series of regulatory actions led to product-reduction concessions by Juul Labs Inc.

    Juul’s four-week dollar sales in the latest report have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to a 9.2 percent decline in the latest report.