Tag: news

  • U.S. Tobacco Control Experts Support ENDS as Quit Aid

    U.S. Tobacco Control Experts Support ENDS as Quit Aid

    A new paper co-authored by a majority of recognized tobacco control experts in the United Sates endorses the harm reduction benefits of vaping for adult smokers trying to quit combustible cigarettes. The group of experts state that the public image of vaping products must be improved and electronic nicotine-delivery systems (ENDS) should be promoted as a safer alternative to combustible cigarettes.

    “Opponents focus on e-cigarettes’ risks for young people, while supporters emphasize the potential for e-cigarettes to assist smokers in quitting smoking. Most US health organizations, media coverage, and policymakers have focused primarily on risks to youths,” the report states. “Because of their messaging, much of the public—including most smokers—now consider e-cigarette use as dangerous as or more dangerous than smoking. By contrast, the National Academies of Science, Engineering, and Medicine concluded that e-cigarette use is likely far less hazardous than smoking. Policies intended to reduce adolescent vaping may also reduce adult smokers’ use of e-cigarettes in quit attempts.”

    The paper, published August 19 in The American Journal of Public Health, was led by Kenneth Warner, a professor emeritus of health management and policy at the University of Michigan and a distinguished tobacco control expert. Fifteen former presidents of the Society for Research on Nicotine and Tobacco (SRNT), the leading scientific professional society focused on nicotine and tobacco, co-authored the paper.

    The authors present four categories of evidence supporting vaping as a quit aid for combustible tobacco use: the results of randomized trials, which show e-cigarettes outperform other cessation methods like nicotine patches; population studies, the findings of which “are consistent with a near doubling of quit attempt success”; cigarette sales, which decrease rapidly as vaping sales increase; and the unintended consequences of policies restricting vaping, such as bans that unintentionally shot up cigarette smoking.

    “The major elements of the public health community that are concerned with tobacco have been singularly focused on the risk to kids,” Warner told Alex Norcia of Filter. “They seem to truly have no interest whatsoever in adult smokers. The other piece is that you’re seeing lots of allegedly scientific papers that are raising health concerns that are unwarranted.” One such paper, which claimed that vaping increased the likelihood of having a heart attack, was later retracted.

    The paper also presents “a sensible mix of policies” to boost ENDS use, including taxing traditional cigarettes higher than e-cigarettes to encourage adult smokers to switch, allowing flavored vaping products available only at vape shops, restricting advertising to limit youth initiation and reducing the nicotine levels in cigarettes while ensuring the availability of “consumer-acceptable” reduced-risk nicotine products.

    “Because evidence indicates that e-cigarette use can increase the odds of quitting smoking, many scientists, including this essay’s authors, encourage the health community, media, and policymakers to more carefully weigh vaping’s potential to reduce adult smoking-attributable mortality,” the paper states.

  • Group of 31 States Wants FDA to Ban Most E-Liquid Flavors

    Group of 31 States Wants FDA to Ban Most E-Liquid Flavors

    A coalition of 31 U.S. states and territories has penned a letter the U.S. Food and Drug Administration (FDA) to asking the agency to ban all flavors other than tobacco, limit nicotine levels and restrict the marketing of all electronic nicotine delivery system (ENDS) products. The group wants the regulations to also apply to oral nicotine products such as pouches, gum and lozenges.

    Credit: Balint Radu

    Led by New York Attorney General Letitia James, the group’s letter to the FDA argues that the FDA must address the epidemic of youth use of ENDS products by imposing restrictions and age verifications on traditional and digital marketing tactics aimed towards youth, according to a press release. The group claims that e-cigarettes and oral nicotine products have not received marketing authorization from the FDA, as required by federal law.

    “Flavored nicotine products attract kids to dangerous, habit-forming products that only jeopardize their health,” said James. “New York has taken important steps to protect our kids by banning non-tobacco flavored vapor products and limiting the sale of e-cigarettes, but the FDA must also do its part to curb the youth nicotine epidemic. The health and wellbeing of our kids is our top priority and the federal government must act now.”

    The FDA must make a decision by Sept. 9 on whether to allow nicotine products to stay on the market through its premarket tobacco product application (PMTA) pathway for any ENDS product that submitted the application by Sept. 9, 2020. The group’s proposed restrictions would require the FDA to deny approval for most products.

    The coalition argues that banning candy, mint, fruit, and menthol flavors, is essential to eliminating the appeal of the products to youth consumers. Other signatories to the letter are the attorneys general of Idaho, Illinois, Nebraska, North Carolina, and Tennessee. Additional states joining the letter include Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Guam, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Utah, Vermont, Washington, and Wisconsin.

    James has a long history of challenging the ENDS industry. In April 2019, she led a coalition of seven states in urging the FDA to take stronger action in addressing “the scourge of e-cigarette use among youths” by taking proposed measures such as strengthening guidance, beginning enforcement earlier and banning online sales of e-cigarettes.

    Later that year, James filed a lawsuit against the electronic cigarette company JUUL Labs for deceptive and misleading marketing of its e-cigarettes, which “contributed to the ongoing youth vaping epidemic in New York state.” In December 2020, James ordered dozens of retailers across New York state to immediately stop selling e-cigarette products to underage customers and to stop selling flavored vaping products in violation of New York state law.

    Several recent studies have found that banning flavored vaping products boosts sales of combustible cigarettes and youth use. If vapor product sales were restricted to tobacco flavors, one-third of U.S. vapers between the ages of 18 and 34 would switch to smoking combustible cigarettes, according to at least three known studies.

  • Biodegradable Filter Maker to Supply Poda

    Biodegradable Filter Maker to Supply Poda

    Photo: ASDF

    Poda Lifestyle and Wellness has entered into a supply agreement with biodegradable filter manufacturer Greenbutts.

     Greenbutts has developed a natural filter technology that was created to provide an alternative to the common nonbiodegradable cellulose acetate cigarette filter. Greenbutts created a natural, rapidly degrading cigarette filter using a proprietary blend of food-grade fiber materials including flax, cotton and manila hemp with no artificial compounds or chemical residues. The unique blend of materials is designed to allow for the same sensory experience and filter manufacturing run rates as acetate filters. Greenbutts filters will disperse in water within a few minutes and will degrade in compost within seven days as opposed to 10–15 years as is the case with traditional cellulose acetate filters.

    “Poda is committed to ensuring that the company contributes to a brighter future for all of our stakeholders,” said Ryan Selby, Poda CEO, in a statement. “As CEO, I take this responsibility very seriously, and I am devoted to ensuring that Poda delivers industry-leading performance on our core principles of strong environmental management, responsible societal impacts and robust corporate governance. Pursuant to this commitment, I am very pleased to announce today that Poda has entered into a supply agreement with Greenbutts, one of the world’s leading manufacturers of biodegradable cigarette filters.”

    “This supply agreement will provide the company with access to 100 percent biodegradable filters for use in our Beyond Burn Poda Pods. The inclusion of Greenbutts’ biodegradable filters into our already biodegradable and compostable Poda Pods allows Poda the ability to offer a completely biodegradable and truly compostable heat-not-burn product, something that has never been done in the heat-not-burn tobacco market. … We are thrilled to have secured this supply agreement.”

     “We have spent the last 10 years relentlessly pursuing the perfect biodegradable cigarette filter,” said Tadas Lisauskus, co-founder and CEO of Greenbutts. “Now that our patented product is ready for commercialization, we are very pleased to have entered this supply agreement with Poda. Traditional cellulose acetate cigarette filters are among the single most commonly littered items globally, and we are committed to the goal of eliminating environmental pollution caused by improperly discarded cigarette butts. Greenbutts’ biodegradable filters are made from natural sources and quickly biodegrade in natural settings. Combining our proprietary biodegradable filters with Poda’s unique and proprietary biodegradable heat-not-burn cigarettes is surely a winning combination.”

  • Canadian Vaping Group Wants End to Flavor Ban Proposal

    Canadian Vaping Group Wants End to Flavor Ban Proposal

    The Canadian government has proposed restrictions on flavored vape products, which Health Canada acknowledges will result in increased combustible cigarette smoking. The justification for the flavor ban is that flavor restrictions will lessen youth vaping rates, according to the Canadian Vaping Association (CVA). However, youth rates are already in decline.

    Credit: Kristina Blokhin

    The Canadian Tobacco and Vaping Survey, 2020, found that youth vaping has declined since 2019. Currently, youth daily vaping is 4.7 percent and Health Canada expects the recently implemented nicotine ceiling will further reduce use and experimentation.

    “Youth daily vaping and addiction rates are actually quite low and expected by tobacco control experts to continue to decline. Generally, youth vaping rates are discussed using data on the amount of youth that have tried vaping over the past 30 days,” said Darryl Tempest, executive director of the CVA. “This is a poor metric to base regulation on because it represents experimentation and not habitual use. Young people that try vaping once at a party are included in this figure. These surveys are also misleading because they include age of majority respondents. If these respondents were excluded from the survey, daily vaping among minors is around 2 percent.”

    In a press release, Tempest stated that if other adult products were regulated consistently with the same concern as past 30-day vape use, both cannabis and alcohol would require severe restrictions, as both daily and past 30-day use prevalence are greater than nicotine vaping.

    “Alcohol is considerably more harmful than nicotine vaping and despite its use being significantly more prevalent than vaping among youth, flavor restrictions have not been considered. This is likely because like vaping, youth are not drinking for flavors,” Tempest states. “Canada has set a goal to reduce tobacco use prevalence to 5 percent or less by 2035. Restricting flavors will push thousands of vapers back to smoking and jeopardize current smoking reduction targets. The CVA calls on Health Canada to forgo the flavor ban and instead focus on proven methods such as increased enforcement and education programs.”

  • Bantam Non-Tobacco Flavors Head to Scientific Review

    Bantam Non-Tobacco Flavors Head to Scientific Review

    The U.S. Food and Drug Administration has informed e-liquid manufacturer Bantam Vape that its non-tobacco flavored electronic nicotine delivery system (ENDS) products are now in the agency’s formal scientific review stage of the premarket tobacco product application (PMTA) process, according to a press release. Scientific review is the final step in the PMTA process prior to FDA’s decision to grant a marketing order.

    Bantam e-liquids
    Bantam is seeking marketing orders from FDA for its suite of e-liquid products. Credit: Bantam Vape

    “Following the receipt of Bantam’s filing letter, it has waited in anticipation for FDA to begin the next step in the PMTA process – formal scientific review,” said Bantam spokesperson Anthony Dillon. “As we approach the one-year anniversary of the filing deadline, this action represents a critical stage in FDA’s consideration of Bantam’s request for a marketing order.”

    The FDA completed a preliminary review of Bantam’s PMTAs in November 2020, making its applications eligible for formal substantive review. During the substantive review phase, FDA will conduct an in-depth evaluation of Bantam’s scientific studies and other materials it submitted in conjunction with the brand’s applications.

    This includes FDA’s consideration of Bantam’s product testing for harmful and potentially harmful constituents (HPHCs) and physical characteristics of the e-liquids and aerosol at multiple time points; an analysis of leachable chemicals and stability testing of its e-liquids at multiple time points; microbial testing of the final e-liquids at multiple time points; in vitro toxicity testing including Ames, micronucleus and neutral red uptake (NRU) studies; four pharmacokinetic and topography studies for multiple flavors at various nicotine concentrations; and consumer surveys to understand the demographic and usage patterns of its e-liquids. Multiple comprehensive, quantitative risk assessments across many areas of potential risk for the Bantam products were also provided to FDA, demonstrating that Bantam products are appropriate for the protection of public health.

    Additionally, to ensure Bantam’s ongoing ability to provide consumers with “high-quality, science-based e-liquid products” following the Sept. 9, 2021 deadline, the brand submitted a formal extension request to FDA. Bantam is hopeful that FDA will grant the extension, which would provide the regulatory agency with additional time to review Bantam’s complete applications and allow the brand’s products to remain on the market while the applications are under review.

    “Entering the coveted scientific review phase is a significant development. This is especially true given FDA’s growing enforcement actions against non-compliant brands,” said Dillon. “Bantam remains confident in its PMTA submissions and will continue to engage with FDA in order to obtain the marketing orders needed to stay on the market moving forward.”

  • PMI Launches ‘Cleaner’ Bladeless IQOS in Japan

    PMI Launches ‘Cleaner’ Bladeless IQOS in Japan

    Photo: Kuznietsov Dmitriy

    Philip Morris International has launched IQOS Iluma, the brand’s first tobacco-heating system based on induction-heating technology, in Japan.

    The device’s Smartcore induction system heats the tobacco from within the new Terea Smartcore Stick. These newly designed sticks are to be used only with IQOS Iluma, which features an auto-start function that detects when the Terea stick is inserted and automatically turns on the device.

    According to PMI, the bladeless IQOS devices offer a cleaner way to heat tobacco from the core without burning it. They also provide a more consistent experience and leave no tobacco residue, eliminating the need to clean the device. Additionally, the devices generate no combustion and no smoke. PMI says its market research indicates that IQOS Iluma provides a more pleasurable experience compared to previous IQOS generations.

    “IQOS Iluma is our most innovative offering to date and the new flagship in our portfolio of science-backed, smoke-free products. Its breakthrough induction-heating technology heats tobacco from within, without burning, so there’s no smoke, no ash and, like previous IQOS devices, it emits, on average, 95 percent lower levels of harmful chemicals compared with cigarettes,” said Michele Cattoni, vice president of heated-tobacco platforms at PMI, in a statement.

    “However, unlike our previous tobacco-heating systems, IQOS Iluma has no blade. That means no tobacco residue or cleaning—ever. With this, and other product features, we aim to address consumer pain points that may have hindered some adult smokers from beginning or maintaining their journey away from cigarettes in the past.”

    IQOS Iluma is available in two versions—IQOS Iluma Prime and IQOS Iluma. Both devices use new induction-heating technology but offer different designs. IQOS Iluma Prime and IQOS Iluma are available in Japan for pre-order on IQOS.com beginning Aug. 17, 2021, and for purchase at IQOS stores on Aug. 18, 2021.

    As of June 30, 2021, PMI’s smoke-free products are available in 67 markets. The company has stated its ambition to be present in 100 markets with its smoke-free products by 2025. There are more than 20 million users of the IQOS tobacco-heating system globally, and PMI estimates that more than 73 percent (approximately 14.7 million) of these men and women have switched completely to IQOS and stopped smoking with the balance in various stages of switching. PMI’s ambition is that by 2025, at least 40 million PMI cigarette smokers who would otherwise continue to smoke will have switched to smoke-free products. Furthermore, the company’s ambition is that more than half of its net revenues will come from smoke-free products by 2025.

  • Columbia, Missouri Considers Flavored E-Liquid Ban

    Columbia, Missouri Considers Flavored E-Liquid Ban

    City council members in Columbia, Missouri will review a report from the Missouri Board of Health concerning banning flavored vaping products in an effort “to reduce the number of youth vaping in Boone County.”

    Credit: Spirit of America

    According to an agenda memo, the Board of Health began studying the issue of youth vaping and its impact on mental and physical health in October 2019. Now, the board has sent the report to council, requesting assistance to prevent teen vaping, according to ABC17 News.

    The report details three recommendations that could help decrease youth vaping, including zoning restrictions on vape shops, since vape shops can currently operate near schools. Health officials also recommend a ban on flavored vaping products since currently e-cigarettes are “sold in over 15,000 flavors.”

    The board is also recommending the council explore higher taxes on vaping products to increase the cost and hopefully reduce use by youth. Multiple studies have found that flavor bans actually boost youth use of tobacco and vaping products.

    No vote is expected on the report Monday night.

  • Vapers Urged to See Doctor Ahead of New Rules

    Vapers Urged to See Doctor Ahead of New Rules

    Photo: Taco Tuinstra

    The Therapeutic Goods Administration (TGA) is urging Australian vapers to make appointments with their general practitioners to discuss their smoking cessation options ahead of new vaping rules.

    Effective Oct. 1, Australian consumers will need a valid prescription to legally obtain nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine, from an overseas website. A valid prescription is already required to purchase nicotine vaping products from Australian pharmacies.

    Purchase of nicotine vaping products from other Australian sources will remain illegal, the TGA said in guidance documents released on Aug. 12.

    From Oct. 1, Australian Border Force officials can stop an import at the Australian border and destroy the product if they suspect that it is unlawful and there is not a prescription available.

    According to the TGA, the new rules balance the need to prevent adolescents and young adults from taking up nicotine vaping (and potentially smoking) while enabling current smokers to readily access these products for smoking cessation with appropriate medical advice.

    While the TGA has not yet registered any nicotine vaping products, the agency says it is working closely with several potential applicant companies.

  • Former Juul Labs CEO Takes Lead at Digital Pharmacy

    Former Juul Labs CEO Takes Lead at Digital Pharmacy

    Kevin Burns, who resigned in 2019 as chief executive officer of Juul Labs Inc. amid growing controversy over the marketing of e-cigarettes, was named CEO of online service Alto Pharmacy, according to Bloomberg.

    Burns, who joined Alto a year ago as chief operating officer, replaces co-founder Matt Gamache-Asselin as CEO, according to a memo sent to employees Thursday. Gamache-Asselin plans to remain involved, leading the product and technology organization.

    Burns joined Juul in 2017, when the e-cigarette maker enjoyed a heady valuation and was seen as one of the leading companies in the burgeoning industry. But growing use of vaping devices by teens and young non-smokers drew an outcry from public health officials, and the company announced the day Burns departed that it would stop advertising and lobbying.

    Alto, part of a crop of hot startups in the online pharmacy space, was founded in 2015. The company has explored the idea of going public via a blank-check firm, Bloomberg reported in May, and was projected then to have revenue of about $700 million this year. Burns worked at yogurt maker Chobani and at private equity firm TPG Capital before joining Juul.

  • Georgia State Begins Aerosol Research Study for ENDS

    Georgia State Begins Aerosol Research Study for ENDS

    A research initiative on the potential harmful effects of electronic nicotine delivery systems (ENDS) by Chemical Insights, an institute of Underwriters Laboratories and Georgia State University’s School of Public Health are now underway. The collaboration will characterize airborne particulate aerosols and volatile organic chemicals released during e-cigarette use and determine human exposure levels and toxicity for users and bystanders, according to a press release.

    Essentra Scientific Services’ new laboratory is dedicated to testing electronic cigarettes.

    “With a focus on public health and safety benefits, our research findings will identify specific particles and chemicals that infiltrate the lungs of a user so that steps can be taken to reduce human health risks,” said Marilyn Black, vice president and senior technical advisor with Chemical Insights.

    The release states that one contributing factor to youth use of ENDS is the perception that ENDS are a safer alternative to cigarettes and other traditional tobacco products. “However, a series of studies have proven pulmonary toxicity in e-cigarettes and a link to negative impacts on adolescents’ respiratory health,” the release states. “ENDS lags in product safety testing for numerous proprietary liquids and aerosol delivery methods available in the expanding marketplace.”

    The study will reportedly provide scientifically sound data to inform policy makers, healthcare providers, manufacturers and consumers of potential health risks and approaches for product usage and label warnings to educate consumers of potential respiratory hazards, according to Roby Greenwald, assistant professor in the School of Public Health and co-principal investigator of the study. “We’re looking at multiple liquids and aerosol delivery methods that are readily available to better understand toxicity and their impact on human health.”

    The U.S. Food and Drug Administration is currently evaluating the harm-reduction potential of vapor products through its premarket tobacco product application (PMTA) process. The regulatory agency has stated that ENDS are safer than combustible tobacco products, but do not come without risk.

    Research findings will begin to be released in fall 2021.