Author: Staff Writer

  • Researchers to Study Health Impact of Dual Use

    Researchers to Study Health Impact of Dual Use

    Photo: tcsaba

    A new project sponsored by the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) will investigate the consequences of the combined use of conventional cigarettes and electronic cigarettes on human health.

    Titled, “MAGnitude of cigarette substitutioN after Initiation oF e-cigarettes and its Impact on biomArkers of exposure and potenTial harm in dual users” (“Magnificat”), the study will involve more than 300 dual users.

    Using specific biomarkers, clinical endpoints and behavioral correlations, researchers will be monitoring participants’ health to quantify the impact of transitioning to combustion-free products.

    Participants will be asked to reduce the consumption of conventional cigarettes and switch to electronic cigarettes for a controlled period. According to CoEHAR, the results of the study will be of great interest in addressing questions related to smoking harm reduction in both clinical and behavioral contexts.

    Tobacco Reporter profiled the work of CoEHAR in its January 2024 issue (see “Reviewing their Peers.”)

  • Innokin Launches New ‘Trine’ Vaping System

    Innokin Launches New ‘Trine’ Vaping System

    Innokin launched Trine, a redefinition of the structure of pod systems, namely atomizer, control and battery (removable), according to a press release.

    The new 3-in-1 solution improves the reusability of the battery, according to the press release. 

    Trine features removable batteries for pod systems, extending the life cycle of devices far beyond that of an individual battery while enabling safe recycling, according to Innokin.

    Trine ensures safe battery disposal by integrating EcoDrain, a battery discharge technology setting a new industry standard as an eco-safe solution for battery disposal. It addresses the challenges associated with handling discarded batteries, ensuring safe battery discharge before recycling.

    The technology minimizes fire hazards and actively reduces the detrimental environmental impact caused by battery waste, according to the company.

  • PMI Gets Appeals Court Support for Suit Dismissal

    PMI Gets Appeals Court Support for Suit Dismissal

    The United States Court of Appeals for the 2nd Circuit on Dec. 26, 2023, affirmed a district court’s dismissal of a putative class action asserting claims against Philip Morris International that the company made false or misleading statements regarding both the scientific studies it conducted in support of an application to the Food and Drug Administration and the outlook for the company’s sales growth in Japanese markets, according to Lexology.

    The district court held that the plaintiffs failed to adequately prove falsity or scienter. The 2nd Circuit affirmed the dismissal, holding that the plaintiffs failed to adequately plead falsity.

    The court decided two questions of first impression in the 2nd Circuit, holding a securities fraud defendant’s statement that its scientific studies comply with a methodological standard that is published and internationally recognized, but stated in general and inherently subjective terms, is properly analyzed as a statement of opinion rather than a statement of fact, and holding that, whereas a securities fraud defendant’s statement expresses an interpretation of scientific data that is ultimately endorsed by the FDA, such a statement is per se “reasonable” (i.e., supported by “meaningful inquiry”) as a matter of law. 

    The plaintiffs alleged that PMI made misrepresentations in securities filings and public statements about clinical studies it conducted in support of an application to the FDA to sell IQOS in the U.S. and market IQOS as reduced risk. The plaintiffs also alleged that PMI made misleading statements about its growth projections in Japan regarding IQOS. The district court found that none of the challenged statements were false or misleading because all the challenged statements were true, inactionable puffery or inactionable statements of opinion. Furthermore, the district court found that the plaintiffs failed to establish the required strong inference of scienter, either by alleging facts showing motive and opportunity to commit fraud or strong circumstantial evidence of conscious misbehavior or recklessness. Accordingly, the district court granted the defendants’ motion to dismiss the plaintiffs’ first amended complaint and denied the plaintiffs’ motion for reconsideration. After the district court dismissed the plaintiffs’ second amended complaint, this time with prejudice, the plaintiffs appealed.

  • Next-Generation Nicotine Market in 2024: Hardman

    Next-Generation Nicotine Market in 2024: Hardman

    Image: Vapor Voice archive

    What can the next-generation nicotine industry expect in 2024?

    By Paul Hardman

    The U.K. government’s proposal for a “smoke-free” generation and changing consumer opinions toward nicotine products are causing a shift in consumer habits. The year 2023 shone a spotlight on e-cigarette compliance, with a potential ban on disposable vapes on the horizon. So, how will this year’s events impact the manufacturing of nicotine products, and what trends and regulations are we likely to see going into 2024?

    Nicotine Pouches

    Nicotine pouches represent an extraordinary opportunity to support tobacco harm reduction in adult smokers. Sweden, the world’s most advanced nicotine pouch market, is on the brink of being smoke-free, with less than 5 percent of its population smoking.

    However, in the U.K., there is a regulatory gap that allows those under 18 to purchase nicotine pouches legally. In addition, there are concerns that nicotine pouch manufacturers could fall into the same traps as some disposable e-cigarette companies, by creating products that appeal to youth.

    If youth use becomes an issue, the easiest move for regulators is to categorize nicotine pouches in the same way as oral tobacco products like snus—rendering them illegal. An alternative response might be to categorize these products as nicotine-replacement therapies and place them under medical product regulations, which would restrict their access.

    To keep these products available to adult smokers who wish to quit, manufacturers can act as if regulation is already in place: generate data, devise safety frameworks and ensure the quality of products entering the market. Importantly, manufacturers should present and market their products in responsible ways, including avoiding bright colors, not imitating other consumer goods (e.g., soft drinks) and refraining from using any type of cartoon/video game characters.

    Non-Heated Technologies

    We have yet to witness a vape product approved via the U.K. Marketing Authorization Application (MAA) pathway, which enables nicotine products to be marketed as smoking cessation nicotine-replacement tools and prescribed by healthcare professionals. However, non-heated vape technology might facilitate MAA approval by addressing the core problem of delivered dose uniformity (DDU).

    One example of a non-heated vape technology involves ultrasound sonication, which enables the atomization of e-liquids to create an aerosol, similar to technology used in medical nebulizers. The droplet size and dosage can be predefined according to the dimensions of the mesh, ensuring uniformity in the vapor, thus improving DDU. As we go into 2024, we will likely see more manufacturers exploring this approach. In parallel, e-liquids will be developed specifically for this technology.

    Product Development

    Nicotine product manufacturers have been moving toward a quality-by-design (QbD) development process, and we will see this continue in 2024. There are no specific guidelines or requirements for the stability testing of nicotine products other than the scientific justification for shelf life. Employing a QbD approach demonstrates a higher level of due diligence, which could produce safer, higher quality nicotine-delivery systems.

    In addition, manufacturers are starting to implement extractables and leachables studies during the development process in anticipation of the new guidelines being set out by the European Committee for Standardization. Once these guidelines are published, we can expect to see a more standardized approach throughout the industry.

  • BAT Launches Glo Hyper Pro Heated Tobacco Device

    BAT Launches Glo Hyper Pro Heated Tobacco Device

    Image: BAT

    BAT has launched a new version of its Glo heating device. Glo is an alternative to smoking that doesn’t involve burning, producing fewer and lower levels of toxicants than conventional cigarettes.

    The Glo Hyper Pro device is lightweight, fits easily in consumers’ pockets and comes with improvements in performance, according to the company. With this new device, one charge takes approximately 90 minutes and lasts all day. Once charged, consumers can expect to use the device for 20 sessions in total.

    “We’re proud that today, over 8.8 million adult consumers now use Glo,” said Kingsley Wheaton, chief strategy and growth officer at BAT, in a statement. “This latest version is our most advanced yet, with a much improved user experience. We continue to listen to consumers and enhance our products so that they find Glo a satisfying alternative to continuing to smoke. Ultimately, BAT aims to support smokers to switch to these reduced-risk products in order to deliver benefits for consumers, society and our stakeholders.”

    The wider Glo range is sold in over 20 markets around the world. The Glo Hyper Pro device has been launched in Japan, Italy and Poland, with further global market rollouts planned during 2024.

  • Another Study Finds Vape More Effective Than NRTs

    Another Study Finds Vape More Effective Than NRTs

    Nicotine e-cigarettes are more effective quit-smoking products than conventional nicotine-replacement therapies (NRTs), reports University of Massachusetts Amherst, citing the latest Cochrane review.

    The review found high certainty evidence that e-cigarettes lead to better chances of quitting smoking than using patches, gums, lozenges or other traditional NRTs.

    “In England, quite different from the rest of the world, e-cigarettes have been embraced by public health agencies as a tool to help people reduce the harm from smoking,” said Jamie Hartmann-Boyce, assistant professor of health policy and promotion in the School of Public Health and Health Sciences at the University of Massachusetts Amherst.

    “Most of the adults in the U.S. who smoke want to quit, but many find it really difficult to do so,” said Hartmann-Boyce, who conducted research at the University of Oxford in England before joining the University of Massachusetts Amherst earlier this year and is the senior author of the review and a Cochrane editor. “We need a range of evidence-based options for people to use to quit smoking, as some people will try many different ways of quitting before finding one that works for them.”

    The review included 88 studies and more than 27,235 participants, with most of the studies taking place in the U.S., the U.K. or Italy.

    “We have very clear evidence that, though not risk-free, nicotine e-cigarettes are substantially less harmful than smoking,” Hartmann-Boyce said. “Some people who haven’t had success in the past with other quit aids have found e-cigarettes have helped them.”

    For every 100 people using nicotine e-cigarettes to quit smoking, eight to 10 are expected to successfully quit compared to six of 100 people using traditional NRTs and four of 100 trying to quit without support or with only behavioral support, according to the review.

    “Not everything is either entirely harmful or beneficial,” Hartmann-Boyce said. “Different things can have different impacts on different populations. Evidence shows that nicotine e-cigarettes can help people quit smoking and that people who don’t smoke shouldn’t use e-cigarettes.”

    Hartmann-Boyce compared tobacco smoking versus e-cigarette use to the treatment for substance use disorders involving opioids. “We’re not going to prescribe methadone to people who aren’t addicted to opioids,” she said. “But for people addicted to opioids, we recognize that methadone is a helpful thing.”

    In 2021, a study by Queen Mary University of London, published in Addiction, shows that e-cigarettes are more effective in achieving long-term smoking reduction and cessation than NRTs.

    The U.S. Food and Drug Administration has not approved any e-cigarettes as medications to help adults quit smoking. “While certain e-cigarettes may help adult smokers transition completely away from, or significantly reduce their use of, more harmful combusted cigarettes, the law’s public health standard balances that potential with the known and substantial risk with regard to youth appeal, uptake and use of these highly addictive products,” said Robert Califf, FDA commissioner.

  • Study Finds Cytisine More Effective than NRTs

    Study Finds Cytisine More Effective than NRTs

    Image: molekuul.be

    Cytisine, a low-cost, generic stop-smoking aid that has been used in eastern Europe since the 1960s, increases the chances of successful smoking cessation by more than two-fold compared with placebo and may be more effective than nicotine replacement therapy, according to a new study published in Addiction. The cessation tool reportedly has a benign safety profile, with no evidence of serious safety concerns. 

    Cytisine is a plant-based compound that eases smoking withdrawal symptoms. It was first synthesized in Bulgaria in 1964 as Tabex and later spread to other countries in eastern Europe and Asia, where it is still marketed. In 2017, the Polish pharmaceutical company Aflofarm began selling it as Desmoxan, a prescription-only medicine, and Canada approved it as an over-the-counter natural health product, Cravv.

    This study pooled the results of eight randomized controlled trials comparing cytisine with placebo, with nearly 6,000 patients. The combined results showed that cytisine increases the chances of successful smoking cessation by more than twofold compared with placebo.

    The study also looked at two randomized controlled trials comparing cytisine with nicotine replacement therapy, with modest results in favor of cytisine, and three trials comparing cytisine with varenicline, without a clear benefit for cytisine.

    “Our study adds to the evidence that cytisine is an effective and inexpensive stop-smoking aid,” said lead author Omar De Santi in a statement. “It could be very useful in reducing smoking in low- and middle-income countries where cost-effective smoking cessation drugs are urgently needed.”

    Cytisine is currently not licensed or marketed in most countries outside of central and eastern Europe, making it unavailable in most of the world. At the end of January, cytisine pills are due to become available in the U.K., according to National World.

  • Court Rules FDA Sent Vapor Makers on ‘Wild Goose Chase’

    Court Rules FDA Sent Vapor Makers on ‘Wild Goose Chase’

    Image: BCFC

    Two e-liquid companies will be able to resubmit their marketing applications to the U.S. Food and Drug Administration following a court ruling, reports Bloomberg Law.

    On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.

    The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.

    The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.

    In a dissenting opinion, Judge Catharina Haynes stated that the agency “properly fulfilled its statutory mandate by considering the relevant portions of Petitioners’ PMTAs and coming to a reasonable conclusion that marketing Petitioners’ products is not appropriate for public health.”

    Oldham stated that the manufacturers dutifully spent untold millions “conforming their behavior and their applications to FDA’s say-so.”

    “Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency’s volte face. Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the one million plans.”

    In an X post, Michael Siegel, a professor at Boston University School of Public Health, stated that the ruling “exposed” the FDA’s wrongful rejection of applications for flavored vapes, ultimately resulting in a “win for public health.”

    Eric Heyer, a lawyer for e-liquid makers Triton Distribution and Vapetasia LLC, said he was pleased with the ruling and hoped it would lead the FDA to make “a significant course correction by communicating with specificity” what companies must do to get approval.

    “No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people,” Oldham wrote, apparently likening executive branch agencies such as the FDA to a separate branch of government. “And FDA’s regulatory switcheroos in this case bear no resemblance to square corners.”

    It is expected that the FDA will seek a review of the decision by the Supreme Court of the United States, however, the justice department hasn’t made an official announcement.

  • New McKinney Specialty Labs to Test Vape Products

    New McKinney Specialty Labs to Test Vape Products

    Willie McKinney

    Jan. 1, 2024, marked the official launch of McKinney Specialty Labs, a scientific organization with expertise in testing nicotine and other aerosolized products.

    “We are excited to announce the launch of McKinney Specialty Labs and to offer our scientific knowledge and regulatory expertise to support the growing market of inhalable products across different industries,” said Willie McKinney, CEO. “We believe that our commitment to science, quality, innovation and customer service makes us a preferred aerosol testing provider for companies of all sizes.”

    McKinney Specialty Labs provides a wide range of testing and consulting services to ensure that product quality and performance are maintained throughout the life cycle of the product: chemical analysis, physical testing, microbiological testing, toxicology testing and regulatory compliance.

    McKinney Specialty Labs employs nearly 100 experienced scientists and technicians with expertise in aerosol science, analytical chemistry, toxicology and regulatory compliance. The lab is equipped with state-of-the-art equipment and adheres to strict quality standards.

  • Juul Labs Investors Claim Bailout Benefited Insiders

    Juul Labs Investors Claim Bailout Benefited Insiders

    Credit: Kikkerdirk

    A group of Juul Labs investors is challenging a November 2022 financial bailout by directors Nick Pritzker and Riaz Valani, alleging that the deal benefited insiders at the expense of other investors, reports The Wall Street Journal.

    A pioneer in the vaping business, Juul Labs went from dominating the U.S. market to fighting for its survival in a short time. Following its initial success, the company came under regulatory scrutiny over its marketing practices. Thousands of lawsuits alleging the company contributed to an “epidemic” of underage vaping took a toll on the company’s finances.

    After the Food and Drug Administration ordered its e-cigarettes off the market and a court stayed the order, Juul began exploring bankruptcy in June 2022.

    To avoid bankruptcy, Pritzker and Valani in September 2022 refinanced a Juul term loan and later that fall loaned Juul more money to cover operating costs. Finally, the two directors, along with Juul co-founders James Monsees and Adam Bowen, backstopped a sweeping legal settlement and made an equity investment in Juul.

    Juul, after approaching dozens of potential investors, closed a funding round in October 2023 that raised $1.27 billion. That sum included money that entities connected to Pritzker, Valani, and Juul’s two co-founders committed for Juul’s legal settlement and an additional $45 million from the same four investors.

    Entities tied to Valani and Pritzker now own nearly half of Juul, while most other investors have had their stakes sharply diluted amid the rescue.

    Affiliates of hedge fund D1 Capital Partners and two other investors sued Juul in October 2023 alleging that Pritzker and Valani “leveraged a distressed situation for their own personal gain to the detriment of Juul’s other stakeholders.”

    Juul in 2024 aims to raise another $330 million as it fights to keep its existing products on the U.S. market and submits new vaping products for federal authorization.