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  • Preventative Measures

    Preventative Measures

    Photo: Metamorworks

    Innovations in technology and regulation could help ease the concerns surrounding youth access to vaping products.

    By Timothy S. Donahue

    Most tobacco control experts agree that vaping is safer than smoking combustible cigarettes. The primary concern for anti-vaping groups, legislators and regulatory officials isn’t where e-cigarettes fall on the continuum of risk; it’s about preventing youth access to nicotine products, whether underage is defined as under age 21, as it is in the United States, or as under age 18, as it is in many other markets. The best way to prevent youth access is through innovative technology, according to vapor industry experts. Technology and regulatory policies will both be required for the vaping industry to satisfy its skeptics.

    Technological innovations have been the vaping industry’s primary contribution to battling youth access. Several companies have developed devices that use biometrics, such as fingerprint and facial recognition. The OBS Cube FP Kit, for example, uses fingerprint recognition to prevent unauthorized use. However, a 2020 review by ecigclick.com found the fingerprinting function complicated to configure. “The instruction manual is total pants … it really is,” the reviewer wrote. “So far, I haven’t worked out how to use the fingerprint stuff; there are diagrams in the book which relate to bugger all on the actual device.”

    Juul Labs launched its C1 in Canada in 2019. The device paired with an Android smartphone to limit who could use it and to provide monitoring of what and how often the user vaped. Juul says the C1 could only be used if people passed age verification and facial recognition checks. The C1 also had a system that could be set to automatically lock when it was not being used or was away from the phone to which it was linked.

    Juul Labs then launched the Juul2, which had many of the same child safety features as the now discontinued C1. The Juul2 can also recognize and authenticate proprietary Juul2 pods when they’re attached, limiting the ability to use counterfeit pods or refill pods with other substances, such as THC.

    The OBS Cube FP Kit, for example, uses fingerprint recognition to prevent unauthorized use. (Photo: OSB)

    Steven Yang, senior director of FEELM R&D, says that FEELM has incorporated designs into its products that prevent misuse by children, for example, by requiring the user to follow a specific sequence of procedures to activate the device. 

    “With a number of [the] industry’s leading patents, FEELM is exploring ways to integrate Bluetooth, fingerprint, airflow switch, sensor and other electronic technologies to create a child lock on products,” Yang says, adding that many Chinese vaping industry leaders have already adopted ID verification and facial recognition technologies.

    “FEELM’s strategic partner and China’s leading vape brand, RELX, has initiated Sunflower System in 2019. Based on AI and big data, the Sunflower System is integrated into different scenarios, such as RELX chain stores and the RELX app to prevent minors from purchasing vaping products,” explains Yang. “The Sunflower System has been extended to all RELX chain stores in China to ensure each purchase order is traceable. Moreover, through big data and GPS, the Sunflower System can automatically filter the addresses that do not meet the legal requirements of opening a vape store—for example, near schools.”

    Project Sunflower consists of adopting ID and facial recognition technologies to ensure that only adults can purchase products in its Chinese stores, according to RELX. Minors are not allowed to enter RELX stores, and in-store face-scanning cameras send alerts to RELX store staff if a suspected minor enters the store. Any suspected minor that is not able to present legal, valid ID proving his or her age is asked to leave the RELX store.

    Upon purchasing a product, RELX customers also need to verify their age through a facial recognition process that matches the customer’s face with the photo on the customer’s Resident Identity Card,” says a RELX representative. “This process is to ensure that the person in the store is using their own valid identification and not attempting to impersonate an adult.”

    While facial recognition measures are widely used and accepted in China, they may encounter resistance elsewhere. Chris Howard, vice president, general counsel and chief compliance officer for E-Alternative Solutions, a U.S.-based e-cigarette manufacturer, says that consumers have generally accepted biometric controls in phones, tablets and other devices that use fingerprints or faces to unlock the screens.

    Those who are tech savvy would likely welcome such an alternative in their vaping products, he says. However, traditional cigarettes don’t have any electronic controls to prevent unlawful use, so if vaping regulations follow tobacco rules, that would limit these types of innovations. 

    RLX Technologies has deployed facial recognition technologies to ensure that only adults can purchase its products in the company’s Chinese stores. (Photo: RLX Technolgies)

    “The idea that such a requirement would be necessary for vapor products to receive marketing orders seems unlikely. It is important to remember that adult smokers may be unwilling to deal with an electronically locked tobacco product,” says Howard. “While some may enjoy the novelty, many may just use a tobacco product—likely higher risk—that is easier to use. Many questions surround the use of biometrics in products. There are legal privacy issues, which would increase the cost of such devices.”

    Manufacturers must also remain aware of regulatory restrictions in the markets they operate within, according to Yang. FEELM has developed protocols to help retailers and distributors comply with local guidelines. Yang says the company attaches clear warning labels on its closed-system vaping devices and includes language in user manuals stating that the products are intended for use only by adults.

    “We also focus to ensure that the retail stores in which our products are sold have mechanisms in place to verify the age of the consumers purchasing products manufactured by us so as to comply with local laws and regulations in relation to age restriction,” Yang says. “Moreover, our website and our major customers’ web stores require visitors to enter their age before entering the websites.”

    While technology is an important component of a comprehensive strategy to prevent youth access, experts note that the industry and its regulators should also acknowledge technology’s limitations. Having grown up with smartphones, online social networks and e-commerce, today’s youngsters are the most digitally savvy generation to date. While the technical solutions to deter underage access may deter some, sufficiently motivated young buyers are likely to overcome such measures with relatively little effort.

    Regulatory Response

    Taxation has long been the preferred deterrent to youth access by regulators. Studies suggest, however, that increasing taxes doesn’t always have the desired impact. Instead, these measures discourage combustible smokers from switching to a safer alternative, according to a study by Steve Pociask and Liam Sigaud for the American Consumer Institute Center for Citizen Research. The researchers state, “overzealous or poorly designed restrictions [like tax increases] on vaping, combined with misleading information about e-cigarettes’ actual health risks, are deterring smokers from pursuing a potentially life-saving alternative.”

    Tim Andrews, director of Consumer Issues for Americans for Tax Reform, says that increasing taxes on reduced-risk tobacco alternatives will not reduce youth access but punish adult vaping consumers, leading many back to deadly combustible cigarettes.

    “Paradoxically, by creating a booming black market, which, by definition, possesses none of the rigorous age verification processes required by legal retailers, vapor taxes may increase not decrease youth access,” he says. “Youth vaping has plummeted in recent years due to increased enforcement of existing law. [According to the U.S. Centers for Disease Control and Prevention, only 3.1 percent of high school students vape daily.] Adequate and appropriate enforcement of existing law—not increasing taxes—is what will continue to drive this number down.”

    Tobacco harm reduction advocates also stress the importance of risk-proportionate pricing along with proper education about the products available to encourage smokers who cannot or will not quit nicotine to consider alternatives that are less harmful than cigarettes. By taxing the most harmful products—combustible cigarettes—at significantly higher levels than reduced-risk alternatives, regulators can nudge consumers to the least unhealthy options.

    Chris Howard

    Other innovative regulatory responses to youth vaping have had mixed results. Outside taxation and Tobacco 21 laws in the U.S., any effectiveness seems hard to prove. Research suggests that there are few studies available that show what impact differing regulatory actions have on youth vaping. A study published in BMC Public Health, “Policies that limit youth access and exposure to tobacco: a scientific neglect of the first stages of the policy process,” examined 200 international peer-reviewed articles. The researchers found that scientific evidence on the policy process for youth prevention initiatives were scarce.

    “The processes influencing the adoption of youth access and exposure policies have been grossly understudied. A better understanding of the policy process is essential to understand country variations in tobacco control policy,” the researchers wrote. They then went on to suggest that “policymakers can adopt and implement various supply-side policies to limit youth access and exposure to tobacco, such as increasing the minimum age of sale, limiting the number or type of tobacco outlets or banning the display of tobacco products.”

    Howard questions whether regulations limiting the number of tobacco outlets/vape shops or display bans would materially impact youth access. “Which companies should lose their business licenses?  Should only major chains, with arguably more control over storefronts, be permitted to sell tobacco products?” Howard asks. “How will removal of businesses prevent youth from obtaining tobacco products? Yes, there will be [fewer] stores to find products [at], but that doesn’t mean youth vaping will decline. During the ‘youth vaping epidemic,’* Walmart, arguably the largest retail footprint in the U.S., removed vapor products from its stores—is there evidence of reduced youth vaping as a result? Finally, banning tobacco product displays may impact youth exposure to products but would also reduce adult smokers’ exposure to different, potentially less harmful products.”

    Incentivizing Success

    There may be more innovative options to consider in controlling youth access. Another potential avenue to curb youth access may be to require manufacturers to offer incentives to retailers to maintain good practices. B2B sales discounts or incentives for meeting certain standards is likely to go a long way toward limiting youth access, according to Howard.

    “Manufacturers can incentivize limiting the number of products in a transaction to prevent straw sales, passing compliance checks, tobacco sales training and participating in the We Card program to encourage retailers to ‘up their game’ in preventing youth access,” he says.

    States are slowly becoming more innovative in their regulatory approach to youth vaping. Hawaii, for example, is considering the passage of a law that would require its Department of Health (DOH) to coordinate with its Department of Education (DOE) to establish a “take back” program for students to “voluntarily dispose of electronic smoking devices, flavored tobacco or synthetic nicotine products, and tobacco products in their possession.” If passed, the rules would also require the DOH and DOE to coordinate quarterly meetings with students on addressing the youth vaping epidemic.

    Many industry experts agree that the vaping industry, tobacco control community and regulators should be working together to solve the problem of youth uptake. However, that seems unlikely. It could be argued that the world’s most prominent regulator, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), should be bringing stakeholders together to seek out common solutions to these problems. That hasn’t happened, according to Howard.

    “It appears CTP felt compelled to use a club, as opposed to a scalpel, to excise youth vapor use. Banning flavored pods and blanket denials of millions of PMTAs [premarket tobacco product applications] for flavored products through sweeping MDOs [marketing denial orders] removed most industry stakeholders in just about a month,” says Howard. “While much of this was thrust upon CTP by outside forces, it is hard to imagine, when they can completely control the issue, why would CTP now resort to compromise solutions?

    “CTP and the tobacco control lobby both detest those bad actors that market their products without regard to this important issue. Companies that actively follow the rules detest these bad actors too.  CTP, tobacco control and the ethical side of the industry should join forces to root these bad actors out.”

    *The surge in U.S. teen vaping was mainly a U.S. phenomenon. The most recent Centers for Disease Control and Prevention data suggest that episode is largely over, with both youth smoking and vaping at low levels. See https://www.cdc.gov/mmwr/volumes/71/ss/ss7105a1.htm?s_cid=ss7105a1_w.
  • Seeking Synergies

    Seeking Synergies

    Photo: Feelm

    Tobacco companies are applying the expertise gained with reduced-risk products to new business areas.

    By Stefanie Rossel

    In their journey of transforming their businesses away from combustible cigarettes toward reduced-risk alternatives, tobacco companies have invested billions of dollars into innovation and scientific research over the past two decades. In return, they have obtained a wealth of expertise in adjacent areas—the potential of which they have just started to explore. Today, their goal is no longer limited to merely lowering harm but also to advancing health.

    The list of recent initiatives and moves illustrating this shift is impressive. In September 2021, BAT announced the construction of an innovation hub in Trieste, Italy. In addition to hosting a new manufacturing site for the company’s reduced-risk products (RRPs), the facility will house an innovation lab and center of excellence for digital transformation and marketing as well as a digital boutique. On an area of 20,000 square meters, BAT plans to develop multiple production lines for European and global export of its RRPs.

    According to BAT Chief Marketing Officer Kingsley Wheaton, the innovation hub, which involves an investment of up to €500 million ($549 million) over the next five years, will play a key role in the company’s transformation toward reducing the health impact of its business. Trieste was chosen as the location for the hub as it is already a globally recognized center of excellence in research and science, BAT said.

    Philip Morris International is demonstrating commitment to transformation with a change of location: In November 2021, the company announced it would relocate its headquarters to Stamford, Connecticut, USA, this summer. The new facility is intended to become a center of state-of-the-art innovation and serve PMI’s smoke-free ambitions, which now also include areas such as inhaled therapeutics. Occupying a 6,642-square-meter campus, the Stamford headquarters will house the PMI Americas region and other corporate functions. PMI’s operations center will remain in Lausanne, Switzerland.

    The transition of nicotine companies to adjacent business areas is evident in China as well. SmooreTech, the world’s largest vaping device maker in terms of revenue, recently established a fundamental research institute with three centers and hired a chief scientific officer with a deep background in respiratory medicine. Among other activities, the institute will perform physical and toxicology testing, data analysis and develop standards for vaping devices as they seem set to explore related areas in respiratory medicine. In 2020, SmooreTech became the first company in the Chinese vaping sector to get approval for conducting a national research program on vaping harm reduction, which it will conduct jointly with Tongji University.

    From Cigarettes to Pharma

    Tobacco companies have been aware of the medicinal potential of the tobacco plant for some time now (see “The Virtuous Weed”). In 2008, PMI acquired a stake in Medicago, a Canadian biopharmaceutical company. BAT purchased U.S.-based Kentucky BioProcessing (KBP) in 2014. Medicago and KBP have both been working on tobacco plant-based vaccines. In January, Health Canada approved Medicago’s Covifenz vaccination against Covid-19—the world’s first vaccine approved for human use that utilizes a plant-based protein technology. BAT has been performing clinical trials on its Covid-19 vaccine candidate. In January this year, BAT launched KBio, a new company that will leverage the existing and extensive plant-based technology capabilities of BAT and KBP and focus on delivering treatments for rare and infectious diseases.

    These developments are part of the tobacco industry’s desire to move “beyond nicotine.” PMI plans to generate at least $1 billion in revenues from such new business by 2025. Last summer, it acquired the Danish oral drug delivery specialist Fertin Pharma for $820 million and the U.K.-based asthma inhaler manufacturer Vectura for $1.2 billion. In August, the tobacco company took over U.S. respiratory drug company OtiTopic for an undisclosed sum.

    Fertin Pharma concentrates on research, creation and manufacturing of gums, pouches and liquefiable tablets as well as various solid oral systems to deliver active ingredients, such as nicotine. The takeover has given PMI access to Fertin Pharma’s technologies, expertise and talent, which includes almost 200 research and development specialists.

    While the Danish company can help PMI increase its footprint in the modern oral category, Fertin Pharma’s oral drug delivery platforms also complement PMI’s experience with inhalation technologies and could be used to develop scientifically proven self-care wellness products, such as over-the-counter solutions and supplements for better living.

    Commenting on the Fertin Pharma deal, PMI CEO Jacek Olczak said that his company’s future was “centered on health, science, technology and sustainable business practices to deliver innovative products and solutions that aim to improve people’s lives and create a net positive impact on society.”

    “PMI’s future is centered on health, science, technology, and sustainable business practices to deliver innovative products and solutions that aim to improve people’s lives and create a net positive impact on society.”

    Critical Role

    Vectura specializes in inhaled drug delivery solutions. At the time of the acquisition, the company had 13 inhaled and 11 noninhaled products in its portfolio. The new subsidiary will provide PMI with another 200 scientists who are knowledgeable about formulation, inhalation, devices, clinical manufacturing and regulatory issues. The company will also provide access to new technology and pharmaceutical development capabilities.

    PMI aims to develop a fully owned pipeline of inhaled therapeutics and respiratory drug delivery systems. Vectura, says PMI, will play a critical role in PMI’s beyond nicotine strategy, which the acquisition, together with the Fermin Pharma deal, is expected to accelerate.

    OtiTopic, PMI’s third recent acquisition in the pharmaceutical field, has developed an inhalable acetylsalicylic acid treatment for acute myocardial infarction that is currently undergoing clinical trials. The product comprises a novel, proprietary aspirin formulation that, delivered via a dry powder inhaler, enters the bloodstream faster than oral tablets. If approved by the U.S. Food and Drug Administration, the treatment can address the needs of more than 83 million people at risk for myocardial infarction in the U.S. alone, according to PMI.

    According to PMI Chief Life Sciences Officer Jorge Insuasty, PMI’s beyond nicotine initiatives will initially focus on respiratory delivery and botanical products addressing areas such as energy, sleep, calm and focus. While currently less developed than established tools, such as pills and syrups, respiratory delivery has advantages over traditional medication delivery methods, Insuasty explained in a recent edition of PMI’s Scientific Update. Medicines delivered via the respiratory tract allow a rapid onset of the drug effect and potentially reduce side effects due to the lower dose that might be needed compared to taking a pill, for example. The same holds true for botanicals, an area in which PMI has gained considerable expertise during its work with plant substrates and aerosolization.

    PMI healthcare ambitions are supported by its venture capital unit, PMI Equity Partners. The $150 million Swiss-based fund invests in companies that are involved in respiratory delivery, botanical sciences, health monitoring technologies, computational research methodologies and other innovations that have the potential to benefit health.

    Focus on Recreational Products

    BAT, meanwhile, has singled out personalized well-being as a starting point for developing opportunities beyond nicotine. In its annual report, the company said it was taking a “disciplined approach” to its beyond nicotine strategy as it expects continuous growth in the emerging market for well-being and “active” products, particularly for CBD. Fortune Business Insights estimates that the global CBD market, which stood at $3.68 billion in 2021, will increase to $55.79 billion in 2028, reflecting a compound annual growth rate of 47.49 percent.

    BAT says its strength is its superior understanding of consumers. By combining contextual information with biometric data sets, the company believes it can build a comprehensive model of moods, behaviors and rituals. In January 2021, BAT launched its first vapor CBD product, Vuse CBD Zone, in Manchester, U.K.

    The diversification drive is backed by BAT’s March 2021 £126 million ($165 million) acquisition of a 19.9 percent stake in the Canadian cannabis producer Organigram. Organigram grows cannabis and manufactures cannabis-derived products. The investment will provide BAT with access to research and development technologies, product innovation and cannabis expertise. The two companies will establish a center of excellence at Organigram’s New Brunswick site to develop next-generation cannabis products with an initial focus on CBD.

    Like PMI, BAT is supported by a corporate venture capital arm in its transformation effort. Established in 2020, Btomorrow Ventures seeks to invest in health and wellness, functional products, science, sustainability and technology sectors.

    The nicotine industry’s transformation has just begun. Slowly but surely, several of the companies that most people still identify as creators of health problems are becoming developers of health solutions. They will have to overcome many hurdles on their journey, including public skepticism and resistance from groups such as the World Health Organization, which recently indicated it would reject Medicago’s Covid-19 vaccine because of the biopharmaceutical firm’s link to PMI. If the nicotine companies succeed in their transformation, however, it would arguably represent one of the most remarkable metamorphoses in corporate history.

  • Unlikely Bedfellows

    Unlikely Bedfellows

    Photo: Dmitry

    How free-flowing data streams can help advance public health goals for nicotine products.

    By Cheryl K. Olson

    How might new technologies engage public health in transforming the tobacco sector? Let’s take a look at three unlikely scientific bedfellows: sewage, Covid-19 and smoking harm reduction.

    Of the many innovations born from the Covid-19 pandemic, my favorite is the U.S. Centers for Disease Control and Prevention’s National Wastewater Surveillance System (NWSS). Since September 2020, the NWSS has tapped into underused data streams flowing through our communities to get early warnings of local disease spread. It’s not perfect; you can’t predict how many people are sick, and it misses people not hooked up to municipal collection systems. But the information is there for the taking. It doesn’t depend on persuading people to show up and get tested. 

    The smoking harm reduction parallel? Technology innovations can also help advance public health goals for nicotine products using the less malodorous but equally free-flowing data streams of search engines and social media. This is information people have already provided, with no need to persuade them to fill out surveys or file a report. We can systematically search those streams to look for evidence of product adverse experiences or youth misuse of tobacco products or to hunt for and counteract nicotine misinformation.

    I found a guide to some of these new methods in sociologist Navin Kumar, a postdoctoral associate at the Yale School of Medicine. He uses techniques like social computing, machine learning and natural language analysis to promote health, including tobacco harm reduction.

    Countering Misinformation

    Kumar’s research group has done several studies looking at how new technologies can identify and potentially counter health misinformation. As an example of how to study web-based narratives in tobacco control, the researchers tackled two controversial areas at once by mapping how misinformation spread about vaping (especially CBD from cannabis) to help treat Covid-19. This included collecting vaping-related text fragments from a wide range of web sources, including health provider forums, news articles and blogs as well as social media. They also generated word clouds (a fun and intuitive way to depict the most-used words) to see how the use of key terms changed before and after Covid-19 was reported to the World Health Organization. The results showed a shift from words related to vaping bans to positive mentions of CBD and CBD oil.

    There are many challenges in applying these techniques to counter nicotine misinformation. For a start, we need to understand how people talk about nicotine products in online conversations as opposed to formal news reports. A study by Kumar and colleagues analyzed the framing of vaping in social media and how words used to describe vaping and their meanings shifted over time. In earlier years, “happy” and “wonderful” were among the most frequent words associated with vaping. From 2017 on, these gave way to words like “ban,” “lung” and “teen.” The study vividly illustrates (with those wonderful word clouds) the social media shift from seeing vaping as an alternative to cigarettes to viewing vaping as about harm and regulation like the news media did.

    Another problem: It turns out it’s easier to get people to buy into twaddle than to stop them from doing so. Said Kumar, “People tend to believe new misinformation; it’s harder to remove misinformation such as ‘vaccines have microchips.’” One of Kumar’s recent studies was a randomized controlled trial to try to counter tobacco product misinformation. Results were promising, but the challenge is huge. How can a metaphorical cupful of accurate information received in a study counter the buckets of misinformation people get on a daily basis?

    That’s why researchers such as Kumar are working on automated ways to detect misinformation on social media using machine learning. If responsible parties can detect the latest mutation in tobacco product misinformation as it emerges, “They could respond before it has a chance to take hold. And go to Facebook and other outlets to counteract it,” said Kumar.

    New technologies, such as social computing, machine learning and natural language analysis, may help counter online misinformation about nicotine products. (Photo: Jo Panuwat D)

    Adverse Experiences 

    The goals of reporting are to identify safety risks, to share lessons learned so our mistakes are new instead of repeats of the past and to raise the cost to potential bad actors of disregarding customer safety. The U.S. Food and Drug Administration’s Center for Tobacco Products takes voluntary reports from anyone—including product users, researchers and health professionals—about “adverse experiences.” You can report a tobacco product concern through the FDA’s central safety reporting portal at www.safetyreporting.hhs.gov, which also takes reports about marketed human and animal drugs and biologics, foods and dietary supplements.

    Traditional ways of reporting adverse experiences to the FDA leave a lot to be desired. Since the system is primarily voluntary, a busy human must find the time and motivation to report the problem. Under-reporting is assumed, but no one knows by how much or how reporting may differ by product, user or symptom type. Important details may be left out of the report, making it hard to spot patterns (or creating misleading patterns as in the case of e-cigarette or vaping use-associated lung injury (EVALI)). Reporting can also be biased by things like news reports and litigation. The blossoming variety of reduced-harm nicotine products further complicates finding and addressing safety issues when market shares are small and issues are infrequent.

    If your company’s tobacco product gets a premarket tobacco product application (PMTA) marketing granted order from the FDA, postmarket reporting of adverse experiences is required as part of the deal. “Serious and unexpected” adverse experiences that companies are told about or discover must be reported through that FDA portal within 15 days. The FDA may also require other postmarket reporting to stay comfortable with keeping a new tobacco product on the market. It’s in your interest to avoid surprises.

    This approach is still untested for tobacco products, but publications are proliferating using these methods. I ran across articles that used machine learning and natural language processing to monitor for adverse effects of Covid-19 vaccines on Twitter and for health risks from the mood-altering plant kratom on Reddit and Twitter.

    As with our example of using wastewater to predict Covid-19 spread, Kumar notes that multiple data sources better predict outcomes. “So you can use reports on Twitter combined with YouTube and [the] news to predict adverse experiences,” he said. Look to computer science publications for the latest publications on nicotine products; they aren’t caught up in the tobacco harm reduction battles now raging in many public health journals.

    How do These Tech Innovations Look to Public Health Authorities?

    Are these promising innovations likely to percolate through into accepted practice? Will regulators look upon creative high-tech approaches with favor or scorn? To look for clues, I searched the abstracts (summaries) of studies accepted for the March 2022 meeting of the Society for Research on Nicotine and Tobacco (SRNT). (SRNT is not, at present, an industry-friendly organization and, therefore, is a useful gauge of sentiment among academics and regulators.) Over two dozen studies involved using social media data for research, most simply to gather information and look for patterns. Some involved lifting data from Reddit, Twitter or Instagram about descriptions or perceptions of particular tobacco products then using conventional qualitative methods (coding by human readers) to explore topics and feelings. Others used social network analysis to understand how information about products or policies spread. 

    Two studies supported the possibility of collecting adverse experiences through social media. One coded mentions of positive and negative health outcomes from vaping found on Twitter and Reddit. Another studied videos posted to the TikTok app (with hashtag #nicsick).

    One study combined old and new methods by using an age detection algorithm with Reddit metadata to sort posted comments on vaping and then hand-reviewing the most popular posts by each age group. A nicotine product company could potentially use an age detection algorithm to show regulators that their social media accounts don’t attract youth.

    Wearable sensors were used to detect smoking behavior as part of a smartphone-delivered smoking cessation program. Behavior studies documenting the transition from smoking to vaping might benefit from including wearable technologies. We might find, for example, that people who’ve completely transitioned to vaping have better sleep quality.

    New technologies bring new potential but also novel problems. For example, social media has been hailed as a new cost-effective, efficient way to recruit subjects for research, especially hard-to-find subgroups. My research team did have some success recently using social media platforms, such as Facebook, to locate a particular “vulnerable population” for PMTA behavioral studies. However, it also attracted responses from scammers, automated survey bots and professional survey takers, which took a lot of time and creativity to block or identify and remove.

     

    Forewarned is Forearmed

    Derek Yach

    One example of using these advanced techniques to find early signals of both misinformation and potential health concerns is an e-cigarette or vaping use-associated lung injury (EVALI) monitoring and alerting platform developed by Skai (formerly Signals Analytics) for the Foundation for a Smoke-Free World.

    As a proof of concept, the platform retrospectively analyzed and compared vaping-related content from social media and news sources. In social media comments about specific symptoms and vape ingredients, Skai’s platform spotted signals of the direct link between seizures and vaping synthetic CBD nearly a year before official reports appeared. This kind of early information, while not definitive, would allow public health authorities and the industry to respond quickly to prevent harm and provide corrective facts in appropriate language.

    Disinformation on social media, from naive misunderstandings to deliberate manipulations, will be a fact of life for years to come. Taking advantage of these analytical techniques allows the industry to demonstrate socially responsible leadership in advancing public health. Why be blindsided by EVALI’s inevitable successor when there are tools to detect and respond to it? –Derek Yach

    *https://skai.io/reports-and-whitepapers/early-detection-of-pandemics-and-outbreaks/?msclkid=4ac806b7a95011ecb5d22adb0bd2b48e

  • All in the Mind

    All in the Mind

    Photo: andriano_cz

    A human-centric health ecosystem could unleash tobacco harm reduction’s full potential.

    By Stefanie Rossel

    In their efforts to end the era of combustible cigarettes, governments, public health authorities and other stakeholders today have a much larger toolkit at their disposal than they did at the turn of the millennium—at least in theory because only a fraction of available strategies are currently being employed.

    Due to increasing connectivity, the Fourth Industrial Revolution has brought rapid changes to technology, industries and society. It is also transforming the healthcare system—insurance companies seeking to promote a healthy lifestyle by asking their customers to use wearable devices that record physical activity and calorie intake are just one example.

    In order to better deal with today’s complex challenges, healthcare has in recent years become more human-centric, striving to understand human needs and how design—both the process of designing and the outcome of that process—can respond to these needs. “Design” in this context refers not only to products, services and procedures but also to strategies and policies.

    A human-centric health ecosystem (HCHE) involves understanding people and their needs, engaging stakeholders throughout the design process and systematically addressing interactions between the micro-level, meso-level and macro-level of sociotechnical care systems as well as the transition of individual interests to collective interests.

    This new approach to healthcare requires a holistic systemic approach, major organizational change and well-designed, dedicated interventions, such as products, services or procedures to be used by patients, caregivers and medical professionals to facilitate and implement the system.

    The role of the patient in this system changes accordingly: Instead of being a passive recipient of medical directions, he or she becomes a well-informed, responsible patient, intrinsically motivated to actively contribute to the success of his or her treatment. In contrast to the traditional approach, he or she doesn’t simply passively comply with instructions and wait for professionals to solve their problems but makes use of a technology-enabled ecosystem with an embedded choice architecture that encourages the desirable behavior and seeks support from a variety of sources.

    This healthcare model is shifting the focus from treatment toward prevention. Centralized, capital-intensive diagnostics facilities will be aided and perhaps even replaced by individual, on-demand or continuous inexpensive and readily available technologies, such as the mentioned wearables. Sensors in these devices generate data that enable disease prevention with the help of machine learning. Diagnostic and treatment data could be collected in a global database that practitioners can access but that is owned by the patients. Finally, instead of applying homogeneous therapies across groups of patients with similar health issues, treatments are likely to become more personalized.

    Behavioral Triggers

    The novel concept also holds promise for the prevention of noncommunicable diseases (NCDs), for which tobacco use is one of the greatest risk factors. The U.K.’s progressive tobacco harm reduction (THR) strategy, for example, incorporates many HCHE components. It has established a comprehensive infrastructure that includes institutions and healthcare professionals to help smokers to switch to less hazardous products or quit nicotine altogether. In 2017, the U.K. launched a Tobacco Control Plan that stresses the importance of innovation and less harmful alternatives. According to studies, the U.K.’s approach has been able to reduce smoking prevalence from around 20 percent in 2011 to between 13.8 percent and 16 percent in 2021.

    But the HCHE model offers further opportunities. Focusing on the individual and his or her perceptions, intentions and behaviors influencing personal health results, it is a demand-driven structure. Personal health outcomes, in turn, will ultimately influence population health. A fully developed HCHE environment uses a vast range of behavioral triggers that can encourage healthy decisions and eventually impact the incidence and prevalence of NCDs.

    At the 2017 World Economic Forum (WEF) in Davos, Willis Towers Watson published a white paper assessing the progress in preventing NCDs with the help of behavioral economics as part of the Human-Centric Health project. According to the white paper, mortality rates due to NCDs are projected to increase from 38 million to 62 million by 2040. While NCDs presently impact mostly high-income countries, they are growing fastest in low-income and middle-income countries.

    Participants in the Human-Centric Health project were tasked to develop and disseminate knowledge and tools for behavioral changes that would lead to long-term healthier lifestyles. The experts were also asked to identify public-private cooperation opportunities across nontraditional health and healthcare stakeholders, for which the WEF could provide a platform. The project touched upon smoking cessation but did not make use of the THR concept.

    Making Healthy Choices

    Human decision-making depends heavily on heuristics, mental shortcuts that can facilitate problem-solving in situations of limited knowledge and time. Heuristic processes are based on experience, thus enabling people to quickly make the thousands of decisions they must make every day. Not all precepts of behavioral economics, though, lead to choices that support good health. The WEF white paper reviews some of the more powerful principles in behavioral economics that may contribute to healthier behavior within the HCHE if being applied appropriately.

    “Present bias,” for example, is a strong motivator: Humans tend to assign greater value to payoffs that are closer to the present time than those that occur further in the future—if people want something, they want it immediately. A strategy for health improvement should thus present choices that combine a current pleasure with a behavior that will lead to better health in the future and emphasize the near-term advantages of healthy behavior rather than the benefits that might be achieved later. A case study described by the white paper suggested glycemic control in diabetes patients reliant on food banks could be improved by providing clients with diabetes-appropriate food, blood sugar monitoring, primary care referral and self-management support.

    Another behavioral trigger is loss aversion: People sense the pain of loss more deeply than the pleasure of gain. Recently, this insight has been used in initiatives to encourage smoking cessation: Smokers received a payment at the outset of the program, which they would be forced to pay back if they failed to keep their commitment to quit smoking.

    Health choices can also be influenced by framing—by expressing the consequences of disease in survival rates rather than mortality rates, for example—even if the results are equal. The HCHE system may emphasize benefits that can be achieved through a specific action or the ease of healthy behavior compared with other activities people voluntarily decide on.

    The HCHE system also takes advantage of the knowledge that humans respond better to narratives than logic or statistics. By telling compelling stories that people can relate to, health practitioners can drive healthier behaviors. Of course, facts must be given accurately, but data alone don’t necessarily drive change.

    Humans are also subject to social norms—a person married to or friendly with smokers is more likely to smoke than a person without such relationships, according to the white paper. Findings like this, however, can also be used to achieve a positive effect—for example, by incorporating social media and influencers into information campaigns or asking people to make public commitments to future change.

    Choice architecture and defaults can nudge people toward healthier decisions. In a realm of choices, humans tend to stay with a default as it takes less energy than making an active decision and allows them to focus on more important concerns. A prominent display of healthy food in shops, for example, can thus help people make healthier choices.

    Humans’ tendency toward “irrational optimism” and “depletion” are additional behavioral triggers that can be taken advantage of to stimulate desirable behaviors. Including a lottery element in health incentives will generate attention at low cost. As people only have a limited span of attention, health improvement efforts should focus on measures with the most potential benefit while requiring the least cognitive effort of the targeted population.

    Stakeholders

    A successful HCHE, the white paper argues, resembles a consumer purchase model in which informed buyers express demands that support their well-being and stakeholders succeed by recognizing and meeting those demands. The paper identifies three actors that can greatly impact NCDs—insurers, retailers and technology.

    Insurers can contribute to the HCHE by providing health assistance, for instance, through health coaching, paying healthcare claims and providing incentives, such as rewards to encourage smoking cessation. They can also provide information about achieving and maintaining health, including health risk assessments, biometric screening and education.

    Next to increasing their inventories of healthy items, retailers, who act as a principal source of consumer products and therefore exercise particularly powerful influence over dietary quality, can provide access to selected health services, such as vaccinations on-site, and work with policymakers to develop pricing policies that encourage consumption of healthier foods and beverages. In the case of tobacco, the white paper recommends a reduced inventory, citing the example of CVS Caremark, a U.S. retailer that in 2014 stopped selling cigarettes.

    While CVS Caremark’s sales declined during the following year, its decision reduced total cigarette sales by 1 percent across 13 U.S. states while nicotine patch purchases increased by 4 percent immediately after tobacco sales ended.

    Health-related technology, the third component mentioned in the report, refers to the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve or prevent a health problem and improve the quality of lives.

    For patients suffering from chronic obstructive pulmonary disease or asthma, for instance, tracking usage of inhalers that provide vital medication can be challenging. An estimated 70 percent to 90 percent of patients use their inhalers improperly, thus delivering insufficient levels of medication to their lungs. In late 2018, the U.S. Food and Drug Administration approved the first digital inhaler with built-in sensors that detect when the inhaler is used and measure breathing. The sensors connect to a smartphone app, recording data that can be shared with doctors who can evaluate a patient’s inhaler usage. There are many ways that these technologies could be adapted for e-cigarettes, heat-not-burn devices and related products.

    The technology sector is also where reduced-risk tobacco products (RRPs) come into play as the gap between recreational and therapeutic inhalers is narrowing. Among recently published patents for nicotine vapor devices and heated-tobacco products, most cover therapeutic innovations, including vaping products that employ sensors (see “In the Pipeline,” page 20).

    The combination of new technologies and behavioral economics allow for healthy choices to be the easier choices. Laws that regulate products proportionate to their risk compliment and support this.

    Properly integrated into the HCHE, RRPs could drive tremendous progress in public health. The private sector has already realized the potential of RRPs as a smoking cessation tool. It is time for regulators to follow their example.

     

  • From Coercion to Empowerment

    From Coercion to Empowerment

    David Sweanor

    Tobacco harm reduction advocate David Sweanor describes the shift required to reduce the health toll of smoking.

    By Derek Yach

    David Sweanor has played a global role in steering the World Health Organization, governments and nongovernmental organizations to use the most powerful interventions they have to end smoking. His focus on policy measures to reduce the carnage from cigarette smoking, including a leading role on excise taxes, marketing restrictions and smoke-free policies, has long included tobacco harm reduction (THR). And in the process, Sweanor has highlighted the need to move from blunt approaches to all tobacco products to a system that regulates products proportionate to their risk. In a recent conversation, Sweanor discussed the origins of innovation in THR.

    “Hobbyists” and consumers seeking safer products have long tried to develop products that deliver nicotine without other toxic ingredients common in combustible cigarettes (see “Major Milestones”). Our conversation focused on transformation underway in leading tobacco companies.

    Sweanor believes that leading tobacco companies have a clear vision of the endgame for their transformation—addressing health, wellness and consumer needs profitably. This was largely forced upon them by advancements in technology, upstart competitors and consumer demand. In contrast, leaders in tobacco control, he believes, are trapped in a vision set in the 1970s that relies on coercion rather than empathy and empowerment and ignores the role of disruptive technologies.

    Sweanor laid out progress reported in the latest round of quarterly earnings by leading tobacco companies. Analysts highlighted the role of reduced-risk products as increasingly driving corporate profitability. Philip Morris International now gets 30 percent of total revenue from reduced-risk products and BAT gets 12 percent, with Altria and Imperial advancing through single digits. And Sweanor stressed the fundamental role that competition and investments in innovative research have played in driving this progress.

    The funding, volume, quality and diversity of industry research have accelerated over the past decade, and the nicotine business has attracted new and innovative players. Industry research is more interdisciplinary than most public-funded research and includes cutting-edge insights from toxicology, systems biology, epidemiology and pharmacology enhanced by clinical insights from respiratory medicine, oncology and cardiovascular disease.

    Sweanor is concerned that at a time when we need more engagement between industry and public health researchers, more barriers are being created that discourage debate, counterproductively protect the cigarette trade and prolong the epidemic of diseases and deaths caused by cigarette smoking. The Society for Research on Nicotine and Tobacco’s ban on tobacco industry participation in its conferences is only the latest example of industry exclusion.

    To demonstrate that they have truly embraced transformation, says Sweanor, tobacco companies and other players in the consumer nicotine market should:

    • push ahead with investments and the launch of healthier, safer products designed to end combustible use;
    • be more proactive in challenging misinformation and the laws that protect the cigarette business from competition;
    • share patents addressing core aspects of health and safety with smaller companies and state monopolies in low-income and middle-income countries—this could be done in many ways within World Trade Organization rules; and
    • place key data of public health policy relevance in the public domain. This includes, for example, conversion rates from combustibles to reduced-risk products and consumer research on the viability of reduced-risk alternatives to cigarettes. Sweanor stressed that all companies need to do this. Much could be learned from a related effort undertaken by food companies in the United States led by the Healthy Weight Foundation.

    Above all, he believes that this is the time for companies to work with governments to more aggressively end the sale of combustibles. “They should not await permission from unyielding anti-tobacco groups before fully engaging in efforts to protect the health of their consumers,” said Sweanor.

    Sweanor discussed the emergence of industry initiatives that build on their investments to end combustibles (see “In the Pipeline”). From Covid-19 vaccines derived from tobacco plants (see “The Virtuous Weed”) to deeper insights into medication aerosolization and what this might mean for new classes of pharmaceuticals delivered through 21st century delivery systems, Sweanor stated that it is clear that companies are not stopping their transformation journey. “There are no examples from across other sectors that when such profoundly disruptive change happens, it ever returns to the status quo,” he said. “The arrow of innovation points toward healthier and more environmentally sustainable products and services.”

    In time, the recent analyst views that some tobacco companies will become life sciences companies tackling major health issues may well come true!

  • Gene Tree Recognized for Vaping Technology

    Gene Tree Recognized for Vaping Technology

    Photo ICCPP

    ICCPP’s Gene Tree nano-microcrystalline ceramic vaporizer core won China CE Magazine’s Pioneer Technology Award 2021.

    Launched in September 2021, Gene Tree is the first “0 powder definition” ceramic core in the vapor industry. The manufacturing process is designed to eliminate dust and thus avoids the harm caused by powder falling of ordinary ceramic cores.

    The high-void porous structure of the Gene Tree core, combined with the application of food-grade lipophilic rare earth oxide, gives it excellent e-juice “guiding and locking” ability. It not only enhances stability and prolongs the product’s lifespan, but also prevents leakage, dry burns and explosions while optimizing flavor.

    According to ICCPP, the product’s self-developed heating slurry is more consistent with the thermodynamic properties of porous ceramics, greatly reducing the phenomenon of core slurry. Even after 4,000 tests of dry burning at 2.5 watts, the heating film and resistance value remained intact. The service life of dry burning at 6 watts is up to five times that of other products.

    China CE Magazine is an influential publication in China’s electronic consumer goods industry.

  • Michele Mital to lead FDA CTP

    Michele Mital to lead FDA CTP

    Illustration: Skypixel | Dreamstime.com

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will name Michele Mital, the current deputy director of the CTP, as acting director when Mitch Zeller retires in April, reports Vaping360.

    The news was first reported Wednesday afternoon in a tweet by FDA Tracker and confirmed by Filter reporter Alex Norcia after speaking with FDA sources. No formal announcement has been made.

    Mital joined the FDA in 1996 and has held various positions in the agency, including in the Office of Legislation. Since the CTP was formed in 2009, Mital has worked there in various capacities. She was named deputy director in 2018.

    The FDA is still looking for a permanent director.

  • Armenian Counterfeiters Arrested in France

    Armenian Counterfeiters Arrested in France

    Photo: Europol

    Authorities dismantled an Armenian criminal gang in France, detaining 11 individuals and seizing more than 2.5 tons of counterfeit cigarettes, along with €100,000 ($111,689) in cash and €150,000 in winning lottery tickets, according to Europol. Four guns and various types of ammunition were also confiscated.

    The investigation was completed by French Customs with support of Europol’s European Financial and Economic Crime Centre and the French National Police. They simultaneously searched 13 sites in and around Lyon, France.

    The seized cigarettes were imported from different European countries before being stored in warehouses and then sold on the black market in multiple French cities.

  • WHO To Review Policies After Denying Vaccine

    WHO To Review Policies After Denying Vaccine

    Photo: Tom

    The World Health Organization is reviewing its policies after the global health body denied Medicago’s Covifenz Covid-19 vaccine emergency-use approval, according to The Times Colonist.

    The WHO denied the vaccine due to the company’s ties with the tobacco industry; Philip Morris is a minority stakeholder in Medicago.

    “Medicago was informed of this decision and has been apprised of WHO’s policies on tobacco,” the WHO stated.

    However, the WHO’s policies may change as the organization reevaluates its policies following the tobacco industry’s attempts to diversify into other categories.

    “WHO is currently holding discussions on how to address a general trend of the tobacco industry investing in the health industry,” the WHO said.

    Once the WHO makes a decision on its policies, the Medicago vaccine application could be reviewed.

    Medicago is waiting on a response from the WHO detailing why the vaccine application was denied. “Once we receive this, we will review the rationale and continue to discuss next steps with our partners and shareholders,” said Takashi Nagao, Medicago’s president.

  • Bottleneck Broken in Cultivated Meat

    Bottleneck Broken in Cultivated Meat

    Photo: BioBetter

    BioBetter, an Israeli biotech firm, is using tobacco plants to significantly reduce the cost of cultivated meat and advance it rapidly to scale-up.

    As numerous cultivated meat start-ups move beyond the proof-of-concept phase, they run against one of the biggest challenges facing this budding industry. Developing a scalable and cost-effective production platform to make cultured meat affordable for the mass market has proven to be a primary stumbling block.

    Cell-derived meat requires a culture medium composed of a mix of amino acids, nutrients, and—most importantly—growth factors (GF’s) without which cells cannot multiply. Currently, such media are costly due to the complexity of producing GF’s. For example, insulin and transferrin GFs are collected from livestock, making it difficult to obtain large quantities. Some can be attained via fermentation of yeast or bacteria, but those methods require expensive facilities. The purification process also is complicated and expensive.

    “The Good Food Institutes determined that approximately a 100-fold reduction in insulin and transferrin costs is required to make cultivated meat economically viable,” explains Dana Yarden, co-founder of BioBetter, in a press note. “It is estimated that growth factors and cell-culture media can constitute 55 to 95% of the marginal cost in manufacturing cell-based foods.”

    BioBetter harnessed the inherent advantages of tobacco plants by turning them into bioreactors for expression and large-scale production of the proteins. Plant bioreactors use renewable energy (sunlight) and fixate CO2. They are self-forming, self-sustaining, and biodegradable. BioBetter uses open-field plantations to enable fast, efficient, and flexible response to market needs.

    “There are multiple advantages to using Nicotiana tabacum as a hardy vector for producing GFs of non-animal origin,” says Amit Yaari of BioBetter. “It is an abundant crop that has no place in the food-and-feed chain due to its extremely bitter taste and content of undesirable alkaloids. The global trend for reducing tobacco smoking also is raising concerns among tobacco growers that the crop might eventually become obsolete. Yet the tobacco plant has huge potential to become a key component in the future of food.” Tobacco plants can achieve up to four growth cycles annually and be harvested all year. This translates to more voluminous outputs per square meter of growing space.

    BioBetter says its uniqueness lies in refining and highlighting the advantages of the tobacco plant platform for production on a huge scale. The start-up applies a proprietary protein extraction and purification technology that enables it to exploit nearly the entire plant, and at the same time deliver a high purity product at broad scale production. The company currently sources tobacco plants from local growers but the goal is to eventually source the raw material from tobacco growers globally. Based on cultivation in open fields and BioBetter’s proprietary purification technology, the cost of growth factors production is dramatically reduced, bringing cost efficiency to cultured meat production.