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  • Thailand: New Graphic Health Warnings

    Thailand: New Graphic Health Warnings

    Photo: kikujungboy

    Retailers and wholesalers in Thailand will have to sell cigarette packs with newly designed warning labels beginning April 11, reports The Bangkok Post.

    The new packs must have text warnings and newly designed pictorial warnings showing graphic details of the consequences of smoking, according to Khachornsak Kaewcharas, deputy director-general of the Department of Disease Control.

    “Violators who still sell cigarette packets with the old pictorial warnings are liable to a fine of no more than THB40,000 [$1,197],” he said.

  • More Ads for Menthol E-Cigarettes

    More Ads for Menthol E-Cigarettes

    When the U.S. Food and Drug Administration banned flavored tobacco products, email and mailed advertisements for those products fell; however, ads for menthol-flavored products more than doubled, according to the Truth Initiative citing a Tobacco Control study.

    The study showed that partial flavor bans may not deter consumers, including youth, away from tobacco products. “Rather, manufacturers and consumers are adapting to new FDA regulations,” the study authors write. “The restriction of some flavored e-cigarette products has resulted in a shift of the sales and marketing of restricted flavored e-cigarette products toward other available flavored e-cigarette products.”

    “A more comprehensive approach that includes the consideration of disposables, refillable devices and other flavored e-cigarettes not covered by the current FDA guidance is needed to offer the most benefit for prevention efforts among youth and young adults,” the authors write.

    The FDA is expected to ban menthol-flavored products sometime this year.

  • PMI Gives Ukrainian Army Cigarettes

    PMI Gives Ukrainian Army Cigarettes

    Photo: Exclusive Dn

    Philip Morris International has given the Ukrainian Army 500,000 packs of cigarettes, reports the Washington Examiner.

    “Philip Morris donated 500,000 packs of cigarettes to help the army,” said People’s Deputy of Ukraine Danylo Hetmantsev. “Lviv Tobacco Factory and JT International Ukraine also handed over cigarettes to the military today in all regions where there are logistics warehouses.”

    PMI stopped most operations in Ukraine due to the invasion of Russian forces, and the company stopped marketing and product launches in Russia.

    “This included sales, distribution, and manufacturing,” said Corey Henry, PMI’s Director of U.S. Communications. “The Ukrainian army approached our colleagues and asked for stock in our warehouse in one of the most heavily bombed regions. We complied with the authorities’ request.”

    “Our focus and all our efforts over the last four weeks have been to ensure the safety and security of our Ukrainian colleagues,” said CEO Jacek Olczak in a statement. “We stand in solidarity with the innocent men, women and children who are suffering.”

  • Brazil Mulls Legalizing E-Cigarettes

    Brazil Mulls Legalizing E-Cigarettes

    Photo: Rmcarvalhobsb

    E-cigarettes may become legal in Brazil later this year as ANVISA, the federal health sanitary agency, plans to revisit its regulations regarding the products. Proponents of vaping have been pushing the government to legalize the products to help smokers quit combustibles, but critics are concerned about  youth usage as well as potential higher rates of vaping that could follow legalization.

    Electronic tobacco products have been banned in Brazil since 2009, but there are currently shops that sell the products anyway, often with statements that the products are safe, according to The World.

    “Once the product is legally allowed to be commercialized, it gets into the distribution network of the tobacco companies, which have one of the best distribution systems around,” said Stella Bialous, a Brazilian expert on tobacco issues and a professor from the University of California, San Francisco. She fears that more people would likely take up vaping if the products are allowed to be commercialized. In 2019, less than 1 percent of Brazilians used e-cigarettes. However, if the products are commercialized, they would become more easily available, and that percentage could quickly rise.

    “Considering that these products are attractive to youth and that we can’t affirm that they really work for tobacco cessation, we believe that we must prioritize the public policies to prevent smoke initiation and also to promote health for the Brazilian population,” said Monica Andreis, the executive director from ACT Promocao da Saude, a nongovernmental organization that focuses on tobacco control policies.

    “Brazil has a leadership role in Latin America and also around the world related to tobacco control policies. I believe that the decision from ANVISA has the potential to influence other countries in Latin America,” Andreis said.

    ANVISA has not commented on the situation, stating that it is still analyzing data. “Up to this point, there are still uncertainties and controversies related to the risks attributed to these devices,” the agency stated in February.

  • In the Pipeline

    In the Pipeline

    Photo: Imperial Brands

    A glimpse at patent registrations shows what the future of tobacco harm reduction may look like.

    By Stefanie Rossel

    Since the first filter cigarette was manufactured in 1934, the cigarette has stayed more or less the same. Despite some tweaks to filters, papers and tobacco blends over the decades, innovation was not exactly the word that came to mind in the context of combustible cigarettes. So it’s little wonder that when the World Health Organization Framework Convention on Tobacco Control (FCTC) was drafted in the late 1990s, its authors could not imagine a future product much different from the familiar tobacco column wrapped in paper. As a consequence, the FCTC makes little to no reference to intellectual property or technology.

    The past two decades have proven the FCTC creators—and many other observers—wrong. While the WHO was trying to cut down tobacco consumption with classic strategies, such as tax hikes, smoking bans and health warnings, a new generation of reduced-risk products, including e-cigarettes and tobacco-heating devices, entered the market. Many of these products bore little resemblance to the combustible cigarette that the FCTC was designed to tackle.

    Developed by independent entrepreneurs, the first vapor products surprised the tobacco industry as much as they did their WHO counterparts. After realizing the potential, however, cigarette manufacturers redirected some of their formidable resources at developing the sector, creating a multitude of new reduced-risk technologies.

    In recent years, the leading tobacco companies have pumped billions into research and development to offer their customers smoke-free alternatives. Philip Morris International alone had invested $9 billion in R&D by 2019. Median R&D expenses stood at $495 million for the fiscal years ending December 2017 to December 2021. They peaked in December 2021 at $617 million.

    BAT has spent more than $2.6 billion on R&D investment since 2012. In a preliminary statement in February 2022, the company said that it had further increased next-generation products investment by £496 million ($653.44 million) in 2021.

    Japan Tobacco International invested $2 billion between 2015 and 2020. The efforts are likely to pay off not just in terms of having less risky products available but also financially. Euromonitor expects the global retail value of the reduced-risk category to exceed $100 billion by 2025, up from $40 million in 2020.

    Developed by indpendent entrepreneurs, the first vapor products surprised the tobacco industry as much as they did their WHO counterparts (Illustration: VPR Brands)

    A Different Strategy

    As technology investments increase, intellectual property is becoming more valuable—and contested, as demonstrated by the recent PMI/Reynolds American Inc. dispute. In September 2021, the U.S. International Trade Commission (ITC) ruled that PMI’s IQOS heated-tobacco product (HTP) infringes on two RAI patents. After the Biden administration failed to intervene, PMI and its U.S. partner, Altria Group, were barred from importing IQOS devices in the U.S.

    The case is charged because IQOS is currently the only electronic nicotine product with a modified-risk tobacco product (MRTP) designation from the U.S. Food and Drug Administration, which allows Altria to market the product with reduced exposure information. Among other things, the company may tell consumers that its heating system significantly reduces the production of harmful and potentially harmful chemicals compared to conventional cigarettes. The ITC ruling means that American smokers currently don’t have access to IQOS. PMI is now looking at manufacturing IQOS in the U.S.

    Unlike the WHO, the FDA, which was authorized to regulate tobacco products by the 2009 Family Smoking Prevention and Control Act, acknowledges that electronic nicotine-delivery system products are fundamentally different from combustible cigarettes, and the agency has provisions to accommodate reduced-risk products.

    To receive MRTP designation, a manufacturer must provide scientific evidence showing that its product is “appropriate to promote the public health” as defined by the FDA. Although criticized as a long-winded and costly pathway—PMI handed in more than a million pages of documentation to support its IQOS application—the process at least offers a prospect for reduced-risk products, which is more promising than the WHO’s “quit-or-die” attitude.

    Roya Ghafale at the 2021 GTNF conference in London

    Innovation in the Making

    Tobacco and vapor companies’ substantial R&D spending is reflected in the number of tobacco harm reduction (THR) patents. Between 2010 and 2020, an estimated 73,758 patents were published globally in the areas of nicotine vapor products, smokeless nicotine products and HTPs, according to the 2021 Patent Landscape Report, a study prepared by Oxfirst Managing Director Roya Ghafele for the Foundation for a Smoke-Free World.

    Established tobacco companies, such as PMI, BAT and the China National Tobacco Corp. (CNTC), hold the largest patent portfolios in the THR space, showing that the development of less hazardous nicotine-delivery systems is a priority in their strategies. In terms of patents published, nicotine vapor technology is the fastest-growing THR technology, with a compound annual growth rate of 9.1 percent. It is followed by heated-tobacco technology, which has been growing 4.1 percent per year, and smokeless tobacco technology, which has a 1.1 percent annual growth rate.

    Geographically, patent publications are concentrated in high-income or upper-middle-income countries. Companies operating in the tobacco and cannabis sectors dominate patent activity: In tobacco-heating technology, CNTC, PMI and BAT account for 15 percent of patents published in the past 10 years. China leads with an estimated 22,956 patent publications followed by the U.S. with an estimated 14,344 publications. In the Africa and Middle East region, patent activity remains limited to Israel, Morocco and South Africa, according to the report. In nicotine vapor technology, the picture is similar: About 10 percent of all patents granted during the past decade are held by CNTC, PMI and Kimree Hi-Tech, a Chinese e-cigarette manufacturer.

    An increasing number of vapor patent applications cover technologies for therapeutic purposes.
    (Photo: Respira Technologies)

    Toward Therapeutic Uses

    The patent filings provide a glimpse into what the future of THR might hold. Interestingly, the number of patents for nicotine vapor technologies that could result in medical smoking cessation devices or be applied to other therapeutic purposes has increased substantially over the studied period. Between 2010 and 2020, 48 percent of patents were filed under classifications related to medical or veterinary science. According to the report, this indicates a shift from recreational technology toward more therapeutically oriented technology. While many patents currently focus on the vaporization of cannabinoids instead of nicotine, there is also mention of other therapeutic drugs, including those targeted at relieving pain, fever, inflammation and disorders of the nervous system.

    As far as the hardware is concerned, the number of patents referring to sprayers or atomizers adapted for therapeutic purposes ranks second behind those for inhaling appliances shaped like cigars, cigarettes or pipes.

    Patents relating to electrical heating or constructional details, such as the connection of cartridges and battery parts, also represent a large part of publications. BAT’s Pure Tech development is an example of this trend. The ultra-slim, micro-engineered stainless steel distiller plate acts as both the heater and wick, replacing the traditional coil and wick system and thus optimizing the aerosol process so that there is less risk of thermal breakdown in products. In its Science & Innovation Report 2020–21, the company calls Pure Tech a game-changer. Laboratory tests show that the vapor generated by this technology contains around 99 percent fewer and lower levels of certain toxicants compared to cigarette smoke, according to BAT. In biological tests, cells exposed to this vapor exhibited a much lower response or no response at all compared to cigarette smoke, a result that strongly suggested that this technology could contribute to the reduced-risk profile of its vapor products, BAT said.

    PMI has filed patents for vaping technology that includes sensors that are designed to monitor the characteristics of their users and provide therapeutic data, according to the Patent Landscape Report. Should these devices make their way into consumer nicotine products, Ghafele concludes, this would shift the purpose of these products from purely recreational to therapeutic, making nicotine businesses potential partners for insurance companies, public health authorities and other related industries. It could also further normalize—and improve access to—reduced-risk product technologies.

    While the patent publications by nicotine companies indicate a “pharmaceuticalizaton” of these industries, patent filings by pharmaceutical companies active in nicotine-replacement therapies suggest that these players remained focused on pharmaceutical uses for nicotine and are uninterested in entering the recreational nicotine space.

    To make headway in global tobacco harm reduction, critics say tobacco companies should make their innovations more accessible to customers in low- and middle-income countries. (Photo: BAT)

    Reserved for High-Income Countries

    In heated-tobacco technology, Ghafele found, most patents related to the design and manufacture of devices with an emphasis on the heating element, which tobacco companies seek to improve to increase the efficiency of their technology. BAT’s current Glo HTP range is heated by induction technology, thus avoiding direct contact between the electronics and the heating element. JTI’s Ploom S and Ploom X HTP models, by contrast, work with the company’s proprietary HeatFlow technology, where a ribbed heat chamber heats the tobacco stick from the outside for minimal charring.

    Following the blade-heating technology employed in initial generations of IQOS, PMI has added induction to heat the tobacco in its latest generation of HTP devices, IQOS ILUMA, which launched in 2021. The company’s TEEPS HTP platform, meanwhile, uses carbon-heating technology. The device works without electronics. It features a charcoal tip that is lit to produce heat. In the charcoal tip, oxygen reacts with the carbon in a combustion process, producing heat and carbon dioxide. An aluminum disk separates the charcoal from the tobacco, transferring the heat but blocking the airflow, thus preventing the tobacco from reaching the ignition point.

    Of the HTP patents analyzed by Ghafele, 38 percent were filed under therapy-related codes. The frequent mention of antineoplastic agents, which are medications used for cancer treatment, could indicate that companies are researching these agents to reduce the health risks of their products, she notes. There was also high patent activity relating to the therapeutic use of nicotine for neurological disorders, such as Parkinson’s disease or Alzheimer’s disease.

    While the report suggests that the once-staid tobacco industry has evolved into a highly innovative sector, it also reveals a shortcoming: Few of the patent applications are filed in the developing world, where intellectual property protections tend to be weak. Given that most smokers live in low-income and middle-income countries, this represents a missed opportunity for tobacco harm reduction.

    To bridge the gap, says Ghafele, stakeholders should explore ways to better integrate the needs of developing countries and motivate tobacco companies to offer potentially less harmful products outside of the wealthy world.

  • Major Milestones

    Major Milestones

    Photo: Uwell

    Vaping technology has come a long way. Here are the most impactful breakthroughs from the past 15 years.

    By Mike Huml

    The e-cigarette, which may very well be the most effective harm reduction device ever conceived to address preventable diseases, is built upon the simplest circuit possible. In essence, an e-cigarette is a resistor, a switch and a power source. From this simple circuit, thousands of variations arose over the course of about 15 years. During this Golden Age of regulatory limbo, the vapor industry exploded, and with that came endless innovation and constant refinement, transforming that little cig-a-like into all the products vapers enjoy today. Throughout this process, several innovations stand out as milestones. These innovations would improve the quality, consistency or convenience of the vaping experience. The nature of these changes necessarily contributed to reduced risk and increased uptake among populations.

    The Cig-a-Like

    Photo: Wabeno

    While more an invention than an innovation, the e-cigarettes that were available circa 2008 were not based on a revolutionary concept. Patents for similar but rudimentary e-cigarettes date back as far as the 1930s, but it wasn’t until the new millennium that all the pieces came together into a marketable product. Early adopters of the technology readily admit that first-generation e-cigarettes left much to be desired. What these pioneers agreed on, however, was the potential of these products. By improving the hardware and e-liquids—which could be accomplished with relatively inexpensive and readily available components—those early e-cigarettes could be turned into truly viable alternatives to their combustible counterparts.

    Cig-a-likes provided brutally short battery lives, weak but perceptible vapor, questionable flavor reproduction and a penchant for leaking and “spitback.” Almost immediately, e-cigarette users began tinkering with modifications to these products to mitigate the negative aspects. Cartridge “polyfill” was replaced with aquarium filter to increase absorption and prevent stray fibers from sticking to the bridge of the atomizer. Some wouldn’t be bothered with cartridges at all, nor the inconsistent draw and spitback associated with them, and replaced the cartridge with a “drip tip.” With one or two drops of e-liquid applied directly to the atomizer, the experience became more consistent at the cost of convenience. Longer batteries were soon made available to increase battery life, but it wasn’t until an increase in girth was an option that vapers and manufacturers collectively had an epiphany that would change everything: E-cigarettes don’t need to look like cigarettes.

    The eGo

    Photo: Joyetech

    The eGo, and other similar variations like the Riva, resembled a cigar more than anything. As battery life was a primary turnoff to curious parties, the idea that a battery could last a full day jump-started an entire era of e-cigarette popularity. The eGo could be found in affordable kits at almost every e-cigarette retailer, and it was available in different colors with different atomizers to match. Cartomizers and clearomizers largely replaced the old cartridge-plus-atomizer combination, and with inconvenience slowly becoming alleviated and customization increasing, the e-cigarette market saw a remarkable boom. There was still work to be done, however, as each starter kit required a tutorial and a certain degree of patience. Investment in new technology was still minimal and mostly took the form of variety instead of quality. Customization of appearance was great, but there was still hardly any customization of the vape experience itself. Atomizers of varying resistances were available, and small batch “modding” filled a niche need for higher power with different voltages by stacking batteries in series, but the gap between these two progressions was still wide.

    The Provari and Variable Voltage

    Photo: onVaping

    The Provari from Provape was in a class of its own. Coveted by all vapers, this device was the Cadillac of vaping. It single-handedly popularized the concept of variable voltage. Instead of trying and buying atomizers of multiple resistances, the Provari provided a range of output voltages, effectively allowing the user to adjust the amount of vapor and heat generated by atomizers of most any resistance available at the time. Unfortunately, the Provari was expensive, rare and much larger than the eGo. However, the Provari was rugged, durable and made in America—all features in high demand and low supply. Any mod from the variable voltage era took its cues from the Provari in terms of both performance and aesthetic. Eventually, variable voltage technology worked its way all the way down to the eGo in a new variation known mainly as the eGo Twist. Rampant cloning and intellectual property theft became a real issue during this time, but for better or worse, it led to countless variations of variable voltage devices, including the eGo Twist, eGo Spinner, eGo VV and many others.

    The Tank

    Photo: Uwell

    Up until this point, e-liquid was dripped directly onto an atomizer or absorbed by some type of filler. As power and performance increased, e-liquid was being consumed at a faster rate, and a larger supply was required in order to avoid constant refilling and dry hits. By modifying cartomizers by punching a hole in the casing and inserting it into a clear plastic cylinder, the “carto tank” was born. Early versions had trouble with both leaking and dry hits due to wicking inconsistencies, but again, there was potential. The idea of free-floating liquid in a reservoir changed how innovators thought about e-liquid delivery, leading to popular products such as the clearomizer, which was smaller than a tank but paired perfectly with the eGo’s size, came in a variety of fun colors and could be filled up much faster than a standard cartomizer. At this time, sides were chosen. Team Cartomizer enjoyed more vapor production and a draw that more closely resembled that of a traditional cigarette at the cost of convenience while Team Clearomizer had a range of colors to choose from and a smooth draw at the cost of leaking and dry hits. As time went on, the technologies and methods used to create these early tanks improved into the sub-ohm tanks that we enjoy today. Almost all common sub-ohm tanks take inspiration from both camps, with a vertically oriented coil surrounded by a filler material (cartomizer) housed in a clear tank with free-floating e-liquid. Although a range of preset resistances were available to pair with variable voltage devices during this time, due to generally poor quality-assurance standards, even multiple coils with the same advertised resistances could perform drastically differently from one another, even when fired at the same voltage. To combat this, a new technology had to emerge.

    The Darwin and Variable Wattage

    The Darwin from Evolv flew under the radar, mostly due to its boxy appearance, unique design that favored cartomizers specifically and a general lack of electrical knowledge among nonhobbyist vapers. But make no mistake, the Darwin was a game-changer, and its technology was enthusiastically copied by other manufacturers. To simplify: With a variable wattage device, atomizer resistance no longer mattered. Once a user decided that they enjoyed vaping at 10 watts, an atomizer of any resistance could be attached, and it would always vape the same way. Even minor inconsistencies between atomizers of the same resistance had no noticeable impact on the vaping experience. As variable wattage technology slowly made variable voltage obsolete, stores no longer had to carry extensive varieties of identical cartomizers, clearomizers or other atomizers with different resistances. Vapers no longer had to stalk their favorite retailer in the hopes that their favorite 2.5-ohm cartomizer would finally be restocked. Most importantly, variable wattage directly led to a blanket increase in overall consistency of vapor products.

    The Road Less Traveled—Mechanical Mods, Rebuildable Atomizers and Sub-Ohm Vaping

    Photo: Bedya

    While mainstream vaping was evolving, another phenomenon was taking place. While features, gadgets and color variety appealed to the mainstream, technology simply wasn’t moving fast enough for the hobbyist vaper. They wanted one thing: vapor. Nothing else mattered. Convenience? Safety? What are these words? By removing the internals from the mod formula in order to provide the cleanest, most direct pathway for electricity to flow from the battery to the coil and dropping coil resistance to below 1 ohm, sub-ohm vaping was born. The chips used to regulate mainstream mods provided too many amperage limitations, and hobbyist vapers spent ludicrous amounts of money because they favored craftmanship over new gizmos and pure performance over convenience. Of course, no premade atomizer was available at a resistance below even 1.25 ohms, so the DIY crowd began to, in fact, DIY. Small operations began manufacturing limited runs of solid metal mods and large atomizers in which the coil could be built by the end user. This allowed for maximum performance customization but minimal convenience. Additionally, this setup inherently presented the highest risk potential as there was no board to protect from pulling too many amps from a battery that wasn’t designed with vaping in mind. As such, surprisingly large leaps in battery efficiency and safety resulted from a spike in the demand for high-amperage batteries.

    The DNA Board

    Seeing multiple factions form in the vaping community, Evolv recognized a need. Some mainstream vapers wanted to “chuck clouds” safely and without the hassle of rebuilding and using a mechanical mod, which could be prohibitively expensive. Conversely, some hobbyist vapers ashamedly admitted that it would be nice to be able to enjoy some of the conveniences of “normie” mods without sacrificing too much performance. The DNA20 board finally proved that it was possible to vape sub-ohm coils on a regulated device and to do it safely. Any atomizer with a resistance down to 0.8 ohms could be used up to a maximum power of 20 watts—a far cry from the triple-digit wattages some mechanical mod users were accustomed to, but the DNA20 was a successful first step toward uniting a community that was just beginning to coalesce.

    Around this same time, vaping could no longer be ignored by the media and health officials. Partly exaggeration and partially due to the uptick in the popularity of vaping, reports of varying credibility started making headlines, with media outlets reporting on battery explosions, “popcorn lung” and heavy metal toxicity. Some of those health concerns turned out to be spurious, often due to flawed study designs.

    “This study was conducted by firing a two-ohm clearomizer from three years ago at six volts and measuring the levels of heavy metals and other pollutants,” researchers of such materials might write. “The results show an abundance of heavy metals, formaldehyde and silica particulates.”

    Yes, all vapers knew that dry hits were bad, but they were also repulsive to experience, and so these studies didn’t accurately reflect how users were using vapor products in the real world. However, it brought up a decent point. Vaping was regarded as safer than smoking, but it could always be safer. Having gone through a couple iterations of their DNA board, Evolv released their newest chipset that would change the industry yet again.

    Temperature Control

    Photo: EcigaretteDirect

    The DNA40 was an improvement over the DNA20 and the DNA30 in terms of power output and other functionality, but more than that, it was the progenitor of every temperature control device available today. When using a coil comprised of nickel, the DNA40 could calculate the temperature of the coil by measuring the change in resistance due to heat. Since it could calculate the temperature, it could maintain said temperature by adjusting the wattage by way of voltage in order to effectively eliminate dry hits. The chemical changes caused by overheating e-liquid, wire and wicking material now had a safeguard in the form of temperature control. This technology was naturally copied and can be found on almost every modern vaping device. Even pod systems use a simple version of temperature control technology. Several years after the release of the DNA40 and seeing an increase in demand for high-wattage devices, the DNA200 was released with a refined version of temperature control that could use additional wire types but that also included a revolutionary piece of software called eScribe.

    eScribe Software

    Available for free to anyone with a PC or Mac, eScribe provides not only the most comprehensive suite of features and customization options for vapers who use devices with a DNA board but also tools for researchers and scientists studying the health effects of vaping, allowing them to plot and record data with ease. The user features include custom screens, easy firmware updates, additional profiles and more. However, with more and more attention being brought upon vaping, particularly the health element, eScribe is the perfect tool for anyone to conduct their own studies and experiments. Everybody from the curious hobbyist vaper to large health institutions can access the features in eScribe and easily troubleshoot their device or go as far as to conduct large-scale studies.

    Pod Systems and Nicotine Salt

    Photo: Bantham

    Sometimes, things come full circle. With vaping technology reaching a plateau due to an overall increase in quality across the board, becoming more affordable and accessible on beginner-focused devices and inevitably facing government regulations, it became easy to provide a small device that delivered on the promise that cig-a-likes made years before. Although pod systems generally still don’t resemble analog cigarettes in appearance, the vape experience has never been closer to feeling like smoking. Years of trial and error, innovation and refinement led to the widespread popularity of these inexpensive, simple devices. Additionally, while liquid nicotine had been the standard prior to the existence of pod systems, nicotine salts provide a level of nicotine comparable to smoking but without the overly harsh throat hit and pungent flavor of e-liquid that contains a large percentage of liquid nicotine solution. Together, pod systems and nicotine salt e-liquid provide a foolproof package that anybody can pick up at a local retailer, fill up and begin using immediately and with no prior knowledge of vaping or its underlying electrical concepts. Meanwhile, synthetic nicotine is presenting new opportunities given its lower levels of contaminants and its suitability for standardization of safety and quality.

    Thanks to years of innovation, we are inundated with vaping products that not only provide a consistent, convenient and enjoyable alternative to smoking but that are also safer, more so than vaping used to be. As vapers looking back on the past decade, it’s clear that every technological innovation for the sake of a better vaping experience was also an innovation in harm reduction. The original cig-a-like was a proof-of-concept that demonstrated immense potential and got innovators excited for future prospects. The eGo addressed pressing needs of users but also directly led to a decrease in smoking, a net positive for public health. Moving from fixed voltage to variable voltage to variable wattage saw a directly linked connection to increased consistency and overall product quality while continuing to appeal to more and more people. Mechanical mods and sub-ohm vaping sparked a demand for safer and more efficient battery technology, which has huge implications for many other technological industries. With temperature control technology and eScribe, we see an answer to the health concerns, warranted or not, from health agencies and others. Pod systems bring everything full circle, utilizing all the advances in vapor technology while maintaining a simple, no-hassle design reminiscent of the original e-cigarette—where it all started.

    Vaping technology has come a long way in a short 15 years. What started as a hobby of passionate vapers triggered a wave of innovations, first pursued by independent entrepreneurs and later turbocharged by the investments of well-resourced traditional tobacco companies. This has resulted in mass production of safer nicotine products, giving smokers a welcome alternative to deadly combustibles. While the majority of consumers are now embracing standardized products, the hobbyists will likely continue innovating, further pushing the boundaries of technology in what was once considered a staid business.

  • 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.