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  • Tobacco Control’s Nervous Breakdown

    Tobacco Control’s Nervous Breakdown

    Photo: Xalanx

    Innovation in the recreational nicotine market is revolutionizing the tobacco industry and disrupting tobacco control.

    By Clive Bates

    In his groundbreaking 1997 book, The Innovator’s Dilemma, Clayton Christensen defined the concept of “disruptive innovation.” The term is often used carelessly, but disruptive innovation has several characteristics that apply in today’s tobacco and nicotine market. In essence, it is a theory of how entrants to a market can challenge incumbents by focusing on unmet needs using novel business models exploiting simple enabling technologies.

    In the nicotine market, the lithium-ion battery provided a critical enabling technology with sufficient power and energy density to replace combustion with electrical heating to create an inhalable aerosol in a compact and convenient form. Once the concept took off in the early 2010s, the technology rapidly evolved through at least four major generations during the decade. The disruption has never stopped, and the emerging incumbents in the vape industry now face disruption from disposable single-use vape products. It isn’t just technology; the business model has changed and adapted over time, embracing user-driven innovation, new retailing models such as specialized vape shops and international e-commerce, and a pro-health marketing proposition spread through social media.  

    A new wave of innovation is now breaking with the rapid rise of oral nicotine pouches. This newer trend may prove even more disruptive—a low-tech, low-cost nicotine delivery with negligible health consequences, no intrusion on others and none of the stigma attached to tobacco. Through vaping, consumers have deconflated tobacco and nicotine use and are now primed to adopt this technology.

    The regulatory environment also played a critical role, but more for what it didn’t do than what it did. In the United States in 2009, the U.K. in 2010 and the European Union in 2013, there were failed attempts to classify and regulate vaping products as medicines. Several core pharmaceutical regulation concepts are hostile to vaping. Vaping products are not smoking cessation therapies but pleasurable consumer alternatives to smoking that require nicotine delivery equivalent to cigarettes. Medicine regulators are not at ease with pleasure, or what they would call “abuse liability,” yet pleasure is integral to their success as consumer products.

    Let’s delve deeper and ask who is disrupted and how.

    First, the incumbent tobacco companies. In the standard model of disruptive innovation, these giants would be caught off guard by fast-moving entrants bringing new technology to a vanguard of early adopting consumers, rapidly changing the market dynamics. This would be felt most keenly as a loss of “pricing power” (the ability to raise prices to compensate for declining cigarette volumes) and a squeeze on margins and revenue in the profitable incumbent cigarette business. This should happen as the existing customer base of people who smoke is exposed to a wide range of low-cost alternatives without many downsides. So far, I don’t think this squeeze on the cigarette business has happened to anything to the extent it might have and still could, even though the companies have entered these markets and developed heated-tobacco products. The reason is that regulators are slamming on the brakes in response to activist and political pressure—disrupting the disruption. Regulatory excess has combined with activists and academics working tirelessly to nurture false risk perceptions and reinforce doubt about the wisdom of stopping smoking by switching to a reduced-risk product. The tobacco industry has been protected from the most severe disruption with the unintentional help of the tobacco control mainstream.

    Second, disruption has wrong-footed regulators and legislators. In response to rapid changes in the market, regulators and legislators have blundered in without first understanding (or perhaps without caring about) the complex adaptive system in which their rules would be applied. Because the new products function as economic substitutes for cigarettes, we expect three primary responses to excessive regulation: more smoking than there otherwise would be, more illicit trade in the new products, and consumers adopting risky workarounds, such as mixing their own flavored e-liquids. For example, limiting nicotine strength in the European Union made it harder to bring to market the pod devices that have been successful in reducing smoking in the United States. Flavor bans in the United States made vapes less appealing and caused more people to smoke, in some cases including young people. The prescription-only availability of vapes in Australia has led to a chaotic, lawless mess, with more than 90 percent supplied via informal, illegal channels. With their mission to protect the young from vaping, regulators forgot that in a world without vaping, many young people would smoke and, therefore, are benefiting from vaping.

    Third, the rise of the confident consumer. Consumers are the primary beneficiaries of the radical reduction in health and welfare detriments of smoke-free products. We are used to smokers burdened with regret, challenged with stigma and punished by anti-smoking policies. But all of that is driven by the health implications of smoking and the policy response that started in the early 1960s. How does the recreational nicotine consumer change if they are no longer troubled by the health and welfare implications of nicotine use and related policies? Simple economic theory suggests that if the costs and nonmonetary detriments of nicotine use fall, then demand will rise. It is likely, in my view, that there will be new users of nicotine who would never have become smokers in the absence of much safer products. For some, that is profoundly disturbing. For me, it is almost an inevitable consequence of having far lower risks and there being a latent demand for the real or perceived hedonistic, functional and therapeutic benefits of nicotine. Public morality may be shocked, but more people (of any age) using much safer products should not cause a public health crisis—we would be moving to substance use more like drinking coffee.

    Fourth, the existential threat to the tobacco control complex. The public discussion of the emerging landscape of low-risk consumer products seldom focuses on the interest group that is most vulnerable to disruption: the mainstream of tobacco control. It is a complex of interests comprising nonprofit activists, academics, medical and health societies, major institutions (such as the World Health Organization or the U.S. Food and Drug Administration), philanthropists and research-funding bodies. The problem for the mainstream of tobacco control is that without serious harm, the whole movement loses its purpose and its reason to exist. When it comes to low-risk alternatives to smoking, this complex is profoundly confronted by the threat of having nothing to control, no case for intervention and no reason to be. It is a powerful incumbent interest group challenged by new technology, new suppliers and new consumer confidence.

    As a result, the mainstream of this interest group has rejected tobacco harm reduction as a strategy for addressing its own notional goals of reducing death and disease from tobacco use. Instead, it has mounted a rear-guard defense based on a range of strategies, including the following:

    • Falsely implying that noncombustible products are no less risky than cigarettes, that data is too uncertain or short-term, or asserting that reduced risk is no more than a marketing claim of tobacco companies.
    • Asserting that harm reduction is merely a commercial strategy of tobacco companies. The aim here is to attach the reputational baggage of “Big Tobacco” to these new developments. Yet, many independent experts support tobacco harm reduction, and it is good if tobacco companies adopt a business model aligned with reducing health impacts.
    • Excluding or stigmatizing contrarian opinions and creating sealed bubbles open to groupthink. The WHO Framework Convention on Tobacco Control has taken this to new extremes.
    • Shifting emphasis to problematize nicotine rather than the “tar” of cigarette smoke that is the cause of nearly all tobacco-related disease. We are hearing more about “addiction” and less about cancer. Yet, a dependence only meets the definition of addiction if there is serious net harm to the user.
    • A relentless focus on the supposed interests of children without recognizing that would-be smokers among adolescents also benefit from low-risk products and that the demand for nicotine has persisted across generations for hundreds of years. Young people have an interest in the health of the significant adults in their lives as carers, breadwinners and role models.
    • Pressing for prohibitions or equivalent regulation to cigarettes, often with manipulation of language to imply equivalent risk, for example, by stating that heated-tobacco products produce “smoke” or that all tobacco products should be treated the same even though they have very different risks.
    • A blunt refusal to face trade-offs (for example, between the interests of youth and adults) or unintended consequences (for example, increases in smoking) arising from favored policy positions.

    I have watched on in horror as the leadership in tobacco control, albeit with many honorable exceptions, has dogmatically denied and suppressed the opportunity to radically reshape the recreational nicotine market to cause vastly reduced harm and avoid hundreds of millions of premature deaths. It looks like a nervous breakdown is developing in tobacco control in response to profound disruptive innovation. I doubt they will survive it.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • After Disposables

    After Disposables

    Photo: Image: Viktoria Ostroushko

    It is opportune for the industry to revisit the fundamental purpose of vaping—harm reduction and providing a superior consumer experience.

    By Douglas Ming Deng

    Pro or against? It is undeniable that disposable e-cigarettes have been the most popular format in the market over the past four years. Despite earlier predictions of their imminent disappearance, recent events like TPE24 and Champs in February suggest that manufacturers and distributors are still committed to showcasing elaborate disposable models. With features such as increased puff capacity, larger screens and vibrant colors, there seems to be no limit to the innovations of the disposables they’re introducing.

    However, changes are on the horizon, especially since the British government announced a ban on disposable e-cigarettes. The ban has sparked growing concerns among industry stakeholders regarding the life cycle of this category. While compliance has always been a central issue, the heightened emphasis on enforcement in the past months has prompted industry-wide apprehension. Yet, for those familiar with the evolution of vapor products, the shift in exterior designs should not be surprising given the industry’s history of transitioning from closed systems to open systems then to pods, pod-mods and now disposables within the past two decades.

    At the TPE24 and Champs Trade show, numerous disposable products were exhibited with minimal differentiation among them. Instead of specifying their current preferences for an ideal e-cigarette, both distributors and shop buyers voiced their anticipation for what would become popular six months down the line. To predict the future trends of products, it becomes essential to unravel the reasons behind the success of disposables.

    The affordability of disposables lowers the threshold, allowing for a smoother transition for those seeking to switch from combustibles to risk-reduced products (RRPs). Disposables possess clear advantages over device-based systems, particularly in terms of portability, while retaining key features such as noncompatibility of fake cartridges and adjustable coil voltage. In addition, they contribute to relative environmental protection with the increasing volume of liquid filled. However, the downsides of disposables are apparent. Firstly, their disposability sparks significant environmental protection debates, necessitating solutions that incur additional costs and subsequently leading to a general rise in the price of vapor products. Therefore, the next-generation vapor products will be sold at a higher price margin than the current disposables.

    Recently, solutions like paper-based bodies with biodegradable plastic components have been introduced to disposable e-cigarettes. In the EU, regulations mandate the rechargeability of batteries in vape products, establishing a reusable device as the minimum standard for the next generation of e-cigarettes. Moreover, the widespread use of disposables among underage individuals has cast a shadow over the entire category since its inception. While recent reports suggest a decline, with some teenagers deeming vaping immature, the issue remains pertinent. If even a single producer persists in designing disposable vapes with toy-like appearances and cotton candy flavors targeting underage kids, the entire industry could face consequences. This negative externality has become more critical than ever, emphasizing the need for the industry to unite and reach a consensus on addressing these public enemies. It is the right time to reconstruct the value of the whole industry and shape a new image of vapor.

    Noteworthy Changes

    Since the beginning of 2023, the evolution of disposable e-cigarettes has undergone a remarkable surge. For many, the exterior appearance of these products has transformed so swiftly that some manufacturers express concern that their latest models could become outdated before even hitting the market. The size has shifted from compact to large, the weight from light to heavy and the e-liquid tank from small to enormous. The rapid evolution of disposables suggests that the category is approaching the culmination of its development.

    One noteworthy change, above all, is the incorporation of screens on these products. While screens have appeared on vapor products before, recent developments significantly differ, particularly from those on open systems. Within just one year, screens have evolved from simple black-and-white displays to color ones then to TFT-LCD, and some brands have now introduced new products with LED touch screens. The on-screen features change from display of battery life and e-liquid contents to fancy animations ranging from alien UFOs shooting off to fireworks blasting, and they seem to emerge one after another. One might question: Are these high-end features really necessary for a disposable vape product priced at $30?

    As a scholar closely studying the industry over the past two decades, I strongly believe that the integration of screens on disposable vapes marks a significant breakthrough in vape products and could mean the evolution of vapor toward an advanced step. Interactivity is poised to become the defining characteristic of next-generation e-cigarettes. This interactivity fosters a dialogue between end users and other stakeholders in the industry chain.

    Currently, a major obstacle hindering the expansion of vapor to those who seek RRPs is the lack of communication among manufacturers, sellers, end users and regulators. When end users visit a shop, they often lack knowledge about why they are buying an e-cigarette and what product suits their needs. Shop assistants, with varying levels of expertise, recommend products, and some may lack technical knowledge about flavor differences. Neither end users nor sellers often realize that tobacco harm reduction (THR) is the real selling point of vape products. However, a smart device could facilitate communication between end users, manufacturers and sellers, allowing real smoking experiences to be reported to manufacturers for them to conduct consumer-oriented innovation. During my keynote speech at GTNF 2023 in Seoul, I emphasized the concept of a regulatory sandbox. Such a sandbox would only be viable with the presence of a smart vape device. It would enable vape products to be regulated in a closed loop, fostering innovation by allowing regulators to monitor real-time product testing. Enterprises would receive regulatory feedback promptly, adjusting their research and development accordingly. This approach enhances regulatory efficiency and ultimately builds trust among regulators, enterprises and consumers. Thus, the transition will be achieved from “wait and improve” to “test and innovate.”

    In 2022, the introduction of the Lil Aible by KT&G was groundbreaking. This smart device seamlessly integrates the use of heated-tobacco products (HTPs), incorporating both granular and reconstituted tobacco, along with vape technology. The exterior of Lil Aible mirrors the trend observed in disposables today—a robust device featuring a high-definition touch screen. However, the interior features of Lil Aible offer a glimpse into the future of vapor products: the incorporation of an AI function powered by a robust digital CPU. This function not only empowers the e-cigarette to optimize the smoking behavior of each individual user, enabling them to control the total puffs consumed every day, but also enhances harm reduction capabilities. Moreover, the implementation of facial recognition on a smart vape device, when used with due consideration for privacy, can effectively prevent usage by minors. This technology alleviates the burden on regulators for monitoring purposes.

    Furthermore, an AI-empowered device would revolutionize the flavoring process. Currently, manual flavoring is often considered an art, with the addition of various flavor chemicals relying on the blender’s personal taste and experience. However, in the era of digital flavoring, the process resembles coding basic substances through chromatographic fingerprints. The flavor can be precisely replicated on an AI smart vape device, a concept known as decoding. It’s crucial to recognize that e-cigarettes possess a natural electronic endowment, making them inherently suited for digital flavoring. In comparison to substances like alcohol or perfume, e-cigarettes have a distinct advantage in executing digital flavoring. This advantage is particularly pronounced in tobacco-flavored e-liquid, where manual methods may fall short of achieving promising results. The inherently possessed electronic capabilities of e-cigarettes may facilitate more straightforward communication between producers and users.

    Computer Chips Vs. Potato Chips

    Instead of dwelling on the next exterior appearance of e-cigarettes after disposables, it is opportune for the entire industry to revisit the fundamental purpose of vaping—harm reduction and providing a superior consumer experience. Shenzhen, China, renowned as the “Vape Valley,” possesses the capability to spearhead the creation of the next generation of e-cigarettes. During GTNF 2023, we delved into discussions about the future trends of vapor products. Moving forward, professional and technical forums like CORESTA or the Tobacco Science Research Conference serve as valuable platforms to gauge the direction of the next generation of vape products. It is in these forums that the industry can collectively shape the future while staying true to the core principles of harm reduction and delivering an enhanced user experience.

    In the years to come, e-cigarettes will embody characteristics of both fast moving consumer goods and more advanced, versatile electronic durable goods. Rather than opting for radical change, the transition from disposables to next-generation devices will be gradual. Like I said during a 2023 industry conference in Shenzhen, involution might only lead to the production of “potato chips” instead of “computer chips.” While potato chips can satiate basic appetites, aiming for the sophistication of computer chips elevates the vape industry to a higher standard. It is crucial for the industry to recognize this potential, as failure to do so may result in being confined to the low-end recycling sector.

    In conclusion, the narrative of disposable e-cigarettes mirrors the industry’s dynamic spirit—a story of adaptation, innovation and a relentless pursuit of excellence. The application of screens on disposables might disclose the future of vapor. Standing at the precipice of evolution, the industry is not merely chasing trends but actively shaping a future where harm reduction, end user-centric experiences and technological advancements harmoniously coexist. The tale of disposables is but a chapter in a grand saga, with each exhale marking a step into a future where vaping transcends boundaries and emerges as a beacon of possibilities.

    Douglas Ming Deng is a professor of next-generation products industry studies at Yunnan University.
  • Chilling Effects

    Chilling Effects

    Image: Jolita Marcinkene

    Is a menthol ban appropriate for the protection of public health? Hopes, concerns and a reality check

    By Cheryl K. Olson

    Is a U.S. menthol ban finally coming? The 2009 Tobacco Control Act exempted menthol cigarettes from its blanket ban on candy and fruit flavors. Menthol was left out, according to CNN, due to “serious lobbying from the industry.”

    As the Washington Post reported, plans to finalize the rule have been made—and postponed—multiple times by the Biden administration. The announcement of a finalized rule was planned for this month.

    The Food and Drug Administration first announced its “proposed product standards to prohibit menthol as a characterizing flavor in cigarettes” back in April 2022. The stated purpose? To reduce appeal to and experimentation by youth that will lead to regular smoking addiction and to reduce disease and death among adults via fewer cigarettes smoked and more quitting. A ban is also “expected to reduce tobacco-related health disparities.” The ban would target making and selling not individual possession or use.

    Concerns that banning menthol could exacerbate waning enthusiasm for Biden among Black voters appears to be one factor behind the delay. (Hoping to capitalize on this, one conservative group is reportedly testing menthol-focused ads on Black South Carolina primary election voters.) Four in five Black adults who smoke report choosing menthols. 

    The National Association for the Advancement of Colored People, a venerable advocacy organization for Black Americans, supports a federal menthol ban. In a Jan. 12 press release, its senior vice president of global policy called out “the relentless predatory marketing of menthol-flavored cigarettes, [which] has inflicted devastating consequences on Black communities.” This included ads in Black-oriented media, such as Ebony magazine, and sponsored events, such as the Kool Jazz Festival.

    Other organizations, such as Reverend Al Sharpton’s National Action Network, have argued against singling out menthol for a ban. Sharpton has expressed concern that a menthol focus could increase over-policing of Black communities, pointing to the New York City police killing of Eric Garner, who was suspected of selling “loosie” untaxed cigarettes.

    “The illicit market is always open and doesn’t check IDs.”

    Why Menthol?

    In the U.S., menthol has been added to cigarettes for at least 100 years, at times promoted as throat-soothing for coughs and colds. National government surveys find that, as smoking rates overall trend down, the proportion of menthols smoked has crept up.

    These surveys show that menthol smoking is disproportionately higher among subgroups of people regulators consider disadvantaged or vulnerable. This includes Black and Hispanic adults who smoke, young adults, women and persons reporting serious psychological distress.

    Concern that menthol may be a drag on cessation rates has boosted support for a ban. Because it reduces irritation, menthol may make it easier to start smoking. It’s used more often by people who smoke intermittently or experimentally. Researchers have called for more studies to parse and prove a causal role for menthol in increasing smoking and deterring quitting.

    In this century, smoking rates have been stagnant among African-American adults who smoke. A 2020 analysis of U.S. studies did not find an overall effect of menthol on smoking cessation but did find that among African-Americans who smoked, use of menthol was linked to 12 percent lower odds of quitting. 

    Can bans help people quit smoking? To some degree, yes. Pooled results from a 2024 systematic review and meta-analysis of English-language menthol ban studies found that 24 percent of those who smoked menthols had quit cigarettes a year or two later. But results varied widely; bans took place under a variety of conditions, and most of the studies included had small or unrepresentative samples.

    For example, a survey of San Francisco’s ban of menthol and other flavors in all tobacco products found decreased flavored e-cigarette and cigar use and a slight uptick in smoking. The study used a small convenience sample of 247 young adults. Even rigorous economic studies of bans admit to trouble tracking illicit and cross-border sales and other workarounds.

    Regulators are aware of the need for better research. The FDA recently awarded a $3.6 million grant to researchers at the Medical University of South Carolina to study whether banning menthol in cigarettes (and e-cigarettes) would increase quitting or switching. Meanwhile, Rutgers University received two grants totaling $7 million via the National Institutes of Health to study anticipated “disinformation” from industry, aimed at Black and Hispanic young adults, that could “undermine the impact of a ban on menthol cigarettes and flavored cigars.”

    What Could Go Wrong?

    The FDA expects minimal illegal trade in event of a ban. Richard Marianos disagrees. He is a retired assistant director at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and a faculty member at Georgetown University. Marianos says banning products creates crime. 

    Illicit sales of individual cigarettes and contraband packs are already problematic, in part because taxes have driven up costs. Marianos showed me photos of several men, one with a gun in his waistband, at an illegal sales spot outside of a Washington, D.C., Metro station.

    “People come off the train, buy four loosies from the spot, then ration them out during the day,” he says. “You can get your marijuana, your cocaine and your Newports.”

    The flavor ban in California has sparked increased robberies of convenience stores across the border in Arizona, according to Marianos. “A pack of menthol cigarettes that they can steal and sell for $2 apiece at the spot derives a greater profit than a cash register robbery,” he says. “I have videos of crews hitting a Circle K or Wawa, jumping over the counter, sticking up the clerk and—like Santa—putting the cigarettes into a gigantic tarp and taking off.”

    A Canadian study of intended and unintended effects of their menthol ban found that many people purchased menthols on First Nations reserves, where the ban did not apply. Marianos expects that Native American reservations in the U.S. would similarly help meet demand.

    The practical path forward for advocates of an enforceable menthol cigarette ban is to actively promote harm reduction.

    Menthol Workarounds

    The assumption by many tobacco control advocates that Big Tobacco will sabotage menthol bans overlooks the likely ingenuity of individuals. Marianos described one case he ran across: “A guy was going on eBay and buying menthol crystals, spraying regular cigarettes in his basement and then selling them on the corner as menthols.”

    Noting that products to alter cigarette characteristics are illegal under the proposed rule, “FDA does not anticipate a substantial number of individuals would utilize such products.”

    Researchers have documented sales of flavor cards and menthol drops in Canada and various flavor accessories in the European Union to circumvent their menthol bans—predictably leading to calls to ban those items too. 

     “The illicit market is always open and doesn’t check IDs,” notes Nicholas “Grimm” Green, a YouTuber and tobacco harm reduction advocate. “As long as $10 ‘menthol injectors’ exist on Amazon, the idea of a menthol ban is silly.”

    That’s not to say that companies won’t do their part to circumvent a menthol ban. “Tobacco companies have already introduced nonmenthol-menthol cigarettes into the market in California,” says Green. Further, enforcement is lax. “Menthol disposable vapes are available at almost every gas station and head shop in the state,” he adds.

    The California ban, approved by voter referendum, went into effect in December 2022. It covers not just menthol cigarettes but nearly all flavored nicotine products. Researchers have found synthetic cooling agents that give menthol-like effects in cigarettes sold in that state. A journalist from STAT News found widespread sales of flavored products, even in cities that had their own longstanding flavor bans.

    Legal Hurdles

    If the menthol rule comes to pass, store shelves aren’t immediately cleared. Flavor bans enacted by states can take effect within months. Because the proposed federal ban comes out of the FDA’s complex rule-making process, it could take years.

    “If they publish that rule on a Monday, the next day, you’ll see a legal challenge filed to prevent it from ever going into effect,” says Jeffrey Weiss, partner at Flagstaff Ventures and formerly chief engagement officer and general counsel at Njoy. 

    He predicts a dead-end fate for the menthol ban, similar to that of the final rule requiring graphic health warnings on cigarette packs. Why?

    U.S. law requires that adoption of tobacco product standards must be appropriate for the protection of public health. In supplementary information to the proposed menthol rule, the FDA cites research, including population models and expert opinions, on what is expected to happen after a menthol ban.

    “They model that a certain percentage will switch to tobacco cigarettes, a percentage will buy black market menthol cigarettes, a percentage will quit and a percentage will switch to an e-cigarette, primarily menthol,” Weiss says. “But that model doesn’t actually exist—in the sense that there are no authorized menthol e-cigarettes for smokers to switch to.”

    Post-ban, more menthol users are expected to switch to menthol e-cigarettes than to quit using tobacco. In sum, much of the health benefit from banning menthol is supposed to come via unauthorized product use. Products that are themselves banned in a growing number of states and localities.

    Regulators are not unaware of this conundrum. FDA Commissioner Robert Califf has publicly expressed concern about the difficulties that people dependent on menthol cigarettes will face if the products are taken away. For example, he remarked at a 2023 Congressional budget hearing, “[W]here do they [menthol users] go to get help, coming off of a terrible addiction? Our healthcare systems are not set up to deal with that right now.”

    What about evidence for a menthol ban preventing harm to youth? The respected nationally representative Monitoring the Future study found that past-month menthol and nonmenthol cigarette use by non-Hispanic black teens is now less than 1 percent. It’s fallen so low in recent years that “prevalence levels approach a floor effect.” Moreover, today’s Black adolescents use menthol cigarettes at lower levels than non-Black youth.  

    A Better Way?

    Given the high risk of unintended effects and the limited certainty of benefits, is a menthol ban our best plan? “It would be best if the government would think first in the direction of ‘how can we affirmatively help people make positive change?’” Weiss says. “Because prohibitions are hard and costly to enforce.”

    The lack of authorized reduced-harm menthol or mint products is just part of the problem. Another is the FDA’s limited and ambivalent reduced-risk communications.

    Weiss points to the FDA’s routine tweeting of its one-page list of 23 authorized e-cigarette products. At the bottom of the page is a disclaimer: Being authorized “does not mean that these products are safe nor are they ‘FDA approved.’ All tobacco products are harmful.”

    “If you want a current menthol smoker who can’t completely quit to switch to a regulated reduced-harm product—how are they going to do that when you’re telling them that none of these products are safe?” says Weiss. “If it’s an unsafe product, why is that a better choice for me” than a tobacco-flavored cigarette or an illicit menthol one? 

    Active promotion of reduced-harm menthol alternatives seems a sensible way to limit ban backfires. A rigorous laboratory study of adults who smoked menthol cigarettes daily found that menthol-flavored e-cigarettes outshone tobacco-flavored ones in reducing cigarette cravings—including urges to smoke for pleasure. According to the authors (affiliated with prominent universities), this is a known strong predictor of successful smoking cessation.

    The practical path forward for advocates of an enforceable menthol cigarette ban is to actively promote harm reduction. “Encourage FDA to start authorizing menthol e-cigarettes, among other things, so that these smokers would have something to switch to,” says Weiss. “And to make it more likely that a menthol ban could withstand a legal challenge.”

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
  • The Looming Backlash

    The Looming Backlash

    Photo: Swedish Match

    Cracking down on Zyn will only harsh the buzz around the office.

    By Peter Clark

    The calls from Representative Chuck Schumer to “crack down” on Zyn nicotine pouches may harsh the buzz around the office. 

    A recent Bloomberg article found that this product has been gaining popularity among office workers. In the third quarter, Philip Morris International saw a 66 percent jump in sales.

    Schumer may aim to shield developing brains from nicotine, but only 1.5 percent of middle schoolers and high schoolers use nicotine pouches. Flavored nicotine products are critical to adults quitting smoking because they break the connection between nicotine and tobacco.

    If regulation is too heavy-handed, adults will be clamoring for their trusty pack of Marlboros. This initiative is a drag on workplace productivity for the following reasons: more smoke breaks, less focused employees and time lost to illness.

    Restricting Zyn pouches may make workers revert to cigarettes, and this is bad for business. The average smoke break is between 10 minutes and 15 minutes long. These constant breaks add up to approximately an additional week of vacation time.

    Not only is this unjust for nonsmokers, but employers feel the pinch. Studies have estimated that smoke breaks cost companies $3,077 ( per employed smoker) annually. Banning flavors and reducing the nicotine content in Zyn will have workers running for the nearest designated smoking area. 

    Schumer’s demand for regulation overstates the risks and overshadows the benefits. This fear-mongering stems from what Jeffrey Singer, a senior fellow at the Cato Institute, refers to as “Nicotinophobia.” The association between the dangers of cigarettes and harm reduction products that contain nicotine.

    Zyn pouches contain isolated nicotine salt but no tobacco. The danger lies in thousands of chemicals composing cigarette smoke. E-cigarettes also deliver nicotine without tobacco smoke. Public Health England has deemed them 95 percent safer than traditional cigarettes. If we have a safer alternative, it is foolish to ignore its benefits as a nootropic. 

    Studies have found that smokers report that nicotine has “beneficial effects on concentration and memory.” Nicotine also enhances performance on complex tasks. A double-blind study by Nature found that administering small amounts of nicotine (1 mg) boosted performance on intricate tasks. Past research even suggests that nicotine improves “IQ-related tasks.” Nicotine’s impact on IQ has caught the attention of tech mogul Peter Thiel, who has flirted with the idea of using nicotine patches for the nootropic effects.

    Banning or restricting nicotine pouches would have a negative impact on the productivity of former smokers who are Zyn converts. When a nicotine addict tries to quit, they experience temporary cognitive decline. Experts in the field of addiction treatment have observed that withdrawal feels “like the opposite of the drug.” Nicotine is no exception. A 2017 study conducted by the Pennsylvania State University found that nicotine deprivation among smokers had an adverse impact on working memory, “which is critical for our understanding of motivated decision-making.” Other researchers have found that nicotine withdrawal is also associated with decreased reaction time and a decline in verbal and spatial memory. 

    If Zyn users revert to cigarettes, employers will also suffer from reduced productivity due to smoking-related illnesses. The U.S. economy suffers over “$365 billion in lost productivity each year” because of tobacco-related ailments. Not only do chronic diseases contribute to lower productivity, but smokers are also at higher risk for infections—a 12 percent higher risk for viral infections and a 48 percent greater chance of “being diagnosed with respiratory illness,” leaving co-workers to pick up the workload of their sick peers, putting them under unnecessary stress.

    Lawmakers need to realize that targeting Zyn for the sake of America’s youth is misguided. Few kids are using this product, but the harm to adults extends beyond smokers. The impact of smoking-related loss in productivity reverberates throughout the economy. Making Zyn products less appealing to smokers will have our workforce taking excessive breaks, being less focused and being more likely to call out sick. If Schumer wants to tackle a public health crisis facing teens, he should look into automobile accidents, the leading cause of death among teens.

    Peter Clark is an Arizona-based writer and commentator. His work has been published by AzCentral, FEE, AIER, & Real Clear Markets. Follow him on X @blog_logic.
  • All Puff

    All Puff

    Photo: Sevenstock Studio

    Concern about secondhand smoke does not warrant Britain’s generational tobacco ban.

    By Charles Amos

    In recent weeks, I have spoken to hundreds of people about the British government’s plan to ban the sale of tobacco to anyone born after 2009. Most of the responses in favor of it I expected to hear; however, I was surprised at the number of occasions people brought up secondhand smoke as a sufficient reason for prohibition—very often, though this argument was raised only after I had undermined their claim that smoking costs the government lots of money and after I had pointed out the paternalism that was typically their initial justification. Given the propensity of the public to fall back on this point, it is important that it is rebutted.

    A main reason why people object to secondhand smoke is that it is inflicted upon them without their choice. When allied to the idea that it is harmful, many will invoke John Stuart Mill’s harm principle—the idea that the only justification for limiting individual liberty is to prevent harm to others—to justify the tobacco ban. The cost of secondhand smoke has been estimated to be in the region of £700 million ($882.72 million) by Policy Exchange. Nonetheless, the overwhelming majority of this cost evades the central reason people oppose secondhand smoke because it comes from the earlier death of partners or visitors of smokers who choose to be with them. Now relative to smokers not smoking, these partners and visitors are worse off; this worsening can hardly warrant prohibiting smokers from smoking though. Relative to her nephew putting up a handrail on the stairs, a doddery aunt is worse off without it; are we to require he puts up the handrail? No. Hence, it must be admitted that making someone worse off relative to the best situation for them cannot warrant forcing people to provide this best situation.

    Given that we have disposed of the overwhelming majority of the cost of secondhand smoke, we can now focus on the life lost due to the unchosen inhaling of secondhand smoke alone, e.g., when walking past a smoker on the street. Assuming 10 or so occasions in which secondhand smoke is inhaled at a hundredth of the strength of a puff inhaled by the smoker himself gives an annual figure of about 6 seconds lost, or about 2 pence of cost. This is almost certainly an overestimate too; indeed, the first person to publish research on the link between primary smoking and lung cancer, Richard Doll, said, “The effects of other people smoking in my presence is so small, it doesn’t worry me.” Health studies have affirmed this verdict: In 1998, a seven-year study by the World Health Organization found no statistically significant link between secondhand smoke, importantly, including of the chosen type, and lung cancer, and a 2002 study by the Greater London Assembly similarly found the impact of secondhand smoke to be minuscule too. 

    I suspect there will remain those who will still argue that smokers have no right to impose any costs on them whatsoever—and that, hence, smoking should still be banned. This moral reasoning proves too much. If it is accepted, a couple of pence of expected cost, at most, warrants restricting public smoking; analogously, it warrants banning driving, barbequing and coughing in public too, for all of these impose similar or greater costs as well. As English judge Baron Bramwell argued in the Bamford v. Turnley court case of 1862, concerning the passage of smoke over property lines, justice should accept “a rule of give and take, live and let live.” Either that or our moral license to do anything would be seriously limited. Even Mill claimed only harms “without justifiable cause” can be prohibited, and surely, living life is as justifiable a cause as any other.

    At this point, it may be argued that the difference between driving, which exposes people to smoke and the risk of a fatal accident, is that drivers pay their way via fuel duty while smokers do not pay their way via tobacco duty. This is false. As Christopher Snowdon and Mark Tovey have found, smokers contribute about £9 billion in tobacco taxes and save the taxpayer another £10 billion in reduced pension and healthcare costs while their cost in healthcare, litter collection and putting out fires only comes to £4.6 billion, meaning, when we include the estimate of £700 million for secondhand smoke—which is a vast overestimate of the relevant figure—we still find smokers save society about £14 billion a year.

    Plus, it’s pretty rich to ban smoking rooms in pubs and restaurants, where smokers literally internalized their negative externalities, and then, when smokers revert to smoking outside and impose a minuscule externality as a result, to use this minuscule externality as a justification to ban smoking altogether. In reality, it points to the fact that the war on smokers has never really been motivated by stopping harms to others; rather, it has been motivated by an intolerance of smoking itself. And, of course, this whole article has ignored the fact that secondhand smoke in public places can never warrant banning smoking in private places anyway.

    In sum, anyone who accepts that people should be free to drive, barbeque or cough in public must, by the same reasoning, accept that people should be free to smoke in public too. Ultimately, the only reason the public revert to opposing smoking on the basis of the tiny cost of secondhand smoke is their main arguments have failed. Yet even their argument of last resort fails, and with it goes any last justification for the tobacco ban. If people really want to defend the tobacco ban, they should be honest and give their real justification alone, that is: “We’re happy to push people about for their own good.” A questionable justification at best.

    Charles Amos writes The Musing Individualist Substack and formerly attended both King’s College London and The University of Oxford.
  • Northern Exposure

    Northern Exposure

    Vape and modern oral sales are rising, but combustibles remain king of the North American market.

    By Timothy S. Donahue

    It’s constant but unknown. While the nicotine market remains profitable, it is changing. As more major tobacco companies embrace next-generation products, combustible sales will suffer. The evolving regulatory environment will also continue to play a major factor in the North American nicotine market.

    According to Statista, in 2024, revenue in the U.S. nicotine market will reach $107.5 billion. It is projected to experience a compound annual growth rate of 0.62 percent between 2024 and 2028. The largest segment in the market remains combustible cigarettes, with an expected value of $82.7 billion in 2024. The Marlboro brand continues to dominate U.S. cigarette sales with a 50 percent market share.

    E-cigarette revenues are projected to reach $8.8 billion. Statista expects the vape market to experience an annual growth rate of 3.24 percent from 2024 to 2028. Retail sales of nicotine pouches are also seeing unprecedented growth. According to Euromonitor, the U.S. pouch market generated $8.58 billion in 2023 compared to $7.23 billion in the previous year. The U.S. modern oral nicotine market is expected to reach $11.03 billion by 2027.

    The Canadian tobacco market is much smaller than the U.S., reflecting that country’s lower population. Nicotine sales in Canada are projected to generate a revenue of $12.3 billion in 2024. The market is anticipated to experience a compound annual growth rate of 1.10 percent between 2024 and 2028. In Canada, too, combustible cigarettes continue to account for the majority of tobacco sales. The traditional cigarette market is expected to reach a volume of $10.6 billion this year. In 2024, the revenue in the e-cigarette market in Canada is estimated to reach $1.4 billion.

    Nicotine pouches were approved for sale in Canada on July 18, 2023, as a natural health product. Modern oral nicotine pouches are currently outside the scope of the federal Tobacco and Vaping Products Act and the provincial Smoke-Free Ontario Act 2017, which regulate tobacco and vaping products by restricting their advertisement, display and public use. However, that is expected to change soon.

    During an education seminar at the Total Products Expo (TPE) that took place in Las Vegas Jan. 30 to Feb. 2, 2024, Brad Seipel, executive vice president at MARC Research, noted that many of the next-generation tobacco products disrupting the market today have been on the market for over a decade. Innovation in the industry, he said, is being driven with a focus on tobacco harm reduction and a move away from traditional tobacco. “We are now living in a post-tobacco market. It is a nicotine market,” Seipel said.

    Brad Siepel (left) and Jason Carrington (Photo: Chemular)

    Bonnie Herzog, an analyst with Goldman Sachs, observed in an industry report that retailers are seeing customers making fewer trips to the store, which is being driven by consumers switching to alternative nicotine products like modern oral. These products often last longer than a typical pack of combustibles. She also explained that the illicit market for disposable vape products continues to be a growing concern for the nicotine industry and retailers alike as the U.S. Food and Drug Administration’s crackdown on flavors and noncompliant products has driven traffic to the gray/black market or retailers willing to sell unauthorized vaping products.

    She said a broad majority of retailers believe the situation is worsening with the impact felt strongest in urban areas and states with the strictest flavor bans. “Many retailers highlighted that the illicit disposable [e-cigarette] market is impacting cigarette volume, and [Altria] estimates the growth of these illegal products contributed to cigarette industry declines in the range of 1.5 percent to 2.5 percent over the last 12 months,” she said. “Retailers don’t believe the situation will change without more enforcement and are broadly pessimistic given the ubiquity of the offering, tracking/enforcement difficulty and relatively light penalties reducing deterrence.”

    One respondent to the survey pointed out that enforcement fines issued by the FDA are manageable ($19,192 per violation), and the extent of policing hasn’t resolved the issue. Others noted that retailers selling these products (i.e., on the gray market) are making hefty margins on those sales, which are helping them offset losses on (cigarette) sales.

    During Keller and Heckman’s E-Vapor and Tobacco Law Symposium, held Jan. 29–30 in Las Vegas, Brian King, head of the FDA’s Center for Tobacco Products, said his agency carried out a series of coordinated blitzes against Elf Bar and other “illicit” brands at several retailers that resulted in warning letters. The agency then issued civil money penalties following subsequent reinvestigations against retailers found to still be selling illegal products. Many of the recipients of these penalties were small businesses.

    “We do know that we need that comprehensive approach,” said King. “And so, we’ve also taken action on the borders, particularly for products that are coming in internationally. We do have import alerts in place. Those do address products that have been accurately declared. Of course, we know that there are entities that are misdeclaring products as well. Towards that end, we work very closely with colleagues at Customs and Border Protection. We did have an operation that was conducted earlier this year where we seized over $18 million worth of products, including Elf Bar, Funky Republic and several others. It was about 1.4 million units of illegal e-cigarettes. Ultimately, this is one example of ongoing activities. There will be more.”

    TIm Phillips (Photo: Chemular)

    Also speaking at TPE, Tim Philipps, with Tamarind Intelligence, said that a major issue is enforcement. While the FDA’s premarket tobacco product application (PMTA) process is expensive and onerous, it also seems pointless because there is little effort to stop products that skip the regulatory process from being marketed. According to Phillips, even the FDA’s current blitz barely skims the surface of the deepening gray/black markets.

    “The products that you’re getting offered in retail environments, they haven’t gone through a regulatory process, and there’s no signs of that happening, frankly,” he said. “The FDA is stepping up some of its enforcement activity. We’ve seen more and more of this happening, and I think it will keep increasing. But the reality is the market’s not being regulated at all. The same is happening, by the way, in the U.K. and all across Europe. We’re seeing a lot of products come in. The reason is that a lot of these products are being distributed directly to retailers or directly to consumers (from the manufacturer). And that’s been a great success.”

    A looming federal menthol ban could also boost the gray/black markets for nicotine products. The FDA has submitted proposals to the White House Office of Management and Budget (OMB) to ban the use of menthol in cigarettes and other tobacco products and prohibit all nontobacco flavors in cigars. The FDA is also expected to definitively define a “characterizing flavor.” The OMB is currently reviewing these proposals. Before the product standards can be implemented, the OMB must review their potential economic impact.

    The FDA has stated that it expects to announce the final ruling on the menthol ban in March. However, with the U.S. presidential election approaching this November, many industry experts are uncertain if any action will be taken at all. Unsurprisingly, several respondents to Herzog’s retailer survey expressed fatigue with ongoing uncertainties related to the potential federal menthol ban, the FDA’s efforts to enforce bans on illegal disposable vape products and flavors and the agency’s slow progress in completing PMTA reviews. The rapid growth of local flavor bans is also an expanding concern.

    “A number of retailers who are currently not subject to [local] flavor bans anticipate the potential in the near future given rapidly evolving legislative agendas,” Herzog stated. “The looming decision by the FDA on a federal menthol ban on (cigarettes) has also led many retailers to take a wait-and-see approach on carrying gray market vapor products, which are higher margin and more affordable for consumers.”

    The future of nicotine products still holds promise. Seipel said that the dissolvable and heat-not-burn segments have plenty of room for growth as the awareness and usage of those products haven’t yet gotten traction in the North American market. Seipel said as long as there are combustible smokers, there is going to be room for innovative products that help them switch to less harmful alternatives.

    “There’s also [an] opportunity in innovation for helping female smokers …. We have to remember that there are way more people out there that need help [quitting smoking],” he said.

    Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
  • A Misguided Crusade

    A Misguided Crusade

    Photo: Swedish Match

    The campaigns against lower risk nicotine products serve political goals at the expense of public health.

    By Catharine Dockery

    Cigarette smoking remains the leading cause of preventable death in the United States and many other countries. Shouldn’t our leaders do everything they can to prevent deaths and reduce harm? 

    Unfortunately, U.S. Senator Chuck Schumer and the Food and Drug Administration have missed a profound public health opportunity by not encouraging reduced-harm nicotine products such as Zyn. Instead, they are targeting these lifesaving products and proposing wide-reaching bans.

    While youth usage of nicotine is a deeply concerning issue, product prohibitions are an ineffective distraction from the failure of the FDA to act proactively to protect Americans. Flavored recreational nicotine options are essential tools to present combustible cigarette smokers with less harmful options they enjoy. Public health officials need to stop scapegoating harm reduction products targeted to adult smokers and instead focus on addressing youth use.

    Other public health organizations, such as the U.K. National Health Service (NHS), have recognized the potential of harm reduction products in saving lives and promoted recreational nicotine options. For example, their “swap to stop” program has offered new noncombustible tobacco products to smokers in an effort to move them to lower risk alternatives. The NHS website offers that “[i]n recent years, e-cigarettes have become a very popular stop-smoking aid in the U.K. Also known as vapes or e-cigs, they’re far less harmful than cigarettes and can help you quit smoking for good.”

    In the United States, by contrast, government officials and public health agencies are spurning a significant opportunity in reduced-harm nicotine products. In 2023, nearly half a million adults died in the United States from the effects of cigarettes.

    Research demonstrates that flavored nicotine products provide a less harmful option for adult cigarette smokers who are trying to find a substitute for their habit.

    A 2021 study found that among U.S. adults who smoke, despite only 29 percent being aware of nicotine pouches, nearly 17 percent expressed interest in trying the products in the coming six months.

    To the extent adult smokers are able to substitute pouches for cigarettes, it’s absolutely appropriate to view these products as lower harm options on a continuum of risk.

    Some research indicates that e-cigarettes can be more effective than nicotine-replacement therapy products like gums and lozenges at helping smokers quit, showing the role of these products in the public health fight against tobacco-related harm.

    Policymakers’ efforts to restrict harm reduction products are often done under the guise of protecting children. But in no other industry do we consider product bans a reasonable control to address underage use. It would be unheard of to ban alcohol to prevent underage drinking. 

    Product bans have been largely unsuccessful in addressing youth vaping, a failure made clear by the fact that the top 2 youth e-cigarette brands of 2023 are illegal (Elf Bar and Esco Bar, used by 57 percent and 22 percent of youth surveyed, respectively). The FDA has completely failed to enforce bans on these illegal brands with flavors and designs designed specifically to appeal to underage users. The numbers are clear—10 percent of middle school and high school students use tobacco products, and the vast majority of those (7.7 percent) use e-cigarettes. 

    We also need to engage with the facts of youth nicotine abuse. E-cigarettes are far and away the main method of consumption among underage users, used by 7.7 percent of students in 2023 relative to the 1.5 percent using nicotine pouches. Significantly more effort is needed to crack down on illegal sales, particularly online sales, of these products. If product bans can’t solve youth usage issues, can we really justify the public health costs of denying vital options to smokers?

    On this issue, we’re repeatedly offered a false choice between youth nicotine abuse and robust options for adult smokers. This is a purely political characterization of the problem. There are a multitude of actions that can be taken to protect youth from the dangers of nicotine. Significantly stronger enforcement is needed at retailers, both for age verification and to prevent the sale of illegal products.

    A strong FDA focused on hands-on enforcement is needed to ensure that nicotine companies operate responsibly and avoid appealing to underage consumers. We also need stronger import controls on these products, with illegal imports often coming from unfriendly nations. These common-sense actions can protect youth without dramatic costs to adult smokers.

    The public health conversation around nicotine has been unfortunately politicized, and we’ve lost sight of the most important goal: saving lives. Product bans and public policies targeting reduced-harm products would have material impacts on the options available to adult smokers while doing little to address the underlying factors enabling youth nicotine use in this country. Targeting some of the lowest risk tobacco products available is an unacceptable government overreach, serving political rather than public health goals.

     
     
    Catharine Dockery is the founder and general partner of Vice Ventures, a private equity firm that invests in good companies operating in superficially “bad” industries.

    Vice Ventures is the most active private equity nicotine investor in the U.S. The company approaches the sector through a harm reduction lens.

    Prior to founding Vice Ventures, Dockery was a member of Walmart’s mergers and acquisitions team. She also has experience in equity trading and high-yield research.

    Through her work on Vice Ventures, Dockery has been recognized in various media including in 2020 as a headline member of the Forbes 30 Under 30, an index that recognizes notable young people in various industries.

    Dockery graduated from The Gallatin School of Individualized Study at New York University, where she concentrated in the intersection of neuroscience and finance. She grew up in New York and loves a slightly dirty martini with olives on the side.
  • Tension in Panama

    Tension in Panama

    Photo: Claudio Teixteira

    The exclusion of Brazilian representatives from the recent WHO event sparks a debate on transparency.

    By Claudio Teixeira

    At the recent Conference of the Parties (COP10) to the World Health Organization Framework Convention on Tobacco Control (FCTC), held in Panama Feb. 5–10, the exclusion of Brazilian representatives from the state of Rio Grande do Sul, the epicenter of the tobacco industry, generated a wave of criticism for secrecy, exclusion and a lack of democratic transparency. The incident, marked by the refusal to accredit deputies, a state secretary and the press, reveals deep tensions in the global debate on tobacco control, casting doubt on the inclusiveness and openness of the international decision-making process. The controversy at COP10 underscores the challenge of redefining the fight against smoking concerning people, economies and local traditions.

    On the first day of COP10, an incident involving a group of parliamentarians from Rio Grande do Sul, a state in the extreme south of Brazil, highlighted the exclusionary, opaque and nontransparent nature of this important international event in addition to tensions between global health policy and the multiple interests at stake.

    The event aims to advance tobacco control policies, a topic of global importance given the impact of smoking on public health. Delegations from the state parties can participate. However, according to its regulations, the COP can invite other interested parties, such as intergovernmental and nongovernmental organizations, to participate as observers in its meetings. The exclusion of official representatives and the Brazilian press from the meeting generated controversy and heated discussions about democracy, transparency, the need for dialogue and the future of an entire production chain.

    Rio Grande do Sul, a region with a long tradition in tobacco production, found itself at the epicenter of this debate. In this southern state of Brazil, tobacco is not just an agricultural crop; for many rural families, it represents the backbone of their livelihoods, with the sector generating $2.4 billion in exports in 2023. Tobacco is strategically positioned in the regional economy, surpassed only by soy in export volume.

    The exclusion of political representatives and the Brazilian press from COP10 triggered a wave of outrage, highlighting a clash between those who can decide how global public health efforts will proceed and local communities’ social and economic realities.

    ‘Regrettable, Authoritarian and Intransigent’

    State and federal deputies along with the secretary of rural development of the government of Rio Grande do Sul, Ronaldo Santini, expressed their frustration, describing the WHO’s action as “regrettable, authoritarian and intransigent.” The refusal to allow their participation in the event was seen not only as an anti-democratic act but also as a sign of contempt toward communities that economically depend on tobacco cultivation.

    Federal legislator Marcelo Moraes was emphatic in his statement, underscoring the need to expand the debate to include additional dimensions, such as the economy and social aspects. He cited the situation in his region, where the livelihood of more than 70,000 households is sustained by tobacco production and more than 40,000 jobs are generated in its industry.

    Moraes expressed his skepticism about the seriousness and democracy of the convention, criticizing its tendency to marginalize sectors directly involved in the discussion. “This debate needs to be broader,” he said. “I don’t believe this convention is serious, I don’t believe this convention is democratic … it simply excludes those who have a direct interest in this discussion happening here.”

    The congressman also expressed his concern about the ongoing ban on electronic cigarettes in Brazil, noting the considerable number of users who turn to the illegal market to obtain these devices. He highlighted how this situation results in a loss of revenue for the country, which could even benefit from the export of these products. Moraes argued that the ban does not reduce the number of users and advocated for regulation that allows adjusting aspects of the product, which in turn could mitigate health risks and make it less attractive to minors and nonsmokers.

    Regarding the refusal to grant accreditations to participate in the event, the deputy pointed to the organization of the event as responsible, highlighting the role of Vera Costa e Silva, the former general secretary of the event and current leader of the National Commission for the Implementation of the Framework Convention on Tobacco Control in Brazil. The deputy suggested, with a sense of certainty, that her influence within the organizing group could be the reason for the exclusion, given her refusal to allow opposing voices in the discussion.

    Voices Unheard: The Exclusion of Rural and Worker Rights in Global Tobacco Control Dialogues

    Heitor Schuch, a federal deputy respected for his dedication to the rights and interests of workers and rural communities, seems to have a deep commitment to these sectors due to his frequent participation in various legislative commissions, addressing crucial issues such as family agriculture, rural development and environmental conservation.

    Under the scorching sun, outside the premises of the Panama Convention Center, the current leader of the Industry, Commerce and Services Commission in the Chamber of Deputies, Schuch did not hide his discontent and discomfort due to the refusal to allow him access to COP10 as an observer. The Gaucho legislator has clearly expressed his perception of a lack of welcome toward them, reflecting the climate of tension and exclusion that surrounded the event.

    Schuch highlighted that the World Health Organization, through the Secretariat of the FCTC, seems to focus unilaterally, ignoring the critical need for dialogue and transparency in international conversations on tobacco control, where all voices, especially those directly affected, should be heard and considered. He stressed that the WHO is omitting the voices of rural producers, industrial workers and residents of the municipalities where the tobacco-producing companies are located. For Schuch, the exclusion of these important sectors from the conversation is not surprising as it once again evidences a disinterest in including multiple perspectives in the debate.

    On the same day, the deputies’ nighttime visit to the Embassy revealed a complex stance by the Brazilian ambassador, Carlos Henrique Moojen de Abreu e Silva, regarding the exclusion of the delegation.

    Initially, Abreu e Silva offered his support to the delegation, but later, at the COP10 plenary, he emphasized the importance of adopting policies aimed at reducing tobacco production, including tax reforms and the continuation of the vaping ban in Brazil.

    These statements added a new dimension to the already tense debate on tobacco control policies, demonstrating the complexity of reaching a consensus on an issue that requires inclusive and thoughtful dialogue, taking into account both nicotine consumers and those involved in the tobacco production chain.

    Silencing the Press: The Unprecedented Exclusion of Journalists from COP10 and the Quest for Transparency

    Deputy Heitor Schuch shared that, although he had faced similar situations in the past, the recent exclusion of eight Brazilian journalists took him by surprise. He underscored a critical difference this time, highlighting that, unlike previous occasions, in Panama, there was an explicit prohibition against the presence of media.

    This fact highlights a new layer of opacity and control over information emanating from crucial events like COP10, where transparency and access to information should be fundamental pillars. The decision to block press access affects not only freedom of expression but also questions the openness and accountability of international discussions on public health policies.

    Schuch expressed his discontent with this measure, describing it as “regrettable,” especially because Brazil actively engages in promoting press freedom, ensuring its access to all kinds of events and activities. The participation ban in this context, according to the deputy, represents a clear concern that deserves serious and urgent dialogue with Brazil’s Ministry of Foreign Affairs.

    This call to action underscores the need to uphold the principles of transparency and freedom of information, fundamental in any society that prides itself on being democratic, especially in international forums where policies with significant global impact are debated.

    Among the media outlets whose accreditation remained “pending” are names like Ola Jornal, Folha do Mate, Radio Acustica FM, GZH, RBS TV and C3PRESS/The Vaping Today. This uncertainty regarding press participation reflects a broader conflict surrounding access to information and freedom of expression, essential in any debate of public relevance.

    The withholding of accreditations for these media further highlights the opacity with which the event was handled, raising questions about the willingness to facilitate an open dialogue and broad media coverage on public health issues and global tobacco control policies.

    One of the journalists excluded is Leticia Wacholz, the respected editor of Folha do Mate, a newspaper deeply rooted in the life of Venancio Aires city for its dedicated coverage of local interest issues. Her exclusion sets a disconcerting precedent, especially considering her previous participation in COP7 in India and COP8 in Switzerland, where she was accredited without any issues.

    This time, at COP10, the lack of a clear justification from the organizers leaves a void of uncertainty about the basis of this decision. “We meticulously fulfilled all the requirements, submitting the necessary documentation within the established deadlines, and yet, we have been denied entry,” explains Wacholz, visibly frustrated by this unexpected barrier that prevents them from carrying out their journalistic work from Panama, where they moved intending to inform their community about critical developments.

    The journalist underscored the importance of representing a region known for its tobacco industry, insisting on her commitment to offer balanced coverage that includes both public health implications and the interests of her community. “We know, of course, that we are journalists from a tobacco-producing region, but we also want to listen to the health side; it is very important to listen to the health side as well,” added Wacholz. She is aware that the decisions made in Panama will significantly impact her community.

    Her determination to gain access reflects a widespread concern for transparency and the right to information, cornerstones in public debate and the democratic exercise. Wacholz noted that she still hoped for a definitive resolution regarding her exclusion. She commented that the delegation of deputies was in the process of establishing communications that could pave the way for dialogue, possibly with the National Implementation Commission of the Framework Convention, representing the country’s delegation at the conference.

    The possibility of a meeting that opens doors to an understanding could not be confirmed, leaving in suspense the opportunity for excluded representatives and media to participate as observers and cover the global dialogue on tobacco control.

    This uncertainty underscores the critical importance of a firm commitment to inclusivity and transparency for the press in international forums, where policies affecting communities and economies worldwide are discussed. The lack of access for the Brazilian press at COP10 highlights the critical need for a review of the “approval” procedures by the FCTC Secretariat.

    Exclusion and Silence: The Controversial Interpretation of Conflicts of Interest at COP10 and Its Impact on Tobacco Control Dialogue

    A journalist who preferred to remain anonymous commented: “It’s not just individuals considered persona non grata, but all opposing voices are labeled under Article 5.3 of the FCTC, which excludes the participation of organizations or representatives with any connection to the tobacco industry. A journalist coming from a tobacco agricultural and industrial region like Rio Grande do Sul, who wishes to work and inform their community about what is being debated here, seems automatically placed in that conflict of interest, even if they have nothing to do with the tobacco industry.”

    This statement highlights the complexities and sensitivities around debates within the framework of the COP, illustrating how the interpretation of conflicts of interest can not only limit the diversity of perspectives but restrict the essential media coverage for a complete understanding of the topics under discussion.

    In Rio Grande do Sul, where these journalists and official parliament representatives originate, tobacco cultivation is at the pinnacle of family farming enterprises. The region boasts 65,000 producers dedicated to this crop, who in the 2022/2023 season achieved an impressive production of 300 tons, translating into revenues of BRL4.6 billion ($928.61 million). Additionally, the tobacco industry provides direct employment to approximately 25,000 individuals, underscoring its predominant influence on the local economy.

    The incident at COP10 highlights a global dilemma in the redefinition of Tobacco Control: the pressing need to rethink strategies worldwide and incorporate innovations in tobacco control that generate a tangible impact on the reduction of the global rate of diseases attributed to tobacco use. The organizers, under the pretext of avoiding the influence of the tobacco industry, have chosen to silence any critical or divergent voice and requests for debate, thus evading democratic scrutiny.

    The question spontaneously arises: How is it possible to implement effective public health policies in a framework of lack of transparency, closed dialogue and total secrecy?

    The challenge lies in finding a balance that benefits public health without compromising local economies, especially those revolving around controversial crops like tobacco. The exclusion of representatives from Rio Grande do Sul at COP10 uncovers not only a lack of commitment to democratic principles and diplomacy but also underscores the urgency for the WHO to foster open dialogue and develop policy strategies that harmonize global health goals with the economic needs of communities.

    This entails the implementation of integrative strategies that encompass the realities of people. It involves investing in education, ensuring the right to information, promoting safer alternatives to cigarettes and establishing an open and constructive dialogue forum, where all stakeholders, from nicotine consumers to small tobacco farmers and politicians representing thousands of people, are assured that their voices and needs are considered.

    In response to this situation, federal deputies Heitor Schuch, Marcelo Moraes and Rafael Pezenti along with state legislators like Edivilson Brum, Ze Nunes, Marcos Vinicius and Silvana Covatti expressed their protest through a note of repudiation, officially and firmly positioning themselves against the undemocratic stance of the FCTC Secretariat, since the event is financed with public funds. The WHO did not provide a specific justification for why the Brazilian deputies were prevented from attending COP10.

    Claudio Teixeira is a journalist, director of C3PRESS Agency and editor of The Vaping Today. He lives in Brazil.
  • Contemplating the Fallout

    Contemplating the Fallout

    Photo: bennyrobo

    What will the U.K.’s ban on disposable vapes mean for the next-generation nicotine industry?

    By Paul Hardman

    Prime Minister Rishi Sunak recently announced that the U.K. government would ban disposable vapes as part of its plan to tackle the rise in youth vaping. The new measures come as the government responds to a recent consultation on smoking and vaping, which, it says, indicated “overwhelming support” for a ban on disposables. What does this decision mean for the next-generation nicotine industry? And what may come next?

    As well as banning disposable vapes, the U.K. government will implement new powers to restrict vape flavors, introduce plain packaging and change how vapes are displayed. As part of the measures, the government is introducing new fines for shops in England and Wales that sell vapes illegally to children, with Trading Standards officers able to hand out fines on the spot on top of the up to £2,500 ($3,155.58) fines that local authorities can already issue.

    The government may use powers already established under the Environmental Protection Act to enforce the ban, which is expected to come into force at the end of 2024 or early 2025.

    Tackling Youth Access

    Back in 2019, the U.K. government launched its Smoke-Free 2030 ambition, which seeks to reduce tobacco smoking prevalence to below 5 percent by the end of the decade. Alternative methods of accessing nicotine, including vapes, are critical to achieving this smoke-free vision. However, the government’s position on vaping has come under increased scrutiny, partly because of a recorded growth in youth uptake.

    According to an ASH survey, titled “Use of e-cigarettes (vapes) among young people in Britain,” in March/April 2023, the proportion of children experimenting with vaping had grown by 50 percent year-on-year, from one in 13 to one in nine. In 2023, 20.5 percent of children had tried vaping, up from 15.8 percent in 2022 and 13.9 percent in 2020. Popular flavors among respondents included fruit (60 percent) followed by sweet or soft drinks (25 percent).

    The government reports that disposable vapes have been “a driving force behind the alarming rise in youth vaping, with the proportion of 11[-year-old] to 17-year-old vapers using disposables increasing almost ninefold in the last two years.” Some may feel that this trend has been driven by their convenience—they can be purchased, used immediately and discarded. It could also be due to their affordable prices, bright colors and flavor appeal. However, this convenience is important for offering smokers a safer, accessible alternative to combustible cigarettes. Therefore, a balance must be struck.

    On the other hand, pod-based systems are generally less convenient as these often require charging before use. Typically, pod-based systems carry a higher price tag for the whole system than a disposable product, and investment into a certain type of system is therefore required. Once the device has been selected, the user is tied to a particular range of pods. A consumer opting for the more expensive tank-type e-cigarette will need to navigate changing coils and different e-liquid types and strengths, making these more complex than using a disposable vape.

    In our experience, disposable products also tend to contain the highest allowed concentration of nicotine, 20 mg per milliliter, in the form of nicotine salts, which have been shown to be absorbed more rapidly than nicotine freebase and may result in greater nicotine dependence than products with slower uptake.

    The report also references the environmental impact, mentioning that 5 million disposables are discarded each week, the equivalent to the lithium batteries of 5,000 electric vehicles. These are stark figures and put the environmental impact into context.

    The Impact of the Measures

    Though the measures are specifically designed to tackle youth vaping, there will naturally be an impact on the industry as a whole. We may see surging youth popularity for modern oral nicotine pouches, new product categories emerging or a trend toward heated tobacco. It is important that these products do not follow the same path as disposable vapes in terms of youth appeal so that their access can be retained for adult smokers wishing to quit combustible cigarettes. This means robust regulation, regulatory enforcement and responsible behavior from manufacturers and retailers.

    Manufacturers of disposable vapes will now be looking for ways to engineer their products so that they can remain on the market. The technology used in disposable vapes is not necessarily disposable; the batteries are capable of many charge cycles, and it would not be difficult to engineer replaceable tanks. It may be that disposables manufacturers switch to reusable systems, such as pod-type vapes, and keep the look and taste as similar as possible to current products. The “new powers to restrict vape flavors” may be important in ensuring these amended devices are not as appealing to children.

    The government will need to set out a legal definition of disposable vapes and clarify how the ban and restrictions will be implemented. For instance, at this stage, it is unknown whether there will be any additional requirements regarding the notification process and whether manufacturers must submit additional product information to remain compliant with the Tobacco and Related Products Regulations 2016 (TRPR).

    Unless more detail is provided in the legislation, loopholes could appear that manufacturers and retailers might seek to exploit. For example, it is illegal to sell vapes to under-18-year-olds in the U.K., but retailers could still give out disposables to children as free samples. Following recommendations by the Khan review, in April 2023, the government announced that it would be closing this loophole.

    There are concerns among U.K. ministers that some manufacturers may adapt their disposable vapes to circumvent the ban. According to The Guardian, ministers are “eliminating ruses such as attaching charging points to them [disposable vapes].” Interestingly, when asked about manufacturers adding USB charging points to unrefillable vapes to avoid the ban, Health Secretary Victoria Atkins commented: “That’s incredibly cynical [to ask], and it shows, if you like, the battle that the government is prepared to take on.”

    There are also concerns that on-the-spot fines will not be sufficiently high to prevent unscrupulous retailers from selling to under-18-year-olds. After all, it is currently illegal to sell any e-cigarette to youth, but the problem prevails. With £30 million announced to fund HM Revenue and Customs, Border Force and Trading Standards, it will be interesting to see if the amount is sufficient to tackle the issue of illegally imported and sold products.

    It will also be interesting to see if any further measures are introduced for products popular with young people, perhaps to target reusable vapes that are specifically designed to look like something else a child might have on their person, such as a highlighter pen or mascara.

    Nicotine Pouches as “Vaping Alternatives”

    The government mentions that “Vaping alternatives—such as nicotine pouches—will also be outlawed for children who are increasingly turning to these highly addictive substitutes.” While introducing an age restriction is a sensible move, we will have to wait to see what additional regulations will follow for nicotine pouches. For example, whether there will be a cap on nicotine strength and a sensible approach to flavors/graphics and advertising—the sorts of restrictions that ought to be in place for all consumer nicotine products may help reduce youth appeal.

    It is important that nicotine pouches do not fall into the same traps as disposable vapes did. These products can be considered one of the lowest risk consumer nicotine products available, and their access must be maintained to aid adult smokers working to quit or reduce smoking.

    Where Manufacturers Can Go from Here

    In a letter to the Prime Minister, the U.K. Vaping Industry Association expressed its “profound dismay and disappointment” with the decision to proceed with a disposable vape ban. According to the letter, “This decision jeopardizes the significant progress made in reducing smoking rates in the U.K. and poses a threat to the well-being of millions of adults who have successfully quit smoking with the help of vaping.”

    However, it’s possible that a disposable ban could leave a gap in the market for tobacco harm reduction products that are not youth-appealing but appeal to smokers and are sufficiently effective in their nicotine delivery and taste to substitute traditional combustible cigarettes. Of course, all new consumer products will need to comply with the TRPR as well as the new measures that ban disposables, standardize packaging and restrict flavors.

    The Medicinal Pathway

    As the consumer nicotine market faces greater restrictions, we may see a growing number of manufacturers working to get their vapes approved as medicinal products in the U.K. As part of the U.K. government’s vision for a smoke-free future, the Medicines and Healthcare products Regulatory Agency is actively looking to approve e-cigarettes as nicotine-replacement therapies. If licensed as a medicinal product, e-cigarettes do not need to comply with the TRPR limits, such as the 20 mg per milliliter limit on nicotine concentration. The medicinal product route also makes products exempt from the new measures simply because they are not consumer nicotine products. However, the various requirements around marketing and advertising of medicines would apply instead.

    By following the Marketing Authorization Application (MAA) approval pathway, manufacturers can bring flavored, higher concentration nicotine e-cigarettes to U.K. smokers but with a more controlled marketing infrastructure that limits youth access. For instance, products that receive a marketing order under a General Sales license are subject to the same sales restrictions as over-the-counter pharmaceutical products like paracetamol, preventing minors from buying them.

    The medicinal product route gives smokers wishing to quit the confidence that the product has been developed, manufactured and tested to strict medicinal standards. With the ability to use higher concentrations of nicotine, there is the potential to make a product more effective in terms of nicotine delivery compared to consumer products.

    Early in an MAA application, manufacturers can partner with a scientific and regulatory compliance partner to support them through the process, from product design to regulatory approval, to improve their chances of success.

    Summary

    Backed by “overwhelming support,” the new ban on disposables is not without reason but not an approach Broughton advocates. As observed with other products and also reflected by the vaping industry in the U.S., prohibition is rarely effective and could set a dangerous precedent for the entire category. We agree with the sentiment of the new measures with regard to youth access but believe more detail is needed to prevent exploitation and to reassure manufacturers on how they can remain compliant with the TRPR and other relevant standards. Meanwhile, a blanket ban on disposables could spur innovation and the development of new medicinal products but only if manufacturers can access the right support.

    Broughton is modifying its compliance framework as new regulations develop to ensure that its nicotine consulting service complies with the latest guidance. To find out how this framework can support you, visit the Broughton website, www.broughton-group.com.

    Paul Hardman is a managing consultant at Broughton, an independent life sciences contract research organization offering analytical testing services integrated with scientific consultancy and global regulatory support.
  • Defending Liberty

    Defending Liberty

    Photo: Wieslaw

    The U.K.’s proposed generational tobacco products sales ban was variously described as nuts, insane, ludicrous, mad, illiberal, impractical and petty minded by speakers at a House of Commons reception on Feb. 7.

    The reception, which was lively, going on boisterous at times, was hosted by the Conservative MP Giles Watling on behalf of the Freedom Organisation for the Right to Enjoy Tobacco (Forest), whose director, Simon Clark, told the gathering of about 50 invited people the purpose of the event was to bring together a broad coalition of groups to show the breadth of opposition to the ban: the Institute of Economic Affairs, the Taxpayers’ Alliance, the Adam Smith Institute, the Consumer Choice Centre, Students for Liberty and the LSE Hayek Society.

    Watling, a non-smoker but at one time a 60-Marlboro-a-day man, described the proposed ban as insane and said it was not good for the Conservative Party. There were better things that it should be doing than this piece of legislation.

    The idea that there were more important things for the government to be doing was taken up forcefully by Baroness (Claire) Fox of Buckley, who sits in the second chamber, the House of Lords, as a non-affiliated life peer. After outlining some of the huge and urgent domestic and international issues facing the government, she said she found it unbelievable that the prime minister had dedicated precious legislative time and energy on the most ludicrous anti-smoking law.

    Clark, who organised the event, said that, in his view, smoking was a bellwether for liberty and that the war on smoking should be of concern to anybody who cared about individual freedoms. Freedom was all about supporting things that you yourself might not like, he added, before describing how a Forest banner showing a cartoon depiction of the prime minister, Rishi Sunak, pushing a pram under the heading, “Say No to Nanny,” had been confiscated by parliamentary security on the grounds that it might be offensive to some people.

    The generational tobacco sales ban as it is currently proposed would make it illegal to sell tobacco products to anyone born on or after Jan. 1, 2009, which, Clark said, would lead to the ludicrous situation where, for instance, at some point these products could be sold legally to a person of 30 but not to a person of 29.

    This would seem to put retailers in an invidious position and, given the U.K.’s dislike of identity cards, might perhaps sink the proposed ban if it were focused on any other product. But there was a sense that the ban would be difficult to stop. Fox made the point that the government might find it difficult to extricate itself from the proposed ban, even if it wanted to, because it was the one thing around which all the political parties had united.—George Gay