Tag: Clive Bates

  • Surfing while Juggling

    Surfing while Juggling

    Five types of innovation

    By Clive Bates

    Where does innovation in the tobacco and nicotine field come from? Is it the far-sighted senior executive assessing the needs of the evolving market and committing R&D budgets to realize the corporate vision? Or is it the genius scientists and engineers toiling 24/7 in the labs to invent the wonder product that will become The Next Big Thing?

    Both are caricatures, of course, but neither explains how innovation really works.

    In his brilliant book, How Innovation Works, author Matt Ridley points out that “Innovation is not an individual phenomenon but a collective, incremental and messy network phenomenon.” For those involved, I would say it is more like surfing while juggling than a straightforward path from idea to implementation. To see why, let’s look at five types of innovation in the tobacco and nicotine market.

    First, disruptive innovation. The most prominent recent case of disruptive innovation in the tobacco and nicotine field is the rise of electrical heating as an alternative to tobacco combustion to create an inhalable nicotine-bearing aerosol. Though the Chinese inventor Hon Lik is usually credited with inventing the e-cigarette, the truly disruptive innovation came before and from outside the tobacco and nicotine industry. It is what makes the e-cigarette and modern heated-tobacco products possible. The critical disruptive innovation was the lithium-ion battery. By the 2000s, battery technology had steadily progressed to achieve a sufficiently high power and energy density, allowing rapid heating and an adequately long life between recharges within a compact form factor. Developments in battery technology were driven by the demands of the giant and ultra-competitive markets for mobile devices like smartphones and tablets.

    For decades, the intense heat, complex reactions and chemical cocktail generated by the combustion of tobacco leaf at 900 degrees Celsius in the burning coal of a cigarette were unmatched and unmatchable as a means of delivering nicotine to the lungs. The combination of electrically heated coil and e-liquid to generate an aerosol is now competitive. The disruption of the dominance of the cigarette, currently underway and likely to last two decades to three decades, is driven by a fundamental energy transition that degrades the advantage of combustion.

    I refer to the second type as system innovation. This is the consequential economic, regulatory and public health reaction to the initial disruption and may involve hundreds of innovative responses. For example, the emergence of e-cigarettes triggered a creative response in the Stop Smoking Service in the city of Leicester, U.K. Under the leadership of its manager, Louise Ross, the service changed its practice to embrace vaping as a low-risk alternative to smoking that could appeal to many smokers who had previously been beyond the service’s reach. Through the power of example, that experience led to further innovation at the National Centre for Smoking Cessation and Training and with the government’s support to guidance on e-cigarettes issued by the National Health Service.

    But this innovation did not happen linearly, driven only by personal inspiration. It is best seen as “emergent,” arising from a wide range of concurrent changes and influences triggered within the public health ecosystem. The disruptive innovation also led to system innovations in regulation, such as the 2014 European Union Tobacco Products Directive. In 2016, the U.S. Food and Drug Administration’s deeming rule brought vaping products into the definition of tobacco products and under the jurisdiction of the Tobacco Control Act. The initial disruptive innovation also led to innovation in the business models of tobacco companies, but also in the tactics of their traditional adversaries. Tobacco companies started moving their business toward a future in noncombustible nicotine products, and the anti-tobacco groups shifted their focus from preventing disease to fighting nicotine addiction.

    For tobacco and nicotine companies, the disruptive innovation and the system responses it triggers are like a “big wave,” both prized and feared by top surfers. Like a wave, the companies didn’t create it and can’t control it, but their challenge is to catch it, ride it well and not wipe out. The case of Kodak and its destruction under the breaking wave of digital photography is probably the most cited case of an innovation wipeout. But it doesn’t have to be a technology shift. In the 1970s, deregulation in the aviation sector enabled the emergence of the innovative low-cost airline business model. It wasn’t long before major airline incumbents were going under as that big wave gathered pace.

    The disruptive and systems innovations generate a changing paradigm: a big wave of opportunity or destruction that businesses must learn to surf. But why does innovation feel like juggling while surfing? The juggling reflects the frenetic activity of keeping a company moving, in financial balance and ahead of its rivals while it navigates a radically changing context. This brings us to three further types of innovation: the innovation occurring within the changing paradigm.

    So, the third type of innovation is evolutionary. It resembles the Darwinist process of evolution in nature. Here, the consumer provides what evolutionary biologists call selection pressure, and innovation emerges from incremental improvement through trial and error, mirroring what biologists recognize as mutation and natural selection. It will usually be incremental, but its impact will not always be gradual. Evolutionary innovation can make radical inroads into a market by solving a particular problem or exploiting an opportunity.

    A good example is pod-based vaping products using nicotine salts. Salts change how nicotine is absorbed in the airways and allow users to consume smaller volumes of higher strength liquids. The effect of the salts is to allow high-strength nicotine liquids to be used without undue harshness with a smaller battery and tank, enabling a compact and convenient device. This addressed the challenge of providing a convenient and discreet product with effective nicotine delivery. It was wildly successful—at least where regulators allowed it.

    I have seen much handwringing about the recent rise of disposable vaping products. But this is another case of evolutionary innovation. The disposables solve the problem of finding a quick and convenient way into vaping for smokers in the early or tentative stages of switching away from smoking. They are simple to use, low cost and convenient. They don’t require an upfront investment in a device, so they lower the cost of consumer trial and experimentation. Like many innovations, these products have downsides, such as the waste generated. But this is manageable and must be set against the potential benefits and in context with other waste material flows.

    The fourth type of innovation is adaptive. This is a variation of evolutionary innovation, but it arises in response to regulation. Ultimately, it is driven by meeting consumer preferences, but it is triggered by regulatory interventions that would otherwise compromise the consumer experience—ether by design or as an unintended consequence. One example is the mentholation cards that emerged after the European Union ban on menthol-flavored cigarettes. These are inserted into cigarette packs to infuse nonmenthol cigarettes with menthol flavor. Another case is the “shortfill” e-liquid containers that became popular as a workaround to overcome the European Union ban on e-liquid containers of more than 10 mL volume. Much larger containers of nicotine-free vaping liquid are sold only partially filled, allowing the nicotine to be added later—often from nicotine liquids stronger than permitted in the EU.

    As the FDA imposed ever more burdensome regulation on nicotine vapes, small companies introduced synthetic nicotine products because the law confined FDA jurisdiction to nicotine derived from tobacco. This example also illustrates the arms race fought between adaptive innovators and responsive regulators. By March 2022, the FDA had prompted Congress to amend the Tobacco Control Act to apply to nicotine derived from any source, not just tobacco. Adaptive innovations can come with novel risks. For example, regulated bans on flavored e-liquids may lead to consumers adding food or aromatherapy flavoring agents not necessarily intended for vaping.

    The fifth type of innovation is user-driven. The early vaping enthusiasts were hybrid producer-consumers, interacting on user forums with a strong problem-solving ethos and a hands-on approach to product design and construction. Users created innovations like “squonkers” or “squonk mods” to facilitate dripping, a niche style of vaping, by incorporating a flexible liquid bottle into the design of the vaping device. But the most impressive innovations from the user side have been social and community in nature. The vaping forums and vape meets created an elaborate technical and moral support infrastructure. This online community blossomed into vape shops as centers of expertise, personalization and encouragement. The vape shops are now de facto cutting-edge stop-smoking services but with a very different offer to the more clinical settings of traditional services. Even the biggest corporate beasts benefit and learn from user innovation. They should take care not to crush it.

    Innovation is a fluid and dynamic business phenomenon with many simultaneously moving parts embedded in an unpredictably evolving, threatening or promising context. Surfing while juggling is hard and risky, but it is no longer a choice in the tobacco and nicotine business.

  • Harm Reduction Advocates File Fourth MDO Amicus Brief

    Harm Reduction Advocates File Fourth MDO Amicus Brief

    Several court cases challenging the U.S. Food and Drug Administration’s issuing of marketing denial orders (MDOs) in response to its review of premarket tobacco product applications are still pending. Last week, three high profile tobacco harm reduction advocates filed their fourth amicus brief in support of companies that are challenging the FDA.

    scales of justice
    Credit: Sang Hyun Cho

    Clive Bates, director of Counterfactual Consulting, David Abrams, a professor of social and behavioral sciences at the NYU College of Global Public Health, and David Sweanor, adjunct professor of law at the University of Ottawa, filed the latest brief in support of Chicago-based Gripum LLC, which has had its MDO temporarily stayed by the court while the FDA’s actions are reviewed.

    “The PMTA process and [appropriate for the protection of public health] APPH test do not apply to combustible cigarettes, which have a much less onerous path to market; accordingly, the most dangerous products are easily accessible throughout the United States, and their manufacturers do not face the threat of financial ruin from FDA’s regulatory burdens and determinations,” the brief states. “FDA’s regime for evaluating ENDS amounts to a major barrier to entry for less harmful products than cigarettes and unjustified regulatory protection of the incumbent combustible cigarette trade. The harms arising from adult and adolescent cigarette smoking far outweigh the harms arising from youth use of ENDS.”

    The group also addressed the FDA’s having established an onerous new standard of evidence in PMTAs. The FDA has admitted to using a “fatal flaw” checklist to deny over one million PMTAs without further consideration because they do not provide randomized controlled trials, cohort studies, or other types of (unspecified) evidence that FDA had retrospectively deemed necessary. They also state that the APPH test doesn’t differentiate between adults and youth.

    “The APPH test applies to the ‘population as a whole.’ There is no distinction drawn between adolescents and adults in the Act. In some circumstances, ENDS use can be beneficial to adolescents who would otherwise smoke,” the brief states. “As a matter of policy, FDA chooses to take no account of such benefits to youth, but that approach is incompatible with the APPH test in either the PMTA pre-market review process TCA §910(c)(4) or in rulemaking for setting product standards §907(a)(3).”

    The group filed similar briefs in three other cases: Triton v FDA – Fifth Circuit (17 Nov 2021), My Vape Order v FDA – Ninth Circuit (24 Nov) and Bidi Vapor v FDA – Eleventh Circuit (24 Nov).

  • Bates: Selling VLN Diverts Smokers From Better Choices

    Bates: Selling VLN Diverts Smokers From Better Choices

    Photo: 22nd Century Group
    Clive Bates

    The U.S. Food and Drug Administration’s decision to allow 22nd Century Group to market its low-nicotine cigarettes as reduced-risk products will spread confusion and divert smokers from better choices, according to Clive Bates, director of The Counterfactual.

    On Dec. 23, the FDA authorized the marketing of 22nd Century Group’s VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products (MRTP). As part of the MRTP designation, 22nd Century may inform consumers that smoking VLN cigarettes will considerably reduce their exposure to nicotine.

    According to Bates, the FDA decision is misguided because the cigarettes retain the tar that is responsible for smoking-related illness. “We have known for a long time that ‘people smoke for the nicotine but die from the tar,’” writes Bates on his blog.

    “The only value these products have in public health terms is if smokers don’t use them because they are so unsatisfying, and switch to something with lower risk. If they do use them, they are still exposed to thousands of toxins from smoke,” writes Bates. “However, the purpose of the marketing communication is precisely to encourage people to buy these products.”

    If smokers want to reduce their health risks, they are far better advised to switch to a non-combustible vaping or heated tobacco product, according to Bates.

    “So for health-conscious smokers, this is a diversion from a strategy that would actually help them. Instead, the authorized claims falsely promote reduced nicotine exposure as a health benefit.”

  • Bates: COP9 is ‘Closed Bubbles of Cultivated Groupthink’

    Bates: COP9 is ‘Closed Bubbles of Cultivated Groupthink’

    Credit: Artur

    In a new blog post, tobacco control advocate Clive Bates says that the World Health Organization’s tobacco control treaty meetings are “closed bubbles of cultivated groupthink.” Bates compares the United Nation’s climate change treaty with its tobacco control treaty , claiming the two groups use science and logic in completely different ways.

    “At the start of COP9, the head of the [Framework Convention on Tobacco Control] FCTC convention secretariat proudly drew a comparison with the other COP, the one going on in Glasgow dealing with the UN Framework Convention on Climate Change (UNFCC),” Bates writes. “Perhaps she hoping some of the interest in UNFCCC COP-26 would rub off on the altogether more tawdry FCTC COP-9. But the tobacco COP takes an aggressive exclusionary and insular approach to stakeholders that would never be tolerated in the climate COP.”

    clive bates
    Clive Bates

    There is a sharp contrast between the climate COP meetings and tobacco COP meetings, according to Bates. The FCTC tobacco COP has “highly restrictive and opaque practices” that ensure that it operates as an “echo chamber populated by compliant observers.” He says that the COP9 chooses so-called “civil society” organizations according to their willingness to support the FCTC and contribute to its implementation.

    “It excludes many legitimate perspectives: notably consumers, pro-harm reduction public health experts, policy think tanks and critical economists, libertarians, and commercial entities affected by decisions made by COP,” he says. “For this COP, the FCTC process will be used to exclude several organizations and bolster the groupthink bubble … This insularity is not a feature of the UNFCCC climate COP meetings. A comparison with the UN Framework Convention on Climate Change is revealing.”

    In the FCTC, any non-governmental organization (NGO) can be refused observer status at the request of a single party. NGOs are required to be international and committed to tobacco control, ruling out most consumer organizations who see themselves as victims of tobacco control. NGO observers are required to file reports on their activity with the Secretariat for approval. 

    “The Secretariat then makes recommendations about who should be granted observer status, retained as observers, or expelled,” he says. “The ‘civil society’ organizations chosen are mainly grant-funded tobacco control organizations, often with bizarre views about public health that bear little relationship to the norms in the countries they come from or anything like good practice in policy and science.”

  • An Error in Judgment

    An Error in Judgment

    A new Yale University study shows that flavor bans cause an increase in underage smoking.

    By Maria Verven

    A new study by the Yale School of Public Health suggests that San Francisco’s ban on sales of flavored tobacco products may have substantially increased smoking among minors. When San Francisco voters approved a ban on the sale of flavored tobacco products, including menthol cigarettes and flavored e-liquids in 2018, public health groups prematurely celebrated another “win” in their battle to reduce teenage vaping.

    Now advocates of the ban must come to terms with the fact that the flavor ban, and most likely similar flavor bans around the world, are inextricably tied to significant increases in teenage smoking rates. According to the study, the odds that high school students would start smoking conventional cigarettes doubled in San Francisco’s school district after the ban was put into effect when compared to districts that didn’t implement a flavor ban, even when adjusting for individual demographics and other tobacco policies.

    A Threat to Public Health

    Published in JAMA Pediatrics in May 2021, the sole author of the study, Abigail Friedman, associate professor in the Department of Health Policy and Management at the Yale School of Public Health, said the study is the first to assess how complete flavor bans affect youth smoking habits. “These findings suggest a need for caution,” she said. “Even if it is well-intentioned, a law that increases youth smoking poses a threat to public health.”

    Before the ban was implemented, smoking rates in school districts in and around San Francisco were on the decline. Using data on over 95,000 youth from the Youth Risk Behavior Surveillance System’s 2011–2019 school district surveys, Friedman compared trends in smoking rates in San Francisco versus other districts. The findings revealed a glaringly large discrepancy after the flavor ban went into effect. In 2019, San Francisco’s smoking rates rose to more than twice the average of school districts without a flavor ban. In those districts, smoking rates among youth continued to fall.

    E-cigarettes—and particularly those with flavors—have been the most popular tobacco product among U.S. youth since at least 2014. “Some kids who vape choose e-cigarettes over combustible tobacco products because of the flavors,” Friedman said. “For these individuals, banning flavors may remove their primary motivation for choosing vaping over smoking, pushing some of them back toward conventional cigarettes.”

    Michael Siegel, professor in the Department of Community Health Sciences at Boston University School of Public Health, said society is at a critical juncture with regard to youth smoking. “It has plummeted to record lows and on top of that, a culture of vaping has completely replaced the culture of smoking,” he said. “The policies enacted in the next year could likely decide what happens next.”

    Huge Policy Implications

    Credit: JAMA Pediatrics

    The results of the Yale study should have huge implications for other states and even other countries when deciding to ban flavored vapes. According to the National Conference of State Legislatures, five states—California, Massachusetts, New Jersey, New York and Rhode Island—have implemented laws banning flavored electronic nicotine-delivery systems (ENDS), and at least 310 localities have passed restrictions on menthol cigarettes and/or flavored tobacco products (including e-liquids), although these laws vary widely.

    The U.S. Food and Drug Administration implemented a partial ban on the sale of flavored closed-system e-cigarette products in January 2020. The FDA ban exempts menthol and tobacco flavor as well as open tank vaping systems, which tend to be sold in vape shops where age restrictions are more often enforced.

    Members of Congress have been pressuring acting FDA Commissioner Janet Woodcock to ban all flavored e-cigarettes, maintaining that flavors are attracting youth to ENDS products. Woodcock has not indicated whether the agency has plans to ban or otherwise limit the sale of flavored vapes, but a decision could be made this fall.

    When asked to comment on the trend that youth use of cigarettes was declining while their use of ENDS products was on the rise, former FDA Commissioner Scott Gottlieb said the trends are not acceptable, even if they are moving in a more positive direction of reduced overall use of tobacco products. “Even if kids are using ENDS [products] instead of cigarettes—and that migration in part accounts for the decline in youth [combustible] cigarette use—that’s still not an acceptable trade,” he said.

    Clive Bates, a tobacco harm reduction expert and former director of Action on Smoking and Health U.K., called this argument outrageous, adding that just because a regulatory agency believes young people should not smoke or vape does not mean that is how it plays out in the real world. “Public health is about dealing with the world as you find it—not giving instructions to people who are not listening, uninterested in your views and unimpressed by your authority,” said Bates. “But that doesn’t mean a regulator is absolved of responsibility for the consequences (good or bad) of its actions.”

    Since Gottlieb essentially said that the FDA doesn’t care if vaping is helping to reduce smoking, Bates says the FDA is ignoring a big public health benefit that has been a goal of U.S. policy for decades. “The dangerous corollary is [that] the FDA doesn’t care if their anti-vaping measures increase smoking among adolescents. That’s what is so despicable about this lofty attitude—it’s an indifference to the group most at risk,” Bates said. “Yet the FDA doesn’t care if vaping works as an alternative to smoking for adolescents—and this is deeply unethical.”

    Generally, regulators do not allow adolescent experimentation to bend adult society and legitimate choices out of shape, especially if these are beneficial to adults, according to Bates. “It should not be taken as a given that adult products that appeal to adolescents should be banned. For many, it is part of being a teenager to sample the forbidden fruits of adulthood,” Bates explains. “We don’t respond to youth experimentation by banning other potentially harmful adult products like alcohol or cannabis just because adolescents use them,” Bates said. “Though it has risen sharply, vaping is not out of the ordinary compared to the prevalence of other risk behaviors. But crucially, it does not actually pose much risk.”

    Decisions That Kill

    In June, Health Canada admitted in a regulatory impact statement that its intended flavor ban could lead to an increase in the smoking rate. David Sweanor, an industry expert and chair of the advisory board for the Centre for Health, Law, Policy and Ethics at the University of Ottawa, said that the Health Canada statement is basically saying Canadian regulators know they are going to do something that kills Canadians.

    “Countries that simply allow alternatives, even without actively facilitating substitution, are seeing dramatic declines in cigarette sales,” Sweanor said, citing Japan, where cigarette sales over the past five years declined at a very rapid pace—far greater than declines in other countries, including the U.S. “I think the biggest constraint on progress is a lack of understanding of the magnitude of substitution effects. To dramatically reduce the use of lethal cigarettes, we need products that are less hazardous and evidence that consumers will switch to them in sufficient numbers to justify substitution as a policy intervention.”

    Sweanor said efforts that show the extent of substitution effects are blocked by the absence of funding for such research, obstruction from the anti-vaping moralists and those pursuing a “tobacco-free world” agenda. He also believes that tobacco companies may be reluctant to release sales and consumer research data that would bolster policies designed to undermine their lucrative cigarette business. “Jurisdictions that allow viable alternatives to cigarettes, where such products are as accessible as cigarettes and consumers aren’t given misleading information on relative risks, will see far more rapid declines in smoking,” Sweanor said.

    Friedman said the findings from her study strongly suggest that policymakers should be careful not to inadvertently push minors into using the more harmful product. When asked to suggest an alternative policy, she suggested that states consider restricting all tobacco product sales to adult-only (21-plus) retailers. “This would substantively reduce adolescents’ access to tobacco products at convenience stores and gas stations without increasing incentives to choose more lethal combustible products over noncombustible options like e-cigarettes,” she said. 

    Sweanor added that good policies are contagious and would be replicated. “I am confident that science and rationality combined with consumer advocacy will ultimately win,” he said. “Unfortunately, those opposing such policies can cause lengthy delays, which can result in a tragic and avoidable loss of life.”

    Science, Reason and Humanism

    Abigail Friedman, PhD

    Seigel says that there is hope that the Yale study impacts future decisions regarding flavor bans; however, the mainstream anti-tobacco groups are not going to publicize the study because it goes against their preordained conclusions. “If flavor bans are widely adopted, I suspect that many youth who are experimenting with vaping will switch over to cigarette smoking and some will use THC vapes off the black market,” he said. “In contrast, with sensible policies that restrict e-cigarette availability to youth while allowing adult smokers to continue to access them, I think we could drive youth smoking pretty much into the ground—perhaps to a level from which it could never recover.”

    Bates questioned how regulators and lawmakers alike could continue with confidence in implementing flavor bans after seeing the results of the Yale study. He added that he seriously questions whether legislators will admit that the ban was a bad idea and reverse course.

    “It may put the brakes on some of the worst policy mistakes,” he said. “It’s what many of us have been saying should be expected from a flavor ban. But legislators hate to admit they were wrong, so it will probably lead to calls for tougher enforcement and anti-smoking campaigns rather than realizing that the whole idea is wrong.”

    In jurisdictions where viable alternatives to combustible cigarettes are made available, data has shown that the rates of combustible cigarette smoking among youth and young adults is plummeting, according to Sweanor. “More importantly, we are seeing longer term cigarette smokers whose lives are truly on the line, substituting low-risk alternatives,” he said. “People’s response to research depends on motivations. There is a very long and frustrating history of reduced-risk alternatives to cigarettes being attacked by those on a moralist quest to rid the world of nicotine.”

    Vaping products are attacked based on accusations about formaldehyde, popcorn lung, e-cigarette or vaping use-associated lung injury (EVALI), cognitive impairments and a seemingly endless list of other supposed hazards, Sweanor explained, adding that these arguments are ultimately shown to be meritless, but vaping opponents never admit to being wrong.

    “Such behaviors are hallmarks of conspiracy theorists and those seeking to use the power of the state to impose their moral views on the behavior of others. But where lawmakers are open to science, reason and humanism, studies such as this … [Yale study] are very important,” said Sweanor. “Public health breakthroughs are possible when rational lawmakers get past the panics caused by the moralists. We are staring an historically significant public health breakthrough in the face. The sooner lawmakers recognize this, the sooner we can relegate cigarettes to history’s ashtray.”

    The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.

  • Bates: Complaints About ‘Special Juul Issue’ Absurd

    Bates: Complaints About ‘Special Juul Issue’ Absurd

    Clive Bates

    Recent complaints about The American Journal of Health Behavior “Special Issue on Juul” are absurd, anti-scientific and somewhat disturbing, according to Clive Bates, director of The Counterfactual.

    In a letter to the editor, Bates said the Juul Labs monograph provides highly salient information on changes in smoking status, drivers of transition, population health impact and retailer behaviors. “The summary for the introduction to the series should be enough to whet the appetite of the genuinely curious and scientifically engaged,” he wrote.

    According to Bates, the fact that research is done by company in the nicotine-delivery business does not invalidate the findings. In his view, Juul’s scientists have done excellent work that stands on its merits and has now been published after thorough peer review in a reputable journal with transparent disclosure of its provenance.

    “The real question here is why these tobacco control activists show so little curiosity about the changes that are reshaping the U.S. tobacco and nicotine market,” he wrote. “As Juul rose in popularity, we saw unusually rapid declines in cigarette sales and smoking prevalence in both adults and adolescents.

    “The right response to that is to want to know more. The wrong response is to try to suppress or discredit informative data and analysis just because it tells a story that is at variance with a narrative about the evils of both e-cigarettes and the companies that make them.”

  • Video: VApril and Debating the ‘State of Vapor’

    Video: VApril and Debating the ‘State of Vapor’

    Industry experts debated the challenges and opportunities facing the vapor business to mark the start of VApril 2021, the annual awareness campaign launched four years ago by the U.K. Vaping Industry Association (UKVIA) to help educate smokers on how to successfully quit conventional cigarettes by transitioning to vaping.

    Participants in the debate included John Dunne, director general of the UKVIA; Mark Pawsey, MP and chair of the All-Party Parliamentary Group for Vaping; Patricia Kovacevic, global legal and regulatory strategist at Andina Gold Corp.; and Clive Bates, director of Counterfactual Consulting and former director of Action on Smoking and Health.

    The discussion centered around the repercussions of the pandemic on the vaping industry and vapers; how the sector moves on from the events of the last 12 months; how regulatory review this year and COP9 can be a defining moment and accelerate the shift toward a vaping-driven smoke-free society; addressing the misperceptions of vaping, which are deterring adult smokers from making the switch to less harmful alternatives; and the opportunity for the VApril campaign to take the mantle and in the future make smoking in Britain a thing of the past.

    The 2021 VApril month-long initiative will for the second year running be largely digitally based due to the Covid-19 lockdown restrictions. Vape businesses up and down the country, together with vaping trade associations around the world, are getting behind the special month.

    Smokers can visit a special campaign VApril website, which provides a special guide, the Switch on to Vaping Plan, to help them make a successful switch to vape products and in doing so break their smoking habits. They can also have their questions answered by an online expert panel.

  • GTNF: Future of Nicotine Industry is Less-Risky Products

    GTNF: Future of Nicotine Industry is Less-Risky Products

    vapers in bar

    With clearer information, more smokers would switch to lower-risk products.

    By VV Staff

    There are several reasons why people use nicotine. According to Neal Benowitz, professor of medicine, biopharmaceutical sciences, psychiatry and clinical pharmacy at the University of California San Francisco, those reasons include pleasure, stimulation and mood modulation. However, many users don’t understand the adverse effects and risks associated with different delivery mechanisms.

    “Clearly, the decision involving long-term use of the drug for individuals or society depends, at least in part, on adverse health effects. For example, the casual use of cocaine or heroin are discouraged by society because they are hazardous to health,” explains Benowitz. “We know nicotine, per se, is much less hazardous than cigarette smoking, regardless of potential health concerns. That’s a successful argument for electronic nicotine-delivery systems [ENDS].”

    Speaking at a panel titled, “The Future of Nicotine,” during the 2020 Global Tobacco & Nicotine Forum (GTNF) in September, Benowitz said that one of the major questions surrounding tobacco control is whether society can accept nicotine use if the harms were reduced. He says that possibility exists. “The FDA [U.S. Food and Drug Administration] can be a big part of making this happen … there is a misconception surrounding the harm of nicotine compared to combustible products,” which are more deadly than ENDS.

    While acknowledging the validity of Benowitz’ point, Michael Cummings, professor of psychiatry and behavioral sciences at the Medical University of South Carolina, cautioned against the unintended consequences of regulation. Banning a specific delivery mechanism for nicotine, he said, presents a risk. Cummings referred to the FDA’s vision, formulated in 2017, of a world where cigarettes would no longer create and sustain addiction and where adults who need or want nicotine could get it from less-harmful alternative sources.

    “But it seems like we’re going the wrong direction … If we adopt regulations to ban the sale of vaping products as some states and many countries around the world have done, what would be the effect? Well, the effect is that cigarette sales will go up,” said Cummings. “That’s a bad thing. Regulating vaping products like they’re cigarettes—which they’re not—banning flavors, banning internet sales … [these actions] would have a detrimental effect of actually driving up cigarette sales to the detriment of the lower-risk products.”

    Also speaking during the GTNF panel, Clifford E. Douglas, director of the Tobacco Research Network and an adjunct professor of Health Management and Policy at the University of Michigan School of Public Health, said that consumers clearly need a much better understanding of the true nature, including the relative risk, of different tobacco and nicotine products.

    “This includes the fact that nicotine is the root cause of the epidemic of tobacco-related illness and death because it hooks in smokers and keeps many smoking who otherwise would quit,” he explained. “While complete information on all the potential risks and benefits of [vapor products] is not yet available, there is sufficient information … to end deadly combustible tobacco use [which is] responsible for approximately half a million deaths a year and 30 percent of all cancer deaths in the United States.”

    Asked by moderator Clive Bates, director of Counterfactual Consulting, whether there was a regulatory environment possible that incorporated the relative risk of the different types of nicotine-delivery systems, Stefanie Miller, managing director of FiscalNote Markets, said “no.”

    “[There is] no trust among the general public for companies that produce a product containing nicotine, and that is largely based on a misconception around the difference between nicotine and combustible tobacco use. After predatory behavior and negligence of tobacco companies in the 20th Century, most people see this as very black and white. Tobacco companies are bad, and anti-tobacco efforts are purely good,” said Miller. “I think [everyone] who’s tuned in right now knows that the situation is far more nuanced and … the regulations are not accommodative of that nuance.”

    Benowitz says that another major problem with the message on less-risky nicotine products is that there is very little science on the long-term effects of ENDS products. “We have an array of new products, any of which are inhalable,” he said. “We have a lot of short-term data that is promising in terms of reduced exposure in the short term, but we really don’t know about the future long-term consequences.”

    Miller added that cigarette manufacturers could help change the misconceptions surrounding nicotine. It’s the large manufacturers who could make it a goal to end combustible nicotine-delivery systems. “If you’re really clear about setting a strategic goal, and then you do everything possible to accomplish it, you’re more likely than not to win,” she said. “I think that this is [an] important enough [goal] to try.”

    Benowitz said that regulators need to help consumers better understand that the regulators support a shift to less-risky products. He says that only then can the goal of getting rid of combustible products be accomplished.

    “We’re not doing this because nicotine is bad,” he said. “We’re doing this because nicotine sustains harmful cigarette smoking … there are other products that [can deliver] nicotine that are much less harmful.”