Category: Print Edition

  • Acting Unnaturally

    Acting Unnaturally

    Photo: artefacti

    Synthetic versus tobacco-derived nicotine

    Cheryl K. Olson and Willie McKinney

    Every year, the National Youth Tobacco Survey gathers data from U.S. middle school and high school students about all sorts of nicotine products and how they’re used. In 2021, for the first time the most popular brand of e-cigarette among underage users was a synthetic nicotine vape. Puff Bar was named “usual brand” by 26.1 percent of underage vapers, equaling the sum of the next three most popular brands: Vuse (10.8 percent), Smok (9.6 percent) and Juul (5.7 percent). While the summary of these latest findings in Morbidity and Mortality Weekly Report didn’t mention the word “synthetic,” the U.S. Food and Drug Administration certainly took note.

    One reason the FDA pricked up its ears is that synthetic nicotine, also known as nontobacco nicotine, lives in a legal gray area. The Family Smoking Prevention and Tobacco Control Act of 2009 expanded the FDA’s authority to regulate products “made or derived from tobacco” and created its Center for Tobacco Products.

    This begs the question of whether the FDA has regulatory authority over synthetic nicotine. Predictably, manufacturers who use it in ENDS products claim that the FDA does not have that authority. If that’s true, those manufacturers can bypass the lengthy and expensive premarket tobacco product application process and go directly to market. But there are others, including attorneys who’ve studied this law, who believe that even if synthetic nicotine is technically not covered by the 2009 Tobacco Control Act, it meets the definition of a drug and is therefore subject to FDA regulation.

    The substitution of synthetic nicotine for tobacco-derived nicotine has profound implications both for manufacturers and distributors of reduced-harm nicotine products. Is it a smart workaround, a temporary shelter or a costly dead end? Here are some of the key issues as well as ways to limit your risk as a company.

    The Options

    Over the past few months, many makers of flavored e-cigarette products have received marketing denial orders (MDOs) or fear receiving one. An MDO gives that manufacturer a limited number of choices: reapply for approval, get out of the business or sue the FDA for redress—or search for what it hopes is a legal loophole to the FDA’s regulatory authority. Hence, the move to synthetic nicotine as a too clever by half solution that carries with it underlying scientific, economic, legal and ethical issues.

    Let’s start with an economic issue, which may trump all the others. Synthetic nicotine is expensive. In fact, it’s up to 10 times the cost of tobacco-derived nicotine, according to Kevin Burd, CEO of North America Nicotine. One reason is that tobacco-derived nicotine is made from leftover scraps from processing tobacco leaves—often literally the stuff left on the factory floor. Synthetic nicotine, most of which is manufactured in China, is created through a variety of proprietary chemical processes.

    “As volumes increase, I can’t see the price of chemicals used in synthetic coming down to the price of waste tobacco, including dust,” said Burd. “It’s highly unlikely ever to be competitive.”

    Both synthetic nicotine and tobacco-derived nicotine occur in two structural forms (enantiomers) known as R-nicotine and S-nicotine. More than 99 percent of the nicotine in tobacco is S-nicotine. In synthetic nicotine, that balance can be 50-50.

    “Little is known about the pharmacological and metabolic effects of R-nicotine in humans,” says a 2021 article on the rise of synthetic nicotine  in Tobacco Control (Jordt SE. Synthetic nicotine has arrived. Tobacco Control 2021. doi: 10.1136/tobaccocontrol-2021-056626). In other words, synthetic product users could be unwitting research subjects. There are inexpensive tests for distinguishing between R- and S- forms of the chemical and ways of separating the R-isomer from the S-isomer. By comparison, telling the difference between synthetic S-nicotine and tobacco-derived S-nicotine can be quite costly.

    This leads to an interesting paradox. We don’t know how much of the supposed synthetic nicotine is actually tobacco-derived nicotine. There’s a financial incentive for a manufacturer simply to replace the more expensive version with the cheaper chemical and mislabel it. In fact, on its website, Next Generation Labs warns prospective customers, “There are several companies from China claiming to have synthetic nicotine. NGL has tested several of these products and discovered they are made or derived from tobacco.”

    Burd adds, “Quite likely, many [products that claim to be synthetic] are not really synthetic.”

    Some companies are weighing the cost of regulatory compliance versus the higher manufacturing cost of using synthetic nicotine. That’s a false choice, for it underestimates the costs of unknown safety risks, product testing and emerging regulations. Simply marketing a new synthetic nicotine product without providing the necessary scientific and behavioral research data to the FDA will, at the very least, generate a warning letter.

    Remember that the key reason for generating research data on a new product is to explore whether it will harm people. The FDA uses the term APPH (appropriate for the protection of public health). Not doing so puts your business at risk not only from regulatory actions but from civil litigation if someone gets hurt.

    A regulatory update by FDA Center for Tobacco Products Director Mitch Zeller at an Oct. 27 Food and Drug Law Institute conference addressed the challenge posed by synthetic nicotine. Zeller’s slide deck makes clear his belief that e-liquids that do not contain tobacco-derived substances “may still be components or parts of tobacco products and, therefore, subject to FDA’s tobacco control authorities.” It also states that the FDA is “in discussions with Congress about a potential legislative fix.”

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    The Wild West

    Burd expressed concern that synthetic nicotine, and the regulatory uncertainty driving its use, have put the vaping industry “back to the Wild West.” Even the pure S synthetic may contain residues from the unknown solvents that some new manufacturers use. Burd recommends that manufacturers who use synthetic nicotine “test their incoming material (emphasizing impurities and solvents), audit the supplier, do a toxicology review for product safety and be sure to use S-nicotine only.”

    That type of analysis is impractical for end users, of course.

    Finally, there’s the issue of whether a company is a “bad actor” that focuses on short-term financial profits at the expense of both public health and the lives of their customers. The FDA runs the risk of encouraging such unethical behaviors if it broadly bans products from those companies making sincere efforts to reduce the harm done to smokers of combustible cigarettes while ignoring companies that look for legal loopholes.

    A Marketing Throwback?

    The issue of synthetic nicotine regulation is likely to be resolved fairly soon. One reason is that the attractiveness of e-cigarettes to youth is rightfully a major concern of the FDA. Marketing materials for synthetic nicotine products have the tone of advertising done by an earlier iteration of Big Tobacco when it claimed that paper filters, toasting and other irrelevant variables reduced cigarettes’ negative health effects.

    • American Tobacco Company (1930): “20,679 physicians say Luckies are less irritating. Toasting removes dangerous irritants.”
    • Liggett & Myers (1931): “Chesterfield Cigarettes are just as pure as the water you drink.”
    • Brown and Williamson (1949): “Viceroys filter the smoke. As your dentist, I’d recommend Viceroys.”
    • Puff Bar (2021): “Our nicotine products are crafted from a patented manufacturing process, not from tobacco. The result? A virtually tasteless, odorless nicotine without the residual impurities of tobacco-derived nicotine.”
    • Next Generation Labs (2021): “TFN Nicotine is not derived from tobacco leaf, stem, reconstituted sheet, expanded or postproduction waste dust. The nicotine is made using a patented manufacturing process that begins with a natural starter material and progressively builds around the molecules of that material to create a pure synthetic nicotine.”

    These claims (from company websites) about differences between synthetic and tobacco-derived nicotine misleadingly hint at safety without providing real data. They skirt the important scientific issues and focus on emotionally resonant phrases like “begins with a natural starter material,” “without the residual impurities” and “create a pure synthetic nicotine.”

    Adolescents in particular may make the false inferential leap that synthetic nicotine somehow carries less risk or is less addictive than tobacco-derived nicotine, according to new research from Rutgers University and the National Institutes of Health. This, in turn, may lead nonsmoking, nonvaping teens to use the products often enough to become addicted. The risk of any new product to children is a tried-and-true political plank, so it’s likely to gain the attention of members of Congress, who could pass a law declaring all forms of nicotine to be under the purview of the FDA. —WMK and CKO

    Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.
    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.
  • Spanner in the Works

    Spanner in the Works

    Photo: Mariakray

    A patent dispute derails the U.S. rollout of IQOS.

    TR Staff Report

    The deadline of Tobacco Reporter’s December print edition coincided with one for the U.S. Trade Representative to overturn a ruling preventing Altria Group subsidiary Philip Morris USA from importing Philip Morris International’s IQOS tobacco-heating device following a patent dispute.

    On Sept. 30, the International Trade Commission upheld an initial determination that PMI’s IQOS device infringes patents owned by BAT. As a result of the ITC ruling, Philip Morris USA has been barred from importing PMI’s IQOS 2.4, IQOS 3 and IQOS 3 Duo heat-not-burn traditional cigarette products. It was also ordered to halt future sales of those products—marketed as Marlboro HeatSticks—already in the U.S.

    Altria Group asked trade representative Katherine Tai to overturn the ban. Tai had 60 days to do so. By Nov. 30, however, the U.S. Trade Representative’s office confirmed to Bloomberg that no action had been taken by Tai, meaning the IQOS import ban stands.

    BAT welcomed the development. “Today’s announcement provides a measure of success for our enforcement of intellectual property rights to ensure we can continue to innovate, as is common practice among innovation-based industries,” Gareth Cooper, BAT’s assistant general counsel, said in a statement. “As we have strenuously noted, there was no reason to overturn the policy.”

    Altria expressed disappointment with the decision. “We continue to believe that the plaintiff’s patents are invalid and that IQOS does not infringe on those patents,” the company said in a statement.

    “The ITC’s importation ban makes the product unavailable for all consumers who have switched to IQOS, reduces the options for the over 20 million smokers looking for alternatives to cigarettes and ultimately is detrimental to the public health.”

    This sentiment was echoed by Gregory Conley, president of the American Vaping Association, at the time of the ITC’s Sept. 30 decision.

    “By potentially denying them the opportunity to switch to a harm reduction production IQOS, the real losers of this protracted court battle could end up being American adult smokers,” Conley said.

    “While some may use vaping, snus or pouches in the absence of IQOS, far too many American adults will choose to just smoke cigarettes instead.”

    The U.S. Food and Drug Administration authorized IQOS for sale in April 2019. The products debuted in test markets in Atlanta in October 2019 and Richmond, Virginia, in November 2019. During the second quarter, Philip Morris USA expanded retail distribution of Marlboro HeatSticks into the Triad and other metro areas of North Carolina as well as northern Virginia and Georgia.

    In immediate financial terms, the import ban has limited impact on PMI and Altria. IQOS in the U.S. is currently not a meaningful contributor to the companies’ earnings, according to Morgan Stanley. Nonetheless, IQOS is a key element in Altria’s shift away from traditional tobacco products, which have seen falling demand. To achieve its mission “to responsibly lead the transition of smokers to a smoke-free future,” Altria will need a viable alternative to combustible cigarettes in its portfolio.

    Altria will likely appeal to the U.S. Court of Appeals for the Federal Circuit, which handles patent lawsuits. That process could take up to a year to reach a decision, with the likelihood of a successful appeal not favorable, according to industry analysts.

    In the worst-case scenario for Altria and Philip Morris, the two companies would have to go back to the drawing board, moving production to the U.S. or changing up the design enough to avoid patent infringement claims.

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  • Down to the Wire

    Down to the Wire

    Photo: kurgu128

    Uncertainty lingers about the future for vaping as the FDA decides the fate of the remaining marketing applications.

    By Stefanie Rossel

    Two months after the Sept. 9, 2021, deadline for the U.S. Food and Drug Administration to determine the fate of millions of premarket tobacco product applications (PMTAs), uncertainty continues to prevail, and the fate of e-liquids with flavors other than tobacco remains unclear. The agency’s approach to e-cigarette regulation to date, alternatingly labeled a “fiasco” or “bureaucratic chaos” by critics, suggests that the U.S. may be heading toward a de facto ban of all nontobacco flavors.

    The 2009 Tobacco Control Act (TCA) gave the FDA authority to regulate cigarettes, smokeless tobacco, cigarette tobacco and roll-your-own tobacco. The “deeming rule” of Aug. 8, 2016, extended the agency’s authority to electronic nicotine-delivery systems (ENDS), cigars, pipe tobacco, nicotine gels and hookah tobacco. As a result, deemed products are now subject to all TCA rules, including the requirement that any new tobacco product must receive premarket authorization from the FDA to be legally marketed.

    Following litigation by anti-tobacco groups, a court set the deadline for manufacturers to submit their applications by Sept. 9, 2020, and gave the agency one year to decide on them. The time frame presented a daunting challenge to the chronically understaffed agency. The FDA received more than 6.5 million marketing applications for newly deemed tobacco products alone. At press time, the agency had acted on more than 98 percent of these applications. Its actions included refuse-to-accept letters to more than 200,000 applications, a refuse to file order for approximately 4.5 million products submitted by a single company and marketing denial orders (MDOs) for more than 1 million nontobacco-flavored ENDS. Only three new tobacco products received marketing granted orders. The FDA still needs to rule on applications covering about 80,000 products, including those submitted by market leaders such as Juul and NJOY.

    David Sweanor

    Retroactive Change of Requirements

    Most of the MDOs were directed at vape products with flavors other than tobacco, including menthol. The manufacturers, the agency claimed in its MDO letters, had failed to provide sufficient evidence that their nontobacco-flavored products deliver a net public health benefit for adult smokers compared with the “threat posed by the well-documented, alarming levels of youth use” of flavored vapes through either a randomized controlled trial in which a specific group of people is examined through intervals of time, or a longitudinal cohort study, which tracks large groups of people over an extended period of time.

    “It appears that the FDA is planning to significantly hobble the vaping category and thus protect lethal cigarettes from what is perhaps the greatest threat that business has ever faced,” says David Sweanor, adjunct professor of law at the University of Ottawa. “But how far this succeeds depends on many factors, not least what the courts will say about the process.”

    The requirement is now part of the PMTA rules, which the agency finalized in October 2021, and which took effect in November. However, it had not been in the original guidance for PMTA applications, according to critics.

    For most smaller vape manufacturers, the FDA’s ruling has meant the end of their business activities. “Like most vape companies, we cannot remain financially viable with only two [tobacco-flavored] products, and we will most certainly be forced to close our business after eleven years,” California-based Kai’s Virgin Vapor states on its website.

    Paul Blair

    Temporary Stays Granted

    Others have taken legal action. Arguing that the FDA moved the goalpost by retroactively changing the PMTA requirements, MDO recipients filed more than 40 petitions for review and stay on the grounds that the FDA had acted in an “arbitrary and capricious manner.” At the time of writing, at least five companies had been granted a temporary stay either by the FDA or the courts, and their products were back under review.

    Among them was Turning Point Brands, which may now continue to market its vapor products while its PMTAs are being reassessed. “We’re encouraged that the agency has acknowledged the robust nature of our PMTAs for a wide range of tobacco, menthol and other flavored vapor products,” Paul Blair, vice president of government affairs at Turning Point Brands, told Tobacco Reporter. “These open system e-liquids, sold predominantly in vape shops across the U.S., play an important role in providing reduced-risk options to more than 30 million adult smokers who may be looking for alternatives to combustible cigarettes. It is our hope that at the end of the PMTA review process, the agency will preserve the important off-ramp from cigarettes to a wide range of vapor products used by adults. Preserving these options will ensure that the diverse vapor marketplace can help ultimately achieve a more significant reduction in smoking rates across the U.S.”

    “The cases look strong,” Sweanor states. “Administrative bodies, like referees in sporting competitions, are challenged when they seek to change the rules mid-game. This is supposed to be an example of transparent rule-making in a democratic society. There is also a history, in the U.S. and globally, of vaping companies using the courts to overturn laws and administrative rulings that have overly restricted their products and marketing.”

    However, a second review does not guarantee that the products will receive authorization. Critics fear that manufacturers who have received an MDO will continue to appeal the decisions to maximize the time to sell their products. THR advocates hope that legal challenges will force the FDA to make more careful decisions.

    Uncertain Future for Flavors

    There are many indications that the era of nontobacco vapor flavors is coming to an end in the U.S. After bombarding the vapor business with MDOs, the FDA on Oct. 12 approved R.J. Reynolds Vapor Co.’s Vuse Solo and accompanying tobacco-flavored e-liquid pods—the first-ever marketing granted order for an e-cigarette.

    Tobacco harm reduction advocates received the news with mixed feelings. While welcoming the agency’s acknowledgement that vape products can help adult smokers to quit cigarettes, they were disappointed that the order pertained to an outdated device with few users. Furthermore, while authorizing two Vuse tobacco-flavored e-liquid pods, the agency issued 10 MDOs for Vuse Solo nontobacco-flavored pods, claiming that Reynolds failed to demonstrate they were appropriate for the protection of public health.

    The agency is still evaluating Reynolds’ application for menthol-flavored products under the Vuse Solo brand. Menthol is another bone of contention: In late April, the FDA announced that it would initiate a notice and comment rule-making process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos within the next year. Vape manufacturers are hence unsure of whether their mentholated products will remain on the market.

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    Sloppy Assessment

    In its denial of providing marketing authorization to nontobacco-flavored e-liquids, the FDA referred to the most recent National Youth Tobacco Survey (NYTS), arguing the study had shown that among the estimated 2 million middle school and high school students that were using e-cigarettes in 2021, more than eight in 10 were using nontobacco-flavored vape products. It did not mention that, according to the same study, the use of e-cigarette among youths has more than halved over the past two years, from 27.5 percent in 2019 to 11.3 percent currently.

    Critics have accused the FDA of being “obsessed with youth vaping rates and flavors.” The online publication Filter revealed that, in order to cope with the unprecedented flood of PMTA submissions before the court-ordered deadline, the FDA relied on a database query to identify the top-12 manufacturers with the largest number of pending PMTAs for nontobacco-flavored e-liquid products not in the third of three FDA review phases.

    This approach allowed the agency to filter out 85 percent of all pending PMTA applications. It then introduced, apparently for the first time, a “fatal flaw” standard. The fatal flaw review is a simple review in which the reviewer examines the submission to identify whether or not it contains the necessary type of studies. “The fatal flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies,” according to an FDA Center for Tobacco Products Office of Science memorandum cited by Filter.

    With its attempt at speeding up matters, the agency has done itself no favors, say critics. The road to regulatory certainty in the U.S. vape market will likely become even longer. “At this point,” Sweanor suggests, “the solution could be to announce reasonable product standards aimed squarely at reducing harms—as is done with foods—rather than treat each subcategory of each product as if totally independent of other products.”

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • Fighting the Last War

    Fighting the Last War

    A new report by Knowledge-Action-Change urges the World Health Organization to embrace safer nicotine products.

    By George Gay

    On the face of it, it seems odd that a case has to be made for the promotion of safer nicotine products (SNPs) as part of a global tobacco harm reduction (THR) strategy. But making this case, in large part, is the aim of a report published by the U.K.-based public health agency Knowledge-Action-Change (KAC) and launched at a hybrid event on Oct. 27 in London. And it has to be said that the case needs to be made, as becomes clear toward the end of the report, in a section looking toward the future, where it is stated that it is a “moral imperative” that the World Health Organization and its allies retrench from their current “intransigent and obstructive position of not only refusing to accept any positive health benefits from SNPs but actively campaigning against their use.”

    I would agree wholeheartedly with the general sentiment being expressed here, but invoking morality is problematic, I believe. The idea of an overarching morality is not universally accepted because a lot of people believe “morality” resides in the preferences individuals or groups of people have. And, in fact, Harry Shapiro, the author of the report Fighting the Last War: The WHO and International Tobacco Control, seemed to acknowledge this point when, speaking at the launch, he said everybody working in tobacco control was aiming to reduce smoking but that tobacco control split into two broad camps: one comprising those who supported SNPs and THR and the other comprising those who didn’t. This was a good concession to make because having the word “war” in the title of the report seemed to be pointing us back down a road we surely don’t want to travel.

    Misguided and Irrational

    Having said that, this is a good report aimed at challenging the direction of travel of tobacco control under the auspices of the WHO’s Framework Convention on Tobacco Control (FCTC) ahead of the Conference of the Parties to the FCTC, COP9, which was due to take place virtually on Nov. 8–13 (after this report was written). In doing so, the report seeks to address what must surely be one of the most unsound and unreasoned strategies ever to have arisen within the international health community. Put briefly, it is about the WHO and its allies being not immoral but, more worryingly, misguided and irrational.

    According to the WHO, an epidemic of cigarette smoking is currently causing the deaths of 8 million people a year, usually referred to as “premature deaths,” a phrase up there with “pre-ordering” in the list of linguistic curiosities. But while a number of SNP products have been developed that can wean people off tobacco smoking, the most powerful international body charged with protecting the health of people around the world has decided it would be best not to use these products but to apply the old “quit-or-die” patch to the gaping wound. After all, quit-or-die has a long track record whereas the products being offered up are—mention it only in hushed tones—new or newish. The fact that the long track record of quit-or-die is, like the art of bleeding patients, one largely comprising failure seems not to enter the thinking of the WHO and its allies.

    But perhaps this isn’t fair. The report makes the point that the number of smokers worldwide has remained at 1.1 billion for the past 20 years, during which time, I understand, the world’s population rose from 6.11 billion to 7.75 billion, so it could be argued that the number of smokers would, without intervention and with all other things having remained equal, have risen to 1.38 billion. So what has occurred might not be failure, I guess, but it is hardly a galloping success.

    Of course, it might be said correctly that individuals and states are not bound to follow the WHO’s advice, but it is often the case that they do, perhaps because of the peculiar tendency of humans to create or invent institutions or belief systems and then slavishly accept the advice purportedly coming out of them, no matter how daft, rather than go back and question whether there was a fault in the original idea that gave rise to the institution or belief system.

    But I would not recommend going back to question the setting up of the WHO itself, which, to my mind, should be a powerful force in the global fight against transmissible diseases, but to question the WHO’s FCTC, whose provisions are used to steer the direction of travel of the international tobacco control movement.

    A Matter of Interpretation

    Harry Shapiro

    The report does an excellent job of explaining the roles of the WHO, the FCTC, the Conference of the Parties to the FCTC and the FCTC secretariat, the relationship between them and the decision-making processes they employ. This section of the report doesn’t make encouraging reading, however, though it largely defends the FCTC’s provisions and blames the way they are interpreted for the failure to embrace SNPs and THR. It is said that the provisions of the FCTC are no bar to the consideration of scientific advances, new technologies, economic circumstances and the concept of THR. But this is surely no reason to keep heading down the same road hoping things are miraculously going to get better, especially given that the seemingly unaccountable FCTC secretariat is making much of the running, and nation states tend to go with the flow, unlike when they discuss other global issues such as trade. There have been eight FCTC-based COP meetings since the COP first met in 2006, and I cannot help thinking that, given the lack of progress it has made in 15 years of working with the FCTC, the decent thing to do would be to put the COP and the FCTC out of their misery.

    One of the problems identified in respect of COP meetings is that they are almost totally exclusive, owing to a particular interpretation of an FCTC provision. And a comparison is made in the report, and was repeated by others at the report launch, of the FCTC COP meetings and those associated with the Framework Convention on Climate Change (FCCC). The tobacco COPs were said to be shrouded in a level of secrecy comparable to U.N. Security Council meetings whereas to be an observer at the FCCC COP, it was necessary only to demonstrate representation of a national or international body and relevant experience. The inference was that if more people were allowed to observe and even take part in the tobacco COP, things would be better.

    I hate to spoil the party here, but the comparison is a little out of proportion, to my way of thinking. Tobacco COPs look at consumer choices involving various tobacco and nicotine products whereas the FCCC COPs are about trying to prevent the whole of humankind going belly up. The comparison seems also to gloss over the evidence. As I write this, the FCCC COP, COP26, is about to start and is widely expected to end largely in a PR-burnished failure, with the result that the world will be plunged deeper into the existential crisis it is already in and from which it is unlikely to be able to row back. Having more participants doesn’t seem to guarantee success, at least not on its own, even where the fate of the earth hangs in the balance.

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    The Way Forward

    So, how could things be arranged to ensure a more beneficial outcome to the problem of tobacco smoking? Well, through the employment of THR, where harm reduction is defined in the report as “a range of pragmatic policies, regulations and actions that either reduce health risks by providing safer forms of products or substances or encourage less risky behaviors with an important role in championing social justice and human rights for people who are often among the most marginalized in society.” One of the most frustrating aspects of the refusal of the WHO and parties to the FCTC to embrace THR is that the WHO employs harm reduction in respect of other health issues. Such an inconsistent stance is difficult to understand, but then perhaps there is a visceral satisfaction in bleeding the patient, either actually or metaphorically, through taxation, the main weapon in the quit-or-die armory. Increasing tobacco taxation is held up as a quit-or-die success story, but, in fact, it is a strategy that further impoverishes the often less well-off while providing a boost for black marketers.

    Under a section titled “What can be done? New thinking for the 21st century,” it is said that parties to the FCTC should press for more evidence-based discussions on THR and SNP. This is a nice thought, but given the history laid out in the report, I wonder if it can lead anywhere helpful. I’m sure COP participants believe they are making evidence-based decisions already, but my guess is, to get back to my original point, they are viewing only the evidence that is able to squeeze through their locked-in “moral” filters. The more alcohol they quaff together, the more they come together in the belief that nicotine is evil and shouldn’t be enjoyed. Evidence is no guarantor of success. The EU’s deadly ban on snus, a ban that defies all reason, has been upheld in the courts.

    Under the same section, it is said also that a pragmatic route forward could be the establishment of a working group on THR to take the FCTC forward into the 21st century in a world where SNPs are now available. This, too, is a good thought, but again, given the history laid out in the report, one that might be difficult to pull off. Still, nothing ventured, nothing gained, and the report describes five ways in which such a working group might be able to move things forward.

    One of the key starting points is said to be disaggregating combustible and more dangerous oral tobacco products from safer noncombustible products. But is this likely when, in a world where we hang onto the belief that the U.S. Food and Drug Administration is the paragon of scientific reason, that agency feels it right, and has the right, to “deem” electronic cigarettes to be tobacco products?

    It is easy to become gloomy about the situation, especially when it is considered that even if a smoker is saved from a tobacco-related death through switching to an SNP, she is anyway more likely now to die of a pollution-related disease (for which there is no COP), or, slightly further into the future, the effects of a climate change event.

    But, looking on the bright side, there is a powerful and growing force in support of THR, and it was on display at an event in London on the day following the launch of the Fighting the Last War report. The THR scholarship program, which is described as the jewel in the crown of the KAC, was the subject of a separate report, Tobacco Harm Reduction Scholarship Program: The First Three Years 2018–2021, which describes how the program has built an extensive network of advocates raising awareness of THR around the world.

    The report is worth reading. Although I was aware of the program, I had no idea how extensive it had become. Since its launch, the program has attracted 260 applications and has taken on 75 scholars from 33 countries, 18 of whom have gone on to enhanced scholarships. But perhaps the most significant figures are those describing how 95 percent of the scholars are still working in THR, 27 percent full-time, 50 percent part-time and 18 percent on a voluntary basis.

    The Oct. 28 event was an opportunity also to celebrate the life of Kevin Molloy (1957–2021), who, from 2018 until earlier this year, was head of the scholarship program.

    The Fighting the Last War report, which is part of a series of Global State of Tobacco Harm Reduction reports from KAC, and the scholarship program are funded by grants from the Foundation for a Smoke-Free World, a U.S. nonprofit organization that had no role in the planning or execution of either project.

    George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.
  • No Paper Tiger

    No Paper Tiger

    SWM’s new technology allows for the creation of patterns, designs and logos inside the gum strip without compromising sticking quality. (Photo: SWM)

    Schweitzer-Mauduit International has introduced a new gumming technology to help rolling paper manufacturers protect their brands against counterfeiting.

    By Stefanie Rossel

    In recent years, cigarette rolling papers have been in high demand; the global roll-your-own tobacco product market, valued at $7.49 billion in 2020, is expected to expand at a compound annual growth rate of 4.2 percent from 2021 to 2028, according to Grand View Research. The increasing preference for handrolled or handmade cigarettes, a cheaper alternative to factory-made cigarettes, has been driving the demand for roll-your-own products. It has been aided by the legalization of cannabis for medical and recreational purposes in a growing number of countries around the world.

    As demand for rolling papers has increased, so has counterfeiting of these products. Reports on seizures of significant quantities of fake products, predominantly in the U.S., have repeatedly made the headlines. Rolling paper manufacturers have filed civil actions seeking monetary and punitive damages and injunctive relief from those who traffic in counterfeit goods and who have profited from their sale and distribution. Several leading suppliers of rolling papers have installed dedicated sections on their websites that encourage the reporting of fake products.

    While manufacturers fear the financial damage and the harm counterfeit papers cause to their brands’ image, fake products also pose a grave risk to consumers as they are often manufactured using unsafe production practices and unknown and hazardous or toxic ingredients, such as chlorine bleach or petroleum-based adhesives.

    Pierre Yves Kervennal

    To support its customers in protecting their brands against counterfeiting, Schweitzer-Mauduit International (SWM) has introduced a new generation of gumming technology. “Our new gumming technology is a completely different approach of the existing gumming technology,” explains Pierre Yves Kervennal, product manager for rolling papers at SWM’s engineered papers business unit. “It’s a new space of communication and enhancement of the brand for our customers. The use of natural and colored gum, perfectly in accordance with the legislation, allows us to create patterns, designs and logos inside the gum strip without diminishing the ‘sticking’ quality of the Arabic gum. This opens new opportunities for our clients to differentiate on the market but also communicate with their customers. We called this new service of customization of the gummed band ‘Be Unique.’”

    According to Kervennal, tobacco companies are battling counterfeits every day. “It’s not only a financial loss for them but also a reputation hazard,” he says. “And to be fair, the paper industry didn’t bring a lot of solutions to the market over the recent years. Of course, the filigreed papers and the good market practices such as ‘Know Your Customer’ already protect our customers and make it really hard for forgers, but, unfortunately, this is not 100 percent bulletproof. Our clients now have a new weapon at their disposal. Our innovative and patented technology allows to add an additional layer of complexity whilst giving them additional marketing opportunities. In fact, ‘Be unique’ is just an example of the bank note strategy; each time a new bank note is introduced on the market, new technologies are added to the paper to make it safer.”

    Driven by Cannabis

    In Europe and the Middle East, rolling papers are a historical product of the tobacco industry, Kervennal points out. As such, they face the same kind of issues as any other products from this industry. “It means that major brands can be copied, and with the multiplication of the new distribution channels, the risk of buying counterfeit products is growing for customers. During the Covid crisis and the border closures, we have seen legal markets grow about 10 percent just because the counterfeit products could not come through anymore. In the U.S., this is a very dynamic and trendy market, with some brands already well installed and providing high-quality products. These brands are going to be the ones who will have to fight against counterfeiting—the more dynamic the market is, the more attractive it is for unfair players.” 

    Responsive to consumer demand, SWM is increasingly focusing on solutions that cater to the growing market for recreational cannabis. “In terms of product design, we develop more and more specific grades and product for cannabis use, such as hemp and unbleached paper,” says Kervennal. Another trend in the roll-your-own market is a desire for differentiation. “We observe an increasing demand from companies creating their own brands and looking for new visual design.”

    In the U.S., the RYO papers segment is driven largely by the cannabis market. “Consumers in that market are looking for all-natural products, typically hemp-based products, and brand owners are looking to differentiate their offering through customization,” says Kervennal. “Some additional trend we see in the United States is continuing legalization. Right now, there are 18 states plus the District of Columbia where adult use of cannabis is legal, and that will continue to grow over time. A last trend that we do see is celebrity brand endorsers where brand owners are using celebrities to endorse their brands on social media, which increases demand for roll-your-own papers.”  

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • A Common Language

    A Common Language

    Photo: Drobot Dean

    MedDRA helps evaluators describe the health effects of tobacco products in consistent terms.

    By Samina Qureshi

    From the time the U.S. Congress passed the landmark Family Smoking Prevention and Tobacco Control Act (FSPTCA) granting the Food and Drug Administration authority over select tobacco products in 2009, the tobacco industry has had to expend vast financial and human resources in efforts to effectively comply.

    The FSPTCA in an unprecedented way allows the FDA to implement standards for tobacco products to protect public health. In addition, various statutory pathway applications for new tobacco products must fulfill requirements to record health effects. The applications must have full reports of all investigations to address the health risks of the product. There must also be an established system for maintaining records of health effects. The requirements around recording health effects have to be continued in post-market use of the relevant products.

    These requirements have a framework that somewhat resembles FDA requirements for other regulated product industries, such as pharmaceuticals and devices. Although the adverse event recording, reporting and signal detection requirements are much more stringent in these products, the main objective is similar.

    The FDA’s usual “safe and effective” standard for evaluating medical products does not apply in the same way to tobacco products. Tobacco products are evaluated based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole. This “whole” includes users and nonusers. For developing future regulations, the law requires the FDA to apply a public health approach with a focus on the population overall, not just the individual user.

    It would be pragmatic to utilize the same standardized international medical terminology that is already being used globally for medicinal products for regulatory communication and evaluation of data pertaining to tobacco products as well.

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    The terminology used to capture adverse events throughout the drug development lifecycle from clinical trials to investigational new drug applications (IND), new drug applications (NDA) and post-market surveillance is the Medical Dictionary for Regulatory Activities (MedDRA). MedDRA is a clinically validated international medical terminology dictionary. It contains terms that may be used for capturing and recording adverse events experienced by clinical trial subjects as well as in the general population in post-marketing scenarios associated with the regulated product.

    The terminology consists of a five-level hierarchy in which the concepts are organized from the most granular lowest level term (LLT) to the broadest system organ class (SOC). The most granular level (LLT) contains multiple terms (over 84,000), which are synonyms or lexical variants of one another but are grouped under a preferred term level (PT) at which level each term is a unique medical concept. Each PT term is further organized under a high level term (HLT) based upon anatomy, pathology, physiology, etiology or function. The HLT are in turn linked to high level group terms (HLGTs). Finally, HLGTs are grouped into System Organ Classes (SOCs). The SOC level is the broadest level and are grouped by etiology, manifestation site or purpose (see Figure 1). There are 27 SOCs in total.

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    The structure and organization of a concept is very logical in MedDRA and thus supports sophisticated analyses. MedDRA can be used to analyze individual medical events of interest in a database of compiled events or issues involving a system, organ or etiology using its hierarchical structure. MedDRA is a global terminology and is currently mandatory for use in the EU (European Medicines Agency and EU member states) and Japan (MHLW) and encouraged by other global regulators for drug development lifecycle activities including the FDA. MedDRA is listed in the FDA data standards catalog as a terminology to use. Global MedDRA use is facilitated by the fact that it is a multilingual terminology allowing most users to utilize it in their native languages. MedDRA is currently available in 14 languages (Brazilian Portuguese, Chinese, Czech, Dutch, English, French, German, Hungarian, Italian, Japanese, Korean, Portuguese, Russian and Spanish). MedDRA is also a part of the International Council on Harmonization (ICH) e-submission standards.

    The functions of maintenance, evolving development and distribution of the terminology to users was tasked to the Maintenance and Support Services Organization (MSSO) by the ICH, who owns the terminology.

    MedDRA continuously evolves, and additional concept terms are added with user community input as well as the maintenance organization’s development and proactivity initiatives.

    MedDRA is amenable for adaptation and has added terms that address an increasing number of device and product issue terms over the years. There is an opportunity for users to request concept terms with the twice-yearly version releases of the terminology.

    Almost all of the ICH regulatory members have implemented MedDRA, including the EU, FDA, MHLW, MHRA, and Health Canada. As global regulators expand their scope of products they regulate, other industries, such as tobacco and cosmetics, have correspondingly started to use MedDRA for capturing adverse health events. It is advantageous for industry users to utilize a terminology in their regulatory applications that is familiar to the regulators who are reviewing the product applications. In addition, it is prudent to leverage the hierarchical nature of MedDRA that is amenable for easy analysis.

    MedDRA may be used in all of the statutory pathways for new products in which provisions of the FSPTCA mention recording or reporting adverse health effects related to tobacco products.

    An example of potential use of MedDRA in each of the regulatory pathways for tobacco products is shown in the table below, with the regulatory aspect addressed as mentioned in the FSPTCA section.

    Statutory Pathways for New Products

    Regulatory Aspect

    Relevant FSPTCA Section

    Substantial Equivalence Reports

    Does not raise different questions of public health

    905

    Premarket Tobacco Product Application

    Appropriate for the protection of public health

    910

    Modified-Risk Tobacco Product Application

    Benefits the health of the population as a whole

    911

    In addition, the FSPTCA section 909 “Records and Reports on Tobacco Products” states, “to report … information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience.”

    This particular aspect is best addressed by maintaining a database of adverse health effects reported by consumers on marketed products and may be used to quantify the required events. Pharmaceutical organizations maintain internal safety databases to compile reports of post market adverse events. Many tobacco organizations have adopted this approach and are currently utilizing MedDRA for capturing adverse health effects in their post-market databases. The MedDRA hierarchy is leveraged to perform regular and ad hoc analysis. MedDRA has evolved with the addition of concept terms related specifically to tobacco-related events from the user community.

    The hierarchical structure, adaptability to evolve and availability in multiple global languages positions MedDRA as the best terminology for the tobacco industry to increasingly adopt for regulatory applications and for internal systems. MedDRA is also suited for internal assessment of developing consumer products. The product issues SOC is dedicated with concept terms addressing manufacturing, supply, distribution and quality system issues, thus enabling analysis for issues within this realm. It is very useful for analyzing reports of counterfeit products, a common concern. Currently, over 125 countries utilize MedDRA for their regulatory and product development lifecycle activities.

    Samina Qureshi serves as international medical officer at MSSO in McLean, Virginia, USA.
  • Uniquely Deadly

    Uniquely Deadly

    A street vendor offers smokeless tobacco in Kolkata. (Photo: Taco Tuinstra)

    India’s crackdown on its dangerous smokeless tobaccos in the wake of Covid-19 should be complemented by a more coherent harm reduction strategy.

    By Stefanie Rossel

    The Covid-19 pandemic presented an opportunity for India to intensify its fight against the consumption of local smokeless tobaccos. On April 15, 2020, the government banned the sale of tobacco products, including chewing tobacco, the most widely used form of tobacco in India, as a measure to slow the spread of the coronavirus. Chewing smokeless tobacco products, which in India typically contain areca (betel) nut, increase the production of saliva and create a strong urge to spit—an undesirable habit during a pandemic.

    As in Sweden, smokeless tobacco is significantly more popular than combustible tobacco in India. According to a 2020 analysis, nearly 199.4 million Indian adults consume smokeless tobacco regularly, which is more than twice the number of smokers. This makes it the country with the largest number of smokeless tobacco users. However, unlike Sweden’s snus, which ranks at the bottom of the continuum of risk, Indian smokeless tobaccos are quite risky. Public health experts describe them as “uniquely deadly.”

    There is a wide variety of chewing tobacco available in India. The most commonly used products are khaini, a mixture of tobacco and lime used by 11.2 percent of adults, and gutkha, which consists of tobacco, slaked lime, paraffin wax, catechu (an extract of acacia trees) and crushed areca (betel) nut, and is consumed by 6.8 percent adults. Other smokeless tobaccos use mixtures of betel quid and paan masala.

    What all these types of tobacco have in common is that they are highly addictive and full of carcinogens. In addition to the typical ingredients, these products can be laced with thousands of chemicals. The products are said to have both stimulant and relaxing effects; some are sold as mouth fresheners. Available for a few rupees, they are also affordable for poor people.

    The consumption of smokeless tobacco was above the national average of 21.4 percent in 13 Indian states, with prevalence ranging from 23.5 percent in Bihar to 48.5 percent in the Tripura, according to the 2016–2017 Global Adult Tobacco Survey (GATS).

    Smokeless tobacco consumption is responsible for India’s high rate of oral cancer. With 141.2 million male users compared to 58.2 million female users, consumption of smokeless tobacco is predominantly a male habit. However, three-fifths of the deaths attributable to smokeless tobacco use occur among women. In contrast to smoking, which is generally considered a taboo for women, smokeless tobacco consumption is more socially acceptable. As smokeless tobacco is deeply entrenched in the region’s culture, it tends to pass from one generation to the next. Children as young as 10 years old have been found to regularly use smokeless tobacco.

    Samrat Chowdhery, who leads consumer advocacy for tobacco harm reduction in India and is the past president of the International Network of Nicotine Consumer Organizations, estimates that smokeless tobacco is responsible for 350,000 premature deaths annually in India. “Though this mortality rate is lower than from combustible tobacco, it is still quite high,” he says. “The main reason for this is that Indian/southeastern smokeless tobacco products are handmade or made in poor hygienic conditions, which allows for impurities to creep in. There is no attempt to control or reduce tobacco-specific nitrosamines; the use of slaked lime adds another cancerous component; there is no licensing, standards or quality control; and finally toxic additives, such as nicotine sulphate and flavoring agents, are added to tobacco products.”

    Samrat Chowhery

    Ineffective Ban

    India has been targeting smokeless tobacco as it aims to reduce the number of tobacco users by 30 percent by 2025. In 2012, states started banning the manufacture, sale and distribution—but not consumption—of pre-packaged gutkha under laws governing food, which may not contain tobacco. Some states extended this ban to other tobacco-containing oral products, such as paan masala.

    Enforcement, however, has been patchy. A 2014 World Health Organization study found that 15 percent of respondents continued to purchase prepackaged gutkha. According to a 2018 YouTube feature by The Print, many street vendors in Delhi were unaware of the ban, and police were not taking action.

    A large-scale household survey in Delhi in 2016 revealed that a mere 18.84 percent of gutkha users attempted to quit after the ban, although 97.5 percent of respondents believed tobacco to be harmful or very harmful. Only 2.4 percent successfully quit, the report found. Gutkha, a white-to-brownish granular flavored product, turns saliva bright red, and is usually spat onto a wall or on the ground, causing red stains that are hard to remove. It typically comes in colorful sachets. Following the ban, manufacturers started selling gutkha and tobacco in separate packs. In Delhi, 84.1 percent of pre-ban gutkha users switched to these twin sachets, the household survey found. Many switched from single-dose to multi-dose sachets or to khaini.

    In March 2015, legislators prohibited all smokeless tobacco products including twin packs. Violators risk prison sentences or fines of up to INR25,000 ($336.39).

    “The reporting of the so-called bans is usually skewed by the need to showcase them to their peers from the global tobacco control community,” says R. N. Sharan, retired professor of biochemistry, molecular biology and genetics at North-Eastern Hill University in Shillong, India. “Thus, at global and national forums on tobacco control, India’s attempts to ban risky smokeless tobacco products are often given a high profile and kudos showered on the involved public health advocates as well as policymakers. However, the proof is in the pudding. The bans have been cleverly, and sadly, circumvented by manufacturers, retailers and common ones. On the ground, prohibition seems to have, once again, failed.”

    R. N. Sharan

    Expanded Authorities

    With the advent of the pandemic in India, the government cracked down on tobacco. After the first reports that smoking might increase the risk of severe Covid-19, many Indians attempted to switch from cigarettes to smokeless tobacco. According to Statista, about 77 percent of smokers aged between 25 years old and 39 years old tried to transition to smokeless tobacco.

    In addition to the government’s national directive on Covid-19 management, states and union territories received new powers under the Epidemic Disease Act, the Disaster Management Act and the Indian Penal Code to prohibit use of smokeless tobacco and spitting in public places.

    By May 2020, up to 28 states and union territories had implemented various restrictions linked to smokeless tobacco, according to the Observer Research Foundation. The study’s authors concluded that the jurisdictions were right to act. Despite the country being a signatory to the WHO Framework Convention on Tobacco Control (FCTC), many of the treaty’s recommended policies, such as graphic health warnings on packs and advertising bans, tend to be circumvented by smokeless tobacco products.

    The bans, all of which are outside FCTC policy, strengthened during the pandemic and appeared to have been more uniformly rolled out across the country, giving additional powers to states, the authors stated, but the amendment of some policies within a short span of time was likely to have caused confusion. At the time of writing, several states had extended the bans on smokeless tobacco manufacture, sale and distribution for another year.

    Sharan says there are a number of reasons why the ban on chewing tobacco hasn’t shown the desired results so far. “India’s capabilities for technical analysis of smokeless products are not yet fully up and running, despite significant investment over the years,” he says. “Enforcement on the ground is also a big issue, further complicated by (a) the governance structure where primarily the central government legislates while the responsibility of their implementations remains essentially vested in the state or provincial governments, and (b) a complex web of vested interests.”

    In fact, says Sharan, the Covid-19 pandemic may have made the situation worse. The regulatory apparatus in India has been and continues to be under severe stress from the pandemic, and they can only focus on so many things at one time. This is in sharp contrast to the Food and Drug Administration in the U.S. and the Trading Standards Authority in the U.K., which are well funded, adequately resourced to police the regulated products in the market and empowered to identify prohibited products or pull out noncompliant products from the market and suitably punish the erring vendors/manufacturers if required.

    “It is to be noted that the FDA’s Center for Tobacco Products is funded from fees paid by the industry they regulate, thus ensuring a fair and level marketplace. I am not aware of the existence of any such mechanism in India. In this context, India could be a winner if it chose to learn some lessons from the rest of the world.”

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    Desperately Needed: Harm Reduction

    India closely adheres to the WHO’s abolitionist stance, as evidenced by the country’s 2019 ban on vape products. “My understanding is there is a general denial of harm reduction approaches among governmental stakeholders,” Chowdhery says. “I am not sure, though, how the bans are evaluated or if there is a mechanism for that, though I do keep hearing about smuggling of these goods going up through everyday reports of seizures.

    “My view is that such bans, if not accompanied by meaningful cessation support in the form of in-person counselling centers and affordable, subsidized nicotine-replacement products or substitution products, such as nicotine pouches and snus, for those who can’t or don’t want to quit, along with strong enforcement, will lead to creation of black markets, which end up increasing population-level harm through proliferation of unregulated, substandard products.”

    Sudhanshu Patwardhan, U.K.-based medical doctor and tobacco cessation expert, looked exactly at these issues in a paper, “New Nicotine Pouch Category: A Tobacco Harm Reduction Tool?” which he published with Swedish Scientist Karl Fagerstrom in October 2021.

    “India’s latest GATS [Global Adult Tobacco Survey] data shows that nearly 200 million people continue to use risky forms of oral tobacco,” he says. “With no meaningful cessation support available, nor any affordable and appealing safer nicotine alternatives, consumers are struggling to give up their risky tobacco habit. Frankly, it is naive to expect governments to embrace tobacco harm reduction at face value.

    “The ban on e-cigarettes was partly fueled by irresponsible behavior from multinational companies and international experts’ lack of understanding of the Indian policymaking milieu and worsened by nicotine illiteracy among Indian policymakers and their influencers, such as healthcare professionals. A lot of work needs to be done in India and globally to enable and empower healthcare professionals by disentangling in their minds nicotine’s addictive properties from smoked as well as smokeless tobacco products’ carcinogenic and other harmful properties.

    “Nicotine-replacement therapy is on the WHO’s model essential medicines list and also on India’s essential medicines list. As I and globally renowned nicotine dependence expert Dr. Fagerstrom argue in our paper in the Nicotine and Tobacco Research Journal, ‘there is a great challenge and opportunity in India to bring affordable nicotine pouches that are responsibly manufactured and marketed only to adult tobacco users. It would be important to ensure that adult users’ access and affordability are not compromised by the regulatory regime and the behaviors of profit-maximizing manufacturers.’”

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • Back in Business

    Back in Business

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    After a year of making do with virtual gatherings, industry representatives were delighted to meet each other face to face again during the World Tobacco Middle East exhibition in October. Thousands of tobacco professionals gathered in Dubai to reconnect with one another and learn about the latest product and services. Above are some impressions from the exhibition floor.

    Photos: Elise Rasmussen and Mohamed Ahmed

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  • The Stubborn Squad

    The Stubborn Squad

    Photo: Olrat

    In trying to engineer consumer choices, COP9 delegates persist in their Luddite approach.

    By George Gay

    A lot of silly comparisons have been drawn between the October/November Conference of the Parties (COP26) to the Framework Convention on Climate Control and the November Conference of the Parties (COP9) to the Framework Convention on Tobacco Control (FCTC). One even had it that the two were of equal importance. No. The first concerned an existential crisis for humanity. The second seemingly dallied with dissonance theory as it examined how a single organization could, at one and the same time, try to stop people smoking while strengthening the supply chains that get cigarettes into their hands. In my view, the difference in importance between the two was such that, given COP26 ended with few firm significant commitments, and, consequently, the earth is set to become uninhabitable by humans, the battle of words waged over COP9 amounted to little more than the proverbial fight between two bald men over a comb.

    But others clearly thought differently, so the pressure on the Parties to the FCTC was intense ahead of and during this year’s COP, or as intense as it could have been given the secretive nature of the event. Perhaps the intensity was ramped up because the tobacco harm reduction (THR) deniers at the FCTC, like the climate change deniers, were starting to feel the heat; were starting to show signs that they were coming to realize they had lost or were losing the argument; and because those who support a THR strategy were glimpsing light at the end of the tunnel. Perhaps, too, it was because the Covid-19 pandemic had made people more familiar and comfortable with internet meetings and performances, which enabled THR advocates and consumers to broadcast their side of the argument throughout COP9, while the quit-or-die protagonists and THR deniers at the FCTC, as has become usual, were hunkered down, almost incommunicado—shut off from the infectious ideas and opinions of others, including those whose lives they were attempting to manipulate and control.

    It is not without irony that the failures of the WHO in respect of the devastating pandemic led to changes to the COP9 and MOP2 meetings.

    Of course, there was some official communication around COP9 as when in August the Convention Secretariat issued a media release blaming the Covid-19 pandemic for the fact that planned face-to-face sessions at The Hague, Netherlands, had had to be ditched in favor of virtual meetings; on Nov. 8–13 in the case of COP9; and on Nov. 15–18 in the case of the Meeting of the Parties (MOP2) to the Protocol to Eliminate Illicit Trade in Tobacco Products. It is not without irony that the failures of the World Health Organization—along with those of many governments, institutions, companies and individuals—in respect of the devastating pandemic led to changes to the COP9 and MOP2 meetings. Perhaps if the WHO had had its eye more on viruses than on tobacco … Oh, never mind. But it is worth noting here that in the same release, the Secretariat announced it had “released the first group of documents…” relating to COP9, because the use of the word “released,” rather than, say, “published,” is instructive as to who seems to be in the driving seat at the FCTC—and it isn’t the Parties.

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    Influencing Product Choices

    Looked at one way, the fighting at and on the fringes of COP9 was over the promotion of different products and methods aimed at influencing the consumer product choices made by smokers who are being told, by those who claim to know best, that they, the smokers, should quit the product they are currently using, even though its consumption is perfectly legal. It makes me wonder how many of those calling for smokers to quit their habit drink alcohol, which is probably, in the West, the most socially destructive legal consumer product available—the only legal consumer product I can think of that dulls the brain when used as intended by manufacturers. Hypocrisy, like alcohol, is legal and is leaned upon heavily.

    The fighting is justified by both sides on the grounds that it is over the most efficacious way of getting smokers to quit and thereby adding a few more years to their lives. Whether all smokers want to make this trade-off seems to be seen as of little importance and, in this respect, I would like to applaud Clive Bates for including the following gentle but important reminder in his pre-COP9 published piece “Prohibitionists at Work: How the WHO Damages Public Health Through Hostility to Tobacco Harm Reduction”: “Not everything in life is subordinated to maximizing life expectancy.” Drinkers, of course, will be aware of this.

    What we are witnessing is a commercial fight between the purveyors of nicotine-replacement therapy products, which are promoted by the WHO and not discounted by THR supporters, and the purveyors of THR products, which are frowned upon by the WHO.

    In reality, and in part, what we are witnessing is a commercial fight between the purveyors of nicotine-replacement therapy products, which are promoted by the WHO and not discounted by THR supporters, and the purveyors of THR products, which are frowned upon by the WHO. But, to my way of thinking, there is a vital difference between the approaches of the two sides. I am not going to go into details here because most of the relevant arguments are already familiar to readers of this magazine and because anybody who wants to refresh their knowledge may visit Bates’ excellent piece. But at its most basic, the difference amounts to the fact that those pushing the THR message are offering less risky and hugely less risky substitute products to those smokers who are considering or who have decided they want to quit smoking highly risky combustibles and have not been able to do so using other methods, while the FCTC is intent on discouraging the use of THR products and, instead, forcing all smokers to quit, largely through pricing them out of the market by encouraging governments to apply unconscionable levels of taxes. Unfortunately, some of those who support THR are not above calling for higher taxes on combustibles or describing tobacco tax hikes as “progress” or “success.”

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    Sensible Voices

    Seemingly, the main item to have emerged from the bureaucratic thicket of the COP9 concerned a decision to launch an investment fund that will offer another source of financial support. “This lays a foundation for financial stability for the future implementation of the WHO FCTC,” a post-conference press note stated. “The fund will complement existing revenue received from Parties through assessed contributions and extra budgetary support.”

    I don’t know how this fund will be operated and possibly wouldn’t understand it if I were to be told, but something about the announcement strikes me as important. It seems to me to indicate the Secretariat is perhaps concerned about future contributions from the Parties, and, if this is true, I would say it shows the glimmer of an unusual connection with reality. Sensible voices are starting to be raised. The Philippines’ foreign affairs secretary, Teodoro Locsin Jr., reportedly told the conference that the latest scientific information must be considered in trying to solve the global smoking problem, adding that a balanced and evidence-based approach to safer nicotine products was needed. The Philippines was making progress in moving away from harmful products by introducing products with similar satisfaction but causing far less harm.

    At the same time, if the new financial arrangements are predicted to make the FCTC’s star shine brighter in the future, I think the observers are looking through the wrong end of the telescope, unless, at the same time, the FCTC shifts its focus from quit-or-die to harm reduction. The Philippines’ delegation bravely set the scene for a new direction that, if it is not taken, will see the FCTC’s star implode under the weight of its own contradictions. For instance, the U.K. cannot in all conscience turn up in Panama in 2023, where COP10 is scheduled to be held, showing support for a quit-or-die policy while prescribing harm reduction devices at home. And other countries will surely follow this lead. The Secretariat and its allies are defying logic, and it is possible to do that only for so long. I would venture to say their time is running out.

    A Healthy Body Securing the Supply Chain

    Meanwhile, it surely has to be the case that the three-year-old MOP will collapse even though it, too, is to seek out a new funding stream. The idea that a so-called world health organization is involved in policing the illegal trade in tobacco products again defies logic and seems to hark back to the time when the U.S. Food and Drug Administration seemed to become directly involved (it might still be so involved) in sending underage people into shops to catch retailers selling tobacco products to such people.

    It might take a little time for the MOP nonsense to be exposed, of course, because there is unlikely to be any opposition from the tobacco industry. A press note published to coincide with the opening day of MOP2 said, in part, “During this meeting, Parties will discuss a number of issues, including ways of securing the supply chain of tobacco products….” You have to wonder whether this was meant as a joke. An international health organization is bent on securing the supply chain of tobacco products? Really?

    Certainly, the MOP is a confused entity, partly because of the hopelessly optimistic goal built into the name of the protocol that it is supposed to oversee. Announcing MOP2, a press note referred in the first two paragraphs to its aims as being eliminating, which is in the name, but also stopping and combatting the illegal trade of tobacco products. I guess such vagueness helps guard against the time that an audit of progress is made.

    As far as I could see, MOP2 ended with little more than a few vague promises whose meaninglessness was underscored by the overuse of the word important. “Importantly, MOP2 agreed to strengthen international cooperation to ensure greater assistance between Parties—an important step that is expected to accelerate the adoption of best practices and support the introduction of innovations,” a closing note said. “The Parties also adopted a strategy for mechanisms of assistance and mobilization of financial resources to deepen the implementation of the Protocol.” Hmm.

    An international health organization is bent on securing the supply chain of tobacco products? Really?

    Having said this, I have some sympathy for the WHO. Once most countries had signed up to the ludicrous idea that a global health organization should become involved through the FCTC in trying, among other things, to engineer consumer choices, it was headed into unfamiliar territory. However, it has only itself to blame for the Luddite approach it has taken in the face of the development of new generation tobacco and nicotine products that are far less risky than are combustible cigarettes and that for many smokers provide a satisfactory substitute for combustibles.

    OK, some might argue—in a near-perfect world, but one in which the rights of cigarette smokers were, as usual, pushed to the side—that the WHO might be justified in taking the actions it has. After all, it claims the global prevalence of tobacco use among people 15 years of age and older decreased from 29 percent in 2005 to 22 percent in 2019 and will continue to decrease. Of course, it would be impossible to say why this decrease has occurred, but even if you accept that it is down to FCTC strategies, that doesn’t mean those strategies should be continued exclusively in the future if there are new strategies that can speed things along.

    In addition, we are in the grip of a global pandemic, which has, in general, been poorly handled and led to the deaths of millions of people; we are likely to be ravaged by other pandemics because no meaningful preventative measures are being taken; we are facing an existential environmental crisis; and we are dying in ever-increasing numbers from a global pollution pandemic. At such a time, we need the WHO to focus on risks such as these because these are the risks over which people have little or no control. Smoking is a choice.

    George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.
  • Transformers Versus Abolitionists

    Transformers Versus Abolitionists

    Photo: Grispb

    The two camps in tobacco control

    By Clive Bates

    In November, two major treaties had their Conference of the Parties (COP) meetings. COP26 of the U.N. Framework Convention on Climate Change (UNFCCC) was held in Glasgow, and COP9 of the WHO Framework Convention on Tobacco Control (FCTC) was held online. Both aim to address a globally significant problem, and both aim to achieve radical transformations in the markets for energy and tobacco, respectively.

    Yet, the approach differs significantly. There is tremendous pressure in the climate change treaty to eliminate the combustion of fossil fuels to mitigate environmental risk as rapidly as possible. Climate change activists demand a rapid transition to “net zero,” with energy production moving from coal, oil and gas to renewables such as solar, wind and hydro as soon as possible. Arguments rage about the nature of this transformation and the practicality and fairness of the transition needed to reach it. Should it include nuclear power? Should gas substitute coal? Should tree planting count as negative emissions? The climate treaty is all about harm reduction through market transformation. The debate is about the form of eventual transformation and the pathway to reach it.

    In tobacco and nicotine, we see a different debate. As with climate change, almost everyone agrees there is a problem. Using WHO figures, smoking causes about 8 million premature deaths annually, and many millions more fall severely ill with various forms of cancer, heart disease and respiratory conditions. But in public health, we are sharply divided into two camps—the transformers versus the abolitionists.

    The Transformers

    The transformers see the challenge as bringing down the intolerable burden of disease and death as far and as rapidly as possible by changing the nature of the market for nicotine. They point to the Sustainable Development Goal target (SDG 3.4) to reduce noncommunicable disease mortality by one-third by 2030 compared to 2015, and the inevitable future commitments will follow that. The transformers want the market for tobacco and nicotine to move away from combustible smoked products because the smoke causes most of the harm by far. The transformers are found among pragmatists in public health, the investment community and the companies in the nicotine and tobacco market. The challenge for companies is to transform without hurting their shareholders—they need an account of how the business will evolve. Tobacco control activists often say, “just stop selling cigarettes.” But a listed company can only do this through a credible transformation. Without the support of shareholders, executives would be fired, or the company would face a takeover.

    Two broad strategies are evident for tobacco companies’ transformation. The first strategy is pursuing noncombustible nicotine product market share and growth in a battle of innovation and consumer appeal. The companies are moving into vaping, pouches, smokeless and heated-tobacco products, with competition as a powerful driver of progress. The question that nags at transformers is whether this move is just a niche line extension or the formative stages of a strategic shift. The companies seem to vary, but they are now being tracked by a Tobacco Transformation Index. The second strategy is more subtle and involves diversification of the companies’ activities. This doesn’t mean buying up unrelated firms, such as food or automotive companies, and creating a conglomerate to dilute the tobacco business. Conglomerates are falling out of fashion, with even the once-mighty General Electric announcing the spin out of its healthcare, energy and aviation businesses. For tobacco companies, diversification must involve synergies—meaning the whole must be greater than the sum of the parts. So, for example, we see tobacco companies exploiting their expertise in plant biotechnology, inhalation science and their consumer insights into non-nicotine psychotropics.

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    The Abolitionists

    The abolitionists have a very different endgame in mind. Their implicit and increasingly explicit goal is to eradicate nicotine use and achieve a “nicotine-free society.” Once it is clear that this is the goal, the dogged opposition to transformation becomes straightforward to explain. Reduced-risk products like snus, vapes, pouches or heated-tobacco products are seen as little more than a lifeline for tobacco companies that would otherwise face imminent obliteration. They are not life-saving alternatives to cigarettes but a cynical nicotine maintenance strategy of Big Tobacco.

    There are two problems with the abolitionists.

    The first is that there is no evidence that the demand for nicotine is in decline. With at least a 6,000-year history and currently over a billion users, nicotine use remains a very large-scale and deep-rooted phenomenon. There is even less reason to expect declines in demand for nicotine in the future, and we may see the opposite. The main reason smokers give for quitting smoking is that they are experiencing or anticipating harmful health effects. Remove nearly all the harms associated with smoking, and the main reason for quitting nicotine since 1960 has been mostly eliminated. But this is problematic for the abolitionists: To justify the end of nicotine, nicotine use must be harmful. For abolitionists, the problem with much safer nicotine products is that they destroy the rationale for intervention. That is why there is not much interest in coffee and caffeine control. Unsurprisingly, therefore, we see abolitionists pushing contrived science to show these products really are harmful. They have had some success: The European and American public increasingly believes, incorrectly, that smoke-free products are equally or more dangerous than cigarettes, even though they obviously are not.

    The second problem with the abolitionist position is that the priority given to eliminating nicotine will mean more harm—more cancer and heart disease. This is because a different guiding priority leads, by design, to different trade-offs. If the goal is ending nicotine use, the abolitionist is more likely to be indifferent to whether someone is vaping or smoking. But those behaviors have very different impacts on health. A thought experiment illustrates the trade-off problem: Hypothetically, would you prefer 20 percent smoking or 10 percent smoking and 30 percent vaping? The second case means twice the nicotine use but half the smoking and much less harm. So while they may see the abolition of nicotine as a pure and uncluttered outcome, it will involve a lot more death and disease in the interim and probably indefinitely. Consider the EU ban on snus, which came into effect in 1991. For the abolitionists, this looks like an incremental step toward their nicotine-free society. To the transformers, it seems like a lost opportunity that puts dogma before health. In the intervening 30 years, how many smokers have been denied the option to almost eliminate their risk while the European Union continues to suffer about 700,000 smoking-related deaths annually? The ban on snus is not a step forward in the march toward a nicotine-free society but a step backward in the imperative to transform the European nicotine market.

    Governments are the Real Transformers

    In its February 2021 investor day press release, Philip Morris International made a short but remarkable statement about transformation: “The company believes that with the right regulatory frameworks, dialogue and support from civil society, cigarette sales can end within 10 to 15 years in many countries.” The company is saying to investors that its cash-cow—cigarettes—could be obsolete within the typical corporate planning horizon. This is a striking recognition of just how fast things could change if the transformation strategy were pursued purposefully by all parties. The other important idea here is that transformation needs to be a joint undertaking: Governments set the regulatory and fiscal framework. Governments, civil society, health professionals and academia create the “information environment,” shaping what people see, hear and think about their options. Imagine if everyone with a serious stake in public health got fully behind a transformation strategy?

    The Abolitionists Fighting Transformation

    The abolitionists are threatened by transformation as it will deny them the justification for a nicotine-free society. So they are fighting transformation, with agencies right up to the WHO pressing for the outright prohibition of noncombustible products or regulations that would treat low-risk products no differently than high-risk cigarettes. This approach has nothing to do with health and everything to do with the threat that low-risk products present to the goal of the nicotine-free society. We also see anti-tobacco activists trying to block the diversification strategy of tobacco companies—for example, making the absurd argument they should not even use their biotech capabilities to try to make Covid-19 vaccines. In the most disturbing case so far, activists tried to block tobacco industry diversification through the acquisition of a pharmaceutical company specializing in inhalation technologies. Once the transaction was completed, they threatened the employees with ostracization. One day, these scientists were good guys; the next day, they were bad guys, even though they were doing the same thing with the same purpose—just with different owners.

    It’s almost as if these activists need tobacco companies to be permanent cigarette companies and nothing else. Perhaps they need an unambiguously evil enemy that fits their activist business model rather than a transformation that threatens to deny them the reason to exist.

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