Category: Print Edition

  • Focusing Minds

    Focusing Minds

    Photo: Pexels from Pixabay

    The post-Brexit review of tobacco regulations provides an opportunity to hasten smokers’ transition to less-harmful nicotine products.

    Writing in The Guardian on Jan. 13, associate editor and columnist Martin Kettle wrote that “in almost every material respect the U.K. is currently worse off than before 1 January.” He was, of course, commenting on Brexit, about which the government, in the words of the late music hall comedian, Billy Russell, can be said to have “promised us everything, given us nothing and, before we got it, taken it off us.” There is no Brexit dividend, only a growing Brexit deficit, which can be clearly seen even though the government is trying to brush it under the carpet laid down by the Covid-19 pandemic.

    Having said that, perhaps there is at least the potential for a dividend in one specific area. There seems to be a chance that the U.K. government, which has for many years been supportive of the idea of tobacco harm reduction, might, after emerging from under the stultifying EU Tobacco Products Directive, develop tobacco and nicotine regulations fit for an age that has left behind the failed idea of quit-or-die and embraced the development of a range of new generation products that are less risky to consume than are combustible cigarettes.

    Certainly, the U.K. Vaping Industry Association [UKVIA] believes there is such an opportunity. On March 15, it launched its Blueprint for Better Regulation in response to the U.K. government’s consultation on the Tobacco and Related Products Regulations (and the Standardized Packaging of Tobacco Products Regulations), in which it was seeking until March 19 feedback on the effectiveness of the legislation in achieving its objectives, and on any unintended consequences that may have occurred.

    In a foreword to the Blueprint, the UKVIA’s director general, John Dunne, said the review of the regulations represented a defining moment in the history of the vaping industry, one of the leading market disruptors of the 21st century responsible for a significant decline in smoking across the U.K. It also presented the biggest opportunity yet for the government to create fair and proportionate vaping regulation that supported its 2030 smoke-free target and ensured the sector could make a bigger contribution to the nation’s public health and economy in the future.

    To achieve such a goal, the UKVIA is recommending that the government takes an evidence-based approach to revising regulations that would, in part, help counter the misinformation being widely disseminated about vaping: misinformation that is providing an increasingly powerful drag on efforts to encourage people to switch from smoking to vaping, even though vaping is hugely less risky and less costly than is smoking. It wants the government and health authorities to mount campaigns aimed at encouraging such switching, and it wants the industry to be able to mount its own officially sanctioned but effective, multichannel, consumer-communication campaigns, including with those buying online. And it wants a regulated but workable environment in which its members can develop vaping products capable of competing with conventional cigarettes, especially on a nicotine-satisfaction basis.

    In what might be seen as an unexpected move, but which is a smart one for an industry necessarily looking to be seen as responsible, the UKVIA is recommending that the regulations reach out to include “additional products and components,” especially nicotine-free e-liquids.

    There is, of course, much more in the UKVIA’s Blueprint. No such presentation would be complete without a discussion about the important role flavors play in encouraging people to switch from smoking to vaping and the need to address e-liquid bottle sizes so as to reduce plastic waste and improve customer convenience, while not increasing the risk-profile of the e-liquids. The Blueprint looks at packaging and labeling, descriptors, and product quality and safety. It supports age restrictions on the purchase of vaping products and the need to work with trading standards officers in ensuring such restrictions are enforced. And it recommends that the government acts in relation to vaping in public places so that vaping is not conflated with smoking.

    A firm deadline

    What are the chances? Well, Dunne appears to be confident, and, with some justification, since, to a large extent, the UKVIA is pushing at an open door. The government could be willing to work with at least some of the UKVIA’s ideas, perhaps all of them, partly because smoking is most prevalent among disadvantaged groups and the government has been saying it wants to level-up the U.K. But caution has to be advised. Two skills the U.K. government is known for are its shape-shifting and U-turns. And one concern must be the government’s likely reaction if it found that conversions to vaping picked up so fast that tax revenues from tobacco fell dramatically.

    And in this regard, I feel the UKVIA might have missed a trick, though I’m sure it must have crossed its members’ minds and, for some reason, been rejected. To cement things in place, might it not have been a good idea to ask the government to declare a date, some years ahead, on which combustible cigarettes could no longer be sold legally within the U.K.? I know that some would complain that this would be prohibition, while tagging on the rusty old argument that alcohol prohibition didn’t work in the U.S. and therefore it wouldn’t work with cigarettes anywhere. But the conflation of alcohol prohibition in the U.S. and a potential tobacco prohibition elsewhere never comprised a rational argument. And, in any case, what is being suggested is not prohibition but substitution and transition. Smokers would not be being abandoned, because they could still get a nicotine fix after cigarette sales were banned.

    One of the arguments for putting such an end date in place would be that it would focus minds. It is clear that where the automobile industry has been presented with end dates for the sale of vehicles powered by fossil fuels, manufacturers have steamed ahead and some have been encouraged to aim at beating the deadline. From combustion to batteries; there has to be a connection.

    Of course, the implementation of such a deadline in respect of combustible cigarettes would have to be dependent on regulations being changed so that those involved in the development of new-generation, tobacco-harm-reduction products could operate in a regulated but not restrictive environment. In fairness to smokers, it would need to be the case that they were presented with products that reproduced where possible at least the characteristics of smoking that most attracts them to the habit.

    There is something else, too. Switching messages listed in the Blueprint seem to be way too long: 12-21 words apiece. If there is one thing the U.K.’s Conservative Party, the party of government, is good at, it is effective messaging, which it likes to keep to three or four words. I mean, if you can get people to vote for the Conservatives with the message, “Get Brexit done,” imagine what you could do with: “Don’t smoke, vape.” And while it’s at it, why shouldn’t the government require messages on combustible-cigarette packaging that say: “Switch to vaping”; or “Get switching done.”

    Formidable opponents

    One problem in all of this is that there are some powerful forces acting against tobacco harm reduction. In March, the UKVIA issued a press note, titled, “The U.K. Vaping Industry Association [UKVIA] blasts World Health Organization and says it risks becoming an ‘enemy of harm-reduction.’” What the UKVIA objected to in the first instance was what it described as “[r]ecent recommendations made by the WHO study group on Tobacco Product Regulations that would prohibit electronic nicotine and non-nicotine delivery systems where the user can control device features and liquid ingredients.” But it said also that the WHO had called for a ban on vaping systems that have a higher “abuse liability” than conventional cigarettes have; systems that, for example, allow the user to control the emission rate of nicotine.

    Dunne made the point that vaping’s success as an industry, and its potential for public health improvements, were built on empowering personal choice. “Different systems, styles and flavors give consumers the options they need to leave combustible cigarettes behind,” he said. “I would urge the WHO to engage with vapers, to hear their stories and discover the life-changing decisions they’ve made… Prohibition is simply not the answer.”

    The U.K. has a genuine opportunity to promote harm-reduction as a valid, progressive strategy for public health on the world stage.

    John Dunne, director general, UKVIA

    Dunne believes the WHO poses a threat to smoking-cessation and harm-reduction in the U.K. because it is out of touch. He said, for instance, that the WHO claimed there was little evidence that vaping helped people to quit smoking. But Public Health England had found in its Vaping Evidence Review 2021 that smoking quit rates involving a vaping product were higher than with any other method in every English region. “For the WHO to hold such contrary views is either bad science or bad faith,” he added. “Both risk it becoming an enemy of harm-reduction.”

    The press note said also the U.K. was due to send a delegation to the COP9 meeting, the November 2021 Conference of the Parties to the WHO’s Framework Convention on Tobacco Control. This would be the first time the U.K. had attended such a meeting since leaving the EU, and the UKVIA had been among expert guests invited by the All-Party Parliamentary Group for Vaping to advise on the COP9 delegation’s approach. “The U.K. has a genuine opportunity to promote harm-reduction as a valid, progressive strategy for public health on the world stage,” said Dunne. “We must not allow misinformation to undermine this potential, irrespective of the source.”

    But the UKVIA has a further problem. In another press note in March, it said it was deeply concerned by news that U.K. businesses were being impacted by the U.S.’ “Vape Mail” ban, part of a congressional spending bill passed under former President Trump. By April 5 [after this report was written], leading carriers such as UPS, FedEx, DHL and the U.S. Postal Service were due to be off-limits for vaping shipments.

    “The vaping supply chain is a global one, bringing together resources and expertise from around the world,” said Dunne. “It is bitterly disappointing to see these American restrictions having a negative impact in the U.K., but the nature of the supply chain makes it inevitable. In the EU too we are hearing of vaping businesses being turned away from major carriers.

    “The potential impact on public health is grave, as so many people are relying on shipped goods as a lifeline during the pandemic. Without proper access to harm-reduction products we know people can revert to smoking cigarettes, today in the U.S. but perhaps tomorrow in the U.K. With businesses already struggling through lockdown, and our health services under great strain, supply chain issues really are the last thing we need.”

    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.
  • Lessons From History

    Lessons From History

    A poster from the U.S. National Crime Prevention Council urging consumers to report suspected fake vapor products.

    In their fight against illegal vapor products, authorities risk repeating the mistakes made in the same struggle against illicit combustible cigarettes.

    By George Gay

    I don’t go along with the idea that people who buy illicit cigarettes should be condemned on the grounds that, in doing so, they encourage organized crime because, to my mind, this amounts to stand-out hypocrisy even in a world whose wheels are liberally oiled with hypocrisy. Governments, through taxation, knowingly raise the prices of cigarettes to levels at which many smokers cannot afford them, and they do this while declaring that cigarettes are highly addictive. The outcome—the promotion of the illegal trade in cigarettes—is built into this strategy, which, in fact, in most cases at least, is aimed primarily at increasing tax revenues.

    But this sort of hypocrisy is easier to take than the sort of hand-wringing hypocrisy encased in government claims that they have only smokers’ interests at heart when they act against the illegal trade. Having spent decades telling us that tobacco smoke is deadly, they suggest that the smoke issuing from illicit cigarettes is even more deadly than the deadly smoke issuing from cigarettes produced in regulated factories; they have deemed that there are degrees of deadly. To them, apparently, smoking kills, but smoking illicit cigarettes kills you deader. Hmm.

    If you allow a consumer product to become popular and then make it unavailable to the person in the street by adding greedy levels of tax, you are as good as issuing an invitation to criminals

    Having said that, and while still maintaining the need to cast a critical eye over claims about illegal trade in general, I have to admit that the illegal trade in vaping products is in a different league to that of cigarettes. There are clearly some elements of illegally traded vaping products, such as e-liquid containers and batteries, the use of which could cause unnecessary risks to consumers and others. But note, there is a major difference between cigarettes and vaping products. The former is a product that is so risky to consume that it is unlikely to be made any riskier by unregulated manufacture whereas the latter is a low-risk product that could be made riskier by unregulated manufacture.

    Notwithstanding this, various authorities around the world seem to be repeating, in the case of vapor products, the sorts of mistakes that, previously made in respect of combustible cigarettes, have led to a massive illegal trade in cigarettes. And this is so, even though it’s not difficult to understand the pitfalls. If you allow a consumer product to become popular and then make it unavailable to the person in the street by adding greedy levels of tax and/or by forcing manufacturers to degrade the appealing qualities of that product, you are as good as issuing an invitation to criminals, organized or not.

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    Openly boosting the market

    I wrote above that the authorities were repeating mistakes, but this is a little misleading, at least in the U.S. because there the authorities seem to have OK’d open carry in respect of mistakes—they seem to be boosting the illegal market in vapor products. In January, an official “toolkit” aimed at addressing the U.S. black market in vapor products described how, a year earlier, the Food and Drug Administration, as part of its enforcement priorities for vapor products, was targeting: any flavored cartridge-based product using flavors other than tobacco or menthol; all other products for which the manufacturer had failed to take or was failing to take adequate measures to prevent minors’ access; and any product that was targeted to minors or that was marketed in a way likely to promote use by minors.

    Of course, it’s easy to say, “well, fair enough, other flavors are simply not permitted.” But the ban on these other flavors was not taken in a knowledge vacuum. Those other flavors were a lifeline for some adult consumers wishing to switch from high-risk cigarettes to low-risk vaping products. And the importance of this lifeline is acknowledged in the toolkit, which was produced by a partnership between the National Intellectual Property Rights Coordination Center and the National Crime Prevention Council. “FDA also acknowledged the risk of an illicit trade of ‘black market’ … vapor products arising out of this new enforcement policy but maintained that it has the regulatory tools and enforcement authorities to address such products,” the toolkit says.

    Does this strike you as odd? The National Crime Prevention (my emphasis) Council is apparently happy to work with the FDA while it participates in the creation of a black market for vapor products. That is not crime prevention: It is crime control at best and crime uncontrol at worst.

    If you read through the toolkit, one of the justifications for banning most flavors in vapor products and thereby fanning the flames of the illegal trade in them is that these flavors appeal to minors and therefore encourage them to use vapor products. But there must be something else going on here. According to the toolkit, the black market for vapor products is an “emerging concern across the country.” And “[f]irst and foremost they [black market products] undermine tobacco control measures to address underage use of tobacco and nicotine products.” But the toolkit also tells us that, according to the 2020 National Youth Tobacco Survey (NYTS) conducted by the FDA and the Centers for Disease Prevention and Control* (CDC), there has been a decline in underage use of vapor products. “In 2019, 28 percent of high school students and 11 percent of middle school students used vapor products,” the toolkit quoted. “In 2020, 19.6 percent of high school students and 4.7 percent of middle school students used vapor products. This amounted to 1.8 million fewer high school [students] and middle school students using vapor products in 2020 compared to 2019.” (*Usually, but less logically, called the Centers for Disease Control and Prevention.)

    But there are other concerns that the toolkit highlights. “According to FDA, ‘[a]dditional risks posed by these [illicit] products include the potential that they contain harmful chemicals or constituents that are not present in other products, that they are manufactured using comparatively poor quality controls and that they are designed in ways that facilitate modifications by distributors or users—all of which increase the risk of adverse events.’”

    There is truth in this, but note the “potential” qualification and the reference to designs that facilitate modifications, which, according to my reading, muddies the waters. The toolkit talks of the ability of users to add illicit substances such as tetrahydrocannabinol (THC), but this is outside the sphere of vaping with nicotine, the lifeline for many smokers.

    The toolkit also says that black market products contribute to and facilitate other criminal activity that threatens the U.S. economy, public health and community safety as well as violating the intellectual property rights of U.S. companies. And here we come to an important crossroads. Is the fight against black market vapor products there to protect consumers or companies?

    Well, the IPR Center says, working in partnership with Philip Morris International (PMI) and Juul Labs, it is “proud to offer a training course on illicit trade in tobacco and vapor products,” which, we must hope, refers to a course on combatting the illegal trade in tobacco and vapor products. I have no problem with PMI and Juul playing such a role. In fact, I would imagine that these two companies have a lot to bring to the table. But there does seem to be a worrying level of inconsistency in the way that tobacco/nicotine companies are viewed: on the one hand as partners and on the other hand as pariahs.

    While PMI and Juul have a lot to bring to the table, they also have a lot to lose, unfairly, in the way of intellectual property rights, but then it is surely the case that a lot of smaller companies have had their intellectual property rights taken away from them by the actions of the FDA in demanding ludicrously complex and expensive market authorization applications. And why don’t consumers get a say? It would seem from the toolkit that their sole function is to be the audience during lectures on how to behave. Is that going to go down well with an ex-smoker who has had the vaping product she used to quit her cigarette habit withdrawn because it’s too appealing?

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    Missing figures

    One of the weaknesses of the toolkit is its lack of supporting figures, and you have to wonder why this is so. On Jan. 13, it was announced that, during December 2020, U.S. Customs and Border Protection (CBP) officers at the Dallas Fort Worth International Airport, working in conjunction with FDA agents, had seized 42 shipments from China that contained 33,681 “units of e-cigarettes,” later confirmed to comprise 33,681 individual e-cigarettes, each with a flavored cartridge. The seized goods were said to have a manufacturer’s suggested retail price of $719,453. Now I know there is a tendency for certain authorities in the U.S. to panic, but it seems odd to me that this haul should be the subject of a press announcement. After all, it doesn’t seem big enough to have threatened the end of civilization. I mean, it’s not like the borders had been crossed by a deadly virus.

    Nevertheless, given that the 33,681 units were the result of a week-long joint operation by the CBP and the FDA, it is perhaps likely that the total haul for fiscal year 2021 (Oct. 1, 2020, to Sept. 30, 2021) will be higher than that for fiscal year 2020, which saw 93,590 units seized as part of 69 incidents, especially since the fiscal year 2020 haul was up significantly from that of fiscal year 2019: 14,418 units seized as part of eight incidents.

    The trend is upward. I couldn’t obtain figures for fiscal years 2017 and 2018 but was told that, since the start of an FDA enforcement policy in January 2020, the number of seizures had increased by a factor of eight, which I took to mean that the numbers for 2017 and 2018 would have been low to negligible—as you would have expected.

    Will the trend continue upward? Almost certainly in the short-term to medium-term because the FDA describes its enforcement activities as continuing and aggressive, though, being charitable, there will be some downward pressure because, presumably, it will take a while to filter through to some manufacturers that this enforcement policy is in place.

    The FDA press note announcing the December 2020 seizures said that it and the CBP had been looking to intercept “counterfeit or other violative e-cigarettes, including certain flavored e-cigarettes imported to the U.S. that did not meet the Federal Food, Drug and Cosmetic Act (FD&C Act) requirements as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).” Counterfeit trade is likely to continue at a rate that will be partly determined by the success or otherwise of the continuing strategy of seizures and, therefore, the profitability of the operations of those offering such products. At the same time, the import of products including illicit flavors is likely to increase, despite the downward pressure mentioned above, simply because a strong demand has built up for these products among adults. A caveat has to be added here, however, because it is not beyond the bounds of possibility that flavored products might be passed for sale as part of the FDA’s review of premarket tobacco product applications for vapor products. But I wouldn’t hold out too much hope. The press note contained copious amounts of the usual hand-wringing about flavored vaping products and their effect on young people.

    The press note also includes a quote about how protecting U.S. consumers from “illicit and especially harmful tobacco products, such as counterfeit or flavored e-cigarettes, is of utmost importance to the FDA.” The note said, “we will continue to investigate and remove from the marketplace products that pose a particular danger to the public health.” As far as I could ascertain, however, the dangers described on a CDC website to which I was directed by the FDA apply to both licit and illicit products and, in any case, are shot through with qualifications along the lines of “might be” and “could in the future” or are the sorts of dangers that people, young and old, are exposed to while walking down the street.

    A recent study, reported by Oliver Milman in The Guardian in February, found that, worldwide in 2018, air pollution caused by the burning of fossil fuels was responsible for more deaths than tobacco smoking and malaria combined. I would imagine that the number of deaths caused by vaping with nicotine is some way down the list—perhaps just above the number of deaths that occur each year after people are attacked by mutant goldfish.

    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.
  • Innovation and its Enemies

    Innovation and its Enemies

    Photo: Gualtiero Boffi | Dreamstime.com

    Understanding the war on vaping

    By Clive Bates

    How did vaping emerge, and why do so many in public health oppose it? It is a perplexing question, but the explanation starts with innovation.

    The essential development was progress with a critical technology—the lithium-ion battery—that made new categories of consumer nicotine product possible in a compact form acceptable to consumers. Driven by the insatiable demand for miniaturization from mobile phones and other portable devices, these batteries have improved to deliver ever greater energy density (essential for good battery life) and power density (essential for rapid heating and responsiveness to human interaction). In one sense, vaping and heated-tobacco products are novel energy technologies. The critical innovation is that they change the heat source used to form the inhalable nicotine-bearing aerosol from combustion to electricity. Burning tobacco generates the heat, and the tobacco smoke is the aerosol, but the products of combustion are also the prime driver of the disease burden. There is no combustion with electrical heating, so no products of combustion and therefore much lower disease risk. This is the fundamental, game-changing innovation.

    Once the lithium-ion battery had overcome the primary heat source problem, innovators had at their disposal a platform for further innovation. In his recent book, How Innovation Works, Matt Ridley analyzes the origins of innovation:

    “The main ingredient in the secret sauce that leads to innovation is freedom. Freedom to exchange, experiment, invest and fail; freedom from appropriation or restriction by chiefs, priests and thieves; freedom on the part of consumers to reward the innovations they like and reject the ones they do not.”

    So in the relatively open regulatory environment of the past decade, we see a wave of intense innovator activity, all tested and selected in the marketplace through rapid introduction and consumer uptake or rejection in a process that mirrors natural selection in ecology. The surge of innovation includes the emergence of a vast range of flavors and branding, refillable devices, mods and tanks, variable power, temperature control and new heating element designs. It brought on “sub-ohm” devices designed for the consumption of large volumes of weak liquids and “pod” devices designed for the consumption of low volumes of high strength liquid from a compact device. Some of the innovation has been elegantly synergistic. For example, the use of acids in pod devices allowed for the formation of “protonated” nicotine salts, which improved pharmacokinetic nicotine delivery to a level that could rival cigarettes. But these acids also facilitate the use of high-strength nicotine liquids by reducing harshness. Higher strengths mean users inhale lower quantities of liquid, so less heating is required, allowing for smaller batteries and a more compact and consumer-friendly format. That has turned out to be a very successful combination.

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    Alongside the developments in technology, there have been major commercial and social innovations. Vape shops provide a service that helps people quit, but outside a medical or treatment paradigm without labeling their customers as “patients” suffering from a psychiatric disorder. Innovation has been driven spontaneously through social media with influential product reviewers using YouTube and other social media to exert “selection pressure” on innovators. A vaping subculture of user-driven camaraderie, support, advice, and scientific and engineering insight has flourished and provided users with a sense of purpose and independence of manufacturers and public health activists.

    These developments have combined to create a powerful rival “value proposition” to cigarettes and smoking—an alternative way to use the relatively mild lifestyle drug nicotine but without nearly all the lethal side effects. For public health campaigners, it should be a triumph—and recognized as the approaching endgame for the burden of cancer, heart and lung disease, and premature death caused by nicotine consumption through smoking. Isn’t this precisely what we should look for in innovation?

    Not everyone agrees.

    Despite this promise, thousands of well-funded and dedicated tobacco control activists and academics oppose these developments. The question is: Why? What is driving this opposition?

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    The coalition opposing vaping is formidable, drawing together the World Health Organization, major regulators, public health agencies like the Centers for Disease Control and Prevention in the United States, hundreds of academics and research funders, health and medical societies, activist groups and journalists. But why has this coalition directed its firepower against tobacco harm reduction, even though many of the same actors would support harm reduction for illicit drugs, HIV and sexual health?

    We should start by considering if the opposition is grounded in a legitimate analysis of public health objectives and an imperative to do the right thing. I believe we can dispose of this explanation quite quickly. If that were the case, we would see much more intellectual energy consumed over trade-offs and agonizing over the likely unintended consequences of policy proposals. There would be a richer discussion of objectives, ethical dilemmas, risk, uncertainty and precaution. Even if that discussion came to a result that opposed vaping and tobacco harm reduction, the analysis to reach that conclusion would look very different to the overconfident assertions seen in practice. For example, the call to “ban flavors,” “raise taxes” or “cap nicotine strengths” would come wrapped in concern for the effects on adult smoking cessation, the welfare of adolescent smokers, illicit trade, home mixing and workarounds, and displacement to other risk behaviors. But we never see this.

    A common suggestion is to “follow the money,” with an insinuation that the opponents of tobacco harm reduction are pursuing grants, tax revenues and employment opportunities and may have stakes in rival business models. Money plays a role and may have a reinforcing effect. It allows for the opposition to form at a very large scale. However, it does not explain why the money is aligned with opposition to tobacco harm reduction. I think the money follows the prevailing mindset or group think in the field rather than the other way around.

    There are two more promising explanations. First, tobacco harm reduction and its innovation model are profoundly countercultural for tobacco control activists and academics. The tobacco control toolkit is filled with punitive, restrictive and coercive tools, wielded with the daunting authority of health and medical experts. It mainly sees the private sector as the root of the problem and governments or nonprofits as providing the solutions. It is called tobacco control for a reason. In contrast, a public health model that works through the free-play of pleasure-seeking consumers interacting with profit-seeking innovators in a lightly regulated and competitive market does not easily fit within that toolbox or that culture.

    The second explanation is institutional inertia. Between 1980 and 2010, funders, academics, activists, regulators, politicians and many committed journalists came together and built a powerful fighting machine to challenge Big Tobacco and drive down smoking. But by 2010, the tobacco wars were becoming stale and somewhat intractable and the troops tired and bored. Innovation such as vaping and heated-tobacco have provided new and revitalizing enemies. Over the last decade, the war on smoking morphed into a war on nicotine. The machine built for fighting smoking swiveled its gun turrets and started blasting away at the new products and their supporters. It did that because that is what those organizations do—it’s in their institutional DNA. The leaders grew up as veterans of the “tobacco wars” and continued their fight on the new fronts. The involvement of the traditional enemy, the tobacco industry, made that much easier given the assumption that there is a permanent irreconcilable conflict between the tobacco industry’s interests and public health.

    In the medium term, the outlook is pessimistic. Nik Modi, an investment analyst with RBC Capital Markets, wrote in January 2021, “Now that the e-cig/vapor threat has been neutralized, we are expecting much more stable cigarette category trends.” That is the kind of “win” that should cause a rethink by the victors. But in the longer term, I am optimistic. The change in energy technology marks a fundamental shift in the industry. I do not believe it will be possible to suppress this innovation indefinitely, and the tobacco control coalition will suffer fatal reputational damage if it tries.

    In his brilliant book, Innovation and its Enemies: Why People Resist New Technologies, the late Calestous Juma showed how innovations that are commonplace today, such as coffee, margarine and refrigeration, were ferociously opposed when they emerged. Juma says:

    “Debates over new technology are part of a long history of social discourse over new products. Claims about the promise of new technology are at times greeted with skepticism, vilification or outright opposition—often dominated by slander, innuendo, scare tactics, conspiracy theories and misinformation. The assumption that new technologies carry unknown risks guides much of the debate. This is often amplified to levels that overshadow the dangers of known risks.” 

    That describes the opposition to vaping and tobacco harm reduction very well. But it also shows that time and knowledge will ultimately prevail. What a shame that so much more harm will be done while tobacco control activists adjust to disruptive innovation.

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    There are two more promising explanations. First, tobacco harm reduction and its innovation model are profoundly countercultural for tobacco control activists and academics. The tobacco control toolkit is filled with punitive, restrictive and coercive tools, wielded with the daunting authority of health and medical experts. It mainly sees the private sector as the root of the problem and governments or nonprofits as providing the solutions. It is called tobacco control for a reason. In contrast, a public health model that works through the free-play of pleasure-seeking consumers interacting with profit-seeking innovators in a lightly regulated and competitive market does not easily fit within that toolbox or that culture.

    The second explanation is institutional inertia. Between 1980 and 2010, funders, academics, activists, regulators, politicians and many committed journalists came together and built a powerful fighting machine to challenge Big Tobacco and drive down smoking. But by 2010, the tobacco wars were becoming stale and somewhat intractable and the troops tired and bored. Innovation such as vaping and heated-tobacco have provided new and revitalizing enemies. Over the last decade, the war on smoking morphed into a war on nicotine. The machine built for fighting smoking swiveled its gun turrets and started blasting away at the new products and their supporters. It did that because that is what those organizations do—it’s in their institutional DNA. The leaders grew up as veterans of the “tobacco wars” and continued their fight on the new fronts. The involvement of the traditional enemy, the tobacco industry, made that much easier given the assumption that there is a permanent irreconcilable conflict between the tobacco industry’s interests and public health.

    In the medium term, the outlook is pessimistic. Nik Modi, an investment analyst with RBC Capital Markets, wrote in January 2021, “Now that the e-cig/vapor threat has been neutralized, we are expecting much more stable cigarette category trends.” That is the kind of “win” that should cause a rethink by the victors. But in the longer term, I am optimistic. The change in energy technology marks a fundamental shift in the industry. I do not believe it will be possible to suppress this innovation indefinitely, and the tobacco control coalition will suffer fatal reputational damage if it tries.

    In his brilliant book, Innovation and its Enemies: Why People Resist New Technologies, the late Calestous Juma showed how innovations that are commonplace today, such as coffee, margarine and refrigeration, were ferociously opposed when they emerged. Juma says:

    “Debates over new technology are part of a long history of social discourse over new products. Claims about the promise of new technology are at times greeted with skepticism, vilification or outright opposition—often dominated by slander, innuendo, scare tactics, conspiracy theories and misinformation. The assumption that new technologies carry unknown risks guides much of the debate. This is often amplified to levels that overshadow the dangers of known risks.” 

    That describes the opposition to vaping and tobacco harm reduction very well. But it also shows that time and knowledge will ultimately prevail. What a shame that so much more harm will be done while tobacco control activists adjust to disruptive innovation.

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

    Existential Threats

    Photo:Trần Tiến Lộc Đỗ from Pixabay

    Participants in Keller and Heckman’s recent vapor law symposium agonize about U.S. shipping restrictions and marketing applications.

    By Timothy S. Donahue

    It is getting more difficult to be in the business of selling and manufacturing vapor products in the United States. Regulations on the industry are forcing many companies to rethink operations or go out of business. During the E-Vapor and Tobacco Law Virtual Symposium, sponsored by the Keller and Heckman law firm, industry experts discussed the current challenges facing the vaping industry. The seminar centered on two regulatory requirements that could regulate e-cigarettes out of existence: premarket tobacco product applications (PMTAs) and the Prevent All Cigarette Trafficking (PACT) Act.

    As part of the Consolidated Appropriations Act 2021 in the most recent Covid-19 relief bill signed into law on Dec. 27, 2020, Congress amended the PACT Act to apply to e-cigarettes and all vaping products. Jeffrey Cohen, associate chief counsel at the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), explained that the PACT Act rules would ban the U.S. Postal Service (USPS) from mailing electronic nicotine-delivery system (ENDS) products.

    Cohen said during the conference that he could not think of a situation, including business-to-business (B2B), where it would be legal to mail ENDS products through the USPS. “Basically, anything that’s covered by PACT, with certain rare exceptions, is nonmailable. You pretty much are not going to be able to mail nicotine-delivery devices anymore,” explained Cohen. “The biggest thing the PACT Act did was … it really wiped out the internet cigarette trade by nonmailability. That’s the biggest hammer in the PACT Act arsenal.”

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    Many participants shared Cohen’s concern about B2B shipments. However, just a few days after the conference ended, those fears were alleviated. On Feb. 19, the USPS published in the Federal Register its rules for mailing ENDS products. This means the rule will take effect on March 27, 2021. The USPS rule states that the agency will mail vapor products under narrowly defined circumstances, including B2B. Exceptions include:

    • Intrastate shipments within Alaska or Hawaii;
    • Shipments between verified and authorized tobacco industry businesses for business purposes, or between such businesses and federal or state agencies for regulatory purposes;
    • Lightweight shipments mailed between adult individuals, limited to 10 per 30-day period;
    • Limited shipments of cigarettes sent by verified and authorized manufacturers to adult smokers for consumer testing purposes; and
    • Limited shipments by federal agencies for public health purposes under similar rules applied to manufacturers conducting consumer testing.
    Azim Chowdhury

    Azim Chowdhury, a partner at Keller and Heckman who moderated the seminar, said that the PACT Act has historically exempted B2B deliveries from the USPS ban. Specifically, the USPS ban does not extend to tobacco products mailed only for business purposes between legally operating businesses that have all applicable state and federal government licenses or permits and are engaged in tobacco product manufacturing, distribution, wholesale, export, import, testing, investigation or research.

    “Companies seeking to use USPS for business-to-business deliveries must first submit an application to the USPS Pricing and Classification Service Center and comply with several other shipping, labeling and delivery requirements,” said Chowdhury.

    The USPS rules also state that the listed exceptions cannot feasibly be applied to inbound or outbound international mail, mail to or from the Freely Associated States or mail presented at overseas Army Post Office, Fleet Post Office or Diplomatic Post Office locations and destined to addresses in the United States. Because of this inability, all ENDS products “in such mail are non-mailable, without exception.”

    In addition to the non-mailing provisions, the PACT Act requires anyone who sells cigarettes or smokeless tobacco to register with the ATF and the tobacco tax administrators of the states into which a shipment is made or in which an advertisement or offer is disseminated, according to Chowdhury. Retailers who ship cigarettes or smokeless tobacco to consumers are further required to label packages as containing tobacco, verify the age and identity of the customer at purchase, use a delivery method (other than USPS) that checks ID and obtains an adult customer signature at delivery, and maintain records of delivery sales for a period of four years after the date of sale, among other things.

    Excluded from the statutory definition are products approved by the U.S. Food and Drug Administration for sale as “tobacco cessation products or for other therapeutic purposes and marketed and sold solely for such purposes.” The USPS also proposes to treat ENDS as a standalone category, “albeit one generally subject to the same restrictions and exceptions as cigarettes, consistent with the statute.”

    The PACT Act also mandates that the ATF produce a list of noncompliant sellers who have violated the conditions of the PACT Act. If a company gets on the noncompliant list, Cohen says that even the common carriers cannot ship the company’s products. He explained that anyone can nominate entities who they believe are noncompliant of the PACT Act.

    “We send a letter out to them indicating that we’re considering putting them on the list. The company has an opportunity to reply and explain to us why they are in compliance,” said Cohen. “Then we make a decision … distribute this [list] to the post office, to credit card companies, to common carriers, and they cannot ship goods sold by people that are on the list.”

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    Still struggling

    PMTAs were due to the U.S. FDA on Sept. 9, 2020. However, many companies submitted incomplete applications and are still working on completing the scientific studies that the applications require. Some companies are submitting PMTAs to get approval for new vaping products to be allowed to be marketed. For a product that was on the market prior to Aug. 8, 2016, to remain on the market, the manufacturer must have submitted a PMTA by the deadline.

    Chowdhury says that the FDA has already started issuing warning letters to companies that did not submit PMTAs, asking them to remove the illegal products from the market. In a recent letter to the industry, the FDA has stated that it is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency did not receive a product application. To date, the FDA has sent warning letters to 30 firms who manufacture and operate websites selling ENDS products, specifically e-liquids, which lack premarket authorization.

    Testing requirements for PMTAs featured prominently as a discussion topic during the seminar. One requirement that can cause the regulatory agency to issue an immediate refuse-to-accept letter is the failure to include an environmental assessment (EA) study. “Despite the lack of direct correlation between environmental impacts and public health assessments, omission of an EA will jeopardize the temporary marketing order for deemed products,” one speaker noted.

    For vapor products, EA studies must include items such as release of aerosol into the air, potential release of biomarkers into aquatic environments after wastewater treatment and biosolids as fertilizer. It should also include the impact of disposing of a product. This includes leftover e-liquid impacts on landfills from empty bottles and cartridges as well as the hardware impacts, such as from batteries and packaging.

    Many participants asked questions about the rules for synthetic nicotine. Chowdhury explained that legislation pending in Congress includes language instructing the FDA to issue a final rule on the regulation of synthetic nicotine.

    “FDA could take the position that because nicotine itself is a drug, it has this effect on the structure, function of the body that once you take away the fact that it’s derived from tobacco … could FDA come after that industry, come after those products as unapproved drugs or unapproved drug delivery devices? That’s a question that we’re waiting to see how FDA reacts as more nicotine products come to market,” he said.

    Nicotine salts were also addressed. If a company has an e-liquid that contains freebase nicotine but switches to a nicotine salt, that is a change in the formulation of the product and therefore creates a new product. “Now that we are in a post-PMTA world, where applications were submitted back in September, if you were to come to market or try to change the labeling of a product now, arguably because review of the label, how it’s perceived, how it impacts the consumer, it’s part of the review process,” explained Chowdhury. “It’s not clear that a labeling change is something you want to do at this point without at least notifying the FDA and providing FDA with the updated labeling in your application.”

    Due to lab space restrictions and Covid-19-related delays, numerous smaller manufacturers are still trying to complete the required testing for incomplete PMTAs. Many manufacturers are concerned about the FDA approving the products produced by major tobacco companies sold in C-stores before approving products from smaller companies whose products are typically sold in vape shops. One speaker noted that the industry is currently “freaking out” about the uncertainty and toughness of the PMTA process, fearing that the market could be handed to large companies.

    These fears are not unfounded. In a Feb. 16 update, the FDA confirmed that, due to the sheer number of applications, the agency has set aside the products with the greatest market share and will push those products through the PMTA process more quickly. The agency stated this was because, “based on their market share,” these companies would provide the biggest impact to overall public health. Since vapor products are tracked nationally only through Nielsen and C-store data, products from Juul Labs, R.J. Reynolds Vapor Co., Njoy and Logic have moved to the front of the PMTA line. Manufacturers selling hardware in untracked vape shop channels have no way of proving market share to the FDA.

    “I don’t think it will be only big tobacco getting PMTAs, but I think there’s a serious risk where you end up with the only flavors being approved are tobacco,” one presenter noted. “It has been a tough year, not just because of Covid, but the uncertainty over PMTAs. People are preparing to change their entire business plans because of the PACT Act. Until the FDA acts on PMTAs, real unity in this industry—not just unity among people selling your exact products—is near impossible. Once there are PMTAs [approved], there’s going to be unity through those with PMTAs to clear the market of those without them.”

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

    Gold Nuggets

    Photo: Stokkete | Dreamstime.com

    Gaining insights from the FDA’s final PMTA rule

    By Willie McKinney and Cheryl K. Olson

    On Jan. 19, the U.S. Food and Drug Administration finalized a “foundational rule” about the “minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs).” Within days, before many of us had a chance to download the 516-page document, let alone read it, the rule disappeared. The link says, “page not found.”

    Don’t worry. This is part of a normal review by the incoming Biden administration of recent rules from the old regime. Given that little FDA staff turnover is expected, their thinking, and the rule, will probably stay the same. The document will be back, nicely formatted.

    What to do while we wait for the final-final rule to appear on the FDA’s site? Well, the bulk of the document addresses “about 1,000 comments” (!) the FDA received on the proposed rule issued in 2019, including many questions from industry folks confused about PMTAs.

    Understanding the subtleties and subtext of the FDA’s responses to comments can dramatically increase your chances of getting a marketing granted order. Ignoring them can lead to a significant waste of time and money.

    Let’s wade into the FDA’s responses and see what gold nuggets of insight we can pan. What fuzzy areas affecting your strategy are now clear? What costly studies or paperwork might be trimmed or skipped?

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    A PMTA is not a box-ticking exercise

    We can begin with how the FDA thinks and what that means for PMTA strategy. Remember, interacting with tobacco product makers and sellers is still relatively new for the FDA’s staff and consultants. As they read comments, held conversations and began reviewing the recent flood of PMTAs, they realized that companies couldn’t figure out what the FDA was asking for. We know this because the PMTA rule lays out, much more clearly than in previous documents, what the FDA needs from companies. There are details on required content and format. The rule contains dozens of “musts”—must list, must include, must state and so on.

    The FDA also says what can happen if you don’t meet minimal requirements: Do this, and we won’t accept or file. Or: This will slow the review process. Think of it as a series of red lights (“FDA will refuse to accept a PMTA … where it lacks constituent testing information required by § 1114.7(i)(1)(v)”) and yellow lights (“FDA may refuse to accept or file an incomplete application for review”). All of this is welcome clarity.

    That doesn’t mean, as we’ve heard it described, that having a PMTA accepted and filed is a check-the-box exercise. Parts of a PMTA are like that, but the substantive review of data definitely is not.

    Many of the comments to the FDA hint at frustration. “Why can’t they just tell me what studies to do so I can market my product?” The short answer is that a PMTA is partly a checklist of required information, but it’s also a narrative. You’re telling a story about why your product is appropriate for the protection of public health (APPH), illustrated by data. An effective PMTA is driven by story—explaining why your product on balance is likely to benefit public health—and merely organized by the PMTA format. 

    If you try to follow the rule document like a cookbook recipe—add a cup of pharmacokinetics (PK) studies and a tablespoon of label comprehension, and it’s baked—you will likely fail. That’s because the rule is descriptive but not prescriptive; it doesn’t tell you how to deliver. Why? First, because each product is different, with its own particular characteristics and target customers and therefore a distinctive set of potential public health benefits and risks that need to be demonstrated or mitigated. Second, a how-to list would tie the FDA’s hands as they make and rethink decisions about what is APPH. In Response 105, the agency notes that “Due to the nature of the Federal rulemaking process … FDA may not be able to update such standards in a timely manner.”

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    Expect APPH to evolve

    APPH is about relative health risks; it’s about “net benefit to the health of the population as a whole.” A definition like that, based on comparing ever-evolving tobacco products, will create a moving target. See FDA’s Response 123: “Because market conditions will change over time, what might be APPH at one point in time may no longer be APPH in the future.”

    A static approach for granting marketing orders means the FDA couldn’t keep riskier products off the market, “thus undermining its core statutory mandate to reduce the harm caused by tobacco product use.” Basically, if you can show that your novel tobacco product is less risky than today’s cigarettes, that’s great. But as more tobacco users move to reduced-risk products, both the comparators and the risk equation will change. And if your tobacco product has, say, slightly more of a potentially harmful chemical than others in its category, adding your product to (or keeping it among) consumers’ options is not reducing harm.

    Save with bridging, bundling and master files

    Another reason the FDA “declines to require that an applicant conduct a list of new studies as part of every application” (Response 59) is that shortcuts are allowed. Applicants can also “provide scientific data to inform FDA’s review” through bridging. Rather than generating all new data on your product, you can sometimes leverage the research literature to show your product is APPH. Just a little new data connects you to more.

    Suppose you show from chemistry that your product releases nicotine in the same way and has the same nicotine concentration as another product already tested in published literature. That may let you bridge to their PK and abuse liability studies, saving you hundreds of thousands or even millions of dollars. In Response 62, the FDA “declines to define” bridging but instead gives useful examples of how to do it.

    Another cost-saving and time-saving shortcut is bundling or combining applications. Let’s say that you have four flavors or two nicotine strengths. The FDA sees them as separate products. But the FDA allows you to submit one PMTA for all of them. A bundled PMTA includes “a single, combined cover letter and table of contents across all products” (Response 19).

    You still need to provide unique information about each product, but you can collect and present it more efficiently. For example, you might conduct and present one bundled perception and intention survey that asks noncustomers about perceptions of the labeling of each of your four flavors in turn. But be aware that the FDA will break up your bundle for review, so list in tables which parts of the PMTA apply to which products. 

    Bundling isn’t always best. Are your harm reduction story and target audiences the same across products? A high nicotine vape may appeal to a heavily addicted smoker, but it has different health implications than a lower nicotine sister product. Combining the two into one PMTA might muddy your case for APPH status.

    A third PMTA shortcut to know about is called a tobacco product master file (TPMF). A master file contains information you can reference again and again for multiple applications. In Response 17, the FDA defines a TPMF as “contain[ing] trade secret and/or confidential commercial information about a tobacco product or component that the owner [e.g., manufacturer, ingredient supplier] does not want to share with other persons” but is willing to share with the FDA. That’s useful if your new tobacco product uses an e-liquid made by a manufacturer who doesn’t want to share their formulation but who will give you a letter of authorization to cite their master file in your PMTA. 

    There are other TPMF options. “When companies want to rely on the same pool of data, FDA encourages the use of shared resources, such as tobacco product master files, where appropriate” (Response 18). This might be the fruits of a thorough literature review on a particular topic. Rather than cite and submit 150 articles over and over, you can reference the master file.

    More information is not always better

    PMTA applicants now need to provide “only high-level marketing plan information” (Response 30) rather than detailed consumer research. The FDA’s main concern is youth exposure. It emphasizes descriptions of intended audiences and how they’ll be targeted. Note, however, that if you have already done consumer research, “the results of such research will be required” to go to the FDA. 

    As Comment 14 notes, “the tobacco industry has a history of marketing its products to … vulnerable populations,” which may include low-income communities, racial/ethnic minority group members, rural residents and youth, among others. Your PMTA story should include how your product might improve (or not worsen) the well-being of some of these vulnerable populations. Harm and benefit to subgroups that are more likely to start, less likely to stop and/or more likely to get sick from using tobacco products “are an important part” of the FDA’s APPH calculations. Groups of interest “will vary depending on type of tobacco product and may change over time.”

    However, the FDA does not clearly state that conducting research with some of these subgroups is unethical or unsafe. This includes people under the age of 21 and women “who are pregnant or trying to become pregnant.” (The document mentions the need for special attention to vulnerable populations, including children and incarcerated persons, when discussing FDA plans to issue future regulations concerning use of Institutional Review Boards for tobacco product clinical studies.)

    In Response 79, the FDA allows for “studies using individuals under the minimum age of sale” with extra protections and parental consent but “does not require it [or] anticipate that it will be necessary.” Don’t go there. Instead, over-sample young adults in your studies as a proxy for youth. Report, for example, whether intentions to use your product were different for people under age 25 compared to the rest.

     

    Cheryl K. Olson is a California-based public health researcher and consultant who specializes in behavioral health issues. She spent 15 years on the faculty of Harvard Medical School.
    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.
  • Blueprint for Exit

    Blueprint for Exit

    Photo: Tobacco Reporter archive

    Following the exit of two leading cigarette manufacturers, Colombian tobacco farmers had to find alternative livelihoods overnight. Their experience offers lessons for growers elsewhere.

    By Stefanie Rossel

    From smallholder tobacco farming to organized large-scale tobacco cultivation to alternative crops in a short time—Colombia’s leaf tobacco sector has experienced a remarkable development in the past 16 years. Its most recent change toward farmer livelihoods independent of tobacco might become a blueprint for other leaf origins facing declining demand for tobacco.

    The takeover of Colombia’s domestic tobacco industry by multinationals was a turning point for the country’s leaf sector. Philip Morris International (PMI) acquired Coltabaco in 2005, and British American Tobacco (BAT) bought Protabaco in 2011.

    “The technological package that had been implemented by the national companies before was very different from the one brought by the multinationals, and this meant radical adaptations for growers,” explains Heliodoro Campos Castillo, founder and general secretary of the National Tobacco Fund in Colombia (Fedetabaco).

    “To give some examples, tobacco farming in Colombia, like almost everywhere in the world, has always been a family business, with everyone from granddads to youngsters participating actively. With multinationals’ child labor policies, this was ended and translated into a reduction in areas cultivated. Other measures that brought about a hard adaptation for growers were the security procedures that did not exist before. Growers accepted them as part of the evolution needed in the sector to improve agricultural practices and did their best to adapt to them. However, these were abrupt changes with very little time for implementation, and the sector suffered with them.”

    Years before the multinationals entered the market, Fedetabaco initiated an investment package of $64 million in Colombia’s tobacco sector, which was co-financed by municipalities, the tobacco industry and institutions and stretched over almost 25 years.

    “Fedetabaco understood the challenges ahead and went beyond the improvements in production to better growers’ livelihoods through different sustainable programs, such as rainfall water collection and reservoirs, housing projects, improvement of curing methods through modernization and, most importantly, promoting sustainability through diversification to grant growers food security and endow them with resources to cover their basic consumption needs,” says Campos Castillo.

    “The improvement of the production system as a whole was an important factor to contribute to this self-sufficient strategy. We are working with the International Tobacco Growers’ Association (ITGA) to make sure the example of Colombia will help growers in other parts of the world.”

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    Local crop alternatives

    Tobacco cultivation in Colombia dates to the 18th century, but the plant plays a minor role in the country’s agriculture. According to the World Health Organization, only 0.03 percent of Colombia’s agricultural land was devoted to tobacco cultivation in 2014. The area used for tobacco cultivation has decreased drastically in the past decade, from 9,589 ha in 2011 to 3,550 ha in 2019, notes Fedetabaco. In line with global trends, annual cigarette consumption in the country declined from 18.4 billion units a year in 2010 to 12.2 billion pieces in 2019, according to USDA estimates. With a market share of 51.4 percent in 2019, PMI contract-purchased about half of the domestic leaf tobacco crop, which corresponded to a planted area of 1,850 ha per year, from 2,300 farmers. BAT, which held the remaining 48.6 percent of the market in 2019, bought tobacco grown on 1,300 ha.

    However, PMI closed its manufacturing operations in Colombia in 2019, citing a rise in contraband and a global trend away from tobacco products. One year later, BAT followed suit.

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    The two companies’ sudden withdrawal left farmers with little time to find viable alternative crops. It directly affected around 2,000 families and 9,000 people whose main source of income was tobacco, says Campos Castillo.

    “Fedetabaco immediately took action to try to mitigate this negative impact in these people’s livelihoods,” he says. “Working closely with the ministry of agriculture and all the sector’s national organizations and institutions, we were able to build up a strategic reconversion program based on a thorough analysis of the situation.

    “As the priority line of action, we took into account the experience and expertise of the farmers and the important contribution their knowledge could bring to the program as well as the ecological and agricultural characteristics to make sure we will act on the right location with the right crop with minimum waste.

    “This program includes maize, yuca and other crops well known by farmers. The investment will cover 3,500 hectares, and its estimated cost is around $10 million. So far, as a shock plan, we have been able to advance, in coordination with the ministry of agriculture, $900,000 to provide seeds and $400,000 to plant maize, but we reached out to ITGA because this will only cover a very small part of the problem.”

    Colombia continues to cultivate limited amounts of cigar tobacco for domestic consumption and exports.

    Cannabis pilot

    To help their farmers find alternative crops after their exit, PMI and BAT commissioned studies from two national nongovernmental organizations (NGOs). While Proterritorio finished its study last year, the Fundes research will be concluded this May. “We hope [the results] will add value to solve the problem,” says Campos Castillo. “Nevertheless, growers feel confident in the program developed by Fedetabaco with the ministry of agriculture, mainly because it has identified viable crops well known by them, such as yuca, Tahiti lemon and maize. We tend to think that there is a similar line of strategy between what we are proposing from Fedetabaco and the ministry of agriculture and the NGOs hired by the companies, but we will have to wait and see when the figures are out.” 

    Of the 18 departments that historically grew tobacco, only two will continue. One of them, in Colombia’s north, produces a dark cigar tobacco exclusively for export. The other, in Santander, cultivates Criollo, a tobacco used primarily for domestic cigars.

    Cannabis, too, could become an alternative for tobacco growers. Colombia legalized the growth, sale and smoking of medicinal cannabis in 2015. After Coltobaco’s closure, Fedetabaco immediately started exploring the potential of cannabis for medicinal, nonpsychoactive purposes. “We are carefully handling this pilot project and expect to have the result of the analysis in terms of cost of production, productivity and quality by the end of 2021.” It is an exciting project because cannabis is cultivated in small areas of around 1,000 square meters to 2,000 square meters—a scale that is familiar to smallholder tobacco farmers. What’s more, the soil and weather conditions in the target regions appear to be suitable for cannabis cultivation.

    Campos Castillo insists that his organization has not stopped working with the government trying to find solutions for tobacco farmers since the departure of PMI and BAT. “The government of Colombia cannot commit to granting the total amount of the funding. Tobacco is a small agriculture share in Colombia, and investment is needed in other rural commodities. Fedetabaco is experienced and has been developing programs for more than 30 years in rural areas in Colombia, so a holistic approach would be to gather all the resources available from companies, [the] government, institutions and our global platform, ITGA, all working together with a single purpose to safeguard the livelihood of these 2,000 families. We remain hopeful that this will happen in the near future.”

    The author would like to thank Mercedes Vazquez for her assistance with this article.

    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.
  • Keen to Connect

    Keen to Connect

    Photos: QBM
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    Quartz Business Media, organizer of the renowned World Tobacco exhibitions, prepares to satisfy the pent-up demand for in-person trade events in 2021.

    TR Staff Report

    Since its first tobacco event in 1973, Quartz Business Media (QBM) has organized industry exhibitions and conferences in Munich, Jakarta, Bali, Macau, Kunming, Hong Kong, Prague, Moscow, Vienna, Amsterdam, Geneva, Nice and The Hague, among other top locations. Today, the company is best known for its popular WT Middle East, WT Europe and WT Asia events held in the tobacco-friendly cities of Dubai, Sofia and Surabaya.

    Always evolving with industry developments and consumer preferences, QBM now also offers events for the shisha and vapor segments—World Shisha and the World Vape Show, both in Dubai. And in 2020, it added the legendary TABEXPO international trade fair to its portfolio, making QBM the truly undisputed leader in industry events.

    Unfortunately, 2020 was also the year that Covid-19 paralyzed the world economy. A pandemic, of course, is hardly an ideal backdrop for big gatherings with handshakes, product samplings and lively after-hours socializing. Also considering the practical hurdles erected by lockdowns and travel restrictions, QBM decided to postpone all its 2020 tobacco events to 2021 and 2022.

    While vaccination programs will continue to make headway in 2021, QBM isn’t taking any chances. To protect visitors and exhibitors from infection, it has established the “Quartz Secure Standards”—a rigorous set of guidelines that includes temperature checks, frequent cleaning and mandatory facemasks along with track-and-trace systems and medical support at its venues.*

    Using modern communication tools to ensure an appropriate social distance, Tobacco Reporter spoke with QBM International Sales Director Colin Case about QBM’s rich history, its plans for the newly added events and what the industry can expect as the pandemic recedes.

    While communication technology has come a long way, it is still no substitute for the in-person gathering.

    Tobacco Reporter: QBM may be the leading tobacco events organizer, but it’s not the only one. What sets your company apart from the competition?

    Case: QBM prides itself on really understanding each distinct community it serves—and listening. The business has a great team [that] knows their industries intimately and cares deeply about those industries. QBM doesn’t facilitate exhibitions for an industry; our events are drivers of the industries they serve.

    Since the first tobacco event in 1973, the team behind QBM and WT has largely remained in place and has worked to help support the tobacco industry through the many twists and turns it has faced. The business is very proud of its accolade as the longest exhibition organizer in the tobacco industry, and as our portfolio of products grows, we look forward to adapting and innovating alongside the industry we serve. 

    What are the characteristics of a successful exhibition?

    Case: Happy exhibitors and happy visitors. The focus must always be on the quality of attendee rather than just the volume.

    What has been the most successful tobacco event you have organized to date? What made it so successful?

    Case: WT Dubai 2019 was a great success. After implementing a new marketing campaign, the event was able to reach more of the industry across the world. With visitors from 90 different countries, it was a truly global event, and we look forward to surpassing this in 2021 at WT Dubai.

    What are the pitfalls in organizing an exhibition? How do you avoid such pitfalls?

    Case: One of the key decisions for an exhibition organizer is to ensure that their partner companies, such as freight forwarders and stand builders, have the depth of experience and company reach to ensure that pitfalls are avoided. This is particularly important in our industry as clearing tobacco products through customs can be challenging and requires skill and personal contacts.

    Selecting the proper time and location are crucial, especially for a business as international as tobacco. What must be considered when selecting a date and a host city?

    Case: The locations that are now associated with World Tobacco, although now well established, were carefully considered at the time to ensure that the host governments were not hostile to the tobacco industry and that the local market had a sufficiently broad tobacco industry to attract good quality visitors. Our current city locations of Dubai, Surabaya and Sofia remain popular and productive venues, and so for the foreseeable future, we will continue with our program.

    Please comment on your decision to add TABEXPO to your portfolio. What made it a suitable addition? What changes will you make to the TABEXPO formula in terms of setup and frequency?

    Case: A fantastic addition to the World Tobacco portfolio, by having TABEXPO as part of our family of shows, it allows us to have more global visibility and helps to knit the global tobacco industry together. To be hosted in London in December 2021, TABEXPO gives the QBM tobacco portfolio a foothold in Western and Eastern Europe, Asia and the Middle East.

    How has the rise in anti-tobacco sentiment affected the business of tobacco exhibitions? For example, has it become more difficult to secure suitable locations and are you encountering restrictions on what products may be displayed? How do you deal with the potential for anti-tobacco protests?

    Case: The welfare and safety of our exhibitors and visitors is paramount. All events follow similar event planning protocols, which think about the social macro-environment where each event is held.  Thankfully, over the 40 years of running tobacco events, we have experienced little protest and will work hard to ensure that continues.

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    How has the rise of vaping changed tobacco exhibitions?

    Case: Vape is an exciting and fast-growing industry. Alongside our World Tobacco portfolio, we also organize World Vape Show London and World Vape Dubai. By having a foothold in both industries, the teams are better placed to understand each industry, plan appropriately and deliver distinct and unique events, which will benefit both communities.

    Please comment on the impact of Covid-19 on your business.

    Case: Like all businesses, no matter what industry, we have been massively impacted by the ongoing situation. [While] we have been unable to host live events, feedback from the market has been overwhelming in their desire to meet again face-to-face when possible. With the global rollout of the vaccines underway, we remain optimistic that we can start hosting events for the tobacco community again in 2021.

    How has the tobacco industry responded to the postponements? Did most 2020 exhibitors sign up for 2021 and 2022 or did you lose exhibitors permanently?

    Case: The industry has been thankfully very supportive and understanding. We are very fortunate that our events are valued by the industry, and with that, the vast majority is committed to exhibiting with us.

    Have you held any virtual events in lieu of physical gatherings? What lessons did you draw from those experiences?

    Case: As a business, we have hosted over 40 different virtual event propositions since last March. [While] a great medium, virtual events are temporary fixes and not long-term solutions to the process of doing meaningful business. The tobacco industry has been clear: They prefer to meet physically and enjoy each other’s company. No amount of technology can replace that. 

    What measures do you have in place at your upcoming events to prevent coronavirus infections?

    Case: We have developed a dedicated Covid-safe exhibition program for all QBM events. All of our venues have also introduced their own Covid protocols.

    Do you expect demand for in-person events to be larger or smaller after the pandemic recedes? Why?

    Case: As said before, people buy people. People crave interaction. Technology can help facilitate that to a limited degree but can never replace it.

    Do you anticipate the pandemic to have lasting effects on the way in which events are conducted? In what way? 

    Case: Not necessarily. I think hygiene and safety measures will become more prevalent at all shows worldwide, but we also believe that the exhibition business, not just for tobacco, has a strong future as people will still need to meet customers and potential customers face-to-face.

    WT Events

    World Vape Show
    Dubai, Sept. 19–21, 2021

    WT Middle East
    Dubai, Oct 26–27, 2021

    TABEXPO
    London, Dec. 9–10, 2021

    World Shisha Dubai
    Dubai Festival City, Dec. 9–10,  2021

    WT Asia
    Surabaya, Jan. 26–27, 2022

    WT Europe
    Sofia, May 18–19, 2022

     

  • Keeping Pace

    Keeping Pace

    Illustration: Essentra

    Filter manufacturers prepare to meet new environmental requirements and consumer preferences.

    By George Gay

    A major challenge for the cigarette filters industry this year, and, by extension, for the cigarette manufacturing industry, will involve the phasing-in of titanium dioxide-free (TiO2-free) acetate tow. In an email exchange in January, Georgi Zisov, sales director at the Bulgaria-based cigarette filters and print house company Yuri Gagarin, said that, initially, the requirement that cigarettes were manufactured with TiO2-free filters would apply only to those destined for sale in the countries of the EU where the requirement was due to come into force in October. But, he added, it would prove inefficient for tow producers, filter manufacturers and end users to deal simultaneously with both traditional and TiO2-free tow, so, starting this year, there was likely to be a push for the adoption of filters made with TiO2-free tow across all markets, something that would probably be achieved within a few years, allowing those involved once again to enjoy economies of scale. Yuri Gagarin, Zisov said, had already started trials with TiO2-free tow for a number of customers both within and without the EU.

    TiO2, which is used as a bleaching agent to make tow appear whiter, is considered to be harmful to health, something that, to my mind, raises a number of questions, not the least of which has to be why, therefore, is it used in some food products and toothpaste? OK, perhaps the form used in these products is different to that used for bleaching, though, having said that, TiO2 was banned from foodstuffs in France last year.

    Nevertheless, I think it is worth asking if it is believed that the health concerns raised by the addition of TiO2 to filters—where it is presumably heated but not burned during the consumption of a cigarette—is separate from or merely part of the “deadly” risk posed by inhaling the smoke from the combustion of the tobacco rod and paper? If it is considered to be part of the overall risk, it would seem to me, admittedly somebody untrained in chemistry, that the argument for removing it from the health equation does not stack up, at least at the level of the individual smoker. In this case, it would seem likely that the removal of TiO2 could be said with any degree of certainty only to change the health risk because, due to the complex chemistry involved, it would surely not be known whether that risk had been lowered or raised. There would, of course, be a better argument for removing TiO2 if it presented a known separate and additional risk, though it is difficult to understand how such a separate, additional risk could be demonstrated at this time, if ever.

    And there is a side issue here. The undesirability of raising the risk is obvious, but lowering it could suggest to consumers that cigarettes were now less risky than they were previously, leading to a surge in consumption.

    Georgi Zisov (right) and Onik Arabyan (left) of Yuri Gagagrin

    No quick fix

    None of this is to suggest that removing TiO2 is not a good idea. It probably is, but I feel that it is necessary to try to understand our motives, even if we have to admit that they are based on a gut feeling. I buy unbleached coffee filters on the basis of a vague idea that not bleaching the paper used in their manufacture might extend by a millisecond the date at which the earth’s ecosystems finally collapse under the weight of human indifference.

    But perhaps that’s not fair. Asked what the main factors were that drive the global market for cigarette and roll-your-own (RYO) filters manufactured by specialist suppliers, Seng Keong Low (SK), global marketing manager at Essentra, told me that these comprised consumer preferences legislation and customer demand.   

    “For example, single-use plastics legislation, particularly in the EU, has brought sustainability to the forefront of consumers’ minds,” he said in an email exchange. “Due to the pending restrictions on plastic filters and the evolving consumer preferences for a more eco-friendly option, paper-based and other nonwoven alternative materials will be the future of the industry. As such, Essentra has invested our innovations efforts in finding a more sustainable option and recently launched three new plastic-free filters in our ECO range” (see sidebar).

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    But things are not as simple as they might sometimes seem to be. “There has also always been an incongruous relationship between the tobacco industry and environmental, social and corporate governance initiatives,” said SK. “Despite this, we at Essentra believe in being the pioneers to drive the industry to go green by launching nonplastic alternatives to address the issue right from the source.

    “However, we are also very cognizant of the fact that while providing a nonplastic alternative is a step in the right direction, it will ultimately come down to the consumers’ willingness to make the right choices as well. Based on positive indications from our own consumer research, we expect a slow start, but as more momentum and positive sentiment builds up, a snowball effect will rapidly accelerate the shift toward a green alternative.

    “In the end, there is no quick-fix solution, and the initiative to educate and convince consumers will require the cooperation of and collaboration between regulators, cigarette manufacturers and tobacco products manufacturers, and we at Essentra are proud to be the ones to take the first step in this journey.”

    One problem here is that consumers are not necessarily the good guys. Whereas industry players have a role to play in improving the environmental credentials of cigarette filters and in consumer education, it is only consumers who can stop discarding filter butts in an anti-social manner. The gains made by switching to more environmentally friendly filter materials are undermined if butts containing the toxic materials filtered from tobacco smoke are thrown away thoughtlessly, allowing those materials to leach out.

    Legislation is one of the other issues driving change, and it must be said that there are few factors as powerful as new laws in ensuring change takes place within a reasonable time. Zisov told me that the recycling costs associated with cigarette butts containing plastic materials comprised one of the main factors that drove filter and cigarette manufacturers to look for more environmentally friendly filter materials. Currently, the amount that had to be paid to companies that recycled such butts was increasing each year, and, recently, those costs had doubled in Bulgaria.

    That was one of the reasons why there was currently a lot of interest in cigarette filters formed from crimped paper, Zisov said. The filtration properties of crimped paper were not as good as those of acetate tow, but they were being improved.

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    New opportunities

    While the challenges posed by complying with new cigarette and filter regulations are considerable, these regulations also present opportunities. Zisov said that while the annual, global demand for the filters supplied by specialist manufacturers was currently falling, Yuri Gagarin’s volumes during the past four years had been stable and were expected to remain stable in the foreseeable future. In part, the reason for this optimism was that the company had dramatically increased its product portfolio during the recent past so while demand for its monoacetate offerings had fallen, this fall had been more than offset by increased demand for complex filters, such as hollow and dual charcoal products.

    Another reason is that as cigarettes become more expensive year on year, interest in RYO cigarettes grows and with it demand for RYO filters. And while it was true that, since price was the main driver of the RYO market, demand for special RYO filters was still relatively low, interest in different specification filters was increasing tremendously in some markets, said Zisov. The suppliers of these filters to the retail market were looking for varying segment diameters, lengths and hardness along with, for instance, flavor and charcoal applications.

    Of course, the existence of such diversity within what is still a relatively small volume plays into the hands of specialist filter manufacturers. Meeting such a demand takes a lot of resources and requires a skilled workforce, so the suppliers to the retail market are drawn to using specialist suppliers and thus avoiding the fixed costs of manufacturing. There is a downside to this, however, because it implies considerable investments in new technology and knowhow for the specialist filter manufacturer, and, given that such investment is being made at a time when volumes are merely stable, profits are likely to be squeezed.

    While not ignoring the fact that the traditional cigarette industry has been under pressure for many years and will continue to decline, Essentra, too, sees opportunities. It predicts, for instance, an increase in demand for slimmer cigarettes and, therefore, slimmer filters in Africa with the uptake there of smoking among increasing numbers of women. In other markets such as China and South Korea, Essentra has identified an increasing demand for innovative new flavors, a demand that called out for “exotic flavored filters to cater to those evolving taste profiles.”

    At the same time, demand for super slims and shaped filters was growing in China, and tobacco manufacturers were using more specialized filters to provide differentiation within their premium ranges and unique smoking experiences for their consumers.

    Meanwhile, as smoking regulations become stricter around the world, opportunities were arising in respect of heated-tobacco products. “Tobacco-heated products are also becoming increasingly popular,” said SK, “with the current pandemic situation accelerating the switch from traditional smoking as consumers become increasingly health conscious. With such a potential growth opportunity available in this segment of the market, we have also invested our innovations efforts into filters that can cater to tobacco-heated products.”

    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.
  • Proper Context

    Proper Context

    Photo: Dan Johnston from Pixabay

    Will the EU consider the relative risk of e-cigarettes when it revises its Tobacco Products Directive?

    By Stefanie Rossel

    Two days at the beginning of next month are likely to have a significant impact on the future of tobacco harm reduction (THR) in the European Union (EU). In its plenary meeting on March 3–4, 2021, the EU Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) will adopt its final opinion on e-cigarettes. Whether it substantially differs from the committee’s preliminary opinion, published in September 2020, remains to be seen.

    Under article 28 of the EU Tobacco Products Directive 2014/40/EU (TPD), the European Commission (EC) has been tasked with reporting to the European Parliament, the European Council and other committees on the application of the directive by May 20, 2021. The article stipulates that the commission shall review the directive in light of scientific and technical developments in order to consider legislative amendments and that it shall pay special attention to e-cigarettes. In this, it is to be assisted by experts such as those from SCHEER so that it has all the necessary, most recent and up-to-date information at its disposal.

    In article 20 of its 2014 version, the TPD standardizes safety and quality requirements for nicotine-containing e-cigarettes, such as provisions on the ingredients that can be used in e-liquids and maximum nicotine content. The SCHEER report, meant to be a scientific review of the health effects of e-cigarettes, was one of several studies the EC mandated on the application of the TPD on the use and opinions of consumers of tobacco and related products and on product perception. It is important as it may be part of the basis for a further revision of the TPD, which is under consideration. And it could have contributed to making the EU a forerunner in sensible regulation of tobacco and nicotine products, proportionate to their risk.

    However, vapor advocates were dissapointed when the SCHEER committee released its preliminary opinion on Sept. 23, 2020. The Independent European Vape Alliance (IEVA) called the report “fundamentally flawed.” Christopher Snowden, head of lifestyle economics at the Institute of Economic Affairs, described the document as a “step backward.” Clive Bates, director of Counterfactual Consulting, called the report “misjudged, poorly executed and unhelpful.”

    Areas of concern included the committee’s conclusion that there is insufficient evidence that e-cigarettes are a useful tool for smokers seeking alternatives, despite quoting two randomized control trials stating the opposite. The committee was also accused of ignoring scientific literature published after April 2019, most of which supports the argument that vaping facilitates THR. In its risk assessment, critics said, the SCHEER committee had not chosen a comparative risk-based approach but a simpler hazard-based approach, stating the potential risks of using e-cigarettes without even attempting to compare these with the risks from cigarette smoking, which are exponentially higher.

    According to the report’s findings, there is strong evidence that e-cigarettes are a gateway to smoking. The data on which this conclusion is founded, however, is almost exclusively from the U.S., which has an entirely different regulatory regime. The committee also failed to acknowledge that in the EU, smoking among young people has declined significantly.

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    Ignoring relative risks

    Abrie du Plessis

    “My view, from a regulatory perspective, is that the preliminary SCHEER opinion does not really address the most pertinent question on harm reduction, which has become even more pressing since the 2014 TPD,” says Abrie du Plessis, an associate at the South African Trade Law Center in Cape Town, who spent more than a decade following the developments of the World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC) and the the 2014 TPD. “This question is about positioning e-cigarette effects and impacts relative to those of combustible cigarettes. There is, in my view, an urgent need to do this in a comprehensive and evidence-based manner. The preliminary opinion unfortunately fails to do this.”

    A possible explanation is that the SCHEER committee simply considered such a comparison to be outside of its remit. In the minutes of its most recent working group meeting on Dec. 2, 2020, it states, “The mandating Commission service clarified that there was no specific mentioning of harm reduction in the terms of reference.”

    “This is very significant,” du Plessis explains. “What it means is that there is a strong possibility that any further submissions on this topic could be disregarded and that the final opinion, to be adopted on [March 3 to March 4, 2021], will still not address the wider issue of harm reduction. The final opinion will then probably not make any real contribution in respect of the wider policy debate on tobacco harm reduction, and this narrow focus may therefore limit its value for EU policymakers. If the opinion indeed stays the same, then the Commission will have to look elsewhere for answers to the policy questions on harm reduction that it may want to address in the next TPD.”

    The public health community, du Plessis adds, is divided on which tobacco harm reduction policies to support. The WHO holds an ideological bias against e-cigarettes, favoring cessation of all nicotine consumption. As party to the WHO’s FCTC, the EU is likely to take its cues from the global health body.

    “This bias could have played a role at the SCHEER level, but I think that there is another possibility, which is that the committee simply opted for quite a narrow interpretation of its mandate, and in the end did not really address the wider issue of tobacco harm reduction or its rapidly evolving evidence base,” says du Plessis. “The SCHEER report is, however, only one of the inputs into the upcoming Commission report to the European Parliament, and the debate could soon shift to the actual mooted proposals, to a wider range of inputs to be considered and to inclusive participation in the further legislative process.”

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    Under pressure

    In line with its formal stakeholder dialogue procedures, the SCHEER is obliged to seek feedback from the scientific community and other stakeholders before publishing its final opinion. During the commenting period following the release of the preliminary opinion, which ended on Oct. 26, 2020, the SHEER received 691 contributions. Any proposed changes to the opinion had to be tabled by Jan. 12, 2021.

    However, the SCHEER may not feel obliged to take all comments into consideration; the EU has received much criticism about the level of tobacco influence in the shaping of the 2014 TPD. Besides, provisions in the TPD require it to respect international treaties such as the FCTC and its article 5.3, which discourages tobacco industry involvement in policymaking.

    “My view is that the committee will certainly consider the comments it receives, but it will act in line with its stakeholder dialogue procedures,” explains du Plessis. “The point to keep in mind is that the committee will carefully vet all comments received for relevance to the preliminary opinion and to its interpretation of its mandate.

    “On top of this, all submissions will have to comply with its further detailed rules of procedure. This means that there is a clear risk that a significant number of submissions may be disregarded. There is also significant time pressure as the final opinion is now almost two months overdue and must feed into the article 28 report planned for [May 20, 2021].

    “I agree that article 5.3 of the FCTC can create pressure on the committee to exclude studies or evidence originating from [the] industry. I, however, think that openly disqualifying peer-reviewed scientific studies simply on this basis would be detrimental to the standing of the committee.”

    The EU Commission finds itself in the less-than-ideal situation that its TPD review will commence before the next FCTC Conference of the Parties (COP9), which had to be postponed to November 2021 due to the coronavirus pandemic. “The 2014 Tobacco Products Directive confirms that developments, such as internationally agreed rules and standards on tobacco and related products, are relevant to the EU legislative process,” says du Plessis. “Before the Covid-19 pandemic, the EU was in a position that it could benefit from possible discussions at COP9, which was originally scheduled for November 2020, before it had to publish its own article 28 report—with proposed amendments to the TPD—by [May 20, 2021]. The postponement of COP9 by one year means that the EU Commission will no longer enjoy this benefit. With its own scientific opinion not addressing key questions on harm reduction in sufficient detail, a valid question would be whether it is at this stage in a position to propose any further evidence-based measures on tobacco harm reduction.”

    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 Mixed Record

    A Mixed Record

    FDA Center for Tobacco Products Director Mitch Zeller explains the agency’s compresive plan on tobacco and nicotine regulation during the 2017 Global Tobacco and Nicotine Forum in New York City.
    (Photo: David Parker)

    FDA’s comprehensive plan on tobacco and nicotine regulation, three years later

    By Beth Oliva and Philip Langer

    In July 2017, FDA unveiled its “Comprehensive Plan on Tobacco and Nicotine Regulation”—a plan that, in FDA’s words, “places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulations.”1 While the comprehensive plan outlined several areas of focus (such as regulation of flavored products and the use and impacts of premium cigars), in announcing the comprehensive plan, FDA placed significant emphasis on two specific issues. First was the prospect of reducing nicotine levels in combustible cigarettes to nonaddictive levels through “achievable products standards;” second was “fostering innovation where innovation could truly make a public health difference.”2 When introducing the plan, former FDA Commissioner Scott Gottlieb said this:

    Looking at ways to reduce nicotine levels in cigarettes so that they are minimally or nonaddictive, while not altering the nicotine content of noncombustible products such as e-cigarettes, is a cornerstone of our new and more comprehensive approach to effective tobacco regulation.

    [W]e must recognize the potential for innovation to lead to less harmful products, which, under FDA’s oversight, could be part of a solution. While there’s still much research to be done on these products and the risks that they may pose, they may also present benefits that we must consider.3

    Nearly 3.5 years after FDA’s rollout of the comprehensive plan, it is worthwhile to explore what FDA has done—and not done—in pursuing its quest to reduce nicotine in combustible cigarettes and foster innovation for noncombustible products. Has FDA made meaningful progress toward achieving the ambitious goals it set in 2017? Or has FDA simply paid lip service to the comprehensive plan without any serious action? A review of FDA activity over the last few years suggests a mixed record of accomplishment in the development of a national reduced nicotine standard and progress toward turning the vision of reduced-risk tobacco products into a reality. FDA in its public-facing comments remains steadfastly committed to the initiative, and while progress on complex issues such as these must be measured over years rather than months, it has been slow. Recent developments and the current posture of tobacco regulation, however, suggest the coming years will be critical to the success or failure of the comprehensive plan.

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    2018—Progress in the exploration of a reduced nicotine standard

    There is no question that FDA has taken steps to explore the reduction of nicotine in combustible cigarettes since announcing the comprehensive plan in July 2017. The first significant step was in March 2018 when FDA issued an Advance Notice of Proposed Rulemaking (ANPRM), seeking public comment on the development of a reduced nicotine product standard.4 Specifically, FDA sought comments, research and data on myriad topics, including a potential appropriate maximum nicotine level; whether a nicotine product standard should cover other combustible tobacco products; and what unintended consequences could result from a nicotine product standard (such as illicit trade or increase in smoking). The comment period remained open for about four months and by its close, the public docket had garnered nearly 8,000 comments.5 

    Around the same time, FDA funded research and an article by agency researcher Benjamin Apelberg and others in The New England Journal of Medicine titled “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States.”6 The article acknowledged “a continuum of risk for products that deliver nicotine” and used a simulation model to conclude that “enacting a regulation to lower the nicotine content of cigarettes to minimally addictive levels in the United States would lead to a substantial reduction in tobacco-related mortality, despite uncertainty about the precise magnitude of the effects on smoking behaviors.”7

    In a continued show of dedication to the prospect of developing a reduced nicotine standard, in May 2018, Center for Tobacco Products Director Mitch Zeller submitted an article to the Society for Research on Nicotine and Tobacco titled “The Future of Nicotine Regulation: Key Questions and Challenges.”8 In the article (eventually published in 2019), Zeller stated that FDA’s “renewed focus on nicotine” was premised on the “continuum of risk” and invited FDA’s stakeholders to contribute perspective as FDA continued to “shape its tobacco regulatory strategy.” In the article, Zeller stated that a policy centered on nicotine was the priority in FDA’s tobacco regulatory strategy and that “FDA’s strategic regulatory approach is designed to support innovation in developing products with net public health benefits.”9

    Overall, throughout 2018, FDA appeared to “hit the ground running” in exploring reduced nicotine levels in cigarettes through a national product standard. The ANPRM, along with funding research and submitting content to scientific journals, indicated a strong start. Yet at the same time, little was being done publicly on the second prong of the comprehensive plan—encouraging innovation in new products with potential public health benefits.

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    2019—FDA hits a stall

    While 2018 showed commitment to the first prong of the plan, 2019 did not build on the prior year’s advances. The agency did, however, move forward in certain ways in encouraging innovation for potentially reduced-risk products.10 In 2019, FDA issued the draft guidance on enforcement priorities for e-cigarettes (March 2019); the proposed substantial equivalence (SE) rule (April 2019); the proposed premarket tobacco product applications (PMTA) rule (September 2019); and the final guidance document for PMTAs for e-cigarettes. These documents showed an expanded FDA focus from the reduced nicotine prong of the comprehensive plan to also encouraging at least some limited innovation in potentially reduced-risk products. The agency also, helpfully, began to look at providing more transparency and predictability to tobacco regulation. While FDA has issued draft rules, however, nothing has been finalized; in addition, the final PMTA guidance document for e-cigarette products is just that—only useful for those products and not any other potentially reduced-risk product.11 Further demonstrating that FDA’s focus shifted is that while FDA’s spring 2019 unified agenda included a potential regulation to reduce or “cap” nicotine in cigarettes (as did the 2018 agenda), such a regulation was entirely absent from FDA’s fall 2019 unified agenda.

    What FDA most notably accomplished in 2019 was the approval of two PMTAs and the granting of the first modified-risk tobacco product (MRTP) order. First, in April 2019, FDA issued PMTA marketing orders for the IQOS tobacco-heating system and charger along with the Marlboro Heatsticks in regular, smooth menthol and fresh menthol flavors, finding that “the marketing of the products is appropriate for the protection of the public health.”12 In December 2019, FDA authorized the marketing of 22nd Century’s two reduced nicotine cigarettes—Moonlight and Moonlight Menthol, similarly finding that “the marketing of the products is appropriate for the protection of the public health.” Second, in October 2019, FDA issued the first MRTP orders, authorizing Swedish Match North America to use specific modified-risk messaging on its General snus products—the culmination of a five-year process for the company and FDA.

    Regarding the reduced nicotine standard, however, there was no public indication by FDA of progress toward promulgation of a standard. In response to inquiries from the public on why the initiative did not appear on the fall 2019 unified agenda, FDA stated that the omission of a reduced nicotine standard regulation did not mean FDA was not continuing to work on the initiative. Still, this shift change was understandably interpreted by the public as a possible wavering in FDA’s dedication to the initiative.

    2020—A continued stall and concern from the public

    In response to a reduced nicotine regulation being absent from FDA’s fall 2019 unified agenda, Congressman Frank Pallone submitted a letter to FDA Commissioner Stephen Hahn in February 2020 to “voice [his] concern” that FDA “appears to be reconsidering regulations that would set a maximum nicotine level in cigarettes in order to make them less addictive.”13 In a similar vein, John Pritchard—vice president of regulatory science at 22nd Century—penned an op-ed in November 2020 noting, “late last year, without warning or significant explanation, the FDA abruptly removed the proposed rule-making to reduce nicotine levels in cigarettes from its regulatory agenda. Even before the Covid-19 pandemic struck, policymakers decided there were more immediate priorities than cigarette addiction and the roughly half [a] million Americans who die from it each year.”14 Pritchard pleaded with FDA to revisit its plan and accelerate its own actions.

    Last year brought the unexpected tragedy of the pandemic, which obviously and understandably impacted all FDA efforts. Perhaps partly as a result, it also brought little public progress with respect to FDA’s development of a reduced nicotine standard. There were no requests for proposal, research or articles released in conjunction with the nicotine reduction initiative, and the initiative continued to remain absent from FDA’s unified list and long-term actions list throughout the year.

    On the innovation front, in July 2020, FDA did issue an MRTP order authorizing IQOS to be marketed with a reduced exposure claim, but not a reduced-risk claim. The MRTP application by Philip Morris International included requests for MRTPs for both claims. While this second MRTP order is undoubtedly an important step, to date, FDA has still not decided upon the separate MRTP applications for the 22nd Century reduced nicotine cigarettes. Such an approval would be a significant endorsement of the reduced nicotine approach and its impact on harm reduction.

    Closing out 2020—a renewed interest?

    After this period of inactivity on the reduced nicotine standard, the end of 2020 brought an unexpected move from FDA: In December 2020, 22nd Century announced that FDA (along with the National Institute on Drug Abuse) submitted an order for 3.6 million very low nicotine research cigarettes. FDA stated that the cigarettes are to be used for numerous research initiatives, including the potential implementation of a national reduced nicotine standard. Further, at the Food and Drug Law Institute’s Tobacco and Nicotine Products Conference in September 2020, Zeller confirmed that FDA remained committed to everything contained in the comprehensive plan, including focus on reduction of nicotine in combustible cigarettes. Starting research on this issue would indicate a step toward that commitment.

    On the issue of potentially reduced risk products, however, FDA has not yet indicated how it will look at the hundreds of thousands (if not millions) of PMTAs it received in September 2020 for products across the continuum of risk. These include applications for e-cigarettes as well as tobacco-free nicotine pouches, nicotine toothpicks, nicotine dissolvable products and other innovative products to deliver nicotine without the combustion elements of cigarettes. No further guidance documents have been issued from the agency nor has the agency provided further clarity on how it will determine if these products are “appropriate for the protection of the public health.”

    Therefore, FDA closed out 2020 with continued public-facing dedication to the initiative as well as a potentially significant step toward achieving it. The reduced nicotine regulation continues, however, to be absent from FDA’s unified agenda and long-term actions list, including that released in December 2020. That unified agenda does, however, indicate FDA’s intention to continue to work on other important rules, such as the final rule for PMTAs, the final rule for SEs and a proposed rule for MRTPs.

    Looking forward

    In summary, FDA’s progress toward developing and implementing a reduced nicotine product standard and encouraging innovation for potentially reduced-risk products and products authorized to use modified risk or exposure claims has arguably been unsteady. Of course, the public does not have insight into FDA’s internal workings, and there is the distinct possibility (or perhaps probability) that progress is occurring (such as continued review of comments to the ANPRM, development of a proposed rule and other research initiatives as well as developing guidance documents for other noncombustible products) out of public sight.  

    FDA’s recent order of 3.6 million research cigarettes is a promising step as was the granting of the first MRTP orders. The new year, which will include agency evaluation of PMTAs, will hopefully demonstrate continued advancement toward the goals of the 2017 comprehensive plan. While some may have expected that the agency would already be much further along, measuring progress is a subjective exercise. There should be agreement by all, however, that in 2021, FDA must show—by action, not just word—its continuing commitment to the public health goals outlined in 2017.

    Beth Oliva is a partner at Fox Rothschild LLP
    Philip Langer is an associate at Fox Rothschild LLP

    References

    1 FDA news release, July 27, 2017

    2 Speech of former FDA Commissioner Scott Gottlieb, July 27, 2017.

    3 Id.

    4 FDA special announcement, March 15, 2018

    5 Federal Register Docket No. FDA-2017-N-6189, “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes”

    6 Apelberg, Benjamin J., Feirman, Shari P., Salazar, Esther, et al., “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States,” May 3, 2018

    7 Id.

    8 Zeller, Mitch, “The Future of Nicotine Regulation: Key Questions and Challenges,” Nicotine & Tobacco Research, 2019, 331-332, Oxford

    9 Id. at 332.

    10 In order to receive a marketing order, any innovative new tobacco product must be found to be “appropriate for the protection of the public health” and thereby at least demonstrate the potential to be a reduced-risk product.

    11 On Dec. 31, 2020, FDA sent both the “Final Rule on Content and Format of Substantial Equivalence Reports” and the “Final Rule on Premarket Tobacco Product Applications and Record Keeping Requirements” to the Office of Management and Budget for its review.

    12 In December 2020, FDA issued a further PMTA order for the IQOS 3 device (the initial order was on the IQOS 2.4 device), finding “the similarities in the product designs of IQOS 2.4 and IQOS 3, as well as the fact that the same Heatsticks are used in both devices, make it unlikely there are new concerns related to health effects, product quality, human factors or product misuse for IQOS 3 as compared to IQOS 2.4. As the two devices have similar operating procedures, use the same tobacco sources and produce comparable aerosols, FDA has no reason to believe the IQOS 3 device will result in different nicotine exposure, use patterns, user populations or abuse liability.”

    13 Letter from Congressman Frank Pallone to Stephen Hahn, Feb. 25, 2020

    14 Pritchard, John, “It’s Time for the Government to Refocus on Respiratory Health,” Nov. 19, 2020