Category: Print Edition

The Therapeutic Track

Photo: goodmanphoto
Key considerations for designing vapes as medical devices
By Pete Lomas
To further support the transition from smoking to reduced-risk nicotine products, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is encouraging next-generation nicotine product manufacturers to consider the marketing authorization application (MAA) route to market. Nicotine products, such as vape devices, authorized via this regulatory pathway can be marketed as smoking cessation tools and prescribed by healthcare professionals.
This article discusses how manufacturers can design vapes to improve their chances of MAA approval, giving a particular focus to delivered dose uniformity (DDU), which is a critical parameter for any authorized medical inhalation device.
Medicinal vapes will be classified in a similar way as conventional pressurized metered dose inhalers (pMDIs), meaning they must meet similar criteria for approval. One key criteria is DDU, a measure used to ensure patients are getting the same amount of drug delivery both within and between devices.
Achieving DDU is challenging in vapes for several reasons. Most consumer vapes rely on traditional coil and wick technology. The wick is saturated with e-liquid, and when the coil heats up, the wick releases vapor for the user to inhale. Coil-based and wick-based vapes are prone to inconsistency caused by a variety of issues, such as variation in battery life, power delivery and temperature, to highlight a few.
The MHRA recognizes that vapes are fundamentally different from pMDIs and has made some concessions related to DDU. However, manufacturers must achieve nine out of 10 doses within 25 percent of the mean and all doses within 35 percent of the mean. In addition, the mean of 10 puffs must fall within 15 percent of the label claim. To have the best chance of MAA approval, manufacturers should design vapes well within these limits. Manufacturers can achieve this by adapting existing vape designs or by turning to novel technology.
Adapting Existing Technology
Several areas of product development influence DDU, including airflow, e-liquid properties, test methods, e-liquid delivery, packaging, production and power delivery. Ceramic heating elements are one example of a way manufacturers are changing their designs to improve DDU. Ceramic elements improve the consistency of power delivery while more accurately controlling the wicking rate via engineering of the wick’s pore size.
Another way a design can be adapted is with the introduction of thermocontrols that regulate power delivery and therefore the temperature of the coil. Thermocontrols help ensure the same amount of vapor is being released with each inhale by setting a temperature limit that applies to the wick no matter the battery level of the device. Vape manufacturers can also consider the influence of the airflow path on DDU, such as tightening manufacturing tolerances.

Photo: makcoud
Emerging Technologies
Alternatively, vape manufacturers can make use of emerging electronic nicotine-delivery system technologies to improve dosage consistency. Better control of droplet size can be achieved with devices based on piezo ceramic meshes, a similar technology to that used in medical nebulizers. E-cigarette devices based on piezo technology use mechanical forces, in the form of ultrasonic waves, to convert the e-liquid into vapor in a process known as atomization. The droplet size and dosage can be predefined through the mesh dimensions, allowing for uniformity in the vapor.
Another emerging technology is microfluidic liquid delivery. This technology uses the surface tension of the liquid to transport it along micro channels for “wicking” and is a more engineered solution than conventional wicks.
Regulatory Insight
Businesses with products undergoing the premarket tobacco product application process can reuse this data to reduce the number of new studies required for an MAA. However, MAA applicants should expect the process to be extended. Working with a scientific and regulatory compliance partner that can support you through the process, from product design to regulatory approval, can increase your chances of success.
Pete Lomas is a managing consultant at Broughton, a global scientific consultancy-based contract research organization serving customers operating in the pharmaceuticals, next-generation nicotine-delivery products and cannabinoids industries. Among other services, the company offers support with the MAA pathway. For more information, visit www.broughton-group.com/maa-regulatory-support-and-submission-service.
October 2, 2023
Snatching Defeat from the Jaws of Victory?
Will the European Union enable or obstruct the market-based demise of the cigarette?
By Clive Bates
There are so many genuinely terrible ways to regulate combustible tobacco and smoke-free nicotine products that achieving one of the less terrible ways is a triumph. Unlike the United States, the European Union hasn’t imposed gigantic regulatory burdens that choke the life out of all but the largest companies, relentlessly favoring tobacco majors over their smaller rivals. Unlike Australia, the EU pulled back from regulating vapes as if they were medicines. Australia was once a leader in tobacco control, but now it has become a chaotic fiasco of sluggish declines in smoking and a massive black market. Despite the prohibition campaigns of the World Health Organization, the EU has resisted most forms of prohibition, though with the inexplicable exception of snus. To state the obvious, prohibition doesn’t cause banned products to disappear; it merely removes law-abiding suppliers and hands the residual market to criminals and unregulated informal traders.
In contrast, the EU has developed a range of measures to address tobacco and nicotine risks that are not especially disproportionate or discriminatory, reasonably precautionary and not particularly prone to harmful unintended consequences. As a result, the EU has a diverse range of lawfully available safer alternatives to smoking and, therefore, the regulatory basis for tobacco harm reduction for the member states that wish to pursue it. By international standards, it is a modest success.
European elections will be held in June 2024, and a new legislative program will emerge a few months later, with the most intensive legislative activity expected in 2025. So, the question is where next? I am sorry to report that the Brussels hive mind of bureaucrats, politicians and interest groups is on course to turn a modest success into a conspicuous failure, putting millions of lives at risk.
The EU’s Public Health Aims are Focused on Reducing Disease
There is a renewed impetus behind EU tobacco policy. In 2021, the EU launched its plan for addressing cancer, Europe’s Beating Cancer Plan. In 2022, it launched a separate plan for addressing noncommunicable diseases other than cancer, known as Healthier Together. Both place considerable emphasis on tobacco, and both stress the “tobacco-free generation” objective to reduce tobacco use to less than 5 percent of adults by 2040 compared to around 25 percent today.
Regulatory Instruments
To deliver this agenda, the EU has three main instruments to regulate tobacco and related products, such as e-cigarettes. These are in the form of “directives,” or legally binding agreements that member states will implement in domestic legislation that complies with the terms of the directive.
The Tobacco Products Directive (TPD: 2014/40/EU) governs standards for products, packaging, warnings and several aspects of commerce in tobacco products. This directive also provides for the regulation of e-cigarettes, including advertising and promotion of these safer alternatives. The TPD is under active review following an evaluation of the legislative framework for tobacco control, and a new European Commission (EC) proposal is expected late in 2024.
The Tobacco Advertising Directive (TAD: 2003/33/EC) bans tobacco advertising, promotion and sponsorship with a potential cross-border reach. Member states control fixed advertising, such as billboards. The TAD will likely be revised alongside the TPD to create a unified approach to tobacco and related products, such as e-cigarettes.
The Tobacco Excise Directive (TED: 2011/64/EU) provides a framework for harmonizing tobacco tax design. Member states generally set the levels of excise duty but are subject to minimum levels set in the directive. The TED has been subject to a lengthy review process since 2016. Taxation matters are sensitive with the member states, and each has a veto on any proposals. Controversy struck on Dec. 7, 2022, when new proposals were pulled from publication, as several Eastern European nations noticed that it would create large increases in tobacco prices for them.
The EU, as a party to the Framework Convention on Tobacco Control, will also form a common position to take into the November negotiations at the 10th Conference of the Parties to the Framework Convention on Tobacco Control in Panama. By endorsing the positions of the WHO, the EU will build momentum for further regulation aligned with the WHO approach.
The EU also has a range of softer instruments, such as the nonbinding 2009 Council Recommendation on Smoke-Free Environments (2009/C 296/02). In July 2022, the EC issued a call for evidence for a proposal for an updated recommendation that would apply to heated-tobacco products and e-cigarettes.
The Outlook is Bleak
It is never easy to see the big picture in the EU through the relentless blizzard of initiatives, consultations, reports, working groups and statements. However, some disturbing developments are emerging.
First, the major error of strategy. The EC sees the newer tobacco and nicotine products (heated tobacco, pouches, e-cigarettes) as a threat rather than as an opportunity to reduce cancer and NCDs. There is no sign that it recognizes or is interested in exploiting the radically different risks to health posed by smoked and smoke-free products. It should be treating tobacco products differently and proportionately according to risk. However, it is moving in the opposite direction toward treating all tobacco and nicotine products as if they were cigarettes. The effect will be to protect the cigarette trade, promote smoking, slow the decline of serious diseases and nurture the criminalization of supply and workarounds.
Second, instead of reversing the absurd and indefensible ban on snus, rumors suggest that the EC may even try to extend this ban to nicotine pouches. Snus has already reduced adult smoking in Sweden to close to the EU’s 2040 tobacco-free target of 5 percent, with measurable improvements in cancer and cardiovascular outcomes. Encouraging “free movement” of pouches would build on the snus proof-of-concept and help to reduce smoking across the EU. Regulation of purity and total nicotine density in pouches makes sense. However, a ban will simply deny users a significant harm reduction opportunity and create an influx of illicit high-strength pouches.
Third, there are moves to extend the ban on characterizing flavors in combustible tobacco products to all nicotine products. The EC has already done this for heated-tobacco products and could extend severe ingredient restrictions to vaping products. The government of the Netherlands, in alliance with the public health agency RIVM, has adopted a “whitelist” approach of permitting a few ingredients used chiefly to make artificial tobacco flavors. If adopted by the EU, this system would radically constrain the legal vaping market in which consumers are drawn to the diversity and ever-changing range of flavors as an alternative to smoking. At a December 2022 conference presentation in Paris, an RIVM official, Reinskje Talhout, presented on the Netherlands’ approach. After 33 pages of detailed analysis showing how to create a (short) list of permitted ingredients, she included the following slide on “Possible unintended consequences.”
The challenge is well summarized on this slide. Yet the advocates of broad flavor bans have no response. They have largely ignored the malign market and behavioral dynamics that they are likely to unleash.
Fourth, changes in the excise regime will dull the consumer economic incentives to switch from high-risk cigarettes to low-risk, noncombustible products. The minimum tax levels envisaged in leaked proposals are far greater than would be implied by the difference in risk compared to cigarettes. If the excise regime were more proportionate to the risk, the tax take would be outweighed by the costs of tax administration, and it would barely be worth raising excise duties. Member states should insist on their right to set zero minimum taxes on noncombustibles as it is their right to pursue tobacco harm reduction domestically. There would also be a scope for setting maximum tax levels for safer products to maintain a material difference in taxation between the highest-risk products and lowest-risk products.
Fifth, the EC plans to make it harder for European citizens to learn of safer alternatives to smoking by imposing further controls on advertising and promotion and possibly to willfully mislead consumers with packaging and warnings that implicitly exaggerate the risks of low-risk alternatives to smoking. Again, the regulatory tactic is to treat all products as if they are as harmful as cigarettes when what is required is more nuanced risk communication. If the EU follows the direction of the WHO, it will risk drifting into inappropriate restrictions on free speech and legitimate opinion.
The question for me is why? What fearful autocratic reflex causes the EC to suppress pro-health innovation and see opportunity as a threat? There is an opportunity here for the free movement of goods and services within a well-functioning internal market to deliver a high level of health and consumer protection. The internal market, if allowed to function as intended, could end the cigarette era and epidemic of smoking-related disease. Yet its most ardent champion, the EC, appears unwilling to let the internal market crush the cigarette trade through the power of consumer preference, competition and creative destruction. What a pity.
Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
October 1, 2023
Star Power
Image: mitrija
When smoking gets better press than vaping
By Cheryl K. Olson
Celebrity news sites have reported sightings of Sasha Obama, the daughter of the former president, smoking cigarettes. There she is, puffing with friends outside a glamourous Los Angeles party. And here, exhaling while exiting a luxury wellness spa. She makes no apparent attempt to evade the photographers.
No longer taboo, cigarettes are increasingly seen dangling from the lips of celebrities, on the streets and on-screen. Once-ubiquitous mentions of vaping as trendy and cool have gone up in smoke. Cigarettes, by contrast, appear to be inching back toward social acceptability. Worse, this may be coming at the expense of the vastly less harmful alternative nicotine product.
Let’s review some recent examples of this shift in celebrity cigarette media coverage and perceptions and some potential implications for normal humans.
‘Cigfluencers’
A recent New York Times article, “A Viral Cigarette Brand? In 2023?,” details, and arguably promotes, efforts to get a small cigarette brand called Hestia into the mouths of influential New Yorkers. It mentions that the product is illegal to sell at retail in that state and legal in only four others. The goal of this campaign, it says, is to turn the brand “into a kind of cult status object for those still willing to risk the many dangers of smoking.”
Billboards selling cigarette brands may be illegal, but “cigfluencing” by bloggers and podcasters with names like Meg Superstar Princess appears to be A-OK. So is handing out Hestias at exclusive events. The receding cool of vaping seems to help fuel the promotion of Hestias as naughty-chic.
“Paradoxically, a boom in vaping over the last few years has made burning an actual paper-wrapped, plant-and-chemical-filled cigarette practically taboo,” says the New York Times article. “And for that reason, among people like Meg Superstar Princess, it’s making a comeback. (‘God Hates Vapes,’ a recent post on the Hestia Instagram account, proclaimed.)”
‘She Looks Fabulous’
Twenty years ago, a clutch of studies found that seeing smoking in movies encouraged teens to initiate cigarette use. Smoking in films and television declined but never faded completely. Recently, depictions of smoking are reportedly surging on youth-oriented media.
Viewers noted and even mocked chain smoking by the protagonist, played by Lily-Rose Depp, of a new HBO series. “You would think The Idol was a cigarette commercial the way Jocelyn [Depp] couldn’t do anything without smoking,” one watcher tweeted on social media platform X.
Depp, aged 24, apparently also smokes in real life. She left the Cannes premiere of The Idol in vintage Chanel, accessorized with cat-eye sunglasses and a lit cigarette.
“The smoking is a conscious decision. She looks fabulous, unfortunately,” a nightlife reporter told The Guardian newspaper. The article, titled “Celebrities are Smoking Again,” states that “many Gen Z stars are holding old Hollywood’s once beloved props,” eschewing green juices and yoga mats. A paparazzo states that for years, stars asked him to delete snaps showing them smoking. No longer.
Raising the issue of e-cigarette use, the article says it “may lack the star power of cigarettes.” The nightlife reporter is quoted as saying, “I’m not sure it ever looked cool to vape, but it definitely doesn’t look cool now” and that culturally, “vaping has entered its death phase.”
The Guardian separately reported on an August 2023 New York THNK1994 pop-up museum exhibit, which called itself The Museum of Smoking. It was described as “a tongue-in-cheek love letter to a terrible, but admittedly captivating, habit.”
Covering “iconic moments in smoking history,” the exhibit featured celebrity photos and memorabilia from the 1990s onward. There were also video installations, original art and gift shop “merch” inspired by them. An example of merch: The Mary Kate and Ash Tray, bearing a cartoon of puffing Olsen twins.
The glib tone of the exhibit was exemplified by this program note: “Do not start smoking. Do not start vaping either. But if it’s too late and you’re already here, then welcome, isn’t it gorgeous?”
Oddly, this trend of romanticizing cigarettes in media is being used to raise further concerns about vaping. A July article in Bustle quotes Truth Initiative CEO Robin Koval on this point. Since youth smoking rates are down, the logic goes, smoking in media becomes a tobacco industry ploy to hook replacement “smokers” on e-cigarettes.
Koval mentions a study by the Truth Initiative linking high exposure to tobacco imagery in television shows to increased youth initiation of vaping. Over 99 percent of the 444 “tobacco incidents” identified in their sample of programs featured combustible cigarettes. Just nine featured vaping, and eight of those came from a single series (Fuller House).
It’s notable that the study connected television viewing in 2018 to increased vaping in 2019, the year youth e-cigarette use peaked before declining. No significant association was found between TV tobacco imagery exposure and starting to smoke cigarettes.
News Coverage Imbalance
Of course, there’s more to press coverage than celebrity news. Another thing making vaping uncool is the steady drip of media reports on purported health risks of e-cigarettes. A search for the term “cigarette” in Google News for August and September brings up many more stories about the dangers of e-cigarettes than on the risks of smoking. This sample of intimidating headlines is typical:
“Vapour from Vapes May Paralyse our Immune Cells”;
“Vape Tongue: E-Cigs Lead to People Losing Sense of Taste”;
“E-Cigarettes Reduce Testicle Size and Sperm Count—New Study”;
“Possible Link Between E-Cigarette Use and Increased Risk of Stroke”;
“Vaping Found To Be the Biggest Risk Factor for Teenage Tobacco Smoking.”
Cigarette dangers are literally old news; relatively few new studies are generated and covered. Most of these vaping stories come from press releases that summarize and promote academic research. News stories based on press releases are a primary way the general public learns about advances in science and medicine. Such stories unfortunately tend to amplify the errors or weaknesses of their original sources. High risk of bias and methodological issues in vaping research have been noted in recent expert reviews.
Setting aside issues with particular studies and the larger field … the sheer quantity of negative press about vaping versus smoking gives the impression that e-cigarettes are at least as dangerous, and perhaps more so, than cigarettes. And research shows that’s exactly what the public has come to believe.
Far From the Influencers
Most of us are not trendy urban influencers and do not hang out with them. How might these views trickle down to local media and affect everyday people?
Skip Murray, a tobacco harm reduction specialist at the Minnesota Smoke Free Alliance, works in a tourist-dependent area of the Midwestern U.S. ringed by scenic lakes. I asked her how smoking and vaping are viewed today in her community.
While driving to work, “I never hear anything on the radio about smoking,” Murray says, “just about vaping and how it’s bad. In the ads and in comments that the DJs make when they do their morning talk thing.”
As she parks her car and watches people walking by, she sees more smoking than vaping. “And it makes me really sad,” she adds.
Murray’s office doorway has a small, protected alcove and is located next to a bar. “Every morning when I come to my office, the first thing I do is sweep up the cigarette butts outside my door, left by the bar patrons getting out of the wind while they have a smoke,” she says.
Murray has observed increased negative media coverage of pollution caused by vaping. Despite this, she has yet to sweep up any e-cigarette-related debris: “Not a Juul pod, a coil or a used disposable vape.”
A Silver Lining?
If vaping is no longer cool and edgy, could there be a silver(-haired) lining? Perhaps a bit of boring could save lives. I’m thinking of retirement-age folks who smoked and took part in a recent qualitative study I led. We asked what had attracted them to a simple “cigalike” vape.
A woman in her 70s told us, “I think those ones that are big and put out clouds of smoke are ridiculous.” A man in his 60s said, “I smoked cigarettes a long time. This thing looked like a cigarette, so voila! I got them and stayed with them.”
Older people trialing and switching to vapes would be a huge win for public health. Leave the cigarettes to the influencers!
But seriously, let’s hope for a quick end to this dangerous trend.
I leave you with this much more entertaining recent headline from The Onion: “Nation’s Older Sister’s Friends Announce Plan to Split Single Cigarette Among 9 of Them.”
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
October 1, 2023
Spreading the Risk

Mercedes Vazquez
Protecting farmer livelihoods as demand for leaf tobacco changes.
By George Gay
Somebody once observed that while nobody knows what comes next, everybody does it. This notion came to mind recently when I was asked to write a story about efforts being made to diversify tobacco farmers’ income streams as demand for leaf stagnates, a story that had to be based on predictions about what comes next in respect of demand for tobacco.
The question about future demand might seem simple to answer, but for every argument I came up with for a likely global demise of leaf demand, I was able to come up with another suggesting an increasing demand. It did not help that when I started my research, I came across stories about four producer countries on three continents that were aiming to increase their productions next season, though whether from high points or low points I could not be sure. I must admit, too, that next season is not the future, but neither can I ignore it. I am mindful of something the International Tobacco Growers’ Association’s Mercedes Vazquez told me: that the long term was nowadays no more than a year—a telling observation summing up the insecurity many tobacco growers live with daily, even as critical suppliers to a wealthy industry.
But, whatever happens, everybody will have to do what comes next and, as things stand, a lot of people seem to be betting leaf demand will stagnate and fall. So what is to be done? How can we protect, and hopefully even improve, the livelihoods of the millions of people and their families who currently produce tobacco and rely upon the income it earns, some of whom currently live in poverty? After all, it is easy to talk about global demand or lack of it, but many of the solutions will, of necessity, come down to the level of individual farmers. Certainly, my first impression from talking to people was that this is a devilishly difficult subject, partly because of its diversity. Tobacco comes in a variety of types and styles while its production is geographically widespread under a range of conditions, some of them changing, and subject to different government regulations. It is carried out by commercial farmers and smallholders, who are given varying amounts of support and who sell their tobacco either over auction floors or via contract arrangements, each of which is open to good or bad practices.
Seeking Alternatives
Notwithstanding this diversity, however, the overall impression I was given was that there was no need to panic, though, for various reasons not necessarily solely to do with falling demand, the urgency in certain countries is higher than that in others. If leaf demand is going to fall, it is not going to fall precipitously in most markets. But that is not to say there is room for complacency, especially in those countries where tobacco contributes substantially to their foreign exchange earnings.
On the other hand, perhaps there is reason to panic. Another impression I was given was that there are few, previously unexploited, viable options available to farmers who want to stay in business while quitting tobacco production substantially or completely. It is also the case that identifying viable alternatives takes time, investment, research, market development and the cooperation of a wide range of stakeholders, not all of them holding the same stakes.
It must be remembered that tobacco growers tend to be canny operators who didn’t come down with the last shower of rain. Many of them already largely know which other crops work on their land and which do not because, partly in order to preserve their soils in good condition, they practice crop rotation, and in order to supplement their incomes or help feed their families, they keep a weather eye out for what their neighbors are doing and what the various markets are telling them.
Of course, they can always use some help. And the greater the need for tobacco growers to expand the number of crops they grow or to diversify into other activities, the more important it is that such diversifications are coordinated, at least at the regional level, more likely at the national level, and perhaps internationally. If all the world’s tobacco growers suddenly switched to producing groundnuts, the market for this product would go, well, nuts. Admittedly, that is unlikely to happen because diversifications will be governed by local conditions such as weather, soils, farmer skills, established markets, the availability of inputs and irrigation water, regulations, etc. Nevertheless, there is a need for coordination through organizations and companies with skills in this area.
Long-Term Viability
One such company is Alliance One International, whose vice president of global agronomy, Helio Moura, had, in part, the following to say in an emailed response to questions. “At Alliance One, we are focused on the long-term viability of our business and the sustainability—in all aspects—of the farmers with whom we contract. Our company has an ESG [environmental, social and governance] target to improve 100 percent of our contracted farmers’ livelihoods through good agricultural practices and opportunities for crop diversification and have introduced a number of crops to our grower base, including but not limited to maize in South America and groundnuts in Africa.
“Agricultural production of any kind has challenges. Farmers today are navigating climate change, succession planning, inflation and more. The reality is, a large portion of tobacco growers are smallholder farmers, growing on 10 ha or less of land. They rely on their tobacco crop as their base or supplemental income, making tobacco a significant part of many of the economies in the countries where we operate.
“To promote positive outcomes for our growers, we implement a variety of measures, including research and development initiatives, ongoing grower education and strategic partnerships, to best position contracted farmers to cultivate high-quality, high-yield complementary crops ….”
Meanwhile, Paulo Saath, vice president of Global Supply Chain Leaf at Japan Tobacco International, which sources tobacco from 34 countries and collaborates with about 62,000 farmers, had this to say: “One of the most effective strategies to overcome the challenges rural communities face, primarily poverty, is agricultural development.
“JTI’s Agricultural Labor Practices program aims to enhance the work environment of farmers by creating fairer working conditions, improve their well-being as well as their families’ and help them generate stable tobacco revenue. In Malawi, where tobacco is one of the most profitable value chains, since we vertically integrated our operations in 2009, contracted farmers have seen their average yields increase by around 140 percent, from 800 kg per hectare to 1,950 kg [per hectare] in 2023.
“We have set out Minimum Agronomic Standards by which our contracted growers are encouraged to rotate tobacco with complementary crops such as maize, groundnuts, soya as well as livestock and [are] provided with seeds and fertilizers. This helps them supplement their tobacco income, guarantee food security, entrench Good Agricultural Practices by improving soil health, and build climate change resilience ….
“In Malawi, we have a team of agronomy technicians who routinely visit our directly contracted growers, providing technical advice on how to improve the tobacco yield and quality and also building farm management capabilities (including financial planning, agroforestry, soil management, and human and labor rights).”
Evidenced-Based Initiatives
Candida Nakhumwa
One thing that strikes me about these comments is that while there is much emphasis on improving and diversifying income streams, there is no mention of a stagnation or decline in demand for tobacco. So is it really the case that such a stagnation or decline is happening or is on the horizon? Not perhaps if you talk to the Malawi Tobacco Commission, which earlier this year said it was hoping this season’s leaf prices would motivate growers to produce more tobacco during the next season.
More tobacco? Perhaps not a good idea, according to a report by the Foundation for a Smoke-Free World (FSFW), at least in the case of smallholder Malawian growers. This is what the FSFW had to say in the key takeaways section of its March 2022 Malawi Country Report: “Smallholder farmers occupy the lowest-valued component of the tobacco value chain. As the most vulnerable link in the value chain, farmers are frequently forced to grow tobacco at their own expense, literally and figuratively. Contract farming arrangements with major tobacco buyers often leave many smallholder farmers in poverty and some in perpetual debt. Their surrounding environment suffers as a result of deforestation and soil degradation. The collective impact of growing tobacco on the lived experiences of smallholder farmers and their families thus underscores the need to find alternative crops or livelihoods.”
I must say, however, that I was told by Candida Nakhumwa, vice president and Malawi country director of the FSFW, that the FSFW’s involvement in Malawi was also about addressing a decline in tobacco demand, which she put at 5 percent a year in respect of burley, the tobacco crop largely produced by the smallholder farmers with which the FSFW mainly interacts. Nakhumwa said that in Malawi, with a rural population of about 80 percent, addressing this decline had to be looked at as urgent. But, at the same time, it had to be looked at thoroughly, which, from what she told me, it is apparently doing, through a wide range of evidence-based initiatives.
The FSFW’s program concentrates on identifying alternative crops and researching their viability in an effort to diversify away from tobacco dependence. It supports farmers in increasing their productivity and production of nontobacco crops, which traditionally has been low, through the introduction of improved technologies in the form, for instance, of better seeds, plant nutrition, crop protection, irrigation and good agricultural practices.
The program also seeks to develop systems around new crops and activities that are supported by research and extension services and that have available structured and competitive markets. And this was not easy to achieve, Nakhumwa said, adding that, nevertheless, the FSFW had already made “tremendous progress.” Some farmers had totally transitioned away from tobacco to alternatives, such as groundnuts and soyabeans, and in doing so had increased their incomes, she said.
That is Malawi, of course, which has been fortunate in attracting the attention of the FSFW. Elsewhere, efforts are probably less structured.
Farmer Involvement
Nakhumwa emphasized time and again that all aspects of the FSFW’s wide-ranging research and efforts were centered on the farmers, who, after all, were the ones driving the economy. And it was farmer participation, or rather the lack of it, that was very much on the mind of Vazquez, who made the point that farmers were often left out of discussions around developments affecting their futures. What I took away from speaking and corresponding with Vazquez was that whereas the ITGA and farmers in general were willing to discuss tobacco growers transitioning out of tobacco, those advocating such moves had to be cognizant of the fact that, like it or not, tobacco often provided the best chance for farmers to support their families and wider communities. Given this, transitioning, unless carefully thought through, could be devastating. It had to be remembered that no crops or business activities were risk-free. No market was immune from exploitation by those intent on doing so.
Of course, there are any number of reasons why some growers and countries will continue to grow tobacco and some will not and why some will reduce production and some will not. For instance, there will be a move away from tobacco production because younger generations are often reluctant to take up farming. And there are the pending EU regulations that, from next year, will investigate supply chain issues, such as deforestation and child labor.
The ITGA says it supports balanced regulation aimed at maintaining good governance in supply chains and addressing social and environmental issues. But it points out that addressing these issues in relation to smallholder farmers means firstly tackling poverty, the root cause of these issues, with decent incomes. As was made clear at the most recent ITGA regional meeting, grower sustainability needs to start with grower viability.
In fact, I don’t think it’s unfair to ask why smallholder tobacco growers should live in poverty when they are stakeholders—and surely vital stakeholders—in a wealthy industry. That’s a rhetorical question, by the way.
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.

October 1, 2023
Reinventing for Sustainability

Photo: Filtrona
Industry suppliers are helping tobacco companies reduce the environmental impact of their operations.
By Stefanie Rossel
Globally, consumers and regulators are pushing for more sustainable products, including tobacco products. For the environment, tobacco production is a damaging business. In 2014, cigarette manufacturing was responsible for 84 million tons, or 0.2 percent, of the world’s carbon dioxide emissions. As part of their harm reduction strategy, tobacco companies have been working to lower not only the health risks of their products but also the environmental impact of their operations. Leading players are aiming to achieve carbon neutrality by 2030 and “net-zero across” their value chains by 2050.
To make tobacco products more environmentally friendly, there are two main levers: cigarette filters and cigarette packaging. Worldwide, 98 percent of cigarette filters consist of cellulose acetate (CA), a polymer that takes up to 10 years to degrade in the environment. Cigarette butts are among the most littered items on earth. The films and tear tapes used for cigarette packaging are made from polypropylene, a petroleum-based plastic.
To support their clients in reducing their environmental footprints, industry suppliers have been rethinking traditional, nonsustainable components and developing greener solutions, thereby also considering the effects these new solutions might have on production processes and the supply chain. Close cooperation with other suppliers and partners plays a vital role in this process.
“We are all on the journey together,” says Robert Pye, CEO of Singapore-based specialty filter manufacturer Filtrona. “We are working closely together with the larger players at the front end of the market and also with suppliers who offer interesting solutions for base materials. Where we come into play is the design of the filter. We use our scientific services to examine the smoke chemistry in these products, to understand the phenols, taste and nicotine that’s delivered.”
Filtrona says it has seen significantly increased interest in its sustainable filter products, such as its ECO range of fiber-based, biodegradable filter products. In the European Union, this is partly a result of the Single-Use Plastics Directive (SUPD), which entered into force in 2021 and bans the sale of single-use plastic-containing items such as plates, cutlery, straws and cotton bud sticks as well as food containers and expanded polystyrene cups. The law exempts cigarette filters. However, starting in December, it will oblige tobacco manufacturers to cover the costs of consumer awareness campaigns and extended producer responsibility (EPR) schemes tackling the cleanup, transport and treatment of litter. The EU is expected to ban filters in the long term.
Greener Solutions
To support its ECO product line, Filtrona opened a center of excellence in Budapest this summer, which will increase the company’s production capacity and speed-to-market of sustainable filter solutions. The center combines Filtrona’s extensive experience in manufacturing nonwoven filters with advanced, high-speed production technology and the latest testing methods to produce sustainable filters for various tobacco product applications, including cigarettes, heated-tobacco products (HTPs), cigarillos, cigars, roll-your-own and make-your-own cigarettes. The center enables tobacco companies to develop and manufacture a portfolio of sustainable tobacco products. “The facility can manufacture products at volumes varied in many special nonwoven products,” says Pye. “It’s important to us that we have one location that meets the needs of what is in the SUPD roadmap. We want to make sure we’re ahead of the curve in terms of capability and investment. We already invested several million dollars in this site to implement sustainable machinery from the leading manufacturers and will continue to invest in the future.”
With the launch of its Evolute fiber-based filtering media in June 2022, SWM, too, is offering nonplastic alternatives to CA filters. Evolute products can be used for all tobacco products that require filters, including filter tips, roll-your-own tobacco, tubes, cigarillos and conventional cigarettes. “Our solutions are ready to use and show a very good performance on the makers,” explains Alice Jaussaud, product manager for Evolute filtering media at SWM. The company already has a natural fiber filter solution on the market and is working on the next generation of sustainable and alternative filter solutions. “We are working on a day-to-day basis with key industry stakeholders,” she adds. “We create cooperations with the whole value chain to offer our customers more than a simple raw material solution but a raw material that fits their needs. We work closely with our customers to support them in their transition, to ensure high runnability performance on the maker and to develop the ideal filter design to provide the full solution.”
Scarcity as Driver
Persisting supply shortages in acetate tow and rising CA prices have recently driven the need for solutions that are not based on polymer, says Pye. They have also caused California-based biodegradable cigarette filter manufacturer Greenbutts to be “inundated with inquiries from every corner of the globe,” according to Chief Strategy Officer Luis Sanches. “We are responding quickly to each potential client with prototypes, quotations and fulfilled orders,” he says.
The company has developed a patented substrate and filters made of all-natural, food-grade fibers, such as abaca fiber, cotton flock and industrial hemp as well as a starch-based binder. The product is sold in bulk or as ready-made rods of filters and filter tips. Partnering with Boegli-Gravures, Greenbutts introduced and accelerated the Greenbossing technology, which resulted in a second-generation solution that significantly enhances the sensorial filtration technology for both low-tar and high-tar products, according to Sanches.
Greenbutts is working closely with all key OEMs to ensure its substrate is fully qualified and ready to roll out the transition from CA to Greenbutts, he says. “As part of our innovation strategy, there is a need to ensure the newly filed IPs are fully adaptable and successfully integrated in a wide range of existing and next-generation filter makers.”
Greenbutts partners with an Italian tobacco equipment manufacturer, Montrade, from which it recently acquired a machine with multiple filter manufacturing capabilities. “This will enable Greenbutts to increase the production specification offerings beyond mono-acetate filter replacement,” says Sanches. “The different formats and new machine features will enlarge our product portfolio choices in a much larger geography.”
A Paper Tsunami
Montrade has developed several solutions for the manufacture of sustainable filters, among them a new version of its paper crimper with rod former, which uses 15 percent to 20 percent less paper than traditional crimpers, according to Sales Director Antonella Giannini. “Thus, a very homogeneous and stable filter can be created with no variation in pressure drop and superb quality,” she says. “The retention of paper is much higher than that of CA, which means that tar and nicotine will be reduced—if you use less paper, you will get less of the typical taste of a paper filter. For better machinability in the downstream process, we have increased the hardness.”
Giannini confirms that the market is moving toward sustainable solutions. “It is a constant trend increase, and we expect it will accelerate further in 2024,” she says. “I call it ‘paper tsunami,’ and we are ready to face it. In the last six months, we have delivered many lines, and we have acquired many orders for sustainable filter makers and many paper-crimping modules. It is important to say that we offer not only complete crimping machines but also a crimping module for easy and fast connection to any existing rod maker machine, like KDF. We offer the option to upgrade the existing fleet of rod makers to meet the future scenario of sustainable filters.”
The priority, she adds, is to retain the smoking experience. “It is not an easy task, but there are teams of engineers and scientists that are ambitious to win; I am sure they will,” she says.
Pye is equally confident in the ability of his specialists. “With the ECO range, what we have learned from our developments with different customers and their own developments is that we can reproduce all the same complexities of filters that we produce in CA—tubes, carbon, flavor capsule, varying different pressure drops or changing taste profiles,” he says. “We have the building blocks to have a successful product range within the area of sustainable filter solutions.”
Despite the availability of products and manufacturing equipment, the transition to more environmentally friendly filters will take time. Supply chains must be organized, and capacity must be built. As Pye points out, even in an advanced market like Western Europe, this will be quite challenging. Key considerations are consumer acceptance, scalability and cost, with consumer acceptance taking precedence, according to Sanches.
Demand Growing Outside the EU
Demand for sustainable filter solutions will receive another boost once all EU member states have transposed the EPR scheme into national rules, according to Jaussaud. Like Pye, she observes growing demand also outside Europe, for instance in Canada, Australia and New Zealand. In the end, regulation will be the biggest influencer of sustainable filter solutions, says Pye. The Conference of the Parties to the Framework Convention on Tobacco Control, scheduled to take place in November in Panama City, will also address the problems posed by single-use plastics. “It is likely that many countries across the globe will adopt the guidelines and transpose them into country-specific laws and respective enforcement,” says Sanches.
Giannini believes that transition will start accelerating in 2025. China, the world’s largest cigarette market, is likely to take much longer than Europe to turn to sustainable filters, she says, in part because it is a conservative market with a significant domestic acetate tow industry.
While acknowledging the role of regulation, Jaussaud says there are other factors as well. “We clearly see a growing interest from the tobacco industry to move to sustainable solutions,” she says. “However, it’s a big change, so it takes time to make the transition concrete. It’s a long journey, but it has already started.”
The push for sustainable filters has yet to become evident in heated-tobacco products, according to Pye. “In reality, there is a shift toward more acetate tow-based products,” he says. “But it’s just a matter of time.” HTPs are an important segment for Filtrona, for which it also provides a range of sustainable products. The company recently conducted a sample testing at a large HTP manufacturer, which is currently in the review process. It has also invested in its testing facility in Surabaya, Indonesia, to ensure it has all requirements to test HTPs, especially their thermal characteristics.
Jaussaud emphasizes that SWM’s Evolute range is suitable for all the tobacco filter segments, including HTPs. “We have trials going on in this field,” she says. “It will not necessarily take longer for HTPs to adopt sustainable filter solutions—the customers behind HTPs want sustainable solutions as much as cigarette smokers. We would like to support converting all filter segments, not only combustible cigarettes.”
Greenbutts is also evaluating HTPs. “According to the latest assessments, our substrate is unfolding as a viable replacement for CA components in THPs [tobacco-heating products],” says Sanches.
A Sustainable Shell
In addition to filters, cigarette packaging, too, offers considerable potential for more sustainable solutions. Filtrona recently introduced Rippatape Halo, a patent-pending paper-based tear tape that provides a sustainable offering for the easy opening of paper and board packaging. “Tear tapes are a niche in the market, but we also offer sustainable solutions in this area,” explains Pye. “It is challenging because the type of product must have a number of characteristics, such as strength and opening performance. Halo Rippatape follows the characteristics of our Rippatape range, so it’s very close. The product has been on the market for six months now, and we’re starting to see some broad-based interest. But if a tobacco product is wrapped with fossil-based plastic, there’s of course not much point in an eco-tear tape solution.”
Innovia Films, a global producer of differentiated specialty biaxially oriented polypropylene (BOPP), is also offering sustainable packaging solutions. In 2018, it introduced Encore, a range of recyclable films. One of the films in the range incorporates a bio-based raw material that reduces the use of fossil-based packaging and the carbon footprint, and another aids the circular economy by using a chemically recycled polymer.
The Encore films are certified ISCC PLUS, a global sustainability certification system. According to the Innovia, the sustainable films have the same properties as the equivalent fossil-based BOPP film, including high clarity and gloss, high stiffness and printability.
To reduce carbon emissions and product waste, conserve resources and move to a circular economy, Innovia has been using Lifecycle Analysis to measure the benefit of product changes. “If packaging does not provide a functional benefit, it should be removed, regardless of the material selected,” says Alicia Crane, product manager at Innovia. “If it adds additional barrier benefits to increase shelf life and reduce waste and thus carbon emissions and product tracking, every effort should be made to reduce the weight of the packaging material required and make sure that it can be recycled into as near a closed-loop application as possible.”

Photo: Innovia
Make it Circular
For organic products, one of the packaging’s key functions is to provide a barrier against undesired elements. On top of requiring oxygen and flavor barriers like most food products, tobacco products traditionally have required a tropical vapor barrier, and the material must meet regulatory requirements. Depending on formulation and coating, the Encore range provides good moisture barrier and excellent functionality on high-speed machines, according to Innovia. In addition, the films require little energy and carbon during production, and they are able to be recycled effectively many times without suffering a degradation of their properties.
The variant based on a bio-based material is bio-circular, according to Crane: “Using ISCC PLUS-certified resins and the mass-balance approach, second-generation feedstock waste from other industries, such as tall oil or used cooking oil, can be used as alternative raw material sources to produce polypropylene resins. Because these raw materials go in at the primary stage of the production process, the ultimate films produced have exactly the same fingerprint as standard films, and all physical and mechanical properties are identical. The film importantly has food contact status. Because of the move from fossil-based sourcing, the material has a reduced carbon impact, which, depending on the percentage switched, can result in carbon-neutral film, cradle to gate.”
The circular product, which follows the same ISCC guidance and mass balance approach, employs raw materials that come from recycled mixed waste plastic by using chemical recycled processing. Tobacco films can be made with up to 90 percent recycled content. The film has the exact same physical and mechanical properties and food contact status, says Crane. “The consumer readily understands that higher levels of recycled materials mean less waste is being disposed of and more valued resources are kept in the economy,” she says. “The demand for recycled content has been significant, being more than the new investment in chemical recycling facilities has been able to deliver. This demand will only increase with new regulations coming into place. Bio circular does not see the same level of pull at present; perhaps the regulation on carbon emissions is behind that on packaging waste.”
Mechanical recycled content, which goes directly into the product, is enjoying considerable interest, she adds. It is another tool to retain valued resources and help build a circular economy.
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.

October 1, 2023
In Demand

Photo: RTF
Suppliers of reconstituted tobacco step up production to satisfy market requirements.
By Stefanie Rossel
Danil Bekmamatov
Demand for reconstituted tobacco leaf (RTL), also known as homogenized tobacco, has held up remarkably well in recent years. In 2021, amid the Covid pandemic, the global RTL business grew by $8 million, according to Russian Tobacco Factory (RTF). And despite the political and economic upheaval in the wake of the Ukraine war, the upward trend continues, prompting some RTL companies to expand their production capacity.
Pioneered in the 1930s, recon tobacco fits well with the current zeitgeist, with its focus on sustainability. Initially, RTL was developed to allow tobacco companies to use the leftovers from cigarette production that were previously discarded. The process saved the valuable raw materials, such as tobacco dust, scraps and stems, and reintegrated them into manufacturing process. Today, homogenized tobacco has a variety of applications. In addition to a cost-saving filler material, it is an essential ingredient in cigarette blend design that enables cigarette manufacturers to lower the nicotine content of their products.
There are several methods to manufacture RTL. Next to the papermaking method invented by Schweitzer-Mauduit International, there is the nano fiber technology developed by Recon Inc. and employed by Star Agritech International (SAI) and a process called band cast, which is also known as slurry-type recon.
A fourth method is the pressing technology, for which patents began to appear in the 1960s. RTF has perfected a variety of this technology known as the roller-rolling method. Using high pressure, the process creates a tobacco sheet with such tensile strength and elasticity that it can be processed in the same way as tobacco leaf. According to RTF, the sheet will retain its shape when passing through all stages of the primary, including the drying conditioning cylinder.
According to RTF CEO Danil Bekmamatov, the process is the result of extensive laboratory work along with trial and error. “The technology has been honed for three years,” he says. “At the beginning, we used only short stems and scrap as raw materials; now, we have developed the practice of processing sections of tobacco veins from a cigarette machine in the amount of 100 percent of the used tobacco material. We have also learned how to introduce up to 5 percent of tobacco dust from the aspiration systems of the cigarette shop without losing RTL quality.”
The strength of RTF’s approach lies in the simplicity of the concept. “Our technology avoids the costly process of producing nano-fiber cellulose,” says Bekmamatov. “Our product contains 90 percent tobacco and the minimal amount of adhesives necessary. Our proprietary method involves multi-stage rolling with the proper roller friction. We enhance the strength properties of recon tobacco through mechanical action alone, minimizing the use of chemicals.”
The process also consumes less water than competing technologies, an increasingly important factor as tobacco companies seek to lower the ecological footprint of their products. Skipping the nano-fiber cellulose production step allows users to save energy, leading to a more affordable recon product. “Only by reducing the amount of water to the required production minimum—in our case, up to 40 percent—is it possible to obtain an environmentally friendly technology with low production costs,” says Bekmamatov.
A More Sustainable Process
Reducing the carbon footprint was not the primary objective when RTF set out to develop its recon technology. According to Bekmamatov, it was just a positive consequence of the simplicity of the process and recipe. “For our recon production, less water is used than for the floor polisher that serves this line,” he says. “It is the simplicity of the technology and the recipe—all the components of which you have repeatedly seen in the patents of other researchers—that is a key factor in the spread of technology. Due to reverse engineering, the technology is easily repeatable. Therefore, we are interested in creating joint ventures anywhere in the world on an equal partnership basis—and not in selling ready-made production lines. In this regard, two negotiating processes are currently carried on—one is inside Russia, and the other one is outside of it.”
Based in Samara, about 1,100 km southeast of Moscow, RTF was established in 2017. In addition to recon, it sells cut-rolled stems and cut-rag tobacco. The company inaugurated Russia’s first RTL production line in 2019. A second line is set to become operational at the end of 2023. RTF caters to customers worldwide.
“Both for the client and for us, only the economy at the stage of logistics is important,” says Bekmamatov. “Logistic costs also become decisive in the issue of processing tobacco byproducts of the primary and secondary process on a give-and-take basis. For example, a number of contracts with neighboring CIS enterprises make it possible to process third-party tobacco waste with low road transport costs. On the other hand, the supply of secondary process tobacco material in sea containers from the UAE turned out to be unviable. I do not want to say that sea transport is expensive and makes it unprofitable to process waste from other countries. I just want to convey the idea that each direction needs to be calculated, and that we are ready to do this work with a great deal of responsibility. We do not exclude the possibility of building new RTL plants in other countries to reduce the cost of RTL for the end customer.”
Difficult Conditions
According to Bekmamatov, Russia has been importing increasing volumes of cigar tobacco and inexpensive machine-made cigars containing recon—yet there is virtually no import of RTL bobbins for cigar machines. “There is only one conclusion that can be drawn: there is a great interest in inexpensive cigars on the part of the consumer despite the hypocritical dispute in the cigar community about the quality of machine-rolled products using recon and the unwillingness of the tobacco business to invest in this area, mastering new technologies, processes, purchasing new equipment,” says Bekmamatov.
Meanwhile, Russia has been producing and importing increasing volumes of cigarillos. “I can only assume that this is due to the excise policy when premium cigarettes are almost equal in price to more prestigious cigarillos and also due to a low entry threshold for secondary manufacturers, who have enough existing equipment to launch a new product line based on papermaking recon wrapper cigarillos,” he says. “Moreover, among smokers, there are no loud discussions about the ‘insufficient naturalness’ of such tobacco products.”
Like other Russian companies, RTF has been impacted by the Western sanctions following the Ukraine war. Among other things, the restrictions have forced the company’s engineering department to source components such as electronics, gears and belts from Russian and Chinese suppliers rather than Western ones. In addition, the sanctions have made it difficult to source tobacco from traditional suppliers and conduct foreign exchange transactions. It has also driven up the price of logistics.
Yet RTF proved resourceful and solved the problems as they arose. “We were the first in the Russian Federation to build new routes for the supply of raw materials, which are now used by other companies,” says Bekmamatov. “And we solved banking problems by opening new companies outside the Russian Federation.”
Increasing Capacity
Expansion is also on the agenda of SAI, an international supplier of unmanufactured tobacco and tobacco derivatives based in Istanbul. Since 2018, SAI has been operating a nano fiber recon factory in Brazil. In early 2019, it opened a slurry-process recon plant in Bondowoso, Indonesia. “Recon demand has not changed as far as the usual players go,” says SAI President and CEO Iqbal Lambat. “Our factories in Brazil and Indonesia are running at full capacity, and we have added a second line in Bondowoso to double capacity.”
SAI’s recon production capacity exceeds 6,000 tons annually, making it a top 3 global supplier alongside SWM’s LTR Industries and KT&G’s Tae-A Industrial Co. affiliate, according to Lambat. “Demand for recon continues to increase as small[-sized] and medium-sized cigarette manufacturers understand the benefits of incorporating recon in their blends,” he says. “Recon is half the price of cheap tobacco in the current tobacco undersupply situation. Recon is becoming a worldwide phenomenon as small[-sized] and medium-sized companies come on board with better understanding of the benefits.”
To cater to increasing demand, Start aims to complete a second nano fiber plant with an annual capacity of 6,000 tons by early 2026 in Brazil. “This will ease the pressure on our current Brazilian factory,” says Lambat. “We are also planning a nano fiber plant in Tunisia and in Uganda. Both plants are slated to be operational in early 2025 as well. The Tunisian plant is relatively advanced and could come on stream in the Free Zone of Bizerte in 2024.”
To Lambat, nano fiber is the recon gold standard in terms of sensory impact, as it has half of the stem content as other RTLs, the highest filling power of all RTLs and excellent combustibility. In addition, nano fiber is a sustainable solution. “Nano fiber remains the most eco-friendly RTL production process within the industry,” he says. “As an example, production of 1,000 kg of nano fiber requires less than 50 liters of water. By comparison, the papermaking process requires three liters of water per kilogram of recon produced. So, for 1,000 tons of papermaking recon, 3,000 liters of water will be used and turned into brown water, which then needs industrial scrubbing to be able to release the water into existing effluent systems. So, by comparison, a ton of nano fiber produced uses 50 liters of water versus papermaking at 3,000 liters. So, I’d say, nano fiber is already ahead of the game.”
Specialized Solutions
Nano fiber technology does not work well for the kretek cigarettes that dominate the Indonesian cigarette market, however. “Because kretek has as much as 30 percent cloves, it is necessary to use an alternative binding method, and slurry-type production is better suited,” says Lambat.
The company broke new ground when it opened its recon plant in Java four years ago to turn the waste from clove cigarettes production into kretek recon. “In the startup early experience, Indonesian cigarette manufacturers expected the kretek recon to ‘crackle and spark’ as normal cloves do when lit up,” recalls Lambat. “Of course, kretek recon cannot do that, and now, some four years later, our product has achieved broad product acceptance in Indonesia, and we have more demand than capacity—hence the addition of a second line to double capacity in Indonesia, which is already being commissioned for startup by the end of 2023.”
SAI has more ideas for specialized RTL products in the pipeline. One is the development of a shisha-type recon offering similar chemical characteristics as original shisha tobacco. “Absorption is in the high five to six ratio limits,” says Lambat. “The product was developed with nano fiber recon from the Star Brazil factory in conjunction with a leading tobacco flavor company in Germany. Prototype products have received broad product acceptance across major markets of the Middle East. As shisha tobacco is in short supply globally, this innovation will alleviate demand.”
The other novel product is a 100 percent recon manufactured with oriental tobacco from Turkiye, Greece and Macedonia. “Given the current high—and increasing—price of oriental tobacco, this will prove to be a welcome substitute at literally half the price for classical oriental tobacco,” says Lambat.
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.

October 1, 2023
Doubling Down

Australia’s proposed crackdown on vaping is unlikely to achieve its objectives.
By Stefanie Rossel
As a vaper in Australia, you basically have two choices. The first option is to behave like a good citizen, go to your doctor, get a prescription and convince a pharmacist to sell it to you. The alternative is to be not so good and do what 92 percent of Australian vapers do—source your e-cigarettes on the black market. Vapes have been regulated Down Under since October 2021 but so poorly that Australian health professionals speaking at the Warsaw Global Forum on Nicotine in June apologized for the legislation.
Getting a prescription is more difficult than one might think, according to Carolyn Beaumont, an Australian general practitioner (GP) who advocates for the right of adult smokers to access vaping products. As Beaumont explained during her presentation, among the many barriers is the challenge to find a doctor who is not only familiar with vaping products but also believes in their potential as smoking cessation tools. But Australia is a huge country, where most of the population—and doctors—live along the Eastern Seaboard. In other regions, there are fewer physicians. Additionally, clinics may not be open daily, wait times are getting worse, and more GPs are charging privately. An estimated 20 percent of Australians have no regular GP; Beaumont said it could be even 35 percent.
Doctors often lack product knowledge and have an inadequate understanding of smoking, vaping and nicotine dependence. Tobacco harm reduction is not taught in Australia, according to Beaumont, and the medical guidelines are not supportive of vaping. Doctors also face an administrative barrier: They need to be registered as an authorized nicotine prescriber. However, the prevailing negative media narrative in Australia makes many GPs reluctant to register. In April 2023, the Australian Department of Health and Aged Care listed 1,963 authorized prescribers nationwide, which equals one in 20 practitioners.
Once vapers have secured a prescription, they need to find a pharmacy that sells vapes. But few establishments do so, and often, they have only limited stock. Vapes can also be ordered online and imported for personal use under the Therapeutic Goods Administration’s (TGA) personal importation scheme. With a valid prescription, Australians may legally import a three-month supply per order. “It remains illegal for other Australian retailers, such as tobacconists, vape shops and convenience stores, to sell you nicotine vaping products, even if you have a prescription,” the TGA stresses on its website.
At present, merely 8 percent of vapers have a prescription, and only 2 percent purchase from pharmacies, according to a Roy Morgain survey in February 2023.
Additional Restrictions
Colin Mendelsohn
Things are unlikely to get easier for smokers seeking less hazardous alternatives to combustible cigarettes. In May 2023, Health Minister Mark Butler announced a further crackdown on recreational vaping. He claimed that vaping had been advertised to the public as a therapeutic product meant to help smokers quit but instead spawned a new generation of nicotine users, particularly young people. At press time, details on the new rules were unavailable, but tobacco harm reduction advocates were bracing for restrictions on disposable vapes, flavor options and nicotine concentrations, along with a requirement to package vaping products in pharmaceutical-style packaging and an end to the personal importation scheme, with sales permitted only through authorized pharmacies.
Writing on his blog, professor Simon Chapman, a determined opponent of vaping, suggested that Butler might ban refillable vaporizers as well. The planned legislation will require federal authorities to seize products at the border and states to police retail sales, but so far, it has not allocated any funding to enforcement.
The proposed plan is de facto prohibition, according to Colin Mendelsohn, a former GP who has been helping smokers quit for more than 30 years. “It is a doubling down on a failed highly restrictive model that has been rejected by vapers and prescribing doctors and has created a thriving black market, which sells freely to underage users,” he says. “The history of prohibition and the war on drugs shows consistently that it does not reduce long-term illicit drug supply, and there is no reason to believe that this will be different. Bans are effective short-term political strategies but are bad public health policy. The Australian Border Force (ABF) does not have the resources or interest in intercepting vapes and is correctly more focused on dangerous illicit drugs, such as heroin, cocaine, ice, etc., or weapons.”
In an interview in May, ABF Chief Michael Outram warned that banning vapes at the border wouldn’t be enough to stamp out a rampant black market, as his organization managed to intercept barely 75 percent to 80 percent of illicit drugs making their way into Australia “on a good day.” Of the 8 million containers coming into the country each year, only 1 percent to 1.5 percent are scanned.
The proposed crackdown, cautions Mendelsohn, will likely have many unintended consequences. “Criminal networks will continue to find ways to import vapes,” he says. “This is a high-profit and low-risk crime, and it is accompanied by stand-over tactics, such as firebombing of retail outlets, gang wars and violence, and corruption of officials. The proceeds fund other, more serious criminal activities. There will be continuing sales to youth and more difficult legal access for adult smokers. Some vapers will relapse to smoking. It will be harder for current smokers to switch to vaping.”
According to Mendelsohn, the planned law will criminalize otherwise law-abiding citizens who simply want to improve their health, and cause the government to lose revenue from taxes, licensing and vape shops while shouldering increased cost of policing, enforcement, the justice system and prisons. “We will continue to see dodgy, mislabeled, unregulated products with high nicotine levels,” he says. “The harm from unregulated black market products was demonstrated during the EVALI [e-cigarette or vaping product use-associated lung injury] outbreak. There will also be higher prices, increased drug potency [and] stockpiling of nicotine e-liquids prior to the change. All legal, legitimate vape businesses will be closed. It’s a violation of the human right to access a safer alternative to smoking.”
Unsuccessful Measures
Low-income and otherwise disadvantaged people, among whom rates of smoking and smoking-related death and disease are significantly higher than in the rest of the population, will be disproportionately affected, according to Mendelsohn. “Australian research has shown that vaping may help to reduce health inequalities,” he says. “Smoking is a leading cause of financial stress in disadvantaged populations, especially at a time of sluggish wage growth, high interest rates and a high cost of living. Spending is diverted from food, clothing, etc., to smoking.”
Australia has the highest cigarette prices in the world, with a pack of 20 retailing at AUD40 ($25.60). Based on a consumption of 13 cigarettes a day, the average cost of smoking is AUD11,850 per year. Vaping, by comparison, costs AUD500 to AUD1,500 per year, depending on the device used.
“At the current high levels, further tax rises are no longer effective due to the law of diminishing returns,” says Mendelsohn. “Many addicted smokers are simply unable to quit no matter how high the price. Smoking rates in Australia have not declined over the last four years in spite of high prices, plain packaging and other tobacco control strategies.”
So where’s the consumer in all of this? Mendelsohn says that the lack of a consumer voice is a big problem. “We had a New Nicotine Alliance AU, which disbanded about five years ago. Recently, the Australian Smokefree Alternatives Consumer Association was formed but is still very quiet. Legalise Vaping is a part of the Australian Taxpayers Association and is the most active advocacy group. I believe they have had some indirect tobacco company funding in the past, but they are focused on legalizing and regulating vaping and the rights of adults to make their own choices. Overall, they do an excellent job with limited resources. All anti-vaping groups are subject to great scrutiny and are smeared and undermined by anti-vaping advocates if there is any potential opportunity.”
Ideology Instead of Science
Butler’s plan has attracted criticism from several institutions. On July 8, internal confidential e-mails sent by members of the Australian National Advisory Council on Alcohol and Other Drugs (ANACAD) expressed concerns about further restrictions, saying it would exacerbate the black market problem, criminalize more people and make smoking more attractive. On July 18, Mendelsohn and a group of more than 40 experts from Australia and New Zealand urged lawmakers to listen to the ANACAD ahead of Butler’s proposed vaping crackdown. At the time of this interview, they had not received a response to their letter.
Mendelsohn is not optimistic that Butler will change course. “Butler has committed himself to this crackdown, and there is no indication that he will soften his approach,” he says. “He is taking advice from a small group of ideologically driven tobacco control academics and health bureaucrats with extreme anti-vaping views.” According to Mendelsohn, Butler operates in a bubble and is ignoring the pro-vaping arguments. “He has refused to meet with Dr. Wodak [a fellow tobacco harm reduction proponent] and me, although we met with his adviser, who was clearly committed to a predetermined position,” says Mendelsohn. “He is under considerable pressure from Australian health charities, medical associations, public health organizations and state governments that are almost universally opposed to vaping. The media is also hostile to vaping. Any turnaround will be very difficult politically.”
Vaping policy in Australia, says Mendelsohn, is driven by ideology rather than science. “Australia’s peak health and medical research organization, the National Health and Medical Research Council (NHMRC), prepared an anti-vaping position paper on vaping. The NHMRC is very influential in guiding national health policy. The NHMRC document was critiqued in a peer-reviewed article in Addiction by leading Australian and international experts and found to be riddled with serious scientific flaws and misinformation. However, it remains unchanged.”
For sensible regulation of vaping, says Mendelsohn, Australia should look to its neighbor, New Zealand, which in August 2020 legalized and regulated vaping. “Over the next two years, there was an unprecedented 33 percent decline in the adult smoking rate among those aged 15 and over—from 13.7 percent to 9.2 percent. In Australia during the same period, the smoking rate increased by 4.5 percent. In that time, there have been no major smoke-free policy interventions, almost no mass media spend on quit campaigns and no tobacco tax increases in NZ.”
Lessons From Drug Policy
Alex Wodak
Alex Wodak, Mendelsohn’s ally in the battle for harm reduction-based legislation, is more confident that Australia will eventually change its stance on vaping. Wodak has dedicated his career to drug harm reduction and was instrumental in reforming drug law in Australia. Together with colleagues, he created the country’s first needle exchange program in 1986 and its first medically supervised injecting center in 1999. At this time, both were pre-legal.
He observes parallels with his country’s current crackdown on vaping. “The World Health Organization opposed drug harm reduction, including needle and syringe programs for a few years in the 1990s, apparently relenting to intense U.S. pressure,” says Wodak. “The default policy for communities, governments and the WHO for new drugs, new forms of drug administration and new forms of drug harm reduction is generally negative. It seems sensible to be initially cautious about changing situations regarding drugs, but we have a problem when the opposition to a new form of drug harm reduction is maintained long after the evidence of effectiveness and safety has become compelling, especially when the costs of delay are so substantial as they are with needle and syringe programs and tobacco harm reduction.
“The case in favor of vaping and other forms of tobacco harm reduction is now overwhelming. Smokers increasingly prefer to continue to use nicotine but prefer to consume it in safer ways. Many traded tobacco companies are transforming from combustible cigarettes to safer products, some faster than others, but they are changing. Investors pay higher prices for tobacco companies transforming more rapidly. Unfortunately, tobacco control, governments and the WHO are still resisting change, which now seems inevitable. This change is an enormous opportunity for public health, similar to the scale of the benefits from vaccination.”
Wodak remembers the time when harm reduction was refused in favor of an abstinence-only approach in drug policy circles. “The political debate lags behind the scientific debate,” he says. “There are many lessons from this experience. It is important to continue improving the quantity and quality of evidence. It eventually does make a difference. Being polite and respectful to harm reduction opponents matters. So does persistence. There are no shortcuts. Harm reduction involves consequentialism—that is, making an assessment of both the benefits and costs of a policy or intervention. Opposition to harm reduction often involves deontology—that is, following a set principle, such as aiming for a tobacco-free—or nicotine-free—outcome rather than a smoke-free outcome. The net effect of the policy or intervention is not a concern.”
Staying Power Needed
The current approach of the Australian government to vaping is unsustainable, Wodak emphasizes. “It is destined to collapse sooner or later,” he says. “Opponents of harm reduction are unable to justify why a far safer option is severely restricted while a deadly option remains readily available. Despite dominating politics, mainstream media and medical and health publications, 73 percent of Australians support vaping being regulated like cigarettes and alcohol while only 20 percent support prescription-only regulation of vaping.”
The new approach announced by Butler on May 1 requires legislation to be passed by the House of Representatives and the Senate. “This legislation will most likely be passed by the House of Representatives but is unlikely to be passed by the Senate,” says Wodak. “The black market currently meets 92 percent of the demand from a rapidly growing number of adult Australian vapers, now estimated to number 1.3 million. Although the government asserts it will strengthen law enforcement border efforts to reduce the number of illegal vapes entering Australia, now estimated at about 10 million per month, no additional funds have been provided for this purpose. Heroin was prohibited 70 years ago in Australia. However, in 2022, a survey of people who use drugs found that 87 percent said that obtaining heroin was ‘easy’ or ‘very easy.’ When demand for a good or service is strong and controls are easy to subvert, as is the case with vaping, other sources of supply almost invariably emerge.”
Wodak views the battle for vaping reform in Australia through the lens of drug harm reduction rather than from a perspective of tobacco control. “I have been involved in battles for drug law reform in Australia over about 40 years. We have won almost all of these battles, although it has often taken more time and effort than we would have preferred. I am very confident that tobacco harm reduction will prevail in Australia. Taking a bet against drug harm reduction is very brave as harm reduction almost always wins.”
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.

October 1, 2023
Dispelling Myths
Photo: Elena Milevska
A disturbingly larges share of doctors believe that nicotine causes smoking-related diseases.
By George Gay
For a long time, people involved in tobacco harm reduction (THR) have bemoaned the fact that many doctors wrongly believe that consuming nicotine causes smoking-related diseases. Clearly, the concern as far as THR advocates are concerned is that, logically, these doctors are unlikely to recommend that smokers transition from combustible cigarettes to other forms of nicotine delivery, such as those afforded by electronic cigarettes, nicotine pouches and, one must assume, even nicotine patches.
This concern was highlighted in a July 20 press note issued on behalf of the Foundation for a Smoke-Free World (FSFW), which said that a survey of more than 15,000 physicians in 11 countries had found, in part, that 77 percent of doctors mistakenly believed nicotine caused lung cancer, and 78 percent mistakenly believed it caused atherosclerosis. The Doctors’ Survey was carried out online by Sermo with doctors based in China, Germany, Greece, India, Indonesia, Israel, Italy, Japan, South Africa, the U.K. and the U.S.
“It is imperative that doctors get the proper training to learn the facts about nicotine and tobacco harm reduction options that can help their smoking patients quit,” Muhammad Ahmed, the FSFW’s director of health and science research, was quoted in the press note as saying. “With more than 7 million smokers dying annually from smoking-related diseases worldwide, many lives can be saved if doctors become more knowledgeable about the cessation tools available.”
Now, the FSFW is inviting researchers to submit (contact support@smokefreeworld.org) proposals to further analyze the Doctors’ Survey findings and propose programs to help improve doctors’ “fluency about smoking cessation and tobacco harm reduction.”
The report of the Doctors’ Survey has much to recommend it, and I would urge anybody interested in THR to read it. One of its strengths, I would suggest, is that it is a practical attempt to help address the chronic problems associated with doctors being generally ill-informed about nicotine. And it is to be hoped that this practical emphasis continues as researchers further analyze the survey’s findings and propose remedial actions. It would be unfortunate if there were a focus on analysis that led to academic drift. We should not lose sight of the fact that this is about helping smokers, not about helping indigent academics—the words “more research is needed” should be proscribed.
Primary Sources
While generally supporting this initiative, I have a few concerns and questions about some of the issues that the survey raises. There is what looks like an unnecessary reference to IQOS in one of the report’s tables, something of an “own goal” I would have thought, given that the FSFW comes under attack for the source of its funding, notwithstanding such attacks might be unwarranted and unfair.
And I hope that whatever comes out of the proposals for improving doctors’ “fluency about smoking cessation and tobacco harm reduction,” it clears up a couple of questions. Doctors in Japan are said in the survey report to believe mistakenly that “light” cigarettes are less harmful than other cigarettes, but what are doctors working in the EU to make of this “mistake” when the authorities there impose a limit on deliveries? Is it out of malice or a sense of a lightness of being that the authorities in the EU allow only the sale of “lighter” cigarettes? And a related question would ask if anybody knows whether there is any point in doctors recommending smokers cut their consumption. Does anybody know if the risks of smoking are proportionate to consumption levels—in respect of delivery levels per stick and/or by daily stick consumption?
More importantly, the question arises as to whether we know if doctors are the primary source of the information on smoking and quitting that people absorb and act upon. If so, the direction of the FSFW’s travel seems correct and important. If not, it would seem irrational to spend a lot of time and money trying to improve the training of doctors in this area, especially given that if they haven’t figured out the role of nicotine by now, it is possibly going to take a lot of effort to get through to them. I certainly cannot see how the doctor route could be universally applicable given that many governments oppose at least some aspects of THR, and many health services are at least partly state institutions.
A cursory internet search indicated that, in the U.K., patients had on average 8.7 consultations with general practitioners during 2018–2019, 3.3 of them face-to-face. Compare that with the uncountable number of times these same people would have gawped at their mobile phones. So, in a country such as the U.K., where the government is convinced of the effectiveness of THR, it would perhaps be better for it to use social media to get messages across. I am not advocating the usual sort of official messages that comprise little more than a tissue of lies but messages simply about the relative safety of nicotine as the government sees it. Otherwise, messages could be included, for instance, on the shirts of professional sorts of people, on public transport and on public buildings. And given the increasingly authoritarian nature of the U.K. government, perhaps it might consider the compulsory tattooing of people with these important messages.
Another problem was brought to light when Ahmed said that it was imperative for doctors to receive the proper training to learn the facts about nicotine and tobacco harm reduction options that can help their smoking patients quit. The obvious questions arise as to who gets to decide what amounts to proper training and what the facts are in a postmodern world. The facts, for example, as they apply to the use of THR principles and as they are decreed by the authorities in India and the U.K., are likely to be very different.
The World Health Organization, though paying lip service to THR, opposes the shift from inhaling tar and nicotine to inhaling just nicotine. And the U.S. Food and Drug Administration, whose influence stretches beyond the U.S., while also paying lip service to THR, has done much to discourage smokers making such a shift. In fact, the FDA, at the same time, has de facto promoted the smoking of tar-delivering, low-nicotine combustible cigarettes. What is a trainee doctor to make of such policies—such implied facts?
Of course, such issues will not have escaped the attention of those behind this initiative, but it concerns me that any attempt at trying to resolve them, either universally or on a state-by-state basis, will simply lead to delays in reaching THR objectives. The vaping advisory industry, in all its guises, should not be seen as being more important than the vaping industry.
Evaluating the Curriculum
But I have a bigger concern. The ad nauseam message coming from governments and organizations such as the WHO and the FDA is that “[c]igarette smoking remains the leading cause of preventable disease, disability and death ….” In fact, that quote comes from the Centers for Disease Control and Prevention and refers to the U.S.
At the same time, the message coming from the Doctors’ Survey is that most doctors are ill-informed about issues surrounding smoking and nicotine consumption because they have received little or no training on smoking cessation. “This may reflect the cursory training they’ve received in smoking and harm,” is a quote from the survey referring to doctors in Italy.
Let me paraphrase these two positions:
Cigarette smoking is the leading cause of preventable disease, disability and death.
Most doctors receive only cursory training in respect of the leading cause of preventable disease, disability and death.
It seems I am being asked to believe that doctors, charged, in part, with helping people avoid sickness, are not being properly trained in respect of the most threatening health concern of all. How can I reconcile these two positions or overcome the apparent state of insanity they describe? I could assume, I suppose, that those who devise the curriculums at the base of doctor training courses are not in full control of their mental faculties, that they insist doctors should, when you visit them, be able to rattle off the names of the 206 bones in your body but not be able to give you sound advice on the leading cause of preventable disease, disability and death. On the whole, I find such an explanation unlikely given that we are talking about the curriculum advisers in 11 countries. They cannot all have taken leave of their senses.
So, I am left with the conclusion that either No. 1 or No. 2 above must be wrong, and I am leaning toward the idea that it is No. 1 that is wrong. But before I expand on this idea, I need to make three points. Firstly, I am not saying cigarette smoking is anything but hugely harmful. I think it stands to reason that inhaling anything but pure air is not a good idea and is likely to cause you harm. Secondly, I am not saying cigarette smoking was never the leading cause of preventable disease, disability and death. Thirdly, I have read in recent times about three things reported to be the leading cause of early deaths in humans: tobacco smoking, outdoor pollution and poor diet.
Above, I quote Ahmed as saying more than 7 million smokers die annually from smoking-related diseases worldwide. But what does this mean? It is arguably a completely open-ended figure, one that might or might not approach or even surpass the WHO’s 8 million. OK, you could argue the “more than 7 million” is just a throwaway, ballpark figure aimed at underlining the severity of this issue, but surely it is necessary to have more than a ballpark figure before we start trying to build a sturdy quit-smoking edifice?
Recently, The Guardian newspaper’s health editor, Andrew Gregory, made the point that long-term exposure to air pollution is associated with chronic conditions such as heart disease, asthma and lung cancer.
Clearly, separating many cigarette-smoking deaths from pollution-related deaths must be difficult, if not impossible, so I find it odd that health professionals are willing to accept and work on the basis of what seem to be highly dubious smoking-related-disease figures. Why are health professionals so keen on expending huge amounts of effort and money addressing what they blindly accept to be the problems caused by smoking, which, by the way, are likely decreasing and which individuals can address for themselves, rather than expend that effort and money addressing the much bigger and growing health problem posed by pollution, over which individuals have next to no control and which are going to get worse as the population of the world approaches 10 billion and becomes even more concentrated in megacities? It is time to ask “cui bono” and “cui malo”?
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.
October 1, 2023
Party Time

Photo: Hanohiki
The industry will not be present as the FCTC parties debate future tobacco and nicotine policies in Panama this autumn.
By Taco Tuinstra
From Nov. 20 to Nov. 25, delegates representing the countries that have signed to the Framework Convention on Tobacco Control (FCTC) will gather in Panama City to discuss tobacco and nicotine policies at the 10th Conference of the Parties (COP10). It’s an event that warrants close scrutiny because the decisions taken at the COP tend to have profound implications on the nicotine business and its customers, impacting the future of manufacturers, suppliers and tobacco growers along with stakeholders such as smokers and vapers.
“COP is a highly influential global policy center for tobacco,” explains Flora Okereke, head of global insights and foresights at BAT. “It covers everything in the tobacco value chain from ‘seed to smoke.’” Even though the forum’s guidelines are just recommendations, many of the guidelines make it into national legislation.
Major policies, such as plain packaging and flavor restrictions, were floated at the COP before they were adopted by leading markets. The COP also inspired the bans on industry science that have proliferated in recent years—a development that Okereke considers to be even more detrimental to the cause of tobacco harm reduction (THR) than the event’s well-established restrictions on industry engagement.
In addition to impact at the national level, the COP also holds considerable institutional sway globally. “The FCTC is lodged not under the WHO but under the U.N., which means it has implications for trade, agriculture and finance as well,” notes Derek Yach, a global health expert who was deeply involved in the crafting of the treaty two decades ago. Through its interactions with bodies such as the World Health Organization, the World Trade Organization (WTO) and the World Bank, the COP is able to spread its tobacco control philosophies, which tend to favor prohibition over more progressive approaches.
All this implies that the COP bears an outsized influence on the future of the nicotine business.
So, what can the industry expect from COP10? Experts who have been following the preparations expect debates about the “tobacco endgame,” which includes nicotine reduction, retailer quotas and generational tobacco purchasing bans. They also anticipate talks on contents and emissions testing and measurements, filters and ventilation, and pricing and tax increases.
At press time, documents had been released for discussions about extending advertising/sponsorship restrictions to corporate campaigns and newer media; supporting anti-tobacco litigation; and discouraging industry diversification into pharmaceuticals and other areas. Also on the agenda: a proposal to redefine aerosol from tobacco-heating products as smoke—a move that critics have described as an attempt to rewrite basic scientific principles.
In addition, the COP delegates will consider recognizing tobacco control as fundamental to the right to health, clearing the way to attack the industry as a violator of human rights and subject it to additional liability. However, they will not discuss the negative impact of such an approach on smokers and tobacco farmers—two highly stigmatized groups. Participants in the Panama event will likely also debate emerging evidence on new products. Worryingly, they may push for e-cigarettes and tobacco-heating products to be regulated like combustible cigarettes, a development that critics say is not based on science and would discourage the THR that has been underway in many countries.
Rejecting Harm Reduction
To tobacco harm reduction proponents, the COP’s growing aversion to THR and the potential of new nicotine products is among its most disturbing characteristics. Even though FCTC Article 1(d) identifies harm reduction as a fundamental tobacco control strategy, THR has been given short shrift during the biennial conferences, with delegates pushing increasingly prohibitionist policies with each subsequent gathering.
That attitude, says Okereke, is particularly unwarranted considering the emergence of reduced-risk alternatives to smoking. While acknowledging that the first port of call should be smoking cessation, she believes that those who do not wish to quit using nicotine deserve access to better alternatives. “Despite years of tobacco control, more than 1 billion people continue to smoke,” says Okereke. “What do we do with those people? Can we at least offer them alternatives to reduce risks? Years ago, there would have been no options. But thanks to technology, smokers now have real alternatives.”
Yach is bothered by the inability of the COP delegates to engage in the science. “That’s a failure of imagination,” he says, especially when considering how their colleagues in medicine and other areas have embraced the concept of harm reduction. According to Yach, some of the ambassadors who negotiated the FCTC were also involved in the WTO Doha round about AIDS drug pricing at the start of the new millennium. But whereas the WTO approach was all about patents and innovation, the FCTC never mentions those words. “The people negotiating that treaty simply assumed there was no possibility for improvement in tobacco,” he says.

Despite years of tobacco control, more than 1 billion people continue to smoke. What do we do with those people? Can we at least offer them alternatives to reduce risks? Years ago, there would have been no options. But thanks to technology, smokers now have real alternatives.
Flora Okereke, head of global insights and foresights, BAT
Yach suspects that the resistance to progressive policies is fueled by the fear that THR is an industry trick to sustain sales. But while there may have been legitimate concerns in the early years of THR, he says those should have evaporated as more science became available. “Once we started seeing the big shift out of combustibles and better science showing that the exposure levels [of the new products] were almost unmeasurable, one would expect change.”
The other factor that has pushed hostility to THR, according to Yach, is the U.S. response to e-cigarettes. “The U.S. approach puts kids—even the theoretical concern about underage vaping—above the real gain to adult smokers who could benefit from new products,” he says. “This ‘kiddification’ policy became the norm internationally once the billionaire philanthropist Michael Bloomberg started pouring hundreds of millions of dollars into extending the campaign across India, Pakistan and other countries. The impact was significant. In 2019, India, one of the world’s largest tobacco markets, banned e-cigarettes, depriving some 100 million combustible cigarette smokers of safer alternatives.
Bloomberg’s resistance to THR is puzzling given that his charitable foundation funds some of the best harm reduction programs outside of tobacco control, tackling tough issues such as HIV and drug abuse, for example. Reliable sources indicate that the foundation’s unwillingness to extend the harm reduction philosophy to tobacco control has caused divisions even within the organization, providing a sliver of hope that Bloomberg may over time become more amenable to THR.
Resisting Engagement
For the time being, however, the COP’s opposition to THR is likely to persist, especially in light of its reluctance to hear dissenting views. Just like the rejection of THR, the ban on industry engagement is not spelled out in the treaty. FCTC Article 5.3 instructs parties to protect public health polices from the tobacco industry’s commercial and other vested interests, but it does not prohibit discussions or engagement outright, which the framers of the treaty realized would be unworkable. “We knew at the time that such a ban was impossible in the case of the Chinese government [which operates the world’s largest tobacco conglomerate] and other countries with state monopolies,” says Yach. Yet the Secretariat took an extreme interpretation of Article 5.3., and it is the nonbinding guidelines—but not the treaty itself—that contain the words “prohibit,” “ban” and “do not involve,” according to him.
As a result, the FCTC is the only treaty in the UN system where key stakeholders often lack the ability to share their views and insights. Whereas energy companies, including those working in fossil fuel industries, have had ample opportunity to engage during the U.N. Climate Change Conferences and share their insights into how to bring about the desired transition to green energy, the tobacco industry and the rest of the general public will be excluded from having input in Panama, just like at virtually every COP since the creation of the FCTC.
Such exclusion is detrimental because it means the best available science on tobacco issues will not be taken on board during the COP discussions. Conducting research is expensive—often prohibitively so for noncommercial actors. The industry spends a lot of money on science, according to Okereke. “Nobody else will do that level of research except if they are paid,” she says. But if the industry pays a third party to conduct science, that work will still be treated with suspicion. “Despite industry conducting most science related to new products, COP has historically dismissed our research. Industry is also unable to communicate its findings to consumers because it is prevented from doing so.”
This situation, says Okereke, has contributed to unhelpful misperceptions, even among specialists. For example, a recent survey commissioned by the Foundation for a Smoke-Free World found that nearly 80 percent of doctors worldwide mistakenly believe that nicotine causes lung cancer, thwarting efforts to help smokers quit with the help of less harmful products.
Remember the Mandate
Okereke and Yach believe COP delegates should remember their original mandate—to reduce the death and disease caused by tobacco use. Over the years, the FCTC has expanded its scope from a narrow focus on tobacco to targeting nicotine and the industry as such. This has led to bizarre positions such as opposition to diversification. “On the one hand, they want industry to move out of tobacco—yet when the industry takes steps to do that, they try to block it,” says Okereke. The ultimate objective of the FCTC, she notes, is not to increase the number of laws or to turn the screws on industry but to improve public health.
In this context, it is telling that some of the countries with the most progressive approaches to new nicotine products have made the greatest progress. Smoking rates in Japan, the United States and Britain, for example, have fallen to record low levels without the prohibitionist measures recommended by the COP. In Japan, the slump in smoking is attributed largely to the success of heat-not-burn products while e-cigarettes are likely to have contributed to the declining popularity of traditional cigarettes in the U.S. Britain’s success in lowering smoking—by the end of 2022, prevalence had fallen to just 13.3 percent—is widely credited to that country’s progressive regulatory approach to vaping.
By contrast, many early adopters of the FCTC that have been attending the COP for the past 17 years continue to struggle with high smoking rates. With a smoking prevalence of more than 80 percent among adult men, Jordan, which ratified the FCTC in June 2004, has the world’s highest share of male cigarette consumers, for instance.

The moment you use the phrase ‘appropriate for the protection of public health,’ you run against the rationale given for banning involvement of the industry, which is that there is an irreconcilable difference between the tobacco industry and public health. If something is APPH, then there is no irreconcilable conflict—there is a way to reconcile it through reduced-risk products.”
Derek Yach, global health expert
Given the prevailing restrictions on industry engagement, THR activists hope that representatives of countries with progressive policies toward new products will share their success stories with other COP delegates, many of whom come from developing countries with particularly high smoking rates and more limited regulatory capacity. The U.K. is particularly well placed in this regard because its government has actively supported moving smokers to less harmful products. Sweden’s success in reducing smoking is also worthy of discussion at COP10; thanks to snus, smoking prevalence in Sweden is poised to dip below the 5 percent that is widely considered to be the hallmark of a smoke-free society.
The other candidate is the U.S. Having signed the FCTC but not yet ratified it, that country is entitled to intervene during the COP discussions. “The U.S. Food and Drug Administration simply needs to highlight the products it has authorized based on the phrase ‘appropriate for the protection of the public health,’ or APPH,” says Yach. “If something is APPH in the U.S., it must be APPH everywhere. The moment you use that phrase, you run against the rationale given for banning involvement of the industry, which is that there is an irreconcilable difference between the tobacco industry and public health. If something is APPH, then there is no irreconcilable conflict—there is a way to reconcile it through reduced-risk products [RRPs].”
Yet, while Yach believes that the U.K., the U.S. and other countries with more progressive tobacco control policies have an obligation to speak about their successes, he is not holding his breath. The demonization of the industry runs so deep, he notes, that they may hesitate to boast about the success of their accommodative regulatory frameworks.
So, deprived of a voice, the nicotine business will be left off of the guest list again as COP delegates descend on Panama this autumn. The worst outcome of this conference, from the industry’s perspective, would be a series of prohibitionist policy recommendations, with delegates urging bans on flavors and disposable e-cigarettes, for example, along with tax structures that would make it unviable to move ahead with RRPs. Without flavors and risk-proportionate taxation, smokers will have fewer incentives to switch to smoking alternatives, and if governments ban RRPs altogether, the only product available will be the riskiest of all—the combustible cigarette.
A better outcome would be for COP delegates to acknowledge that THR has a role to play in mitigating the health impact of tobacco use and to provide for an unbiased review of evidence related to new products. For example, an independent commission could be convened to review the scientific evidence on RRPs that has come out since the last COP, including the FDA product authorizations and the decisions of the U.K. government and others based on science.
Though clearly concerned about what might transpire in Panama, Okereke and Yach remain optimistic about the outlook for THR in the longer term. “I believe the story we are telling is compelling,” says Okereke. “The data and the narrative support our positions. In the 10 years since BAT launched its first e-cigarette, we now count over 24 million adult consumers of less risky alternatives to smoking.” While acknowledging concerns about youth uptake and the environment, she is convinced that these issues can be addressed without resorting to prohibition and depriving smokers of such alternatives. Yach, too, sees reason to be hopeful, albeit not immediately. The data, he says, speaks for itself: “In the end—after everything else has been tried—science does win.”
The millions of smokers looking for less harmful alternatives will be hoping that victory comes sooner than later.
Welcome to the Party: Meet Your Hosts
The Framework Convention on Tobacco Control (FCTC) is an international agreement established to combat the global health problems caused by tobacco use. A framework convention establishes broad commitments and leaves the setting of specific actions and targets either to subsequent more detailed agreements (usually called protocols) or to national legislation.
The first treaty to be negotiated under the auspices of the World Health Organization, the FCTC defines tobacco control as “a range of supply demand and harm reduction strategies that aim to improve the health of population by eliminating or reducing their consumption of tobacco products and exposure to tobacco smoke.”
The FCTC was adopted by the World Health Assembly (the highest decision-making body of the WHO) on May 21, 2003, and entered into force on Feb. 27, 2005. To date, 182 countries have signed and ratified the FCTC. Six countries have signed the convention but not ratified it; nine have done neither. This makes the FCTC one of the most widely adopted U.N. treaties.
The Conference of the Parties is the governing body of the convention. Meeting every two years, it is the venue for discussions about the implementation of the FCTC. All countries, whether they have ratified the treaty or not, can actively participate in discussions. Countries that have ratified the convention are known as “parties.” Countries that have not ratified have observer status and may intervene during the discussions. Delegations typically comprise health officials, although other domestic departmental interests along with nongovernmental organizations and subject specialists might also attend. Past COPs have taken place in Geneva, Durban and Seoul, among other cities. The 2021 gathering took place virtually due to the Covid-19 pandemic.
The FCTC Secretariat supports and implements the business of the COP between meetings. While in theory, this body simply administers the COP, it plays a significant role in determining the agenda of each meeting.
The above descriptions are based on a COP10 briefing paper published by The Global State of Tobacco Harm Reduction, which is available in multiple languages. The full text of the FCTC is here.
Taco Tuinstra is Tobacco Reporter’s editorial director.Based in Raleigh, North Carolina, USA, he coordinates the work of staff writers and contributors.On his watch, Tobacco Reporter has won several awards for editorial excellence.Since joining the magazine in 1997, Taco has visited more than 75 countries to meet industry representatives in their markets and to report tobacco news firsthand.

September 6, 2023
A Leap Forward for Public Health?

Image: waldemarus
China’s new rules on vape manufacturing will help tackle illicit trade only if they are properly enforced.
By Ian M. Fearon
The vape industry is in the midst of a growing crisis and facing an existential threat. This may seem like a pessimistic, and perhaps provocative, statement, but without those within the industry taking action to change course, the lives of the billion smokers across the globe could be placed at an increased risk.
The vape industry has always been controversial, although wrongly so. After all, nobody in their right mind doubts that when cigarettes are substituted with e-cigarettes, there are huge gains for both individual and population health. Despite this, those in “tobacco control” have become, and will remain, steadfastly resolute in their desire to remove vapes from markets across the world. While their motives are not abundantly clear, they certainly don’t appear to mesh with a desire to improve global health and may instead represent a nicotine prohibitionist standpoint. But their work is adding to the growing likelihood that vapes could be banished across the world. Or, as is currently the case in Australia, confined to prescriptions issued by physicians and not as freely available as, well, cigarettes.
Perhaps the biggest single threat to the vape industry is the mass marketing of both illegal and illicit products across the world. Wherever you look, in the United States and Canada, across Europe, in Australia and New Zealand, and pretty much any other global market in which vapes are sold, illegal products are abundant. They are causing problems by being made available to youth with scant regard for the impact this may have on public health and on the future of a lifesaving industry. In the U.K., recent assessments of vapor from illegal and illicit vapes have found them to contain high levels of poisonous metals, such as lead, or contain levels of nicotine higher than those allowed under U.K. regulatory law. And a recent investigation found evidence of the production of counterfeit products with inadequate manufacturing quality control and unhygienic product testing processes. The illicit trade is hugely damaging to the legitimate industry and makes the work of vape prohibitionists in tobacco control so much easier.
One way of stemming the flow of potentially dangerous illicit products is to act at the source. China is acknowledged as the birthplace of the modern e-cigarette, following the pioneering work of the Chinese pharmacist, Hon Lik, in the early 2000s. Chinese companies are also by far the world’s biggest e-cigarette manufacturers, with production coming mainly from the estimated 1,000 factories located in China’s Silicon Valley, Shenzhen. Recent figures show that Chinese e-cigarette manufacturing is growing at record levels, with $5.5 billion worth of vapes manufactured in the country in the first half of this year, up by almost 30 percent compared with the first half of 2022. Between $300 million and $400 million worth of these are imported each month into the U.S. and the U.K., the largest export destinations for Chinese e-cigarettes. Remarkably, $20 million worth are exported each month to Australia, a marketplace in which e-cigarettes are legal only on prescription. In that country, the end result will undoubtedly be greater restrictions on vaping, perhaps even for authorized prescription products, and many other countries are considering similar actions.
Regulating the expanse and diversity of Chinese vape manufacturing is not an easy task, but doing so would have a profound impact globally as it could make a huge dent in the supply of illicit vapes across the world. Recently, the Chinese State Tobacco Monopoly Administration (STMA) issued guidelines that may promise to clean up Chinese vape manufacturing. These guidelines are lengthy and complex but focus on a single area: the establishment of quality management systems in vape manufacturing facilities. To comply, manufacturers must, at least, implement quality and safety standards, assess and control their e-cigarette production, properly train their personnel, ensure manufacturing and distribution traceability, and complete export registrations and declarations. Products must not only be manufactured under stringent conditions, but they are also required to meet any relevant legal requirements in their export destination. And importantly, manufacturers must halt production if any safety issues arise or are brought to their attention in order to prevent and reduce harm. According to the guidelines, governments and other international organizations can report issues to Chinese authorities and have their concerns addressed.
The biggest question on everyone’s lips has to be this one: Will the STMA guidelines be enforced—and how? If we look at the status quo, regulations elsewhere are being ignored by many manufacturers and distributors of illicit vaping products, putting profit first and public health second. In the U.S., the Food and Drug Administration issues a constant stream of warning letters threatening enforcement action. But much like the fairground game whack-a-mole, as soon as one company or vape source has action taken against it, another one takes its place. The FDA’s finite resources cannot tackle this constant evolution. In the U.K., despite the scale of the vape black market, a recent assessment of enforcement actions showed that even when action is taken against distributors of illicit and potentially dangerous vapes, local Trading Standards teams have issued fines lower in aggregate than the maximum allowed by law of £2,500 ($3,181). The situation is analogous to the illicit cigarette trade of years past in which the potential financial gains far outweighed the likely punishment.
The question then becomes: Will the new STMA guidelines change the supply and distribution of illicit vapes, or, as has been the case in other jurisdictions, will the guidelines be weakly enforced? This concern, that the new guidelines will be meaningless and unenforced, is shared by the U.S. Smoke-Free Alternatives Trade Association (SFATA). When asked for their views on the new guidelines, SFATA President and CEO April Meyers suggested that while the new guidelines could theoretically increase the quality of vapor products coming out of China, she was unwilling to place any bets on such an outcome. Citing the scope and complexity of the political landscape in China, Meyers doubts that protecting the youth of other nations is at the top of regulators’ minds in Beijing, especially when there is so much money involved. Such a view is understandable given that the guidelines are suggesting that the Chinese government can fix enforcement issues elsewhere in the world.
Without doubt, the new Chinese guidelines are a positive step. The guidelines recognize the public health issues regarding the manufacturing and distribution of illicit vapes and offer a potential mechanism through which this damaging illegal trade can be eroded. But without strict enforcement, and instead relying on manufacturers to interpret the guidelines, implement appropriate quality control procedures, and to self-police, the guidelines may do little to alter the current status quo.
It’s a major irony that those companies already committed both to lawful distribution of vapor products and to the improvement of public health are facing action from regulators in the form of flavor bans and other restrictions while the illicit trade carries on regardless. The industry needs guidelines and product standards, but what it needs more than that is stricter enforcement. And stricter enforcement should include better approaches to identify and prevent illicit products from crossing borders, not just identifying them at the point of manufacture. This applies not just in China but everywhere in the world where vapor products can be sold. The existence of lifesaving consumer vapor products is at stake and, perhaps more importantly, so is public health. With the new Chinese guidelines, we are moving in the right direction. But without proper enforcement, we may carry on, in public health terms, walking backward.
Ian M. Fearon is chief scientific officer at McKinney Regulatory Science Advisors.

September 1, 2023