Category: Print Edition

The Next Level

Photos: Hauni
Hauni has entered the hemp cigarette market with three machines for cylindrical pre-roll manufacture.
By Stefanie Rossel
In the past years, cannabis has rapidly transited out of its dirty corner, turning into one of the world’s fastest growing industries. Business intelligence companies outbid each other with forecasts for the category. According to a 2019 report by Arcview Market Research and BDS Analytics, for example, global licensed store sales are expected to reach $40.6 billion by 2024, and that estimate does not even take into account general retailers selling cannabidiol (CBD) products and cannabinoid-based drug developers selling marijuana-derived pharmaceuticals.
The U.S. is projected to remain the world’s largest market with a forecast $30.1 billion in marijuana spending by 2024, the report says. Canada, which legalized recreational cannabis in October 2018, is expected to experience similar growth rates. Despite slower growth, the total cannabis market, including medical use, is forecast to generate up to $7 billion in sales in 2020 with $2 billion to $4 billion in the legal recreational market, according to cannabisbusinessplans.com.
While recreational cannabis remains prohibited at the U.S. federal level, 11 states have legalized the substance since 2012. Medicinal use is legal in 33 states. According to New Frontier Data, 223 million Americans, or 68 percent of the population, now live in a state that has expanded access to CBD, medical cannabis or full adult use. The organization lists related investments of $13.8 billion and $11 billion in 2018 and 2019, respectively.
The 2018 Farm Bill has turbocharged the boom: Among other things, it removed hemp’s low amounts of THC from the Controlled Substances Act. Furthermore, the bill allows hemp production in all 50 states for any use, including flower production and CBD or other cannabinoid extraction, as well as interstate commerce. The U.S. defines hemp as cannabis that contains 0.3 percent or less tetrahydrocannabinol (THC), the psychoactive substance in cannabis that produces the “high” people experience when they smoke marijuana or eat foods containing it. Legally, “marijuana” refers to cannabis that has more than 0.3 percent THC by dry weight. For an intoxicating effect, a THC content of 5 percent to 10 percent is required. The nonpsychoactive component in cannabis, CBD, is believed to provide health and wellness benefits.
While Research and Markets expects the overall U.S. market for cannabis derivatives to increase at a compound annual growth rate of 23 percent by 2027, Nielsen has singled out smokable hemp as one of the fastest growing and most lucrative segments in the CBD and hemp industry. For 2020, the firm projects U.S. sales of smokable hemp to reach up to $80 million. By 2025, it is expected to stand at $300 million to $400 million, representing about 5 percent of the hemp-derived CBD consumer products category in the U.S., which Nielsen expects to increase from $1.7 billion to $2 billion in 2020 to $6 billion to $7 billion in the next five years.

Opportunity for technological progress
The considerable potential of the legal smokable hemp category suggests opportunity for suppliers of machinery designed for tobacco products. Almost two years ago, a U.S. provider of tobacco processing equipment already ventured into this field with dedicated cannabis drying and processing machinery. Now German tobacco machinery manufacturer Hauni Maschinenbau is entering the market. At the open house event of its Hauni Richmond subsidiary in October, the company launched three machines for cylindrical pre-roll making as well as a range of accompanying equipment.
Thomas Gruss
To efficiently increase production levels in the smokable hemp industry, technological advances are the next logical step, according to Thomas Gruss, head of business development for hemp/cannabis projects at Hauni. “Typically, the hemp cigarette industry consists of small-scale manufacturers that produce pre-rolls manually or semi-automatically,” he says. “To produce THC-containing pre-rolls made from processed cannabis flowers, the cones or tubes are stacked vertically into a tray. A so-called ‘knock box’ containing the ground cannabis flowers is put on top. By shaking the knock box, the blossom material is fed into the cones or tubes. Even some larger companies mainly work with knock boxes, which involves a lot of manual labor and is rather inefficient, resulting in an output of approximately 2,000 pre-rolls per day per operator.
“There are other manufacturers that use machinery, but this allows only for a typical manufacturing speed of 30 to 40 pre-rolls a minute,” Gruss continues. “A third group manufactures ‘king-size’ hemp cigarettes that are made from biomass and resemble regular tobacco cigarettes. Those companies produce on old cigarette-making equipment. Overall, there is a clear trend within the industry toward machine-made production, and it is toward cylindrical tubes as hemp cigarettes become more of a mainstream product. With our machine models, we want to address all three manufacturer groups.”
For tobacco cigarette manufacturing, the Hauni group of companies offers a range with a variety of production speeds. However, a one-to-one transfer of its tobacco manufacturing technology to the new category proved impossible. Cannabis is a more complex raw material than tobacco. The latter is consumed primarily for its main active substance, nicotine. The lion’s share of the world’s tobacco harvest ends up in combustible cigarettes, the dominant nicotine-delivery device. Farmers cure tobacco leaves—as opposed to blossoms—and manufacturers thresh it into a relatively dry, string-line mass that is comparatively easy to process.
By contrast, cannabis contains more than 100 different chemicals, called cannabinoids, each of which has a different effect on the body. The various plant parts fetch greatly differing prices on the market. The dried blossoms, which contain THC in the shape of small resinous beads, are the most valuable, selling for about $2,000 per pound. This means they cannot be damaged during the pre-roll manufacturing process. Processing the blossoms is also challenging because they are sticky, thus requiring frequent machinery cleanings. The finished joints sell for $12 to $20 per piece; unlike tobacco cigarettes, THC-containing pre-rolls are sold in batches of seven units at most.
To produce more affordable CBD-containing hemp cigarettes, which usually retail at $13 for a pack of 20, manufacturers use cannabis biomass, which consists of leaves, stems and blossom parts. This shredded hemp makes a crumbly filling, requiring the tube or cone to be twisted or closed at the end.
In addition to the mechanical challenges of manufacturing cannabis products, most players lack the financial resources of their tobacco counterparts. “The cannabis market is quite sensitive when it comes to large investments,” says Gruss. “Players in the U.S. are not willing to invest millions of dollars in a higher speed maker as tobacco companies would, as most of them have to finance their equipment from their own resources. Besides, the market is still small compared to the cigarette market. Our objective, hence, was to offer machinery that costs well below the million-dollar figure benchmark.”

For varying requirements
To cater to the cannabis sector’s varying needs, Hauni has developed three different solutions. The company’s tube-filling TFM is an entry-level model with an output of 85 pre-rolls per minute. The machine automatically fills cylindrical, standard pre-manufactured hemp filter tubes and closes their ends with a folding motion rather than a twisting motion.
Hemp or biomass is fed horizontally into the open tube, thereby avoiding any human contact with the raw material. The maker creates a homogeneous filling, which is compressed to make the material less likely to trickle out of the finished cigarette. Its careful handling of the filling material also makes the TFM suitable for larger companies manufacturing pre-rolls containing expensive flowers, according to Gruss. The machine layout has been kept simple, avoiding the need for a skilled operator. The TFM runs on household power, is easy to handle and to clean and allows for easy weight change.
Cantos is a semi-automatic maker that can process hemp biomass as well as pure flower material. The machine is based on the company’s tobacco cigarette rod maker technology and coupled with a flexible filter assembler. The maker allows for cylindrical rod formation with or without a filter, running at speeds of up to 150 pre-rolls a minute. The plug-and-play machine enables flexible format settings with only a small amount of format parts required for diameter changes and no parts required for length changes. It can handle small batch sizes, has an online weight control system and allows for the attachment of different filter types.
“For the TFM and Cantos, the stipulation was to design machines that require as little external infrastructure as possible,” says Gruss. “Unlike in the tobacco industry, there are few trained operators in the cannabis sector. The larger a machine, the more complicated and time-consuming the operating and cleaning process. We developed the Cantos in such a way that it is mostly cleaning resistant. The parts that need to be cleaned can be reached easily.”
Nano-H is the company’s premium model—a fully automatic maker for industrial production that can manufacture up to 5,000 pre-rolls a minute and has been optimized for shredded hemp blends and processed paper. Heavy particles such as stems and seeds are separated, and a microwave system with closed-loop weight control allows for highly accurate rod formation for a homogeneous hemp rod with minimized waste. Manufacture is batch compliant. Hauni provides full operator training and technical support.

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Full-service
To handle the sticky raw material, Hauni deployed technology it had developed for other tricky products, such as kreteks. The cannabis machines are also capable of processing thin papers because cannabis consumers tend to prefer papers with gauges between 16 grams per square meter and 18 grams per square meter, which is thinner than papers typically used for commercial tobacco cigarettes. The construction of the filter in hemp cigarettes is equally important. Like the other components, it is supposed to be “natural” with low draw resistance and minimal taste adulteration. For many cannabis consumers, the primary purpose of a filter is not smoke filtration but to prevent particles from falling out of their cigarette.
In response to such preferences, Hauni has developed a “crutch-type” filter maker that manufactures biodegradable filters typically made from natural fleece or paper bobbins
To further support customers in their development of pre-roll products, Hauni also offers a hemp flavor collection and is testing a reconstituted hemp paper at its new pilot recon plant in Hamburg, Germany. “There is a lot of interest in the market to manufacture tobacco-heated products that contain hemp. Once the raw material has been processed into a reconstituted sheet, it can be used much more conveniently in a blend,” notes Gruss.
For the time being, cannabis cigarette products remain largely unregulated. Gruss expects this to change soon. “Tar and carbon monoxide limits will become relevant as well as hemp-specific alkaloids,” he says. Anticipating such developments, Hauni has adapted its quality control, emission testing and smoke analysis equipment for cannabis smoking products. Completing its offerings, the company has added a hemp recovery unit. Increased automation, he insists, will contribute to both the quality of hemp cigarettes and the growth of the sector.

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.

December 1, 2020
Changing the Narrative

George Cassels-Smith
(Photo: TTI)
George Cassels-Smith hopes ELiquiTech’s new synthetic nicotine will help change the debate between the nicotine industry and regulators.
By George Gay
After reading a recent story by Timothy Donahue about SyNic, a synthesized form of nicotine that is said to be as pure as ultrapure, tobacco-derived nicotine, I had the opportunity of asking George Cassels-Smith, the CEO of eLiquiTech, the company with sole distribution rights for SyNic to the tobacco and electronic nicotine-delivery system industries, what the point of this new product was. Of course, I didn’t put it as bluntly as that, but I was interested in understanding why it was deemed necessary to launch a purer version of nicotine when tobacco-derived nicotine was available that already met the presumably exacting standards of the regulators overseeing the pharmaceutical industry and its various nicotine-replacement therapy products.
His answer could be summed up as “Why not?” Of course, he didn’t put it as bluntly as that. After all, it had taken five years to develop SyNic in a program requiring the input of people with 40 years’ experience in synthesizing drugs and 30-plus patents to their names, working with sophisticated equipment under highly controlled conditions.
Nevertheless, “Why not?” is a persuasively simple response, and it comes in a range of expanded forms. At one end of the range, it has to do with the nicotine consumer. Cassels-Smith said that, today, just about everybody has lived in environments in which we were exposed to toxic pollution over which we had little or no control; so the smart thing to do was to reduce our exposure to toxins wherever we did have such control. For instance, if you were going to consume nicotine, why not consume the purest form available?
Meanwhile, at the other end of the range, you become caught up in something more complex: in the politics of tobacco—which, by the way, Cassels-Smith dislikes intensely but in which, inevitably, he finds himself entangled. He believes—perhaps “hopes” is a more accurate description—that SyNic might form part of a campaign to change the debate between the tobacco and nicotine industries on the one hand and regulators on the other. At the moment, regulators see tobacco and nicotine users only from the point of view of the harm they cause to themselves and the people around them, which leads those regulators to have as their ultimate goal the elimination of tobacco and nicotine consumption.
But as Cassels-Smith says, if that is the position taken by regulators, there has to be room for a debate about the use of tobacco and nicotine products that don’t expose people to toxins and harm. All the concerns that regulators had could be removed by providing scientific proof that the user was not harming himself and that there was no secondhand exposure, said Cassels-Smith. An example might be where a consumer used a nicotine pouch manufactured with SyNic nicotine.

A product with potential—on multiple levels
Skewed playing field
This sounds persuasive, but one obstacle to such a debate’s getting started is the lack of a level regulatory playing field when it comes to the different products offered by the pharmaceutical and tobacco industries as a means of meeting the needs of those with nicotine cravings. Cassels-Smith said that, over the years, the advice for the use of pharmaceutical-industry-produced nicotine gum had gone from specifying occasional use and then quitting to, if necessary, chewing it all the time, anytime; and there was no reason why this latest advice for nicotine gum should not apply to nicotine pouches. “I believe in a clean nicotine-delivery future,” he said during a telephone conversation in October. “All the stimulation without any baggage.”
At this point I asked whether Cassels-Smith was talking about a very limited range of tobacco- and nicotine-industry products, but he assured me that the ability of SyNic to deliver cleaner products was not as limited as might first be thought. He sees the opportunity and possibility, given the right regulatory framework, for the development of, for instance, many products based on the heat-not-burn principle whereby thermal processes applied to tobacco using temperatures below that needed for combustion was able to deliver the same taste and nicotine satisfaction as a traditional cigarette but without the tar. And he spoke enthusiastically of vapor devices based on SyNic that also were thermally regulated.
Cassels-Smith conceded, however, that SyNic’s impact on traditional cigarettes would be limited only to providing for a delivery that was a little cleaner with higher levels of nicotine, which was what people smoked for, limiting the intake of other compounds. But in almost every other type of tobacco and nicotine product, it could be used almost exclusively to create a much more compelling argument with regulators—an argument that said the consumers of this product were healthy people who were not being made unhealthy by consistently using this product.
Political minefield
The trouble is, as things stand, there is no level playing field, something that was being reflected in the reaction to SyNic, which, when I spoke with Cassels-Smith, was due for launch within a couple of weeks. Whereas the pharmaceutical industry was looking at the new product secure in the knowledge that it could substitute SyNic for whatever nicotine it was then using without having to resubmit its consumer products for fresh regulatory approval (the synthesized nicotine molecule is identical to the tobacco-derived nicotine molecule), the mood within the tobacco and nicotine industries was different. Although, in theory, tobacco and nicotine companies could also make a straight substitution of the nicotine used in products with premarket tobacco authorization or premarket tobacco product applications (PMTAs) before the U.S. Food and Drug Administration, they were wary of doing so in case they were seen to be making medical claims for those products, which would put them on the wrong side of the regulations and might lead to the FDA categorizing those products as drugs.
And this concern about the interpretation that might be put on the inclusion of SyNic in tobacco and nicotine products was at the base of one of the major issues that was clearly of concern to Cassels-Smith. Given that SyNic is a nicotine that offers the very highest level of purity, it would seem that the ethical thing to do would be to make it as widely available as quickly as possible so that the maximum good was delivered to the maximum number of people. But this is not going to happen—at least not immediately. SyNic will not be made available in the U.S. to consumers or to companies without premarket tobacco authorization or PMTAs under review by the FDA; and outside the U.S., it will be made available only to companies working within the regulations of the countries in which they sell their products.
Why is this? Alas, we are back in Cassels-Smith’s least favorite world—the world of politics. He readily acknowledges the important work that a lot of independent, medium-sized and smaller-sized companies have put into creating products that effectively wean people from cigarette use, and he anguishes over the fact that because many of these companies do not have the resources to submit PMTAs, in effect, they are now being “thrown under the bus.” “Somewhere in the sensibilities of this American, that is anti-capitalist and anti-health,” he said. “I would vastly prefer a published set of standards to guide the industry.”
But Cassels-Smith finds himself in one of those “we are where we are” situations. If he allowed sales of SyNic to individuals and companies without premarket tobacco authorization or PMTAs under review, the FDA, given its definition of a “tobacco” product, might take the view that eLiquiTech was using a nontobacco-derived nicotine to try to circumvent the agency’s authority. At the same time, in the U.S., a state could quickly ban SyNic if the authorities there decided, for whatever reason, that this product might undermine their ultimate goal of creating a smoke-free, nicotine-free world. Add to that the fact that selling SyNic to companies without premarket tobacco authorization or PMTAs under review might not go down well with those companies that have gone through the costly process of creating a PMTA, and it is easy to see how Cassels-Smith finds himself having to tiptoe through a political minefield.
“In my heart of hearts, I want to sell it to everybody because a high tide raises all ships,” said Cassels-Smith. “But my problem is that it is too political an issue right now in the U.S. And rather than having the whole technology killed, I want to sell it to responsible manufacturers, get it widely accepted and then maybe there will be a chance for everybody else. But the product needs to survive to allow nicotine users to take it to the next dimension.”

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Changing the narrative
As we came to the end of our conversation, Cassels-Smith said he wanted people to know that he wasn’t against natural nicotine, which he had described earlier as having an impurity profile that was “still quite safe.” But he added that he was very much in support of a new alternative that could change the narrative with regulators worldwide.
I would guess, however, that making such a change is not going to be easy, in part because of something Cassels-Smith alluded to above: the fact that the tobacco/nicotine debate largely concerns the regulators and the pharmaceutical industry while all but excluding the tobacco and nicotine industries.
While reading up on nicotine before my conversation with Cassels-Smith, I was taken with the following sentence in a scientific paper: “This review aims to summarize literature on various modes of nicotine-replacement therapy methods currently used to treat nicotine dependence and to give an overview about future possible approaches to treat tobacco use disorder.” This is another example of the medicalization of tobacco and nicotine use, which often has it that tobacco and nicotine users are “patients” who have to be treated by doctors prescribing pharmaceutical products—often nicotine-based products.
There is some truth in the idea that a consumer is a patient if she goes to a doctor seeking help to quit her habit, but I’m sure that those who don’t would not consider themselves to be suffering from a “tobacco use disorder,” whatever that might be. Take Cassels-Smith, for instance. He is an ex-smoker who now uses nicotine pouches, which he has in his mouth almost constantly; and this is what he told me about his habit: “Do I think I’m doing myself harm?” he asked. “No, because I’m taking the cleanest forms of nicotine that I can. Do I think it [tobacco/nicotine] is much maligned? Absolutely. Do I try and speak out as much as possible? Absolutely. But sometimes I believe I am talking to people who don’t want to find a solution; they just want to call it a problem and get rid of it.”
Despite all this, Cassels-Smith ended on a positive note, saying that SyNic was a tool that could change the narrative. And partly, his positive outlook might be down to the fact that these are early days. One important nontobacco application for SyNic might turn out to be its use in nicotine patches. These patches could be used long-term by people trying to ameliorate the symptoms of Alzheimer’s disease, but long-term use can cause skin irritation among the older people who typically suffer from this disease. SyNic is said to be smoother on the skin and therefore allows for the necessary long-term use. As Cassels-Smith said, there are many different ways in which SyNic could be used, and there are “other unique things that I cannot mention right now because they are still in the process of being patented.”
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.

December 1, 2020
Going Natural

Photos: Zig-Zag
As consumer interest in untreated products increases, Zig-Zag has expanded its unbleached and hemp papers segment.
By Stefanie Rossel
Although a niche of the tobacco market, hand-rolled cigarettes have always had their fan base. Compared to factory-made cigarettes, they represent a less expensive way of smoking, especially in tax-heavy environments. As the Covid-19 pandemic continues to depress the disposable incomes of many people, the popularity of roll-your-own and make-your-own tobacco products is likely to increase. Affordability aside, hand-rolled cigarettes have another advantage: They allow their users to create a custom-made smoke. The right paper is key to the smoking experience.
In recent years, unbleached and “natural” papers have become more popular. “Over the long history of rolling papers, there have been numerous evolutions of preference for consumers,” explains Curtis Berry, brand director of Zig-Zag, a leading brand of rolling papers that originated in France 140 years ago. “At one point in this evolution, smokers wanted a consistent and cleaner looking paper, hence our whitening process that eliminates imperfections and provides a consistent look and performance, which is still preferred by many today.
“Recently, there has been a growing consumer interest in products with natural attributes, including rolling papers, so we introduced the Zig-Zag Organic Hemp and Zig-Zag Unbleached products to satisfy that need. In addition, there is also interest in the pre-rolled cone form factor, which provides convenience with a perfect smoke every time. With the addition of our new products, we feel we are providing the widest range of premium papers that meet the diverse preferences within the marketplace.”
The company’s first unbleached paper was the Organic Hemp Paper, which it introduced in the U.S. at the start of 2018. Zig-Zag unbleached paper, made from a different blend of fibers, was created and first released in Canada in late 2018 followed by the U.S. launch in early 2019. The products are available in an extra thin and ultra thin quality as thinner papers tamper less with the flavor profile of tobacco.
“Out of the gate, we’ve had very positive feedback,” says Berry. “Consumers love the natural hue, ease of rolling and smoking characteristics. We feel like we really created a great product that adds to our well-rounded portfolio of Zig-Zag paper. From that feedback, we decided to add an unbleached version of our Classic Ultra-Thin Cones.”

Zig-Zag’s unbleached offerings cater to growing consumer interest in products with natural attributes.
What’s left out
The manufacturing process of unbleached rolling paper is basically the same as that for regular rolling paper and has a centuries-long artisan tradition. “Paper is essentially a mixture of fibers from various sources,” says Berry. “The creation of every Zig-Zag rolling paper begins with the sourcing and selection of the finest 100 percent natural plant fibers. The manufacturing process has two key phases, pulping and sheeting.”
In the pulping phase, the raw vegetal matter is broken down into small fibers. These ground fibers are further refined using a high temperature and pressure-washing process. For its classic white papers, Zig-Zag uses a proprietary “whitening” process, which is skipped for the production of unbleached papers thus allowing the finished paper to reflect the natural hue of the fibers. “Some uninformed people have claimed that ‘unbleached’ means that white papers are made with household bleach or something like it,” Berry points out. “That is simply ridiculous. The bleaching step for white papers utilizes an oxygenation process, with no residue of any kind on the paper. There is no ‘bleach’ or chlorine used in the whitening process. ‘Unbleached’ merely refers to the absence of the oxygenation process in making the paper, which means the paper has that natural hue of the fibers versus a classic white look.”
The washed fibers are then suspended in a solution of pure water. This solution only contains a few ounces of fibers per gallon and is around 99.5 percent water. This fibrous solution is sprayed onto a large canvas “forming table” where the fibers naturally interweave, and water is drained away. The material goes through a series of presses and heated cylinders to compress and finish drying the sheet. These sheets are then rolled up and cut into reels of paper to be ready for a complex watermarking operation, natural gum application and packaged in interleaved booklets originally invented by the founders of Zig-Zag as Berry points out. All Zig-Zag papers are vegan, genetically unmodified, bleach-free, dye-free and cruelty-free.
Since all papers the company manufactures are made in the same process, little conversion was required to produce unbleached and hemp papers. “The investment came in developing the right blend of fibers and then skipping the ‘whitening’ process of the pulping stage to allow the natural characteristics of the fibers to be present in the final paper.”
Here to stay
While a large variety of materials, including more unusual inputs such as rice or esparto (a harsh needle grass), can be used to manufacture rolling papers, Zig-Zag uses only four types of fibers within its blend: hemp, flax, soft wood and hard wood. “Each of our papers uses a unique blend of fibers from various plants that are sustainably harvested,” says Berry. “The fiber blend of a paper will change how the final dried sheet comes out. Different combinations of long and short fibers from these various plants will change the paper’s strength, feel, thickness, porosity and burn rate. Unbleached paper has its own unique blend of these fibers.” Consumer preferences are varied, he adds. “Some consumers prefer the classic white look. Others prefer a natural hue. Still others prefer all hemp fibers over any other blend. Either way, we have them covered.”
Berry says he sees nothing but upside for the unbleached paper and cone segment: “We are excited to continue to explore other opportunities within this category. We believe the unbleached category is here to stay and will continue to grow.”
The company has witnessed increasing demand for its accessories. “We’ve had rollers for many years, and our trays were launched around the same time as our organic hemp papers. Just like with our paper portfolio, we want to be able to cater to the wide range of smokers, and we know this involves providing the right tools and accessories that assist in the different rolling rituals each one of us has.”

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.

December 1, 2020
Thoughtful Reflection

The first virtual GTNF was a resounding success. More than 1,650 delegates from at least 51 countries logged in to participate in the conference. Over the course of four days, and in three times zones, regulators, public health officials and industry representatives shared their views on “Sustainable change through innovation and regulation.” Following is a sampling of the keynotes and panel discussions.

Kingsley Wheaton: “A whole of society approach to policymaking”
British American Tobacco’s (BAT) Chief Marketing Officer Kingsley Wheaton called for meaningful change in the way that global tobacco and nicotine policies are developed. He stressed the need for a United Nations-style “whole of society” approach to policy development and emphasized the benefits that this more inclusive tobacco harm reduction approach could deliver. BAT’s purpose, he said, is to build “a better tomorrow” by reducing the health impacts of its business.
Earlier this year, the company announced a bold aim: to have 50 million consumers of noncombustible products by 2030. To this end, BAT has invested substantially in “a range of vibrant new noncombustible categories for adult consumers,” according to Wheaton. Its portfolio of potentially reduced-risk products now comprises vapor, tobacco-heating and modern oral offerings.
Innovation is focused not only on products but also on how BAT engages with consumers. Wheaton said the company has rapidly adopted new technologies and digital capabilities in consumer markets. In the U.S., for example, BAT recently launched a vapor subscription service. After just three months, subscribers accounted for half of the company’s U.S. e-commerce revenue.
BAT’s new products have clearly resonated with consumers. In 2019, noncombustibles reached 10 percent of group revenues, with the growth in volume and value shares continuing to accelerate in all three categories. Just five years after launching Vype in the U.K., nearly a third of BAT’s revenue in that market is now from vapor products. In Japan, Glo now accounts for nearly half of the group’s business.
However, said Wheaton, growth would have been even more dramatic had more policymakers around the world supported the company’s new category development with proportionate, risk-based regulation. “Many significant markets remain in ‘regulatory lock,’” he said.
The central question, according to Wheaton, is how to accelerate acceptance of tobacco harm reduction as a genuine public health policy—just as it is recognized within the WHO Framework Convention on Tobacco Control (FCTC) and by the U.S. Food and Drug Administration (FDA). “This is not a debate of us versus them but rather about evidence, education and the science underpinning tobacco harm reduction,” he said.
Wheaton insisted the industry should be part of the debate. Worldwide, 1.1 billion people consume tobacco and nicotine products. “To exclude manufacturers from that conversation is like cutting off one’s nose to spite one’s face,” he said.
Yet the WHO continues to believe that the tobacco industry cannot be a partner in effective tobacco control, advocating for tobacco companies to be excluded from any dialogue with government. Wheaton called this a paradox. “How can this approach and Article 5.3 of the FCTC realistically be implemented when the largest cigarette manufacturer on earth is wholly owned by a WHO member state?” he said, referring to the treaty’s provision against tobacco industry influence on policymaking and the fact that the China National Tobacco Corp. is a state monopoly.
“We need a system that acknowledges the expertise and the ambition of companies like BAT to deliver a better tomorrow—one that is clear about harm caused by smoking yet recognizes more holistically and consistently where the real public health gains can be made, by actively supporting consumer choice and the role of tobacco harm reduction,” said Wheaton.
Despite the challenges, Wheaton was confident that role of combustible products in BAT’s business would continue to decline. “People will gradually forget what the ‘t’ in BAT stands for,” he predicted. The company’s goal is to meet the consumer needs that combustible cigarettes historically satisfied—socialization, connectivity, concentration and relaxation. “Those needs can be met by alternative nicotine solutions in many ways, so we’ll see a burgeoning of innovation and categories as we grasp how to meet those underlying consumer needs that smoking has historically met.”

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Panel: The future of nicotine
There are several reasons why people use nicotine. According to Neal Benowitz, professor of medicine, biopharmaceutical sciences, psychiatry and clinical pharmacy at the University of California San Francisco, those reasons include pleasure, stimulation and mood modulation. However, many users don’t understand the adverse effects and risks associated with different delivery mechanisms.
“Clearly, the decision involving long-term use of the drug for individuals or society depends, at least in part, on adverse health effects. For example, the casual use of cocaine or heroin are discouraged by society because they are hazardous to health,” explains Benowitz. “We know nicotine, per se, is much less hazardous than cigarette smoking, regardless of potential health concerns. That’s a successful argument for electronic nicotine-delivery systems [ENDS].”
Benowitz said that one of the major questions surrounding tobacco control is whether society can accept nicotine use if the harms were reduced. He says that possibility exists. “The FDA can be a big part of making this happen … there is a misconception surrounding the harm of nicotine compared to combustible products,” which are more deadly than ENDS.
While acknowledging the validity of Benowitz’ point, Michael Cummings, professor of psychiatry and behavioral sciences at the Medical University of South Carolina, cautioned against the unintended consequences of regulation. Banning a specific delivery mechanism for nicotine, he said, presents a risk. Cummings referred to the FDA’s vision, formulated in 2017, of a world where cigarettes would no longer create and sustain addiction and where adults who need or want nicotine could get it from less harmful alternative sources.
“But it seems like we’re going the wrong direction … If we adopt regulations to ban the sale of vaping products as some states and many countries around the world have done, what would be the effect? Well, the effect is that cigarette sales will go up,” said Cummings. “That’s a bad thing. Regulating vaping products like they’re cigarettes—which they’re not—banning flavors, banning internet sales … [these actions] would have a detrimental effect of actually driving up cigarette sales to the detriment of the lower risk products.”
Also speaking during the GTNF panel, Clifford E. Douglas, director of the Tobacco Research Network and an adjunct professor of health management and policy at the University of Michigan School of Public Health, said that consumers clearly need a much better understanding of the true nature, including the relative risk, of different tobacco and nicotine products.
“This includes the fact that nicotine is the root cause of the epidemic of tobacco-related illness and death because it hooks in smokers and keeps many smoking who otherwise would quit,” he explained. “While complete information on all the potential risks and benefits of [vapor products] is not yet available, there is sufficient information … to end deadly combustible tobacco use, [which is] responsible for approximately half a million deaths a year and 30 percent of all cancer deaths in the United States.”
Asked by moderator Clive Bates, director of Counterfactual Consulting, whether there was a regulatory environment possible that incorporated the relative risk of the different types of nicotine-delivery systems, Stefanie Miller, managing director of FiscalNote Markets, said, “no.”
“[There is] no trust among the general public for companies that produce a product containing nicotine, and that is largely based on a misconception around the difference between nicotine and combustible tobacco use,” she said. “After predatory behavior and negligence of tobacco companies in the 20th century, most people see this as very black and white. Tobacco companies are bad, and anti-tobacco efforts are purely good,” said Miller. “I think [everyone] who’s tuned in right now knows that the situation is far more nuanced and … the regulations are not accommodative of that nuance.”
Benowitz says that another major problem with the message on less-risky nicotine products is that there is very little science on the long-term effects of ENDS products. “We have an array of new products, any of which are inhalable,” he said. “We have a lot of short-term data that is promising in terms of reduced exposure in the short term, but we really don’t know about the future long-term consequences.”
Miller added that cigarette manufacturers could help change the misconceptions surrounding nicotine. It’s the large manufacturers who could make it a goal to end combustible nicotine-delivery systems. “If you’re really clear about setting a strategic goal, and then you do everything possible to accomplish it, you’re more likely than not to win,” she said. “I think that this is [an] important enough [goal] to try.”
Benowitz said that regulators need to help consumers better understand that the regulators support a shift to less-risky products. He says that only then can the goal of getting rid of combustible products be accomplished.
“We’re not doing this because nicotine is bad,” he said. “We’re doing this because nicotine sustains harmful cigarette smoking … there are other products that [can deliver] nicotine that are much less harmful.”

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Suzanne Wise: Achieving sustainable growth
Suzanne Wise, senior vice president of corporate affairs and communications at Japan Tobacco International (JTI), considered the question of how to achieve sustainable growth.
Understanding consumers is the key to success, she said—but the way people consume is changing rapidly and accelerated by the Covid-19 crisis. To meet the challenge, JTI has been moving from a highly centralized model to a more decentralized one. This allows the company not only to increase speed to market but also helps it put the consumer at the center of its transformation.
She cited the example of Germany, where JTI sells Winston-branded tobacco in buckets for make-your-own (MYO) consumers. Mindful of consumers’ increasing sensitivity about plastic waste, JTI reengineered its packaging. The Winston bucket now uses 16 percent less plastic than before without comprising on convenience or consumer appeal.
While 16 percent may not sound impressive, it translates into 78 tons of plastic that has been taken out of the packaging of one product line in one country every year, according to Wise. “It’s a big deal,” she said.
Wise noted that JTI’s ability to achieve meaningful and sustainable growth relies on three pillars: its ability to innovate, a sensible regulatory environment and consumer acceptance of new products. Data and behavioral insights confirm that while some consumers are interested in reduced-risk products (RRPs), the majority still want to buy traditional tobacco products. Despite the rapid growth of next-generations products, cigarettes still accounted for 86 percent of total global tobacco sales by value in 2019. “That means we must innovate for both RRPs and combustibles,” said Wise.
In 2019, JTI ranked among the Top 100 companies for European patent applications filed. While many filings were for RRPs, 60 filings focused on combustibles, covering areas such as packaging, filters and flavorings. The company has also invested in agronomy, developing new seed varieties to increase crop productivity, lower the levels of certain undesirable constituents and benefit growers, for example.
Wise then stressed the importance of a balanced regulatory framework, one that protects consumer choice, encourages rigorous quality standards while maintaining a level and competitive playing field. “Less regulation can lead to more innovation but also encourages inappropriate risk-taking,” she said. “When that comes at the cost of quality and safety, the negatives outweigh the positives.”
She cautioned that in the absence of a robust regulatory framework, there was no place for short-term opportunism. “Otherwise, we risk putting off consumers, destabilizing the industry and attracting knee-jerk regulation to counterbalance the actions of those looking for a quick return,” she said. Wise pointed to California, which recently became the second U.S. state to ban flavored tobacco and vapor products—a political decision with no scientific basis that risks fueling illegality, she said.
The industry’s ability to innovate is tempered by consumer acceptance of new products, Wise noted. She cited several innovations, including early smokeless cigarettes in the late 1980s, which, for a variety of reasons, failed to take off. She stressed the importance of consumer choice and the ability of adult consumers to make informed decisions. “It is counterproductive for government to prevent the industry from sharing information about their products and then making decisions on behalf of consumers and not treating them like adults,” she said.
Last year’s Evali crisis in the United States demonstrated how vulnerable the industry is to misinformation, according to Wise. A mysterious outbreak of lung illness spawned a media frenzy—“cat nip for the media,” as Wise put it—and a severe regulatory backlash, with authorities restricting vaping before the cause had been determined. Evali was later attributed to vitamin E acetate in THC products sold through informal channels, but by that time, the damage had been done. Nielsen figures showed a staggering 25 percent drop in global retail vapor sales in the months following the crisis.
While acknowledging that standing up for smokers and consumer choice might be perceived as bold in some quarters, Wise insisted it was the right thing to do. “We don’t encourage smoking; we know that it is bad for health,” she said. “We believe in freedom of choice: the right to choose cigarettes or RRPs or to quit. That’s what we mean by a consumer-centric approach; it reflects reality.”

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K.C. Crosthwaite: Seizing the historical harm reduction opportunity
K.C. Crosthwaite, chairman and CEO of Juul Labs, described the historic opportunity provided by new technologies for tobacco harm reduction and the barriers that need to be overcome to realize it. “We have today what was never available before: the tools and technology to end the era of smoking,” he said.
It is by now widely accepted that smokers smoke for the nicotine but get sick from the “tar”—the byproducts of combustion. Nicotine is delivered on a continuum of risk, explained Crosthwaite. Traditional cigarettes are by far the most dangerous delivery device because of the tobacco smoke, which is associated with cancer, respiratory illnesses and other diseases. On the other end of the scale are nicotine replacement products that supply “clean” nicotine.
Juul Labs’ Juul system delivers nicotine without burning tobacco, which puts it at the lower end of the risk continuum. This summer, Juul Labs submitted a premarket tobacco product application for its Juul system to the FDA, which, if approved, would allow the company to continue marketing the product in the United States.
Crosthwaite believes the Juul system is “appropriate for the protection of the public health” as required by the FDA. Over the past five years, he said, 2 million U.S. adults have switched completely away from combustible cigarettes using Juul products. At the same time, Crosthwaite acknowledged that harm reduction for adult smokers cannot come at the cost of underage use. Juul Labs has been criticized for contributing to an increase in teen vaping in the U.S. Upon becoming CEO about a year ago, Crosthwaite vowed to “reset” the company. “Juul has learned lessons of past,” he said. “We are now more disciplined and focused on responsible stewardship of products.”
While the possibilities offered by reduced-risk products for tobacco harm reduction are considerable, Crosthwaite warned that the world is at risk of losing the opportunity due in part to the precarious regulatory landscape. Around the globe, regulatory frameworks tip the balance in favor of cigarettes. “One-third of the world population lives in countries that ban nicotine vapor products,” he said. “As a result of these restrictions, and despite being available for more than a decade, vapor products account for 3 percent of cigarette sales worldwide.”
Meanwhile, cigarettes—the riskiest category—are readily available everywhere.
On top of that, many smokers are confused about the risks compared to cigarettes. Misconceptions about these products are at an all-time high, according to Crosthwaite. In some surveys, 80 percent of respondents incorrectly indicated that nicotine causes cancer.
Crosthwaite called for risk-proportionate regulation that would allow reduced-risk products to compete with cigarettes. Among other things, that means they must be able to deliver nicotine levels that are sufficiently satisfying. In that context, Crosthwaite criticized the EU cap on nicotine levels in e-liquids, which he said may inhibit smokers from switching by making e-cigarettes a less appealing option.
Regulatory pathways must include minimum quality and safety standards, he said. But they cannot be so burdensome that they become de facto barriers to market. Crosthwaite called for collaborative action by governments, civil society, public health bodies and industry to realize a risk-proportionate system. “If we get this right, we can accelerate the end of the age of the cigarette,” he said.

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Panel: Comparative Regulations: Who is getting it right and ‘WHO’ could be doing better?
The first panel discussion in the GTNF’s Asia time zone compared nicotine regulations around the world. Chris Allen, chief scientific officer at Broughton Nicotine Services, noted that regulation should be driven by sound science, not politics. “That is not always the case,” he said. Regulations, he added, should also be progressive. “They should allow innovation and have the ability to evolve,” he said. “If today’s aviation regulations were in place 100 years ago, air travel as we know it now may not have been possible.”
Moderated by RAI Services’ senior vice president of scientific and regulatory affairs, Mike Odgen, the panel explored the question of who is getting regulation right and who could do better. A consensus emerged that while no one was doing everything correctly, some regulatory bodies were doing a better job than others.
Citing 7 million tobacco-related deaths annually worldwide, Derick Yach, president of the Foundation for a Smoke-Free World (FSFW), said the goal of regulators should be to reduce the harm caused by tobacco as quickly as possible. “Governments are failing us,” he said, before singling out some “green shoots” of decent policy decisions. Yach pointed to the EU’s decision to exclude tobacco harm reduction (THR) products from its recently enacted ban on menthol cigarettes; the U.K.’s integration of THR into cessation at the clinical setting and the U.S. FDA’s decision to grant modified-risk orders to IQOS and general snus.
“Yet the World Health Organization, which should be putting it all together, is making little progress,” he noted. According to Yach, THR is part of the definition of tobacco control. The concept featured prominently when work started on the Framework Convention for Tobacco Control (FCTC). “Instead, we are hearing calls for bans on THR products in low-[income] and middle-income countries where the health consequences of combustible products are the harshest,” he lamented.
Trade law consultant Abrie Du Plessis urged tobacco and vapor companies to share their input as the EU starts evaluating novel tobacco products in preparation for its next Tobacco Products Directive (TPD). By May 2021, the EU is required to publish a report on novel tobacco products and propose amendments to the TPD. Enacted in 2014, the current directive does not address the harm reduction potential of such products. The rapporteurs will be looking into the impact of novel products on uptake among young people and nonsmokers and their contribution to cessation, among other issues.
Whatever new regulations the EU adopts may reverberate beyond the single market. According to Du Plessis, the upcoming report is required to consider rules at the international level. However, the Conference of the Parties to the FCTC, which was scheduled to take place this month in the Netherlands, has been postponed to November 2021. As a result, the sequence of events has been overturned; the FCTC will meet after the EU report. “This means the EU may lead the FCTC rather than the other way around,” says Du Plessis.
The panelists agreed that the regulatory processes around the world were too sluggish considering the tobacco-related mortality and morbidity. “If smoking wasn’t killing the number of people it is, it would probably be justified to go about this rulemaking in a very leisurely way,” said Yach. He contrasted the glacial pace for tobacco to the Covid-19 response where “every rule in the book is stripped because this is a fast-moving pandemic.”
“Yet there is no difference between the two except in timing,” said Yach, referring to the death tolls extracted by tobacco use and the coronavirus. “If we took the Covid-19 approach, the goal should be to strip away the regulatory nonsense to get lifesaving products into the hands of people in the quickest, safest possible way. Then we would see progress at lightning speed rather than what is now a trickle.”

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Panel: Scientists Talk
The second panel discussion during the 2020 GTNF in the Asia time zone featured top scientists from the leading tobacco companies discussing the role of science in the tobacco and nicotine business.
Moderated by Teo Forcht-Dagi, honorary professor at Queens University, the panel included Maria Gogova, vice president of regulatory sciences and regulatory affairs at Altria Client Services; Ian Jones, R&D principal scientist at Japan Tobacco International; David O’Reilly, director of scientific research for British American Tobacco; and Joe Thompson, chief scientific officer at Imperial Brands.
Asked to identify the most salient scientific issues facing the tobacco and nicotine industries, the panelists named the communication of science and data gaps, among other topics.
Today’s alternatives to combustible products represent an unprecedented opportunity to reduce the risks of smoking, but without consumer trust in the product, the opportunity will not live up to its potential.
Jones summarized the challenge by quoting Anne Roe. “Nothing in science has any value to society if it is not communicated,” the American psychologist reportedly said. “It helps if it’s understandable too,” Jones added, quoting a coworker this time.
Despite the substantial and growing body of evidence that vaping is less harmful than smoking, an increasing number of consumers believes the opposite. Between 2014 and 2016, the share of U.S. adult smokers who perceived vaping as being equally or more harmful than smoking increased from 44 percent to 68.4 percent, according to the PATH study.
Such misconceptions are fueled by flawed studies and sloppy media coverage, according to Thompson. For example, a 2019 research paper erroneously linked e-cigarette usage among adults to heart attacks, generating sensationalist headlines. Its authors were later forced to retract the study, but by that time, the damage in terms of public perception had been done.
O’Reilly noted that most people’s understanding of tobacco and disease is about 30 years out of date, causing them to confuse nicotine with products of combustion. He said it was depressing to see how even many medical and scientific professionals misunderstand the issues, mistakenly attributing cancer and respiratory diseases to nicotine, for example. “It is one thing for the public to struggle with nuances of nicotine toxicology, but the misperceptions of our colleagues in [the] scientific and medical world must be addressed,” he said.
The panelists agreed the industry should step up its science communications and use all available channels (while noting that some channels are off-limits) to get its message across. Jones called on the industry’s communicators to be open, transparent and take the time to understand their audience. “Don’t sit on your pedestal and try to bedazzle everybody,” he said. O’Reilly said the automotive industry provided a good analogy to describe the tobacco industry’s transformation to the public. “Moving away from combustion will benefit public health,” he said.
The panel then turned its attention to data gaps—what we don’t know. A recent review by the Committee on Toxicology that advises the U.K. Department of Health was broadly supportive of vaping but also pointed to the lack of information on the performance of cigarette alternatives over time. This presents a challenge not only because of the sector’s age—many products simply haven’t been around for long enough to conduct epidemiological studies—but also because it is hard to follow people over time. Contrary to the traditional cigarette business where smokers typically stay with the same product and brand for the duration of their smoking “career,” vapers change products frequently, either due to evolving technology or changing preferences. So tracking them is difficult.
While acknowledging the data gap, Gogova said the absence of epidemiology should not be used as an excuse to foreclose tobacco harm reduction opportunity and/or the authorization of modified-risk claims, as doing so would leave the field to combustible cigarettes—the riskiest option.
Despite the relative youthfulness of the vapor sector, O’Reilly said it was time to start considering population-based studies. “We are in a different space today then at the start of the GFNF in terms of science. In a number of countries, the uptake of alternative products has been going on for some time now.”
The panel also pondered the question of how to recruit scientists. Fortunately, the industry’s transformation has made that task easier in recent years. Many scientists are attracted by the opportunity to help reduce the harm caused by smoking. According to O’Reilly, scientists could arguably do more to avoid a billion premature deaths by joining the tobacco industry than by signing up for academia or other sectors. As Jones explained, science is about curiosity, about wanting to learn more, ask questions and pull things to pieces to see how they work. Unlike the situation 20 to 30 years ago when tobacco science had stagnated, the transformation that the industry is undergoing provides all of that.
Encouragingly, all panelists reported that scientists today have a big seat at the table inside tobacco companies’ board rooms. Science is viewed as fundamental, they said. It makes sense: One of the greatest challenges to sustainability for the industry is achieving tobacco harm reduction that is based in sound science. Without science, the industry has no foundation to transform itself and continue its operations.
Panel: One billion voices: Grassroots consumer rights advocacy
The panel discussion “One billion voices” debated the difference consumer advocates can make in promoting harm reduction and risk-proportionate regulatory frameworks. Clarisse Yvette Virgino, member of the Coalition of Asia Pacific Harm Reduction Advocates, provided a powerful example of consumer advocacy in action. The Philippines had originally intended to ban electronic nicotine-delivery systems (ENDS). Through active discussions with lawmakers, consumer groups and their allies managed to avert prohibition.
Plenty of challenges remain, however. Philippine law classifies e-cigarettes and tobacco-heating devices as tobacco products, which means they are subject to similarly strict restrictions. What’s more, damaging misperceptions persist, with many inaccurately viewing ENDS as equally or more harmful than cigarettes. The government closely toes the anti-harm reduction line set out by the WHO, and President Rodrigo Duterte has repeatedly made negative comments about vaping.
The situation is worse in India where the government last year banned e-cigarettesand tobacco-heating products, denying the country’s 110 million smokers access to less harmful alternatives. Samrat Chowdhery, president of the International Network of Nicotine Consumer Organizations, bemoaned the exclusion of nicotine consumers from the debate. “Once somebody starts using a tobacco product, their experiences and opinions no longer matter,” he lamented. The ban has spawned a thriving black market—but without the quality controls that were in place previously, according to Chowdhery. It has also driven many vapers back to smoking.
India’s hostility to harm reduction extends to oral products. The country boasts a huge smokeless market with offerings such as gutka and pan masala. As Chowdhery points out, however, not all smokeless tobacco products are created equal; the segment has its own risk continuum, with snus and modern oral products at the low end of the scale and Indian smokeless near the top. “Indian smokeless is extremely deadly,” he says. “It is linked to about 350,000 premature deaths annually.”
The availability of less unhealthy smokeless alternatives should make India ripe for substitution. “Unfortunately, Indian tobacco control is trying to conflate risk, using the example of Indian smokeless to claim that all smokeless tobacco products are bad,” said Chowdhery. The other obstacle is price: Indian smokeless is extremely cheap—cheaper even than bidis, the most used form of smoked tobacco in India. “So if you look at converting gutka and pan masala users, then the price point has to be where consumers can afford it,” he said.
The panel debated the challenge of communicating the benefits of cigarette alternatives. Heneage Mitchell, director of Factasia, said his organization was constantly struggling to counter misinformation. Erroneous headlines depicting vaping and smoking as equally harmful have a huge impact, he said, but it is difficult to get publishers to retract their stories. And unlike their adversaries, vapor advocates have limited resources. “They have billions; we have pennies,” said Mitchell, comparing his finances with those of the WHO and Bloomberg Philanthropies. Lacking budgets, consumer advocates are relying on social media to make their voices heard—but the way those platforms are designed means that activists are often finding themselves in echo chambers, preaching to the choir. “There is no magic bullet,” Mitchell said.
Making matters worse, some 50 percent of the world’s tobacco production is controlled, through whole or partial stakes in tobacco companies, by governments that have signed the treaty. “That makes the FCTC an institutional tobacco trader lobby,” said Chowdhery. Tellingly, when Canada and the EU in 2018 supported making the FCTC proceedings transparent, they were countered by countries such as Thailand and India, which have substantial interests in their tobacco industries.
Despite the formidable obstacles to harm reduction, the panelists took heart from the fact that consumers are becoming more vocal. The personal experience with lifesaving devices has made many eager to speak up. Chowdhery said he was encouraged to see how many so-called experts are now facing pushback from consumers who are “calling bullshit.”
Moderator Alex Clark, CEO of the U.S. Consumer Advocates for Smoke-Free Alternatives Association, and Australian tobacco harm reduction advocate Andrew Thompson urged vapers and their supporters to leverage their power as voters. “Tobacco control needs to get off the tracks and get on the train,” said Thompson.

Hiroya Kumamaru: The Japanese experience
Hiroya Kumamaru, a cardiovascular surgeon and vice director of AOI International Hospital in Kawasaki, Japan, discussed the remarkable decline of smoking in Japan following the introduction of heated-tobacco products (HTPs) in 2014.
Smoking is the biggest cause of disease and premature death in Japan, ahead of other prominent causes such as hypertension and diabetes. In 2010, 157,000 people in Japan died from smoking-related diseases, including malignancies and respiratory afflictions.
The economic damage is substantial too. The Japan Health Economics Research Group estimates the annual loss due to smoking at ¥4.3 trillion ($40.81 billion), mainly in the form of lost working hours, cleaning cost, fire safety expense and medical expenditures. This figure far outweighs the positive impact on Japan’s economy of smoking, which the research group puts at ¥2.8 trillion (primarily tax income) per year.
Japan has long struggled with stubbornly high smoking rates. In 1989, more than 50 percent of men and about 10 percent of women smoked, according to the National Health and Nutrition Survey. In recent years, however, the figure has started to come down dramatically. Between 2015 and 2019, domestic cigarette sales decreased from 180 billion sticks to 120 billion sticks—a drop of more than 30 percent. The share of smokers over the age of 20 is now below 18 percent in Japan.
Experts attribute the decline to the introduction of HTPs, which satisfy smokers’ cravings but likely present a lower risk to their health. Kumamaru cited research by Bekki et al. of Philip Morris International’s (PMI) IQOS HTP, which showed that the nicotine concentration in the smoke—the part that provides the satisfaction—was almost the same as that of conventional cigarettes while the concentration of tobacco-specific nitrosamines (TSNAs) and carbon monoxide—components associated with illness—were one-fifth and one-hundredth of those in conventional cigarettes, respectively.
Since their debut in 2014, HTPs have captured 24.3 percent of all tobacco sales in Japan. More than a quarter of Japanese smokers have embraced HTPs, with at least 70 percent using these products exclusively. Among men in their twenties and thirties, more than 50 use HTPs, according to the Japan National Health and Nutrition Survey (2018), which was published in January 2020.
Meanwhile, Japan’s overall smoking rate continues to decline, which suggests the new products are enticing smokers to switch rather than recruiting new users. PMI data show an insignificant share of new smokers started because of its HTP product, IQOS, in 2017. According to Kumamaru, this shows there is no “gateway” effect from having HTPs on the market.
While impressed by the impact of HTPs on smoking rates, Kumamaru said he had even greater expectations of the tobacco harm reduction potential of vapor products. Manufacturers have hesitated to launch e-cigarettes in Japan in part because of regulatory issues, but he nonetheless expected launches in the vapor segment soon.
Click here to read more session summaries from the 2020 GTNF.
November 1, 2020
Feet to the Fire
Photo: Alexey Novikov |Dreamstime
Five questions for the Framework Convention on Tobacco Control as the treaty marks its 15th anniversary
By George Gay
This year marks the 15th anniversary of the entering into force of the World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC), but I won’t be sending a card. I’m sure the parties to the FCTC will understand. It’s nothing personal. It’s just that it’s unwise, especially for somebody of my age, to make unnecessary trips to the shops and post office just now because, while the WHO had its eyes focused firmly on tobacco smoke, a colossal, deadly pandemic arrived on the doorstep, seemingly without very many people in the global health community noticing. Or, if they did notice it, perhaps they didn’t like to make a big deal of it straight away, presumably because they didn’t want to make a fuss and alarm people unnecessarily.
Nevertheless, I guess that the pandemic has put a bit of a damper on the FCTC’s anniversary celebrations, which kicked off on Feb. 27, two days after the WHO’s coronavirus timeline described the director-general of the organization, Tedros Adhanom Ghebreyesus, as having “repeatedly called for ‘solidarity, not stigma’ to address Covid-19.” So at least one good can come out of this mess. We can assume, I suppose, that the WHO, which has spent 15 years using the FCTC to urge national governments to stigmatize smokers, has now realized that stigmatizing certain groups of people is discrimination at its most ugly and grossly unfair.
The elephant in the WHO’s smoke-filled rooms wasn’t even called a pandemic—such a nasty word—until March 11, but, about 10 months on, Covid-19 has been responsible for the premature deaths of more than a million people, huge social upheavals, domestic and international political rows, and catastrophic economic damage that is causing untold hardship, especially among the financially worse off. I believe the virus that causes Covid-19 is thought to have become endemic in some areas. Still, let’s not get into a blame game. After all, anybody can make a mistake.

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Ruling out harm reduction
I have long found it difficult to understand why a global health organization would become obsessed with tobacco smoking, which is legal and a lifestyle choice for some perfectly respectable people, but seemingly be less bothered about devastating health threats that can sweep across national borders and that the person in the street has almost no defense against. Let’s not pretend that the current pandemic could not have been predicted and that it caught everybody by surprise.
I can be sure of two things, however. Nobody will be held to account for this mess, and the parties to the FCTC will continue to pat themselves on the back for “saving lives.” Of course, in reality, not one life has been saved in the physical sense. Some lives might have been extended but without the FCTC asking the people concerned whether they wanted to have their lives extended. The view of this point from Geneva will, after all, be different to that from, say, some of the world’s many war zones.
I have from time to time also wondered why the WHO feels compelled to stick it to smokers alone, and my curiosity was roused once again by a number of recent comments from respected members of the health community who have suggested the WHO has lost its way with tobacco. These comments suggest the WHO is ignoring what is currently the most promising tobacco harm reduction tools by, de facto, ruling out the use of innovative nicotine-delivery products produced by the tobacco and nicotine industries to transition cigarette smokers to far less risky habits.

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Picking on smokers
So I decided it was time to take a fresh look at the FCTC treaty text, and I didn’t have to read far to find what probably is the answer to part of my query. The very first item in the preamble to the treaty says the parties to the convention are determined “to give priority to their right to protect public health.” It jumps out at you, doesn’t it? The words “their right.” What exactly do they mean by “their right”? Do they believe this right has been divinely bestowed and that their mission is to save lives at a spiritual level? It seems unlikely in this day and age, but you have to wonder when you observe some of their inquisitional-style tactics, such as putting smokers on the tax rack, geared up with the Protocol to Eliminate Illicit Trade in Tobacco Products, which came into force in September 2018, despite the fact that, even now, it has only attracted the support of 58 parties out of the FCTC’s 181.
And how is it that the parties to the FCTC assume that their rights override the right of smokers to smoke? I would willingly concede that the parties to the FCTC, in so far that they represent governments, have an “obligation” to protect the public, which is part of the democratic contract between voters and governments, but I get nervous when rights are invoked. Obligations tend to make people set to work; rights tend to cause people to forget their obligations, mount their high horses and launch moral crusades. And let’s face it, you cannot mount a moral crusade against an invisible virus—you just look silly. If you want to mount a moral crusade, you need to do it with panache, and that needs an identifiable enemy. A windmill, perhaps, or better still, a smoker.
But even if the WHO needs an enemy it can point at, why did it pick on smokers and smokers alone? It was a conscious choice and one of which it is proud. One of the first sentences of the anniversary website proclaims that the FCTC is the only international treaty negotiated under the auspices of the WHO. There is, in other words, no treaty aimed at stigmatizing drinkers, polluters and the other groups of people involved in harmful activities that affect other people as well as themselves. This is odd to my way of thinking because it is becoming clear that pollution is causing far greater damage to people’s health than smoking, especially in the case of young people.

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The questions
So what is the FCTC about? It’s difficult to say because it’s a shadowy organization that shuns publicity, save that contained in the controlled announcements it puts out. Attendance at its meetings is strictly controlled so that, I guess, everybody present is in agreement about stigmatizing smokers before these events get under way. And in such circumstances, the only way to find out about this organization is to conduct an “interview,” using a modified version of what I understand is the five-point questionnaire devised by the late Tony Benn for interrogating the powerful:
What rights do you, the FCTC, believe you have in respect of involving yourself in the lives of smokers?
From where did you get these rights?
In whose interests do you use these rights?
To whom are you accountable?
How do we get rid of you?
What worries me, in respect of the first question, is that the FCTC might be laboring under the misapprehension that ethics and rights are linked: that taking what it sees as an ethical, nose-in-the-air stance on tobacco smoking in itself confers on it the right to encourage regulations opposed to such smoking. This is nonsense. It is quite possible to be opposed to something ethically but be willing to uphold other people’s rights to avail themselves of that thing. I would imagine that just about every government in the world claims to be ethically opposed to tobacco smoking but nevertheless does not introduce legislation aimed at ending it anytime soon.
I cannot answer the second question because, as far as I am aware, there has been no divine intervention. And if that right was bestowed by some nondivine being, and given the fact that smoking is legal, you get into a circular argument about who gave that being the right to bestow such a right …
I know the answer to the third question, however. It is present and future generations. The anniversary website tells us, “The aim of the convention is to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke.” This is all very noble, if one is willing to concede that the parties to the FCTC have the right to act in this way, but it still raises numerous questions. One is why is there no protection from alcohol consumption, which almost certainly is playing an indirect part in increasing the spread of Covid-19, and no protection from pollution? After all, there is no point acting to protect future generations from tobacco consumption and smoke if, because of pollution, climate change and environmental breakdown, there aren’t going to be many future generations as currently seems likely. Another is why is there no stigmatization of those who consume alcohol? Down at my local supermarket, I can choose from row upon row of alcoholic drinks, some of them flavored, but none of the bottles or cans that contain these drinks show graphic warnings stigmatizing drunks with pictures depicting them beating their partners to death, urinating in their pants or choking on their own vomit.
To whom is the FCTC accountable—or more pointedly, beholden? I guess it’s those who hold the purse strings, though it is clearly the case that they are not holding the organization to account. A better health outcome could be achieved by doing away with the FCTC’s meetings and giving the considerable amounts of money saved to the world’s poorest to spend as they see fit. This would have the added benefit of saving the environment from the considerable damage inflicted by flying representatives of the 181 parties to and from the meeting venues.
Finally, question five. How do we get rid of you? Simply by having governments, which best understand how their societies operate, take full control of their own tobacco policies. There is no need for a supranational body to oversee the demise of the tobacco industry. The industry is supplying the tools to do the job, and all that national governments have to do is aid that process by allowing sensible, truthful advertising of the new products and by keeping an eye on those products. If the WHO wants a role, it should concern itself with ensuring that tobacco growers, especially those in Africa, are given the tools to transition away from tobacco and into other, more lucrative operations.
And if the FCTC wants to maintain a role, it should change its ways by treating smokers as ends in themselves not as a means to an end.
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.
November 1, 2020
The Irreconcilable Conflict Principle

Photo: Nataliia Shcherbyna – Dreamstime.com
The governing idea of tobacco control
By Clive Bates
Sometimes defining an iron rule or governing idea and reorganizing our understanding of the world around it can be immensely revealing. Einstein developed the special theory of relativity from an assumption that the speed of light in a vacuum is unwaveringly constant. The most surprising results follow from that. Darwin showed that a simple mechanism, variation and natural selection, could explain much of the astonishing complexity of the natural world. Governing ideas are found everywhere: supply, demand and prices in economics; innocent-until-proven-guilty in criminal justice; and mutually assured destruction in arms control are further examples.
So, is there a governing idea in tobacco policy? Something that shapes everything and means that the world is understood through rigorous application of that rule? I think there is, but it is playing an ever larger, more polarizing and counterproductive role. The starting point is Article 5.3 of the World Health Organization Framework Convention on Tobacco Control (FCTC). Though often overstated, Article 5.3 is fairly innocuous:
In setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law.
When read as originally intended by the FCTC drafters in 2003, this aims, quite reasonably, to guard against the improper commercial influence of Big Tobacco on public health policy. There is nothing wrong with that. Many governments would quite happily apply the same principle to Big Oil in climate change policy or Big Pharma in healthcare policy. It is essentially an expression of good practice in policymaking.

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But Article 5.3 didn’t stop there. In 2008, the concept was developed into Guidelines for the implementation of Article 5.3. Note the title—it does not suggest new treaty provisions are introduced but that the guidelines will implement the treaty as it is. However, the guidelines do more than this. Much more. They set out four guiding principles for Article 5.3, and the first of these is the most troubling:
Principle 1: There is a fundamental and irreconcilable conflict between the tobacco industry’s interests and public health policy interests.
Wow—that’s quite a statement. Let us refer to this as the “irreconcilable conflict principle.” First, it is qualitatively different from Article 5.3: It is a finding of fact rather than a principle that governs the process of policymaking. The finding is also permanent and inescapable—under this principle, no matter what the tobacco industry does or becomes, its actions will always be in conflict with public health. This is not merely expressed as a cautionary note from history, a lesson for which there is at least some supporting evidence. It is binding on the future and expressed as a permanent truth.
I think the irreconcilable conflict principle is the governing idea, the iron rule of tobacco control. I do not wish to imply that this emerged in 2008 or because of these guidelines. The direction of causation is the other way. This was coded into the guidelines because it is the governing idea of tobacco control. In agreeing to this at the urging of tobacco control activists, complacent or complicit bureaucrats greatly extended the reach of the FCTC, apparently without appreciating the potential negative consequences.

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This means that anything that is in the interests of tobacco companies must, by definition, be bad for public health. It means nothing can be both in interests of public health and the tobacco industry. In the same way that Einstein assumed the speed of light was a constant and his understanding of the world was reshaped around that, so we see tobacco control reshaping its worldview around the irreconcilable conflict principle. The important difference is that Einstein was basically right, and his radical insight advanced human understanding. For tobacco control, this governing idea is wrong—at least some of the time and in several ways. Consider the following implications.
First, the irreconcilable conflict principle drives implausible explanatory theories. The experience of snus in Sweden clearly challenges the guiding principle: Widespread use of a tobacco product made by tobacco companies is responsible for Sweden’s unusually low smoking prevalence and with that, an unusually low level of cancer and heart disease in the male population. This alone should be enough to justify abandoning the principle. Yet Sweden’s public health establishment has been driven to find ever more desperately implausible reasons to explain the observed reality. These include absurd ideas about the role of Sweden’s generous paternity leave system and Sweden’s involvement in the Second World War. Tobacco control advocates have consistently opposed any lifting of the European Union ban on snus because to do so would be to violate their guiding idea, the irreconcilable conflict principle.
Second, the irreconcilable conflict principle is shifting the goals of tobacco control. With the rise of vaping, tobacco control objectives have steadily shifted from tackling the health consequences of smoking, something that can be eliminated with technology. Now they increasingly stress opposition to nicotine use itself, something that is intrinsic to the industry. In this way, the industry can always be at fault and the inviolability of the principle maintained.
Third, the irreconcilable conflict principle distorts science. If your iron rule is that nothing good ever comes from tobacco companies, then you are motivated to develop science demonstrating conflicts with public health. So, we see more scientists claiming that there is no difference in risk between smoking and vaping or that the data are so uncertain that nothing is or can be known about relative risk. Both are plainly wrong. Randomized controlled trials (RCTs) show vaping is more effective for smoking cessation than nicotine-replacement therapy. After years of lamenting the paucity of vaping RCTs, tobacco control activists have pivoted to express doubts about their validity or redefined quitting smoking to mean quitting nicotine.

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Fourth, the irreconcilable conflict principle has made mainstream tobacco controllers into enemies of innovation. The U.S. Food and Drug Administration (FDA) recently granted the right to a tobacco company to claim that its heated-tobacco product was a reduced-risk product after concluding that it was appropriate for the protection of public health. A calamity: that would violate the irreconcilable conflict principle. Predictably, this triggered a backlash of denial and desperate arguments to show that the FDA was somehow mistaken and that there was no benefit to public health even though FDA was merely allowing a statement of the obvious to be made.
Fifth, the irreconcilable conflict principle has created a self-amplifying echo chamber in tobacco control. Suppose there are people in public health who do think that some of the things done by tobacco companies are positive. Under the guiding principle, how can that be unless such people have a conflict of interest or are in some way working to further the interests of Big Tobacco? We can see this in some of the extraordinary efforts that tobacco control fora have made to exclude these dissonant voices. That includes the hurdles to achieving observer status at the FCTC itself and attending major events like the World Conference on Tobacco or Health. This conference has eligibility criteria explicitly based on the irreconcilable conflict principle and contains a catch-all exclusion for anyone who “works to promote tobacco products, their sale or to limit their regulation.” What if you think (like me, for example) that it would be good for public health if smokers switched to snus or heated-tobacco products and that regulation should be proportionate to risk rather than “unlimited”? The aim is to define this norm-challenging perspective as pro-industry and therefore anti-health and thereby to keep it out of earshot. An Australian anti-tobacco activist has even proposed an “Article 5.3 for civil society,” in which “reinforcing Big Tobacco’s pariah status” would be the purpose.
Sixth, the irreconcilable conflict principle distorts rather than protects policymaking. Those who adhere to the principle cannot recommend policies that would encourage low-risk nicotine products at the expense of cigarettes as that would be to accept that they have a role in public health. So we see that tobacco control activists and many academics have adopted hostile regulatory paradigms for reduced-risk products: prohibition, pharmaceutical or equivalence to cigarettes. All are designed to reject the notion of any benefit from reduced-risk tobacco products. When Bloomberg Philanthropies recently advertised a new round of tobacco control grants, it stressed the “passage and implementation of Article 5.3” and linked this to Michael Bloomberg’s preferred MPOWER policy framework for tobacco control. Mr. Bloomberg is on record favoring vaping prohibition, and he sees no role for reduced-risk products. Perhaps public health policies now need to be protected from these vested interests?
There should be one guiding principle for tobacco control: to reduce harm to the greatest extent and as quickly as possible. The irreconcilable conflict principle is a relic of the past and fails a modern reality check. It is the reason why tobacco control activists may now be doing more harm than good.
Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).

November 1, 2020
Joining the Race

Suthira Taychakhoonavudh (left) and Waranyoo Phoolcharoen
Thailand is developing its own tobacco plant-based coronavirus vaccine.
By Stefanie Rossel
It’s been almost a year now since Covid-19 broke out, and the pandemic still rages around the world. The spread of the virus has set off a global race for a vaccine—consensus among experts is that only an effective inoculation will end the contagion. As of Sept. 28, 40 candidate vaccines were in clinical evaluation and 151 were in the preclinical trial phase, according to the World Health Organization (WHO).
However, speed isn’t everything. Russia, which on Aug. 11 became the first country to approve a Covid-19 vaccine, soon faced criticism by researchers who highlighted questionable data in the vaccine trial results. AstraZeneca and Oxford University temporarily put on hold clinical trials for their Covid-19 serum after a participant showed an adverse reaction. In the U.S., President Donald Trump has politicized coronavirus vaccine approvals, insisting a serum was likely to be approved by election day (Nov. 3), despite reservations expressed by regulatory bodies such as the U.S. Food and Drug Administration (FDA).
While the trials are still ongoing, the WHO, physicians and vaccine manufacturers have already begun to develop different scenarios for the distribution of a serum once it has been approved. A vaccine shortage is likely in the early stages, and the issue of fair sharing has yet to be resolved. Several high-income countries have already secured contracts with leading pharmaceutical and life science companies, putting lower income countries at risk of missing out on a coronavirus vaccine.
To avoid this scenario, Thailand is developing its own vaccine. The kingdom is keen to avoid a repeat of its 2009 experience when the swine flu hit Asia. Although a vaccine against the swine flu was ready within two months after the outbreak, and Thailand had worked out deals with overseas developers to buy 2 million doses, the goods arrived only after the pandemic had subsided. By the time it was over, the virus had infected more than 47,000 Thais and killed 347.

First of its kind
Although Thailand has been doing comparatively well in the Covid-19 crisis, with roughly 3,600 infections out of its 68 million population by the end of September, the country nevertheless wants to avoid depending on imports. In August, the Thai government gave thb1 billion ($31.6 million) to the National Vaccine Institute (NVI) to support development and production of vaccines against the coronavirus and other diseases. Compared to other nations, the sum is small—the U.S. federal government, for example, has invested more than $9 billion, spread among seven companies, in the development of a Covid-19 vaccine. But if one of Thailand’s vaccine candidates will be approved for human trials, it will be the first such anticoronavirus vaccine developed in Southeast Asia.
“Governmental funding in Thailand is quite limited,” explains Waranyoo Phoolcharoen, associate professor in the Department of Pharmacognosy and Pharmaceutical Botany of Chulalongkorn University in Bangkok and head of development for a Covid-19 vaccine candidate. “To date, most vaccines are imported. There is currently no facility to produce the vaccine entirely—from laboratory to manufacturing and human trial—in Thailand.”
Chulalongkorn University, which has two centers in vaccine research and development, has become the focus of present vaccine developments against the coronavirus in Thailand. One initiative has applied mRNA technology transferred from the U.S., and another is using tobacco plants to develop an inoculation.
Tobacco plants have proven their potential as an efficient biopharmaceutical producer of vaccines. It’s a road other contenders in the race for a cure have chosen as well, among them U.S.-based Kentucky BioProcessing, a subsidiary of British American Tobacco, and Medicago, a privately held Canadian biotech company in which Philip Morris International bought a stake in 2008.
Basically, the manufacturing process involves identification and reception of genetic sequences from a pandemic strain to produce a virus-like particle (VLP), or antigen. VLPs resemble a virus, allowing them to be recognized readily by the immune system, but they lack the core genetic material, making them noninfectious and unable to replicate. Before the genetic construct representing the protein of interest is inserted, plants are seeded, germinate and grow. They are then genetically modified with the VLP in a technique known as transient expression.
With this transformation, plants incubate for several days during which they are reproducing the target protein. At this point, they are harvested and crushed to create a green-juice slurry. This liquid passes through filtration processes and sophisticated purification techniques to produce a final product. The process, which employs Nicotiana benthamiana, a close relative of the tobacco type used for cigarette production, can deliver a vaccine for testing in less than a month after production of the VLP.
Using tobacco plant technology has several advantages over conventional vaccine production processes. It can reproduce the antigen consistently with high fidelity and allows for rapid production of scale within a short period of time. It is also potentially safer given the fact that tobacco plants can’t host pathogens that cause human disease. In contrast to conventional vaccines, which often require refrigeration, a tobacco plant-based formulation remains stable at room temperature, making it suitable for distribution in warmer climates.
For Thailand, using tobacco has the additional advantage that the country can rely on its own resources, says Phoolcharoen. According to The Bangkok Post, Thailand has 10,450 tobacco growers, of whom 15 have production capacity of more than 12,000 kg a year. “Although we use different species of the tobacco used for cigarette manufacture, people have approached us and want to grow tobacco for our vaccine. The cost for tobacco cultivation is very low in Thailand—farmers view it as a business opportunity. Although funding is limited, molecular pharming matches the country.”

Plant technology reproduces antigens with high fidelity and allows manufacturers to rapidly scale up production.
A chance for young researchers
For Phoolcharoen and her team, the Covid-19 vaccine project represents a unique opportunity. Eighteen months ago, she established Baiya Phytopharm, a biopharmaceutical startup, together with Suthira Taychakhoonavudh. The plant technology-based platform can produce biopharmaceutical products within weeks rather than months or years, which results in faster and lower cost research and development, Phoolcharoen points out. The team also worked on a cure for the hand-mouth-foot virus, which is widespread among infants in Thailand. The company also has products against rabies, cancer and the Ebola virus in the pipeline. With the advent of Covid-19, the platform shifted its focus and capacity completely to produce SARS-CoV-2 vaccines and therapeutic monoclonal antibodies.
If approved by Thailand’s Food and Drug Administration (FDA), the company’s vaccine would be the first to be produced from the laboratory to clinical trials in the country, Phoolcharoen says. “The business environment in Thailand differs largely insofar that the big pharmaceutical players only have their marketing side in our country but not the R&D and manufacture. For graduates in Thailand’s pharma industry, this means that there are hardly any adequate jobs. As a consequence, there is a lot of brain drain among highly qualified young scientists.”
Baiya Phytopharm aims to promote the commercialization of biopharma research in Thailand. “With the startup, I wanted to create a workplace for my students,” explains Phoolcharoen. “The company is based on the campus. My partner, the CEO of Baiya Phytopharm, is also a faculty member in the faculty of pharmaceutical sciences [at] Chulalongkorn University. She is a pharmacoeconomist taking care of business models, marketing and fundraising. I am responsible for research and use the platform for my students to give them practical lessons and experience. The students are all employees of Baiya Phytopharm and use the company’s project as their theses. We have post-doctoral researchers, Ph.D., master and undergraduate students presently work on different variations of the Covid-19 vaccine. This way, the students learn about planning, marketing—and about being rushed. We hope that there will be more biopharma startups like us in Thailand. The ecosystem will build up the capacity in the country, and in the future, we will be able to develop drugs and vaccines in the region, for the region.”

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Positive results
In March 2020, Baiya Phytopharm launched a Covid-19 test kit and started studying its vaccine candidates in mice. Further trials of the vaccine on monkeys in June showed promising results: All primates generated neutralizing antibodies, which means that the antibodies induced by the candidate vaccine can block the coronavirus from penetrating or damaging cells. Meanwhile, the company has started toxicology testing on rats and is preparing for the clinical trial phase, which it hopes to begin next year in June.
Much of the timing depends on finding the right facilities for the production process. “In order to be allowed for use in humans, the tobacco plants with the inserted Covid-19 proteins need to be purified; tobacco proteins have to be removed,” says Phoolcharoen. “There are only two facilities in Thailand which can be used, but they have never done any purification of proteins.”
Her company is in talks with the NVI to see if it is ready to collaborate in the purification process of the vaccine candidates. If so, the vaccine could be ready for human trials around the beginning of next year. Otherwise, a new plant would have to be built, delaying the process by about nine months. Once facilities are available, more than 10 million doses of the vaccine could be produced in one month. The aim is to offer an affordable vaccine, possibly also to other Southeast Asian countries.
So far, Baiya Phytopharm mostly used the co-founders’ money and the donation for a Covid-19 test kit for its vaccine research. However, the startup is raising funds to finance the phase I clinical trial and is hoping for private investors. “We will start with a crowdfunding campaign,” says Phoolcharoen. To her, the vaccine development is a long-term engagement. “We know that something like the Covid-19 outbreak is likely to happen again. So it makes sense to be prepared.”

Baiya Phytopharm employees are working on different variations of the Covid-19 vaccine.
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.

November 1, 2020
Recon Revival

Photos: SWM and SAI
New applications are creating new opportunities for reconstituted leaf tobacco.
By Stefanie Rossel
While many industries are still suffering the impact of the Covid-19 crisis, the reconstituted tobacco leaf (RTL) sector has remained largely unaffected. RTL suppliers report positive developments and remain optimistic. Also known as homogenized tobacco or recon, RTL was developed by SWM International (SWM) in the 1950s to save the valuable raw material by combining remnants of virgin tobacco during production. Today RTL is used for a multitude of applications.
In addition to reducing the filling cost of various tobacco product blends and reducing waste, RTL plays a vital role in cigarette blend design. What’s more, a dedicated form of recon, custom-made from carefully blended tobacco leaves, is the essential component of the consumables used in tobacco-heated products (THP).
There are several ways to produce reconstituted tobacco. Next to SWM’s papermaking method, there is the nano fiber technology developed by Star Agritech International (SAI) and a process called band cast, which is also known as slurry-type recon. Each of these types can be used in THP consumables.
Bruno de Veyrac
Bruno de Veyrac, SWM’s new generation product (NGP) director, says the RTL industry has held its own in the current challenging business environment. “So far, the Covid-19 pandemic has not affected our customers’ recon demand,” he says. “On the contrary, demand remains very strong during this period. We haven’t faced any supply disruption on both product lines conventional and THP. We have had to be creative to keep all our development programs with customers on track. And the global travel restriction makes it challenging to maintain close contact with our customers as we work to develop new products and to promote our product portfolio. We are working on virtual events to overcome this situation and will be sharing details on these events in the coming weeks.”

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SAI president and CEO Iqbal Lambat says that his company’s recon sales were impacted as many countries locked down. “This resulted in some of our client’s factories completely shutting down for three to four months. As a result, deliveries were delayed.”
Like de Veyrac, however, he remains optimistic. With global consumption of combustible cigarettes declining for years now, demand for recon was shrinking even before the pandemic. Currently, there is a discrepancy of about 50 percent between global RTL demand and capacity, which SWM estimates at 335,000 tons.
De Veyrac believes demand for recon will grow for several reasons. “First, apart from all multinationals and most tobacco monopolies, recon is not fully understood among small[-sized] and medium-sized companies. These companies represent 10 percent of global production. Second, the price of recon is cheaper than most tobaccos in the world. Having a ‘cheaper’ constituent in the blend with substitution rates of 10 [percent] to 20 percent and higher filling power than tobacco lamina drives better blend cost optimization. Third, with increasing legislation on lowering tar and nicotine levels worldwide, recon addition to the blend is one avenue to achieve this without compromising taste and draw.”
According to de Veyrac, recon can follow a different trajectory from cigarette sales as the inclusion rate can be adjusted upward or downward. “Thus it can offset or amplify the impact of the cigarette market attrition rate,” he explains. “This can vary from one customer to another and from one region to another. For the moment, we have been successful in mitigating the cigarette market attrition impact with our footprint in growing segments like cut rag and by promoting innovative products.”
De Veyrac cites SWM’s Nexfill as a success story. “This tobacco product was developed to deliver added value, such as an improved sensory experience, and allows blenders to substitute some tobacco strips thanks to advantages such as consistency, low degradability and immediate availability,” he says.

Since 2014, SWM has a joint venture with the China National Tobacco Corp.
Preparing for China
Meanwhile in China, the world’s largest market for combustible cigarettes with 350 million smokers, the excess RTL capacity versus demand remains unchanged, according to Steven Shu, general manager at SWM China. This is despite efforts in recent years to add a higher proportion of recon to cigarette blends, which traditionally have a rather low share of homogenized tobacco.
Steven Shu
Since 2014, SWM has a joint venture with the China National Tobacco Corp. (CNTC). “Functional, i.e., flavor sensory, RTL offers added value compared to cost-driven combustible cigarette blends,” Shu points out. “Therefore, the cost-driven RTL has higher share among low-end cigarette brands while the functional RTL has a higher share among medium-to-high-end brands. The key success factor in this market is the unique value offered for cigarette designing and processing. Indeed, the RTL product applications can be extended to cigarette peripheral applications such as cigarette paper, tipping paper and filter media. The commercialization and scale-up of THP products is a unique opportunity to boost overall RTL demand in China.”
Although China manufactures most of the world’s vapor hardware, domestic sales of next-generation products are comparatively small. “China has banned most electronic cigarette categories arguing that electronic cigarettes would take away market share from conventional cigarettes and progressively destroy the livelihoods of millions of farmers and workers employed by the tobacco sector,” Lambat explains. “There are some 30 million people engaged in the tobacco sector in China.”
For THP, no regulation has been implemented yet. According to Tobacco China Online, the CNTC is actively pursuing THPs. By March 2020, there were 852 open patents for THP and 56 patents for THP-related RTL, most of which were owned by the CNTC, the publication found.
“In the field of THP, China tobacco companies have made technological innovations and introduced various heating methods, such as chemical heating, infrared heating or other heating methods, to bypass Philip Morris International [PMI] IQOS’ heating method with a heating blade in order to reduce the possibility of intellectual property disputes with PMI,” says Lambat. “However, there are no THP products commercialized at present in China.”
Shu says that SWM is ready to supply the Chinese THP market as soon as it opens. “We have built a great expertise on THP papermaking recon over the past seven years, and we have the necessary assets to anticipate the THP market start in China. For the moment, CNTCs is conducting some market tests outside China with varied success. Product designs may evolve in the coming months, building on early consumer feedback and the challenging patent environment. Chinese authorities will most probably allow THP product sales in China only when they will be fully ready with the right products.”

Demand on the rise
China left aside, THP demand for RTL has increased remarkably in recent years, according to de Veyrac. “Over the last four years, we have managed to slow the erosion of recon papermaking in the conventional market, and it is now eroding less quickly than the conventional market. Indeed, papermaking recon sales for the THP market have been growing and now represent more than 20 percent of our recon sales. The THP market has shown some volatility, such as in Japan with the plateauing situation observed in 2018–2019, but hopefully the Japanese market is growing again. The launch of THP products in other markets, such as CIS and Europe, supports the global demand of THP papermaking recon, even if the growth rate is smaller than in Japan.”
The recon weight-per-stick on today’s THP consumable is eight times to 15 times that of the conventional cigarette, he explains. “A current THP stick contains 100 percent of recon as opposed to 5 percent to 15 percent in a conventional cigarette. So the growth of THP papermaking recon demand is much faster than the attrition of conventional recon demand.”
SAI selectively supplies recon to THP manufacturers, relates Lambat. “To be forthright, there is only one successful THP product in the world—IQOS,” he says. “There are many companies looking at the segment, but none have been remotely successful. Initially launched in 2014 in Nagoya, Japan, and Milan, Italy, IQOS is being gradually rolled out to other countries. As of October 2019, I have been informed that IQOS is available in 49 countries. However, I am equally informed that as much as 90 percent of all IQOS sales take place in a single country—Japan.”
Last year, SAI developed a THP device and tobacco sticks with its Chinese partner, Global Leaf. The design of the product, named XGen, however, was changed into a Juul-like vaping device in light of Juul’s promising development. “Our foray into XGen in the test market of South Africa has been highly successful apart from the lockdown—i.e., total smoking ban—period [of] April to August.”

SAI nanofiber supplied as cut rag
All eyes on IQOS
Many expect the U.S. to become the next major market for IQOS. Following premarket approval by the Food and Drug Administration (FDA), PMI launched the product in select markets in 2019. In July 2020, the FDA granted PMI “exposure modification” orders for IQOS, allowing the company to tell consumers that the product releases fewer harmful chemicals than a combustible cigarette.
Initial growth has been slow and has likely been impacted by the Covid-19 pandemic, according to de Veyrac. PMI is vertically integrating for recon supply, he adds, so this is unlikely to impact the supply-demand balance. “However, the significant step of FDA recognition of IQOS as a ‘reduced exposure product’ is very positive for this segment,” he says.
Another development that might bring new opportunities for the RTL sector has not materialized yet. The FDA intends to restrict the amount of nicotine in cigarettes and other tobacco products to make them “minimally addictive.” To date, however, the agency has taken no action to achieve this goal. “Should this legislation pass, then the opportunity for recon will be significant in the USA as well as internationally as other countries follow a USA-copycat approach,” says Lambat.
“We believe that papermaking recon is a strategic tool for the reduction of tar in general and nicotine in particular,” de Veyrac explains. “The challenge will be to reduce the nicotine while maintaining an acceptable taste, but we can also consider blending some botanicals, which will deliver natural flavors without adding nicotine. We are working on this topic with cigarette manufacturers in this region. In parallel, our experience with THP helps as papermaking recon in this environment plays a central role for taste generation and nicotine regulation. Moreover, we have found that in this new field there is no limitation on the percentage of recon in a blend. It is very difficult to predict the impact on recon sales of this type of maximum nicotine rule as we do not know what thresholds will be set or where and when they will be applied. Nevertheless, we do not see a shortfall of capacity even in this region.”

Reconstituted tobacco leaf originally was developed by SWM International.
Opportunities ahead
SWM diversified from tobacco in 2013, complementing its traditional tobacco and paper business now part of its Engineered Papers unit, with a second business unit, Advanced Materials & Structures, which specializes in resin-based materials for a variety of industries and applications. RTL, however, continues to play an essential role.
De Veyrac believes that papermaking recon capacity will remain higher than demand for the foreseeable future. “I see this as a great opportunity for developing new recon utilization in various product lines,” he says. “THP is one, and we believe that new platforms will be launched in the near future which are not cigarette-like, and papermaking recon will remain the major active component to generate the aerosol and transfer the natural nicotine and taste contained in the original tobacco. We also see that papermaking recon is still attractive to conventional cigarettes and OTP products, such as shisha, RYO or snus. The change and volatility of some markets and the pressure on some crops due to geopolitical or weather effects provide some uncertainty on the balance between the tobacco supply and demand and give more incentive to balance risk on blend structure. Papermaking recon is a sustainable product with permanent availability and short lead-time delivery. In addition, the high control and standard of those next-generation products will be maintained and even reinforced. An industrial process such as papermaking will ensure that those standards are fully respected, which is critical for our customers.”
SWM has also used its expertise in the papermaking process to explore another promising business category: Through its LeafLAB botanical-based product platform, SWM produces hemp “recon,” a malleable sheet from hemp leaf and flower biomass that allows for custom-made blending (see “Recon Mission: Hemp,” page xx).
SAI has chosen a different road, diversifying within the field of tobacco. According to Lambat, the company is on its way to transform itself from being a trader to being a producer. It therefore has invested heavily in derivatives. Among other things, it runs two recon factories.
“In the past 12 months, we have had a full year of ownership and management of our nano fiber recon plant in Santa Cruz, Brazil,” says Lambat. “The Brazilian senior management team has further perfected the manufacturing line and increased the plant’s output by 25 percent through efficiency generated modifications. Our full capacity of 3,000 tons per annum is fully booked. This line produces both Virginia and American blend recon,” says Lambat.
SAI has created a team to focus on capacity expansion. “This will consist of establishing a brand-new nano fiber recon plant with a target capacity output of 6,000 tons per annum. This will be housed in a new, dedicated building in Santa Cruz and will bring together our leaf trading team under one roof. We expect the new Brazil plant to be operational in the second half of 2021. The current recon line in Brazil will be deployed to Asia, and the selection of country is not yet decided, but Malaysia and South Korea are high up on the selection list. The capacity of Brazil, Asia and South Africa will exceed 12,000 tons per annum.”
The company broke new ground when it opened a recon line in Surabaya, Indonesia, in June 2019 that is devoted exclusively to the clove-flavored kretek sector. “In Indonesia, our recon plant in Java is now serving multiple clients with multinational and local manufacturers,” says Lambat. “It has also started exporting to the Philippines, Malaysia and Australia. The main service in Indonesia is toll production of clients’ kretek waste to kretek recon. We are evaluating establishing a recon line in southern Africa, most likely producing band cast as it is simpler to produce than nano fiber. And finally, we are evaluating an RTL line in Europe that will focus on the production of recon for cigar wrapper and binder in machine-made cigars. Both projects are slated for implementation in 2021.”
SWM is also considering such options.
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.

November 1, 2020
On the Right Track

Photo courtesy of Covectra
Leveraging serialization technology to combat tobacco tax evasion and counterfeiting
By Terrence P. O’Neill
Over the years, the U.S. federal government has endeavored to reduce tobacco use by heavily taxing products such as cigarettes, cigars, dips and nicotine pouches. A primary target of this strategy are underage consumers who tend to be price-sensitive and must be at least 21 years old to purchase these products at retail outlets since President Donald Trump signed Tobacco 21 legislation into law in December 2019.
Unfortunately, the lack of tax harmonization at the state level has created lucrative arbitrage opportunities for diverters to smuggle tobacco products from lower tax states to those with higher taxes. The unintended consequences include billions in lost local and state revenues and the development of gray markets that often supply the unauthorized channels servicing underage consumers.
Historically, states have depended on tax stamps or other static markings to maintain the integrity of its tobacco commerce; however, over time, savvy diverters developed product sources and supply chain partnerships to circumvent these checks and balances that were better suited for a simpler time.
Today, there are smart, cost-effective packaging technologies that provide beneficial value for all the stakeholders: agencies looking to maintain the integrity of the tax system or discourage underage tobacco use as well as those who manufacture these products—solutions that create a new level of transparency by uniquely identifying products that are monitored as they traverse the supply chain to the point of sale and to the consumer. Disruptive technologies that raise significant barriers to product diversion/tax evasion can also be the foundation on which new e-commerce and brand loyalty programs are launched.

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Fundamental benefits
Barcode identifiers have been permeating world commerce over the past 30 years, documenting data such as manufacturer, production dates and product codes. Initially its use was much like a tax stamp—one barcode for the many units in a production lot. Technology evolved; serialization enabled manufacturers to uniquely serialize each unit of production and aggregation allowed for each of the unique serial numbers involved in the packaging process (unit, pack, pallet) to be linked and then shared among trusted supply chain partners. New production and trade capabilities were created, and consequential efficiencies have been realized.
Track-and-trace solutions utilize the aggregation data shared between organizations by monitoring the product as it moves (tracking) and providing a history of where it has been (tracing). Like many new technologies, the initial benefits of track-and-trace were garnered within the internal business units from which the data was derived; however, over time, forward-thinking organizations have developed new strategies and solutions few could have imagined.
When one considers the factors that lead to tax evasion, the benefits of track-and-trace to enhance supply chain security are fundamental. Increased visibility to the movement of product from the manufacturer to the point of sale and the ability to develop an investigatory thread of who handled the product creates opportunities to prevent, monitor and respond to threats diverters pose. Additionally, as other internal organizations discover new methods of leveraging the track-and-trace data and supply chain partners become more sensitive to channel irregularities, the barriers to diversion are greatly reinforced.

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Brand loyalty and e-commerce
The value of track-and-trace can be a shared benefit for all the stakeholders as well. A recent supply chain assessment conducted among small, medium and large tobacco wholesalers revealed several opportunities where track-and-trace could improve operations—particularly for wholesalers that service many retail customers who spend vital resources and time reconciling returns. Many of the organizations advised that they are certain they pay rebates on products they did not sell; however, they are reluctant to risk the business relationship debating their suspicions. Unit-level track-and-track eliminates any disagreements as the wholesaler and retailer will be able to verify all returns with 100 percent accuracy. It also eliminates return debates with manufacturers, especially for products that experience frequent price changes or are periodically offered at discounts.
Manufacturers are also finding innovative ways of incorporating track-and-trace into other commercial initiatives such as brand loyalty programs and e-commerce models. Cloud-based solutions enable omnichannel branding platforms for targeted emails, SMS campaigns, games/contests/sweepstakes/points-based systems that create personalized messaging and enhance the depth of knowledge relative to customers, all of which can be connected through a consumer’s smartphone and track-and-trace integration.
Online tobacco e-commerce requires sites to maintain comprehensive information pertaining to all sales. Unit-level serialization provides an efficient method to track each transaction to its lowest level as well as to link with other processes required to complete the transaction, such as age verification.
When looking to partner with a company to develop and execute a track-and-trace strategy, it is important to look for those that have experience bringing together cross-functional organizations within a manufacturer across the supply chain and other external entities such as government regulatory agencies. Understanding how change will affect people, processes, data and technology needs to be thoroughly understood from production to consumption.

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A manageable endeavor
Technology should be adaptable and developed to be interoperable across IT systems not proprietary black boxes that require you to adapt to them. Integrating line, packaging, printing and vision systems, while complex, should not be presented as or understood to be a Herculean endeavor.
Track-and-trace solutions tend to rapidly grow in scope as the organization learns and discovers new ways of using the data and capabilities. Projects will require strict prioritization of goals and multigenerational delivery schedules to prevent scope creep from becoming a bottleneck or overwhelming an organization’s capacity for change.
Lastly, the regulatory requirements in the tobacco industry often change and evolve. Track-and-trace solutions offer manufacturers the opportunity to have a good faith dialogue with these agencies by demonstrating their efforts to comply with and improve upon the government’s interest in reducing tax evasion and addressing underage consumption. This provides a rare and vital opportunity to be a proactive partner in molding what the regulatory future may look like rather than being a passive onlooker waiting to react.
Terrence P. O’Neill serves as director of new product development at Covectra, a leader in track-and-trace solutions. O’Neill can be reached at toneill@covectra.com.

November 1, 2020
Exposing Claptrap

Photo: Myriam Zilles | PixaBay
If England wants to achieve its target of reducing smoking incidence to 5 percent by 2030, it should debunk the myriad stories that are presenting vaping in an inaccurately negative light.
By George Gay
One figure in a recent report on smoking habits in the U.K. seemed to be of special note. According to the report, “Adult smoking habits in the U.K.: 2019”*, which was published on July 7 by the Office for National Statistics (ONS), 52.7 percent of Great Britain’s smokers say they intend (my emphasis) to quit smoking.
Only 52.7 percent? That is below the figures usually quoted in respect of the proportion of smokers who want to quit. For instance, according to the September 2018 edition of Public Health England’s (PHE) Health Matters, about 60 percent of England’s smokers wanted (my emphasis) to quit.
So these figures raise an interesting issue, assuming the numbers are correct and are reasonably comparable*. For one thing, it seems odd that something of the order of 7.3 percent of smokers want to give up but don’t intend to do so because that means more than half a million people are seemingly acting irrationally, even looked at from their own subjective point of view. I mean, if our actions are observed by others, we are probably all seen to be acting irrationally at one time or another, but it is quite another matter for an individual to knowingly act in what she regards to be an irrational manner.
There could, however, be another explanation for this phenomenon. It could be that roughly half a million smokers in Great Britain have decided that while they want to quit, they are so sure they cannot that they don’t intend to try. If these people are fatalist or determinists, so be it. But it is a different matter if they have been convinced that they cannot quit. And this could be the case. Some of those in tobacco control have seemingly done what they would consider to be an excellent job of convincing smokers that quitting is almost impossible.
But this, of course, is nonsense. The ONS report also says that “62.5 percent of those who have ever smoked [in Great Britain] said they had quit, based on our estimates from the Opinions and Lifestyle Survey.” Interestingly, the ONS report presents, too, a comparison with the equivalent figure for 1974, 26.7 percent, which perhaps casts doubt on the claim that manufacturers in recent years have rigged formulations to make cigarettes more addictive—whatever more addictive might mean.
In fact, you would have to doubt whether the 52.7 percent figure is meaningful. The report also says that 21.2 percent of smokers intend to quit within the next three months, so it has to be assumed the other 31.5 percent have put no time limit on their intentions. In this case, I would suggest that while the “intention” expressed by the 21.2 percent of smokers is akin to a student’s multi-colored study plan, the “intention” expressed by the 31.5 percent of smokers who are looking beyond three months is nothing more than a pipe dream.

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Why it matters
This is important for the authorities because England has a target of reducing its incidence of smoking to 5 percent or lower by 2030. As of last year, the ONS reports, the incidence was down to 13.9 percent, so if the proportion of smokers in England falls during the next 11 years by the same amount as it fell between 2018 and 2019 in Great Britain (14.7 percent to 14.1 percent), the target is not going to be met.
The question is: Will the incidence fall by 0.6 of a percentage point year-on-year? In which case, it would drop to 7 percent to 8 percent by 2030. The ONS researchers referred to the 0.6 percentage point fall between 2018 and 2019 as “significant,” so it could be difficult to maintain such a fall every year given that it is probably reasonable to assume that the further the overall percentage falls, the more the smoker base will be reduced to a hard core. On the other hand, the further the overall percentage falls, the smaller the community of smokers will become, which raises the question of how long even committed smokers will continue with their habit once most of their acquaintances no longer join them outside the pub for a smoke.
And, of course, there is the million-dollar question around what effect the spread of Covid-19 has had and is having on the incidence of smoking. How many smokers are going to believe those who suggest that smoking and/or consuming tobacco or nicotine can help prevent the onset of the disease, and how many are going to worry that, as some claim, smoking and/or the consumption of tobacco or nicotine is likely to make their health outcomes worse if they do contract the disease?
But there is a billion-dollar question too. Are those intent on stopping smokers quitting their habit by switching to less risky tobacco or nicotine products going to continue to enjoy “success”? It has been said many times that the switch to vaping has stalled in the U.K., something that is strange because public health in the country has generally acted in a reasonably supportive way when it comes to vaping and its benefits. For instance, take this passage from Health Matters:
“There is a widespread misconception amongst smokers and health professionals that most of the harm of smoking comes from nicotine. This is perhaps the greatest obstacle we face as it leads to both nicotine-replacement therapy (NRT) and e-cigarettes being perceived as harmful, and as a result, smokers may not make a quit attempt using one of these routes.
Leading health organizations, including the Royal College of Physicians, Royal College of General Practitioners and the British Medical Association have all provided advice on the important role of e-cigarettes in helping smokers to quit.”
One of the issues that holds smokers back from switching to vaping is that smokers enjoy smoking and will clutch at any straws that help them, in good conscience, to continue with their habit, so if somebody comes along and casts doubt on the safety of consuming nicotine by other means, they will latch on to that doubt, no matter how ludicrous the ideas on which that doubt is based are. As is described in the accompanying piece, even though the lung injury saga of 2019 played out in the U.S. and involved a substance not permitted for vaping in the U.K., it probably damaged the cause of vaping in the U.K.
And there is no end to such tales. One story precis I saw recently claimed in its first sentence that “New research … shows that there are more unknown dangers associated with vaping.” What is written here makes no sense. More than what? And how do we who are not Donald Rumsfeld know that there are unknown dangers? In addition, the research seemed to assume that flavor molecules that attacked plastic would have the same effect on human tissue—somewhat akin to assuming that your stomach lining ends up looking like the inside of a teapot.
I cannot help thinking that if progress is to be made in reducing the U.K.’s smoking incidence in line with its 2030 target, organizations such as PHE should, as well as continuing their helpful work in trying to publicize the positive aspects of vaping, act quickly to debunk in the public sphere the myriad stories that are presenting vaping in an inaccurately negative light.
*The report’s figures come from two separate data sources, with those for the U.K. (England, Wales, Scotland and Northern Ireland) coming from the Annual Population Survey and those for Great Britain (England, Wales and Scotland) coming from the Opinion and Lifestyle Survey. I have taken the liberty of conflating some data in respect of Great Britain and England, and I have also conflated data that refers to adult smokers as being over the age of 16 and data referring to adult smokers as over 18. I have done this because it is the concepts behind the figures rather than the figures themselves that are of interest here.

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Philip Morris’ progress toward a smoke-free England
Patrick Muttart
It is now about three years since Philip Morris posed the question, Can Britain go smoke-free in the next 10 years? and Tobacco Reporter in July took the opportunity of this anniversary to ask Patrick Muttart, director of external affairs for the U.K. and Ireland at Philip Morris Limited, what progress had been made.
Tobacco Reporter: Part of the problem that Britain faced three years ago was that while vaping had helped a lot of people quit smoking, the switch from smoking to vaping had, for a number of reasons, stalled. Assuming that there has been some uptick in switching from smoking to the consumption of less-risky products, which products have been responsible for that uptick?
Philip Morris U.K.: Smoking prevalence rates are falling in the U.K. as more people either quit cigarettes altogether or switch to alternative products. Official figures from the ONS [Office for National Statistics] in July show that the proportion of current smokers in the U.K. has dropped from 14.7 percent in 2018 to 14.1 percent in 2019—continuing a downward trend since 2011. Central to this decline has been the role of smoke-free alternatives, such as e-cigarettes and heated-tobacco and more recently nicotine pouches.
In Great Britain, nearly 3 million people use an e-cigarette. Despite this, regular e-cigarette use has plateaued in recent years. A growing number of smokers in the U.K. mistakenly believe that vaping is equally or more harmful than smoking following the highly publicized reports in the U.S. of the lung injury outbreak in 2019. The substance identified as the primary cause of the outbreak in the U.S. is banned in regulated vaping products in the U.K. Nevertheless, these false fears have clearly affected smokers’ views towards vaping in the U.K. and come as the number of smokers who intend to quit continues to fall.
With product development and scientific substantiation working in lockstep together, tobacco manufacturers must therefore offer smoke-free alternatives that adult smokers can have confidence in. This will go some way in easing safety concerns, so smokers aren’t deterred from switching if they cannot quit altogether.
Philip Morris has invested significantly in its smokefree portfolio to offer products that are a better alternative to smoking and meet adult consumer preferences. IQOS, a heated-tobacco product, produces up to 95 percent less harmful chemicals* compared to cigarettes and by using real tobacco instead of liquid, delivers a more familiar and satisfying tobacco experience.
In the U.K., heated-tobacco volumes during the second quarter of 2020 increased more than five-fold over the prior year quarter, demonstrating the growing popularity in the category while underlining the huge role that tobacco-based smoke-free products can play in helping people switch to less harmful alternatives.
Do you think the U.S. Food and Drug Administration’s (FDA) authorization of the marketing in the U.S. of IQOS as a modified-risk tobacco product (MRTP) will help progress toward your smoke-free target in the U.K.?
The FDA’s authorization of the marketing of IQOS in the U.S. is an important milestone on our journey to becoming smoke-free. It marks the first time that [the] FDA has granted MRTP marketing orders for an innovative electronic alternative to cigarettes.
Following a multi-year review of PMI’s [Philip Morris International’s] evidence as well as a number of independent studies, the FDA decided that smokers who switch completely from conventional cigarettes to IQOS significantly reduce their exposure to harmful or potentially harmful chemicals in accordance with their interpretation of the U.S. law. Their authorization confirms that IQOS is distinctly different to cigarettes because it has been demonstrated to reduce exposure to harmful chemicals and that this information should be communicated to consumers to help guide their choice.
While the MRTP designation applies in the U.S., it is consistent with earlier conclusions of other leading regulatory and scientific bodies, including those in the U.K., which found that IQOS emits lower levels of harmful toxicants.
We believe that this latest decision by the FDA—and its previous decision to grant an oral tobacco alternative a modified-risk status—strengthens the argument for the U.K. to carefully review these next-generation tobacco-based alternatives, which have undergone comprehensive and robust scientific assessment. —G.G.
*Philip Morris points out that this does not necessarily equal a 95 percent reduction in risk. IQOS is not risk free.
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, 2020