Category: Harm Reduction

All Eyes on Harm Reduction

Photo: Borgwaldt KC
Suppliers of instrumentation and lab services are focusing on novel nicotine products.
By Stefanie Rossel
Two things are for sure: Instrumentation and lab service suppliers don’t have any time to be idle. And a look at their most recent innovations conveys a good idea about where the nicotine industry is heading.
Two years ago, instrumentation manufacturers and providers of laboratory services were busy supporting makers of electronic nicotine-delivery systems (ENDS) with their submissions for premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration.
“It certainly has been an interesting two years for ENDS manufacturers,” says Chris Allen, chief executive officer of Broughton, a U.K.-based contract research organization helping companies with delivering full-service regulatory projects.
Chris Allen
“In the last few weeks, there have been marketing denial orders (MDOs) for multiple Myblu and Juul products as well as three high-profile manufacturers being awarded marketing orders for their products. Broughton is thrilled to have played a significant part in the granting of some of these marketing orders, and we expect more to come soon.
“With these five separate PMTA decisions, the FDA has given the industry an indication of where the bar is set for gaining a marketing order. It also gives additional insight into its evaluation process as the rationale behind the Myblu and Juul MDOs were very different. Although not everyone benefited from these decisions directly, they have given manufacturers new confidence to move forward with product development and future business roadmap decisions.”
Nicotine companies are now considering new PMTA applications, modified-risk tobacco product (MRTP) applications and marketing authorization applications for products under European Medicines Agency regulation. “The industry isn’t losing its appetite or ambition for innovation and new product development,” says Allen. The PMTA process is now firmly established as one of the costs of selling next-generation nicotine products in the U.S., and manufacturers have adapted to this and are moving forward.”
In addition to full-service solutions, Allen observes a significant interest in Broughton’s standalone services, such as toxicological assessments and laboratory services, many of which are in support of preparing for or responding to PMTA deficiencies. “Unfortunately, many companies have been provided with a substandard service for their PMTAs. Now [that] we have understood the bar for gaining approval, many companies are requesting us to provide extra evidence to submit before their applications enter into substantive review.”
Focus on Reduced-Risk Products
Joost Elvers
Reduced-risk product (RRP) testing continues to be at the core of instrumentation suppliers’ business. “The industry as well as governmental organizations still have a strong focus on new-generation products like e-cigarettes and heated-tobacco products (HTPs),” notes Joost Elvers, group leader of key account management at Borgwaldt KC, a German manufacturer of quality control instruments and devices that is part of the Hauni group of companies, which also includes metrology specialist Sodim. “New product designs combined with upcoming further regulations and standardizations will continuously require close support,” says Joost. “Besides, the combustible product category experienced a focus revival with the opening of markets to cannabis and hemp products. We are therefore strengthening our portfolio of quality control equipment for the different product categories as well as our broad range of emissions testing devices. Furthermore, with the reduction of Covid-19 measures in companies and countries, our team of service engineers has increased its service activities again to support our customers on site in addition to the remote services that have been introduced over the last 2.5 years.”
U.K.-based Cerulean is focusing on three tobacco-related areas, according to Ian Tindall, head of innovation and marketing.
“The first is supporting companies within the ever-expanding heated-tobacco product market,” he says. “This still requires a lot of specialist equipment to generate information needed in support of MRTP applications as well as other product development activities.
“Also, with increasing amounts of products coming to full-scale production, we are finding routine quality assurance equipment is definitely an area we see as expanding. Partly, we are addressing this need by working with our sister company G.D in providing closed-loop control for makers and combiners and partly, it is rolling out and deploying our X-ray equipment to monitor combiner output.
“A second area we are really excited about is in producing routine test equipment for modern oral products as we see this as a rapidly growing area where quality assurance can be automated and improved. We launched a product, the Orion, just for this market, and we have received almost overwhelming positive feedback from companies.
“The final area is in supplying test equipment for the safe regulation of legal recreational cannabis use in the United States. We have rapidly found that this is not another cigarette-type application, and we are learning alongside clients how to ensure the safety and compliance to regulation of these now legal products.”
While the Orion is currently one of Cerulean’s most sought-after products, Tindall has detected another trend, which he finds difficult to describe. “It’s the service that starts with a customer saying, ‘I want to measure something, but I am not quite sure what,’” says Tindall. “The service is about working with customers to develop test and measurement equipment for new-to-the-world products that have no background of tests to ensure conformance.”
While Cerulean’s commitment to customer confidentiality prevents Tindall from elaborating on current projects, he cites the example of a customer who wants to prevent burst capsules from wetting tipping paper. “We might come up with a way to measure the radial and longitudinal positioning of the capsule in the filter, which prevents liquid getting too close to the outside tipping paper,” he says.
New Testing for New Products
Cerulean’s Orion
Cerulean’s Orion, the first automated snus test station to enter the market, is but one example of an array of innovations for testing novel nicotine products. Currently, the Orion measures the weight, length and width of the pouch along with the tensile strength of the pouch seams as well as extension against load.
“We will, before the end of Q3, deploy extra measurements in the form of longitudinal pouch seam position and overlap, pouch transverse seam size and pouch moisture,” says Tindall. “We are listening to the customer base and expect to be adding further enhancements in the future once we have really established what is important to our customers, including the potential for auto-sampling and feedback to a maker to reduce reject rates. We expect Orion to follow the trajectory of most of our products in that it will be developed and enhanced as our customers’ needs change.” The Orion can be used for all types of modern oral pouches as long as the size fits in the maximum and minimum dimensions allowed and the pouches follow a rectilinear format.
Sodim recently introduced a test station dedicated to the testing of HTP consumables. “HTP and RRP confront us with many challenges, such as different format compatibility and new measurement request,” says Christine Camilleri, director of sales and marketing at Sodim.
“This, combined with sustainability, guides our development team toward instruments [that are] fully scalable, responding to the needs of this market as regards to quick product changes. All our test stations are compatible with HTP products of any size. Multiple diameter measurements on filter rods are an example.”
From Borgwaldt comes the LM1E DtL, a new vaping machine that provides direct-to-lung testing. ISO 20768 requires aerosol to fill the mouth before entering the lung, which is commonly named mouth-to-lung vaping.
Consumers, however, tend to vape different products differently. Borgwaldt KC developed the LM1E-DtL based on the draft development standard of CEN/TC437. “This vaping machine fulfills the requirements of an additional vaping regimen considering inhalation from an electronic cigarette directly into the lung,” explains Elvers. “As you can easily imagine, the emissions composition differs from that generated under the ISO 20768 process and therefore reflects the consumer exposition much better.”
Design Support
The industry’s focus on RRPs is reflected in the demand for lab services too. With nicotine pouches, one of the most rapidly growing segments within the reduced-risk category, Broughton is seeing much interest in its consulting and testing services. “There are some interesting innovations around oral pouch materials, so our feeling is that the scope for oral pouches will grow beyond nicotine. The products are covered by the PMTA process within the U.S., so we have been busy providing support for these applications. Within the EU, any work performed is typically to support product development and/or due diligence. As per the ENDS analysis, the focus is placed upon nicotine content and HPHCS [harmful and potentially harmful constituents]. However, automated (flow-through) dissolution analysis is widely used to support the R&D process.”
Broughton is also offering development services for next-generation products as well as for cannabinoids, another big theme in the sector. The company already has a medicinal cannabis and CDB business. For novel nicotine products, it has launched a division that helps customers design their products in a way that increases the chance of regulatory approval, for example by ensuring that development decisions taken early in a project support the later stages of a planned regulatory submission or go-to-market strategy.
“This could be early development material or ingredient selection to expedite extractables and leachable studies or ensuring product designs are suitable for mass-market manufacturing scale-up,” says Allen. “Our services are completely scalable to the needs of the client so we can help with one stage of product realization or work as an extension of an in-house development team all through the product lifecycle. We created the service in response to requests from existing clients, so we know there is a demand for this sort of expert advice and consultancy.”
As far as trends are concerned, Allen sees growth in the diversity of nicotine-delivery systems. “There are more heated-tobacco products, more modern oral nicotine pouch manufacturers plus innovations like water-based vape devices and new heating mechanisms,” he says. “Disposable vape devices are also growing in popularity, and there are some exciting innovations around device material selection, especially focused on improving the recyclability of products, which we predict will be very important in the future. At Broughton, we work with a wide variety of ENDS manufacturers of different sizes and backgrounds. We are seeing a lot of new technology coming from regions like the Middle East, India and Indonesia in addition to where you’d expect it to come from, such as the USA and China. It really is a very dynamic industry with lots of new players looking to bring something different and differentiated to the market.”
Greener Measurements
While flexibility plays an important role in novel-products testing equipment, Borgwaldt KC and Sodim have also noticed growing demand for sustainability. “We can currently see two trends gaining momentum within our customer base. One is for sure the change in available product portfolios of some of our customer groups; the other is the realization of sustainability targets in the instruments environment,” explains Elvers.
“We therefore spend many efforts in making flexible emissions testing solutions for combustible cigarettes and cigars as well as for the new electronic product segment of ENDS. The successful launch of the 10-port vaping machine NGX10 and its continuous modularization with further add-ons shows us the high demand for such a modern and ENDS-dedicated solution on the market. Besides this, the trend of rethinking life cycles of instruments and how they can be converted for new demands to save resources made us create our ‘lifetime extension’ program in which we update older instruments with the newest measuring technology by fully building upon existing infrastructure and reusing or refurbishing existing parts for a more sustainable outcome.”
Camilleri notes that customers are moving to “green” products, such as hemp and cannabis. “On physical parameters, they are aiming to get fast measuring solutions in a quickly changing market,” she says. “Specific developments become the norm compared to standard solutions in the past. We orientate our products on super flexible instruments adapted to different market environments and production allowing long-term evolution of test stations, including the possibility to upgrade them to cater to new product trends. Our products can have several lives in different segments of the industry, reducing the impact on the environment.”

Christine Camilleri
Testing Without Standards
As more countries legalize cannabis, instrumentation makers detect new opportunities—even though testing standards are not yet in place. “Weight is currently the most important parameter, but we also see a new interest to measure the same physical parameters as in conventional cigarettes to improve the quality of the products and reduce cost generated by waste,” says Camilleri, whose company has adapted its Sodiline and Sodiqube test stations to cannabis testing.
Borgwaldt and Sodim are active in the raw material and emissions testing segments of cannabis products. “Combined with the experience gained with production machines of our sister companies Garbuio and Hauni, we established ourselves as a main contact point for raw material and production control as well as emissions testing for cannabis products,” says Elvers.
Borgwaldt has developed an electrostatic precipitation trap, HV1, which is used to trap emissions for the analysis of metals. Being a phytoextracting plant, cannabis collects and saves metals from the soil so that these elements will be released during the smoking and consumption process. “This smoking and vaping machine-independent solution can be used as a flexible add-on for the emission control of metals of cannabis products,” says Elvers.
Cerulean also has an electrostatic precipitator trap upgrade kit in its portfolio. The company has been working with Kaycha Labs in Denver, Colorado, USA, to overcome some of the problems inherent in the Colorado state requirement for emissions testing for metals, and it has published several white papers describing some of the changes required to allow a vaping machine to work with highly viscous cannabis oils. “This work supports the multiple machines we have sold to legal operations in the United States and hopefully demonstrates our commitment to this new industry,” says Tindall. He hopes that a set of practical conditions and analysis standard operating procedures can be adopted by the cannabis industry that provide a basis for comparisons from state to state.
Agility is Key
Regarding future requirements for testing equipment and lab services, Sodim and Borgwaldt KC say agility will be key. “Demands change within months, [and] products appear and disappear on the markets in a short period of time, therefore we as a supplier of quality control and emissions testing equipment have to keep up and even overtake these market demands and show our ability to react fastest to new market challenges,” says Camilleri, speaking for both companies.
“Also, digital solutions within the instruments business are expected to play a bigger role in the future. This can be related to the use of data being generated by measurement equipment or the combination and common usage of such data by the measuring instrument and the manufacturing systems. Even the partial replacement of physical measurements by a digital process is something to be considered as a future requirement.”
“My personal view is that we have probably hit, or are near to hitting, an innovation ceiling for vaping products,” predicts Tindall. “HTPs are still in a growth phase, and there will be other entrants beyond the big players currently in the market. There will be novel HTPs for sure over the coming five years.”
Tindall expects quality assessment and quality control for physical tests to transition from the laboratory to the production floor. “This means we need to have robustness and simplicity of operation in the forefront of our equipment design,” he says. “Especially if, as I expect, HTP manufacture is increasingly accompanied by more stringent traceability [requirements] as HTPs become even more highly regulated than combustible cigarettes. This will make current good manufacturing practice a baseline requirement that our equipment would need to support. Moreover, the interconnectedness of manufacturing processes and data retrieval becomes a fundamental of design and not just an afterthought.”
The recreational cannabis market, he says, will continue to spread. “This will mean that belatedly, there will be regulation of emissions, requiring new vaping equipment.”
With more than 1 billion adult smokers in the world—a number that is still increasing—Allen expects demand for testing to support regulatory submissions to increase over time, with a demand for more sensitive testing criteria, more in-depth analysis of test data and great insight from real-world evidence based on human factor studies over longer time periods.
“Remember, this is still a very young industry, so continuing to collect data is going to be essential to underpin belief in reduced-risk products and their contribution to tobacco harm reduction,” he says.
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.

August 1, 2022
Tools Of The Trade

Photo: JTI
At a summer event in London, JTI showcases some of the devices that may help England achieve its smoke-free ambitions.
By George Gay
In his U.K. government-commissioned review, “Making Smoking Obsolete” [in England], Javed Khan said he had seen no evidence of a plan by industry to move toward meeting the ultimatum “for industry to make smoking obsolete,” which was included in the government’s 2019 prevention green paper. I’m not certain what is meant by “industry” here, but assuming it means partly or exclusively the tobacco industry, and perhaps the nicotine industry, this statement seems extraordinary. After all, one of Khan’s reviews, “Critical Interventions,” recommends promoting as effective tools to encourage smokers to quit their habit some of the products that, for well over a decade, the tobacco and nicotine industries have been developing, making available and promoting insofar as they have been allowed to do so.
The independent e-cigarette industry has arisen almost solely for the purpose of converting as many smokers to vapers as possible—to making smoking obsolete, if you like. That is its raison d’etre. Of course, a purist might complain that individual vaping industry firms also want to make a profit, but making a reasonable profit provides funding for new developments and, more generally, makes the world go round.
So perhaps the government’s ultimatum was aimed only at the tobacco industry. But even in this case, it seems somewhat uncharitable not to give recognition to the enormous investments and efforts that have been made by tobacco companies in developing what I am comfortable calling lower risk products and, especially, in the scientific validation of their products’ lower risk credentials. And this is not to mention that, as far as I am aware, it was individual tobacco companies that first started to apply the concept of “harm reduction” to tobacco/nicotine consumption and that, in the U.K., first suggested setting a target date for ending smoking: 2027.
If my memory serves me correctly, the emergence of the tobacco harm reduction principle predated the arrival of vaping products and was based on snus, a product that is without doubt one of the least risky tobacco products of all but one that, inexplicably, was and is banned in the U.K. and one that Khan believes should remain banned. And it is worth mentioning that the country might conceivably have been well on the way to meeting the 2027 target if the government had been more ambitious and reacted more positively in 2017, when the target was suggested, largely based on the use of heated-tobacco products (HTPs). Certainly, I think the U.K. would have been in a better place if e-cigarette companies had been allowed to advertise the consumption of their vaping products as being 95 percent less risky than the consumption of combustible cigarettes, a figure that, to its credit, the government had long accepted.
Coincidentally, a range of U.K.-market, lower risk products was on display during Japan Tobacco International U.K.’s summer event held at the Mandarin Oriental Hotel in London on July 13, one of which was launched in 2019 and another of which was launched in 2020—so, in line with the government’s ultimatum, though not necessarily in response to it. There were three products in all—a vaping device, an HTP and a nicotine pouch—so, at the very least, JTI U.K. must be given credit for having made a huge effort, if not toward making smoking obsolete per se but toward providing as far as it can the tools and encouragement for smokers to switch to less harmful products. It is, after all, beyond the power of a single company to “make” smoking obsolete; only the government has the power to come close to doing that and, no doubt for good reasons, it has chosen not to do so.
The summer event, dubbed “Innovating for Tomorrow,” was attended by about 300 people, including those representing trade and retail partners, community investment partners, agencies, think tanks and the media. About 20 politicians from across the political spectrum were also scheduled to attend, though whether they all tore themselves away from the Conservative Party’s leadership hustings in Westminster I don’t know. Given this attendance and an abundance of fine drinks and delicious food, it is not surprising that the evening was devoted, aside from two short speeches—by Charlie Cunningham-Reid, U.K. corporate affairs and communications vice president for JTI U.K., and Gemma Bateson, U.K. sales director—to relaxed discussions around and away from the product displays. On what was for England a hot day, the venue, with its two large, airy rooms and pleasant garden overlooking Hyde Park, lent itself to such discussions.
One of the products on display was Logic Compact (more information on the products displayed is available at www.jti.com/europe/united-kingdom), a closed-tank e-cigarette that is used with pods of e-liquid available in a range of flavors. At the display stand for these products, much was made of the high level of testing that was carried out on the devices and e-liquids. And, interestingly, a figure from the Office of National Statistics that was on display had it that about 3.3 million people in the U.K. used e-cigarettes, which was something of a testament to the effort that had been made by the vaping and tobacco industries to deliver smoking obsolescence.
The most recent JTI U.K. reduced-risk product to be made available on the U.K. market and that was on display at the summer event was Ploom, an HTP launched in 2020. Ploom is said to offer an authentic smokeless tobacco experience delivered through the action of an innovative heating technology that causes no combustion and no burning and therefore produces no smoke or tar. Consumers have already embraced e-cigarettes, and the government has largely accepted them, so JTI U.K. will be hoping to see the same level of acceptance for HTPs. These products are certainly likely to appeal to consumers on price, especially those used to paying around £9 ($10.77) for a pack of cigarettes. After an initial outlay of about £45 on a device, consumers pay about £4.50 for a pack of 20 EVO tobacco sticks, which come in a range of flavors and strengths.
Meanwhile, JTI U.K.’s Nordic Spirit nicotine pouches, which were launched in the U.K. in 2019 and are available in a range of flavors and strengths, are said to comprise a discreet product that can be used at any time since, on consumption, they produce no smoke or vapor and contain no tobacco. Here is a product, I think, that indicates the length JTI U.K. has gone to cut the use of combustible products. When it launched Nordic Spirit, the company could have had little idea how the product was going to be received because there was little knowledge about such products among U.K. consumers, who, after all, had not been allowed to buy snus, a cousin of the nicotine pouch. Surprisingly, perhaps, but encouragingly, participants at the London event were told that sales growth had been good, which is perhaps an indication of the importance of choice in offering alternative products to smokers, who too often are treated as if they comprised one homogeneous group with one set of likes and aspirations.
The news about the growing interest in nicotine pouches must be good, too, for the environment. This is a pared-back product that must have a low negative impact on the environment, a feature that we are all discovering is hugely important. I have to say, too, that during conversations around the display stands, I heard of the initiatives being undertaken by JTI U.K. to ensure that when alternative devices are no longer operable, they are disposed of properly. There is probably some way to go in regard to this, but you have to say that these efforts are likely to be some way ahead of those of the government. As I am writing this piece, of the five people still standing for the leadership of the Conservative Party and therefore to become the next prime minister, only one was unequivocally backing the government’s net-zero emissions by 2050 target.
It’s worth noting that a small pamphlet, “JTI U.K. at a Glance,” that was made available to participants at the summer event indicated that JTI is still committed, throughout its global operations, to net-zero greenhouse gas emissions by 2050.
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.

August 1, 2022
Report Supports Vaping as Smoking Alternative

Photo: andriano_cz
A new report published by Belgian’s Superior Health Council supports vaping as a safer alternative to smoking or as a quitting aid that can significantly reduce health risks.
Based on the current state of knowledge, the report concludes that the exclusive use of e-cigarettes by (ex-)smokers—provided that they actually stop smoking—could lead to a significant reduction in health risks
The report also states that vaping is not risk-free and is therefore not recommended for nonsmokers, especially the young. Further long-term safety data are needed.
The council prepares scientific advisory reports to guide Belgian political decisionmakers and health professionals. The report took two years to prepare and was a consensus document prepared by a wide range of experts with different views.
While restrictions on vaping are prudent the report warns that “limiting vaping and other nicotine use does not jeopardize the goal of reducing the prevalence of smoking.”
Advocates of tobacco harm reduction welcomed the report. “Wisely, the guidelines advise risk-proportionate regulation of vaping,” wrote Colin Mendelsohn, a medical professional and founding chairman of the Australian Tobacco Harm Reduction Association, on his website. “Vaping is much less harmful than smoking and should be regulated much more lightly in line with the lower risk.
July 2, 2022
Activists Outraged Over Vaping Policy Guidance

Photo: pixarno
Tobacco harm reduction activists are outraged over a new Australian government document on vaping.
The National Health and Medical Research Council (NHMRC) recently published its 2022 CEO Statement on Electronic Cigarettes, which provides guidance to public health policymakers.
According to the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA), the document falsely claims that vaping is not an effective quit-smoking tool, but a gateway to smoking with most vapers becoming dual users. Vaping, the document states, also increases the risk of smoking relapse. The NHMRC exaggerates the health impacts, poisoning and explosion risks of e-cigarettes, according to CAPHRA, while references to toxins and potential harms are made without a fair comparison to smoking.
“This latest government document on vaping makes outrageously false claims and will only cost more Australian smokers their lives,” says Nancy Loucas, executive coordinator of CAPHRA.
“Ridiculously, Australia’s chief medical officer considers vaping the next biggest health issue after COVID-19. Has he ever heard of smoking which kills over 20,000 Australians every year? This 18-page document is a complete joke. It is full of statements that can be easily debunked by international science and human evidence the world over,” says Loucas.

This egregious document is not worth the paper it’s written on, yet it’s now the bible for public health guidance in and around Australia.
Nancy Loucas, executive coordinator, CAPHRA
CAPHRA says Australia’s hardline anti-vaping approach is increasingly out of step with other Asia Pacific countries, with the Philippines, Malaysia and Thailand set to lift their vaping bans. What’s more, New Zealand, across the Tasman, is already operating under a regulatory framework that has seen smoking rates decline.
“This egregious document is not worth the paper it’s written on, yet it’s now the bible for public health guidance in and around Australia,” says Loucas.
It is illegal to sell, supply or possess nicotine vaping products, with Australia the only Western democracy that requires a nicotine prescription to vape. Alarmingly, 2.3 million Australians continue to smoke cigarettes.
Last year Australia’s Therapeutic Goods Administration expanded its prescription-only model with customs clamping down at the border on the likes of personal imports of nicotine vaping liquids from overseas websites.
July 1, 2022
All Hands on Deck

Photo: The Global Forum on Nicotine
Tobacco harm reduction is gaining momentum but continues to face many hurdles.
By Stefanie Rossel
“Tobacco harm reduction: Here for good“ was the theme of this year’s Global Forum on Nicotine (GFN) conference, which took place in Warsaw June 16–18, 2022. Around 50 speakers and panelists discussed the issues that will determine the future of safer nicotine use and tobacco harm reduction (THR). The meeting was preceded by a day of satellite events and once again featured the International Symposium on Nicotine Technology, which highlighted the latest technological advances in the rapidly changing nicotine delivery landscape.
Two hundred years after the first snus brand was launched in Sweden and almost 20 years after the Chinese pharmacist Hon Lik invented the modern electronic cigarette, THR continues to face challenges. While THR is making good progress in high-income countries, low-income and middle-income countries (LMICs), where about 80 percent of global tobacco users live, are mostly excluded. In India, for example, where smokers of bidi cigarettes and consumers of hazardous oral tobaccos such as gutka represent 85 percent to 90 percent of tobacco users, bidi packs do not even carry health warnings. While gutka is officially banned, prohibition is not enforced. Instead, health authorities focus on the harms of vaping. Although vape products are banned in the country, they are readily available on the black market.
Thailand legalized the cultivation and consumption in food and beverages of cannabis in early June but continues to prohibit vaping under strict penalties. Vapers risk a jail sentence of up to 10 years. An observational study in South African hospitals not only demonstrated that inpatients had a lack of knowledge of nicotine-replacement therapy (NRT) but also that doctors in LMICs are often not trained to explain to patients how to use NRTs. Research comparing THR in Russia, China, Indonesia and India found that once smokers have understood that combustible cigarettes are harmful, the key challenge is changing behavior. In Russia and China, consumers are generally aware of reduced-risk products (RRPs) whereas in India and Indonesia, nicotine is considered the most harmful constituent, and few people know that RRPs exist.

Uncontrolled Influence
Most LMICs have ratified the World Health Organization’s Framework Convention on Tobacco Control (FCTC), which takes a dim view of vaping. This position is backed by one of its largest donors, billionaire and former New York City mayor Michael Bloomberg. In his keynote presentation, journalist Marc Gunther demonstrated that philanthropy is an excise of power that requires scrutiny.
By pumping millions of dollars into nonprofits and anti-vaping groups worldwide while funding university researchers, a media initiative and a nonprofit health consultancy through the Bloomberg Philanthropies foundation has created an effective global anti-vaping campaign that is not driven by science, according to Gunther. For example, The Union a Bloomberg-backed nongovernmental organization headquartered in Paris, recently published a paper calling for a ban on all e-cigarettes in LMICs. Most damaging, Gunther said, was the relationship between Bloomberg and the WHO, which the billionaire has generously funded with many millions of dollars for a variety of projects, including $5 million for its tobacco work in 2019.
While few countries ban RRPs outright, the products often face prohibition by stealth. This month, Germany started applying a tax to e-cigarettes, which came on top of the previously applied value tax. With e-liquids now being taxed by volume, their price has almost doubled, which prevents smokers from switching as it conveys the impression that a product taxed so high must be equally as harmful as combustible cigarettes.
In the U.S., the Food and Drug Administration picks the winners and losers through its tobacco product authorization process with little regard for consumers. The agency’s requirement for comprehensive scientific documentation of a product’s contribution to the protection of public health represents a hurdle that only the largest and most amply funded nicotine companies can manage.
Prohibiting elements that make vapor products appeal to smokers, such as nontobacco flavors, are also a kind of stealth prohibition that has no effect on overall smoking or vaping prevalence. U.S. states that ban flavors miss out on tax revenues and Master Settlement Agreement money while the number of smokers stays the same and vapers buy their products in neighboring states. Prohibition by stealth, panelists agreed, stifles innovation and, given the discrimination against vape products compared to combustibles, may be potentially illegal in trade law terms.

Academic Freedom Under Threat
Misinformation about RRPs and the question of who can be trusted remains one of the biggest issues in tobacco harm reduction. While the trust in science has generally increased through Covid-19, countless flawed studies on less hazardous nicotine products continue to circulate, contributing to misperceptions among consumers. Google Scholar ranks studies according to popularity rather than quality, so even two years after e-cigarette or vaping use associated lung injury (EVALI), studies attributing the outbreak to nicotine vapes rather than illicit THC products still feature prominently in search results. But even research professionals are often interested only in the title, abstract and conclusion of a study and thus fail to detect flawed methodologies.
A recent example of misinformation is the claim by several emission studies that the aerosol of vape products is polluted with heavy metals. By providing a concise explanation of the ingredients of e-liquids and the complex chemical processes that take place in a device during vaping, Miroslaw Dworniczak, a Polish chemist and author, refuted this assumption, concluding that despite the presence of some potentially dangerous compounds, e-cigarettes were far less risky than regular cigarettes. Mexican physicist Roberto Sussman, who examined 12 studies on metals in e-cigarette emissions, found that all of them were methodologically flawed.
Having become ideological rather than evidence-based, the health debate about vaping is full of contradictions. Mark Tyndall, an infectious disease specialist from Canada, compared his experience working with HIV with the experience in vaping. It took 40 years for HIV to lose its association with fear, blame and stigma—issues that smokers and vapers are facing too. Medical treatment of AIDS was the greatest breakthrough—vaping, he claimed, could be a similarly efficient weapon to treat smoking.
Stigma is also present in the academic world, and it goes far beyond suspicion of tobacco-funded studies. Scientists detected “the ghost of Senator Joseph R. McCarthy,” the paranoid U.S. communist hunter of the 1950s, as they often confronted hostility from fellow academics and institutions. Experiences of suppressed academic freedom ranged from a lack of institutional support for THR research to “mobbing” and exclusion from faculties.

Here for Good, but …
So, is tobacco industry transformation a myth or a reality? Sharing her view from the corporate side, Flora Okereke, head of global regulatory insights and foresights at BAT, said that her company’s efforts to help smokers switch to less risky products—and therefore doing something for society—had given employees a sense of pride. Peter Stanbury, a political economist, evaluator and management consultant, pointed out that companies such as British Petroleum are also in the process of transformation, driven internally by people who realize that change is required and externally by regulation.
In advancing tobacco harm reduction, regional networks in THR consumer advocacy play a vital role. Nancy Loucas, founder and executive coordinator for the Coalition of Asia Pacific Tobacco Harm Reduction Advocates, related how her organization, faced with challenges such as government interests in tobacco growing and manufacturing, notably in China and Indonesia, and foreign philanthropist influence in the development of policy, achieved a paradigm shift in several countries by working with an expert advisory group.
Tobacco harm reduction, panelists agreed, is here to stay; consumers have a right to it. But accessibility of THR will remain a problem, and more restrictions are on the horizon.
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.

July 1, 2022
Bentley: Juul Exit Bad For Harm Reduction

Photo: steheap
The Food and Drug Administration’s order to remove Juul products from the U.S. market threatens progress in tobacco harm reduction, according to Guy Bentley, director of consumer freedom at the Reason Foundation.
Guy Bentley
Writing on the foundation’s website, Bentley reminds his audience that e-cigarettes are not only less harmful than their combustible counterparts, but they are also more effective in helping smokers quit than FDA-approved therapies such as nicotine gum and patches
The FDA, he writes, acknowledged as much when it authorized Vuse e-cigarettes in 2021 and claims it recognizes the role these safer nicotine alternatives can play in reducing smoking.
If the Juul order is implemented, says Bentley, many Juul users will likely return to smoking, while a portion of smokers who would have transitioned to Juul will continue to light up.
Bentley says the FDA Juul denial makes a mockery of the claim that it’s evaluating science in the best interests of public health. A study published in the New England Journal of Medicine found e-cigarettes to be twice as effective as traditional nicotine replacement therapies.
According to Bentley, the decision also punctures a hole in the logic of the FDA’s recently announced policy to reduce nicotine levels in cigarettes to minimally or non-addictive levels. Without an acceptable legal alternative, smokers may simply smoke more cigarettes to get their nicotine fix.
“By banning the most popular e-cigarette among adults, the agency’s commitment to transitioning smokers to safer alternatives rings hollow,” writes Bentley.
June 30, 2022
Ramström: Tobacco Harm Reduction Works

Photo: Finn Bjurvoll Hansen
A new study launched at the ninth annual Global Forum on Nicotine in Warsaw shows implementation of the World Health Organization’s tobacco control measures known as MPOWER has no clear association with low-levels of tobacco-related mortality in Europe.
Instead, the independent research, conducted by Lars M. Ramström, shows that switching from smoking to Swedish-style snus, a safer nicotine product, is a more effective strategy to reduce the harms caused by tobacco.
In 2007, the WHO launched MPOWER, a process and monitoring mechanism to implement the Framework Convention on Tobacco Control. Comprising six measures, it aims to reduce the demand for tobacco. But, despite 15 years of MPOWER, there are still 1.1 billion smokers worldwide, a total unchanged since 2000, and 8 million annual tobacco-related deaths, according to researchers.
To assess MPOWER’s effectiveness, Ramström compared the extent of implementation of these tobacco control measures with tobacco-related death rates across Europe by using figures provided by the Tobacco Control Scale (TSC), a tool that grades every European country’s level of MPOWER application, and data on tobacco-related mortality from The Global Burden of Disease.
After analyzing his results, Ramström found no correlation between tobacco-related mortality and a country’s level of implementation of MPOWER measures for Europe’s women, and a very weak correlation for the continent’s men.
Crucially, though, the two countries with the lowest tobacco-related mortality for men were Sweden and Norway. In both nations a large proportion of male smokers have switched from cigarettes to Swedish-style snus, a product that is freely available in both, but banned from sale in the EU except Sweden. Despite Sweden’s TCS score being below average, it has achieved a lower rate of tobacco-related mortality than all the countries that have higher levels of MPOWER implementation except Norway, providing further evidence in support of tobacco harm reduction.
June 17, 2022
EU Urged to Embrace Harm Reduction

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Medical and addiction experts called on the EU to embrace tobacco harm reduction during an event organized by the Centre for Economic and Market Analysis (CETA) in Prague.
Debating how a tobacco-free generation—where less than 5 percent of EU-citizens use tobacco—can be achieved by 2040, they concluded that the objectives laid out in Europe’s Beating Cancer Plan cannot be attained under current circumstances and that a revised tobacco control policy based on scientific evidence is needed.
“If the European Commission is serious about its plans to reduce the number of smokers and the impact of smoking, it must start considering the concept of risk reduction in the area of smoking,” said Czech National Drug Coordinator Manager Jindřich Vobořil, in a statement.
“The Czech Government has committed itself to this approach in its program statement for the upcoming [EU] Presidency. I will also promote it in relation to the ongoing evaluation of the Tobacco Products Directive, which is an effective policy to achieve a real reduction in the number of smokers of conventional cigarettes,” he added.
“The data show that the abstinence approach is inadequate. The solution for smokers is to switch to less harmful alternatives,” noted Ernest Groman, of the Vienna Nicotine Institute. The only European country close to the 5 percent target is Sweden. According to the experts, the low number of smokers is mainly due to the availability of less harmful alternatives.
During the event, the CETA published a study ranking EU member states according to their ability to implement the concept of risk reduction. The Czech Republic finished second.
The Czech government should use the upcoming EU Presidency to undertake a comprehensive review of tobacco dependence policies based on science rather than emotion, according to CETA Research Director Aleš Rod, who also sits on a Czech government advisory board.
June 10, 2022
Bangladesh: MPs Want Tobacco-Free Country

Photo: LadyInBlack | Adobe Stock
About 40 Members of Parliament (MPs) adopted a declaration to achieve tobacco-free status in Bangladesh by 2040, according to The Dhaka Tribune.
MP Habibe Millat presented the declaration at a media briefing on May 20, 2022, in Cox’s Bazar. The three-day Conference on Achieving a Tobacco-Free Bangladesh by 2040 was organized by the Bangladesh Parliamentary Forum for Health and Well-Being (BPFHW) at the Sea Pearl Resort. The conference was organized in association with the Shastho Shurokkha Foundation and Campaign for Tobacco-Free Kids (CTFK) Bangladesh.
Signed by Habibe, chairman of the BPFHW, the 16-point declaration acknowledged the progress on the commitment so far, recognized the urgent need for action and recommended some key actions to realize the vision.
Officials noted progress through the Smoking and Using of Tobacco Products (Control) Act 2005, as amended in 2013, and the Smoking and Tobacco Products Usage (Control) Rules 2006 and 2015, which led to a reduction in overall adult smoking rates from 43.3 percent in 2009 to 35.3 percent in 2017.
May 23, 2022
White Coats, Fuzzy Facts?

Photo: Lisa F. Young
Educating physicians on nicotine and the risk continuum.
By Cheryl K. Olson
In an earlier edition of Tobacco Reporter, I described the globally widespread, misplaced fears about the health risks of nicotine—and the critical need for credible messengers to counter those fears (see “Watch Your Mouth,” Tobacco Reporter, March 2022). People generally trust their doctors for health information. Smokers do too.¹ The limited data available suggest smokers trust their doctors over other sources of information on e-cigarettes² and that most patients using e-cigarettes would appreciate at least a brief discussion or handout.³
Are physicians positioned to take advantage of that trust? Can they effectively guide patients who can’t or won’t quit nicotine toward lifesaving alternatives to smoking? Getting patients to stop smoking is top priority. Cigarettes are still the leading preventable cause of illness and death in the U.S. and many other nations. Smoking rates are stagnant among vulnerable populations, including those who are older, low-income or struggling with chronic physical or mental illness.⁴ Thanks in part to media-driven fears of vaping lung injuries and to e-cigarette flavor bans, cigarette sales are actually on the rise.^{5, 6}
Before doctors can help, they must be armed with accurate information and believe that taking action is necessary.
Physicians are Confused About Nicotine
One huge obstacle is a widespread physician perception that nicotine is dangerous. The first sentence in a 2021 survey report from the Journal of General Internal Medicine states, “Nicotine is responsible for the highly addictive nature of tobacco products, but most tobacco-caused disease is not directly caused by nicotine but rather by other chemicals present in tobacco or tobacco smoke.”⁷ Stunningly, four of five physicians in this U.S. survey strongly agreed (incorrectly!) that nicotine causes cancer, cardiovascular disease and chronic obstructive pulmonary disease. There were only minor variations across medical specialties. Recent surveys across countries have similar findings.
What effects might these beliefs have on physician willingness to recommend nicotine-replacement therapies to patients who smoke? And what about recreational nicotine products?
Physicians Don’t Understand the Continuum of Risk
Another barrier is ignorance about or fear of reduced-harm products that aren’t pharmaceuticals. I couldn’t locate any studies on what, if anything, doctors know about the full range of novel recreational nicotine products. However, a 2020 review from the University of Queensland⁸ found 45 qualitative and quantitative studies internationally that looked at what physicians believe and do regarding electronic nicotine-delivery systems (ENDS). Doctors were aware of ENDS but far from experts in their health effects and use for smoking cessation. Most of what they knew came from media stories or patients. “This lack of knowledge and feeling of being ‘uninformed’ was reported consistently by [healthcare professionals] across and within studies.”
The latest and largest U.S. study of what doctors say to patients about vaping appeared in the April 2022 issue of JAMA Network Open.⁹ The Rutgers University authors surveyed a national cross-section of 2,058 board-certified physicians. The conclusion? “More than half of the physicians believed that all tobacco products are equally harmful, and this belief was associated with lower rates of recommending e-cigarettes.” The authors argue that “it is critical to address physician nicotine misperceptions and to correct misperceptions regarding the relative harm of various tobacco products,” as the “FDA authorization process” introduces more modified-risk products.
What Might Start to Open Minds?
I asked a young physician friend (a third-year resident at Virginia Commonwealth University) what he and his fellow doctors would want to know about reduced-harm nicotine products that their patients might be using. He immediately mentioned wanting to see results from randomized controlled trials (RCTs) on “products that will help patients quit harmful tobacco products but also data regarding health outcomes. For example, what are the rates of lung cancer in a patient who smokes cigarettes for 10 years versus someone who vapes for 10 years?”
This is the sort of response we expect and was consistent with the JAMA Network Open survey findings. But can data alone change beliefs?
An earlier study from the Rutgers researchers involving structured interviews with doctors gives reason for doubt.¹⁰ Most doctors they talked to were at least neutral about attempts to switch to e-cigarettes for patients who had failed with traditional smoking cessation methods. But five of the 35 doctors were adamantly opposed; they would not recommend vaping to patients even if future RCTs found e-cigarettes to be equal or superior to other quit methods. One oncologist said, “Based on what I’ve heard and read about them, I don’t think so. It seems like they’re actually, like I said, kind of dangerous.”
A careful read suggests that physicians who believed e-cigarettes could be effective switching tools—about half of those interviewed—were so persuaded by a combination of stories and data. Patients, friends or family members had cut down or quit cigarettes through vaping. And, perhaps sensitized to the issue by these stories, the doctors recalled seeing one or more studies that backed up their personal observations. Interestingly, 11 of the doctors who doubted e-cigarette effectiveness cited the hand-to-mouth behavior similarities to smoking as a negative rather than a positive for switching. This suggests they don’t know smokers.
Physician Harm Reduction
Sudhanshu Patwardhan
During his postdoctoral training as a primary care physician, Sudhanshu Patwardhan grew increasingly concerned about the ineffectiveness of the advice and treatments given to patients who smoked combustible cigarettes. Since then, he’s focused his clinical and research career on harm reduction for addicted smokers. He’s currently based in Great Britain, where he’s the director of the Centre for Health Research and Education.
Patwardhan has researched physicians and nicotine in the U.K., Sweden, Greece and India. For the past year, he and I have been talking about the clinical and public policy challenges that come with shifting toward a harm reduction approach to smoking cessation.
“Consistently, between 65 [percent and] 80 percent of surveyed physicians across all these countries harbor misperceptions about nicotine,” he said. “It’s no wonder that, universally, ‘Why replace one addiction with another?’ is one of the commonest attitudes [among physicians] for nicotine-replacement therapy for tobacco cessation using a harm reduction approach.
“Doctors forget that in addition to its long-term effects, inhaling the smoke from burning tobacco induces the breakdown of many drugs, thus making those treatments ineffective. Many psychiatrists I interact with admit to simply increasing the dose of the administered medications to compensate for the loss of effectiveness due to smoke-induced breakdown but don’t offer cessation support simultaneously. This, of course, leads to higher side effects and poorer patient outcomes—all because physicians are not sensitized to and empowered about tobacco cessation and harm reduction.
“Most freshly minted doctors would know how to recognize the most esoteric heart murmur but have no practical experience in the basics of behavioral intervention or the role of medications for tobacco cessations. Pharmacology and clinical medicine barely touch on nicotine-replacement therapy and give no clues to trainee doctors on what to prescribe, for how long and how to manage cravings and withdrawal symptoms effectively. Most noncommunicable diseases have tobacco use as a risk factor. Yet doctors simply do not address it along with the presenting complaint.
“Our center’s strategy focuses on the root of the issue: We’re developing and conducting peer-based education of healthcare providers in a safe and nonjudgmental environment. Our approach and materials are country specific. For example, in the U.K., e-cigarettes are a part of the suite of potential harm reduction tools offered by the National Health Service. In India, however, e-cigarettes are currently banned and not licensed for smoking cessation. There, we focus on approved approaches, such as nicotine-replacement therapy, bupropion and varenicline.”
“We need to start overhauling the medical education curriculum in this area. We’re conducting pilot programs at some medical schools with exciting results and will publish those data. Practicing physicians also need training to increase their effectiveness. Finally, scaling up of nicotine education for healthcare providers can be a significant challenge, especially for countries as wide as the U.S. or as populated as India. Digital tech tools, such as cessation apps, short media presentations, including online videos and smart print campaigns designed for social media, can all help.”–C.K.O.
References
¹ Nelms E et al. Trust in physicians among rural Medicaid-enrolled smokers. Journal of Rural Health, 2014: 30(2), 214–220. doi:10.1111/jrh.12046.
² Wackowski OA et al. Smokers’ sources of e-cigarette awareness and risk information. Preventive Medicine Reports, 2015: 906–910, http://dx.doi.org/10.1016/j.pmedr.2015.10.006.
³ Doescher MP et al. Patient perspectives on discussions of electronic cigarettes in primary care. Journal of the American Board of Family Medicine, 2018, doi: 10.3122/jabfm.2018.01.170206.
⁴ Zhu S-H et al. Smoking prevalence in Medicaid has been declining at a negligible rate. PLoS One, 2017, https://doi.org/10.1371/journal.pone.0178279.
⁵ Xu Y et al. The impact of banning electronic nicotine-delivery systems on combustible cigarette sales: Evidence from U.S. state-level policies. Value in Health, 2022, doi: 10.1016/j.jval.2021.12.006.
⁶ Federal Trade Commission. FTC report finds annual cigarette sales increased for the first time in 20 years. October 2021. www.ftc.gov/news-events/news/press-releases/2021/10/ftc-report-finds-annual-cigarette-sales-increased-first-time-20-years.
⁷ Steinberg MB et al. Nicotine risk perceptions among U.S. physicians. Journal of General Internal Medicine, 2020, doi: 10.1007/s11606-020-06172-8.
⁸ Erku DA et al. Beliefs and self-reported practices of healthcare professionals regarding electronic nicotine-delivery systems (ENDS): a mixed-methods systematic review and synthesis. Nicotine & Tobacco Research, 2020 https://doi.org/10.1093/ntr/ntz046.
⁹ Delnevo CD et al. Communication between U.S. physicians and patients regarding electronic cigarette use. JAMA Network Open, 2022, doi:10.1001/jamanetworkopen.2022.6692.
¹⁰ Singh B et al. Knowledge, recommendation and beliefs of e-cigarettes among physicians involved in tobacco cessation: A qualitative study. Preventive Medicine Reports, 2017 http://dx.doi.org/10.1016/j.pmedr.2017.07.012.
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Associates. She spent 15 years on the faculty of Harvard Medical School.

May 1, 2022