Blog - Tobacco Reporter

RJR Vaping Technology Claims Invalidated

A U.S. administrative tribunal has invalidated two claims in a R.J. Reynolds vaping patent, reports Law360.

The Patent Trial and Appeal Board said on June 30 that two claims in U.S. Patent No. 9,814,268, which covers “a tobacco-containing, electrically-powered smoking article” designed to burn a minimal amount of tobacco, can’t stand because they are obvious in light of previous e-cigarette patents.

The ruling represents a second win for Philip Morris Products after a Virginia federal jury awarded it more than $10 million last month in drawn-out clash between the tobacco giants.

July 2, 2022

Court Tosses Punitive Award Against PM

A U.S. federal appeals court tossed out a $9 million punitive-damages award awarded by a lower court against Philip Morris USA in a case filed by a woman who suffered a smoking-related illness that led to her legs being amputated, reports The Free Press.

Donna Brown filed the lawsuit in 2007 in the federal Middle District of Florida, and a jury sided with her on claims for strict liability, negligence, fraudulent concealment and conspiracy to fraudulently conceal. It awarded Brown nearly $8.29 million in compensatory damages and $9 million in punitive damages.

In its appeal, Philip Morris pointed to a recent Florida Supreme Court opinion that said plaintiffs must show that they relied on misleading information from cigarette makers to prevail on claims for fraudulent concealment and conspiracy to fraudulently conceal.

In its June 30 ruling, the 11th U.S. Circuit Court of Appeals said Brown had presented “insufficient evidence” to show that she relied on specific false or misleading statements by the company.

The Atlanta-based court overturned the verdicts on the fraud-related claims but upheld the verdicts against the cigarette maker on strict liability and negligence.

The lawsuit was one of thousands of cases filed against tobacco companies after a 2006 Florida Supreme Court decision established critical findings about issues such as the dangers of smoking and misrepresentation by cigarette makers. Those lawsuits are known as Engle Progeny cases.

July 2, 2022

Report Supports Vaping as Smoking Alternative

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

Panama Bans Vaping Imports and Sales

Panamanian President Laurentino Cortizo has signed legislation banning the sale of vapor products, reports Vaping360. The country had already prohibited e-cigarette sales in 2014 by executive decree.

The new law prohibits not only sales and imports of e-cigarettes, but also bans consumption in any place where smoking is not allowed. The ban includes internet purchases and authorizes customs officials to inspect and seize shipments. Resellers are still allowed to import vapor products intended for export to third countries.

Consumer vaping advocates have warned that restrictions on vaping products will push vapers to illegal products of questionable quality.

Panama joins more than a dozen Latin American and Caribbean countries with vape bans. On May 31, Mexican President Andrés Manuel López Obrador signed a decree outlawing the sale of e-cigarettes.

Panama will host the 1oth Conference of the Parties to the Framework Convention on Tobacco Control in 2023.

July 2, 2022

Activists Outraged Over Vaping Policy Guidance

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

Smoore Recognized for Industrial Design

Smoore has been recognized by the Shenzhen Municipality Industrial Design Development Support Program for its innovation and design capabilities.

The municipality singled out the vaping technology’s specialist for its “innovative design and achievement transformation of closed-pod electronic atomizer based on leadless ceramic heating technology.”

The industrial design team of Feelm, Smoore’s flagship atomization brand, has designed a number of solutions that combine consumer experience with advanced smart manufacturing.

Between 2020 and 2022, Feelm’s industrial design team won eight prestige International design awards, including the Red Dot Award, the iF Design Award, the German National Design Award and the MUSE Design Award.

In 2022, won a Red Dot Product Design Awards for four products, including a lipstick-inspired vaporizer with a twistable nozzle that prevents dust from collecting on the mouthpiece, and an eco-friendly disposable e-cigarette composed of recyclable and reusable aluminum foil.

“Feelm design is devoted to helping clients in improving the user experience from the perspective of a vaping tech brand,” said Totom Lu, head of Feelm Industrial design team, in a statement. “I think the future direction of design of closed-pod vaping solution should lean on three dimensions: product experience, emotional experience—to identify problems before users notice them—and sustainable experience, to focus on product sustainability.”

July 1, 2022

Fit for the Future

Thanks to its agility and relentless focus on personal service, Hail & Cotton remains in excellent shape even after a century in business.

By Stefanie Rossel

In our fast-moving age, few companies can claim to have reached a century. Tobacco merchant Hail & Cotton International Group (HC) is a prominent member of this exclusive club. A lot has changed since the days when E. A. Hail and M. R. Cotton started the company in Louisville, Kentucky, USA.

“Their focus was on [the] dark fired and dark air-cured tobaccos that were grown in Western Kentucky and Northern Middle Tennessee,” relates Chris Cooksey, president of the company’s North America operations. “They were buying their tobaccos directly from growers and grower associations and then processing and selling it on to European manufacturers for cigarette and cigar consumption. As the European market grew, so did Hail & Cotton, going on to become the largest leaf dealer of U.S. dark fired tobacco. We think Mr. Hail and Mr. Cotton would be very proud that Hail & Cotton not only remains in existence but [also] with the company’s impressive growth and continued tradition of excellence.”

Today, HC has fully integrated operations and sourcing capabilities from 20 different countries—including all the world’s major tobacco producing countries—on five continents. “This means not only has our reach greatly expanded but so has our product offering,” says Andy Spies, president of international operations.

Today, HC’s product portfolio is highly diverse: Various dark air-cured types and dark fire-cured tobaccos are still on offer, but they have been complemented by flue-cured, burley and oriental tobaccos for applications in cigarettes, pipes, cigars, chewing tobacco, moist snuff, snus, roll-your-own and water pipes.

“We pride ourselves on the wide variety of quality tobaccos we offer, but we also take great pleasure in offering other value-added services such as fermentation, sweating, blending, cut rag and long-term third-party dry storage services,” says Spies. “Besides our growth, but not unique to HC or the tobacco industry, the modern business environment has transformed dramatically over the last 100 years. No longer is a business trip to another continent a long journey over the ocean by ship or are sales conducted merely on a handshake. The whole world is a different place in terms of communications, transport, governance, finance, regulation, etc. We have all therefore been forced to change, and HC will continue to adapt and transform ourselves so we remain up to date and relevant in this changing, dynamic yet still great industry.”

Unique Management Structure

Since 1999, Hail & Cotton has been part of U.S.-based Luckett Holdings (formerly Luckett Tobaccos). Following the takeover, Hail & Cotton consolidated its operations by relocating its threshing facility and corporate headquarters to Springfield, Tennessee. Since then, the company has constantly modernized its processing facilities and built or acquired industrial properties to accommodate customer requirements for receiving, purchasing, processing and packed storage of tobaccos of U.S. and other origins.

More than a decade ago, a merger greatly expanded Hail & Cotton’s reach. In 2011, the company acquired CdF International Group—which in turn had emerged from the combination of Spanish leaf merchant Compania General de Tabacos de Filipinas with Netherlands-based Lippoel Leaf in 2007. Today, the company also has joint equity partnerships with CTA in Brazil and BHC in Zimbabwe. Together, they service a customer base of approximately 350 all over the world.

For many years, HC has been contracting directly with most of its farmers, depending on origin. The company has nearly 30,000 growers in its operations around the world. “Tobacco growers in all parts of the world face different challenges each year,” says Eric van der Linden, president of dark air-cured operations. “In countries where we contract tobacco, our agronomy teams work with our growers to help improve farming practices that not only improve yields but also aim to protect the resources that are important to sustaining their farms for future generations. We also participate in various industry organizations and undertake several country-specific projects and initiatives aimed at preserving the environment and enhancing our farmers’ sustainability and livelihoods.”

The company stands out not only because of its long tradition and diverse product range but also because of the way it is managed: In contrast to other businesses, which are often led by one person, HC has three presidents with each of them heading one division. “Indeed, this is unique, but to us, it makes a lot of sense,” says Cooksey. “Our three divisions are very different not only in geography and product offering but also in dynamics. This model enables us to exercise our unique traits and expertise in different types of tobacco and countries that benefit our customers when they are looking at new projects for different products. When you work with a group that has no politics and all [are] pulling in the same direction with the same goals and passion that you [have], it is an incredible and very rewarding experience. We can count on each other without any reservation. This same tone runs throughout the company and generates an extremely powerful teamworking and united culture. The synergies we provide for each division continue to strengthen our company, enhance our products and increase our growth. It has also allowed us to build a great network and develop good friendships with our colleagues from different parts of the world. It is what sets our company apart from others.”

Trialing Times

Each of the three presidents has more than 30 years of industry experience—a long time during which the leaf sector has seen significant changes, among them the phasing out of tobacco subsidies, increasing restrictions for tobacco products, the financial crisis of 2008 and a continuous decrease in global cigarette consumption.

“You can also add regulation, legislation, anti-tobacco lobbies, increased competition, competing products and increased stakeholder expectations on environmental social governance (ESG),” comments Spies. “Declining consumption and consolidations are, however, probably the biggest challenges. Declining consumption is set to continue, and it makes it difficult not only for leaf dealers to plan but for our customers as well. When you factor in a decline in manufacturers of tobacco products due to consolidations and mergers, it adds another layer of complexity. Despite these challenges, HC has continued to grow each year over the past 10 years and is determined to continue this trajectory. Challenges and change and how a company responds to them is what builds a stronger company, and HC is stronger today than it has ever been.”

The Covid-19 pandemic has brought with it new challenges for companies worldwide, such as a container shortage, rising shipping costs and extended delivery times. HC has not been exempt from the issues brought on by the virus, according to van der Linden. “From labor shortages to shipping delays and everything in between, it has been a challenge,” he says. “We took as many steps as possible, such as positioning tobacco in strategic locations closer to ports to be able to move when possible. We do not believe there is one strategy that we have implemented that sticks out. What does stand out is our positive attitude and perseverance in maintaining a steady supply of product to our customers.”

Fit for the Future

Taken together, the challenges of the past years have actually been positive for the company, according to Cooksey. “We have greatly expanded our footprint and our client portfolio. Thus far, we have continued to experience growth in a declining industry. This is a testament to our employees’ passion, knowledge, experience and teamworking culture. We are fortunate to have so many people in this company who care about what they do and how they do it.”

Fresh blood in the team is welcome—the company is currently seeking to attract new talent, Cooksey explains. “We think we provide a few uniquely positive things: Young people get excellent training; they gain experience and are then held accountable earlier than, say, in a bigger, multinational company. We run a flat reporting structure, and we promote a culture that demands mutual respect and teamwork. We all work very hard, but we also like to still have fun, and we think that goes a long way in your job and career.”

To make the company fit for the next 100 years, HC is working with an international consultancy to effectively address and tackle ESG in the future. “HC fully recognizes the importance of ensuring that we understand our impact on the environment and human rights,” says Spies. “The issues facing the tobacco industry are not unlike those facing other agricultural businesses globally—such as ensuring that the potential and actual impacts to people and environment in the supply chain are understood and addressed in order to operate responsibly.”

In terms of size, Mr. Hail and Mr. Cotton may not recognize their company today—but they would definitely recognize the way in which it is run: still focused on its service to the customer and the grower, adaptable to the ever-changing industry and committed to growth. The founders would have been pleased to see that HC is well prepared for the future and will continue to play an important role in the tobacco industry.

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

Choppy waters

Machinery makers navigate supply chain challenges and customers’ changing product portfolios.

By George Gay

I was rummaging around in my office the other day, looking for something that I didn’t find, but as is often the case when rummaging, I did find many things for which I wasn’t looking. One of those things was a 20-year-old CD with the name of a tobacco machinery company on it and the title “Past, Present and Future,” and given that I was due to write a machinery story, I decided to take a look. The CD contained a PowerPoint presentation with 44 slides, 20 of them dedicated to the past, 23 to the present and one to the future. The future slide was unique not only in respect of it being the only one to address the future but also because it was blank except for the words “The Future.”

I don’t blame the presenter for being cautious. Predicting the future of the tobacco industry and its various sectors has always been fraught. The industry has been written off, prematurely, more times than I care to remember. But there is no doubt that, nowadays, the storm clouds appear to be more threatening, partly because they are coming from both within the tobacco industry and without. The range of regulations that govern the industry is becoming wider and more radical at a time when, partly in response to those regulations, the industry has chosen to transform itself.

So where is the industry, and, in particular, the tobacco machinery sector headed? It hardly seems worth stating that the future of the tobacco machinery business is linked to the future of the tobacco business, and, since the tobacco business is in decline, the tobacco machinery business must be in decline. End of story. But, of course, the situation is far more complex than that.

One obvious caveat that has to be added to this story concerns the offshoot the tobacco industry has grown, comprising lower risk tobacco and nicotine products. The problem here, however, is that it is not easy to predict whether this offshoot will flourish or atrophy. And, even if it does flourish, it is not easy to predict what the conversion rate of smokers to the consumption of these new types of products will be. It has to be remembered that if the traditional tobacco business is in decline, the opportunity for converting smokers diminishes, though this could be offset if nonsmokers were drawn to these products.

While some countries are encouraging, or at least not discouraging, such new products, others with huge populations are banning (India) or discouraging (China) them. In some countries, and for some time, entry to the new products markets will probably remain prohibitively expensive for many consumers, and there is the looming problem associated with environmental issues.

Optimization

Nevertheless, asked what the situation would look like in three years’ to five years’ time, Norbert Schulz-Nemak of TMQS had no hesitation in saying new-generation products (NGPs) will have taken a higher share of the overall market simply because such a conversion is a strategic goal of multinational companies. But combustible cigarettes would still be around because they were relatively cheap to buy and relatively easy to consume.

Was it the case, though, that the tobacco industry might split into a number of tobacco industries operating quite differently in various regions or countries in response to local regulatory environments and, therefore, the different products on sale within those regions or countries? It is not difficult to imagine a U.K. market without tobacco but with e-cigarettes completely divorced from an India market without e-cigarettes but with tobacco.

But in response, Schulz-Nemak said TMQS believed the only split would be in respect of technology. Tobacco manufacturers would continue a process started some time ago whereby they had concentrated the manufacture of their various products within specific manufacturing sites, thus optimizing the use of those sites. Focusing within individual sites on the machinery and processes necessary only for specific products provided for clear structures and logistics. Obviously, added Schulz-Nemak, there would be exceptions, but generally speaking, such developments were logical.

Maintaining Existing Equipment

Despite the transitions that the industry is going through, tobacco manufacturers large and small will clearly aim to maintain production levels and efficiencies within their traditional operations while keeping their businesses flexible enough to deal with future market trends. And this, according to TMQS, is leading many companies to be more cautious in their planning than they had been previously.

Catering for an increasing portfolio of NGPs and vaping products involved a costly exercise in bringing in new machinery, said Schulz-Nemak. And this was occurring at a time when combustible cigarettes still accounted for the major output of manufacturers—combustible cigarettes whose production lines also needed investments, both routine and regulation-specific, such as those requiring the manufacture of biodegradable filters.

Schulz-Nemak said that, in the case of secondary machinery, TMQS could help optimize production while keeping expenditure down. This potentially meant eliminating the need to invest in new machinery and then, perhaps, having to invest in new supporting infrastructure, different spares and materials. TMQS could offer machinery improvements, including those extending the life of equipment. It could provide everything from routine maintenance to repairs, conversions, extensions and modernizations. And it could offer support with spare parts and assembly groups.

Filling the Gaps

One change that has happened in the recent past is that tobacco manufacturers have tended to reduce their traditional product portfolios, which, presumably, has pushed more production toward the long-run end of the manufacturing continuum, and which, in turn, would have helped maintain demand for high-end, high-capacity machinery. But there is a flip side to this. When products are removed from the market, the holes created are seen as opportunities by entrepreneurs. This phenomenon is to be observed in many industries, and while it tends to be more subdued in the case of tobacco because taxes often dominate the retail prices of cigarettes, it happens. This raises the question of whether the inevitable gaps left in the market will see the emergence of more niche players requiring more modest machinery, either new or rebuilt, and simpler factory layouts.

In fact, Reto Iten of Iten Metals told me recently that the strength of demand for relatively old, slower cigarette making machinery was currently “amazing.” Demand was being driven by niche manufacturers that might want to produce, for instance, a CBD cigarette or an environmentally friendly cigarette, perhaps one using organic tobacco or one using only locally grown tobacco. With the right machines, such manufacturers, which were active on relatively small but attractive markets, could use high-quality cut rag to make good-tasting cigarettes.

So why aren’t we all getting in on the act? Well, according to Iten, to be successful at such niche manufacturing, you have to be willing to make a certain level of investment. A secondhand maker that had been the subject of only an overhaul would probably produce more hassles than cigarettes. And buying the sorts of equipment sold by his company—rebuilt, as-new machines based on original OEM drawings—was not easy at the moment because of a number of factors, not the least of which was the lack of donor machines. In fact, Iten said he had plenty of inquiries at the moment but nothing to offer, so recently, he had been in discussions about how to overcome the current shortages of donor Molins Mk8 and Mk9 makers, especially their machine bases, since the mechanics and electronics of these machines were well known and could be reproduced fairly easily.

Materials and Manpower

For start-ups, Iten recommends a standard industrial cigarette maker, such as the Mk8. For such machines, it was not difficult to find consumables and spare parts, many of which were off the shelf, and for others of which the original drawings were available so that they could be made by a proficient engineering company. Because of the Mk8’s ubiquity, even skilled operators were often available locally, but the machine’s most important advantage was that it produced a quality product.

But there are other problems with delivering rebuilt machinery, one of which comprises recent interruptions to deliveries of suitable raw materials. Not all materials were currently available, said Iten, so there were times when effort had to be expended finding substitutes, which increased costs and lead times. And these disruptions are occurring not only in respect of mechanical parts and materials. Electronic components, including PLC components, that used to be available immediately off the shelf are now subject to delivery times of six months or more. “The planning of a project has become really messy,” said Iten in an emailed reply. “It is simply not possible to keep a delivery time agreement these days.”

In fact, Iten described the delivery interruptions, which had started in 2020 with a lack of container availability and had become worse since May 2020, as “incredible.” Now, before a machine rebuilding project was started, it was necessary to have ordered all of the e-parts for the PLC control. A shortage of manpower was another factor—one that was causing some workshops to be operating under capacity.

Iten said he expected the current problems to last through 2022 and even expand. It was not possible, he added, to gauge what would happen during 2023, but it was likely that things would remain difficult.

Meanwhile, TMQS also helps niche tobacco manufacturers set up their operations. Schulz-Nemak said TMQS could rework machinery and set it up so as to operate easily and flexibly to meet a wide range of production needs. It could provide additional machinery, high-quality parts and assembly groups.

And when it came to setting up small operations, TMQS could combine forces with experts in different fields to create the optimum, cost-effective production lines.

The writer would like to thank Chris Crawley, global business development consultant to the tobacco industry, for his input on this piece.

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.

July 1, 2022

Pathways To Acceptance

Scientists, regulators and industry must work together to help change perceptions of nicotine.

By Phil Saunders

A recent story in Tobacco Reporter highlighted that more than 60 percent of U.S. doctors are confused about the tobacco harm reduction risk continuum. Many incorrectly believe that all nicotine products are equally harmful, making them unlikely to recommend e-cigarettes to people trying to quit smoking.

Elsewhere, the picture isn’t that different. For example, a survey released earlier this year showed that in England, one of the most pro-vaping countries in the world, only 40 percent of local authorities actively offer e-cigarettes as part of stop-smoking services. This might seem more positive, but it still leaves the remaining 60 percent unconvinced.

There are some positive developments in Australia, which recently scrapped its earlier plans to ban e-cigarette imports. Hollie Hughes, chair of a committee established to examine vaping, recently stated that she believes vaping to be “an incredibly powerful cessation tool” that is part of the discussion on reducing smoking rates in the country. But there are still many countries with extremely high smoking rates where e-cigarettes are completely illegal, including India, Mexico, Brazil and Singapore.

There is obviously still a long way to go to get a unified acceptance of the role reduced-risk nicotine products can play in tobacco harm reduction.

Perception is Key

Fundamentally, the issue is that nicotine is perceived as the bad guy. That is why 60 percent of doctors in the U.S. don’t understand e-cigarettes. For years, the popular discourse has equated tobacco and nicotine as completely interchangeable in terms of smokers’ health and the damage it does to society. Widespread misperceptions around nicotine remain the industry’s biggest challenge and are the No. 1 issue that public health bodies and regulators will need to address to change the status quo.

Recently, U.K. Secretary of State for Health and Social Care Sajid Javid announced that anyone born after 2008 in the U.K. will not be allowed to purchase tobacco products and that the minimum age will raise every year. A similar approach is also being considered in Denmark. But Javid is not considering including e-cigarettes in this approach, which may be an acknowledgment that he at least doesn’t see nicotine as the biggest issue impacting smokers’ health.

What is obvious is that the scientific community, regulators and the wider electronic nicotine-delivery system (ENDS) industry must work together to help change perceptions about nicotine and educate people about the difference between tobacco and nicotine.

A Supportive Regulatory Environment

Taking England as an example of an environment supportive of vaping, the Tobacco and Related Products regulatory framework for e-cigarettes as consumer products is a light touch compared with the premarket tobacco product application (PMTA) in the U.S. As a result, the U.K. offers one of the world’s fastest consumer routes to market for new vape products and has a thriving vape retail sector and a falling adult smoker rate.

The U.K.’s Medicines and Healthcare products Regulatory Agency is now also actively encouraging the use of e-cigarettes to support smoking cessation. The Department of Health and Social Care 2017 Tobacco Control Plan states that the scientific evidence is clear that e-cigarettes are less harmful to health than smoking cigarettes. The U.K. has now set a target to be “smoke-free” by 2030 with vaping and next-generation alternatives seen as a key enabler in reaching that goal. A review commissioned by the government recommends that the National Health Service increases efforts to encourage smokers, particularly pregnant women, to switch to vaping and e-cigarettes.

Scientific Substantiation

Undoubtedly, we need to be led by science. Regulatory submissions, conference presentations, scientific posters and papers must continue to add to the body of evidence demonstrating the role of noncombustible next-generation nicotine-delivery products in tobacco harm reduction.

“Real world” evidence and behavioral studies are also invaluable, particularly to convince regulators and medical professionals of smokers’ switching habits and that these products don’t encourage “on-ramping” of nonsmokers, particularly youth. Peer groups and professional bodies also have their role to play in supporting this aim to be driven by science rather than opinion and media headlines.

In the U.S., the huge amount of data now available due to the rigor of the PMTA process is also invaluable. Companies have spent millions of dollars on scientific studies to demonstrate to the Food and Drug Administration that their products are appropriate for the protection of the public health.

However, there is still the issue of a lack of independent scientific research into vaping as most universities shun research into tobacco-related products. The FDA’s first PMTA marketing orders for consumer vape products in the U.S. are the closest the ENDS industry has to independently verified in-depth scientific evidence that vape products can be evaluated as less harmful than smoking cigarettes.

Industry Opportunities

The next step in product acceptance is to see companies start to further develop consumer products for a medicinal regulatory pathway. Acceptance as a medicinal device to help smokers quit would further legitimize vaping as reduced harm. Achieving this could also lead the way for nicotine strengths to be prescribed at higher dosage levels to support smokers to give up more effectively through a medically monitored offramping process.

Looking to the Future

There are still significant global differences in the acceptance and understanding of the role of e-cigarettes in supporting tobacco harm reduction. The confusion between the different roles tobacco and nicotine play in causing smoking-related diseases, however, remains a common limitation.

Robust regulatory frameworks for both consumer and medical ENDS will help build legitimacy for the sector with both regulators and consumers. In this way, regulation is an important tool to help build confidence in the sector.

Whichever market is chosen for a product, an in-depth understanding of that country’s regulatory frameworks and ongoing investment in gathering scientific evidence is essential. The start of manufacturers looking to gain regulatory approval for their ENDS as medical devices will be an important next step in the industry’s journey to acceptance.

Phil Saunders is the strategic partnership manager at Broughton.

July 1, 2022

All Hands on Deck

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