Category: Uncategorized

Seeking Synergies

Photo: Feelm

Tobacco companies are applying the expertise gained with reduced-risk products to new business areas.
By Stefanie Rossel
In their journey of transforming their businesses away from combustible cigarettes toward reduced-risk alternatives, tobacco companies have invested billions of dollars into innovation and scientific research over the past two decades. In return, they have obtained a wealth of expertise in adjacent areas—the potential of which they have just started to explore. Today, their goal is no longer limited to merely lowering harm but also to advancing health.
The list of recent initiatives and moves illustrating this shift is impressive. In September 2021, BAT announced the construction of an innovation hub in Trieste, Italy. In addition to hosting a new manufacturing site for the company’s reduced-risk products (RRPs), the facility will house an innovation lab and center of excellence for digital transformation and marketing as well as a digital boutique. On an area of 20,000 square meters, BAT plans to develop multiple production lines for European and global export of its RRPs.
According to BAT Chief Marketing Officer Kingsley Wheaton, the innovation hub, which involves an investment of up to €500 million ($549 million) over the next five years, will play a key role in the company’s transformation toward reducing the health impact of its business. Trieste was chosen as the location for the hub as it is already a globally recognized center of excellence in research and science, BAT said.
Philip Morris International is demonstrating commitment to transformation with a change of location: In November 2021, the company announced it would relocate its headquarters to Stamford, Connecticut, USA, this summer. The new facility is intended to become a center of state-of-the-art innovation and serve PMI’s smoke-free ambitions, which now also include areas such as inhaled therapeutics. Occupying a 6,642-square-meter campus, the Stamford headquarters will house the PMI Americas region and other corporate functions. PMI’s operations center will remain in Lausanne, Switzerland.
The transition of nicotine companies to adjacent business areas is evident in China as well. SmooreTech, the world’s largest vaping device maker in terms of revenue, recently established a fundamental research institute with three centers and hired a chief scientific officer with a deep background in respiratory medicine. Among other activities, the institute will perform physical and toxicology testing, data analysis and develop standards for vaping devices as they seem set to explore related areas in respiratory medicine. In 2020, SmooreTech became the first company in the Chinese vaping sector to get approval for conducting a national research program on vaping harm reduction, which it will conduct jointly with Tongji University.

From Cigarettes to Pharma
Tobacco companies have been aware of the medicinal potential of the tobacco plant for some time now (see “The Virtuous Weed”). In 2008, PMI acquired a stake in Medicago, a Canadian biopharmaceutical company. BAT purchased U.S.-based Kentucky BioProcessing (KBP) in 2014. Medicago and KBP have both been working on tobacco plant-based vaccines. In January, Health Canada approved Medicago’s Covifenz vaccination against Covid-19—the world’s first vaccine approved for human use that utilizes a plant-based protein technology. BAT has been performing clinical trials on its Covid-19 vaccine candidate. In January this year, BAT launched KBio, a new company that will leverage the existing and extensive plant-based technology capabilities of BAT and KBP and focus on delivering treatments for rare and infectious diseases.
These developments are part of the tobacco industry’s desire to move “beyond nicotine.” PMI plans to generate at least $1 billion in revenues from such new business by 2025. Last summer, it acquired the Danish oral drug delivery specialist Fertin Pharma for $820 million and the U.K.-based asthma inhaler manufacturer Vectura for $1.2 billion. In August, the tobacco company took over U.S. respiratory drug company OtiTopic for an undisclosed sum.
Fertin Pharma concentrates on research, creation and manufacturing of gums, pouches and liquefiable tablets as well as various solid oral systems to deliver active ingredients, such as nicotine. The takeover has given PMI access to Fertin Pharma’s technologies, expertise and talent, which includes almost 200 research and development specialists.
While the Danish company can help PMI increase its footprint in the modern oral category, Fertin Pharma’s oral drug delivery platforms also complement PMI’s experience with inhalation technologies and could be used to develop scientifically proven self-care wellness products, such as over-the-counter solutions and supplements for better living.
Commenting on the Fertin Pharma deal, PMI CEO Jacek Olczak said that his company’s future was “centered on health, science, technology and sustainable business practices to deliver innovative products and solutions that aim to improve people’s lives and create a net positive impact on society.”

“PMI’s future is centered on health, science, technology, and sustainable business practices to deliver innovative products and solutions that aim to improve people’s lives and create a net positive impact on society.”

Jacek Olczak, CEO, PMI

Critical Role
Vectura specializes in inhaled drug delivery solutions. At the time of the acquisition, the company had 13 inhaled and 11 noninhaled products in its portfolio. The new subsidiary will provide PMI with another 200 scientists who are knowledgeable about formulation, inhalation, devices, clinical manufacturing and regulatory issues. The company will also provide access to new technology and pharmaceutical development capabilities.
PMI aims to develop a fully owned pipeline of inhaled therapeutics and respiratory drug delivery systems. Vectura, says PMI, will play a critical role in PMI’s beyond nicotine strategy, which the acquisition, together with the Fermin Pharma deal, is expected to accelerate.
OtiTopic, PMI’s third recent acquisition in the pharmaceutical field, has developed an inhalable acetylsalicylic acid treatment for acute myocardial infarction that is currently undergoing clinical trials. The product comprises a novel, proprietary aspirin formulation that, delivered via a dry powder inhaler, enters the bloodstream faster than oral tablets. If approved by the U.S. Food and Drug Administration, the treatment can address the needs of more than 83 million people at risk for myocardial infarction in the U.S. alone, according to PMI.
According to PMI Chief Life Sciences Officer Jorge Insuasty, PMI’s beyond nicotine initiatives will initially focus on respiratory delivery and botanical products addressing areas such as energy, sleep, calm and focus. While currently less developed than established tools, such as pills and syrups, respiratory delivery has advantages over traditional medication delivery methods, Insuasty explained in a recent edition of PMI’s Scientific Update. Medicines delivered via the respiratory tract allow a rapid onset of the drug effect and potentially reduce side effects due to the lower dose that might be needed compared to taking a pill, for example. The same holds true for botanicals, an area in which PMI has gained considerable expertise during its work with plant substrates and aerosolization.
PMI healthcare ambitions are supported by its venture capital unit, PMI Equity Partners. The $150 million Swiss-based fund invests in companies that are involved in respiratory delivery, botanical sciences, health monitoring technologies, computational research methodologies and other innovations that have the potential to benefit health.

Focus on Recreational Products
BAT, meanwhile, has singled out personalized well-being as a starting point for developing opportunities beyond nicotine. In its annual report, the company said it was taking a “disciplined approach” to its beyond nicotine strategy as it expects continuous growth in the emerging market for well-being and “active” products, particularly for CBD. Fortune Business Insights estimates that the global CBD market, which stood at $3.68 billion in 2021, will increase to $55.79 billion in 2028, reflecting a compound annual growth rate of 47.49 percent.
BAT says its strength is its superior understanding of consumers. By combining contextual information with biometric data sets, the company believes it can build a comprehensive model of moods, behaviors and rituals. In January 2021, BAT launched its first vapor CBD product, Vuse CBD Zone, in Manchester, U.K.
The diversification drive is backed by BAT’s March 2021 £126 million ($165 million) acquisition of a 19.9 percent stake in the Canadian cannabis producer Organigram. Organigram grows cannabis and manufactures cannabis-derived products. The investment will provide BAT with access to research and development technologies, product innovation and cannabis expertise. The two companies will establish a center of excellence at Organigram’s New Brunswick site to develop next-generation cannabis products with an initial focus on CBD.
Like PMI, BAT is supported by a corporate venture capital arm in its transformation effort. Established in 2020, Btomorrow Ventures seeks to invest in health and wellness, functional products, science, sustainability and technology sectors.
The nicotine industry’s transformation has just begun. Slowly but surely, several of the companies that most people still identify as creators of health problems are becoming developers of health solutions. They will have to overcome many hurdles on their journey, including public skepticism and resistance from groups such as the World Health Organization, which recently indicated it would reject Medicago’s Covid-19 vaccine because of the biopharmaceutical firm’s link to PMI. If the nicotine companies succeed in their transformation, however, it would arguably represent one of the most remarkable metamorphoses in corporate history.

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.

April 1, 2022
Unlikely Bedfellows

Photo: Dmitry

How free-flowing data streams can help advance public health goals for nicotine products.
By Cheryl K. Olson
How might new technologies engage public health in transforming the tobacco sector? Let’s take a look at three unlikely scientific bedfellows: sewage, Covid-19 and smoking harm reduction.
Of the many innovations born from the Covid-19 pandemic, my favorite is the U.S. Centers for Disease Control and Prevention’s National Wastewater Surveillance System (NWSS). Since September 2020, the NWSS has tapped into underused data streams flowing through our communities to get early warnings of local disease spread. It’s not perfect; you can’t predict how many people are sick, and it misses people not hooked up to municipal collection systems. But the information is there for the taking. It doesn’t depend on persuading people to show up and get tested.
The smoking harm reduction parallel? Technology innovations can also help advance public health goals for nicotine products using the less malodorous but equally free-flowing data streams of search engines and social media. This is information people have already provided, with no need to persuade them to fill out surveys or file a report. We can systematically search those streams to look for evidence of product adverse experiences or youth misuse of tobacco products or to hunt for and counteract nicotine misinformation.
I found a guide to some of these new methods in sociologist Navin Kumar, a postdoctoral associate at the Yale School of Medicine. He uses techniques like social computing, machine learning and natural language analysis to promote health, including tobacco harm reduction.

Countering Misinformation
Kumar’s research group has done several studies looking at how new technologies can identify and potentially counter health misinformation. As an example of how to study web-based narratives in tobacco control, the researchers tackled two controversial areas at once by mapping how misinformation spread about vaping (especially CBD from cannabis) to help treat Covid-19. This included collecting vaping-related text fragments from a wide range of web sources, including health provider forums, news articles and blogs as well as social media. They also generated word clouds (a fun and intuitive way to depict the most-used words) to see how the use of key terms changed before and after Covid-19 was reported to the World Health Organization. The results showed a shift from words related to vaping bans to positive mentions of CBD and CBD oil.
There are many challenges in applying these techniques to counter nicotine misinformation. For a start, we need to understand how people talk about nicotine products in online conversations as opposed to formal news reports. A study by Kumar and colleagues analyzed the framing of vaping in social media and how words used to describe vaping and their meanings shifted over time. In earlier years, “happy” and “wonderful” were among the most frequent words associated with vaping. From 2017 on, these gave way to words like “ban,” “lung” and “teen.” The study vividly illustrates (with those wonderful word clouds) the social media shift from seeing vaping as an alternative to cigarettes to viewing vaping as about harm and regulation like the news media did.
Another problem: It turns out it’s easier to get people to buy into twaddle than to stop them from doing so. Said Kumar, “People tend to believe new misinformation; it’s harder to remove misinformation such as ‘vaccines have microchips.’” One of Kumar’s recent studies was a randomized controlled trial to try to counter tobacco product misinformation. Results were promising, but the challenge is huge. How can a metaphorical cupful of accurate information received in a study counter the buckets of misinformation people get on a daily basis?
That’s why researchers such as Kumar are working on automated ways to detect misinformation on social media using machine learning. If responsible parties can detect the latest mutation in tobacco product misinformation as it emerges, “They could respond before it has a chance to take hold. And go to Facebook and other outlets to counteract it,” said Kumar.

New technologies, such as social computing, machine learning and natural language analysis, may help counter online misinformation about nicotine products. (Photo: Jo Panuwat D)

Adverse Experiences
The goals of reporting are to identify safety risks, to share lessons learned so our mistakes are new instead of repeats of the past and to raise the cost to potential bad actors of disregarding customer safety. The U.S. Food and Drug Administration’s Center for Tobacco Products takes voluntary reports from anyone—including product users, researchers and health professionals—about “adverse experiences.” You can report a tobacco product concern through the FDA’s central safety reporting portal at www.safetyreporting.hhs.gov, which also takes reports about marketed human and animal drugs and biologics, foods and dietary supplements.
Traditional ways of reporting adverse experiences to the FDA leave a lot to be desired. Since the system is primarily voluntary, a busy human must find the time and motivation to report the problem. Under-reporting is assumed, but no one knows by how much or how reporting may differ by product, user or symptom type. Important details may be left out of the report, making it hard to spot patterns (or creating misleading patterns as in the case of e-cigarette or vaping use-associated lung injury (EVALI)). Reporting can also be biased by things like news reports and litigation. The blossoming variety of reduced-harm nicotine products further complicates finding and addressing safety issues when market shares are small and issues are infrequent.
If your company’s tobacco product gets a premarket tobacco product application (PMTA) marketing granted order from the FDA, postmarket reporting of adverse experiences is required as part of the deal. “Serious and unexpected” adverse experiences that companies are told about or discover must be reported through that FDA portal within 15 days. The FDA may also require other postmarket reporting to stay comfortable with keeping a new tobacco product on the market. It’s in your interest to avoid surprises.
This approach is still untested for tobacco products, but publications are proliferating using these methods. I ran across articles that used machine learning and natural language processing to monitor for adverse effects of Covid-19 vaccines on Twitter and for health risks from the mood-altering plant kratom on Reddit and Twitter.
As with our example of using wastewater to predict Covid-19 spread, Kumar notes that multiple data sources better predict outcomes. “So you can use reports on Twitter combined with YouTube and [the] news to predict adverse experiences,” he said. Look to computer science publications for the latest publications on nicotine products; they aren’t caught up in the tobacco harm reduction battles now raging in many public health journals.

How do These Tech Innovations Look to Public Health Authorities?
Are these promising innovations likely to percolate through into accepted practice? Will regulators look upon creative high-tech approaches with favor or scorn? To look for clues, I searched the abstracts (summaries) of studies accepted for the March 2022 meeting of the Society for Research on Nicotine and Tobacco (SRNT). (SRNT is not, at present, an industry-friendly organization and, therefore, is a useful gauge of sentiment among academics and regulators.) Over two dozen studies involved using social media data for research, most simply to gather information and look for patterns. Some involved lifting data from Reddit, Twitter or Instagram about descriptions or perceptions of particular tobacco products then using conventional qualitative methods (coding by human readers) to explore topics and feelings. Others used social network analysis to understand how information about products or policies spread.
Two studies supported the possibility of collecting adverse experiences through social media. One coded mentions of positive and negative health outcomes from vaping found on Twitter and Reddit. Another studied videos posted to the TikTok app (with hashtag #nicsick).
One study combined old and new methods by using an age detection algorithm with Reddit metadata to sort posted comments on vaping and then hand-reviewing the most popular posts by each age group. A nicotine product company could potentially use an age detection algorithm to show regulators that their social media accounts don’t attract youth.
Wearable sensors were used to detect smoking behavior as part of a smartphone-delivered smoking cessation program. Behavior studies documenting the transition from smoking to vaping might benefit from including wearable technologies. We might find, for example, that people who’ve completely transitioned to vaping have better sleep quality.
New technologies bring new potential but also novel problems. For example, social media has been hailed as a new cost-effective, efficient way to recruit subjects for research, especially hard-to-find subgroups. My research team did have some success recently using social media platforms, such as Facebook, to locate a particular “vulnerable population” for PMTA behavioral studies. However, it also attracted responses from scammers, automated survey bots and professional survey takers, which took a lot of time and creativity to block or identify and remove.

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.

Forewarned is Forearmed
Derek Yach
One example of using these advanced techniques to find early signals of both misinformation and potential health concerns is an e-cigarette or vaping use-associated lung injury (EVALI) monitoring and alerting platform developed by Skai (formerly Signals Analytics) for the Foundation for a Smoke-Free World.
As a proof of concept, the platform retrospectively analyzed and compared vaping-related content from social media and news sources. In social media comments about specific symptoms and vape ingredients, Skai’s platform spotted signals of the direct link between seizures and vaping synthetic CBD nearly a year before official reports appeared. This kind of early information, while not definitive, would allow public health authorities and the industry to respond quickly to prevent harm and provide corrective facts in appropriate language.
Disinformation on social media, from naive misunderstandings to deliberate manipulations, will be a fact of life for years to come. Taking advantage of these analytical techniques allows the industry to demonstrate socially responsible leadership in advancing public health. Why be blindsided by EVALI’s inevitable successor when there are tools to detect and respond to it? –Derek Yach
*https://skai.io/reports-and-whitepapers/early-detection-of-pandemics-and-outbreaks/?msclkid=4ac806b7a95011ecb5d22adb0bd2b48e

April 1, 2022
From Coercion to Empowerment
David Sweanor

Tobacco harm reduction advocate David Sweanor describes the shift required to reduce the health toll of smoking.
By Derek Yach
David Sweanor has played a global role in steering the World Health Organization, governments and nongovernmental organizations to use the most powerful interventions they have to end smoking. His focus on policy measures to reduce the carnage from cigarette smoking, including a leading role on excise taxes, marketing restrictions and smoke-free policies, has long included tobacco harm reduction (THR). And in the process, Sweanor has highlighted the need to move from blunt approaches to all tobacco products to a system that regulates products proportionate to their risk. In a recent conversation, Sweanor discussed the origins of innovation in THR.
“Hobbyists” and consumers seeking safer products have long tried to develop products that deliver nicotine without other toxic ingredients common in combustible cigarettes (see “Major Milestones”). Our conversation focused on transformation underway in leading tobacco companies.
Sweanor believes that leading tobacco companies have a clear vision of the endgame for their transformation—addressing health, wellness and consumer needs profitably. This was largely forced upon them by advancements in technology, upstart competitors and consumer demand. In contrast, leaders in tobacco control, he believes, are trapped in a vision set in the 1970s that relies on coercion rather than empathy and empowerment and ignores the role of disruptive technologies.
Sweanor laid out progress reported in the latest round of quarterly earnings by leading tobacco companies. Analysts highlighted the role of reduced-risk products as increasingly driving corporate profitability. Philip Morris International now gets 30 percent of total revenue from reduced-risk products and BAT gets 12 percent, with Altria and Imperial advancing through single digits. And Sweanor stressed the fundamental role that competition and investments in innovative research have played in driving this progress.

The funding, volume, quality and diversity of industry research have accelerated over the past decade, and the nicotine business has attracted new and innovative players. Industry research is more interdisciplinary than most public-funded research and includes cutting-edge insights from toxicology, systems biology, epidemiology and pharmacology enhanced by clinical insights from respiratory medicine, oncology and cardiovascular disease.
Sweanor is concerned that at a time when we need more engagement between industry and public health researchers, more barriers are being created that discourage debate, counterproductively protect the cigarette trade and prolong the epidemic of diseases and deaths caused by cigarette smoking. The Society for Research on Nicotine and Tobacco’s ban on tobacco industry participation in its conferences is only the latest example of industry exclusion.
To demonstrate that they have truly embraced transformation, says Sweanor, tobacco companies and other players in the consumer nicotine market should:
push ahead with investments and the launch of healthier, safer products designed to end combustible use;
be more proactive in challenging misinformation and the laws that protect the cigarette business from competition;
share patents addressing core aspects of health and safety with smaller companies and state monopolies in low-income and middle-income countries—this could be done in many ways within World Trade Organization rules; and
place key data of public health policy relevance in the public domain. This includes, for example, conversion rates from combustibles to reduced-risk products and consumer research on the viability of reduced-risk alternatives to cigarettes. Sweanor stressed that all companies need to do this. Much could be learned from a related effort undertaken by food companies in the United States led by the Healthy Weight Foundation.
Above all, he believes that this is the time for companies to work with governments to more aggressively end the sale of combustibles. “They should not await permission from unyielding anti-tobacco groups before fully engaging in efforts to protect the health of their consumers,” said Sweanor.
Sweanor discussed the emergence of industry initiatives that build on their investments to end combustibles (see “In the Pipeline”). From Covid-19 vaccines derived from tobacco plants (see “The Virtuous Weed”) to deeper insights into medication aerosolization and what this might mean for new classes of pharmaceuticals delivered through 21st century delivery systems, Sweanor stated that it is clear that companies are not stopping their transformation journey. “There are no examples from across other sectors that when such profoundly disruptive change happens, it ever returns to the status quo,” he said. “The arrow of innovation points toward healthier and more environmentally sustainable products and services.”
In time, the recent analyst views that some tobacco companies will become life sciences companies tackling major health issues may well come true!

Derek Yach has been a global health expert and anti-smoking advocate for more than 30 years. Throughout his career, he has supported and led smoking cessation research and policy development and has been a strong proponent of harm reduction policies,

Previously, Yach was the director of the Foundation for a Smoke-Free World, and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.
April 1, 2022
Swedish Match Publishes 2021 Report

Photo: Swedish Match

Swedish Match has published its annual report for 2021.
The annual report describes Swedish Match’s operations, strategy and financial development and is available to download at www.swedishmatch.com/annual-reports.
Swedish Match reported record sales and operating profit in 2021, with double-digit growth in both revenues and earnings in local currencies across all product segments.
Full-year growth was driven by strong performance in the Smokefree product segment with considerable growth in both the U.S. and Scandinavia. Growing demand for natural leaf cigars drove the robust full year local currency financial performance for the Cigars product segment. The lights product segment too displayed strong underlying performance.
“Our sales performance in 2021 was outstanding, hitting a new all-time high,” said Lars Dahlgren, CEO of Swedish Match, in statement. Dahlgren was particularly pleased with the performance and potential of the company’s nicotine pouches, which grew by more than 50 percent in the U.S. and Scandinavia in 2021.

March 25, 2022
Multinationals Continue to Monitor Situation in Ukraine

Photo: JTI

Multinational tobacco manufacturers have not stopped their operations in Russia but have done so in Ukraine.
In the wake of Russia’s invasion of Ukraine and the stance taken by companies such as Apple and Stora Enso in halting sales in Russia, Tobacco Reporter asked the multinationals whether they had stopped sales of their products in Russia or when, if ever, they intended to do so. They were further asked why they had not stopped sales, given that this was the case.
“Our priority is our employees, and we are taking the necessary measures to ensure their safety,” said a spokesperson for Japan Tobacco International. “Our operations in Russia are fully functional and we have contingency plans in place to ensure business continuity if the situation were to change. As a responsible international company, we are fully committed to complying with all applicable national and international sanctions.
“We are closely monitoring the situation and cannot comment any further.”
Meanwhile, a spokesperson for Imperial Brands said: “We are monitoring the situation in both Ukraine and Russia very closely. Our prime concern remains for the welfare of our people in Ukraine, where we have suspended our operations for safety reasons. We will continue to update our plans as necessary.”
And a spokesperson for British American Tobacco said: “We are deeply concerned about the conflict in Ukraine. The safety and wellbeing of our people in Ukraine and across the region is our first priority.
“We have suspended all business and manufacturing operations in Ukraine and are providing all the assistance we can to our colleagues, including relocation and temporary accommodation.
“In Russia, our wholly owned subsidiary has been in operation for more than 30 years. BAT always complies with relevant regulation and legislation wherever we operate, and we are aligned with all international sanctions.’
“We continue to closely monitor the situation as it evolves.”
Philip Morris International had not responded by the deadline.

March 4, 2022
Watch Your Mouth

Image: martialred

What the industry can’t (and could) say about harm reduction
By Cheryl K. Olson
Surveys show that the public perceives nicotine as the devil behind most of the cancer and heart disease caused by smoking. E-cigarettes and nicotine-replacement therapies alike are misperceived as relatively risky by many smokers. Even physicians are likely to believe nicotine is dangerous. The now entrenched view of nicotine as public health villain is the predictable result of years of emotion-based anti-vaping campaigns from government and advocacy groups and a steady drip of media reports on the latest perceived danger or deception from the nicotine industry. This includes coverage of the e-cigarette or vaping use-associated lung injury crisis that wrongly linked deaths from THC vaping to nicotine vapes.
The hundreds of thousands of deaths from smoking take place out of sight; they’re old news, not worth mentioning. When I was a public health graduate student in the 1990s, there was much conversation about how to make those deaths newsworthy. Advocacy groups looked for vivid imagery and metaphors to make their case: Hey, deaths from smoking are like a jumbo jet crashing in flames every day! Those deaths are still happening; the campaigns are not.
The Real Cost media campaign, run by the U.S. Food and Drug Administration since 2014, now targets vaping instead of smoking. Creativity in advertising is now focused on fanciful brain worms and similarly unsupported high-fear imagery.
Over drinks at the 2021 London GTNF meeting, I heard conversations bemoaning the passing of those government antismoking efforts and wondering how the FDA or Centers for Disease Control (CDC) could be persuaded to target nicotine misperceptions. In the “before times” (pre-FDA regulation and pre-Tobacco Control Act of 2009), as an academic who consulted to the industry, I headed a multi-year stop-smoking campaign funded by Philip Morris USA. QuitAssist was created to expand upon and encourage the use of existing smoking cessation materials from government and nonprofit organizations. This naturally made me wonder whether, even in this changed regulatory environment, the industry could find a way to pick up the dropped baton and lead a new communications effort.
What stops nicotine product companies from pushing back against this tide of misinformation and misperceptions? You’d think there would be a strong incentive for companies to educate the public. After all, if everyone believes that the health danger in cigarettes comes from the nicotine instead of the byproducts of combustion, why would smokers who can’t or won’t quit even consider switching to vastly less dangerous alternative nicotine products?
Since the GTNF meeting, I’ve talked with people from legacy and upstart nicotine product companies working with these issues from various corporate communications, regulatory and legal angles to try to understand the “carrots and sticks” that shape how the industry responds.
Companies reflexively blame the FDA regulations for their inaction. This has merit. To prevent new outbreaks of old Big Tobacco deceptive practices, the wording of the law can block companies from speaking obvious truths. But there are also surprising hidden disincentives to educate the public about nicotine. Will it upset shareholders? Will it upset regulators? Is it worth the money? Will it create litigation risk?
What makes nicotine product makers watch their mouths when it comes to public education? It’s complicated. If we envision the forces blocking industry communication as an iceberg, let’s start with the visible tip: what the law says that you can’t say.

The Rules
The most commonly cited roadblock to correcting misperceptions about nicotine harm reduction is Section 911 of the Family Smoking Prevention and Tobacco Control Act of 2009.
Without a specific modified-risk claim pre-authorized by the FDA, a product’s label or advertising can’t state or imply it carries lower risk of disease or harm than another commercially marketed tobacco product. That’s pretty straightforward. But what’s next is not: you can’t even say the product “or its smoke contains a reduced level of a substance or presents a reduced exposure of a substance” or that the product “does not contain or is free of a substance” even when those statements are empirically true.
Based on this language, a company could not repeat facts from published research. It could not share the grudging admission from the CDC’s website that “E-cigarette aerosol generally contains fewer toxic chemicals than the deadly mix of 7,000 chemicals in smoke from regular cigarettes.”
This seemingly outrageous restriction on factual speech should be understood in historical context. The Act initially only covered cigarettes, cigarette tobacco, roll-your-own tobacco and traditional smokeless tobacco. With the language about advertising and communications, its authors were thinking about “light” cigarettes and similarly implied health claims that were misleading or taken out of context—not novel nicotine products that might be truly and even massively less risky. The FDA was empowered to issue regulations deeming other tobacco products to be covered by the Act, adding e-cigarettes in 2016.

The Risk/Benefit Calculation
Now, let’s look at the larger underwater part of that iceberg: the less visible factors that block companies from taking action.

Shareholders. Legacy tobacco companies like to focus publicly on their novel nicotine products and the transition away from combustibles. But there’s no denying that traditional tobacco products, especially cigarettes, are where the money is. Shareholders expect companies to act conservatively when it comes to their primary source of income. And some of the profits from combustibles support the massive R&D costs of transitioning to less dangerous products. However desirable the transition to the future world of reduced consumer harm and reduced litigation risk … as one person told me, it’s a good ESG (environmental, social and governance) story, but the incentives aren’t there.

Litigation risk. Despite the 1998 Master Settlement Agreement and FDA regulation, multinational tobacco companies remain in near-constant litigation on the cigarette front. Today’s tobacco industry is stuck with the legacy of decades of bad behavior; every action is scrutinized for intent to addict and harm fresh generations of users. So, an attempt to partner with a physician for public education conjures up images of 1930s Lucky Strike ads with smiling white-coated pitchmen. And as one insider explained, it becomes a cost to the business if it gets interpreted in court as evidence of further bad acting.

Cost. Section 911 of the Tobacco Control Act does allow the option of seeking authorization through the modified-risk tobacco product (MRTP) pathway to make a modified-risk claim. In 2019, Swedish Match was first to earn this status, allowing claims of lower risk of mouth cancer and five other ills if used instead of cigarettes to appear on eight General Snus products.
Unlike Europe, which takes a category approach to regulation, the U.S. regulates products one by one, even for very similar products with low youth use, such as vaping liquids. One person estimated that the cost of research to support an MRTP claim would be equivalent to what their company spent to support that product’s PMTA for marketing authorization: millions of dollars for claims that may not even be relevant or understandable to the average smoker.

Regulator pushback. Especially in the current regulatory environment of low trust, confusing guidance, pending legal cases and thousands of products in regulatory limbo, few companies want to risk further antagonizing the FDA. When I raised hypotheticals of education efforts that could be undertaken by nicotine product makers, I heard stories of wonderful might-have-been campaigns nixed by lawyers. A collaboration between the industry and respected researchers and their university, based on extensive focus group testing with smokers? Add a catchy slogan and creative messaging plus incentives and prizes to encourage smokers to try reduced-risk products and to stay off cigarettes? The FDA is lukewarm on the plan. Big Tobacco dollars that could have supported a huge smoking cessation effort go unspent.

The Right Audience and the Best Messenger
A final concern among industry insiders is a frank understanding of their own lack of credibility. Does it make sense to spend money on messages that won’t be believed? They point to research showing that government agencies and health professionals are the most trusted sources of information.
It’s noteworthy that recent research suggests that government agencies are less trusted by groups that disproportionately suffer from smoking, such as racial/ethnic minorities and lower income persons. And the FDA’s actions speak loudly: When smokers see their favorite vaping products removed from websites or store shelves while very low-nicotine cigarettes are authorized, what message does that send to consumers?
The industry’s best hope for correcting nicotine misperceptions likely comes from indirect public education, through health professionals and consumer advocacy organizations. But industry folks might also consider how to educate regulators, who may not know many or even any smokers, about the realities of their lives and needs.

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.

March 1, 2022
Unintended Consequences

Photo: Manatee County Sheriff’s Office

The number of crimes committed at specialty retail outlets has grown dramatically over the past few years.
By Timothy S. Donahue
Every year, hundreds if not thousands of cannabis dispensaries, vape shops and tobacco outlets are robbed or burglarized in the U.S. On July 10, in Lincoln, Nebraska, between 2 a.m. and 5 a.m., the police department responded to alarms at two vape shops where officers found shattered storefront glass at both locations. The thieves targeted CBD (cannabidiol) and Delta-8 THC (tetrahydrocannabinol) products. The pair of break-ins happened two days after another similar burglary, totaling three in as many days. The businesses lost tens of thousands of dollars in merchandise.
Timothy Goodman, a manager at the Lincoln Vapor location, said that break-in was just the latest in a string of six incidents in approximately the last two years, according to news reports. Goodman, who has worked at Lincoln Vapor for nearly four years, said it’s his understanding that every break-in can be linked back to the same group.
The burglars stole $2,000–$3,000 worth of merchandise in May 2021 and have lifted around $16,000 in products from the business through the last year and a half, according to Goodman. Most products were hardware and cannabis products, such as CBD and Delta-8 THC. “It’s frustrating beyond belief,” he said. “I wake up most nights in the middle of the night and check the cameras to make sure nobody got in.”
The rise in vape shop crimes may be an unintended consequence of recent regulatory actions, such as tax increases, flavor bans and raising the age to purchase vaping and tobacco products to 21, according to many industry experts. Richard Marianos, a senior law enforcement consultant who has served more than 27 years at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and who is now a consultant and adjunct lecturer at Georgetown University, says crime is often an unintended and overlooked consequence of regulatory constraints on the marketplace that encourage the growth of black markets.
Marianos said that taxes and flavor bans bring prohibition, and prohibition brings crime. “These regulatory actions mean a dramatic increase in street sales to kids, and that is what we have seen all over the United States,” said Marianos. “If you have any form of tobacco harm reduction in your state, just throw that completely out the window [if you are going to implement flavor bans and raise taxes exorbitantly] because it forces young adults and people who can’t afford these products into a growing black market. In terms of law enforcement, the issue is that there has been 150 percent increase in smash-and-grabs because of the difficulty of purchasing these products.”
Sam Salaymeh, president and CEO of AMV Holdings, parent to a chain of 113 Kure CBD & Vape shops across the U.S., said that his stores have seen a major increase in crime over the past two years. During Covid-19 lockdowns in 2020 through early 2021, AMV stores had over 20 burglaries combined. “There is a myriad of stories that come with these break-ins, but the main theme is criminals are trying to get to high-value items that are small in size—and that would be the CBD/cannabis products … etc.,” explains Salaymeh. “This is happening more and more across the country.”
During a one-hour period on Dec. 20, five separate retail locations—three vape shops and two tobacco/vape outlets—suffered a string of robberies by three men wearing masks that crossed the Southeast region of Los Angeles County. A shop owner said the criminals pretended to be customers when one pulled a gun and demanded money while two others snatched merchandise from the store’s shelves, according to news reports.
“We now have organized crews that go out and hit multiple stores like convenience stores, gas stations, vape shops in a single night or a weekend … they don’t go for cash registers; they want the tobacco products because they can sell it on the street cheaper than what it’s being sold for with these high taxes and these prohibitions,” says Marianos. “They’re making a fortune in the black market the same way the dope dealers are selling cocaine and heroin because the taxes on vaping and tobacco products are going through the roof.”

Phoito: Lexington Police Department

Crimes of Convenience
In 2020, there were 102,677 robbery incidents and 102,677 offenses reported in the U.S. by 9,991 law enforcement agencies that submitted National Incident-Based Reporting System (NIBRS) data. Nearly 25 percent of those incidents were committed at convenience stores (13,721), gas stations (7,006) and specialty stores, where vape shops are lumped into (5,372) combined. If criminals are looking for quick cash, then robbing convenience stores or small specialty retail shops is one of the best ways to do it, according to the FBI.
John Cavanaugh, owner of California-based Vaping Industries, says that thieves have broken into his stores numerous times. Typically, thieves try to take what’s immediately available. “They broke in after hours … broke the glass, popped open the register, grabbed the cash, broke into my office, got the petty cash and then rolled out,” he said. “I think we are starting to see more robberies than burglaries lately, and I think that it’s an easier target to hit a vape shop or a smoke shop with guns because the layout is small, there’s only typically one or two employees and—especially with cannabis dispensaries—there’s a lot of cash on hand.”
The terms “burglary” and “robbery” are not interchangeable. They have meaningful differences. Burglary involves a person illegally entering a building to commit a crime while inside. Robbery is typically when someone takes something of value directly from another person using force or fear. There is a far greater chance that someone committing a robbery will do so armed compared to burglaries, which typically occur after hours. Convenience stores accounted for nearly 13 percent of all violent crimes suffered in 2020, and gas stations accounted for about 12 percent.
Across North America, crimes involving vapor, tobacco or cannabis shops are getting more violent. On Dec. 3, in Calgary, Canada, officials said a “number of people” entered Jerry’s Smoke and Vape just after 6:30 p.m. According to a police report, one of the suspects pointed a gun at the clerk, and the bandits made off with cash and merchandise.
On Sept. 12, in British Columbia, a suspect entered a vape shop alone armed with a shotgun. After threatening an employee, the suspect took an undisclosed amount of cash and product before escaping on foot. Over the weekend of May 29 to June 1, 2020, thieves burglarized several cannabis dispensaries, distribution centers and cultivation in Los Angeles, Oakland, San Francisco and other cities, stealing legal commercial cannabis products and cash. On Sept. 11, 2021, in Calgary, Canada, three masked men entered a dispensary armed, held off staff and got away with a quantity of cannabis products.
Cavanaugh said robberies are more common at cannabis dispensaries than vape shops because cannabis dispensaries have a lot of cash on hand, especially in the U.S. where very few banks will work with marijuana businesses. There are also numerous illegal cannabis dispensaries, which perpetrators know are less likely to notify law enforcement.
“Before all of this started happening over the last few years, I didn’t really believe in upping my security. Now, I have to make sure that there are panic buttons, that my staff are properly trained for when somebody comes in with guns blazing,” he says. “They need to know to just give it all up. Give them the cash and whatever they want. It’s OK. It isn’t worth your life. I’m also now spending extra money for high-end security cameras and security systems. It’s frustrating.”

Photo: UK Vapers

Crime Prevention
According to Marianos, there are several reasons why thieves target convenience stores and gas stations and now vape shops and dispensaries: operating hours and low numbers of staff on site, and these types of stores have smaller layouts, so it’s easier to find the expensive/high demand products and there is the potential for large amounts of cash on-site.
“You don’t want it to make product accessible where somebody can just take a trash can, throw it through the window and get into your shop and take all your stuff,” says Marianos. “More cameras, limiting the amount of people that are coming in like they do at jewelry stores—these businesses need a similar model that retailers with high-end products have. In some higher crime areas, you may even have to hire a security guard.”
Vandalism, from smash-and-grab types of crimes, has occurred so often at AMV stores in recent years that Salaymeh says he has a toolkit in his garage ready to go at a moment’s notice with everything needed to board up a store. He says he involuntarily became an expert at it. Salaymeh says that while it is rare for AMV stores to alter operating hours, it is a tactic they have used in the past. He says that having at least two staff members at all times in some locations, installing security cameras and other security measures are the primary tools store owners have in their arsenal to help deter crime.
“Security cameras help us at least get the story behind what happened and potentially pictures of the thieves. We also try to limit the access potential thieves have to valuable product … and we’ve tried to keep the lights on after hours so that people can actually see that these products aren’t lying around or in display cases,” he says. “We leave the register drawer open so that people, when they walk up, they see there’s no cash.”
Another unintended consequence of overzealous taxation and regulation is the impact it has on local law enforcement, according to Marianos. He says enacting some of these rules are, in effect, giving police more work to do in terms of harassment violations that have no teeth instead of fighting real crime. “Instead of being able to work on what they should be working on—to serve and protect—are we going to be calling the police because someone is vaping a flavor?” he asks. “What is law enforcement going to do with all this nonsense? What are they going to charge the guy with? What is the crime? Do you know what I mean? It becomes an hour and a half just sitting around trying to figure out what we’re going to do here.”
During his interview with Vapor Voice, Salaymeh’s phone rang. It was the security firm ADT. One of the AMV stores had an alarm going off. He said it happens multiple times a week. There is insurance available for specialty shops, but both Cavanaugh and Salaymeh say it is expensive. The deductible is often higher than the amount of damage suffered during a crime. Both say they rarely, if ever, claim any damages with their insurance companies.
Another overlooked result of rising crimes in these specialty sectors is the impact on the economy and the lives of employees. Cavanaugh said that crime has forced him to shutter two stores, and he now struggles to keep the doors open in his remaining location. Increases in crime, overregulation and misinformation concerning the health and safety of vaping, and the causes (illegal THC vaping products) of e-cigarette or vaping use-associated lung injury have been too much to bear. “We are doing our best to deal with the reality of today’s vaping industry,” Cavanaugh said. “I want to keep my doors open, and people depend on us; that’s important.”
Salaymeh says he had to close some stores during the Covid-19 pandemic, some of which were temporary. The closures weren’t all crime-related, he explains, but most of them were. There was a period when stores were not allowed to be open, so burglaries were happening, and stores couldn’t sell anything to try to recover losses. “We’re trying to keep people employed. The height of the pandemic was a very, very, very difficult time for our company and many companies like us. The primary victims of these senseless crimes are the people who don’t have a job to go back to because I shut down 18 stores during that time,” he says. “Think about that.”

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

March 1, 2022
Tobacco and Vapor News Around the World

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Click on a country to read about the latest tobacco and vapor developments there.

February 8, 2022
Tipping the Scales

Tipping papers serve both functional and aesthetic purposes. Not only do they help ensure the integrity of the rod-filter construction and play a role in cigarette ventilation, but they also provide useful real estate for decorations. Using sophisticated printing and embossing technologies, manufacturers can appeal to senses of sight and touch. For this article, Tobacco Reporter interviewed two prominent industry suppliers about their innovations relating to tipping papers.

What you see is what you feel—the growing interest in embossed tipping papers
It is always interesting when opportunities are identified and exploited within business sectors, such as the traditional tobacco products market, that are, overall, less than vibrant. It seems to indicate that somebody, a team perhaps, or even a whole company, has been thinking outside the box—or, in one case at least, thinking big inside the box.
Toward the end of last year, the Tann Group told Tobacco Reporter that for the past five years it had been enjoying a “tremendous” increase in interest for embossed tipping papers—an increase that had required it to make major investments in machinery and personnel to keep up with demand. And it seems that, for at least three reasons, this increase in interest is likely to be maintained. One is the vital feedback loop that is powered by consumer demand and that is clearly working hard in this case. Another is that while the increase in demand has been widely spread, it has not gone global—yet. And yet another is that, working within the letter and spirit of even strict regulations, cigarette manufacturers can use some embossed tipping papers to help maintain the attractiveness of their products even when and where those regulations are being imposed so as to reduce product appeal.
But more of that later. Firstly, it is necessary to explain for those not already familiar with embossing as it applies to tipping paper, something about the types of embossing that are available for such applications, which comprise macro-technology, micro-technology and nanotechnology. Macro-embossing delivers a haptic effect, one that doesn’t require any special surface treatments of the tipping paper, such as printing or coatings, and that is experienced by a smoker through her fingers and lips because the bosses produced by this process, which are in the submillimeter range, are large enough for them to be detected by touch. By contrast, in the case of both micro-embossing and nano-embossing, the surface deformations produced are respectively within the micrometer and nanometer ranges, which are too small to be detected by touch but which interact with visible light and in this way provide some spectacular visual effects.
In the case of micro-embossing, the structures produced influence the reflection of visible light, so this technology is used only on tipping papers that have metallized surfaces, such as those produced by metallic hot foil stamping, and not on plain paper. Without micro-embossing, the light reflected by stamped hot foil items, such as lines and logos, would be clear and shiny as it would be when reflected by polished metallic surfaces. But with micro-embossing, the light reflection becomes diffuse and scattered as it is on matte metallic surfaces, and this gives the hot foil designs a satiny appearance.
The nano-embossed structures, meanwhile, cause the light that strikes them to be diffracted in such a way as to produce an interference effect—to be split into the spectrum of colors and thereby to deliver rainbow visuals, holographic impressions and the “tilted image” effects that are strongly dependent on the angle at which they are viewed. Nano-embossing, which requires the tipping paper to have a full-surface color, produces its strongest effects the darker that the background color is.
Of the three types of embossed tipping paper on offer, the Tann Group says it is the macro-embossed one that is currently most in demand because it communicates with consumers on both a haptic and a visual level, something the company describes as a “what you see is what you feel” concept. But it is the case that embossed tipping papers, whether they employ macro-embossing, micro-embossing or nano-embossing, are used mainly on premium brands, partly because of the haptic and visual upgrades they provide but also simply because of the higher prices that such tipping papers command.
It follows, then, that embossed tipping papers, whether macro-embossed, micro-embossed or nano-embossed, are particularly popular in those places where premium brands are most in demand, including duty-free outlets. Currently, demand for embossed tipping paper is mainly coming from the countries of the CIS and Asia, including China and South-East Asia, but it is expected that the trend will move to parts of Europe and Central and Latin America.
Of course, due to stricter regulations that will govern tobacco products in the future, including those imposed through the EU’s second Tobacco Products Directive, it will become more and more difficult in certain regions to apply to tipping papers special features, such as special inks, aromas/flavors and metallic elements. However, embossing technologies—and especially macro-embossing—provide potential options to maintain the appeal of tipping papers while complying with such regulations, because no extra chemical treatment of the tipping paper or application of special inks is required. With the help of purely mechanical converting of tipping papers, there will still be opportunities for effective design upgrades that do not come into conflict with regulatory or sensory/toxicological restrictions.
Given the importance of maintaining product appeal while complying with regulatory requirements, it is worth mentioning, too, that the embossing techniques described here can be applied also to printed paper inner liners, which is the first point of interaction, contact and, therefore, communication that the consumer has with a brand after opening a pack of cigarettes.
Examples of off-the-shelf macro-embossed, micro-embossed and nano-embossed tipping papers are available from the Tann Group, which also offers a design service as part of development projects in which customers get to see and feel the finished product prior to a market launch. —George Gay

Into the Void: The Fine Art of Cigarette Ventilation
Thinking recently about the perforation of cigarette tipping paper, I was reminded that Leonardo da Vinci is credited with once having said that among the great things that are found among us, the existence of nothing is the greatest. I’m sure you can see where this is leading. The perforation of tipping paper allows for the controlled dilution of tobacco smoke, so, given that in many parts of the world, controlling the deliveries of tobacco smoke constituents is the subject of government regulation, it is no overstatement to say that perforating technology plays a vital role in cigarette manufacture. And so here is a case where a vital role is played by perforations—holes if you like, and what are holes if not nothing?
Of course, this introduction is somewhat misleading because, in the case of perforations, the nothingness “created” is defined by the material in which they are made—the tipping paper, though it is still the case that some such papers are not perforated.
But in the main they are. Axel Nather, head of sales and marketing at Micro Laser Technology (MLT), told Tobacco Reporter in an email exchange early this year that a few manufacturing processes still used electrostatic perforation, which worked well where only very low levels of ventilation were required. However, he said, as government regulations and end users demanded cigarettes with increasingly lower deliveries, laser perforation was ultimately the solution. Laser perforation could be used to produce very stable low-ventilation, medium-ventilation and high-ventilation levels, and ventilation level adjustment was very simple, requiring only changing the hole sizes, track numbers and hole quantities.
With MLT systems, the operator can instigate these adjustments, and, in the case of online equipment, additional parameters can also be set, so, for example, thicker cardboards can be perforated or cut.
The use here of the word “cut” needs some explanation as does the reference to “online” equipment. When it started in business 20 years ago, MLT developed and supplied offline laser perforation machinery, but during the past 10 years, it has also been offering and supplying online equipment. This means the company has three main groups of tobacco industry customers comprising cigarette manufacturers of all sizes, paper converters and machine builders that integrate MLT’s laser equipment into their production lines.
Offline machinery, which comprises stand-alone machinery, is almost always supplied directly to customers. On the other hand, online equipment can, as stated above, be taken up by manufacturers when MLT’s equipment is fitted to OEM cigarette making machinery, and it can be retrofitted to existing manufacturing lines either by MLT or by specialist rebuilders. And finally, there are laboratory systems, which, Nather said, could be delivered with many technically exciting elements.
Finally, that is, in relation to perforation machinery and equipment. The tobacco industry also uses MLT’s systems for laser cutting and laser scribing, mainly in the production of cigarette packaging, where cardboard and foils are cut and scribed. But MLT’s laser perforating and cutting systems have come into their own with the rise of heat-not-burn (HnB) products. Mostly, HnB products are made with relatively thick materials, such as cardboard, said Nather, so for this reason, MLT had developed laser systems that could generate extremely short pulses of very high powered lasers. This allowed the creation of very small, clean holes, and it also meant that many thousands of “cardboard sticks” could be perforated per minute. And if the speed was still not sufficient, two lasers could be used simultaneously to double the speed.
All this adds up to what Nather described as a pleasing and increasing level of project inquiries and sales, despite the fact that in 2020 the coronavirus pandemic had had a significant impact on the entire tobacco industry, with projects often being delayed. Nather mentioned in particular steadily increasing inquiries in the area of online perforation and HnB products. And he said MLT’s service department was currently very busy because, in part, it now maintained older laser systems produced by other suppliers and refurbished their laser sources.
One of the reasons that Nather gave for the increasing level of interest was the innovative nature of the tobacco industry, especially in the area of new product developments, for which MLT’s laser systems were often needed. “This is, of course, very gratifying; development projects are always a great pleasure when exciting products are created,” he said. “As a medium-sized company, we are very flexible and can react relatively quickly.”
The one challenge Nather mentioned concerned the effects of the coronavirus pandemic, and I asked him what difficulties MLT had faced and what steps it had been able to take to ameliorate those difficulties. Some tobacco industry projects had been postponed and others had taken longer than normally would have been the case, he said, especially during 2020 and early 2021. In addition, travel had been difficult, and, in some cases, it had not been possible to enter some countries, such as the U.S., for a relatively long time.
In response, MLT had created the circumstances whereby systems could be put into operation virtually, often by helping customers through webcam-based remote maintenance. Interestingly, Nather added that while MLT was glad traveling had become easier again, it would continue to use or even expand the possibilities offered by online maintenance and commissioning. —George Gay

February 1, 2022
The Chosen Few

Amanda Wheeler (Photo: Malcolm Griffiths)

The FDA is getting rid of the little companies that created the vaping industry while using the big companies to take the industry to new heights of scientific overkill.
By George Gay
Amanda Wheeler is angry.
I know this because I listened to her presentation on day two of the Global Tobacco and Nicotine Forum (GTNF), which was held in London in September 2021.
I know, also, that she has every right to be angry—very angry. But despite the provocation she has suffered, her anger was not immoderate or discourteous. It was a controlled, calmly articulated anger—the sort that, if it had been aimed at me, would have had me checking where the door was. Indeed, I think I checked anyway—you can never be too careful.
Who is Wheeler? She is the founder and owner of the U.S.-based e-liquid manufacturer and retail store JVapes and president of the American Vapor Manufacturers’ Association.
Who is she angry with? I think it would be fair to say she is angry with a lot of people and organizations, but mainly she is angry with the U.S. Food and Drug Administration, some politicians, large swathes of the U.S. media, “scientists” who put their names to the findings of flawed research into vaping and people who use their wealth and influence to spread misleading stories about vaping, sometimes based on flawed research.
Why is she angry? Well, the shenanigans and pettifoggery the above organizations and individuals have been getting up to has resulted in almost the entire U.S. vaping industry being faced with an existential threat. And just in case you have been on an interplanetary mission for the past 10 years, let me explain why this is, to say the very least, disappointing. Vaping comprises a harm reduction tool that actually works—that, because it mimics reasonably closely all the enjoyable and satisfying aspects of tobacco smoking but at a tiny fraction of the risk, provides people who want to quit smoking with an exit route that leads to a significantly improved quality of life. To put things in perspective, I am told, even by those opposed to vaping, that in the U.S., more than 400,000 people die of smoking-related diseases each year.

Undermining an Obvious Solution
And yet, outside the vaping industry and the village of smokers and vapers, vaping generally goes down like a lead balloon in the U.S. Why? Well, a cynic such as me can think of a whole raft of reasons, none of which reflect well on the intellects or ethics of those opposing vaping. But it’s the inconsistency I simply cannot understand. Why would politicians charge the FDA with reducing the problems caused by tobacco smoking, but then, when a solution—vaping—dropped into its lap, undermine that solution wholesale? It makes no sense. Why, when given the current circumstances, you have to assume politicians wanted smoking—and the flow of money it draws in—to continue, did they ask the FDA to intervene in the first place? After all, they didn’t, as far as I know, ask the FDA to intervene in the case of alcohol, even though the U.S. comes fourth on the worldwide league table of populations who get drunk the most.
“Oh, but what about the problem of vaping among young people?” will come the anguished cry from some politicians, the FDA and an army of other organizations. Well, let’s examine the facts. I am told that about 11 percent of U.S. high school students recently reported using a vape once in the previous 30 days while 3 percent of U.S. high schoolers reported vaping nicotine daily. Also recently, about 20 percent of 10th graders and about 34 percent of 12th graders reported using alcohol in the previous 30-day period while about 9 percent of 10th graders and 20 percent of 12th graders reported being drunk in the past 30 days. By the way, for the sake of our interplanetary travelers, I should include the reminder that it is not possible to become drunk by vaping nicotine.
Perhaps the answer to these inconsistencies lies in tradition or tradition’s running mate, inertia. In Australia, which comes top of the worldwide league in respect of the number of times people report getting drunk during any one year and in respect of seeking emergency medical treatment because of alcohol poisoning, you can buy alcohol at drive-through bottle shops. But you must have a prescription to buy nicotine-based vaping products, and you can buy them only from pharmacies or through the Personal Importation Scheme. Come on, you know it makes sense.

A Flawed Process, Not Flawed Products
In can be illuminating to discover what some individuals and organizations think of as making sense. In a piece on Open Access Government on Dec. 13 titled, “Tobacco control and prevention efforts in the U.S.,” the director of the FDA’s Center for Tobacco Products (CTP), Mitch Zeller, was quoted as saying, in part, “After receiving millions of premarket applications [premarket tobacco product applications—PMTAs] for e-cigarette products last year, the agency has recently issued marketing denials [marketing denial orders—MDOs] for over one million flavored ENDS [electronic nicotine-delivery systems].” And later, he was quoted as saying, “… R.J. Reynolds Vapor Company [RJRVC] … received marketing authorization in October 2021 for an ENDS device and tobacco-flavored e-liquid pods after FDA determined ….” This, a more or less one-in-a-million approval rate, is what the FDA seems to see as a success.
OK, it would be easy to accept the FDA’s glee at having blocked a million products if these products had been flawed, but, on any reasonable judgment, this seems not to be the case. The million products seem to have fallen foul of a flawed process, one in which the goalposts might have been moved after applications were submitted. I would direct anybody interested in what went on to a piece in Filter by Alex Norcia, “FDA Memos Reveal its ‘Fatal Flaw’ Rejection Plan for Flavored Vapes” (see https://filtermag.org/fda-memos-flavored-vapes). As Norcia makes clear, the situation is complex, but some things seem reasonably clear, at least to the cynic in me. The FDA seems to have found an expedient way of getting itself out of a trap created by a pincer movement in which, on one side, anti-vaping organizations, using the courts, had forced onto the FDA a totally unrealistic deadline for approving or denying millions of vaping product marketing applications while, on the other side, baying politicians had picked up the scent of a populist crusade—one opposed to vaping flavors.
Simply put, the vaping scene in the U.S. seems to be chaotic. The regulatory environment in which the vaping industry operates should and could be effective but simple. After all, it concerns a consumer product, not something to blast you into interplanetary space. But this environment has instead been rendered enormously complex and chaotic. And, as a consequence, the industry has been rendered at one and the same time both chaotic and, product-wise, moribund, an almost miraculous misachievement.

Playing Catch-Up
The odd thing is that things could be worse. At present, what is happening in the U.S. amounts to a phony war. While the existential threat exists, within the chaos and complexity, life goes on, in part covered by a legal fudge. Vaping product owners and vaping shops are still selling some of their products, and consumers are still able to access some of their favorite brands. This is because some products, especially tobacco-flavored and menthol-flavored ones, while not having been approved, have not been issued with MDOs, even though the deadline for PMTA decisions has passed. In addition, some MDOs are the subject of court challenges, some products that have been the subject of MDOs have been left on the market, presumably because their owners figure it is going to take time for the FDA to catch up with them, and some brand owners have switched their e-liquid formulations from tobacco-derived nicotine to synthetic nicotine, which does not come under the authority of the FDA.
Not yet, it doesn’t. At his FDA commissioner nomination hearing on Dec. 14, Robert Califf reportedly said there were in synthetic nicotine two enantiomers of nicotine, one of which did not occur in nature and whose properties were not known. He then went on to say that because of this, it would be necessary to close this loophole, which I take to mean he thought it was time for the FDA to take authority over synthetic nicotine. There are at least three problems with this as far as I can see. Firstly, synthetic nicotine does not comprise a loophole. It has been around long enough that the FDA must have been aware of it and have chosen not to include it when it performed its nontobacco-into-tobacco deeming sorcery.
Secondly, Califf was apparently saying synthetic nicotine and tobacco-derived nicotine were different, so they had to be treated the same, which is a non sequitur. Thirdly, it seems as though, in saying what he did, Califf has created a false and ultimately unhelpful dichotomy. I am told by people who know about such things that the important issue is not about the difference between tobacco-derived nicotine and synthetic nicotine but between nicotine that complies with U.S. and European pharmacopeias and nicotine that doesn’t comply. I believe that in some cases, synthetic nicotine outperforms tobacco-derived nicotine in this regard.

Favoring the Big Guys
There is one other notable thing about this fatally shambolic situation, and that concerns the wedge that is being driven between the major tobacco manufacturers and the smaller vaping companies. During a panel session at the GTNF mentioned at the start of this piece, somebody asked how long the U.S. public should be patient with the FDA while it got its vaping act together. In response, another participant seemed to defend the FDA, in part by saying that even given most products fell foul of the agency’s PMTA process, the public would still have the choice of two products. Both of these products were owned by major tobacco companies—one was an oral product and one was IQOS.
I cannot help feeling that though the PMTA process favors the major tobacco manufacturers and is clearly helping them in their competition against the smaller companies, the majors need to look at and be seen to look at the interests of the smoking and vaping public, which are clearly not being served by the FDA. Like Wheeler, they need to state publicly that what is going on is counterproductive. As somebody once said in relation to another matter, if you economize on the foundations of a building and spend the money saved taking it higher, sooner or later, the whole edifice is going to come tumbling down. And this is what the FDA seems to be about. It is de facto getting rid of the little companies that formed the foundations of the vaping industry while using the big companies to take the industry to new heights of scientific extremism and overkill.
Just how dangerous such a strategy can be has been demonstrated by the fact that one of the two “products of choice,” IQOS, has been banned from the U.S. market over a patent dispute. Does anybody think it’s okay to reduce consumer choice to one oral product—and, of course, let’s not forget the RJRVC product—no matter how good it might be? We’re talking more than 400,000 lives a year, remember.
To my way of thinking, the major manufacturers need to join Wheeler and become constructively angry.

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.

February 1, 2022