Author: Marissa Dean

  • Thailand: Home Vaping is Domestic Violence

    Thailand: Home Vaping is Domestic Violence

    Image: Zerophoto

    Exposure to secondhand vapor from vaping at home could be considered a violation of Thailand’s child protection laws, according to child health and rights experts who are calling for more awareness of the dangers of vaping around children, reports The Pattaya Mail.

    Under national laws, vaping around children could be considered “domestic violence,” according to Thai authorities. They are calling for stricter enforcement.

    The Royal College of Pediatricians of Thailand wants stronger government measures to restrict the import and sale of e-cigarettes and increase educational campaigns about the risks of nicotine.

  • U.S. Court Reverses ‘Elf’ Trademark Suit

    U.S. Court Reverses ‘Elf’ Trademark Suit

    Image: Olivier Le Moal

    A ban on a Chinese company selling “Elfbar” vapes can’t stand because a district court failed to analyze whether the rightsholder’s use of “Elf” on an illegal product negated its trademark rights, the Federal Circuit court stated.

    “Elfbar” seller Shenzhen Weiboli Technology Co. Ltd. argued the “unlawful use doctrine” precluded a preliminary injunction as plaintiff VPR Brands LP failed to clear its “new tobacco product” with the government as required under federal law, according to Bloomberg.

    The U.S. Court of Appeals stated in its opinion that the district court wrongly dismissed the defense without considering the propriety of the doctrine, a proper standard or Weiboli’s evidence.

    The Federal Circuit ruled that the district judge who ordered the injunction “misread” precedent and relied on a “deficient” legal analysis.

    A U.S. federal judge on Feb. 23 ordered Shenzhen Weiboli Technology to stop marketing its Elfbar e-cigarettes in the U.S., finding that VPR Brands, which makes and sells Elf brand vapes, is likely to succeed on its claims that the Elfbar vapes infringe its trademark.

    According to U.S. District Judge Aileen M. Cannon, VPR has shown there is a likelihood of confusion and the company stands to suffer harm if its Chinese competitor is allowed to keep selling the Elfbar vapes.

    In November, VPR asked for an injunction blocking Shenzhen Weiboli from continuing to use the Elfbar mark, arguing the alleged infringement is costing VPR about $100 million because of the effect on future sales.

    VPR claims Shenzhen Weiboli is not only infringing VPR’s Elf trademark but also its patent for its e-cigarette device.

  • Virginia Commission Mulls Grant Requests

    Virginia Commission Mulls Grant Requests

    Photo: Sarah Vogelsong | Virginia Mercury

    Virginia’s Tobacco Region Revitalization Commission has $12 million to spend on energy projects as part of a legislative mandate to revitalize the economies of two regions that are no longer receiving economic benefits from the tobacco industry, reports Virginia Mercury.

    The Energy Ingenuity Committee, at the commission’s last meeting, discussed applications it received for two rounds of the funds that opened this year. A third round of funds is expected to open following the commission’s next meeting scheduled for September.

    “We rolled it out earlier this year,” said Jerry Silva, director of regional energy development and innovation for the commission. “We really did not know what the application level would be.”

    The Tobacco Region Revitalization Commission was formed in 1999 with 28 legislative and citizen members representing Southside and Southwest Virginia. The commission allocates funds from the 1998 Master Settlement Agreement, which was the beginning of the demise of the tobacco industry’s footprint in the two regions.  

    The Energy Ingenuity Fund was recently created by the commission to help increase economic activity surrounding energy development projects. The fund allocated $6 million to each of the two regions and solicited energy development projects.

    To apply for the grants, applicants must be a government entity or nonprofit, have one-for-one matching funds and identify the number of jobs that could be created by the project. Private companies can apply for the grants as long as they partner with a locality to create economic incentives.

    There is a pre-application phase where applicants present ideas to Silva on what the funds could go toward before staff determine what needs more information and what can be submitted as a full application. Silva received 17 pre-applications in round one, with three moving forward to a full vote in May. Round two saw 11 pre-applications, with four expected to move to a vote in September.

    “These are projects that we’re trying to help bridge opportunities that would normally not be opportunities unless we helped them,” Silva said. “We’re trying to make sure we’re the best stewards of the commission’s money and dollars. We want to fund viable projects.”

  • Tanzania Tobacco Exports Hit $438 Million

    Tanzania Tobacco Exports Hit $438 Million

    Image: Tobacco Reporter archive

    Tanzania’s tobacco export value has hit $438.5 million, more than double the previous year, according to data from the Tanzania Revenue Authority (TRA) and Bank of Tanzania (BoT), reports The Guardian.

    The government’s target was $400 million.

    Tobacco exports have now surpassed coffee and cashews as the leading traditional export earning commercial crop. Tobacco is currently produced under contract.

    The value increase is a result of a crop production increase to 122 million kg as well as an increase in commodity price in the world market.

    Tanzania is now the second largest producer of tobacco in Africa following Zimbabwe.

    For the 2024/2025 season, Tanzania aims to produce 200,000 tons of tobacco, and for the 2025/2026 season, the country aims to produce 300,000 tons.

    The goal is to increase export earnings to between $600 million and $700 million annually, according to Hussein Bashe, the minister of agriculture.

    According to Bashe, more than 50 percent of tobacco was bought and sold abroad by local companies, marking a first for the country.

    Statista projections show Tanzania’s tobacco products market generating $644.9 million in revenue in 2024.

  • Brazilian Tobacco Suitable to Ship to China

    Brazilian Tobacco Suitable to Ship to China

    Image: SindiTabaco

    On Aug. 9, the Interstate Tobacco Industry Union (SindiTabaco) hosted a meeting to formalize the closure of the tobacco pre-inspection procedure for the 2023/2024 crop year, one of the requirements of the bilateral trade protocol between Brazil and China. The meeting was held in hybrid format, with the virtual presence of the technicians from the General Administration of Customs China (GACC) and the representative of the Ministry of Agriculture, Livestock and Food Supply (MAPA) and of the National Organization for Brazilian Phytosanitary Protection (ONPF), Pedro Carneiro Abreu.

    Other authorities from Brazil and China attended the event as well.

    “This is a primordial moment for compliance with the protocol. The samples were collected in a very effective manner, and it is with great satisfaction that I inform you that no pests were detected in the collected samples. This once again corroborates the quality of the Brazilian tobacco. China is one of our largest importers of tobacco, and this partnership plays a fundamental role for the continuity of the businesses between the two countries. We are sure that we will continue making strides in this relation,” commented Abreu from MAPA Brasilia.

    “Our participation consists in representing this commitment, which is also shared by minister Carlos Favaro, besides acknowledging this activity as relevant for the entire country. In our understanding, this expresses our responsibility with regard to the Chinese inspection organs,” said Jose Cleber de Souza, superintendent at MAPA RS.

    The MAPA was in charge of collecting the processed tobacco samples and sending them to the Central Analytical Laboratory of the University of Santa Cruz do Sul (UNISC) for laboratory tests that confirm the phytosanitary status of the product prior to shipment. Roque Danieli, tax auditor and head of MAPA’s Plant Health and Inputs Inspection Service in RS, presented details about the pre-inspection activities.

    “During these 23 days in which we worked jointly with the GACC representatives, in virtual format, it was possible to attest to the quality of the 2023/2024 crop and demonstrate that, at field level, the 2024/[20]25 crop is now under cultivation with all the necessary cares in compliance with the requisites set forth on the protocol. The integrated production system gets the credit for the fact that tobacco is the commercial crop that uses the least amount of pesticides at field level, a result of the constant work of the farm extension agents. We hope that the presentation of the works is cause for satisfaction, and next week, we shall send the final report to Brasilia to be forwarded to the GACC,” Danieli said.

    Zhang Nan Zhengrong, Leader of the China Leaf Company Delegation, presented the pre-inspection report to the attendees of the meeting jointly with the technician responsible for the Central Analytical Laboratory of UNISC, professor Adriana Dupont Schneider. She gave details of the analyses.

    “This year, we analyzed a total of 54 lots with samples collected in eight companies. The laboratory activities took 24 days, and they certified the phytosanitary safety with regard to the nine quarantine pests set forth in the agreement, of which, six are types of insects, two weeds and the fungus known as blue mold. All the results were negative for the pests included in China-Brazil trade protocol,” said Schneider.

    “Tobacco is an agricultural crop that suffers harsh criticism but has been vigorously defended by the MAPA,” said SindiTabaco President Iro Schuenke. “This has a lot to do with the social and economic importance of the crop for our country, especially for the South Region. China is our second-largest importer, coming only after Belgium, and every year purchases big amounts of our tobacco. And this is the moment for a special mention of the farmers that cultivate tobacco in Brazil who, along with the farm extension agents, have performed all the necessary works for our compliance with the necessary requisites that have kept Brazil as top leaf exporter over the past 30 years.”

  • No Shortcuts

    No Shortcuts

    The effort to correct nicotine risk misperceptions will be a marathon rather than a sprint.

    By Stefanie Rossel

    “Nicotine contained in tobacco is highly addictive, and tobacco use is a major risk factor for cardiovascular and respiratory diseases, over 20 different types or subtypes of cancer and many other debilitating health conditions.” With phrases like this, the World Health Organization links the undisputed harms of burning and inhaling plant tissue with the ingredient smokers seek in a cigarette.

    Regardless of its form of delivery, such statements suggest, nicotine is the devil incarnate. In spreading this message, it appears, the WHO has done a good job. In a 2021 study funded by the National Cancer Institute, 83.2 percent of surveyed U.S. physicians “strongly agreed” that nicotine directly contributes to the development of cardiovascular disease. Nearly 81 percent thought it contributes to chronic obstructive pulmonary disease (COPD), and 80.5 percent associated nicotine with cancer.

    While recognizing that nicotine is responsible for the addictive nature of tobacco products, the study authors pointed out that the strongest evidence for direct causality for nicotine is for birth defects (neurodevelopment), with only limited evidence supporting causal links to cancer and cardiovascular disease and scarce data for COPD. The misperception that nicotine is responsible for smoking-related health risks, they observed, is not only common among the public but also among other healthcare professionals.

    “Correcting misperceptions should be a priority given that in 2017, the FDA [U.S. Food and Drug Administration] proposed a nicotine-centered framework that includes reducing nicotine content in cigarettes to nonaddictive levels while encouraging safer forms of nicotine use for either harm reduction (e.g., smokeless tobacco) or cessation (pharmacologic NRT [nicotine-replacement therapy]),” the study concluded.

    In product use, risk perceptions play a critical role; they can influence smokers’ decisions on whether to switch to products with lower risk profiles. The messaging is an essential part of changing misperceptions. Studies on nicotine corrective messaging have shown that it was effective in decreasing misperceptions of nicotine harm, but repeated exposure to such messaging was necessary to reduce false beliefs about nicotine and tobacco products.

    With physicians and other healthcare professionals often being the first point of call for people seeking to quit smoking, it is obvious that their misperceptions should be corrected first so that they can educate their patients and accurately convey nicotine’s relative and absolute risks.

    Carolyn Beaumont

    Carolyn Beaumont, a general practitioner (GP) from Victoria, Australia, has taken on the challenging task of educating her colleagues. Since July 1, 2024, all nicotine vapes in Australia have been regulated as therapeutic goods, which means they are available only at pharmacies to help people quit smoking or manage nicotine dependence. Currently, all buyers of nicotine vapes require a prescription from a doctor or a nurse practitioner.

    Starting Oct. 1, the rules will be somewhat relaxed. From that date, people 18 years or over will be able to purchase therapeutic vapes directly from a pharmacy without a prescription. People under 18 will still need a prescription to access vapes, where state and territory laws allow it, to ensure they get appropriate medical advice and supervision.

    The concentration of nicotine in vapes sold in pharmacies without a prescription will be limited to 20 mg per milliliter; people who require vapes with a higher concentration of nicotine will still require a prescription.

    The law requires pharmacists to consult customers of both prescription and nonprescription vapes before allowing them to make a purchase.

    Following the announcement of the new rules, several major pharmacy chains in Australia stated that they will no longer stock vapes. Beaumont is not surprised: “They simply don’t have the time, product knowledge or resources to advise customers on appropriate products and use. It is greatly complicated because any pharmacist-only product must be an approved medical product, yet there are no approved vapes in Australia. They are listed but not approved. Fortunately, there are some online pharmacies who specialize in vapes, and these will continue to operate but likely will require a script to avoid the ‘nonapproved’ issue.”

    “There is no official doctor education in Australia that adequately presents the fuller context of smoking, vaping and nicotine.”

    Enjoyment Doesn’t Feature

    Despite the hostile environment for nicotine, Beaumont says she has found that her colleagues are quite interested in the field of tobacco harm reduction (THR). “Yet, to communicate THR on a larger scale, typically via continuing medical education (CME) courses or webinars, is difficult. These generally require support from the Royal Australian College of General Practitioners (RACGP), and to date, there is no official doctor education in Australia that adequately presents the fuller context of smoking, vaping and nicotine,” she says.

    “In medical school and as a trainee GP, we were taught of the many smoking-related health and social issues. But a more nuanced understanding of working with smokers wasn’t appreciated. We all knew the ‘three A’s’ approach—ask, advise, assist—the measure of nicotine dependence—time to first cigarette—and the first line NRTs. Yet it stopped there as though magically, smokers would be motivated to quit, and this would happen within six months. If not, repeat the process ad nauseum.”

    According to Beaumont, doctors aren’t taught that some smokers like nicotine and simply want a less harmful alternative. “Enjoyment doesn’t feature in medical education,” she says. “Doctor support can truly help some people reduce their use. But it’s not enough for many heavy smokers, and they often become disengaged with the same messaging they keep hearing from doctors.”

    Beaumont is encouraged, though, that Australia’s GP College recently revised its smoking cessation guidelines and increased the recommendation of vaping from “low” to “moderate.” “I hope this will have a reasonable impact on doctors’ willingness to prescribe, or at least be open to the conversation,” she says. “I also hope this signals a greater willingness by the RACGP to support vape-related CME that is broader in scope and includes input from ‘progressives’ such as myself.”

    Beaumont first became aware of vaping as a cessation tool in 2020 when Australia was on the verge of making vapes prescription-only. “My approach was simply this: I listened to the needs of smokers and vapers,” she says. “It didn’t take long before I was convinced of [the] merits [of vaping], and also, I developed a deeper understanding of nicotine use and addiction. Compassion and health improvements were, and still are, the underlying reasons why I’ve remained involved in this field.”

    Beaumont aims to help disadvantaged groups, which are among the most affected by smoking-related death and disease. “It is simply unjust that smokers are also affected by nicotine myths, and it is getting to the point where people think that smoking is better than vaping.”

    “Like so many areas where science is contested, adherents of contrarian positions are rarely persuaded by more science or data.”

    Open Dialogue Required

    Derek Yach

    While some believe that science will correct misperceptions of nicotine, others are skeptical, pointing, for example, to the WHO’s proposal to define aerosols as smoke. Derek Yach, a global health expert originally from South Africa who played a key role in crafting the WHO’s Framework Convention on Tobacco Control, says that while some topics require more research, these gaps should not delay WHO support for THR, noting that they have not prevented the U.S. Food and Drug Administration and other government agencies from authorizing a range of reduced-risk products.

    “Like so many areas where science is contested, including vaccine benefits, climate change or even beliefs that the earth is flat, adherents of contrarian positions are rarely persuaded by more science or data,” says Yach. “Their views deeply reflect emotional, ideological and sometimes cultural views based on their life experiences. A mother whose child gets autism after a vaccine is easily convinced that vaccines are dangerous. A tobacco control advocate who experienced tobacco industry subversion of public policies keeps that view and doubts anything new coming from industry.”

    Having worked on all sides of the issue and having spoken with a wide variety of stakeholders, Yach says that there is no shortcut to finding safe spaces to not only talk honestly about the science but also examine the reasons behind the mutual suspicion. “I saw this bear fruit in the declining years of apartheid when talks about talks led to a peaceful transition of power,” says Yach. “It is possible in that setting; it must be possible in our world.”

    The Morven Dialogues, a series of meetings between U.S. public health officials and tobacco industry representatives first held in 2012, have been a modest example of what is needed, according to Yach.

    “They recently reported on their March 2024 meeting, which brought together industry with some public health leaders in the U.S.,” says Yach. “Further, I see signs of hope in a recent article by authors from public health I have long respected. They argue for dialogue between scientists in the public sector and industry—as I have—and not for boycotts and bans.”

    Without agreement on the basic scientific issues and progress on correcting disinformation, sound policies are unlikely. “A study of how change happens in public health shows that it always starts with physician acceptance of the evidence,” says Yach. “They apply that evidence to themselves, to their patients and through organized efforts to public policy. Recall that no country has ever seen a reduction in their smoking rate before it goes down in physicians. I suspect that is true regarding uptake of THR products. And that starts with doing more to have disagreeing groups talk.”

    It’s going to be an uphill struggle, though: In mid-June, the WHO in a press release expressed “grave concern over the tobacco industry’s manipulative tactics aimed at influencing healthcare providers through continuing medical education programs and thereby advancing the interests of the tobacco industry.”

  • Out of Proportion

    Out of Proportion

    A fine cigar is a basic product that is probably as “natural” as any consumer product can be. | Photo: Laurenx

    The inclusion of fine cigars in the UK generational ban proposal makes no sense.

    By George Gay

    On May 22, the then U.K. prime minister, Rishi Sunak, announced that Parliament was to be dissolved on May 30 and a general election held on July 4.1 The announcement caught even political commentators by surprise because the election could have been held any time during 2024 or January 2025. Clearly, Sunak had decided that his policies were not going to improve the circumstances of most voters, at least in the short term.

    There was certainly a note of desperation in the timing of the announcement because it meant Sunak was abandoning many of what had been referred to as his flagship policies, a move that led The Guardian newspaper to report that his legacy was looking “increasingly threadbare.”

    But it’s an ill wind and, from the point of view of certain sections of the tobacco industry, the announcement came as a relief because it meant the tobacco and vapes bill, which was being pushed through Parliament with cross-party support, was holed below the waterline. The bill contained a provision for banning tobacco sales in the U.K. to anybody born from Jan. 1, 2009, onward, a so-called generational ban.

    It seemed to say something about Sunak that he chose to scupper this policy while it had the wind in its sails, especially since, notwithstanding the timing of events, it could have been pushed through in the last days of Parliament, and given he had so emphasized his commitment to the health of the next generation. In fact, a BBC interviewer on May 24, apparently incredulous that the policy had been abandoned, asked a minister how this could have been the case, only to be told that Sunak had at least won the argument.

    But this was not true because there had been no argument, if “argument” is used to mean a debate during which different ideas are put forward and resolved in a rational manner. Speaking at a Beat the Ban lunch held in London on May 21, Simon Clark, the director of the Freedom Organization for the Right to Enjoy Smoking Tobacco (Forest), had been scathing about the way the bill was being “steamrollered” through Parliament. Following a short public consultation before Christmas, he said, the government had announced that it would not consider any submissions from groups with links to the tobacco industry, which, for instance, included Forest and even retailers. “To the best of my knowledge, that has never happened before,” he added.

    But, once again, this speaks to the makeup of Sunak, who apparently does not like to hear counter arguments and becomes tetchy when he does. So it is hardly surprising that, after the bill’s second reading, when it entered its committee stage, 16 of the 17 Members of Parliament appointed to the committee had voted for the bill, and the other was known to support it. And when it came to inviting people to give oral evidence to the committee, witnesses were almost exclusively supporters of the bill.

    The August court ruling put the FDA in a position where it could regulate as tobacco products vaping articles that contain no tobacco but not premium cigars that contain only tobacco.

    Misplaced Priorities

    Sunak’s scuppering of the bill is unlikely to be the end of the matter because it had near-universal parliamentary approval. This means that a tobacco and vapes bill is likely to be refloated in some form, so it is worthwhile looking at some of the thinking behind this initiative. Any number of stories have been written about proposed generational tobacco bans, but here I would like to consider one aspect of it that I think makes no sense: the fact that the proposed U.K. ban, in encompassing all tobacco products, seems to lack any sense of proportion, something that can be demonstrated by citing the case of fine cigars.

    At a time when, belatedly, serious health concerns are being raised in public about the consumption of alcohol, processed foods, caffeine and social media, and even about gambling and lack of sleep, why would the government’s attention be focused on something as benign as fine cigars, defined here as those cigars comprising only tobacco, water and vegetable-based gum?

    As here defined, a fine cigar is a basic product that is probably as “natural” as any consumer product can be. Fine cigars are not implicated in concerns about flavors, and they cause no problems in relation to filters, batteries and all the other tobacco/nicotine product parts implicated in environmental issues. I would guess that only a tiny minority of the U.K. population smokes fine cigars, that the proportion of such smokers is relatively stable, that fine cigar consumption raises no ethnic or gender issues and that where these products are smoked is already restricted, meaning that certain aspects of concerns about population-level harm must be minimal.

    Including an Outlier

    To examine this issue a little closer, it is instructive to look across the Atlantic at what happened in relation to fine cigars in the U.S., where they are usually referred to as premium cigars. On August 9, 2023, in response to a lawsuit filed by the Cigar Association of America, the Cigar Rights of America (CRA) and the Premium Cigar Association, Judge Amit P. Mehta, sitting in the District Court for the District of Columbia, vacated the Food and Drug Administration’s 2016-imposed deeming regulations2 in so far that they applied to premium cigars. This meant that from that date, the FDA no longer had regulatory authority over premium cigars.

    Ironically, this ruling put the FDA in a position where it could regulate as tobacco products vaping articles that contain no tobacco but not premium cigars that contain only tobacco.

    Mehta apparently decided that the FDA’s decision to regulate premium cigars was arbitrary and capricious, a damning decision given the FDA claims always to act on scientific evidence. According to Drew Perraut, the CRA’s regulatory affairs expert, speaking during a post-court-decision video conference posted on the CRA’s website, the science the CRA provided and its comment on the deeming rule were instrumental in bringing about the court ruling. The CRA, he said, presented evidence to the FDA that there was no detectable evidence of youth usage of premium cigars, along with scientific evidence from the National Institutes of Health showing there was no appreciable rise in morbidity or mortality associated with smoking premium cigars. Judge Mehta found that the FDA had not considered those scientific issues and had not responded adequately.

    It seems to me that even if the FDA does not fully accept the CRA’s evidence that smoking premium cigars does not significantly increase morbidity and mortality levels, that these products do not appeal to young people and that there is no evidence of their addictiveness, it must concede that premium cigars comprise an outlier in these areas. You can work that out on the back of an envelope.

    The danger posed by fine cigar smoking is a planetary system away from that caused by cigarette smoking.

    The Scent of Spite

    But the FDA immediately appealed Mehta’s decision, so the question arises as to why. What is the problem here? Would it not have been more efficient not to prioritize premium cigars but spend the resources of the FDA on dealing with what seems to be an already burdensome workload created by more troublesome products? Would it not have been better to allow an industry that does little harm, creates pleasure and employs a lot of people relative to its size to get on with what it does without undue interference?

    The pursuit of premium cigars looks like vindictiveness, as does the pursuit of fine cigars in the U.K. There must be a sense that the people who seek to regulate unduly and ultimately do away with premium/fine cigars cannot understand the pleasure that these products provide and for this “reason” want to get rid of them.

    Sailing back across the Atlantic, one might wonder what the U.K. Parliament’s beef with fine cigars is. Surely, even given that many parliamentarians seem in recent times to have become culturally impaired to the point of boorishness, those in government must realize that the appeal of fine cigars is a world away from that of cigarettes. They must realize that the danger posed by fine cigar smoking is a planetary system away from that caused by cigarette smoking. In fact, the world of fine cigars is close to that of fine wines because the consumption of each is not about addiction or even habit but about pleasure, fulfilment and, often, enjoying the company of like-minded people.

    A generational ban will have no immediate effect on sales of fine cigars in the U.K. because of the age profile of those who smoke them. But it will mean that, in the future, when those born after the end of 2008 are in their mid-thirties and want to consume a sophisticated product that does not addle their brains, make them fat or deprive them of sleep, they will have the devil of a job finding somebody who is willing to sell them fine cigars.

    A ban on the sales of fine cigars makes no sense. And, for similar reasons, it makes no sense when it is applied to pipe tobacco and snus. It is to be hoped that if in the U.K. the prospect of a generational tobacco sales ban is raised again, it is considered carefully and not made the subject of sledgehammer policies.

    1 The Conservative government led by Sunak was defeated at the July 4 election and replaced by a Labour government led by Prime Minister Sir Keir Starmer.

    2 The FDA was granted regulatory authority over the manufacture, distribution and marketing of tobacco products under the Tobacco Control Act of 2009, but, initially, such authority was applied only to cigarettes, roll-your-own tobacco and smokeless tobacco. In 2014, as was its right, the FDA started the process of bringing other “tobacco” products under its authority. At first, urged by the premium cigar industry, it considered exempting premium cigars but later decided not to, and all other products were the subject of its 2016 “deeming” regulations.

  • Playing with Numbers

    Playing with Numbers

    Photo: Hafiez Razali

    How research methods distort nicotine effects and risks

    By Cheryl K. Olson

    “The paper seems like a joke.” That’s what Harvard researcher Miguel Hernan said recently to the journal Science about a report linking e-cigarettes and strokes.

    The article was concocted by a dubious research group, founded to help young international medical school graduates get coveted authorship credits. Its analysis of U.S. government survey data claimed that respondents who vaped had a higher risk of stroke, at younger ages, than those who smoked. Its glaring flaws included inflating the number of survey takers by tens of thousands and failing to correct for the relative youth of vapers.

    Despite this, the 2022 paper’s findings found their way into media headlines and anti-vaping advertising. The Science article credits Gal Cohen and Floe Foxon with sounding the alarm on this appalling study.

    Subtler issues that affect research quality, and how research is perceived by the public, are harder to spot. Research methods may seem a dull or arcane topic. But a peek at how the research sausage is made reveals some simple yet surprising ways that the process can go wrong.

    Sometimes old habits or unquestioned assumptions are to blame. Just as typewriters affect how we text on our mobiles, legacy cigarette research methods and mindsets influence how we study noncombustible nicotine products.

    Hours of Vaping?

    Everyone understands cigarettes. When it comes to totting up use, cigarettes are easy. They come in standard units. You light, puff and extinguish. Not so for products such as vapes. How, then, do researchers compare smoking with these new nicotine-delivery systems?

    “There’s a lot of research showing that people who use e-cigarettes graze throughout the day,” says Arielle Selya, who conducts nicotine product research at Pinney Associates. “Unlike cigarettes, there’s no defined stopping and starting. They don’t have to finish a discrete unit; they just puff on and off.” Measuring this kind of variable, intermittent activity is a challenge.

    This problem is not unique to vaping. Studying nicotine pouch use, I found unexpectedly wide variations in what people did and what they thought was normal. Some tossed a pouch in the trash after 10 minutes or 15 minutes. Others kept one in their mouth for a couple of hours. A few sometimes reused a pouch they’d started earlier or cheeked pouches of two different flavors at once.

    As an example of what can go wrong, Selya pointed to a recent study of vaping and respiratory symptoms. To the authors’ credit, they tried to measure heaviness of e-cigarette use. The problem was the poor fit between their question and the behavior. They asked, “How many hours did you use electronic cigarettes per day?”

    “I’m not a vaper, but that seems like such a strange question,” says Selya. “Like asking how many hours do you spend drinking water?”

    Better approaches to measuring nicotine product use include writing down what you’re doing whenever a device pings you (ecological momentary assessment) or in a daily diary.

    Twisted Terminology

    Another holdover from cigarettes is the way tobacco is seen as the default flavor for all nicotine-containing products.With e-cigarettes, you have to add a tobacco flavor,” notes Selya. “But researchers often say ‘flavored’ when they mean ‘non-tobacco flavored’–in some communications even the NYTS team does this–but tobacco itself is a flavor! This generates misunderstandings.”

    Nicotine research terminology can defy common sense. Consider the concept of “abuse liability.” In everyday English, abuse implies harm. When the U.S. Food and Drug Administration assesses new drugs, stricter regulation may be required if there’s abuse potential, defined as “intentional, nontherapeutic use” to “achieve a desired psychological or physical effect.” An effect like euphoria, hallucinations or distorted thoughts or perceptions. 

    When it comes to reduced-harm nicotine products, abuse potential becomes, weirdly, a plus. A backhanded compliment. If you want to attract someone away from cigarettes, features like rapid nicotine absorption, relaxation and relief of withdrawal encourage that transition.

    Abuse liability also illustrates another nicotine methodology vexation: there is no agreed-on way to measure it. One article looked at comments made by the FDA on manufacturers’ submissions for multiple types of nicotine products. Regulators considered a whole range of measures related to abuse liability, from product chemistry and pharmacokinetics to subjective factors. Of the latter, “liking” the product turned out to be the most reliable and sensitive abuse liability measure!

    Misleading Measures

    Again, cigarettes are simple and familiar. Novel nicotine products, by contrast, come in ever-evolving variations. U.S. government surveys, such as the Population Assessment of Tobacco and Health (PATH) and National Youth Tobacco Survey (NYTS), measure trends in who is using what products. The results are widely used and reported. However, for survey results to make sense, people must understand the questions.

    Discrepancies in results suggest that research participants often misunderstand nicotine products and/or the terms being used to describe them. For example, answers about vaping brands and device types often don’t match. In the NYTS, just two-thirds of teens who said they “usually” used a pod/cartridge brand of e-cigarette (such as Juul, Logic or Vuse) also said they “most often” used a pod/cartridge device. Almost one in five adults in the PATH study had these kinds of mismatched answers about their vaping behavior. 

    Some questions have even larger errors. “The NYTS asks whether your e-cigarette product contains nicotine salts,” says Selya. “And overall, about 50 percent said they don’t know.”

    This is also true for so-called “concept” flavors, she notes. “Not strawberry-banana, but something like cosmic fusion. When youth are asked about concept or ice flavors, they don’t know the characteristics of their product, or maybe don’t understand those words.”

    NYTS first asked youth about tobacco-free nicotine pouches in 2021. That year, just 1.9 percent of teens reported ever using one. Checking the details, I found a flaw: The questionnaire defined nicotine pouches as “flavored.” However, over a third of teen ever-users said the pouch product they used was unflavored. (Perhaps they confused pouches and snus?) 

    A further example: the 2023 NYTS found that 1 percent of youth—an estimated 370,000—had ever used a heated-tobacco product. At the time, that product category was not sold in the United States.

    As Ray Niaura of New York University told me, “That can’t be right. Literally, it’s impossible. So that means it’s measurement error.”

    This suggests young survey takers were befuddled. “Kids aren’t going to know,” says Niaura. “‘Heated tobacco: Yeah. I smoked a cigarette. It’s heated. I light it on fire.’”

    Yet the Centers for Disease Control and Prevention reported the result without comment or explanation.

    If a product is only used by a small percentage of people, these sorts of errors could create unreal changes in year-to-year trends. The reporting of those potentially misleading trends affect the perceptions of academics, regulators and the public. “With that amount of uncertainty and some of the low numbers, it’s hard to figure out what’s the signal versus the noise,” notes Selya.

    Questionable Choices

    Another seemingly simple but complicated issue: Who counts as a current product user? Youth surveys typically ask “have you used e-cigarettes at all, even a puff, in the last 30 days?” Surveys aimed at adults commonly ask, “Do you currently use e-cigarettes some days, every day or not at all?”

    If you assume capturing any youth e-cigarette use is important, then “even a puff” makes sense. But it also makes it difficult to separate teens who are briefly experimenting from teens at risk for problematic ongoing use.

    In studies that look at how using nicotine products affect some aspect of health, researchers choose what outcomes to measure. Their choices can suggest biases or suspicious holes in what’s reported.

    A recent study using PATH data tried to compare e-cigarette use and the age at which people developed asthma. “Why age of asthma onset rather than whether they developed asthma at all?” says Selya. “Often, I read a study and think, did you look at these other related outcomes? If so, why weren’t they published?” This issue of results that may exist but aren’t reported are known as the “file drawer problem.” Preregistering study plans would avoid this issue.

    Researchers, Meet Users

    Before I dove deeply into tobacco harm reduction, my research focused on the effects of violent video games on youth. Finding discrepancies between research reports and what teens told me, I realized that many of the field’s most-cited “experts” had never actually played or even observed the games they studied.

    Similarly, many nicotine researchers seem to have never held or used the noncombusted products they study. This leads to findings that don’t reflect real-world situations. One example is an article by Sebastien Soulet and Roberto Sussman on metal contents of e-cigarette aerosols. They found that researchers were overheating tank vaping devices, generating aerosols that would be “likely repellent to human users.”

    “I think there’s a big disconnect and abysmally low involvement of actual consumers, the people affected by policies,” says Selya. Partnering with people who actually know and use novel nicotine products would be a giant step toward improved research quality.  

    References

    Foxon F. (2023). Discordant device/brand reporting among adolescents who used e-cigarettes in the National Youth Tobacco Survey. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntad228

    Joelving F. (2024). Prescription for controversy. Science. https://www.science.org/content/article/questionable-firms-tempt-young-doctors-with-easy-publications

    Selya A, Ruggieri M, Polosa R. (2024). Measures of youth e-cigarette use: strengths, weaknesses and recommendations. Frontiers in Public Health. https://doi.org/10.3389/fpubh.2024.1412406

    Soulet S, Sussman RA. (2022). A critical review of recent literature on metal contents in e-cigarette aerosol. Toxics. https://www.mdpi.com/2305-6304/10/9/510

    Vansickel A et al. (2022). Human abuse liability assessment of tobacco and nicotine products: approaches for meeting current regulatory recommendations. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntab183

  • The Case for Nicotine

    The Case for Nicotine

    Image: Maridav

    Many policymakers see nicotine as part of the problem; THR proponents see it as part of the solution. Understanding why such deeply opposing views are held also provides a view of the way ahead.

    By Barnaby Page

    Advocates of tobacco harm reduction (THR) and the industry making THR products are accustomed to fighting battles on multiple fronts—simultaneously contending with the threat of flavor bans, new taxes and misrepresentations of science, for example. But perhaps the most essential battle of all is the one against the demonization of nicotine; it’s possible to imagine vaping continuing to exist without nontobacco flavors, for example (even if it might be a less appealing kind of vaping), and it’s possible to imagine consumers continuing to buy THR products even if taxes hike their price, but it’s not really possible to imagine THR without nicotine.

    This means that, while its opponents are not wrong to say that that nicotine is to an extent an initiator and certainly a perpetuator of smoking, it’s also a “friend” as much as an “enemy” in the quest to reduce smoking rates and smoking-related harm. Persuading others, including lawmakers, the medical profession and the public health establishment, to see it this way is a key and decidedly nontrivial task for the THR movement, one that could have profound effects on future policy and regulation concerning THR products and therefore their uptake.

    Smoking and Addiction

    Opposition to nicotine probably derives, at heart, from two somewhat different but related factors: cigarettes and addiction. First, it’s easy to forget—but essential to remember—that until around a decade ago, nicotine effectively meant cigarettes for most people in most countries. Sure, there were other delivery mechanisms (e-cigarettes were already starting to make their presence known; oral products of different kinds had traction in some places; a few people even smoked cigars or pipes), but the cigarette was dominant … and so for the average person, who in a specialist field like this also includes the average policymaker, nicotine was inextricably tied to smoking, which in turn was inextricably tied to combustible cigarettes.

    As a result, it’s not surprising that many people find it difficult to separate the effects of nicotine from the effects of cigarette smoking in their head. (Even some people who ought to know better seem to find it tough.) Meanwhile, public health messaging had for decades reinforced the same point—Superman’s foe, the evil Nick O’Teen, is a classic example.

    Plus, and this brings us to the second point, nicotine was not only that generally sinister thing, a “chemical,” but it was one you could become addicted to. Again, it’s understandable that people who weren’t specialists in addiction science wouldn’t realize that the concept itself was a much-debated thing, and people who had grown up in a War on Drugs era when “drug addicts” were seen as an undifferentiated group of miserable, ruined junkies naturally saw addiction itself—regardless of the addictive substance concerned—as a terrible condition.

    Again, of course, there are those who ought to know better who use the concept to spread distrust; it amused me a few years ago when the then U.S. surgeon general, Jerome Adams, said that nicotine was “as addictive as heroin.” Leaving aside the whole issue of how you assess comparative addictiveness, the logical corollary here was that heroin is no more addictive than nicotine, but I doubt he would have wanted to spread that as a public health message.

    THR advocates need to recognize that the perception is just as potent as the reality.

    The Power of Perception

    In any case, some definitions of addiction or dependency now stipulate that it must be harmful, and it’s highly questionable whether nicotine—once separated from cigarette smoking—falls into that category. So there’s even a case to be made that nicotine addiction doesn’t exist as a problem in the first place. But the bottom line is that it is widely perceived to be harmful and addictive.

    And that is a huge obstacle for THR to overcome. Nicotine is absolutely central to the THR proposition. Indeed, it is founded on the distinction between nicotine and smoking, as famously expressed by Michael Russell when he observed that people smoke for the nicotine but die from the byproducts of smoking. It is the ability to make this distinction that leads to the concept of the continuum of risk—the idea that though different product categories (cigarettes, oral, vapor, heated tobacco, nicotine-replacement therapy [NRT] and so on) may all deliver nicotine, they do so with different risks, with some categories (for example, NRT, pouch and vape) at the bottom of the range while others (all of them involving combustion) are at the maximum.

    This concept is hardly news to anyone involved in THR or indeed anyone in the tobacco industry. But it’s worth repeating that it may not only be an unfamiliar idea but an apparently contradictory one to people outside those worlds if they believe that risk is inherent to nicotine use. Before any progress can be made on improving policy and regulation, this is a misconception that needs to be corrected, and for the reasons that I’ve discussed, it can be quite a deep-seated one. Of course it’s illogical—it’s like concluding that because it is very dangerous to drive on icy roads at high speed, it must be equally dangerous to drive on any road at any speed—but being illogical doesn’t mean it’s not thoroughly believed in by many people.

    The continuum of risk also means that where public health is concerned, logical regulation would focus on the delivery mechanisms (the icy road and the 90 mph) rather than the nicotine (the existence of cars). Except insofar as it may encourage use of more-risky delivery mechanisms, it doesn’t make sense for nicotine itself to be a prime concern. The on-off debate about very low-nicotine cigarettes (VLNCs) is a vivid illustration of this; there are surely questions to be asked about a policy that retains the dangerous thing (combustion) and concentrates on eliminating the far less dangerous thing (nicotine). To be fair, the research on how consumers might use VLNCs in real life is not yet conclusive, and it is possible they would have a deterrent effect beneficial to public health. But it’s difficult to escape the impression that the image of the evil Nick O’Teen is lurking in the background here as well.

    A survey on U.S. vape stores published in 2023 by ECigIntelligence, one of a regular series, found that misconceptions about vaping—which often means misconceptions about nicotine—are a persistent problem.

    What Regulation Might Look Like

    Of course, we can’t realistically expect that lawmakers are going to leave nicotine entirely alone. So if we were going to regulate nicotine the substance—as opposed to characteristics of the delivery mechanisms, and nonproduct issues such as minimum purchase age, advertising and public usage—what areas could be looked at?

    We could regulate nicotine content, which we could measure in two ways: either absolutely—the total amount in a cigarette stick or a vape pod, for example—or comparatively, by measuring concentration. The latter makes more sense for product categories where there is notable variation in product size (for example, e-liquid bottles).

    We could also look at regulating the nicotine yield, which is the amount of nicotine actually emitted from the product and thus available for consumption by the user; although clearly dependent on the nicotine content level to some extent, this is a more meaningful number in terms of effects. (A hypothetical product with very high content yet very low yield would contain an awful lot of nicotine that might just as well not have existed—it would be irrelevant in any calculation of risk or health impact.)

    We could also look at nicotine flux, the rate of nicotine emission—a crucial difference between combustible cigarettes and vapes, for example, and one that strongly affects the actual experience of use. And finally, just to be complete, of course we would want to regulate safety where nicotine is sold in very high concentrations such that accidental consumption of a relatively small amount could have seriously deleterious effects. The perception of risk here is, again, quite possibly exaggerated, but measures like childproofing do nothing to undermine the value of THR, they may prevent some accidents, and many countries have implemented them. This aspect, at least, is a no-brainer ….

    But (apart from the childproof caps) does regulating nicotine itself actually solve any problems that aren’t addressed by, for instance, regulating underage purchase—especially if we don’t consider dependency in itself, among adults, to be a problem?

    The THR movement will have to work relentlessly to keep the focus on risk profiles of delivery mechanisms, not on nicotine.

    The Gateway Effect

    The biggest contender for “problem to be solved” could, of course, be the so-called “gateway effect”—the idea that even when less risky forms of nicotine consumption are available, enjoyment of and/or dependency on them (take your pick) could lead the user toward more-risky forms.

    A logical riposte would be that though doubtless there are individual cases of such a gateway being passed through (as there are individual cases of almost anything you care to imagine), there is no convincing evidence of it happening on a large scale—and in any case, other measures could deter it. If we want to prevent people progressing from vapes to combustibles, the THR argument would go, surely it’s sensible to make vapes more attractive and combustibles less (whether that’s through differential taxation, marketing restrictions, flavor restrictions or other measures). Going in the other direction—for example, reducing nicotine levels in THR products (which are often less effective than combustibles at delivering nicotine to the body anyway)—would likely just have the effect of making THR less attractive to existing smokers and discourage them from switching.

    Nevertheless, the gateway effect is a widespread concern that ties in at an emotional level with the idea of nicotine as an irresistibly addictive substance leading users further and further into its grip. And once again, THR advocates need to recognize that, as is so often in this field, the perception is just as potent as the reality—often more so. Addressing that will be a long and tough task, but the agenda for THR should be clear.

    The THR movement will have to work relentlessly to keep the focus on risk profiles of delivery mechanisms, not on nicotine itself. It will have to encourage policy based on proven risk, not on nicotine-specific characteristics such as concentration that in themselves don’t obviously connect to risk. It will have to put forward convincingly the idea that THR products need to be at least as attractive to the consumer as combustible products if their public health potential is to be realized—this means, in effect, undertaking the very difficult task of persuading policymakers that we should encourage nicotine consumption via THR.

    And, to achieve all this, it will have to educate not just policymakers but also health professionals, the media and the public. This includes actively countering misinformation, but simply saying people are wrong is clearly not going to be persuasive in itself, and it’s those THR advocates who engage directly and deeply with the “nicotine skeptics” who will end up making the biggest difference.

    For not only can nicotine be part of the solution rather than part of the problem, ignoring this is also a risk in itself. We shouldn’t lose the focus on reducing smoking by becoming distracted into reducing nicotine consumption.

  • The Heart of HTMS

    The Heart of HTMS

    woodthorpe
    Ron Woodthorpe

    Celebrating the life and legacy of Ronald Woodthorpe

    By Marissa Dean

    Ronald Woodthorpe passed away on March 26, 2024, at age 86 after a three-year fight with dementia. He is missed by his surviving family and friends, but his legacy remains at the heart of Hampshire Tobacco Machinery Services (HTMS).

    Born in London in 1938, Woodthorpe was always a hard worker, training as a toolmaker after finishing secondary school. He took a job with Robert Legg in 1964 as a toolmaker—the company manufactured tobacco machinery and domestic appliances at the time. The next year, Robert Legg was acquired by American Machine Foundry Co. and renamed AMF-Legg, specializing in machinery for preliminary leaf processing and the processing and manufacture of cigarette and pipe tobacco. During this time, Woodthorpe developed a love for the industry that would span decades.

    In 1974, Woodthorpe was approached by John Payne, a director from AMF-Legg, with the idea to start a new business reengineering and upgrading machines for the tobacco industry. Thus, John Payne Engineering was born, and Woodthorpe was named technical director. The company quickly grew, supporting larger manufacturers like Imperial and BAT. Woodthorpe was involved with developing an upgraded, faster hinge-lid packer based on the Molins HLP 2 during his time at the company, and he inspired a technology transfer with Bulgartabac in the 1970s.

    John Payne Engineering was eventually sold in 1986 to Evered Holdings and later became part of GBE International. This didn’t sit well with Woodthorpe, who decided to start his own business: HTMS.

    HTMS began as a supply company in 1987, supplying spare parts for Molins and Sasib/AMF machinery from a small office and store in Southampton. Woodthorpe’s contacts in the industry supported him, and the business developed well. In 1988, Woodthorpe’s daughter, Gillian, was hired to assist with business administration. Two engineers were then hired to facilitate workshop activity.

    Three years later, the company moved to a larger office with stores beneath and a separate workshop facility. There, they began rebuilding Sasib/AMF soft packing machinery lines. Within the next five years, Woodthorpe’s daughter-in-law, Sara Fielder, and his youngest son, Peter, joined the company. By 1998, HTMS moved again to a larger space across the road, which is where it currently resides.

    Over the next couple years, HTMS bought the rights, technical drawings and casting patterns for the high-speed XL Hinge Lid Packer from John Payne Engineering and GBE making and packing, and Robert Brown, a Molins packing expert who worked with Woodthorpe at John Payne Engineering, was hired. The hinge-lid packer became HTMS’ flagship machine, and Brown’s addition to the team allowed Woodthorpe to further develop the high-speed hinge-lid packer and its associated downstream machinery.

    Woodthorpe was determined, a hard worker, a hard taskmaster and a man who generally would not take no for an answer. The tough standards he placed on himself were reflected in his work ethic and care—he tried every day to do the best he could for his business and his family. Those who knew him felt he was a very fair man who would always get you where you wanted to be and would support you in a time of need.

    “Ron always saw the best in people and encouraged those to find it in themselves,” said Brown. “In that way, he inspired others to achieve levels that they never thought possible, and I was certainly one of those. As long as you tried your best, you were never a failure in Ron’s eyes.”

    HTMS continues Woodthorpe’s ethos of service—the ability to supply immediately and support in times of need. HTMS understands that off-the-shelf supply is paramount to the business and its customers, thanks to Woodthorpe’s dedication and care over the years. Today, the company’s main focus is cigarette and cigar packaging, but it still provides primary equipment in the form of tobacco-cutting machinery and cigarette/cigar making machinery and spares. 

    “People talk about a work-life balance—well, Ron was one of the only people I’ve ever known who loved to ‘live to work’ as much as he did ‘work to live,’ simply because he had an equal amount of love and passion for work as he did his family,” said Sara. “Ron worked longer and harder than most because he wanted to make sure his family were taken care of but also because he loved the job and everything that it encompassed.

    “Ron’s dedication to taking care of ‘all of us’ over the years gave us, the HTMS team, the drive to continue in succeeding where he left off after his retirement, even more so now to continue further to honor his memory,” she said.

    Dedication is a clear theme of Woodthorpe’s life. He retired in 2020 at age 83 after a full life and career, leaving his company under the care of Peter, Sara and Jeff Perress. Even when he retired, it was less from a desire to retire and more from Covid-19 pandemic concerns, according to his son.

    In 2021, Woodthorpe was diagnosed with vascular dementia. Despite the struggles that caring for a loved one with dementia brings, Peter remembers his dad’s lessons of “Never put off till tomorrow what you can achieve today” and “If it’s not fun, don’t do it.”

    HTMS carries Woodthorpe’s core beliefs in quality, value and service at the heart of the business. And though he will be missed, his legacy will live on. “Ron’s enthusiasm, dedication and enjoyment for the job was passed on to all who worked for him,” said Howard Rich, a former colleague.