Tag: regulation

  • Mexico: Top Court Strikes Down Vape Import Ban

    Mexico: Top Court Strikes Down Vape Import Ban

    Image: nanoenomar

    Mexico’s ban on imports of e-cigarettes and related products is unconstitutional, the nation’s top court ruled, reports Meganoticias.

    The First Chamber of the Supreme Court of Justice of the Nation determined that the prohibition imposes excessive restrictions on commercial freedom of Philip Morris Mexico.

    The ruling is limited to Philip Morris Mexico and does not affect similar products that could be brought to market in the future.

    It protects Philip Morris Mexico from future restrictions and sets a legal precedent that could influence future litigation. The judgment specifies that this protection will be maintained until the government amends its General Import and Export Taxation Act.

    According to the Mexican government, an estimated 938,000 teenagers have tried electronic nicotine delivery systems, and about 160,000 use them regularly

    Despite the import ban, vaping has spread rapidly. In 2023, there were an estimated 2.1 million e-cigarette users in Mexico, compared with 975,000 in 2019.

    The Philip Morris Mexico case stems from an October 2022 Supreme Court ruling that deemed some prohibitions on ENDS unconstitutional and allowed certain groups to apply  for permission to continue the import and sale of these products.

  • Tobacco, Nicotine Stocks Rally on Trump Victory

    Tobacco, Nicotine Stocks Rally on Trump Victory

    Image: Paul Tama

    Tobacco stocks rose in the wake of Donald Trump’s victory in the U.S. presidential election, reports The Wall Street Journal.  

    BAT stocks were up 4 percent this morning; its Reynolds American subsidiary was a large donor to the Make America Great Again action committee, which supported the former president’s bid for reelection. Reynolds has been pushing back against the Biden administration’s proposed menthol ban, which was delayed earlier this year. Under another Trump administration, it is likely that a menthol ban would be completely dismantled.

    BAT, Altria and Imperial Brands all have sizable U.S. menthol businesses as the products make up more than a third of the U.S. cigarette market by volume.

    Another Trump administration may also lead to a crackdown on illicit imports of disposable vapes, which primarily come from China. During his first term as president, Trump enthusiastically erected barriers to Chinese imports Such measures could boost some tobacco companies’ e-cigarette brands.

    Expectations that a Trump presidency will strengthen the dollar, however, could be troublesome for Philip Morris International as the multinational makes around 90 percent of sales in other, primarily emerging market, currencies. A possible increase in inflation could also harm tobacco stocks since they are heavily exposed to price-sensitive, low-income consumers.

  • Haypp Happy for Retail Licensing in U.K.Vapes Bill

    Haypp Happy for Retail Licensing in U.K.Vapes Bill

    Vape retailer Haypp welcomed the news that the U.K. government has included a licensing scheme for retailers to sell tobacco, vape, and nicotine products in its Tobacco and Vapes Bill.

    “As a responsible retailer, Haypp.com has long supported the need for a robust licensing system for retailers of vapes, nicotine pouches and tobacco products in the U.K.,” said Markus Lindblad, nicotine retail expert from Haypp.com.

    “The absence of a licensing system in the U.K. has encouraged a wild west type environment where almost anyone can set themselves up as a vape shop. This has not only created challenges for responsible retailers, it has greatly increased the risks of underage vape use and untested products hitting the markets.

    “This proposed scheme could finally bring some law and order to what has been a wild west marketplace. Our most recent annual vape report asked vape users where they bought their first vape, and with 18% saying they bought it from a shop when underage, it is clear that the lack of licensing and enforcement is encouraging underage access.”

    The vape report, produced by Haypp, found that:

    • 54% of UK vapers legally bought their own
    • 18% of UK vapers bought their first vape from a shop when underage
    • 10% of UK vapers bought their first vape online when underage
    • 7% bought their first vape when underage from a major supermarket chain

    In addition to this, 36% of respondents also admitted that they have purchased a vape for a minor, and 11% do so regularly, media reports.

    “What we need to see now are appropriate penalties and enforcement mechanisms,” Lindblad added. “The licensing system will only be effective if there are tough financial penalties for rule breakers and the enforcement authorities are resourced sufficiently to do their job.”

  • Health Ministry Wants to Ban New Tobacco Products

    Health Ministry Wants to Ban New Tobacco Products

    Image: sezerozger

    Vietnam’s health ministry has proposed a national ban on e-cigarettes and tobacco-heating products, reports  Vietnam News.

    During a conference last week, Deputy Minister Tran Van Thuan stressed that all forms of tobacco, including new-generation products, pose a significant threat to public health.

    Nguyen Nho Huy, deputy director of the physical education department at the Ministry of Education and Training, shared that vaping among students had risen from 2.6 percent in 2019 to 8 percent in 2023.

    According to ministry of health data, nearly 1,224 people were hospitalized in 2023 due to health complications directly linked to e-cigarettes and heated tobacco.

    Tran also referenced risks such as battery explosions and nicotine poisoning.

    Heated tobacco, he noted, emits smoke containing toxins similar to those found in traditional cigarettes.

    Participants in the event also expressed concern about the market for illicit vaping products. In the first half of 2024, authorities uncovered 35 cases of illegal trade and possession of drug-infused e-cigarettes, according to Lieutenant Colonel Nguyen Duy Trung.

  • UK Sets Out Vaping Tax, Tobacco Duty in Budget

    UK Sets Out Vaping Tax, Tobacco Duty in Budget

    VV Archives

    The cost of vaping and smoking will increase following tax rises announced in Chancellor Rachel Reeves’ Budget. A new tax on vapes of £2.20 ($2.85) per 10ml of e-liquid will kick in from October 2026.

    That will be accompanied by an equivalent increase of £2.20 per 100 cigarettes in tobacco duty to “maintain the financial incentive to switch from tobacco to vaping.” Reeves also set out immediate above-inflation increases of 2 percent on tobacco and 10 percent for hand-rolled tobacco.

    In its last Budget before losing the election, the previous Conservative government said it wanted to introduce a vaping tax and set up a consultation on the changes. The consultation said the tax aimed to make vaping “less accessible to young people and non-smokers while also raising revenue for funding vital public services like the NHS.”

    It had proposed different levels of tax based on the amount of nicotine in the vaping liquid, according to media reports. However, Reeves has instead opted for a flat rate. In its analysis of responses to the vaping consultation, the government said industry representatives and some public health bodies had opposed a three-tier structure, warning it could result in unintended consequences and create complex bureaucracy.

    Head of the UK Vaping Industry Association, John Dunne, called the vape tax a “nonsensical move” that penalized people who used vapes as a method to give up smoking. “Some three million adults are former smokers thanks to vaping, which is strongly evidenced as the most effective way to quit conventional cigarettes, saving the NHS millions of pounds in treating patients with smoking-related conditions,” he said.

    The new Labour government had already said it wanted to stop vapes being branded to appeal to children and has announced a ban on single-use vapes, due to come into effect in England in June 2025. Ministers have also pledged to continue plans set out by former Prime Minister Rishi Sunak to ban people born in or after 2009 from buying cigarettes.

  • U.S. Urged to Bolster Post-Employment Rules

    U.S. Urged to Bolster Post-Employment Rules

    Image: bluraz

    Public policy experts are calling for stronger federal post-employment regulations as U.S. regulators, including those overseeing the tobacco business, are increasingly losing talent to the private sector.   

    A recent article in The Examination details how, over the past 15 years, nearly two dozen lawyers have left the U.S. Food and Drug Administration and its Center for Tobacco Products to advise, litigate for or work with the tobacco and vaping industry.

    “It seems like every time we get sued in the tobacco industry, a former FDA lawyer is leading the lawsuit,” Commissioner Robert Califf told an FDA oversight organization last year.

    After gaining  FDA experience, lawyers can significantly increase their salaries by moving to a major law firm or corporation. While a lawyer’s salary in the FDA’s chief counsel’s office, for example, starts at around $83,000, a first-year lawyer at a firm made on average $200,000 a year in 2023, according to the National Association for Law Placement.

    Daniel Aaron, a former FDA attorney, says lawyers who’ve left the agency to work on behalf of the tobacco industry not only increase their renumeration but can also have a powerful impact on what lands on store shelves.

    “It’s a huge advantage to getting your product to market.” said Aaron, now a University of Utah law professor. “Ex-FDA lawyers know what the agency is worried about, and how a client can maximize its options. They know not just what the law is, but they know how the FDA will enforce the law.”

    Federal post-employment rules also bar former employees from communicating with or lobbying a federal employee for two years on behalf of a client or employer under certain circumstances. That said, employees are allowed to work “behind the scenes” advising clients, according to the FDA’s post-employment guidelines. 

    Genevieve Kanter, a professor at the University of Southern California who co-published a study in 2023 on the revolving door in health care regulation, believes the rules should be strengthened if society is truly interested in preserving independent government.

    Kanter’s study focused specifically on conflicts of interest of employees at the highest level of the U.S. Department of Health and Human Services; It found that 38 percent percent of the political appointees from the FDA went into private industry, the fourth highest out of roughly two dozen offices and divisions.

    Eric Lindblom, director of the Center for Tobacco Products’ Office of Policy from 2011 to 2016, proposed blocking former staff from working for the tobacco industry for at least one or two years, in all cases, after leaving the policy office. “I thought it was really important that we had that independence,” said Lindblom, now a senior scholar at Georgetown University’s O’Neill Institute.

    The proposal went nowhere.

    The Examination is a publication supported by Bloomberg Philanthropies.

  • FDA Warns Companies For Selling ‘Smart’ Vapes

    FDA Warns Companies For Selling ‘Smart’ Vapes

    The U.S. Food and Drug Administration issued warning letters to nine online retailers and one manufacturer for selling or distributing unauthorized disposable e-cigarettes designed to resemble smart technology, including smartphones and gaming devices.

    The products mentioned in the warning letters are promoted as having various designs and functions that might attract young people, according to an agency press release. These include features like playing games, connecting to smartphones, receiving text or call notifications, playing music, and customizing products with personalized wallpaper.

    “These products may resemble smart devices, but there’s nothing smart about them,” said Brian King, director of FDA’s Center for Tobacco Products. “They’re illegal to sell and a flagrant attempt to target kids.”

    The agency states that the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because they help conceal the nature of the products as tobacco products from parents, teachers, or other adults. Example images of unauthorized products cited in the warning letters compared to electronic devices on the consumer market, such as smartphones and gaming devices.

    “The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to legally market a new product, which is in violation of the Federal Food, Drug, and Cosmetic Act,” the release states.

    In addition to the violations mentioned in the warning letters, the retailers and manufacturer were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalty.

    “FDA is steadfast in our commitment to enforce the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”

  • Vapor Voice Exclusive: Rotting Your Boots

    Vapor Voice Exclusive: Rotting Your Boots

    Credit: Hutpaza

    Vaping opinions may vary depending on a person’s experience and knowledge.

    By George Gay

    On Aug. 24, The Guardian, the daily newspaper to which I subscribe, ran an opinion piece about nicotine pouches and vaping devices in its Journal section, which carries its leaders, opinions, letters, birthdays and obituaries. I much enjoy reading this section, in which the letters are often informative and the birthdays throw up some oddities.

    The famous people listed as having birthdays on the day of the paper are always briefly described in relation to the jobs or activities in which they are involved or, in some cases, the jobs or activities in which they were once involved. For instance, politicians who are no longer active in politics might be referred to as former Members of Parliament, but the “former” label is not usually applied to sportspeople, and this can lead to some amusing results.

    A person celebrating their 60th birthday, for instance, might be described simply as a javelin thrower, but the most impressive birthday announcement I have seen was in an April 2022 paper in which a 91-year-old man was described as a rugby player. Respect.

    The Journal always bears as part of its masthead the assertion that “comment is free … but facts are sacred,” a lofty statement that seems not always to be lived up to, especially when the subject is tobacco or nicotine, subjects about which the paper is po-faced in the extreme and often ill-informed.

    The opinion piece on Aug. 24 told how the writer, a vaper, faced with a six-hour rail journey during which she would not be able to vape, decided to buy some nicotine pouches in the hope that they would make the trip more palatable, even though she had not previously indulged in such products.

    On boarding her train, she placed a pouch in her mouth, but, after 15 minutes, had thrown the entire pack, and presumably the pouch she had experimented with, in the bin. Apparently, she spent the rest of her journey, five hours and 45 minutes, feeling nauseous but not throwing up on the table in front of her. Respect.

    This outcome was somewhat surprising since she also wrote that she had lived for some time in Sweden, where she had come across snus but not used it because she had been warned by friends that first-time users usually were made to feel ill. At this point, I thought the opinion might examine the need for nicotine pouch packs to provide information about how best to start using this product, perhaps suggesting only very limited exposure in the beginning.

    In fact, as I understand it, some products do carry such information in countries where the consumption of oral products is not already established and where the provision of such labeling is permitted.

    Perhaps there might have been a discussion on whether there should be available beginners’ packs with pouches that offer only slow, low-level nicotine deliveries. Such a discussion could then have looked at the ethical issue of offering pouches that might be seen by some as being aimed at people who were not already tobacco or nicotine users.

    It might have been interesting to look, also, at whether, to overcome this issue, all nicotine pouch packs might offer a range of nicotine deliveries. After all, perhaps even long-term users might like to have a low-hit product now and again.

    But no, the writer, Imogen West-Knights, had other ideas. She apparently started thinking about “nicotine and addiction in general.” Although West-Knights did not define what she meant by “addiction,” she had already declared that she was “pathetically addicted” to nicotine and her vape, and later wrote in two instances of nicotine as being “mind-warpingly” addictive.

    She was interested in what she said was a moral quandary thrown up by the question of whether it was “… bad for people to have access to a mind-warpingly addictive substance if it has no health consequences?” In the end, she took a libertarian stance and declared that what others did was none of her business nor that of the government.

    To my way of thinking, she came to the correct conclusion, but she could have saved herself a lot of anguish in respect of nicotine if she had taken the trouble firstly to define addiction. In writing that nicotine had no negative health consequences, she was, in effect, declaring that nicotine was not addictive.

    To be addictive, a product or an activity must be indulged in compulsively, and that activity must have negative health consequences, otherwise, breathing unpolluted air, if such were available, would constitute an addiction.

    I wrote a letter to the newspaper pointing this out, but it didn’t cut any ice. Obviously, what was written came under the “comment is free” part of the declaration, not the “our opposition to tobacco and nicotine is sacred” part.

    I don’t blame West-Knights for her confusion because she had apparently looked up the U.K. National Health Service’s Quit Smoking webpage and found that it stated that “although nicotine is addictive, it is relatively harmless.”

    In other words, the NHS had squeezed nicotine into the addictive category simply by inserting the phrase “relatively harmless.” But, of course, such a fudge raises its own issues because it clearly drags into the addictive sphere all sorts of other products and activities. Indeed, the writer raised the cases of coffee and sugar.

    Which leads me onto another addictive product, water. If, as above, addiction is taken to be the compulsive consumption of a substance or involvement in an activity that causes harm to the consumer or participant, then, apparently, both cigarettes and water are addictive. This came to my notice when reading in The London Review of Books a review by Steven Shapin of a book by Christy Spackman, The Taste of Water: Sensory Perception and the Making of an Industrialized Beverage.

    Shapin made the point that there was a suspicion, if not yet solid evidence, that the toxic pollutants in water posed risks to human health that took in cancer, damage to the nervous system, liver and kidneys, and interference with fertility and development. Sound familiar?

    And there is another parallel. “It is thought that the monetary scale of American lawsuits against companies responsible for PFAS [perfluorinated and polyfluorinated alkyl substances] water pollution may eventually dwarf those involving asbestos and tobacco, considering that people are in a position to decide whether or not to smoke cigarettes, but everybody has to drink water,” Shapin wrote.

    He made the point too that there are potentially dangerous things in water that are difficult for the consumer to detect because they don’t taste, smell or look odd. He didn’t contrast water and tobacco in this instance, but it is the case that cigarette smoke doesn’t sneak up on you in this way because it has a particular smell and is highly visible.

    For the sake of my health, I think it might be time to try overcoming my long-term addiction to water. My grandfather, a beer aficionado of some note, warned me on many occasions that water rotted your boots. Respect.

  • Cognitive Dissonance

    Cognitive Dissonance

    Credit: Good Ideas

    Regulators often run a campaign of hypocrisy when confronting vaping.

    By George Gay

    “However, it is vital that we do not sit and wait for this data [on the long-term health impacts of using nicotine-containing products] and action is taken now to prevent any potential harms caused by vapes.”

    “However, it is crucial that any proposed regulations [on vaping] are based on robust evidence, ensuring they are effective as possible, and implemented without delay.”

    You could be forgiven for assuming that these two quotes have been taken from statements by people or organizations on different sides of the vaping debate because, on the one hand, it is said to be “vital” that action must predate the collection of data while, on the other hand, it is said to be “crucial” that the collection of data must predate action. But you would be wrong.

    The first is from the final paragraph of the Executive Summary of the August-published report from the British Medical Association (BMA: the trade union and professional body for doctors and medical students in the U.K.) titled Taking Your Breath Away: Why We Need Stronger Regulation of Vapes. The second is taken from the final paragraph of the full report.

    Would I be rude in suggesting that the BMA authors might be suffering from cognitive dissonance and that they should try healing themselves before handing out advice willy-nilly? After all, the authors, if not doctors themselves, are representatives of the U.K.’s doctors, people whose opinions those of us of the outer dark tend to accept without question in respect of matters of health.

    And this level of trust, I think, is perfectly reasonable when it comes to face-to-face consultations involving doctors and individual patients. But once doctors become involved in wider concerns, I think it is necessary to take a more jaundiced view of what they have to say.

    Once doctors stop seeing people as individuals and view them only as groups marking points on a graph, they lose that which makes them special, as when they pay more attention to your “body mass index” than to your body. At a populations level, their pronouncements are little more than opinions based not on their medical knowledge but, as in the case of the rest of us, largely on ideologies and prejudices. They become part of the “tyranny of experts.”

    In other words, it is important to keep in mind that once doctors step outside the surgery, they can be just as irrational as you or me—or you at least; let’s keep me out of this. Indeed, some time ago, I was at an event where, at the end of the evening, a person who I knew to be a senior medical doctor was doing the rounds, pouring any remaining wine from the bottles on the tables into his glass and drinking it. The event had attracted a wide range of people, from those in their early 20s to those in their 80s, and even a few teenagers.

    Sitting at a table watching this person, I started to wonder about him. Was he, for instance, an alcoholic or somebody who usually drank in moderation but was on this occasion letting his hair down? Did he understand, care, or was he too far gone to think about the example he was setting to the younger people present?

    Surely, I thought, he must be aware that any level of alcohol consumption creates health risks. Was he a hypocrite who would have been offended if I had smoked or vaped in front of the young people; was he dimmer than his qualifications would have me believe; or was he as heavily into cognitive dissonance as he seemed to be into drinking?

    I often think of this occasion when I read of medical professionals making pronouncements on smoking and vaping (but rarely on drinking). And I thought of it again when I read the BMA report, which should have been called the “however” report. You might have noticed that the two report quotes with which I started this piece both opened with the word “however.”

    Basically, the report could be summed up as one that reluctantly admits the important role that vapes can play in helping smokers quit their habit but then de facto goes on to say, “however,” we don’t like these products and therefore we are calling for them to be debased by regulation to the point where they will not appeal to anybody and smokers will return to smoking. After all, you know where you are with smoking because people have been doing it for a long time.

    The word “however” appears 16 times in the BMA report, whose text takes up only 12 pages. How many times have we seen doctors and researchers put their names to such “however” reports? Reports that purportedly aim at striking a balance between the need to keep vapes appealing enough to smokers so that they are encouraged to give up smoking while not appealing to young people but that, “however,” always come down in support of protecting from themselves a few misbehaving students from well-off families at the expense of trying to help financially impoverished smokers?

    Reports that complain about how smoking is the major cause of premature death worldwide but wind up unable to support the use of the one product that has come along that could make a real dent in the toll caused by smoking because the authors are ideologically opposed to people enjoying using nicotine.

    The authors of such reports like to sex them up by talking of an “epidemic” of vaping that is in part harming “children.” You can imagine them wringing their hands in anguish at what is happening to these middle-class, mischievous students while ignoring the fact that hundreds of thousands of children from financially impoverished families live in poverty, meaning they are undernourished, with all the negative impacts on their life chances that that entails.

    On Dec. 22, just three days before the major feast of Christmas, The Guardian newspaper led with a story titled “Revealed: huge rise in hospital admissions with malnutrition” while on page six it ran with “‘Heartbreaking’: Teachers tell of children with bowed legs and no winter coat.” The latter story, by Jessica Murray, quoted a headteacher as saying some children at her school had bowed legs because they were so deficient in vitamins.

    “We’ve had children so malnourished they’ve had heart murmurs,” the headteacher said. “It’s heartbreaking. It’s not how it should be. It’s the worst I’ve ever seen it. We’ve got two-year-olds coming in and trying to eat sand because they’re so hungry.”

    As the lead story pointed out, such deficiencies can interfere with brain and bone development and cause health problems in later life. But, despite this, there has been little follow-up of these issues since then, with space being given over rather to numerous negative stories about vaping. 

    The BMA reports on health problems visited on children by vaping but set against the damage caused by malnutrition (or any number of other causes, such as ketamine addiction), these problems are minuscule. “The NHS revealed that in 2023, 50 children were admitted to hospital with vaping-related disorders,” the report states “The U.K. has a population of more than 12 million children defined as those 0 years old to 17 years old, so 50 represents 0.0004 percent].

    “This is up from just 11 children three years previously, demonstrating the significant growth in prevalence of vaping in this age group. Vaping-related disorders can range from lung damage to worsening asthma symptoms, which include wheezing, coughing and chest tightness.”

    These numbers are tiny, and, in any case, I wonder if even they can be put down to vaping in the way that malnutrition can be put down to vitamin deficiencies. After all, we are not told how many of the children said to be suffering from the effects of vaping live in our highly polluted cities and/or in the many houses afflicted with damp and mold that are inhabited by impoverished families, but perhaps the doctors assumed that vaping children would live in comfortable houses in leafy suburbs.

    In any case, I don’t wish to sound cynical, but aren’t children suffering from asthma rather asking for trouble if they vape? After all, children who are intolerant or allergic to certain foods are taught to avoid them. We don’t seek to regulate such foods so they become unpalatable to children and adults alike.

    Why is there so much emphasis on children vaping but so little on their going hungry? There are a number of reasons, but, in my opinion, the main one has to do with the fact that coming down on vapers and smokers allows those involved to do some virtue signaling at little or no cost whereas making sure that children are properly fed needs an effort by those responsible that comes with a price tag that most are not willing to pay.

    In fact, the BMA’s report came out at a rather bad time in respect of its attitude to at least some children. The day after publication, The Guardian newspaper ran a story under the heading “BMA accused of witch hunt after transgender care leak.”

    The piece, by health policy editor Denis Campbell, described how the BMA had been heavily criticized by key medical figures since it voted on July 17 for, in effect, rejecting a report by Hilary Cass on transgender care, which put it in the position of being the only medical organization in the U.K. not to accept, and to find fault with, her findings, findings that were accepted by the previous right-of-center government and its left-of-center successor.

    Campbell wrote that the Academy of Medical Royal Colleges, which represents all U.K. doctors professionally, had criticized the BMA’s refusal to accept “the validity of the evidence and consequently the findings of the independent Cass review of gender identity services for children and young people.”

    And ignoring the rule that when in a hole, the best idea is to stop digging, the BMA allegedly undertook a “witch hunt” to try to identify which senior figure leaked that it was set to oppose the Cass review. According to Campbell, critics described the BMA’s action in this regard as “disgraceful” and “Orwellian.”

    None of this will make the slightest difference, of course. Nor will the fact that, in my opinion, the BMA report is largely a rehash of stuff that has gone before many times over because the likelihood is that the government, like the general media, will merely read and relay the recommendations, not the thinking or lack of thinking behind them. They will probably not notice that though the report’s 99 references suggest a scientific accountability, in places it reads more like an essay in that it throws out unreferenced and vague statements such as “there are concerns that,” “there is no doubt,” “many health organizations” and “can also influence belief.”

    Some of what is said seems not to be supported by evidence and amounts to little more than urban myths while some is based on the lazy idea that what happens in the future will be the same as or similar to what happened in the past unless an intervention is made.

    And how does the BMA come up with a sentence such as this: “Novel products such as nicotine pouches are a growing class of noncombustible nicotine product that pose similar public health risks as [those posed by] vapes yet are not sufficiently regulated.” One would have hoped that doctors or their representatives would have figured out that the risks must be different. One activity involves inhalation while the other does not.

    The BMA report, like many such reports in the past, comes with a helping of emotional blackmail. The word “children” is used 55 times, and the phrase “young people” is used 23 times, but while these are not used as synonyms (on 16 occasions on which each of these terms are used, they are used in combination as “children and young people”), we are not told what the difference is between them, so we can assume only that “young people” refers to those people who are 18 years of age or older but who are not middle-aged or old. The word “youth” is used 15 times and the word “adolescent” four times.

    We are also treated to “people under 18” (the usual definition of a child in the U.K., though the National Health Service sometimes refers to children as those under 16), “children 11–17,” “young fashionable models” and even the impersonal “younger market.”

    And what of the “growing epidemic” mentioned in the first sentence of the Executive Summary? Well, this is what is said in the rest of the first paragraph: “Vape use by adults has risen significantly over recent years, but more worryingly, by children and young people. 7.6 percent of 11[-year-olds to] 17-year-olds are now vaping, either regularly or occasionally, compared to 1.3 percent in 2014.”

    I’m reluctant to go to bat against the BMA on the question of an “epidemic,” but what the hey? If the “epidemic” is supposed to refer to children as well as to adults (it’s unclear), under 8 percent seems a little short of a “widespread” outbreak, which is how my dictionary in part defines an epidemic. And this is especially so when you start to pull apart that 7.6 percent figure, which is from Action on Smoking and Health (ASH).

    It is made up of 4.6 percent of “regular” vapers, who, inexplicably, in my view,* are defined as those vaping more than once a week, and 3.1 percent of occasional vapers, defined as those who vape “less than once a week,” which means, I assume, they could vape only once a month, once a year or once a millennium. (*Imagine the reaction of your doctor when, on asking you whether you had regular bowel movements, you said, “Oh yes, more than once a week!”) 

    The truth of the matter is that, as part of this “epidemic,” “ever vaping” (a category it is safe to assume includes even those children who once looked sideways at a vape) fell between 2023 and 2024 in respect of all age groups examined. Of course, this is true only if the figures are correct. I guess the ASH figures are based on “self-reporting,” and it often puzzles me how those collecting data will accept the word of people, some of whom are breaking rules.

    The report seems to me to be poorly written. Take this sentence from the Executive Summary: “The availability of disposable vapes is clearly linked to the sharp rise in child use.” It seems that the BMA is mixing up cause and effect. According to it, the rise in the use of disposable vapes by children has caused the availability of disposable vapes. Well, not caused, because it clearly cannot state that, so it uses the word “linked,” which it hopes will do the same job as “cause” in the minds of the readers. Like I can say my bed is linked to my sleeping, and my knife and fork are linked to my eating.

    This linking business seems to be linked to an ASH graph that appears under the title “Rapid rise in youth vaping 2021–2023 associated with [not linked to, but associated with] growth in use of disposables.” But the graph seems to show nothing of the sort. Rather, as a subheading indicates, it graphs the “Proportion of vapers of all ages who mainly use disposable vapes, by age.” And the BMA does not mention that between 2023 and 2024, the proportion of 11-year-old to 17-year-old vapers who mainly used disposable vapes fell from 69 percent to 54 percent.

    This might come as a surprise, but I am on the same page as the BMA when it comes to one issue: the need, from an environmental perspective, to ban disposable vapes. Companies and consumers have proved time and time again that they are unwilling or unable to dispose of these and other consumer products and their packagings in a manner that does the minimum damage to the environment. They, like much of the rest of the population, seem to be so dim that they cannot absorb the simple but vital environmental message so eloquently expressed about another matter in the film Moonstruck: Don’t shit where you eat.

    Where I diverge from the BMA’s stance is at the point at which it is not willing to accept those products that have been designed by parts of the vaping industry to address these environmental concerns while still offering the positive usage characteristics of disposables.

    In fact, the report’s first recommendation is that the U.K. government bans “the manufacture for commercial sale and the commercial sale of all disposable vapes ….” I’m not sure how far the BMA imagines the U.K. government’s writ runs in such matters, but I would assume that at least a number of China-based manufacturers would be somewhat bemused by such an idea.

    But the BMA, while it is ready with its vaping advice, seems to be rather lost when it comes to the world of vaping. It bemoans the fact that the “nicotine contained in one disposable vape can be equal to [that in] two packs of cigarettes.”

    What is the problem here? It is not the quantity of nicotine in a device that counts but the amount of nicotine delivered to the user, and the amount of nicotine delivered is controlled by the vaper. And surely, if the BMA were really concerned about the environmental consequences of disposables, it would welcome bigger nicotine reservoirs.

    Bizarrely, the BMA also talks of vapes not containing tar. Well, no, but then neither do cigarettes; the tar is a product of the combustion process after a cigarette’s tobacco is set alight. And there is no tobacco in a vape and no combustion process.

    And finally, the BMA notes that “[a]s more young people are using disposable vapes and using them more frequently, there are concerns that they are at significant risk of addiction to nicotine.” Here the risk is probably being exaggerated. According to ASH figures, more 11-year-olds to 17-year-olds (9.5 percent) try vaping only once or twice than go on to become either regular or occasional users (7.6 percent), and 1.3 percent are classed as having been vapers but having quit.

    The question should at least be asked about how this 1.3 percent threw off this appalling addiction. Perhaps they returned to smoking, or did they just get bored with vaping? Young people get bored with things quite easily. That’s the main difference between old people and young folk. The former hang onto the past with a vice-like grip because they cannot compete in the present while the latter want to move on; they are hungry for the future. You can see this reflected in the charts of ASH and the dark forebodings of the BMA that are issued even as the young are moving on, beyond last year’s concerns.

    The report’s second recommendation and the one that has attracted most criticism calls for a ban on all nontobacco vape flavors. The BMA is clearly against vaping, and here at least the organization nails its colors to the mast but not without hitting its thumb in the process.

    Look at this sentence from the report, bearing in mind that the report is supposed to be a serious attempt at influencing government policy and presumably was read by any number of people before being loosed on the world: “However, like children, fruit flavors are the most popular with adults.” Hmm.

    Recommendation three, if implemented, would degrade the aesthetics of vaping devices and their packaging, which would make them less appealing to smokers, a move that would be simply vindictive since the BMA also wants, according to recommendation four, for these products to be kept out of sight at retailers.

    And just in case there were any doubt that the BMA is against vaping full stop, part of recommendation five calls for a government-funded and government-delivered “education campaign”—read propaganda—to warn the public “on the dangers of vapes to reduce appeal.” Again, an awful phrase, but we can figure out what is meant.

    Recommendation five includes some sensible ideas about policing the retail environment, but these are measures that the industry, at least in the form of the U.K. Vaping Industry Association, has been calling for for years. In fact, the recommendations do not go as far as the UKVIA has suggested, though there are signs that the government might be starting to favor the suggestion about licensing retailers that sell vapes.

    This is sensible. Most of the problems that vaping throws up have been caused by 14-years-and-counting of austerity under which the authorities responsible for overseeing retailing have been starved of funds so that checking the import, compliance and retail sale of these products has been nowhere near as vigorous as it should have been.

    But somehow, it is the smoker and the vaper who must be punished for these failures. Children are being naughty in using these products, manufacturers are putting noncompliant products on the market, retailers are selling vapes illegally, the authorities are failing in their duty to stop this abuse, but it is the people who are not doing anything wrong, the smokers and vapers, who are to be made to suffer.

    Recommendation six merely expands the report’s ideas, if you can call them that, to other nicotine products but not to traditional tobacco products.

    I think that one of the problems identified above is that the opinions of doctors should not be given too much credence when they are based on issues that go beyond their individual patients. We know that a lot of medical doctors still believe erroneously that nicotine causes cancer.

    And in a letter to The Guardian at the beginning of September in response to a government proposal to ban smoking in beer gardens, James Scott wrote, in part, “Tobacco is unique among the substances that humans use: When used exactly as intended by the manufacturer, it will harm and eventually kill its consumers. It is categorically different from alcohol and other drugs humans use and needs to be treated as such.”

    This completely ignores recent findings that drinking alcohol also harms and eventually kills its consumers when used exactly as intended. Writing in The Guardian on Aug. 21, Devi Shridhar, chair of global public health at the University of Edinburgh, pointed out that the World Health Organization had stated in January 2023 that there was no safe level of drinking. “The agency highlighted that alcohol causes at least seven types of cancer and that ethanol (alcohol) directly causes cancer when our cells break it down,” Sridhar wrote.

    But of course, it goes so much further than the direct harm caused by consumption. Smokers, unlike drinkers, do not go home and assault their partners just because they have been smoking. They do not start fights in the street just because they have been smoking, and they do not cause vehicle “accidents” just because they have been smoking.

    The problem is that you must have a wide view of society to see things clearly, in the round. On the same day that Scott’s letter was published about the proposed ban on smoking in beer gardens, there was a letter from Robert Lee, the contents of which anybody who has been involved in magistrate court proceedings would recognize as being right on the money.

    “The government’s almost evangelical crackdown on smoking contrasts sharply with its attitude to alcohol, which is responsible for more problems,” Lee wrote. “I sat as a magistrate for many years, and a huge proportion of offenses were directly or indirectly linked to alcohol. But I never heard a defense lawyer plead in mitigation that their client had smoked too many cigarettes.”

    And I cannot imagine that excessive vaping will ever be cited as mitigation in such proceedings. There is only one reason why smoking tobacco and vaping nicotine are under constant attack by all and sundry while drinking ethanol is not, and that is because the U.K. runs on hypocrisy. Let them eat sand.

  • Tools to Quit

    Tools to Quit

    Credit: Qnovia

    The RespiRx, the first inhalable nicotine-replacement therapy, gains IND clearance.

    By VV staff

    A Virginia-based pharmaceutical company is developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform. Qnovia announced that its RespiRxNicotine Inhaler (QN-01) received clearance for its Investigational New Drug (IND) application by the U.S. Food and Drug Administration.

    The company will initiate a Phase 1, randomized, crossover, open-label trial in the U.S. to determine the pharmacokinetics, safety and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes, according to Brian Quigley, CEO of Qnovia.

    “The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company. Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine-replacement therapies [NRTs],” said Quigley. “The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison.

    “We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the U.K. to support an MAA submission to the MHRA [Medicines and Healthcare products Regulatory Agency] in 2026.”

    Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing QN-01 in the U.K., according to Mitch Zeller, the former director of the FDA’s Center for Tobacco Products, who is now serving as Qnovia’s policy and regulatory strategy advisor.

    “There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit ‘cold turkey’ remains the most popular method of quitting smoking,” said Zeller. “There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit.”

    Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, Quigley told Vapor Voice last year (“Licensed to Thrive,” Issue 1, 2023, page ?). Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG.

    RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal by-products.

    RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product.

    Credit: Qnovia

    “The nebulizing unit (cartridge) gets replaced by the patient every one [day] to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”

    Mario Danek, Qnovia’s founder and chief technical officer, agrees that eliminating the cleaning requirement was a priority. “The idea was to create a technology that emulates the form factor of a successful high-adoption consumer product but that is imbued with technologies that would pass CDER’s [Center for Drug Evaluation and Research] stringent standard for safety—combined with Qnovia’s purposeful design features, it should bring patient adherence and quit rates to new highs, which historically have been found lacking in NRT,” he said. “Additionally, from a drug delivery platform perspective, those CDER-aligned device safety requirements are just as imperative to Qnovia’s API expansion strategy into other indication areas.”

    RespiRx is a “step-down” therapy, like many NRT products. However, instead of buying different pods with varying levels of nicotine, Qnovia’s device has a dosage-monitoring system programmed into the device. Uniquely, the use regimen is determined based on how much a smoker is smoking, said Quigley. For example, a one-pack-a-day smoker would start with 20 doses per day. The two-pack-a-day smoker would start with 40 doses per day.

    “Then the device will, over the 12 weeks, gradually reduce the available number of doses to that patient. It is a much more manageable step-down over the 12 weeks, unlike currently available cessation methods. And the device itself will prevent the patient from using more than they’re supposed to use,” said Quigley. “Patients would also have the on-device LCD screen interface to help them understand how to use their doses. That, too, is another benefit of our product versus the existing smoking cessation therapies.”

    Danek said the company is proud to lead the charge in encouraging the innovation and development of safe and effective pharmacotherapies to help the millions of smokers who are trying to quit smoking.

    “We believe our proprietary drug delivery platform has the potential to be a highly differentiated treatment option not only for treatment of nicotine dependence but for a wide variety of treatments that would benefit from inhaled drug delivery,” said Danek.