Author: Staff Writer

  • Shaky Foundations

    Shaky Foundations

    Credit: Mark van Dam

    CTP Director Brian King’s stated ambition to build on the “strong foundation” laid by his predecessors inspires less confidence than he likely intended to communicate.

    By George Gay

    It is usually seen to be a good thing that something has solid foundations, but this is not necessarily so if an architectural carbuncle has been built on those foundations. In this case, those foundations simply make it more difficult to pull the whole edifice down once it has been generally admitted that what has been created is not in the public interest and has to go.

    In what was billed in September by the U.S. Food and Drug Administration as an interview with Brian King, the new director of the FDA’s Center for Tobacco Products (CTP), King was quoted as saying he intended to build upon the “strong foundation of my predecessors.” This is a strange turn of phrase and could perhaps have been better presented as the “strong foundation built by my predecessors,” but never mind.

    Brian King / Credit: FDA

    That aside and given that one has to be diplomatic on the occasion of such an interview, I still wonder what he meant by this statement. As above, a strong foundation is usually seen as a positive, but it is hard to see much that is positive in the legacy on which King has been left to build. I see the foundation he has inherited as anything but strong—as comprising lumps of immovable ideology mixed unevenly with political interference and legal interventions.

    And such a foundation is the very opposite of what King later claims to be the CTP’s driving force—science. Once science melds into such a solid, stultifying foundation, it’s time to call it a day. It’s time to pull the whole edifice down and start again. All that will arise from that foundation will be a dreadful carbuncle.

    King goes on to say that the CTP aims to achieve its longstanding vision of making tobacco-related disease and death a part of America’s past not America’s future. Bold, if hackneyed words, but visions, in my experience, are things usually experienced by people of faith rather than those of science and often by those in need of help.

    And this seems to chime with the foundation on which King is apparently going to build—a foundation that has seen the CTP, time and again, undermine e-cigarettes, the one product that has the potential, in the hands of lightly regulated U.S. entrepreneurs, to encourage a significant proportion of smokers to quit their habit while providing them with a satisfactory substitute.

    I don’t want to criticize King or the CTP unreasonably, but words have meanings, and if you set out to release the text of such an interview, those words should be chosen with care. King goes on to say that the CTP comprises “a dedicated team of more than 1,000 staff who work day in and day out to tirelessly achieve this mission.” Readers will notice here how the “vision” seems to have become a “mission” underpinning the seemingly faith-based nature of the undertaking.

    Credit: Waldemarus

    But there are other aspects of this wording that I take issue with. I’m sure that a lot of those who work at the CTP are good at what they do and keen to achieve the CTP’s aims, but, as in any other group of 1,000 or more people, there will be variation in their skill levels and attitudes. It doesn’t do, I think, to make this sort of sweeping statement about the employees of an organization that some people, perhaps many people, have found wanting. This is the sort of statement made by politicians not scientists. Nor does it help to use the sort of language that has these people working day in and day out tirelessly to achieve this mission. It seems to attempt to posit these 1,000 or more people as somehow superior to the rest of the U.S.’ workers, who presumably are seen to spend some of their days goofing off work.

    Some of the claims made by King seem not to stand up to scrutiny. Certainly, I would have remained [quit] rather than say, as he did, “Over the past 13 years, CTP has made significant strides in … reviewing new tobacco products before they can be legally marketed.” My observation is that if strides have been made in this respect, they have been made through treacle, with the inevitable mess that such high stepping involves.

    But I think that the worst aspect of the interview is what it fails to say rather than what it says. It contains no humility, no admission that some aspects of the CTP’s work have not gone as well as one might have hoped—might have expected given the organization’s hardworking team.

    The interview is couched in corporate speak and reflects the political zeitgeist that has it that admitting mistakes demonstrates weakness whereas, in reality, such admissions show strength and can comprise the first steps in avoiding mistakes in the future and moving on to a better place.

    King tells us that he is a scientist by training and that he’s been working in tobacco control science for the better part of the past two decades. My question is what is tobacco control science? Tobacco control is a rather hazy term, which, I take it, is supposed to refer to the reduction of tobacco use.

    And I cannot help thinking that tobacco use reduction is not about science but about devising regulations and the enforcement of those regulations. Medical science might inform why you need to try to reduce tobacco use, but it has little to say about how you should control it.

    Credit: Photoma

    In part, such confusion occurs because the words “science” and “scientist” are used to cover such a wide range of activities and people. It is very much like engineering and engineers in this respect, as is summed up in the old story of two acquaintances meeting in the street:

    Nancy: Nice dog. Is it yours?

    John: Yes, I got him last week.

    Nancy: Really? You know, I never saw you as a dog person.

    John: You’re right in a way; I’m not a dog person. But I thought he would be useful, his being an engineer and all?

    Nancy: Did you say he was an engineer?

    John: Yes, that’s right.

    Nancy: An engineer? How do you figure that?

    John: Well, every time the doorbell rings, he makes a bolt for the door.

    Surely, it must have been the CTP’s dog that answered the door to the deeming of vaping products as tobacco products; it couldn’t have been a scientist. And yet King makes out that “[s]cience is central to the important work we do.”

    But my suspicions about this claim are roused when he talks, as he does in the interview, of “sound science,” as if he believes there is such a thing as unsound science. But my ideas align with his when he talks of the “best available science,” because here he seems to be validating the idea that all scientific findings are always open to challenge in the future.

    But he loses the plot, to my way of thinking, when he talks of one of the themes of his tenure at the CTP: communication. “Clear, transparent and timely communication is also important to me, including proactively messaging on the great progress our center continues to make on key priorities,” he says. This “proactively messaging” is political-type grandstanding from atop the corporate-type vagueness of the undefined “great progress” and “key priorities.”

    There was a certain irony in King talking of clear, transparent and timely communication because, below the interview as I received it in an email, were links to six stories under the heading “In case you missed it: Recent CTP news,” one story of which was headed “CTP Updates ‘Grandfathered Tobacco Product’ Term to ‘Pre-Existing Tobacco Product.’”

    Apparently, this change had been made because it was discovered that the grandfathered term “when used to describe someone or something exempt from a new law or regulation—has its roots in 19th century racist voting laws.” To me, this then is a progressive move.

    Of course, it seems as if it has taken a while to bring it in, which is in opposition to King’s aim for timely communications, but hey, let’s be generous, King was certainly not head of the CTP when the term “grandfathered” was first used by that body in reference to tobacco products.

    Still, my question is, given a substitute term was deemed necessary and given that clear communication is the aim, why wasn’t a better term than preexisting used? The problem with preexisting, as with grandfathered, is that, standing alone, it is meaningless or almost confusing.

    Preexisting only makes sense in reference to a date or an event, so “preexisting tobacco product” might be seen by some—awkward customers, admittedly—as referring to something that predated the introduction of tobacco products.

    It has to be admitted that this problem is difficult to sort out now. For whatever reason, the grandfathered date as it was then known was set by the CTP as Feb. 15, 2007. So, the only way to make sense of things as they stand would be to make the term “Preexisting Feb. 15, 2007, Tobacco Product.”

    This would be understandable without reference to anything else, but it is a little clumsy. To make things simpler, I would be inclined to pretend that the grandfathered date had been Jan. 1, 2007. That way the term could be “Preexisting 2007 Tobacco Product.” What could be more clear or timely? I’m not sure what transparent communication involves.

    But perhaps it refers to the graphic tobacco package health warnings that the FDA has been trying to bring in for some considerable time. Certainly, it’s not hard to see right through the proposed warnings.

    Credit: Grandbrothers

    Also accompanying the interview was a link to the story “Postponed: Cigarette health warnings effective date now Oct. 6, 2023.” The story explained how, on Aug. 10, a U.S. court, hearing a case brought against the FDA by R.J. Reynolds Tobacco Co., had ordered a further postponement of 90 days in the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule. Despite the postponement, the FDA urged those affected by the requirement to append warnings to tobacco packaging to submit their plans for doing so as soon as possible but no later than Dec. 7, 2022.

    I don’t know on what grounds Reynolds made its challenge. What interests me here is King’s claim about communications necessarily being clear, transparent and timely and how this fits with the proposed tobacco package warnings.

    If it had been me, I would have aimed for the CTP’s communications to be truthful and effective, which would have ruled out most of the communications provided by the warnings, I believe. I find the wording of the warnings quite odd. I’m not a medical person, but I find it confusing that the word “can” seems to be sprinkled about without rhyme or reason. So, you have “Smoking can cause heart disease and strokes by clogging arteries,” but “Smoking causes cataracts, which can lead to blindness.”

    The only meaning I can take from these particular warnings is that some smokers develop heart disease and strokes while all smokers wind up with cataracts, and some of those go blind. Is this true, I wonder? Certainly, it is not true that never having smoked protects you from ever developing cataracts.

    To make this warning truthful and therefore, to my mind, effective, it is necessary to state what proportion of smokers develop cataracts and what proportion of the general population develop them—also, what proportion of smokers with cataracts become blind because of this condition and what proportion of the general public go blind because of this condition.

    As these warnings stand, they are not clear, timely or truthful. In fact, by being sparing with the information they provide, they appear designed to mislead. Smokers aren’t stupid; they can see through this sort of transparent message.

    I believe that King’s introductory interview was poorly conceived and executed. The people involved in tobacco and nicotine, at whatever level, deserved better.

  • JTI Launches Ploom X Heated Tobacco Device in UK

    JTI Launches Ploom X Heated Tobacco Device in UK

    Ploom X (Courtesy: JTI)

    JTI announced that it has launched the Ploom X, a heated tobacco device, in the UK. The new device features upgraded technology to enhance the consumer experience and adds to JTI UK’s ever-evolving range of reduced-risk and alternative products. The technology is already available in Japan.

    “The launch of Ploom X marks a milestone in JTI’s story and also sets a new paradigm in the heated tobacco category,” Mark McGuinness, JTI’s director of Marketing, said. “Ploom X is a truly innovative product that will exceed consumer expectations, making their tobacco moments even more pleasurable and truly unique.”

    Ploom X is the latest heat-not-burn device on the market and represents the “cutting edge” of the next generation of heated tobacco products, according to a press release. The technological upgrades for the Ploom X device include:

    • A redesigned HeatFlow system and a higher heating temperature to ensure a more consistent nicotine delivery and a more enhanced flavor delivery from the first puff. 
    • One simple heating mode which makes the device easy for consumers to use.
    • Adjustments to the airflow system enabling a more consistent vapor delivery and increased vapor volume. 
    • Longer session times of up to 5 minutes and the ability to use more EVO tobacco sticks per charge, with up to 22 sessions with just one charge.
    • A smaller and more compact device. Ploom X users have the opportunity to express themselves by customizing the sleek aesthetic of the device with a colorful range of magnetic front panels that can be switched and swapped, in order to meet individual preferences and tastes.

    Ploom X also has, on average, a 90-95 percent reduction in the levels of 9 constituents recommended by the World Health Organization (WHO) for reduction in cigarette smoke. This does not mean that use of Ploom X is safe or eliminates health or addiction risks associated with tobacco use. No tobacco product is safe.

    Ploom devices are designed to be used exclusively with EVO tobacco sticks which contain ActivBlend, a tobacco blend made from microground and fine cut tobacco that delivers a truly authentic taste experience. With 20 sticks in a pack and a recommended retail price of £4.50, EVO costs less than half the price of a pack of cigarettes.

    EVO tobacco sticks are available in a range of flavors: classic tobacco, unique menthol flavors, fruit and menthol infusions and capsule variants for users who want to have the option to release an additional burst of flavor during a session. 

  • The Next Generation

    The Next Generation

    The SKYX Group is taking a three-pronged approach to electronic nicotine-delivery systems.

    By Maria Verven

    The global crisis of 8 million tobacco-related deaths every year and 1 billion projected deaths this century may be prevented by electronic nicotine-delivery systems, improved pharmaceutical nicotine-replacement therapies and tobacco-free nicotine, among other science-based innovations.

    Kylie Halperin is CEO and co-founder of SKYX Group, a two-year-old company based in New York City that’s working at the intersection of all three concepts. SKYX Group is a consumer hardware and biotechnology company that’s designing and manufacturing inhalable devices.

    The company currently makes consumer devices for the U.S. and European markets and has submitted premarket tobacco product applications (PMTAs) with the U.S. Food and Drug Administration. The company’s R&D portfolio includes devices serving both the pharmaceutical and biotech industries for the inhalation of various active ingredients.

    Halperin co-founded SKYX Group after spending over a decade with leading advertising and marketing firms representing Fortune 500 consumer product companies such as PepsiCo, Dell Revlon and Colgate. In her role with SKYX Group, Halperin is helping create the company’s strategic vision and portfolio positioning and taking a lead role in managing wholesale relationships with major retailers.

    She spoke with Vapor Voice about what SKYX Group is doing to create the next generation of inhalable drug-delivery systems.

    Vapor Voice: What compelled you to co-found SKYX Group?

    Halperin: For me, the story is personal. My father had Parkinson’s disease, and in 2019, it became too hard for him to take his pills. I wished we had access to simple aerosolization devices so he could take his medications.

    Other members in my family have been lifelong smokers. My brother smoked a pack a day for over 20 years and couldn’t kick the habit despite trying every alternative: gums, patches, lozenges, different pod systems, pouches—you name it. If our product could help just one person transition from combustible cigarettes, I would consider it a success story.

    I co-founded SKYX Group with Martin Steinbauer, a Harvard graduate in applied mathematics and former investment analyst at BlackRock in New York. He handles our engineering and tech-focused initiatives in medical inhalable devices and aerosolization technology. An entrepreneur, investor and inventor, Steinbauer co-founded the tobacco-free nicotine vaporizer company SMOOD, which has grown into a global vaping business built on advanced chemistry, patent-protected hardware and sustainability.

    Thanks to our tobacco-flavored SMOOD, my brother has been cigarette-free for over two years. So, there’s a much better chance he can stick around for his children for a long, long time.

    What are the key differentiators in your product, and what factors do you think will contribute to SKYX’s success?

    There are several consumer-facing subsidiaries in the U.S. and European markets for different market segments. So, it was important that our synthetic nicotine vaporizer—SMOOD—was both affordable and approachable. Our target audience is consumers who are former cigarette smokers with an average age of 39 years. 

    SMOODoffers a cleaner, smoother nicotine experience without tobacco. A consumer vaporizer company built with advanced technology and sustainability programs, SMOOD was developed by MIT and Harvard medical engineers. We are excited about transforming the vaping sector by focusing on quality control, safety and reliability. SMOOD satisfies consumer preferences in nicotine delivery, vapor intensity and aroma.

    The SMOOD nicotine line was built after studying existing products and devices in both the consumer and medical inhaler markets. We examined consumer packaged goods in the cosmetics and coffee markets as well as aerosol-delivery devices in the medical industry. As a consumer product, we designed it to offer a sensation and taste to what consumers are familiar with in their daily smoking rituals.

    We also wanted it to be affordable and competitively priced with a pack of cigarettes: one pack of SMOOD is $8.99; two packs are $16.99. One SMOOD (40 mg/2 mL) provides roughly the same amount of nicotine as two packs of cigarettes.

    In our mission to provide reduced-risk products to combustible cigarette smokers, we were an early adopter of synthetic nicotine for its purity and absence of minor tobacco alkaloids. Tobacco manufacturing contributes 84 million metric tons of CO2 emissions each year. Since it’s made in the lab and manufactured according to pharmaceutical standards, synthetic nicotine eliminates the vast majority of those emissions.

    Last but not least, we created SMOOD to be sustainable and environmentally conscious; the vast majority (94 percent) of SMOOD devices can be upcycled. We used a cradle-to-grave approach, designing the product with its end of life in mind and offering a simple collection and true reuse of electronic waste.  

    Although it’s disposable, which we know has environmental concerns (see “What a Waste,” Vapor Voice Issue 4, 2022), we found a way to upcycle the device plastics into building materials and upcycle the battery components into new batteries. This is very important to us as we roll out a recycling structure in the greater U.S.

    Kylie Halperin & Martin Steinbauer

    What are your primary markets, and how will the company distribute and market its products?

    While there are synergies between the pharmaceutical and consumer markets for drug delivery systems, consumers will choose a product on its own merits in the retail market. That’s why we are focused on safety, familiarity, affordability and sustainability.

    We work with full-service distribution partners in the U.S. and Europe that service single to multi-store retail channels, such as convenience stores and gas stations.

    We want to work with retail partners who want to learn more and work with us to place recycling boxes for us to collect. Plus, we want to expand this important call to action to other industry players to work together to proactively combat this issue and build a responsible and sustainable future.

    What’s on the horizon for SKYX? 

    We are excited about protecting public health through quality engineering and smart devices.

    On the growth side of the consumer business, we’re growing our distribution footprint in the U.S. and Europe. Thanks to the great feedback we’ve received from consumers and retail partners, we are developing other new and innovative products that offer an effective and viable alternative to combustible cigarettes.

    On the R&D side, we’re spending a lot of time on the pharmaceutical side of aerosolization technology—e.g., how existing medications that are inhaled can be better administered through a more suitable delivery system. What would it take to make medications that are taken orally currently a great candidate for inhalation? 

    On the consumer side, our goal is for SMOOD vaporizers to be approved by the MHRA [Medicines and Healthcare products Regulatory Agency] and ultimately prescribed by British physicians for smoking cessation.

    We have submitted our PMTA along with excellent HPHC (harmful and potentially harmful constituents) data to the FDA. SMOOD has garnered intellectual property such as patents on hardware, chemical formulations, age/user verification, IoT [Internet of Things]-enabled devices, supply chain optimization and recycling.

    Our team members all have diverse skill sets, and we are dedicated to making a public health impact. But our work has just begun.

    In addition to providing an alternative to combustion cigarettes, we’re excited to use similar technologies to create the next generation of inhalable drug-delivery systems for optimized medication delivery.

  • Unbearable Truth

    Unbearable Truth

    Credit: Polifoto

    ‘Bear bites man’ is a news story, of course, but ‘man bites bear’ is sure to make page one.

    By George Gay

    Look out! There’s a brown, big bear in that tree!

    No, don’t concern yourself, there’s no bear; I was just making a point. No English speaker would utter that warning. What they would say is: Look out! There’s a big, brown bear in that tree!

    If you string adjectives together in English, they follow a certain order in which, for instance, size—big—comes before color—brown—and, for that matter, age—old—comes before shape—fat—and both age and shape come between size and color. I don’t know what the order is off the top of my head, so I had to look it up to describe the examples above, but I, like others, use the correct order instinctively almost all the time.

    The question is, does the order really matter? Well, from a practical point of view, perhaps.

    After all, you wouldn’t want Joe, the person being warned, to get into a semantic argument about whether it was right to say the bear was brown and big or big and brown because, in the meantime, the bear might have come down from the tree and the arguments would turn to whether the animal in question could be described as an angry, big, brown bear, a big, angry brown bear or any of the other adjectival combinations available—and, finally, whether it was creating a big, bloody mess of Joe, or a bloody big mess.

    On the other hand, languages evolve, and if it weren’t the case that the human race was going to be wiped out within the next 100 years by the effects of environmental breakdown, it’s not hard to imagine that, many years into the future, the creature in the tree might have become known by English speakers as a brown, big bear or, in a really progressive society, referred to according to a description chosen by bears or their democratically elected representatives.

    Already, there is a tendency to flexibility—I would say laxity—over word order, especially when it comes to story headings. Take this one from insidesource.com: “Public health’s misinformation against vaping is eroding its credibility.”

    The way that I read this heading is by assuming that “its” refers to vaping because “its” is closer to vaping than it is to the other referential candidate, “public health,” so that what I assume is being said is that the credibility of vaping—as a means of quitting smoking—is being undermined by the misinformation put out under the name of public health.

    Credit: Desdemona72

    There is truth in this because such misinformation does get through to some smokers. But, when you read the story, it turns out that what is being said is that public health is undermining its own credibility by putting out misinformation about vaping.

    Again, the question arises as to whether this confusion matters. I would say yes because I, and perhaps others, would be likely to skip over a story that was about vaping being undermined by public health misinformation because that happens all the time.

    I would be much more likely, however, to read a story about the credibility of public health being undermined because such stories are rarer. “Bear bites man” is a story, of course, but “man bites bear” makes page one.

    Finally, the point is that the heading could be fixed easily as “Public Health’s credibility eroded by its issuing misinformation on vaping.”

    Credibility aside, I shouldn’t think that public health would have been overjoyed to see the following headline from eatthis.com: “Vaping versus smoking marijuana: Which is better for your body?” I cannot help thinking that public health would have found this heading unnecessarily provocative.

    Given that both activities carry a level of risk, the question that public health would probably have preferred is “Vaping versus smoking marijuana: Which is worse for your body?” And this is not withstanding that these activities are seen by many people as having some positive outcomes.

    This is an interesting heading, however. When I first read it, I thought the physical effects of vaping nicotine were being compared with those of smoking marijuana. It took me a while to work out that it was vaping marijuana and smoking marijuana that were being faced off.

    My initial interpretation of the heading might have been perverse, but I think what was written could have been made clearer as “Which is better for your body, vaping marijuana or smoking it?”

    While I usually ignore stories whose headings pose questions because I feel that I am going to be asked to do the story’s heavy lifting, this particular heading is intriguing. In fact, I would have read the whole story had I been a little cleverer and been able to activate the link from the synopsis that I saw.

    One thing that intrigues me is why the headline writer didn’t pose the more general question: “Vaping versus smoking marijuana: Which is better for you?” And why, if she felt she wanted to be more specific, did she go for the body? Why not the mind? “Which is better for your mind?”

    Credit: andriano_cz

    Perhaps some would even have preferred the focus to have been on the soul. I don’t think there is a clue in the “eat this” name because in both cases we’re talking about inhalation. I guess I’ll never know.

    The next heading I would like to look at is from thedrum.com and is perfectly clear as I read it: “Chinese vaping brand accused of flouting advertising rules designed to protect children.” It is clear, but it is misleading in an important way. Compare this heading: “Cudgel accused of breaking man’s skull in vicious daytime attack.”

    Most people would laugh at such a heading, saying that you cannot accuse a cudgel of doing anything; the accusation must be aimed at the person wielding the cudgel. But by the same token, those people would probably not think twice about an accusation being leveled at a vaping brand, an equally ridiculous idea in my view. In fact, it is possibly more ridiculous.

    It is conceivable that a cudgel could be made to stand in the dock and eventually be sent to prison as nonhuman animals have been in the past. But a brand does not have a bodily form.

    The question is, as always, does any of this matter? I would say yes. Leveling the accusation at the brand lets off the hook those who allegedly caused the rules to be flouted.

    What is likely to happen if the allegations are substantiated is that the company that owns the brand name will be fined, a fine that will possibly be recouped through increasing the price customers pay for the product. The person or people who allegedly caused the laws to be flouted will be unaffected and therefore free to repeat the offense either at the same company or at a new one.

    I have written previously about the dangers of anthropomorphism, which crops up in such phrases as “vaping brand accused” and, of course, “the market panicked.” But having said that, I have to admit that it is almost impossible to avoid such anthropomorphism at times as observant readers and pedants will have noticed from a couple of stories above where “public health” is said to be up to all sorts of things that, in fact, only people working in public health can do.

    The problem is that trying to insert phrases such as “people working in public health” every time becomes clumsy and, frankly, unnecessary. And, of course, there are instances where this sort of thing simply doesn’t matter. I recently saw an advertisement for “meditation for businesses.” But beware when it is said that a business was found to have been involved in money laundering.

    Perhaps one problem with headings is that they are thrown together at the last moment and can thus carelessly undermine what might be an article that is worth reading. I noticed this heading in thejournal.ie: “Opinion: E-cigarettes are not part of the solution to a tobacco-free Ireland.”

    This seems blindingly obvious to me. The solution to a tobacco-free Ireland must surely be the introduction of tobacco in the same way that the solution to an alcohol-free Ireland would be the introduction of alcohol.

    The problem here, I think, is the word “solution,” which has been allowed to slosh about all over the place in recent years, and here is clearly adrift. I guess the heading should have read something like: “Opinion: E-cigarettes will not help solve Ireland’s tobacco smoking problem.”

    I must admit that, initially, I was drawn to the following heading on nst.com.my because GEG are my initials: “Two million will die if GEG bill not passed.” Nevertheless, what I really like about this heading is that, without even knowing what GEG stands for, you know that the heading is correct, and, what’s more, you know even that its negation is correct.

    So, the headline writer could have written: “Two million will die if GEG bill passed.” This is because people have finite lives. The 2 million people in question will die. That’s a certainty. What I suppose the headline writer must be getting at is that 2 million people will die prematurely if the bill is not passed. But, to my way of thinking, “dying prematurely” is one of those odd concepts that seems nevertheless to be universally accepted. Surely, it’s just a case of when your number’s up, it’s up.

    If you quit smoking and, on your first smoke-free day, you don’t stop at the tobacconist, you might get hit and killed by a driver jumping the lights at the intersection, something you would have avoided by stopping at the store. But, to my mind, you wouldn’t have died prematurely even then.

    In any case, from the synopsis of the story, it seems as though the emphasis wasn’t on “saving lives;” it was about saving money. Tax revenues from sales of cigarettes weren’t covering the costs of treating smoking-related diseases. A cynical person might be forgiven for reaching the conclusion that the smokers were seen not to be dying “prematurely enough.”

    Credit: Alswart

    And you can look at this another way. By giving up smoking and living a little longer, those 2 million people will have a greater negative impact on the environment than if they had died earlier and therefore might be responsible for the earlier deaths of others. Life and death are not simple matters.

    Now, I would like to draw attention to a heading at colinmendelsohn.com.au: “New Campaign Outlines the Real Truth About Vaping.”

    Colin Mendelsohn is one of those brave souls who has for a long time been trying to inject some rational thinking into the debate in Australia about the use of vaping as a means of helping smokers quit their habit—a debate that has been seriously marred by misinformation. I mean, look at the heading. What does it say about us when Mendelsohn feels it necessary to include the word “real” before the word “truth”?

    OK, this heading from The Herald is way beyond the usual range of stories for a vape-focused magazine, but I just cannot resist it: “Zimbabwe: Tobacco farmers earn $7 million in three days.” At one and the same time, this heading, reporting on April 5 on the first three days of leaf tobacco sales for the 2021–2022 season, is true but manages to grossly understate the work of tobacco growers and imply, incorrectly, that these growers were enjoying some sort of bonanza.

    The first thing to note is that these growers are not people playing the financial markets; they don’t earn that sort of money in three days. The second thing to note is that, in fact, they worked a lot longer than three days just to earn a modest amount of money. And I mean modest.

    Tobacco growers work long days, mostly out in the open, during a long, worry-filled season that can be upset by a whole range of often uncontrollable factors, including plant diseases, unhelpful weather and unscrupulous middle operators. And what do they get at the end of it?

    Well, according to The Star newspaper, reporting more or less at the end of the sales season, growers received an average of about $3.05 per kilogram for their tobacco, a figure that was up 9.3 percent on the $2.79 per kilogram they received the previous season.

    This sounds like a good payday, except that the $3.05 per kilogram of this year was up only 3.7 percent on what they earned in 1996—$2.94 per kilogram. You’re reading that correctly, 1996—more than a quarter of a century ago. The 2022 average price was actually lower than it was in 2008, 2012, 2013 and 2014.

  • Resolving the Past

    Resolving the Past

    Credit: Standap

    The spoils of Juul Labs’ settlement over its marketing practices is not divided equally among the suing states.

    VV staff report

    On Sept. 6, e-cigarette maker Juul Labs agreed to pay $438.5 million to 33 U.S. states and Puerto Rico in a settlement following a two-year investigation into the company’s marketing and sales practices. On Sept. 23, at least one state had opted out of the settlement, and other states are considering the same action.

    The Maine Attorney General’s Office said the state would be backing out of its $11 million agreement with the e-cigarette manufacturer after objecting to certain conditions from the company. As part of the agreement, Juul wanted states to waive the rights of school districts to pursue their own lawsuits. Maine wasn’t willing to agree to that.

    “We are disappointed in the outcome of these negotiations, but ultimately, we were unwilling to waive the rights of other entities who are also trying to hold Juul accountable for its deception,” Attorney General Aaron Frey said in a statement to The Maine Monitor.

    For the remaining states, the multimillion-dollar settlement will be paid out over a period of six years to 10 years. Both the financial and injunctive terms exceed any prior agreement Juul Labs has reached with states to date.

    “We recently submitted an administrative appeal, based on science and evidence, to [the U.S. Food and Drug Administration], demonstrating that its marketing denial order (MDO) of our products was substantively and procedurally flawed and should be rescinded,” Juul Labs wrote in a statement. “We believe that once the FDA does a complete review of all of the science and evidence presented, as required by law and without political interference, we should receive marketing authorization. As we go through the FDA’s administrative appeals process, we continue to offer our products to adult smokers throughout the U.S.”

    The multistate investigation found that Juul became the U.S. e-cigarette market’s leader by “willfully engaging in an advertising campaign that appealed to youth, even though its e-cigarettes are both illegal for youngsters to purchase and are unhealthy for youth to use, according to Connecticut Attorney General William Tong. The investigation found that Juul relentlessly marketed to underage users with launch parties, advertisements using young and trendy-looking models, social media posts and free samples.

    According to the investigation report, Juul’s misguided marketing began in 2015 and 2016 when the company bought ad space on websites targeted at youth, like nick.com, nickjr.com, cartoonnetwork.com and others. “It marketed a technology-focused, sleek design that could be easily concealed and sold its product in flavors known to be attractive to underage users,” New Hampshire Attorney General John Formella said in a press release. “Juul also manipulated the chemical composition of its product to make the vapor less harsh on the throats of the young and inexperienced users. To preserve its young customer base, Juul relied on age verification techniques that it knew were ineffective.”

    Credit: Standap

    The investigation further found that Juul’s original packaging was misleading in that it did not clearly disclose that it contained nicotine and implied that it contained a lower concentration of nicotine than it did. Consumers were also misled to believe that consuming one Juul pod was the equivalent of smoking one pack of combustible cigarettes. The company also misrepresented that its product was a smoking cessation device without FDA approval to make such claims.

    “This settlement with 34 [now 33] states and territories is a significant part of our ongoing commitment to resolve issues from the past,” Juul Labs said. “The terms of the agreement are aligned with our current business practices, which we started to implement after our company-wide reset in the fall of 2019.” Altria invested $12.8 billion for a 35 percent stake in Juul in late 2018 and began guiding the company’s new direction in 2019.

    Connecticut led the investigation and negotiations into Juul Labs’ marketing practices along with Texas and Oregon. The other states and territories involved in the settlement include Alabama, Arkansas, Connecticut, Delaware, Georgia, Hawaii, Idaho, Indiana, Kansas, Kentucky, Maryland, Maine, Mississippi, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Wisconsin and Wyoming. Colorado and New Mexico weren’t part of the settlement but have their own suits pending.

    The plaintiff states will not be splitting the settlement equally. Connecticut will receive a minimum of $16.2 million through the settlement, for example, while Texas will receive $42.8 million. Oregon will receive at least $18.8 million. Tong stated that the settlement total amounts to about 25 percent of Juul’s U.S. sales of $1.9 billion last year. He stated it was an “agreement in principle,” meaning the states will be finalizing the settlement documents over the next several weeks, so the dollar amounts may not be exact. While not expressly stated, it is believed the amount of Juul products sold in a state determined the settlement amounts.

    The money will go to programs, across the states and territory, that aim to reduce tobacco use, especially among young people. The amounts paid begin to increase the longer the company takes to make the payments.

    The remainder of the funds after the investigative leaders’ cuts is estimated to be distributed as follows:

    • Alabama: $15.5 million
    • Arkansas: $13.6 million
    • Delaware: $7.8 million to $8.5 million
    • Georgia: $19 million
    • Hawaii: $6.8 million
    • Idaho: $8.3 million
    • Indiana: Unknown
    • Kansas: $9.8 million
    • Kentucky: $14 million
    • Maryland: $13 million
    • Maine: Opted out
    • Mississippi: Unknown
    • Montana: $6.1 million
    • North Dakota: $6 million
    • Nebraska: Unknown
    • New Hampshire: $8.5 million
    • New Jersey: Unknown
    • Nevada: $14.4 million
    • Ohio: Unknown
    • Oklahoma: $8.9 million
    • Puerto Rico: Unknown
    • Rhode Island: Unknown
    • South Carolina: Unknown
    • South Dakota: $6 million
    • Tennessee: $13 million
    • Utah: $8.6 million
    • Virginia: $16.1 million
    • Vermont: $8 million
    • Wisconsin: $14.4 million
    • Wyoming: Unknown

    Juul previously settled lawsuits in Arizona, Louisiana, North Carolina and Washington. Many states, including Hawaii, also have claims against Altria Group (the parent company of Philip Morris USA and Juul’s largest shareholder) that are not affected by the settlement and remain active. Additionally, the company faces lawsuits filed by New York and California that are still pending, and an estimated 3,600 lawsuits by individuals, school districts and local governments have been consolidated in an action that is still wending its way through a California court.

    In addition to the financial terms, the settlement also forces Juul Labs to comply with a series of strict injunctive terms severely limiting the company’s marketing and sales practices. Most of the limits imposed by settlement won’t immediately affect Juul, which halted use of parties, giveaways and other promotions after coming under scrutiny several years ago. The company currently makes up about one-third of the U.S. retail vaping market, down from 75 percent several years ago. As part of the settlement, the embattled manufacturer has agreed to refrain from:

    • Youth marketing
    • Funding education programs
    • Depicting persons under age 35 in any marketing
    • Use of cartoons
    • Paid product placement
    • Sale of brand-name merchandise
    • Sale of flavors not approved by the FDA
    • Allowing access to websites without age verification on the landing page
    • Representations about nicotine not approved by the FDA
    • Misleading representations about nicotine content
    • Sponsorships/naming rights
    • Advertising in outlets unless 85 percent of the audience is adult
    • Advertising on billboards
    • Advertising on public transportation
    • Advertising on social media (other than testimonials by individuals over the age of 35, with no health claims)
    • Use of paid influencers
    • Direct-to-consumer ads unless age verified
    • Free samples

    The agreement also includes sales and distribution restrictions, including where the product may be displayed/accessed in stores, online sales limits, retail sales limits, age verification on all sales and a retail compliance check protocol. Juul came under its most intense scrutiny earlier this summer when the U.S. Food and Drug Administration attempted to ban all Juul e-cigarettes from the market. A federal appeals court blocked the government’s ban, and then the FDA placed Juul’s MDO under administrative review.

    In late September, the vapor manufacturer filed a lawsuit against the FDA over the agency’s refusal to disclose documents supporting its MDO. In a complaint filed with a federal court in Washington, D.C., Juul Labs accused the FDA of invoking the “widely abused” deliberative process privilege to improperly withhold scientific materials that are “central” to understanding the basis for the June 23 issuance of the MDO, according to Reuters.

    The company claims that the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims that Juul e-cigarettes help smokers quit combustible cigarettes and whether the agency’s reasoning was scientifically sound. “The public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinized decisions in recent years,” Juul Labs stated.

    An FDA spokeswoman declined to comment, saying the agency does not discuss pending litigation.

  • Changes in Greece

    Changes in Greece

    An ancient tobacco powerhouse, Greece is now also home to a lively vaping business.

    By Norm Bour

    If someone asked you “Which country used to process the most tobacco a century ago?” your first answer would probably be the U.S.—and you’d be right. But what would your second choice be? I was shocked to find out it was Greece.

    I was invited to travel through the northern part of Greece for a month, so I dug into the vape space there to see how it was doing compared to other countries, and I was surprised to find the Tobacco Museum of Municipality of Kavala, the first city we stayed in. It’s a rather long name, and I was taken aback since I had no idea that Greece, and specifically the city of Kavala, were important players in the tobacco world.

    A week later, I stayed at a high-end resort in the city of Drama, further to the north, and discovered that this amazing hotel, which was totally renovated 10 years ago, started life in 1911 as a tobacco processing plant, employing a significant number of residents.

    The tobacco that was grown in Greece, known as “basma,” was considered to be among the finest in the world, and the Greeks started cultivation about 200 years ago. By the late 1800s, Kavala had over 150 tobacco shops, and tobacco was big business through the 19th century until about 100 years ago.

    The processing of tobacco leaves and the manufacturing of cigarettes played a key role in the country’s history and contributed to the prosperity of both Kavala and Drama along with the major city of Thessaloniki. It also played a huge part in improving workers’ rights in other industries and employed several female workers.

    A century ago, Greece and Turkey were in turmoil in the aftermath of World War I and the Greco-Turkish War in 1922. There were massive relocations between the two countries, which caused huge unemployment.

    Tobacco helped create a more stable workplace and economy and contributed to Greece’s increasing power in trade.

    Tobacco in Europe took a different path than it did in America. Its history goes back to 1560 when the French ambassador to Portugal first introduced it to Catherine de Medici as a cure for migraines.

    Usage spread to the masses, and about 2,000 smoking pipes dating back to the 17th century were found near Thessaloniki, Greece, during excavations. The growing Ottoman Empire got much of its tobacco from Greece, which at the time was under its rule.

    Pipes back then were not just smoking utensils but also works of art. They became status symbols that indicated their owner’s position in society.

    Smoking remains prevalent in Greece today. Even though incidence has declined, it is still quite popular among the young and old alike. Some 38.2 percent of Greeks aged 15 and up smoke, according to the Global Adult Tobacco Survey. The majority (51.2 percent) is male and about half that share is female.

    Marios Zarnvidis, Smoker Steam vape shop

    In Thessaloniki, I spoke with Marios Zarnvidis from the Smoker Steam vape shop, which opened in 2013. “In 2013 when we opened, having a vape device showed you were cool. The young kids were more focused on that than the health benefits,” he said. “We had four golden years from then until 2017.”

    Then, Philip Morris International’s Papastratos subsidiary, one of the largest tobacco manufacturers in Greece, spent €300 million ($287.83 million) to convert one of its largest plants to exclusively manufacture its IQOS heat-not-burn product.

    That severely impacted Smoker Steam and other shops as people tried these new devices. Over the years, smokers gravitated to their devices of choice. Smoker Steam’s business is now more consistent, but its heydays are gone.

    “Today, about 20 percent of the younger people I know smoke, and their friends who do not [smoke] try to discourage them,” says Zarnvidis. “Our parents’ generation didn’t know of the dangers, but today’s kids do, and they try to support their smoking friends. My father started smoking at age six and finally quit in his mid-30s, and I only smoked for a few years in high school when many of us did—but now I’m 36 and would rather vape.”

    Cigarette and nicotine taxes impact vapor products as well, but e-cigarettes still cost about one-third the price of conventional cigarettes.

    Disposables are new to Greece, and much of the demand came from tourists who had become accustomed to them in their home countries.

    Zarnvidis sells a lot of 10 mL bottles, which surprised me. He explained that they have a high number of attorneys and other professionals who try to be discrete, so they prefer smaller products overall. Those bottles sell for €5 to €6 each.

    Smoker Stream’s top sellers include Alter Ego, a Greek company, and fruit-flavored liquids are still his biggest draw followed by tobacco-flavored liquids. Dinner Lady was a big seller along with Five Pawns, both of which have a significant U.S. presence, but most of his products are made in Greece.

    The vape industry remains under a cloud of paranoia as every year the government threatens to outlaw vape, prompting vapers to hoard products.

    “I hate it when that happens since everyone comes in and stocks up, and then we don’t see them again for a long time,” says Zarnvidis. “I’d much rather see consistent cash flow.”

    Despite the challenges, Greek businessmen are still opening vape shops, often driven by passion.

    Lambros Vlahopoulos opened Serial Vapers three years ago in Ioannina, a town of about 65,000 people. He considers himself to be a hobbyist because he believes in the benefits of vape over smoking. Vlahopoulos says he opened his shop to “spread the word” rather than to make money.

    “This shop is the story of my life and includes many collectibles from my youth,” he says. “Everything inside, all the woodwork, I did myself. I was a heavy smoker since I was 13, and when I discovered vape, I knew this shop, which took eight years to open, was going to be a reflection of my journey.”

    Unlike many of his counterparts in the U.S., Vlahopoulos does not sell disposables. He remains old school, blowing big clouds during our talk. As much as he is not money driven, he insists on carrying only refillable devices and liquids.

    “You can buy disposables anywhere, at any gas station or convenience store,” he says. “You never know what’s inside. I want to know my customers, teach and train them so they can respect the process of quitting smoking.”

    Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.

  • China Bans Celebrities From Endorsing Vape Products

    China Bans Celebrities From Endorsing Vape Products

    Credit: Vege Fox

    In an effort to boost “traditional values” China has banned celebrities from endorsing vaping products. The new rules ban entertainers and influencers from backing the products via social media, television commercials, live-streams and interviews.

    The move is part of President Xi Jinping’s campaign to overhaul the country’s corporate and social landscape, according to media reports.

    E-cigarettes, traditional tobacco and other nicotine products join private tutoring, health foods, healthcare and medical equipment as some of the targeted industries, according to a notice issued by Beijing’s top market regulator, the State Administration for Market Regulation, along with six other government agencies.

    “Celebrities should consciously practice socialist core values ​​in their advertising endorsement activities,” the rules stated. “Activities should conform to social morals and traditional virtues.”

    Xi cemented his control with an unprecedented third term as leader of the country at the quinquennial congress of the Chinese Communist party in Beijing last month.

  • Logic Granted Temporary Stay of FDA’s Menthol MDO

    Logic Granted Temporary Stay of FDA’s Menthol MDO

    Credit: Sundry Photography

    In an expected move, Logic Technology Development obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stays the U.S. Food and Drug Administration’s marketing denial order (MDO).

    The temporary stay issued by the circuit court means that both the Logic Pro Menthol e-Liquid package and the Logic Power Menthol e-Liquid package products can be sold by retailers and wholesalers in the United States while the stay is in place.

    The Third Circuit will now consider a further motion from Logic regarding the MDO that the company has seven days to file, according to media reports.

    “The foregoing motion for a partial administrative stay is GRANTED as follows. The FDA’s marketing-denial order is TEMPORARILY STAYED as to the Logic Pro Menthol e-Liquid Package and the Logic Power Menthol e-Liquid Package products. Within seven days of this order, the petitioner must file its motion for a stay pending the petition,” the order states. “The FDA’s response must be filed within ten days thereafter.

    “The panel considering the stay motion may decide it without waiting for a reply […] so any reply must be filed as quickly as possible (and no later than three days after the response).”

    The temporary administrative stay will remain in effect until a panel of the court decides on Logic’s new stay motion. If no timely stay motion is filed, the clerk is authorized and directed to vacate the temporary administrative stay.

  • Moraga, Calif. Bans Flavors as State Vote looms

    Moraga, Calif. Bans Flavors as State Vote looms

    Credit: Steheap

    At its meeting this week, the Moraga Town Council approved the second reading of an ordinance that will ban the sale of flavored tobacco as of Jan. 1, 2023.

    The vote comes just days before a Nov. 8 vote on a statewide referendum that will ask voters whether or not to keep a statewide ban that was approved in August 2020 but put on hold due to legal challenges.

    In addition to the ban on flavored vaping and other tobacco products, the ordinance prohibits the sale of all electronic smoking devices and e-liquids within the town, and prohibits all non-sale distribution of tobacco products, reports Halfwheel.

    It also updates laws that require all tobacco sales be assisted by a tobacco retailer, meaning that there can be no self-service displays of tobacco products.

    In the ordinance, the town stated that its goal was to reduce access and exposure to these products by younger members of the community, which it believes will promote public health both in minors and adults residing in the town.

    The town also sought to align itself with laws adopted by other cities and towns in Contra Costa County. The bill does not affect the sale of non-flavored tobacco products, such as premium cigars.

    Moraga is located just over 20 miles east of San Francisco and is home to approximately 17,000 residents.

  • Vaporesso’s XROS 3 Expected Release in December

    Vaporesso’s XROS 3 Expected Release in December

    The highly Anticipated release of Vaporesso’s XROS 3 and XROS 3 Mini is expected to hit the retail market in early December. The company recently showcased the new model at the two-day Vapexpo in Paris.

    The XROS series has built a global following as one of the most reliable vape products available on the market. Vaporesso, a division of Smoore Technology, the largest vaping manufacturer in the world, has sold in excess of 40 million units since launching the series in 2020.

    The XROS has also picked up multiple awards for its innovative and trendy design, including a prestigious Red Dot Award in 2022 and multiple Muse Design Awards.

    “In keeping with our company spirit of ‘Cross the Limit’, the XROS series continues to push back the boundaries in terms of what a vaping product can bring to customers,” said Thalia Cheng, chief marketing officer for Vaporesso. “We built the XROS 3 with our customers in mind, allowing them to enjoy our leading vape product performance and an aesthetic that is universally celebrated.”

    The XROS 3 comes with a 1,000 mAh high-density battery and provides users with a “solid and reliable vaping solution that can be used for 48 hours on a single charge”, according to a press release.

    The XROS 3 also features the COREX Heating technology for rapid and even heating, a precise adjustable airflow, and VAPORESSO’s SSS technology to prevent leakage.

    In addition to no leakage, the design means users can top-fill the vape without needing to remove the head, allowing them to easily switch between Tight MTL to Restricted DTL pods, according to the release.