Category: This Issue

  • 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.

  • 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.

  • What a Waste

    What a Waste

    Disposable vapes help smokers to quit combustibles but are deadly for the environment.

    By Maria Verven

    Cigarettes used to be the most littered things in the world.

    Trillions of cigarette butts are thrown onto our streets, parks and beaches every year. The Ocean Conservancy estimates that cigarette butts account for 25 percent of the total number of garbage items collected—over twice as much as any other category. Worldwide, it’s estimated that 1.69 billion pounds of cigarette butts end up as waste each year.

    While some smokers may think their butts will eventually decompose, it actually takes decades for them to degrade. Cigarette filters aren’t made of innocuous cotton; they’re made of cellulose acetate and about 12,000 nonbiodegradable plastic-based fibers.

    The chemicals in a single cigarette butt can contaminate hundreds of gallons of water. They can also be dangerous, causing fatal fires that burn hundreds of acres every year.

    Things have changed dramatically in the last several years as many smokers have switched to vaping, thanks in large part to the convenience of disposable e-cigarettes.

    In fact, these handy-dandy devices appear to be taking over the industry since they’re the simplest and most accessible vaping devices on the market.

    But in the process, we created a whole new environmental hazard that, as of yet, has no easy solution.

    Popular among youth

    Among all the vaping devices on the market, none are more popular than disposable electronic nicotine-delivery systems (ENDS), particularly among young people.

    According to the 2021 National Youth Tobacco Survey, well over half (54 percent) of youth who reported using e-cigarettes had used disposables. The 2020 Population Assessment of Tobacco and Health Study corroborated this finding. It reported that 38 percent of young adults aged 18–24 versus 17 percent of older adults (over age 25) who had used any ENDS product in the past 30 days had used a disposable.

    At the May 2022 Vaper Expo U.K., nearly every vendor offered some variety of disposable device. Many were new to the market that were capitalizing on the trend—as well as renowned companies such as Innokin, which launched its new Aquios Bar disposable device in 10 different flavors.

    “Disposable vapes are certainly the hottest-selling item among smoke-free nicotine-delivery devices,” said Dimitris Agrafiotis, owner of Global eVapor Consulting, executive director of the Tennessee Smoke Free Association and brand ambassador and designer at Innokin Technology.

    Agrafiotis said disposable vapes attract individuals who make impulse buys at various points of sale as well as new users who enjoy the convenience of a product that doesn’t require any knowledge of coils or ohms. They can purchase disposables nearly anywhere where cigarettes are sold. They can simply tear open the package and start vaping, making disposables the perfect solution for beginners.

    “In my experience, vapers who quit smoking use disposable vapes part time as secondary devices when they don’t want to take their usual rig with them, such as at a nice dinner or in situations requiring them to be more discrete,” he said.

    The technology behind disposables has only continued to improve over the past several years. Most vape pens can now deliver around 400 puffs before they’re no longer viable—nearly twice as many puffs as a pack of cigarettes can deliver. Some vape pens with larger batteries can even deliver as much as 5,000 puffs.

    Another significant advance is the use of auto-draw switches that activate the device and heat the coil when the vaper inhales, delivering a smooth and seamless experience.

    And thanks to nicotine salts, disposables offer a smoother vaping experience. While the nicotine level in most disposables is limited to 5 mg, vapers can satisfy their nicotine cravings without a harsh throat hit or any interference in the flavor experience.

    Speaking of flavor, that’s another advantage disposables have over refillable vape devices. Manufacturers often add sweeteners to disposables to make the flavors pop without having to worry that the sweeteners will gunk up and ruin the device. The disposable will be tossed long before that happens.

    The range of flavors available from disposables is mind-blowing. As more and more manufacturers take advantage of the growth in this market, they entice vapers with interesting and often exotic flavor profiles, such as bergamot and carambola.

    While battery technology hasn’t necessarily improved dramatically, some brands have created larger internal or rechargeable batteries in their efforts to increase puff count. This is a step in the right direction to reduce battery waste.

    The environmental impact

    Even refillable and replaceable vape pens typically contain several metal, plastic and cotton elements, making them difficult to separate and recycle. Thus, they tend to end up as general household waste. Even the smaller replaceable coils and pods don’t often get recycled.

    But disposable e-cigarettes are way worse because the vaper disposes the entire device, which is composed of plastic and metal coils as well as a battery cell. While some brands and vape stores offer recycling programs for disposables, most vapers simply toss them into the trash.

    Millions of lithium-ion batteries, hard plastic and nicotine-contaminated pods are being disposed of in our landfills, creating a significant waste problem. Nicotine, including nicotine salt, is listed by the Environmental Protection Agency as an acute hazardous waste. When disposables leak battery acid and/or nicotine into the environment, they harm fish and wildlife in the process.

    The Food and Drug Administration is required under the National Environmental Policy Act to evaluate all major agency actions to determine if they will have a significant impact on the human environment. If the environmental assessment identifies significant environmental effects, the FDA will prepare an environmental impact statement to help make informed decisions on the relevant environmental consequences and alternatives available.

    In addition to assessing potential environmental impacts of new tobacco products during premarket review, the FDA has also posted information for consumers on proper disposal of e-cigarettes and e-liquid waste.

    “While we are excited that lots of people are not inhaling combustible tobacco, we should be concerned over the environmental sustainability and proper ethics in the sale of these products,” Agrafiotis said. “In its quest to market and sell millions of these products, the industry has failed to implement any type of consumer education or recycling initiative that would help alleviate the disaster,” he said.

    “The irony is that in most countries in Europe, plastic straws are banned—and yet these products continue to be dumped by the boatloads. I simply cannot see how governments will allow this to continue, especially in Europe, where environmental waste is such a huge issue,” Agrafiotis said.

    “With TPD 3 approaching and countries already discussing legislative measures, I believe the days are numbered for disposables—at least as we know them right now.”

    What’s the solution?

    The first and most obvious answer is to encourage consumers to use rechargeable devices.

    Consumers could also be encouraged to purchase refillable pod devices, vape pens with replaceable coils or even rebuildable tank atomizers, all of which are far more cost effective in the long run, not to mention more eco-friendly.

    The industry has yet to find ways to encourage and/or incentivize consumers to dispose of these devices in the right manner. When Agrafiotis tried offering a financial incentive for every disposable brought back to his store, there were very few takers.

    “The younger demographic that predominantly uses these products simply doesn’t seem to care,” he said. “At least the older demographic tends to quickly transition from disposables to open systems when they realize the daily costs and environmental impact.”

    Agrafiotis said he’s unaware of any other outlets for collecting and recycling disposable vapes. “At this point, there’s no budget or avenue for us to try and change the existing system. Incentives and/or drop-off points for hazardous waste should have started with the construction and sale of the first disposable vaping device ever made.”

    “The only thing I could do is break the plastic and remove the battery and bring it to a battery recycler, but I would still have to dispose the plastic and nicotine pod in the trash,” he said. “All brands would have to work together to start a viable recycling program, but unfortunately, I simply do not see this is possible.”

    Nevertheless, Agrafiotis said Innokin is striving to reduce environmental waste in its products. Innokin was the first company to start using fully recyclable packaging for its open vapor systems, made entirely of paper with absolutely no plastic, he said.

    The first disposable vaping device that can be disassembled and recycled, the Innokin Enviro uses materials with a lower carbon footprint—a reinforced paper shell—to replace the plastic shell found in most disposable vaping devices.

    “We believe disposable vapes should have less impact on the environment,” Agrafiotis said. “With more efficient manufacturing processes and recyclable designs, our goal is to continually optimize Enviro and make disposable vaping greener. We can only hope demand grows for this approach and more companies follow in the same green footsteps.”

    Clearly, the industry must act quickly to devise solutions before the products that help millions of smokers are carbon taxed or—even worse—removed completely from the market.

    “Most of all, I hope we see more people quit smoking and transition to vaping, regardless of the device they choose to help them. Any vaping devices that can help smokers around the world make the switch is worth pursuing,” Agrafiotis said.

    “Plastic casings and batteries simply should not go into our landfills after just one use,” he said. “More companies should be actively looking at sustainable solutions and proactively working with existing recycling companies to implement programs to keep these products out of our already overflowing landfills.”

    The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry. 

    MORE ON VAPING WASTE

    Garbage facts

    There is an estimated 44.7 million tons of e-waste generated around the world every year. That waste contains up to $65 billion worth of raw materials like gold, silver and platinum sent to a landfill. The amount of global e-waste is expected to increase by almost 17 percent to 52.2 million tons in 2021, or about 8 percent every year, according to Cleanaway Waste Management, an Australian waste management, industrial and environmental services company. 

    Vaping products contain lithium-ion batteries, a heating element and a circuit board. These components—which may include plastic and heavy metals—make disposing of e-cigarettes a considerable challenge because of the various types of chemicals and materials involved in their manufacturing. 

    The global disposable e-cigarettes market size is expected to be valued at $6.34 billion in 2022, according to Future Market Insights (FMI). The overall demand for disposable e-cigarettes is projected to grow at a CAGR of 11.2 percent between 2022 and 2032, totaling around $18.32 billion by 2032.  

    “Demand for non-tobacco products is expected to augment the growth of the disposable e-cigarettes market in the near future. It has been observed that older people prefer this product as it does not have any negative effect on health,” stated an FMI analyst. 

    There are no direct regulations for recycling or use of e-cigarettes, heated-tobacco products (HTPs) or the cellulose acetate filters in combustible cigarettes in the EU, U.S., China and Japan. There is some legislation that regulates the management of e-waste; however, these guidelines typically apply only to cell phones, computers and other large electronic products.

    According to the Global Overview of Recycling Programs for E-Cigarettes, Heated-Tobacco Products and Vaporizers Business for 2022 and Future Prospects of Electronic Devices and Consumables Development report by Research and Markets, large vaping industry players have several recycling programs and recycling targets for the near future: 

    • Philip Morris International established two hubs in Europe and Asia that inspect, process and separate materials from electronic devices for recycling. The effective recycling rate of IQOS devices increased from 30 percent in 2018 to 40 percent in 2020. The target recycling rate is 80 percent by 2025. 
    • BAT replaces plastic elements of vapor products with pulp-based alternatives. The share of recycled waste was 79–80 percent in 2019–2021. The target recycling rate is 95 percent by 2025. 
    • Japan Tobacco International launched a return scheme of used devices through the recycling boxes at shops. In 2020, 67 percent of produced waste was recycled. The target for waste reduction is 20 percent by 2030. 
    • Imperial Brands launched takeback recycling schemes for used vaping devices and pods. The recycling rate decreased from 69 percent in 2017 to 61 percent in 2021. The target recycling rate is 75 percent by 2030. 
    • Other vape companies (Dotmod, Shanlaan, Dovpo and Vinn) launch their own recycling programs by return schemes. Innokin works on battery utilization programs. 
    • FEELM, an atomization brand and an independent business unit of Smoore Technology Ltd., won the IF Design Award 2020 for its eco-friendly Disposable Paper E-cigarette. CCELL launched a new line of disposable vaporizers in 2021. 
    • Recycling companies Gaiaca and TerraCycle cooperate with vape manufacturers to provide services for collecting and recycling e-waste. Some vape producers cooperate directly with recycling companies; for example, RELX cooperates with China Siyan Foundation for Poverty Alleviation. 
    • The Bowman Company offers refill stations to fill empty vapor bottles/pods. It will help to reduce plastic usage for vapor bottle production in the future. 

    It is expected that the future of e-cigarette, HTP and vaporizer recycling will depend on producers’ product life cycle programs. Recycling decisions from large vaping companies to combat waste include using a combination of polylactic acid (PLA) and plastic or starch blend and plastic for the device body; using paper packaging; and making inner packaging consist of paper or paper and PLA. 

    A survey by Opinium on behalf of Material Focus, a not-for-profit established to help the U.K. meet its electrical reuse and recycling targets, found that 18 percent of 4,000 people surveyed in the U.K. had bought a vape device in the previous year, with 7 percent buying a single-use device.  

    The Opinium figures would suggest that about 168 million disposable vapes are being bought every year in the U.K. Two of the biggest brands in the country are Elf Bar and Geek Bar, which between them make up about 60 percent of the market. 

    More than half of people that buy single-use e-cigarettes dispose of them in a general trash bin compared to 33 percent on average for all types of vape, according to the research. While each vape contains just 0.15 g of lithium, the scale of the waste means that about 10 tons of metal is ending up in landfills. – VV staff

  • The Soul of Vaping

    The Soul of Vaping

    So Soul, the rapidly rising vapor brand that began in China in early 2021, has now gone global.

    By Timothy S. Donahue

    Luna Wang wanted to do something different. She was seeing the products that the vapor industry was offering in early 2021, and she could tell that the industry was changing. Disposable devices were becoming the most popular products to help combustible cigarette smokers quit, but the available devices didn’t offer the same flavor or vaping experience that one could get from an open system. Luna Wang wanted to create something better.

    Wang has been in the vaping industry for eight years through various projects. In mid-2021, Wang joined forces with another experienced vapor industry entrepreneur, Peter Zhang. Both also had previous experience working with Fortune 500 companies. Together, they started the So Soul brand in Shenzhen, China, the global capital of e-cigarette manufacturing.

    So Soul soon entered the Chinese market, where more than 300 million smokers reside, and quickly found success. While the company also produces refillable pod products, it was its disposable products that really began to boost So Soul’s sales.

    “So Soul is a creative and dynamic vape brand which believes that innovation could bring freedom of the soul. So Soul has been a maverick and an unconventional company from the beginning,” said Lisa Li, head of media relations for So Soul. “Our founder, Luna, and the rest of the company’s employees are often considered dreamers. We believe that you shouldn’t have to compromise style for substance.”

    So Soul began because its creators believed something was missing in the market. Aside from a device’s appearance, aroma and flavor were two areas that Wang and Zhang felt were lacking in the Chinese vaping industry. The company founded its own research and development laboratory, staffed by the world’s top experts in the field, to develop products that could meet Wang’s high standards.

    “Our line of products offers smokers and vapers alike a range of flavors that are rich, smooth and satisfying. Our designs are inspired by the latest trends in fashion, and we’re always looking for new ways to stand out from the crowd,” said Wang. “Whether you’re a beginner or a seasoned vaper, we’ve got something for everyone.”

    The company devotes 60 percent of its profits to R&D in an effort to always be improving. It wants its products to stand out for their “combination of style, substance and soul,” explains Wang. “We are dedicated to providing our customers with products that are not only stylish and cutting-edge but also made with the highest quality ingredients and backed by extensive research and development.”

    During World Vape Expo Dubai, Wang told Vapor Voice that So Soul has perfected the art of flavor creation, and subtle “fragrances are at the heart of our products.” To accomplish the feat, Wang said that So Soul employs a team of expert mixologists that have years of experience in tobacco product development, and the company only uses the finest ingredients to create its unique flavor blends.

    “Our designs are inspired by the latest trends in fashion, and we’re always looking for new ways to stand out from the crowd. Whether you’re a beginner or a seasoned vaper, we’ve got something for everyone,” said Wang. “In a short space of time, we have already become one of the most popular brands in China. And now we’re bringing our products to the world. We strive to always be at the forefront of the latest technology. Our factory in Shenzhen employs over 1,000 professionals who share our commitment to quality and innovation.”

    An estimated 3 million customers worldwide have tried So Soul’s products. The company prides itself on being a one-stop-shop for all vapers from beginners to advanced nicotine consumers. Wang said that So Soul product users are stylish, creative and aim to present a safer, cheaper alternative to smoking cigarettes. So Soul offers vaping devices with an advanced mesh coil system and that range in volume from 2 mL to 5 mL of nicotine-based e-liquid.

    The company also offers devices that deliver from 600-plus puffs to 10,000 puffs, from bars to boxes and from sleek transparent design styles to designs with exquisitely crafted textures. Although disposable vapes are So Soul’s primary focus currently, Li said the company also provides refillable pod mod devices on demand for its customers.

    “So Soul also provides users with a wide range of flavors that are refreshing, sweet, savory and everything in between from Watermelon Ice, Mixed Berry Ice, Blueberry Ice, Spearmint, Blue Razz Lemonade, to Lemon Strawberry Pie, Pineapple Banana Coconut, Strawberry Watermelon Bubblegum, etc.,” said Wang. “There’s something for everyone. We expect to be responsible for offering the best vaping products to vapers at home and abroad and for pushing the entire industry forward.”

    Currently, So Soul’s products are sold globally in North America, Europe and Asia. The So Soul XC650 (Vibe), Y650 (Box) and S600 (Peak) are some of the most popular devices in the U.K. and European Union, according to Li. Since So Soul X7000 and Y10000 were launched in early 2022, they have been growing a massive market presence and have become popular in the U.S. and Middle East markets, particularly.

    While it depends on how heavily someone vapes and how often they use the device, typically, a So Soul device lasts longer than 92.3 percent of the disposable vape pods in the market, lending to the brand’s popularity. One popular vape reviewer stated that the So Soul X7000 is one of the best disposable vaping devices on the market.

    “The retro look really sets them apart from other disposables but, of course, that’s not the only reason why you should consider them,” the reviewer stated. “The flavors that I tried are all very enjoyable to vape on, and that’s only three out of the 20 that they offer, so there’s plenty more to choose from if the flavors that I tried aren’t quite to your liking.

    “The tight MTL draw is certainly not what I expected, but it was a pleasant surprise. The draw is similar to a cigarette, and that’s going to be a big plus for anyone looking to use these to quit smoking. Add to the fact that these provide a very satisfying draw and up to 7,000 puffs, and you get a great value for your money.”

    One of the major challenges for building the So Soul brand is the varying rules for vapor products from country to country, according to Wang. Regulations in the vaping industry are constantly changing and evolving in nearly every country where e-cigarettes are sold. Those regulatory rules include everything from raising the minimum legal sales age for e-cigarettes in many countries from 18 to 21 and federal, state and local restrictions on flavored e-cigarettes as well as the U.S. Food and Drug Administration recently being given the authority to regulate synthetic products.

    Many countries, like China for example, have even unveiled technical standards for e-cigarettes that will go soon go into effect. In a public document, in April, China’s State Administration for Market Regulation listed the requirements for design, chemical compounds and the mechanics for e-cigarettes that domestic manufacturers must meet in order to sell their products.

    “In addition to staying current on the laws governing the industry, we will keep up to date on the relevant scientific literature concerning the use of vaping products,” said Wang. “We may also consult with independent external scientific and medical experts to lead technology and ingredients innovation, so that we can fulfill our mission of helping people have easy access to affordable, safe and effective alternatives to traditional cigarettes.”

    So Soul’s mission is to promote less risky options for the global tobacco industry. So Soul and its team members are working toward helping create a smoke-free future. Moving forward, she said that the vaping industry is constantly evolving, and So Soul will remain at the forefront of innovation.

    “We have a passion for what we do, and it shows in our products. So Soul is more than just a brand—it’s a lifestyle. It’s about being confident, feeling good and living life to the fullest,” said Wang. “So Soul is style, substance … soul. The perfect vape for those who want it all.”

  • Liquid Success

    Liquid Success

    Zinwi R&D Center

    Zinwi Bio-Tech is the first company to be authorized by the Chinese government to produce e-liquids.

    By Timothy S. Donahue

    The e-cigarette industry is competitive. It is also growing rapidly. According to a recent report from Allied Market Research, the global e-cigarette market was valued at $17.3 billion in 2020 and is projected to reach $94.3 billion by 2031. As stringent regulations are implemented around the world, companies that produce the highest quality products in factories that meet the highest standards are finding themselves in high demand.

    When the State Tobacco Monopoly Administration of China (STMA) passed the Electronic Cigarette Administration Measures in March of this year, it required companies to apply for a license and comply with certain technical standards, including permitted ingredients and additives. Companies applying for the license must submit evidence showing financial and manufacturing fitness, to exacting standards set by the STMA, in a limited time frame.

    According to the SMTA website, fewer than 50 e-cigarette-related companies—including retailers and manufacturers—have received licenses. In June, Zinwi Bio-Tech became one of the first vape industry companies to secure a production license, specifically in the e-liquid category. Jenny Xu, Zinwi’s deputy director for international business, said garnering the license is challenging. Zinwi needed to meet strict quality control standards and go through a screening procedure that proved the company’s strong, reputable status in the industry.

    “The license not only gives Zinwi permission to produce e-liquid in China, helping Zinwi as a leading player in the industry to further enhance its concentration in the e-liquid segment, but also indicates the official recognition on Zinwi’s products, facilities and overall operation,” said Xu. “To secure the license, a company must prove that it is in possession of sufficient funds for production, with adequate facilities and equipment to meet the set standards. The materials and information required to apply are multiple in terms of financial status, production process and quality management.”

    In addition, the time window for submitting applications is narrow—a company must have completed and submitted its application by Sept. 30, 2022. The bar is also high, according to Todd Jiang, Zinwi’s sales director for international business, adding that the STMA’s review of both the application materials and the on-site check are strict as well.

    Jeff Zou entered the vaping industry and began Zinwi in 2016 with the goal of focusing on R&D, production and sales of e-liquid. Headquartered in Shenzhen, China, Zinwi is a high-tech enterprise integrating the R&D, production and sales of e-liquid, having developed into a global leader in the e-liquid solution service sector. Zou believes e-liquid “is at the core of the e-cigarette and has great potential” because it’s needed in every vaping device.

    “All e-liquid is the raw material that consumers vape. Consumers care about taste first followed by brand awareness and product design,” explains Zou. “Especially as the hardware technology becomes more and more mature, and products tend to become standardized, it will not be the hardware that reflects the advantages of e-cigarette brands; instead, the taste of the e-liquid will become the most important factor for consumers to consider when choosing what to vape.”

    In 2021, Zinwi Bio-Tech’s annual e-liquid shipment breached the 2,000-ton mark, equivalent to approximately 1.3 billion pods. Its production base covers an area of nearly 20,000 square meters, with complete production and testing equipment, a standard good manufacturing practices (GMP) workshop and automated production lines. The company’s GMP workshop was completed in 2019 and covers more than 1,800 square meters, according to Xu.

    “Our production base is able to deliver large orders at low cost and handle customer needs in a timely manner. The average monthly production capacity of our e-liquids can reach 600 tons,” Xu said. “We also have plans to expand our manufacturing sites overseas, so the overall production capacity can be further improved.”

    Zinwi Headquarters

    Zinwi’s clients include brand customers as well as original design manufacturer/original equipment manufacturer factories. Most of Zinwi’s e-liquids are used in pod products (including rechargeable closed systems and disposable closed systems). Xu said the majority of Zinwi’s products are initially sold to downstream manufacturers in large quantities and then sub-packaged into pods. The company’s team of professional flavor chemists has developed tens of thousands of e-liquid product formulas.

    “Zinwi produces e-liquid for both export and the Chinese market. The export destinations cover around 20 countries and regions across Europe, America and Canada, the Middle East, Russia and more,” explains Xu. “The company’s team of professional flavor chemists has developed over 40,000 e-liquid product formulas. Popular flavors can vary from region to region, country to country and city to city. For example, European customers prefer high sweetness, moderate coolness and sufficient aroma while Russian customers prefer moderate sweetness, low coolness and sufficient aroma.”

    As of July 2022, Zinwi has approximately 450 employees. The company’s success is based in its strong scientific research ability, secret e-liquid formulas, unique product taste, mastery of market preferences and strict quality control, according to Jiang.

    Zinwi has built a professional quality control and testing team to strictly control the process from raw material procurement, manufacturing to finished product testing, warehousing and after-sales quality, according to Jiang. Through sample collections, retention and traceability systems, Zinwi ensures its product quality with a strict quality control regime, according to Jiang. He says that Zinwi produces an average of 400 quality control samples daily that get stored in its 300-square-meter sample storage facility. The company has an 11-step inspection process conducted by more than 60 quality control professionals.

    The company invested approximately RMB 26 million ($7.4 million) in its R&D efforts in 2021. Jiang said that this year, the company expects to invest about RMB 50 million. Its commitment to quality is supported by numerous accreditations, including ISO9001 certifications, national CNAS laboratory and GMP certifications, and many others.

    “Zinwi has a strong R&D team and first-class scientific research equipment. In 2020, we set up the Atomization Technology Research Institute led by a doctoral team to carry out exploration and research on the basic field of e-liquid,” said Jiang. “Our R&D team continually breaks through the industry’s technical barriers and has obtained and applied for over 200 patents. Our R&D team includes the R&D Center for product R&D and Technology Center for technological innovation.

    “The R&D Center is for customer-oriented e-liquid product development. The Technology Center is for the cutting-edge or basic research on technologies, like essential oil extraction from plant, atomization science, sensory science, etc. The ultimate goal of our product and technology R&D is to realize harm reduction atomization.”

    According to Jiang, recent R&D projects have focused on core raw materials, product safety, consumer experience and health. “We have developed a variety of core raw materials through plant extraction technology. The high-quality core raw materials further enhance the taste of the product, thereby improving the quality of the product,” he says.

    In addition, the company has built a product safety database based on a number of studies of biochemical toxicology, animal toxicology, component analysis and structural identification, among other areas. The knowledge helps guide the company’s research and development of harm reduction products.

    “While pursuing consumer experience of taste, satisfaction, etc., we also insist on guiding product development with experimental data and theoretical research and pursue the concept of safety, low temperature and high-efficiency atomization,” adds Jiang.

    Zinwi Management Team

    When nicotine salts started to explode into the e-liquids market, Zinwi was on the forefront of innovation. Zinwi’s R&D team developed its own nicotine salt technology in 2018, which Jiang said could help vapers achieve a higher level of satisfaction with a softer taste. The company also participates in external research with several universities. Jiang said that the investment allows Zinwi to take advantage of external scientific research institutions and the talent behind those institutions to help Zinwi master the latest technological trends and cutting-edge knowledge.

    “Our cooperative universities and institutions include Guangdong Pharmaceutical University, Shenzhen Institute of Advanced Technology – Chinese Academy of Sciences, Beijing University of Chemical Technology, [Chinese] Society of Toxicology and Shanghai University of Applied Sciences,” said Jiang.

    To remain as active as possible in the industry, Zinwi joined the U.K. Vaping Industry Association and cooperated with its U.S. customers to submit a premarket tobacco product application to the Food and Drug Administration. Xu said that Zinwi’s knowledge of global market preferences in e-liquids can help customers quickly expand their customer base and reduce trial and error costs.

    “Zinwi’s compliance team can provide customers with global compliance solutions for e-liquids. We have rich practical experience and professional knowledge to help customers understand the latest laws and regulations and industry information, ensuring that their products meet the compliance requirements of global markets and thus effectively enhancing their product competitiveness,” said Xu.

    More importantly, the company’s experience in flavor development can set a company apart from its competition. Jiang said that Zinwi’s standardized production, shipping capabilities and quality control processes help the company quickly adapt to changes in a customers’ needs.

    “We may even know the market changes earlier than our customers to give them advice and help them develop unique products,” Jiang says enthusiastically. “Our customization service can efficiently meet clients’ needs and ensure customer satisfaction. We will compare our e-liquid quality and variety of flavors with anyone, but no other e-liquid can compare.”

  • What’s Old is New

    What’s Old is New

    Credit: Toto Jang 1977

    Nicotine was first synthesized nearly 120 years ago and is now being considered a new tobacco product.

    By Timothy S. Donahue

    Synthetic nicotine has been under fire recently. News reports surrounding the product have been negative, and technically, all synthetic nicotine products are illegal in the U.S. Companies had until May 14 to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration to keep their products on the market. Those that did not gain the FDA’s authorization for their synthetic nicotine products would have had to pull those products from the market by July 13. However, the FDA does seem to be using some discretion in its enforcement of synthetic nicotine products.

    During a panel presentation on synthetic nicotine at the Next Generation Nicotine Delivery USA 2022 (NGN) conference in Miami, Florida, in June, Todd Cecil, the acting co-director for the FDA’s Center for Tobacco Products’ Office of Science, commenting from the audience, said that he could not confirm enforcement discretion for synthetic products. He said “everything” on the market after July 13 is illegal. However, he insisted that the agency would evaluate synthetic products based on the science.

    “I can say that without doubt … the Office of Science will evaluate synthetic nicotine as you would any product, and [it] isn’t looked at with bias either for or against. It is up to the application to demonstrate that their product is APPH [appropriate for the protection of public health],” said Cecil. “And, like the rest of the FDA, no end verdict is evaluated in the absence of the dosage form in which it is administered.

    “So, you may well find a lot of synthetic nicotine products coming off of the marketplace because they didn’t hit the requirements of submission, didn’t hit the requirements of data that’s in the rule, or that they have not demonstrated that it’s APPH, all of which is part of this analysis process. It’s not simply a ‘Well, it’s synthetic. That means it’s OK.’ It has to be evaluated as part of [the PMTA].”

    George Cassels-Smith, CEO of Tobacco Technologies Inc., parent to eLiquiTech, the global distributor of SyNic products, said during the NGN panel that public misconceptions present a considerable challenge in the discussion about synthetic nicotine, adding that the FDA may be partly to blame because of the agency’s lack of clarity on the product’s safety and efficacy.

    “Our role now is to work with the FDA and to educate people that [synthetic nicotine] is a viable alternative and that it’s got a good spot in the future of tobacco products and pharmaceutical products, that it ticks all the boxes,” explained Cassels-Smith. “But unless we can educate the consumer, we’ll continue working with a 90 percent misconception of what this product actually is.”

    Tony Abboud
    Tony Abboud

    Tony Abboud, also speaking on the NGN panel, said that anti-vaping zealots, because of a few bad actors in the vaping industry, wrongly believe that synthetic nicotine was created only to evade the regulatory scope of the FDA. Companies like U.K.-based Zanoprima Lifesciences (the parent to SyNic) “have been manufacturing synthetic nicotine and perfecting the scientific process associated with it for years before the deeming regulation took effect, before the deeming regulation was fully implemented and long before the PMTA process kicked off,” said Abboud. “So that fact suggests that circumvention, again, is no longer an argument that is relevant.”

    Synthetic explained

    Synthetic nicotine is not new. Nicotine was first synthesized by Swiss chemist Ame Pictet in 1904. Since extracting nicotine from natural tobacco is efficient and inexpensive and synthesis from precursor compounds is relatively complex and expensive, for more than a century, synthetic nicotine had no commercial role, according to researchers at Stanford University in the U.S.

    Molecules such as nicotine may exist in mirror image forms with identical chemical makeup but sometimes differing biological activity. The nicotine molecule possesses chirality, meaning it exists in two mirror image versions called enantiomers or stereoisomers. Nicotine comes in left (S) and right (R) forms. The (S) isomer of nicotine greatly predominates in tobacco leaf, which contains only small amounts of the (R) variant (0.1 percent to 1.2 percent).

    Most synthetic nicotine has equal parts of both the (S) and (R) isomers. SyNic only has the (S) isomer—the one that holds all the psychotropic effects that nicotine consumers want, according to David Johnson, eLiquiTech’s president and chief scientific officer. SyNic USP/EP, SyNic nicotine bitartrate and SyNic polacrilex resin are manufactured in FDA-registered facilities using current good manufacturing practices. These products have confirmed purity levels of more than 99.9 percent, (S) levels of more than 99.7 percent and are free of tobacco-specific nitrosamines (TSNAs) and carcinogens, according to Johnson.

    “The molecule is the same and the three-dimensional structure’s the same. It’s not different. There’s nothing new. And so all those studies that were done with tobacco-derived nicotine can be bridged to this synthetic product, so it creates some synergies, reduces some effort on the part [of] people who are generating reports and reduces some of the burden on the regulators in terms of assessing the data that’s generated as well,” explains Johnson. “So this seems to be a pretty straightforward case, right? You have a pure product in terms of the active ingredient. You have delivery mechanisms that clearly evolve at the low end of the risk containers, and you have a strong basic science upon which you compare the products and then evaluate them.”

    Naturally derived nicotine and synthetic nicotine are identical on a molecular level. The differences are the individual or potential impurities. Nicotine derived from tobacco can contain potentially harmful impurities if it is not purified sufficiently. That can be difficult and costly because the impurities appear structurally similar to the nicotine molecule itself. But synthetic nicotine is virtually free of any impurities from the beginning, and none of its varieties are carcinogenic.

    ELiquiTech is committed to Zanoprima to serve as SyNic’s global distributor and the manufacturer of record for synthetic nicotine bitartrate and synthetic nicotine polacrilex resin as well as proprietary SyNic e-liquid formulas. Zanoprima holds the patent, and eLiquiTech maintains the exclusive rights for global distribution to the tobacco and electronic nicotine-delivery system industries. ELiquiTech does not sell flavorings for e-liquids.

    Cassels-Smith said the marketplace for synthetic nicotine has been a rollercoaster. He said SyNic does not make any sales to people that do not have an active PMTA. He said that when marketing denial orders for flavored tobacco-derived nicotine products began to come down from the FDA, the demand for synthetic nicotine was strong. However, SyNic only did business with companies that submitted a PMTA. Subsequently, the FDA opened a short window for new products to enter the marketplace.

    “We saw a very robust sampling and ordering process for people to [bring new products to market]. Now, we are in a period where companies would be marketing that product. But surprisingly, I’m not seeing the demand that I experienced in the beginning,” said Cassels-Smith. “My guess is that people are waiting to find out how those applications will be reviewed before they come in. I think their concern is that if there’s a market denial order and they must remove the products from the shelves, they would have excessive inventory and a high exposure to potential cash flow issues.”

    Globally, the United States has always been the country that “tosses the paddle in the water, and then we quickly see over in Europe the ripple effect,” according to Cassels-Smith. He said that he had recently spent time in Europe and was amazed at the number of vapers and heat-not-burn consumers there.

    “The ratio of people that were smoking cigarettes was the smallest that I’ve ever seen in Europe. I was in Poland for the Global Nicotine Forum. Going to the conventions, I was in Birmingham for [the World Vape Show] two weeks prior. Synthetic nicotine was all the rage, and the U.K. is seeing smoking plummet because of its embracing of vapor products. World Vape Show Dubai had many synthetic products too … it’s very strong right now in the Middle East. And most recently, we see that China is licensing companies to produce an estimated 200 metric tons to [a rumored] 500 metric tons of synthetic nicotine. With those kinds of quantities, they must anticipate an extremely strong demand.”

    Credit: NDABCREATIVITY

    Forward thinking

    The vapor industry is always changing. However, nicotine has always been a traditionally quiet segment. When some companies announced that they would use synthetic nicotine to circumvent FDA regulation, the U.S. Congress acted. It changed the definition of tobacco in the Tobacco Control Act to include synthetic nicotine. That change turned the synthetic nicotine market on its head.

    Cassels-Smith predicts a bifurcation in the nicotine market. This is due to factors such as making the cost of synthetic production more affordable and the certain security guarantees that synthetic nicotine offers over its natural cousin. Synthetic nicotine can be purchased for nearly the same price as tobacco-derived nicotine and in some instances for even less. This is due to advancements in the commercially scaled bulk production of synthetic nicotine for use in the tobacco, vaping, pharmaceutical and scientific research industries.

    However, natural nicotine may not be the best option for nicotine-replacement therapy (NRT) and next-generation nicotine products. This is because nicotine extraction outside the U.S. comes from a supply of dust and recon. India, for example, has used its large stocks of tobacco dust to create a crude nicotine, which is then refined into a purer liquid nicotine extraction.

    Several NRT products have been taken off the market by the FDA recently because they were found to contain TSNAs, residuals from the natural nicotine used in the NRT’s production. Synthetic nicotine has no TSNAs, the harmful, cancer-causing chemicals found in combustible tobacco products, because TSNAs are formed when tobacco leaves are grown, cured, aged and processed. The problem with the tobacco used in most naturally derived liquid nicotine is that the leaf used for extraction can’t be traced back to its origins.

    “When you pick up a pack of cigarettes, you can tell that tobacco is grown in this farm, in this soil, with this seed, with this residual pesticide, with this amount of heavy metals … with a nicotine extraction, you have no idea. You can’t track and trace it,” explains Cassels-Smith. “So that’s an advantage to our product. And I think that you’re going to see more and more of tobacco grown from a specific area with a farmer with known residual pesticides and known heavy metal contents of the soil, and that will be extracted. And I call that the pedigree of natural nicotine. I do see an opportunity for a pedigree brand of natural nicotine to have a substantial seat at the table.”

    Johnson said that having a manufacturing process that produces a synthetic nicotine offers a controlled process that’s repeatable, reproducible and well defined. Every raw material that goes into the production process can be traced by lot. Ingredients can all be tracked back to the source. “You’ve got batch records. You’ve got lot tracking. It meets that pharmaceutical model for producing a product that’s very well characterized [and] very reproducible,” said Johnson from the NGN panel stage. “The product that you produce is very low in impurities. It has no TSNAs, OK? Because those are not produced in this process.”

    David Renteln, co-founder and CEO of Lucy Goods, said that a pure, consistent, traceable form of nicotine is both easier to work with and also better for the consumer. He said that if one were to consider what the future of farming is going to look like, it isn’t going to be the traditional growing on billions and billions of acres of land. And land that needs to be used for food won’t be taken up by tobacco.

    “We’re still using farmland to grow tobacco, something that we’ve done for thousands of years [it’s labor intensive and bad for the environment]. The chemical production and synthetic production of key chemicals is something that will definitely not be done [in the future] by just growing plants on essentially two-dimensional plots of land,” said Renteln. “And as a result, the efficiencies are better for the environment, it’s better for human quality of life and labor practices. And when we reach scale, it will probably be less expensive, all the while being better for the manufacturer and the consumer.”

    Credit: TTI

    A closing cause

    The benefits of synthetic nicotine could extend to other products, such as pharmaceuticals. The 1958 Food Additives Amendment requires the FDA to ban additives that are found to cause or induce cancer in humans or animals as indicated by testing, such as TSNAs.

    Cassels-Smith said that this is why his company is preparing its drug master file for SyNic. The lack of track and traceability for natural nicotine has been a problem not only for the tobacco industry but also for the pharmaceutical industry and NRT manufacturers.

    “I think a lot of data needs to be presented, but I think [an] argument clearly can be made that this is more helpful to use in a habitual way than a Nicorette gum or something else in the NRT space. So, yes, a rising tide will lift all ships,” he said. “We will eventually see pharmaceutical, as well as tobacco products, with a cleaner active ingredient because what’s good for the goose is good for the gander.”

    Renteln said that the agency has the ability to do what it wants. It has a high degree of latitude to make decisions that it believes will help the agency achieve its mission: protecting public health. He said that the intent behind regulating vaping products is to ensure that these products that are APPH remain on the market and that those that aren’t APPH are not allowed to remain on the market.

    “We should take an appropriate amount of time and get the burden of evidence that they need to make that decision. I think that there are, just using common sense, products that are more complicated and will require more time to assess, and then there are products where it would be kind of difficult to mess up,” he says. “I think enforcement priorities can make a great deal of sense. We’ve seen that work relatively effectively already, and so I think they’ve got a precedent that’s not perfect but good enough.”

    Instead of overzealous regulatory actions, Renteln said he would like to see more action taken against the bad actors of the industry. Nobody seems to care if they get a warning letter. He thinks misinformation is a serious issue, claiming 90 percent of the doctors he has spoken with believe nicotine causes cancer and is extremely poisonous. He also doesn’t want the FDA’s decisions to be political.

    “The problem we have is misconceptions and people telling false truths. Nicotine isn’t made in a microcosm; nicotine does have an addictive quality to it, but it’s super clean. It’s not carcinogenic,” said Renteln. “My biggest concern is just that there will be a great deal of pressure [on the FDA] to bow to political influences rather than scientific decision-making … that’s really the agency’s role; that’s their mission. That’s their approach to dealing with everything. I think that the scientists at the agency tend to feel very strongly that they’re going to make a decision based on science.”

  • Misdirection, Lies, Hubris

    Misdirection, Lies, Hubris

    Regulating the vaping industry in South Africa is complicated by deception and distraction.

    By Asanda Gcoyi

    The advent of electronic nicotine-delivery systems (ENDS) and electronic non-nicotine delivery systems (ENNDS) has taken the world of public health policy by surprise, it would seem. Nowhere is this more apparent than in developing and under-developed countries.

    Where previously countries with little public health policymaking capacities could rely on the World Health Organization for guidance on tobacco regulation, the deep uncertainties plaguing the WHO on the best way to regulate ENNDS have left many countries unsure how to regulate important innovation in nicotine delivery.

    In South Africa, this challenge has proven particularly acute. As a former leader in tobacco control, the country has struggled to institute an ENNDS regulatory framework. In May 2022, it was four years since the government first published the draft Control of Tobacco Products and Electronic Delivery Systems Bill for public comment. The bill updates the country’s longstanding Tobacco Products Control Act, first adopted in 1993.

    It does this by introducing more restrictions on tobacco sales and consumption. In a stroke of policy confusion, the bill extends the restrictions imposed on combustible cigarettes to ENNDS. To date, the draft bill has not been approved by the Cabinet for tabling in Parliament, precisely because it is based on misinformation and hubris.

    In general, proposals to restrict smoking and make it difficult for nonsmokers to be initiated into the habit are to be welcomed. However, it is entirely misguided to have the prevention of initiation as its sole objective of public health policy in a country with a staggering 8 million smokers out of a population of 60 million.

    South Africa does not have the resources to support smokers quitting. Other than a barely functional quit line, the country does not have any smoking cessation programs sponsored by the public health system. Nicotine-replacement therapy is not freely available. There are no counselling facilities.

    Asanda Gcoyi

    While the South African government cannot generally be regarded as lacking in policy-making capacity, especially in the area of tobacco control, it can be concluded that shifting narratives about ENNDS have left the government in a difficult position. WHO prevarication on the topic has not helped matters.

    Where government could previously rely on the WHO to issue unequivocal policy guidance, the growing impasse between the WHO and members of the public health community in support of ENNDS as a harm reduced alternative to smoking has put government at a loss on how to proceed on ENNDS regulation. Growing scientific evidence challenging the natural inclination of the WHO to castigate behaviors it does not agree with is proving especially challenging.

    While the ENNDS industry in South Africa shares government’s concern about a new generation of nicotine consumers, it remains a concern that government proposals to regulate ENNDS do not correlate with the intended outcome of reducing smoking.

    As has been demonstrated in places such as the U.K., ENNDS are an efficient tool for moving smokers to potentially less harmful alternatives, with some even deciding to quit. It is a major public health policy opportunity, especially for developing countries such as South Africa, to reduce their costs of public health resulting from noncommunicable diseases associated with smoking.

    In the four years that the government has attempted to come up with a regulatory framework for ENNDS, the Vapour Products Association of South Africa (VPASA) has been at the forefront of calling on government to consult beyond its fellow travelers in the anti-tobacco advocacy lobby. Sadly, this has not happened.

    Instead, the government has continued to rely on outdated, heavily biased studies to back up its untenable policy positions, including the rightly maligned and withdrawn study by Stanton Glantz, a researcher with the University of California, San Francisco School of Medicine, titled “Electronic Cigarette Use and Myocardial Infarction Among Adults in the U.S. Population Assessment of Tobacco Health,” published by the Journal of the American Heart Association in 2019.

    Currently, the government looks set to introduce a tax on vaping products. This is partly justified on the basis of this and other problematic studies, some conducted as long ago as 2014. This happens against the backdrop of new scientific studies demonstrating the likely benefits of adopting ENNDS as part of a broader tobacco control strategy.

    Regrettably, South Africa is not alone in embracing such misdirected policies on ENNDS. Whereas there are easy wins on tobacco control, it seems governments across the developing world have resolved to limit the very innovation that promises the most success in weaning smokers off their deadly habit. From Botswana to Kenya to Mauritius, governments in Africa and other parts of the world are resorting to draconian measures to control ENNDS rather than looking closely at the science and embedding this in their regulatory approaches.

    Overall, smokers, especially poor ones, are likely to be the biggest losers in the overzealous regulation of the vaping industry. This is a direct result of governments that fail to take into account their duty to listen not only to the views they like but also those they may not necessarily appreciate.

    The truth is that even the most rabid anti-ENNDS campaigner accepts that there are major differences between smoking and vaping. As such, it makes sense that governments should differentiate between the two behaviors when putting in place regulatory measures. Such differentiation should favor ENNDS over combustible products. This is not happening in the developing world. Certainly, it is not happening in South Africa. Quite the opposite is being pursued.

    Given tobacco’s dominant and entrenched position as the preferred nicotine-delivery system for most nicotine addicts, stringent restrictions against ENNDS disincentivize smokers from switching. Sustained disinformation and outright lies about ENNDS make this worse. Governments complain about the costs of smoking to the public purse yet seek to protect the biggest drivers of such costs by protecting the tobacco industry from the only real alternative to emerge against smoking.

    The VPASA will remain committed to the fight against senseless regulation in South Africa. To not do so would be to fail the millions of South African smokers who are desperate for alternatives to tobacco.

    Asanda Gcoyi is the CEO of the Vapour Products Association of South Africa.