Category: This Issue

  • Havoc in Hemp

    Havoc in Hemp

    Credit: OceanProd

    The proposed Miller Amendment was designed to kill the hemp cannabinoid industry.

    By Rod Kight

    As everyone reading this article likely knows, the Miller Amendment unexpectedly passed a bloc vote in the U.S. House Committee on Agriculture on May 23. In a last-minute turn of events, chairman Glenn Thompson ordered an “en bloc” vote on all amendments rather than voting on them individually.

    This was presumably done because he knew that he did not have enough votes to pass the Miller Amendment on its own. Unfortunately, the tactic worked. This is especially frustrating given that the chairman has previously expressed interest in retaining the current definition of “hemp” for the next farm bill. 

    It is not an exaggeration to say that the Miller Amendment was specifically designed to kill the hemp cannabinoid industry. This is because the Miller Amendment:

    • changes the definition of “hemp” so that total THC must not exceed 0.3 percent;
    • expressly excludes viable seeds from a marijuana plant from the definition of “hemp” even though they contain almost no THC and the DEA itself considers them to be hemp;
    • expressly excludes cannabinoids that the plant produces but which are synthesized or manufactured outside the plant from the definition of “hemp” even if they are produced using cGMP or other internationally accepted quality control standards and are identical to the naturally occurring ones; and
    • expressly excludes “quantifiable amounts” of THC, including THCa, and “any other cannabinoids that have similar effects (or which are marketed to have similar effects) on humans or animals as THC” from the definition of “hemp.”

    Taken together, these provisions of the Miller Amendment strike a deadly blow to the entire hemp cannabinoid industry. If enacted into law, the hemp industry as we know it will no longer exist. If you read the provisions carefully, it should be clear that the Miller Amendment was not written by a hack or even someone who is simply concerned about so-called “intoxicating cannabinoids.”

    This amendment was written by insiders with a very specific agenda. Presently, the author is not known to me. Still, this policy has been the subject of a major lobbying push by a select group of major marijuana organizations to erase the hemp industry. 

    Chris Roberts, writing for MJBizDaily, reported that the“U.S. Cannabis Council—members of which include many multistate marijuana operators—circulated a letter asking lawmakers to exclude from the new Farm Bill any hemp-derived product with ‘detectable quantities of total THC and any other intoxicant that can be derived from hemp, including other forms of THC.’”

    The U.S. Cannabis Council is not the only villain in the war against hemp, but its members include some of the worst actors. It and its members actively advocate for cannabis policy that:

    • promotes the interests of a small handful of large corporate marijuana companies (i.e., marijuana monopolists) over the interests of small businesses;
    • advocates for limited licensure and vertical integration;
    • uses repurposed “Reefer Madness” fearmongering tactics about cannabis intoxication to further its cause; and
    • has initiated a “total war” against hemp with the express goal of completely destroying the hemp cannabinoid industry in what amounts to a bloody turf war.
    Rod Kight

    For anyone who did not previously believe that last point about Big Marijuana’s “total war” against hemp or who has ever asked “why can’t we all just get along?,” today’s congressional shenanigans should be ample proof of Big Marijuana’s end goal of completely eradicating the hemp industry. The Big Marijuana lobby and the monopolistic corporations it serves are willing to resort to backhanded political tactics and otherwise go the distance to take over the cannabis industry to the complete exclusion of the hemp sector. It is time to unite and fight back. This is our rallying cry: Hemp is cannabis. What is good for the hemp industry is good for the cannabis industry. 

    As I discussed in a recent keynote speech at Noco, the hemp industry is emerging as the paradigm for the future of cannabis. By defeating the Big Marijuana monopolists and promoting reasonable laws/regulations, such as the three-pillar approach (see below), we have an opportunity to rewrite the cannabis story and to create an industry where small businesses and farmers can thrive and consumers have access to a wide array of safe cannabis products through a variety of distribution channels.

    Rather than focusing on cannabis intoxication, vertical integration, expensive licensing, prohibiting home-grow, a zero-sum turf war or any other such nonsense, the three-pillar approach addresses three reasonable regulatory “zones” for consumer safety and a healthy industry: (1) age gating, (2) quality control for production and manufacturing, and (3) standardized and informative labeling and marketing. Read/listen to more on the three pillars here. I welcome your input.

    Fortunately, a lot of marijuana companies are beginning to see the “hemp light.” I regularly receive calls from marijuana companies who have decided to pivot to the hemp industry as the path forward for their businesses. They see hemp as a commonsense solution, not a “loophole,” and want assistance making the journey. Hemp is the great uniter, and we welcome anyone who believes in fair play, reasonable regulations and a healthy cannabis economy. 

    Here are some suggestions on how to join the fight and help hemp win the war against oppressive monopolistic interests:

    • Call your federal lawmakers today and let them know that you support hemp. Tell them to “vote no” to the Miller Amendment and to retain the current definition of hemp.
    • Support the organizations that are fighting for hemp with your donations: the American Healthy Alternatives Association, the Hemp Roundtable, the Midwest Hemp Council and the Hemp Industries Association. These organizations are leading the fight against a well-funded greed machine, and they cannot do it without your support. If you want the hemp industry to survive, then donate money to these organizations today! Don’t screw around. Do it now. 
    • Call “bullshit” on the organizations that purport to be pro-cannabis but advocate against hemp. Hemp is cannabis, and these organizations are working against your interests. Inform and educate your friends, colleagues, customers, competition, lawmakers, lobbyists, news media and anyone else who has any interest in cannabis that there is a war raging against hemp that will impact the future of cannabis. NOW IS THE TIME!
    • Stay up to date on news about the farm bill and state-level bills that deal with hemp. We are in a critical time for the industry, and things are moving very rapidly. You owe it to yourself and to the industry to stay informed.
    • Finally, set aside differences with your competition and focus instead on creating a united hemp industry that is dedicated to a positive future for cannabis. If we win, there will be plenty of time to compete, but if we lose, there will be no industry.

    The future of cannabis will be determined by what is happening right now. Act accordingly.

  • Uphill Battle

    Uphill Battle

    Credit: Pormezz

    The motives behind successful quitting require ongoing efforts to understand those reasons.

    By George Gay

    Two Hong Kong news stories published in March provided examples of what, to me, is officialdom’s often muddled thinking around tobacco smoking issues. For instance, there is a belief system operating among some politicians that has it that though the consumption of cigarettes is “addictive,” smokers will quit smoking when the price of cigarettes is raised.

    Such beliefs seem to gloss over a few inconvenient facts. The first is that while “addictive” is a Humpty Dumpty word often used to mean whatever the person using it wants it to mean, most definitions include the idea of compulsion, and, bizarrely, politicians, egged on by tobacco control advocates, have hammered home the idea that smoking compulsion is extremely difficult if not impossible to break.

    So the question arises: What leads politicians to believe that raising the price of cigarettes will overcome this compulsion, which is unrelated to price?

    Another pertinent question would be why so many politicians, apparently convinced that nicotine addiction is almost unbreakable, are not willing to accept the concept of tobacco harm reduction (THR), whereby users continue to consume the addictive nicotine, which is what they crave and which, alone, does not cause harm, but without the harmful products produced during the burning of tobacco.

    This question was raised a long time ago by the availability of vapes, but it has surely been elevated to another level by the arrival of nicotine pouches. What appeared to be a blinkered attitude by some politicians and tobacco control advocates has been raised to the level of pigheaded obstinacy.

    Why? Muddled thinking again, perhaps brought on because of the science, if you can call it that. According to a study by the Ohio State University Comprehensive Cancer Center, nicotine pouches do little to curb smokers’ nicotine cravings. A university press note from Nov. 21 said that researchers had “found that current smokers had a much greater spike of nicotine in their blood levels and much sharper relief from craving symptoms when smoking than when using both the low-dose and higher dose nicotine pouches.”

    I ask you, what is the average politician going to make of this? They are going to say that given these pouches do not work, we may as well ban them and prevent another nicotine product from entering the market, and, without mentioning it, support the continuing use of cigarettes.

    They will not stop to ask themselves whether the science here might be somewhat askew. They will not stop to ask themselves why, if nicotine pouches do not work, there is purportedly a “problem” with increasing sales. They will not stop to ask themselves whether judgments about the efficaciousness of these products are best left to the market rather than the laboratory. And they will not stop to ask themselves whether consumers need scientists to tell them whether nicotine pouches work for them.

    Of course, they will not ask these questions because they are unlikely to see beyond the heading: “Pouches do little to curb cravings: Study.” And this a pity because the press note about the study was not totally negative regarding nicotine pouches.

    “Our challenge is to approach regulation of nicotine pouches to limit their appeal among young people while making them more appealing to adult smokers who would see health benefits by switching from cigarettes—which have the most severe health impacts with long-term use—to nicotine pouches,” the lead study author, Brittney Keller-Hamilton, was quoted as saying.

    I say not totally negative because what is being called for here is a balance between designing nicotine pouches. Hence, they are effective in getting smokers to quit while not allowing them to become attractive to the underaged. This is the self-same quest that has been pursued in the case of vapes, always with the same result: that the products are made less attractive to adult smokers than they need to be to encourage wholesale quitting.

    What comes out of the university worries me also because of an email I received on Oct. 6 from Mediasourcetv, which said the university was continuing its commitment to helping the U.S. Food and Drug Administration better regulate tobacco products. “The Ohio State University was one of seven centers across the United States selected to conduct research aimed at gathering scientific evidence needed for these decisions,” the email said.

    Don’t get me wrong. I am all in favor of the FDA making better decisions about tobacco and nicotine products. In fact, I shall wait with baited breath for this to happen. No, the problem was what came next in the second paragraph.

    “Historically, the tobacco industry has manipulated nicotine in combustible cigarettes and smokeless tobacco products, like chewing tobacco, to sustain dependence among existing users but also to increase their appeal and addictiveness for young people and nonusers,” the email said.

    Firstly, I don’t like the starting point that says, historically, the tobacco industry has manipulated nicotine. This seems to indicate the university, assuming it was the source of the story, is starting from a rather strange position from which it will be difficult to generate objective scientific evidence. How can it be that what happened “historically” can impinge scientifically on the present situation?

    Either you are a scientist or a historian. It is quite possible that nobody still works for the tobacco industry who was involved in manipulating nicotine, so the question arises as to what the link is between the industry of yore and that of today.

    Secondly, I get caught up with the finale: “… but also to increase their appeal and addictiveness for young people and nonusers.” How can it possibly be the case that manipulating nicotine increases the appeal and addictiveness of tobacco products to nonusers? This is utter nonsense.

    These might seem like minor points, but you have a responsibility to take care of what you say when you are writing about what is generally thought to be the product whose consumption causes more preventable disease and death than the consumption of any other consumer product. Otherwise, you cannot be surprised if people dismiss everything you say as gibberish.

    On which point, let me flip back to the middle of the sentence: “like chewing tobacco.” The word “like” here is misleading because it seems to mean something similar to but not the same as. What should have been written, I guess, is “such as chewing tobacco.”

    But I digress. The second inconvenient fact about the worth of raising taxes and, therefore, cigarette prices is that many of the smokers who would otherwise be further impoverished by cigarette price rises probably know where they can buy illicit products that undercut the price of tax-paid cigarettes.

    Indeed, one of the stories on the English-language news website RTHK.com quoted Hong Kong politicians as saying that it was common to see people on public housing estates handing out flyers promoting illicit tobacco products.

    Of course, legislators and the tobacco industry get on their high horses and condemn the purchase of illicit products as somehow morally wrong, but if you are involved in promoting a system where a licit, “addictive” product is deliberately made unaffordable to many of the people within the minority group comprising smokers, you can hardly take the moral high ground. You are the problem.

    The third inconvenient fact is that some smokers, probably a minority of them, can afford to pay the increased prices. And this raises an odd question: Do price increases discriminate against the well off? Let me explain. If politicians really believe that raising the prices of cigarettes will cause people to quit smoking and that quitting will improve the former smokers’ life chances, unless those price rises are enough to cause the richest smokers to quit, then the wealthiest smokers are being discriminated against; they are not being forced into improving their life chances as are poorer smokers.

    Clearly, the only way to bring in a fair system would be to ask all smokers to pay for their cigarettes a price that would be unaffordable even to the richest among their ranks, and, perhaps, to stop nonsmokers from being tempted to take up the habit, the price would have to make cigarettes unaffordable even for the wealthiest person in the country. I think this is called prohibition.

    This might seem like a phantasmic approach, but I do not think it would be much more unreasonable than what happens in Hong Kong, where the authorities during the past couple of years have worried about the damage caused by smoking, used the taxation system to raise the prices of cigarettes and then worried about the increase in sales of illicit cigarettes.

    And when I say “worried,” this is something of an understatement if newspaper stories are anything to go by. The trade of illicit cigarettes is an obsession with endless stories about the quantities and the so-called values of seizures and the incidents of fines and prison sentences handed out to those seen to be breaking the law, even to individuals importing a few cigarettes on which local duties have not been paid.

    One suggestion put forward to help combat this trade has been to require that cigarettes bear customs department labels to show that duty has been paid on them. But this would surely be a sticking-plaster response. Those involved in the illegal trade could knock out labels capable of fooling most people.

    Only those with specialist knowledge and equipment who got up close and personal would know the difference. Clearly, consumers would know the labels and the products were not genuine—they could tell by the product’s price.

    What I find so odd is that authorities will go to all this bother when there is a way of encouraging smokers to quit their habit rather than bludgeoning them into submission—of working with consumers rather than against them. All that needs to happen is for the authorities to remove the ban on alternative, less-risky nicotine products.

    This would make sense—a lot more sense than is to be found in current policies because to try to use pricing to force people to break cigarette smoking addiction when they are not allowed to access acceptable alternative products and when there is a ready supply of illicit products seems to be the triumph of hope over experience.

    The pity is that I sense there are people in authority in Hong Kong who, while they might not be advocating THR yet, could be persuaded that this is the way ahead in the 21st century. I say this because the two stories mentioned at the start of this piece quoted rational voices alongside those of politicians who clearly would never have the courage to admit they had been wrong.

    Some politicians, while aiming to encourage people to quit smoking, obviously understand the difficulties involved and the necessity of treating smokers as ends in themselves, not as a means to an end. The RTHK.com story had two politicians pointing out that government efforts to combat the illegal trade in cigarettes were inadequate given two consecutive years of tax increases on these products and the difficulty in dealing with the trade in illicit products, especially that conducted through overseas websites.

    At the same time, a voice from the retail and wholesale sector quoted in The Standard made the point that the government should focus on better education about the harmful effects of cigarette smoking rather than relying on duty increases alone.

    And a politician also quoted in The Standard called on the government to enhance assistance to people wanting to quit smoking. Calls to a smoking cessation hotline, she said, had increased significantly since the latest tax increase, which had probably caused stress among some smokers. She added that there was a need for continuous efforts to understand the reasons behind successful quitting and the challenges faced by those who failed.

    There is hope, but it will be an uphill battle.

  • All Across Asia

    All Across Asia

    Credit: Adobe Stock

    Several vaping events will take place in Asia and the Middle East this year.

    By Norm Bour

    The vape events world has seen its ups and downs over the past decade, and finding an event close to you can be an effort. Ten years ago, there were dozens in the U.S., many open to the public, who came in with empty bags, hoping to get their share of freebies. As the industry became more professional, international and interconnected—plagued by regulators’ bias and lack of knowledge—the number of events fell. Still, there are some serious players in Asia and the Middle East.

    Each country has its own regulatory challenges, and some continue to host regular events, whether focused on the tobacco industry, like InterTabac and World Tobacco Middle East, or niche industries, like the World Battery Show. However, there is a noticeable concentration on the vape scene, particularly in Asia. In recent years, Dubai and the Middle East have seen a surge in popularity, indicating the region’s growing significance in the global vape industry.

    Of the 20 vape/tobacco events that are scheduled through the rest of 2024, five will be in the Middle East, primarily Dubai, plus one in Cairo. Some of these are considered to be “world” events while others are focused on the Middle East specifically. Three are in the U.S., two are in Indonesia, and single events are held in various other places, including China, Malaysia, Moscow and South Africa, plus the Global Tobacco and Nicotine Forum (GTNF) that will be held Sept. 24–26 in Athens.

    Since I have been in Asia for the past six months and spoke at the World Vape Show Dubai several years ago, I wanted to offer an update on the vape scene on the “far side” of the world. September through October will be a busy four-week period, with three major events taking place in two different countries just a few hundred miles apart.

    The World Vape Show (WVS) team at Quartz Business Events, a significant player in the industry, is organizing the Dubai and Indonesia events. It has a global reach, having held events in Manilla, Warsaw and the U.K. This year, its focus is on Dubai, Indonesia and WVS Paraguay, which was held in March of this year.

    The WVS events, spanning three continents, are particularly noteworthy, with Dubai emerging as a key location. The upcoming event in Surabaya, Indonesia, Oct. 9–10 will be a collaboration with World Tobacco Asia, further underlining the importance of the World Vape Show events.

    Over the past several years, the Middle East has emerged as one of the primary vape markets. Asia is still divided between vape-friendly countries (Malaysia, Indonesia and Vietnam) and the stricter countries of Thailand, Singapore, Cambodia, Laos and Brunei.

    WVS’ partnership with World Tobacco Asia is a good move, bringing a strong recent player in the industry to pool with the longtime WT Asia team, which has been conducting events for three decades. They already have a loyal and interested base, and now that base is learning about vapes as well as tobacco. I can personally attest to the professionalism of this group, as they offer a terrific show held over several days.

    Jake Nixon, the event director for World Vape Show, is optimistic about the Middle East as well as Asia. “There are still a lot of conversations around vape products globally and the health benefits for smokers looking to transition away from combustible cigarettes,” said Nixon. “Exhibitions with a B2B focus enable the industry to come together and discuss any challenges currently being faced.”

    The co-branded event will be held in separate event halls but accessible to all attendees, and both attendees and exhibitors hail from all over the globe. The Surabaya location is unusual in that the majority of Malaysian events are held in Kuala Lumpur whereas the port city of Surabaya is located on the northern island of Java.

    The end of September will also be busy in Indonesia as the annual Vape Fair, one of the biggest in Asia, will be held Sept. 28–29 in Jakarta. This unique B2C event is strategically placed within Southeast Asia’s large footprint and brings in tens of thousands of visitors from all sectors. I asked a representative of the Vape Fair, “Why Indonesia?”

    The representative answered that the Indonesian government takes a common sense approach and “maintains a balanced and proactive stance on vaping, along with permitting the sale and consumption of vaping products while offering comprehensive regulations.”

    Vape Fair is unique in that it remains vape only, along with some heat-not-burn products, and is one of the largest vape-focused shows in the world, which allows the public at large to receive a worldwide audience. The days of the public’s access to vaping events may not be over.

    The company behind Vape Fair, Pamerindo, conducts events worldwide in many sectors. This will be the company’s ninth vaping event, which is noteworthy in such a volatile industry.

    Sept. 6–8 is when the first of these three events starts with the Asia New Tabacco Industry Expo (ANTY) show in Kuala Lumpur at the Malaysia International Convention and Exhibition Centre. An invitation to this event is what started my research on who, when and where there were vaping events in Asia and the Middle East. I was not familiar with the ANTY, but I learned that they have been offering this show for eight years.

    The ANTY is a B2C-only event that is also vape-centered and e-cigarette-centered but invites crossover exhibitors and guests, including the New Tobacco Global Conference (NTGC), which will bring experts together to discuss the industry. The Shenzhen-based ANTY seems to offer this as their primary worldwide vape show since vape and tobacco shows are no longer allowed in China.

    GTNF 2023 (Seoul)

    When I inquired about the “why” behind the ANTY/NTGC location, they also acknowledged that Malaysia, like Indonesia, is one of the most practical locations based on accessibility and reasonable government regulations. They are also optimistic about future shows and want to host more events inside and outside Asia.

    Meanwhile, 5,000 miles to the west, the final show of the year will be the Middle East Vape Show (MEVS 360), held in Cairo Dec. 9–11. More than 100 exhibitors are expected. The following month, a tentative January 2025 show is on the docket to be held in Bahrain.

    I traded emails with Arya Hakim, part of the creative team at SAWA International, based in the Kingdom of Bahrain, probably not the first place we would think of to headquarter a vaping event promotion company. But since 2016, they have been working the vape scene in the Middle East and North Africa (MENA) as well as working behind the scenes with regulators.

    Of course, you would expect this forum to be intensely focused in helping to create collaboration and partnerships, but it also offers workshops and education, always a bonus. “Egypt has the highest tobacco consumption in the MENA area, and we project 1 million of the 20 million current smokers will switch to e-cigs in the future,” said Hakim. “The MEVS show is an opportunity to introduce new technology to old habits.”

    For the past five years, they have been educating the public about the harms of vaping in comparison to traditional smoking, along with showcasing innovations and holding industry workshops.

    As predicted a decade ago, the vape world has become more professional, mainstream and international. The “world is flat” theory holds true in that borders and languages do not matter as much as they once did, and the vape world is more directed by regulations at all levels instead.

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

  • Heated Breakthrough

    Heated Breakthrough

    Greentank is at the forefront of innovation with the launch of its patented Heating Chip technology.

    By Timothy S. Donahue

    The vaping industry is in a constant state of innovation, primarily driven by advancements in hardware. A significant focus has been on enhancing battery quality as well as the electronics and circuitry within vaping systems. Notably, there have been substantial advancements in atomization technology. This includes the development from traditional wire coils and wicks to a more progressive adoption of ceramic materials.

    Atomization technology is crucial because the heating element functions as the core of a vaping system. The coil’s role in atomizing e-liquid is pivotal; the more efficient the element, the better the aerosol production, consistency and flavor. Recently, a leading technology company announced its breakthrough in heating technology, set to revolutionize the market.

    It has been seven years since a significant advance has been made in atomization technology. Enter Greentank: a company with a wholly new design representing a dramatic step-change from the conventional ceramic and wicked coil systems prevalent in many of today’s vaping products, promising enhanced safety, performance and experience.

    Greentank is a business-to-business technology company that specializes in the design, development and manufacturing of precision-made inhalation devices and atomization technology, according to CEO Dustin Koffler. Greentank’s latest innovation in atomization is called Quantum Vape. It replaces cotton wick and ceramic heating elements with a state-of-the-art patented Heating Chip.

    According to Koffler, the Heating Chip outperforms all other leading atomization products. For example, the Heating Chip performs better on key safety metrics such as harmful and potentially harmful constituents (HPHCs) and heavy metal testing than other leading technologies in the market. It also produces the “absolute greatest” release of flavor and the most consistent consumer experience from the first draw to the last, he says.

    “With this breakthrough in inhalation science, we’ve catapulted beyond the current generation of atomization technology,” said Koffler. “Our Heating Chip is set to disrupt the global market. It’s a distinct departure from anything currently available. While many companies focus merely on tweaking the substrates and print materials used in ceramic-based systems, they remain bound to the same ceramic foundation.

    “They’re refining ceramics—making components slightly smaller, slightly tighter, experimenting with new materials and formulations. Greentank, however, is pioneering an entirely novel approach that’s unlike anything witnessed in the industry before.”

    The Heating Chip is small. It comfortably fits on a fingertip and is one-fifth the size of today’s heating solutions. However, Koffler said its high-performance standards are due to advances that have never been achieved before with atomization. Typically, in a ceramic heating element, over time, flavor starts to dissipate naturally. This is because there is caking or buildup inside the pores of the ceramic, causing the temperature throughout the ceramic to vary after each use, leading to thermal cycling. With the Heating Chip, there is zero potential for thermal cycling, according to Greentank; every puff tastes the same as the first.

    “The Heating Chip employs a unique capillary action to draw the oil through the heating element, ensuring that each puff initiates a fresh cycle of material,” explained Koffler. “Many products boast consistent flavor throughout use, yet we’re all aware that the current market offerings fall short in maintaining this throughout the life of the product. In contrast, the Heating Chip integrates nanofabrication into its design.

    “The entire manufacturing process is proprietary, involving novel methods to assemble materials into the Heating Chip that emits no ceramic particle emissions and contains the lowest levels of harmful and potentially harmful constituents. While it’s not feasible to claim complete absence, third-party testing and rigorous chemical analysis have found these HPHCs to be at undetectable levels.”

    Additionally, Greentank only recently completed a longevity study using the Heating Chip in one of the company’s proprietary electronic nicotine-delivery system devices with a target of 15,000 puffs. “We easily achieved this target while demonstrating consistent vapor output from the first puff to the 15,000th puff,” explained Koffler. “Furthermore, we provided these same devices, along with new ones, to Labstat International to conduct aerosol analysis for both carbonyls and metals. The results showed that there was no difference in the safety efficacy from the first puff to the 15,000th puff.”

    Technically Speaking

    To a scientist, it’s a micro channel-based aerosol generator that delivers sub-micron particles according to its proprietary design. To the average consumer, it’s a smoother experience with maximum flavor intensity in a less-risky delivery than currently marketed e-cigarette and cannabis vape products. The Heating Chip isn’t anything like ceramics, said Koffler. Porosity isn’t inconsistent. It’s a chip with thousands of small holes and microchannels that allow for a superior level of precision and control in the atomizing process.

    One of the major challenges in designing the Heating Chip was finding the right talent to help develop the manufacturing process, said Koffler. The manufacturing of the Heating Chip requires specialized equipment, and bringing together a system that worked was incredibly complicated. The manufacturing of the Heating Chip can be compared to producing semiconductors.

    “By adapting pioneering techniques from other advanced industries and tailoring them to meet our specific requirements, we’ve enhanced our technology’s performance,” Koffler revealed. “The expertise of our global team, the precision of the equipment we utilize and our methodical focus on perfecting one aspect of the process at a time has been instrumental in overcoming the challenges we faced.”

    The next generation of atomization technology is moving away from ceramics, according to Koffler. The Heating Chip technology avoids all heavy metal leaching and ceramic particle emissions and ensures the lowest HPHCs all while permitting an unprecedented taste and consistency over a longer lifetime.

    It also offers a smoother experience and better mouth dispersion. Interestingly, the device is also able to create particulate matter small enough to reach lower lung absorption levels for nicotine, much like combustible cigarettes. This could be a giant innovation in getting smokers to adapt to less risky nicotine-delivery systems.

    “Utilizing microfluidic channel technology, we’ve engineered a system that precisely controls aerosol nucleation and optimizes particle size, enriching the sensory experience while maximizing intensity without any harshness,” Koffler detailed. “Our design includes independently arranged channels and a thin film interface that safeguards against chemical reactions and thermal decomposition. This architecture not only enhances flavor fidelity and ensures consistent temperature but also elevates safety standards and reduces potential harm significantly. From the outset, our goal was to achieve unparalleled performance and safety.”

    The size of the Heating Chip is incredible. It’s tiny. It’s one-fifth the size and 100 times the precision of any ceramic atomizer on the market today, according to Koffler. Its reduced size creates greater design flexibility and quicker response times. The Heating Chip is produced on sophisticated micro- electromechanical systems (MEMS) machinery. MEMS is a general term for forming a micron-level three-dimensional structure on a support substrate such as a silicon wafer and integrating functions such as electronic circuits, sensors and actuators.

    “Unlike the broad, imprecise methods typical of ceramic manufacturing, our approach from start to finish is meticulously controlled and exact,” explained Koffler. “This precision is why developing the right equipment for producing the Heating Chip was an extensive process. The level of control we achieve with the MEMS technology not only enhances consistency but also opens up revolutionary possibilities in precise dosing for pharmaceutical applications. This capability to finely tune dosages is a game changer in both vaping and medical fields.”

    Future Markets

    Based in Toronto, Canada, Greentank doesn’t produce nicotine. It doesn’t manufacture e-liquids or cannabis products. At its core, Greentank is a technology and product development company with a focus on safety, performance and reliability. The Heating Chip is not made from ceramics. While the material is proprietary, Koffler insists the technology is something new and its application in inhalation products is only scratching the surface of its potential. It is designed specifically for multiple verticals, predominantly electronic nicotine-delivery systems but also pharmaceuticals and wellness products.

    “We have expanded to over 100 employees across Canada, the U.S., the U.K., Singapore and China, with the majority focused on research and development,” Koffler detailed. “We’ve assembled a highly skilled manufacturing team to produce our innovative chip and have strengthened our engineering and material science capabilities. Last summer, we acquired Numerical Design, a company specializing in microfluidics and microfabrication, boasting an extensive portfolio of patents that further strengthen our intellectual property. This strategic expansion underscores our commitment to leading the edge in technology and manufacturing excellence.”

    Greentank spent over three years developing and testing the technology surrounding the Heating Chip and its manufacturing process. Additionally, it has been created with a robust intellectual property portfolio involving more than 50 patent families to bring forward a variety of advancements. The company’s technology is manufactured in ISO-certified labs, and all products undergo third-party testing.

    The technology is completely different from what exists in today’s inhalation devices. It gives Greentank the flexibility to be adopted into various inputs and varying viscosities. For example, it works well with both low-viscosity water-based e-liquids and high-viscosity resin oils from cannabis materials.

    In March of 2023, Greentank announced that it successfully closed a $16.5 million Series B financing round led by a strategic investor group with more than 15 years of manufacturing experience. The total investment in Greentank to date is now reported at $38.5 million.

    “Our Series B funding was a strategic move to elevate our operations from industrial prowess to global commercialization,” said Koffler. “We’ve established a 20,000-square-foot cutting-edge R&D and manufacturing facility, a project that spanned 18 months to build and equip with the most advanced technology needed to scale our Heating Chip.

    “This facility not only pushes the limits of what’s possible with specialized equipment and expertise but is also designed with flexibility in mind. Our vision was to create a model that can be replicated anywhere in the world, preparing us to expand into any other market as we continue to grow our business.”

    The expansion of the business is about phases, and Koffler said that during the next phase, whether that be the medical or wellness industry, Greentank needs to be able to produce chips to meet global demand with scale in mind. Koffler said this means that the company will look to leverage automation.

    Koffler emphasized that the real measure of Greentank’s success will be seen as the next generation of inhalation devices hits the market. He highlighted that numerous devices are on the cusp of being launched, with the Heating Chip poised to redefine industry benchmarks for safety and efficiency. Currently, Greentank is aiming to influence tobacco harm reduction significantly.

    “At Greentank, our commitment extends beyond mere compliance with regulatory standards; we are dedicated to establishing new paradigms of transparency and consumer safety,” said Koffler. “We are not just participating in the market—we are leading it toward a safer and better future.”

  • A Defining Decade

    A Defining Decade

    Credit: Thomas Trompeter

    The vaping industry has significantly changed in the 10 years since Vapor Voice started publishing.

    By Timothy S. Donahue

    The vaping industry has changed dramatically during the past decade. When Vapor Voice published its first issue in 2014, the e-cigarette industry was about six years old and still in its infancy. Cig-a-likes and tobacco flavors were still popular, but flavors and mods started taking off. In an online article on Dec. 14, 2019, Vapor Voice reported that Clearette was named “Best E-Cigarette and Vapor Line of 2014” in a competition organized by ECig Review Central.

    ECig Review Central gathered 25 leading vapor enthusiasts from around the United States. The judges were blindfolded and sampled 20 prominent e-cigarette brands over six hours. “I liked the bold e-cigs the best,” said one judge. “The throat hit was perfect, and the draw was extremely smooth.”

    Each tester was given a 15-minute to 20-minute break between individual e-cigarettes. Judges rated taste, quality and delivery on a scale of one to 10. In 2014, 21 out of 25 judges rated Clearette’s line as the best tasting. “The entire line was incredible,” stated another judge. “I was thinking it might be a tobacco company’s, but it wasn’t. The vapor tasted just like smoke.” Sadly, like many early vapor companies, Clearette and ECig Review Central are no longer in business.

    These early devices provided little vapor, and battery life was short compared to today’s products. One early industry leader, Njoy, is still producing products, albeit now under the Altria umbrella. The difference between Njoy’s original Daily disposable and its current Daily disposable exemplifies the vapor industry’s technological growth. In addition, Njoy’s Ace pod system is the most technologically advanced vaping product to have received marketing authorization from the U.S. Food and Drug Administration.

    Vapor Voice’s first print edition followed Altria’s announcement to launch its MarkTen e-cigarette nationwide. Altria also purchased Green Smoke for $110 million in cash and up to $20 million in incentive payments. Both the MarkTen and Green Smoke products are no longer on the market. Later that year, Greg Conley started the American Vaping Association, a nonprofit vapor industry advocacy organization that has now become part of the American Vapor Manufacturers Association, and the Oxford English Dictionary voted “vape” as the word of the year. Philip Morris International also launched its heated-tobacco product, IQOS, in Milan, Italy, and Nagoya, Japan.

    In 2014, the U.S. Food and Drug Administration also released its proposed rule for extending its authority to all tobacco products, including e-cigarettes, cigars, hookah and pipe tobacco (“the deeming rule”). The new regulations for electronic nicotine-delivery system (ENDS) products were finalized in 2016. The final deeming regulations were officially published on May 10, 2016, and became effective 90 days later on Aug. 8, 2016.

    The deeming rule changed the vaping industry. Many would say it nearly decimated it. The FDA’s channels for manufacturers and retailers to gain permission to sell their products threatened to put them out of business. According to the Brooklyn Law Review in a 2017 paper, “Through the far-reaching ‘Deeming Rule,’ e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market.”

    The Juul Experience

    Credit: Insurance Journal

    In 2015, we had our first introduction to Juul Labs. During a tobacco industry event in New York, Brian Haynes, with Troutman Pepper, and myself were shown a Juul device by Gal Cohen, Juul Labs’ head of Scientific and Regulatory Affairs. We snuck off into the back corner of a bar together, and he let us both take a few puffs. He wouldn’t let us have one. It blew our minds. We knew then that it was potentially an industry-altering product.

    Juul altered the industry too. Its impact could be summed up as “the good, the bad and the ugly.” The good was that Juul was a technological marvel at the time. The Juul device helped smokers switch to vaping faster than any product before it. Sales began to soar. Juul was the catalyst for the rapid growth of the vaping industry from 2016 to 2019.

    In 2017, Kevin Burns joined Juul Labs as CEO about two years after the company launched Juul. Juul was estimated to make up about 40 percent of the e-cigarette industry at that time. Then, in December 2018, Altria Group invested $12.8 billion in Juul Labs, acquiring a 35 percent interest and valuing the company at $38 billion. Altria claimed Juul Labs would remain a fully independent company.

    Soon after Altria’s investment, Juul Labs began to decline. The company and its advertising practices came under fire. The FDA accused Juul of creating a vaping “epidemic” by hooking youth on vapes, and Burns even went as far as to say he would apologize to parents whose “children were addicted to the company’s products” as concern grew around the teen vaping epidemic.

    There was also the great EVALI scare. The outbreak of “e-cigarette or vaping product use-associated lung injury,” to use the outbreak’s official but misleading name, started in 2019 and was caused by illegal, unregulated cannabis vaping products laced with vitamin E acetate. The U.S. Centers for Disease Control and Prevention, however, wrongly blamed nicotine vaping products. This episode, too, almost ended the e-cigarette industry.

    EVALI and the youth “epidemic” became too much of a burden for Juul Labs. Burns resigned as CEO of the company in September 2019. K.C. Crosthwaite, who was serving as the chief growth officer for Altria, was named his successor. In October 2019, Juul Labs announced it would be laying off about 500 employees by the end of the year. Several Juul Labs executives also moved on from the troubled company that year.

    Stung by Juul’s disappointing performance, Altria announced in October 2019 that it was reducing the value of its investment in Juul by $4.5 billion. In January 2020, the FDA issued a policy prioritizing enforcement against unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. However, the flavor restriction didn’t apply to disposable e-cigarettes. “Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions,” the agency stated.

    Juul subsequently pulled all its flavored pods from the U.S. market except for tobacco and menthol. The impact of the FDA’s rule was devastating for the pod-based Juul and all other pod-based vaping systems. By October 2020, Altria further reduced Juul’s valuation to approximately $10 billion. By March 2021, the valuation was cut to $4.3 billion; by March 2022, it was reduced to $1.6 billion. In July 2022, the valuation of Juul Labs was further cut down to $450 million, which was only 3.5 percent of its original value.

    The fall of Juul may go on to be one of the most significant corporate collapses of this century. Coupled with the FDA’s nonenforcement policy of flavored disposable vaping products, Juul Labs’ downfall caused substantial changes in the vaping industry. No longer were pod systems a dominant force. Instead, sales of disposable vaping products exploded.

    Disposables are King

    Njoy ACE

    The vapor industry has grown dramatically since Vapor Voice started publishing. In 2014, the vaping industry was worth an estimated $7.2 billion, according to Statista. In 2023, its value had grown to more than $23 billion. The global vaping industry is expected to reach more than $26 billion by 2028. The disposable e-cigarette market size was valued at $5.7 billion in 2021 and is poised to grow from $6.8 billion in 2022 to $14.8 billion by 2030, according to SkyQuest Technology.

    While favored by consumers, disposable products present their own issues for the industry. It started with the rise of Puff Bar, which entered the U.S. market in 2019. At the time, it was owned by Cool Clouds Distribution of California. Cool Clouds sold Puff Bar to the brand’s Chinese manufacturer, DS Technology Licensing, in early 2020.

    During the summer of 2020, the FDA instructed Puff Bar to stop selling its products. This decision was made because Puff Bar became a popular alternative to Juul after the latter discontinued some of its flavored products. Critics accused Puff Bar of targeting young people. In February 2021, Puff Bar resumed sales with a new design and synthetic nicotine, which, at the time, was not regulated by the FDA. Most disposable makers followed the same playbook. In 2020, U.S. lawmakers asked the FDA to force Puff Bar off the market.

    Puff Bar sales began to decline; however, it wasn’t long before another disposable brand, Elf Bar, took over the market. Founded in 2007, iMiracle Shenzhen Technology was originally an e-commerce firm. In 2018, the company switched to disposable e-cigarettes and launched the Elf Bar brand with synthetic nicotine. In 2022, the FDA said it needed Congress to act to bring synthetic nicotine under its purview.

    Congress closed the loophole last year. Under the new rules, companies were supposed to remove their flavored synthetic vapes from the market and file premarket tobacco product applications with the FDA. New products continued to be launched anyway. Puff Bar and Elf Bar began introducing products under different brand names, and thousands of other manufacturers followed suit.

    This is where the industry stands today. Disposables dominate the market while pod systems continue to trail far behind. However, the FDA has tried to clamp down on the growth of illegal disposables. The agency has issued over 550 warning letters and more than 100 civil money penalty actions to retailers for selling unauthorized e-cigarettes.

    Primarily, the regulatory agency’s actions have proved ineffective. Few retailers responded to the FDA’s actions. This has forced many states to step in. Due to the federal agency’s inability to control illegal flavored products, many state legislatures have introduced premarket tobacco product application (PMTA) registry bills. These bills require retailers only to sell products on a state list filled with products authorized by the FDA (of which there are only 23) and products with a PMTA under review by the regulatory agency. The Consumer Advocates for Smoke-Free Alternatives Association (CASAA) has issued calls to action for several registry bills. Vaping companies are also being sued for selling flavored disposables without authorization.

    Credit: Postmodern Studio

    Altria and BAT subsidiary R.J. Reynolds (the maker of Vuse vaping products) have taken legal action to kill their vape competition. Last October, Altria subsidiary Njoy filed a lawsuit in a federal district court against dozens of manufacturers, distributors and retailers of disposable vapes, including the Breeze, Elf Bar, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar brands. Njoy asked the court to bar imports by the companies and said it would “consider further litigation activity.”

    In January, a U.S. District Court in California dismissed the lawsuit against many of the disposable vape manufacturers, distributors and retailers. The court found that the defendants did not participate in “the same transaction, occurrence or series of transactions or occurrences,” and therefore were improperly joined in the lawsuit. However, the case against iMiracle, the manufacturer of Elf Bar, has not been dismissed. The case is still pending.

    The environmental impact of disposables is also a growing issue. Many companies are moving away from these products as more countries and U.S. states seek to ban them. Martin Miller, Chief Commercial Officer for Plxsur, a company that recently reached $1 billion in consolidated revenues, (see “Keeping Pace,” pg. 18) said safeguarding the environment and delivering safe and innovative products are core to the company’s sustainability agenda.

    “We have worked closely with our partner companies to put in place commercial strategies to migrate consumers away from disposables. Our Italian business, Puff [no relation to Puff Bar], has already successfully migrated many of its consumers using disposables to pod and open devices,” he said. “These alternative products have already outperformed legacy single-use vapes by volume. Adding to this, migration away from disposables is present across our entire group, with Ireland-based Hale having already launched a new pod system and others with an ever-growing portfolio of owned and third-party pod systems.”

    The e-cigarette industry is still growing rapidly. The Federal Trade Commission issued its third report on e-cigarette sales and advertising nationwide in April. The report found that combined sales of cartridge-based and disposable e-cigarette products to U.S. consumers by nine leading manufacturers increased by approximately $370 million between 2020 and 2021. The total topped $2.67 billion. E-cigarette companies spent $90.6 million more advertising and promoting their products in 2021 than in 2020.

    Reported sales of cartridge products increased from $2.133 billion in 2020 to $2.496 billion in 2021; sales of disposable, non-refillable e-cigarette products increased from $261.9 million in 2020 to $267.1 million in 2021. As technology improves and new products come to market, vaping products will continue to save the lives of many combustible tobacco smokers. That’s one thing that isn’t going to change any time soon.

  • Island Alternatives

    Island Alternatives

    Credit: Solarisys

    Vaping on the island of Sint Maarten is slowly starting to make a dent in combustible cigarettes sales.

    By Timothy S. Donahue

    One in five people smoke combustible cigarettes on the island. There isn’t any wonder why. A carton of the leading super premium brand American Spirits retails for $25. There isn’t much incentive to switch to vaping products when a 3,000-puff disposable vape costs $20 or more. The island of Sint Maarten/Saint Martin (SXM) is duty-free, so traditional tobacco products are cheap. Vaping products, however, can be expensive and limited in choice depending on where you look.

    There are no smoking regulations on Sint Maarten (the Dutch side of the island). However, in Saint Martin (the French side of the island), the rules for smoking are the same as in France. You can smoke or vape pretty much anywhere, though. Research indicates just 1.4 percent of Dutch adults regularly use an e-cigarette, but one in five adults still smokes tobacco. No statistics could be found for the French side.

    Legislation has recently been proposed to ban smoking in all restaurants, bars and casinos; however, smoking is currently allowed inside bars and restaurants in Sint Maarten. Many restaurants do not accept cigar or hookah smoking. Many bars, such as the popular Red Piano in Simpson Bay, encourage the use of e-cigarettes. “You can smoke cigarettes inside. We tried to stop that, but it didn’t work out,” an employee said. “Vaping is strongly encouraged in the smoking section as it is less disturbing for other patrons, staff and entertainers.”

    Kyla Peters (credit: Timothy S. Donahue)

    France’s National Assembly recently unanimously approved a bill to ban disposable e-cigarettes. If that becomes law, and the French side of SXM also bans those products, prices will rise further on the more tourist-heavy Dutch side of the island. Likely, shops on the French side would just keep selling them, however, even if disposables were to be banned technically, according to locals.

    The vaping market is growing in SXM, even with the challenges of cheap combustibles. Kyla Peters, with Don Caribe Souvenirs in Philipsburg, said that many locals are switching to vaping products, but the tourist shops aren’t where they buy them. Residents go to “Chinese grocery stores” (as locals call them) because the products are less expensive and good quality. There have also been a few vape shops that have opened on the island.

    “There are some things locals just won’t buy in the tourism-heavy areas on the island, and vapes are one of those things,” explains Peters. “The difference between buying an Elf Bar, for example, can be $5—or even more than that—less expensive when you start moving further inland.”

    Peters said Elf Bar is the most popular brand that she sells. It is also one of the most popular brands across the island. The most popular flavors are fruit and mint. She also said that the main reason for the higher costs of vaping products on the island is often the cost of shipping. It’s expensive to ship goods to small Caribbean islands. However, that cost is balanced out by the island being duty-free.

    “We don’t have tobacco taxes; there are no customs duties, VAT or other indirect taxes to pay. That is why cigarettes are so cheap. We sell a lot more cigarettes on the island than vapes, but vapes are a growing market,” Peters said. “There are a limited number of vape shops on the island; they are mostly ‘smoke shops’ that sell all types of nicotine products. As the popularity of vaping grows, I do believe the consumer cost of vaping products will come down, and locals, especially, will start to vape more.”

    Stephanne Martin

    Buying vapes at a vape shop is a better alternative than a souvenir shop by a cruise ship port. In February, the Purple Fox Smoke Shop opened in Simpson Bay. The owner, Stephanny Marlin, said that business has been growing steadily. “It’s been great, honestly,” she said. “I would say it’s a mix of both; it’s 50/50, locals and tourists.” She noted that disposables were the most popular items, followed by e-liquids. “We also sell pod systems, but they are not as popular as the other products.”

    The Purple Fox, however, offers a 9,000-puff disposable for $24. That would bring the cost of vaping below even the super low price of combustibles on the island (on a per-puff basis). A former smoker herself, Marlin said many former smokers switched because vapes don’t stink like cigarettes and the cost of vaping has become more reasonable.

    “I quit smoking a while back. But if you buy a pack of cigarettes, maybe it’s $3, $4, and you get, what, 20 cigarettes. But when you’re buying a vape, for example, the ones that I sell, which is 9,000 puffs for $24, you’re getting way more value for your money,” Marlin explains. “So, it’s worth the price. I haven’t had anybody complain about the pricing.”

    The island will likely continue to be a haven for combustible tobacco products. Lawmakers are attempting to enact flavor bans for vaping products, and youth uptake is a concern for the island. However, for an island with such a large number of combustible smokers, the harm reduction potential of vaping on the small island is huge.

  • Playing Whack-a-Mole

    Playing Whack-a-Mole

    Credit: Roman

    The CTP’s inability to apply its enforcement priorities often leaves state regulators and businesses baffled.

    By Rich Hill

    The recent onslaught of vapor registry bills in the United States is creating a lot of anxiety. Proposed registries have brought tension to public hearings and drama on social media. Unfortunately, like most current domestic issues, neither side appears to appreciate the perspective of the other. While only a handful of states have enacted product registries, many legislatures have considered and/or are considering such legislation. Understanding what these registries do, why they are promoted and their consequences is essential for all sides of this debate.

    Rationale for Developing Vapor Product Registries

    At present, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has granted marketing authorization for only a handful of tobacco-flavored vapor products and insists that all other vapor products are illegal. That said, the CTP has communicated its enforcement priorities related to deemed products numerous times. More specifically, the CTP has indicated its intention to prioritize enforcement efforts concerning certain deemed tobacco products (1) not covered by timely filed premarket tobacco product applications (PMTAs), (2) that have been the subject of marketing denial orders or those covered by PMTAs subject to negative determinations, including those rejected on procedural grounds (i.e., refuse-to-accept or refuse-to-file letters), and (3) that raise youth-use concerns.

    Unfortunately, the CTP’s inability to apply these enforcement priorities consistently to the ever-changing and large number of unscrupulous manufacturers often leaves state regulators and businesses baffled about which products are at increased risk of enforcement action.

    In short, this circumstance, with thousands of products remaining the subject of pending PMTAs that fall outside of the scope of the CTP’s enforcement priorities being sold alongside thousands of noncompliant flavored disposable vapor products, many of which fall within the scope of the FDA’s enforcement priorities, creates confusion in the marketplace and for state product regulators. Given the shortfalls in enforcement against vapor products that are not the subject of still-pending PMTAs, state tobacco regulators need a mechanism by which to determine which products should and should not be sold in their states—hence the value of vapor product registries.

    Rich Hill

    How Do Vapor Product Registry Bills Work?

    Vapor product registry bills establish registries requiring companies to submit evidence demonstrating that products that have FDA marketing granted orders are the subject of pending PMTAs filed by specified dates related to PMTA deadlines or are the subject of administrative or judicial reviews. For example, registration in Louisiana requires manufacturers to attest to the marketing granted or still-pending PMTA status of each product and pay a registration fee. Then these products will be placed on a public-facing registry.

    Positive Aspects of Product Registry Bills

    Regardless of one’s position on registry bills, the legislation at least has the potential to create positive change. By way of example, registry bills can:

    • Provide objective criteria. Vapor product registries can theoretically provide objective criteria upon which wholesalers and retailers can rely in making purchasing decisions. While there will be fewer products available, these products may be purchased without the threat of state regulatory enforcement.
    • Supplement CTP enforcement resources. The CTP has limited enforcement resources. While flavored disposable vapor products have been a high enforcement priority for the center, these products still proliferate the retail space. Vapor registries could aid in making up for the CTP’s enforcement limitations.
    • Target youth-friendly products. The 2023 National Youth Tobacco Survey reported that certain flavored disposable vapor products make up the majority of products used by youth. Registries may help in clearing the market of these products that lack pending PMTAs and are the most popular among youth.
    • Generate Revenue. Of course, registries also provide another revenue stream for state governments. With registration fees for each product, the amounts are not insignificant.

    Consequences of Vapor Product Registries

    All legislation and policy decisions invariably come with costs. Vapor product registries are no different. Some examples include:

    • Inhibit harm reduction efforts. Vapor products are harm reduction tools that benefit adult cigarette smokers seeking to quit or reduce their combustible cigarette use. Prohibiting access to such products prohibits access to the tools necessary to reduce combustible cigarette-related mortality and morbidity.
    • May not slow bad actors. Bad actors will continue to be bad actors. If a company violates the rules now, there is little reason to believe that a vapor product registry will prevent such actions.
    • Burden state resources. States are continuing to be required to do more without increased resources. In many instances, state tobacco regulatory enforcement agencies may simply lack the resources to effectively enforce registry requirements.
    • Innovation outpaces regulation. As the industry has observed before, evolution in the space moves more quickly than the regulatory arms can keep up. Innovative products falling outside of the scope of existing regulatory structures undoubtedly will winnow the effectiveness of product registries in the future. Indeed, most recently, innovations such as nicotine analog products are not covered by most registry bills.
    • Prohibitive scope can be too broad. In several instances, products not within the scope of the problem are swept into the “solution.” In a number of cases, modern oral nicotine products—products that sit at the lowest levels of the continuum of risk—are included in these product registry bills, which continues to undercut harm reduction efforts.

    Final Thoughts

    The problems that created the need for product registry legislation will continue. Until federal regulators embrace a harm reduction agenda and provide adult smokers, who will not or cannot quit, the products that have been demonstrated to assist their transition away from combustible cigarettes, the marketplace, whether legitimate or not, will respond by making them available. Vapor product registries, in and of themselves, will not solve the problems in isolation. The policies driving the need for such registries, ineffectual prohibitionist policies, need attention as well. Until the collective vapor product space, including manufacturers, retailers and consumers, aggressively advocates for policy change, new laws and regulations further limiting the ability to serve adult consumers are likely to evolve.

    Richard Hill is senior director of E-Alternative Solutions.

  • The Highs and Lows

    The Highs and Lows

    John Dunne

    The U.K. has been held up as providing the “gold standard” in proportionate vape regulation.

    By John Dunne

    It is astonishing how much ground the vaping industry has covered since Vapor Voice launched in 2014. Back then, the nascent vape industry offered a tantalizing alternative for smokers looking to quit smoking. Cig-a-like devices were the order of the day, but they often leaked, had a limited range of flavors and were rather underpowered. The main thing is that they were not cigarettes and provided a smoking alternative that really worked. It was unclear how e-cigarettes would evolve, but while many dismissed this as a passing fad, budding vaping entrepreneurs were already working on business plans.

    What was clear from the beginning was that a passionate fanbase of devotees emerged, and they spread the word about this new smoking alternative far and wide with evangelical passion. The relatively unsatisfying flavors from these earliest devices turned out to be a massive boon for the fledgling industry as fans made their own e-liquid with readily available ingredients, resulting in an explosion of new flavors being tested on friends and family members.

    These humble beginnings led to the industry that exists today. Many international brands started with someone experimenting with different flavor combinations created in their kitchens or garden sheds, only to discover that they had stumbled upon a product with enormous commercial potential. Technological advances led to more powerful batteries, larger tanks and more efficient heating systems, which excited the growing army of fans.

    The Vaper Expo U.K.—now one of Europe’s most essential vape events—came to the U.K. in May 2015 and saw thousands of vape fans queueing for hours to be among the first into the arena. The interest in vaping was astonishing, and things began to move very quickly. Former smokers morphed into passionate advocates for this new technology. Expos featured spinoff cloud-chasing contests and performances from talented individuals who found they could make a living by producing intricate patterns from exhaled vapor clouds.

    Specialist vape shops sprung up to meet the demand of former smokers and hobbyist vapers while flavor names from these early days were often exotic and fantastical. Names like “Beach Bum,” “Eye of the Tiger,” “Flaming Hot Tamale,” “Dragon’s Crown,” “Vamp Toes” and “German Chocolate Beefcake” dominated.

    E-liquid came in glass bottles of various colors with pipette droppers, and branding often featured the most complex and colorful designs, which would not have looked out of place in a modern art graduate’s portfolio. Many early adopters abandoned their careers to invest their life savings in producing their own e-liquids. As vaping became more popular and moved from niche to mainstream, politicians took notice, and regulation changed everything.

    The European Union updated its 2001 Tobacco Products Directive to include e-cigarettes in 2014 and, after a two-year grace period, the U.K. began enforcing regulations covering product safety, vapor emissions testing and new limits on tank and bottle sizes and nicotine strength. This saw the demise of many hobbyist e-liquid creators who had supplemented their incomes with home-grown e-liquids they sold locally or online, but it also paved the way for the serious players to grow and flourish.

    The U.K. Vaping Industry Association (UKVIA) was formed in 2016 to “support, develop and promote” the vape industry and promote the public health benefits of this reduced-risk alternative to smoking. It was immediately clear that there was a lot of opposition to overcome.

    Just like we have seen in the U.S., the mainstream media in the U.K. found it could generate huge numbers of clicks and views by stirring up a new moral panic around vaping. Scare stories misrepresented already dubious scientific research, and baseless articles linking vaping with cancer, lung disease and heart disease flourished. The press demonized a product that was allowing smokers to quit and quietly ignored the enormous death toll caused by cigarettes.

    I have never been in more demand from national TV, radio and newspapers to speak about vaping. Media interviews can range from productive to utterly frustrating. Some presenters want me on their shows just to shout at me, and others have their minds made up and refuse to listen to reason, but some want a balanced discussion about vaping and its role in harm reduction.

    Emotive subjects, such as environmental concerns and youth access, are staple interview topics, and I am happy to get up at the crack of dawn for the first segment of the morning TV breakfast show or appear live in the studio for a late-night current affairs debate to promote the benefits of the vaping industry.

    The U.K. has been held up as providing the “gold standard” in proportionate vape regulation for the rest of the world to follow. Although not perfect, our regulations have generally offered the right level of public protection while allowing the industry to flourish by offering adult smokers a far less harmful alternative to cigarettes.

    In recent years, that has started to change, with the U.K. poised to ban disposable devices next year on the grounds of environmental and youth access concerns. These concerns are important, but there are better ways to tackle youth vaping. For four years, we have been calling for the government to introduce a vape retail licensing scheme, similar to the way alcohol is licensed, with fines of up to £10,000 ($12,453) per instance for those who sell illegal products or sell to anyone underage. This scheme would fund a national enforcement campaign backed by regular inspections and test purchasing to ensure retailers comply with the law or face losing their license and their ability to trade.

    Vape Club, one of our UKVIA members, has already drafted the framework for such a scheme, yet the government insists it has no plans to introduce such a system. Back in 2016, I could hardly have imagined a future where the vape industry would be proposing more robust and more effective legislation to a government that seems unable or unwilling to do so, yet that is exactly how things turned out.

    We currently have proposed legislation making its way through Parliament that would give the government unprecedented new powers to restrict flavors, point-of-sale displays and packaging. The government accepts that bringing in new restrictions could cause current vapers to resume smoking but, astonishingly, has not conducted a risk assessment to determine the health harms this may bring.

    The evolution of the vape industry in the past decade has brought many challenges and has been far from smooth. The industry started with disposable devices, moved to refillable tank systems, witnessed a recent renaissance in disposables and is moving back to refillable tank systems once again. E-liquid flavors, absolutely vital to help adult smokers quit, will continue to evolve to meet changing consumer demand, but I can’t see a return to the days of “Flaming Hot Tamale,” “Dragon’s Crown” and “Vamp Toes” flavors—and that is not a bad thing.

    We have achieved so much in a decade, and I am convinced we can eventually win over a skeptical media. Until that happens, I will patiently explain why vaping does not cause popcorn lung and how nicotine does not cause cancer.

    I am also heartened to see just how far the vaping industry has come in one decade, and I am intrigued to see what incredible advances will occur between now and 2034.

    John Dunne is the director general of the U.K. Vaping Industry Association.

  • Closing the Space

    Closing the Space

    Cape Town, South Africa (Credit: Deyan)

    At the current rate, tobacco harm reduction is likely to remain a fantasy in South Africa.

    By Asanda Gcoyi

    Like other countries around the world, South Africans have taken to vaping in great numbers over the past 10 years. What started as a small community of smokers seeking out less harmful alternatives to cigarettes has now morphed into a massive industry that is growing in leaps and bounds.

    Since 2013, vaping devices in South Africa have become a ubiquitous sight, with many a smoker giving up their deadly habit in favor of vaping. For the past decade, vaping has remained outside the regulatory net while tobacco has been regulated through the Tobacco Products Control Act, 83, 1993. While hailed in its initial days, the act has failed to reduce South Africa’s smoking rates successfully.

    This is reflected in recent statistics, which show that South Africa’s smoking rate has increased from about 18 percent in 2018 to over 25 percent in 2022. This is a result of lax law enforcement and the proliferation of cheap illicit tobacco products that are reported to account for over 60 percent of the South African smoked tobacco market.

    For a time, harm reduction advocates were hopeful that vaping would make a significant contribution toward reducing smoking in the country. There was even a faint hope that regulators would embrace the vaping industry in the spirit of reducing the harm that smokers are exposed to and hopefully also reduce the external costs of smoking, which are borne mainly by the poorly performing public health system.

    Not so. Over the past two years, the South African government has succumbed to pressure from the anti-smoking lobby, which relies on misinformation and disinformation to discredit tobacco harm reduction. In part, the antipathy toward vaping has arisen out of fears that young people were taking up vaping in droves.

    Except, there is minimal evidence for this contention. The research that has been done is limited in scope and reach, and its conclusions cannot be generalized to the rest of the South African youth. No doubt, young people are curious and are trying out vaping. However, there is no evidence that large numbers are regular vapers or that they are progressing to smoking cigarettes, as has been claimed by those in favor of strict regulations of vaping.

    Asanda Gcoyi

    What is beyond any doubt is that a significant number of young people are smokers due to the accessibility and low prices of illicit tobacco. In its rush to be seen to be doing something about the manufactured crisis of youth vaping, the government has embarked on two processes: the introduction of a vaping tax and the amendment of the country’s tobacco control laws to include vaping.

    After a two-year public consultation charade, the government started levying an excise duty on vaping liquids on June 1, 2023. This immediately made refillable vapes unaffordable for your average vaper, as the price of a 100 mL bottle more than doubled overnight. At ZAR2.90 ($0.16) per milliliter, South Africa’s rate is on the steep side and has made smoking more attractive from a price point of view.

    Perversely, the excise duty has made disposable vapes much cheaper than refillable vapes. Up to the introduction of the tax, refillable vapes had been the preferred choice for smokers who were using vaping as a harm-reduced alternative to smoking. Common wisdom has it that disposable vapes are the most preferred option for young adults and teenagers.

    In introducing the steep rate, the government has failed to deter the people who should not vape from doing so while forcing many former smokers and dual users to vape higher nicotine disposables and revert to smoking due to price.

    Parallel to the tax’s introduction, Parliament has been processing the Tobacco Products and Electronic Delivery Systems Control Bill, which was introduced in December 2022. This anti-harm reduction draft law dismisses the possibility that vaping is less harmful than smoking and that there should be a differentiation in law between how the two are treated.

    It conflates vaping and smoking and extends draconian regulations to vaping, some of which will virtually wipe out any communication about vaping as a harm-reduced alternative to smoking. In the process, it will confirm smoking’s importance as the only viable form of nicotine delivery for the millions of nicotine addicts who do not know enough about vaping or believe the disinformation that vaping is as harmful, if not more so, than smoking.

    Supported by Bloomberg Foundation-funded organizations, the bill is a clear demonstration of the deep-seated disdain that the South African government has for the smoking public. In countless public hearings, the ruling party and its fellow travelers in the anti-tobacco campaign loudly proclaimed their contrived belief that harm reduction is a ruse.

    They have used every opportunity to talk up the dangers of youth vaping while completely ignoring the plight of the more than 10 million smokers in South Africa. In their telling, smokers should just quit because vaping is as bad, if not worse, than smoking. In one hearing, they were even proud to display a poster showing the diseased body of a vaper, science notwithstanding.

    While there is always a chance that the new government to be elected on May 29 will revisit the draft Bill submitted to Parliament, there is little hope among tobacco harm reduction experts of any change in direction. It has become clear that the South African government has lost its ability to make public health policy guided by its unique circumstances. It is content to defer to the ideological prescripts of the World Health Organization and the Framework Convention on Tobacco Control, even when it clearly goes against its own interests as a country.

    This is a disheartening and anti-democratic exercise in policy capture, which, left unchecked, will prejudice South African smokers by foreclosing the possibility of switching to less harmful alternatives. At the current rate, tobacco harm reduction is likely to remain a pipe dream rather than a reality.

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

  • Significant Shifts

    Significant Shifts

    Credit: Nightman

    The vaping industry continues to overcome regulatory challenges and false narratives.

    By Greg Conley

    Over the past decade, Vapor Voice has closely tracked the vaping industry’s turbulent evolution from niche interest to a subject of global attention. These years have been marked by significant shifts due to technological advancements, evolving regulatory landscapes and changing public health views. As a longtime advocate for safer nicotine alternatives, I’ve observed the industry’s struggle for legitimacy and its ongoing battle against misinformation.

    In the early days of the vapor industry, doubts and skepticism were rampant. I had a memorable encounter in 2011 at a conference filled with tobacco industry executives. There, an executive remarked to me, “Enjoy this while it lasts. You’ve got about a year left before the U.S. Food and Drug Administration crushes you.” There was no malice or ill will in his voice but rather a resigned acknowledgement of the regulatory hurdles that lay ahead, courtesy of the FDA’s Center for Tobacco Products (CTP) and the 2009 Family Smoking Prevention and Tobacco Control Act. This insight foretold the imminent regulatory challenges we were about to face.

    Greg Conley

    Initially, certain industry players were confident in their ability to satisfy CTP requirements. Despite the plain text of the Tobacco Control Act, some manufacturers still believed that the CTP would not outright reject flavored products. A stark reality check was dealt when the CTP’s original deeming proposal was leaked online in 2015. Had the Office of Management and Budget at former President Barack Obama’s White House not intervened to object to a provision that would have immediately pulled flavored products from the market, the industry could be radically different today.

    The appointment of Scott Gottlieb as FDA commissioner during former President Donald Trump’s administration was initially met with cheers. This ignited industry hopes for a science-based approach to the impending deadlines for submitting premarket tobacco product applications (PMTAs). Yet, Juul’s skyrocketing popularity and the associated increase in youth vaping quickly became a major point of contention, halting any progress toward streamlining the PMTA process.

    A profound nadir of the last decade was undoubtedly the summer 2019 e-cigarette or vaping product use-associated lung injury (EVALI) crisis. Even as the evidence grew linking the illnesses and deaths to illicit THC products, the legal nicotine vaping industry was unjustly blamed and the subject of sensationalist media coverage. Worse still, several of the nation’s top health officials spearheaded efforts to cloud the true cause of EVALI.

    Notably, one health official who played a central role in the U.S. Centers for Disease Control and Prevention’s mishandling of the EVALI situation now holds a significant role in shaping the future of vaping—Brian King, who heads the CTP. It is deeply ironic that King, who helped add fuel to the fire that caused a remarkable decline in public perception of nicotine vaping, now oversees the CTP’s purported efforts to rectify misconceptions about smoke-free nicotine products.

    As the industry emerged from the doldrums of the EVALI crisis, it faced the longstanding regulatory challenges that advocates had been cautioning about for years. Following numerous delays, the submission deadline for PMTAs for tobacco-derived nicotine vaping products finally arrived in September 2020. Amid the global focus on Covid-19 and the impending presidential election, the media was uninterested in stories about small business concerns with the CTP’s flawed system.

    September 2020 was not an easy month for CTP employees. When it proposed the deeming regulation, the CTP predicted that it would receive fewer than 3,000 PMTAs. However, the vapor industry firmly stood its ground. Through an effort spearheaded by the founding members of the American Vapor Manufacturers Association, over 200 manufacturers inundated the CTP with several million PMTAs.

    As anticipated, chaos ensued. The FDA’s system was completely overwhelmed. The agency was at a loss on how to proceed with the PMTAs. The indecision ended after an April 2021 legislative hearing, during which FDA Acting Commissioner Janet Woodcock was harangued by House Democrats who wanted to see all PMTAs for flavored vaping products immediately denied. She returned to the FDA and mandated that the CTP create a new system to expedite the denial of the backlog of vapor product PMTAs.

    The FDA’s infamous “fatal flaw” memo resulted in the banning of millions of nicotine vaping products. These bans were not based on any direct public health risk posed by the products. Rather, they were implemented because, well, after the PMTA submission deadline had passed, the FDA decided it would not review PMTAs for flavored vaping products without a specific clinical trial or longitudinal study. As a result of ongoing litigation, which could potentially reach the Supreme Court in the next year, many of the PMTAs submitted in 2020 are still pending resolution.

    As a testament to the industry’s dynamic nature, the products caught up in court fights have fallen out of favor with adult consumers. Since 2020, the explosion in popularity of flavored disposable vapes, fueled by ambiguous regulations and enforcement regarding synthetic nicotine, has significantly reshaped the industry. This shift has happened amid steep declines in youth usage and steady increases in adult usage.

    The ongoing legislative and legal battles surrounding disposable vaping products signal the onset of a struggle that will likely shape the next decade of vaping. Approximately 10 million adults in the U.S. use flavored disposables, with a significant portion turning to these products as a complete replacement for combustible tobacco products. In our interconnected society and in a country growing more skeptical about government interference with the private choices of adults, preventing adults from accessing flavored vaping products will prove to be no simple feat.

    Looking back at the evolution of the vaping industry over the last decade, the road has been both rocky and rewarding. From regulatory challenges to breakthroughs in harm reduction, the narrative is rich with lessons learned and battles fought. Amid these uncertainties, one thing is clear: Our journey is far from over.

    Greg Conley is the director of legislative and external affairs for the American Vapor Manufacturers Association.