The vapor industry may finally be able to be optimistic about the future after 2023’s roller coaster ride.
By Chris Howard
In February of this year, Vapor Voice published my reflections on my past 11 years affiliated with the vapor industry. And while many would say that the vapor industry has been a roller coaster, I remain firm in my belief that a place for vapor products exists in a United States harm reduction strategy. That said, the way things are going at present, it could be years before we see this materialize.
At the end of yet another tumultuous year for the vapor industry and the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), now seems like a good time to review my perceptions from February. What have we seen in 2023? On the one hand, the CTP is clearly reacting to the Reagan-Udall Foundation (RUF) process.
The center is prioritizing stakeholder engagement with, for example, in-person visits between Director Brian King and companies throughout the industry and a recent public meeting on the premarket tobacco product application (PMTA) process. Cynics, on the other hand, would be quick to criticize the center, as flavored disposable vapor products appear virtually unrestricted in retail stores across the nation and the PMTA process remains stagnant. Moreover, the progression to more vapor marketing denial orders (menthol) and the promotion of more bans and prohibitions (flavors, cigars, menthol) are also troublesome.
With the above in mind, let’s reflect on what I wrote earlier this year (see “Head in the Clouds,” Vapor Voice, Issue 2, 2023) and discuss what lies ahead in 2024 and beyond.
Make a Long Story Short
In February, I wrote about suggestions from the RUF for the CTP to provide “more detailed summaries of applications that have made it through the process—so that industry can place emphasis on areas that the agency deems to be a higher priority and eliminate superfluous activities that ultimately add little value. Doing this and taking steps to simplify the requirements would ultimately enable both the industry and the CTP to employ a more focused approach, resulting in greater efficiency for all involved.”
The good news is that FDA leadership continues to signal this is a priority for the agency. Moreover, the FDA recently held a public meeting in which they provided additional insight regarding the PMTA process that many in the industry have been seeking. Unfortunately, thousands of PMTAs remain pending, and it is unclear how the FDA will handle this existing burden. Expectations remain high for 2024, and I am optimistic we will see progress soon.
You Get Out What You Put In
Reflecting on the difficulty of the PMTA process, I pointed out the exceptionally high standard the FDA has set for premarket review and that companies cannot take shortcuts and expect good results. We all recognize the standards set for tobacco-derived nicotine products are very high, and many applications fell short of even the minimum requirements.
Looking forward, we should expect this high standard to also be applied to PMTAs filed for nontobacco nicotine (NTN) products. The CTP will apply the same rigor when reviewing NTN products—likely with similar results. Industry cannot expect to file short shrift applications and receive market orders. Time, rigor and resources are required to be successful.
Don’t Hold Your Breath
Credit: Ezume Images
Recall that I suggested it would take the FDA considerable time to increase the efficiency of the PMTA approval process. This continues to be true. And now even more stakeholders are voicing this same concern. Most recently, the Health and Human Services Office of the Inspector General (OIG) published a report titled “The Food and Drug Administration Needs to Improve the Premarket Tobacco Application Review Process for Electronic Nicotine-Delivery Systems to Protect Public Health.”
The OIG audit, in part, focused on the CTP’s inability to review PMTAs within the statutory timeframes and contained a key recommendation “that CTP work with the Office of Personnel Management to obtain direct-hire authority to assist CTP in reaching its full-time equivalent personnel goal and assess the PMTA review process and develop an action plan to resolve the backlog of PMTA applications and achieve compliance with the 180-day statutory timeline.” Ultimately, the report offers yet another series of solutions to what appears to be insurmountable obstacles faced by the FDA.
On the flipside, as the CTP learns more and, hopefully, becomes more efficient in application review, we will most certainly begin to see a more consistent and reliable process. While nothing on the horizon suggests the evidence required to satisfy the “appropriate for the protection of public health” (APPH) standard will lessen, my hope is that we are approaching some level of predictability that will enable companies to refocus on innovation and invest in reduced-harm products.
Two Wrongs Don’t Make a Right
Credit: Jon Anders Wiken
In February, I suggested two wrongs were prevalent in the vapor space. One was the uptick of youth use of vapor products. The other was the sensationalized public health response prioritizing prohibition and often disregarding the opportunity lost by adult smokers seeking alternatives to cigarettes. While we certainly haven’t seen much movement from many in public health, we have seen progress when it comes to youth choices.
In 2019, the National Youth Tobacco Survey (NYTS) reported a shocking 20 percent past 30-day (high school and middle school combined) e-cigarette use. The 2019 report also indicated 27.5 percent of high school students and 10.5 percent of middle school students used e-cigarettes in the past 30 days. Fast-forward four short years and those numbers have decreased dramatically. In 2023, the NYTS reported significant reductions with 7.7 percent overall, 10 percent high school and 4.6 percent middle school past 30-day e-cigarette use. These results clearly indicate that tools like Tobacco 21, public education campaigns and parental engagement work to change youth behaviors.
And it’s worth noting that this reduction occurred despite the proliferation of the noncompliant flavored disposable e-cigarettes available throughout the nation. Unfortunately, instead of lauding success and working to make electronic nicotine-delivery systems more available to adult cigarette smokers, prohibition remains a priority for many, so we still have work to do to prioritize the benefits of reduced harm products for smokers.
When Life Gives You Lemons, Make Lemonade
Credit: Pontus
In February, I indicated, “smokers deserve our efforts to offer satisfying, reduced harm products ….” I still believe that a place for innovation exists in the vapor space. As technology develops and youth vaping numbers continue to decline, new opportunities are inevitable. Of course, the pitfalls associated with long lead time (and expensive) PMTA data development and even longer agency review processes still impede modernization of the category.
That said, the hope is that a better, more predictable, timely and stable review process will take hold. To effect this change, vapor advocates must continue to hold the CTP accountable for implementing reforms in line with RUF recommendations. To be clear, this is a total industry effort. By weeding out bad actors, promoting compliance and continuing to advocate for the lives of smokers, we can succeed in this effort.
I closed my article in February with the hope that I would look back at the end of 2023 to see that the CTP has evolved and used the RUF report to prioritize the continuum of risk and move harm reduction forward. Are we there yet? Unfortunately, no. But that said, I am optimistic that the worst is behind us. Vapor advocates are not giving up, and they don’t seem like they will throw in the towel anytime soon.
More and more smokers are quitting cigarettes with vapor products. And the FDA is gradually making changes to increase efficiency and effectiveness. Hopefully by this time next year, we will be in an even better place with the increased certainty we are seeking.
Chris Howard is executive vice president of new product compliance and external affairs for Swisher and former senior vice president, general counsel and chief compliance officer for E-Alternative Solutions.
Altria has declared war on the illicit disposable devices that are impacting its bottom line.
By Timothy S. Donahue
The illicit e-cigarette market is soaring. Illicit products are estimated to account for more than 60 percent of the $8.3 billion U.S. vaping industry. Statista expects the U.S. electronic nicotine-delivery system (ENDS) market to grow at a compound annual growth rate of 3.93 percent from 2023 to 2028. If the illicit market continues to go unchecked, however, companies that market legal vaping products fear many consumers will simply switch back to combustible products.
“It is very much worth noting that this rapid apparent substitution is happening in an environment where half the vapor market is illicit; the FDA [U.S Food and Drug Administration] has hugely hampered vaping products making it onto the legal market, and consumers are hugely misled on relative risks,” said David Sweanor, an adjunct law professor at the University of Ottawa and a longtime tobacco harm reduction advocate. “As with other markets seeing similarly historic drops in cigarette use as alternative sales soar, it raises the question of just how rapidly cigarette sales could fall if policies were aimed at facilitating that rather than doing things to stymie it.”
Altria, parent to Njoy, a leading brand of legal vaping products in the U.S., according to Nielsen, told investors during a recent conference call that the current state of the market is “intolerable” for both legitimate manufacturers and consumers. Altria CEO Billy Gifford said the regulated market is being overrun by illegal flavored disposable products manufactured and distributed by companies violating the rules and guidance laid out by the FDA. He said that regulation not enforced is indistinguishable from no regulation at all.
“Illegal e-vapor products circumvent the actions of regulators, responsible manufacturers and retailers by evading scientific review, quality manufacturing controls, marketing oversight and legal aids or purchase restrictions. Despite recent actions by the FDA, enforcement has been inadequate and ineffective,” explained Gifford. “We believe the FDA has good tools necessary to bring order to the market. For our part, we are actively engaged with regulators, state and federal lawmakers, and trade partners and other stakeholders to build awareness of these serious issues and drive marketplace enforcement.”
According to Gifford, the lack of enforcement has forced Altria to take a “targeted but necessary action.” The company filed a lawsuit in the District Court for the Central District of California against 34 organizations. Njoy alleges that the defendants are manufacturing, marketing, distributing, selling and/or marketing their flavored disposable ENDS unlawfully for three primary reasons:
They are not authorized pursuant to FDA marketing granted orders as part of the premarket tobacco product application process.
California bans the retail sale of flavored ENDS.
The defendants do not comply with the Prevent All Cigarette Trafficking Act’s delivery sale age verification, registration and filing, record keeping, tax payment and labeling requirements.
Altria is asking for the court to provide appropriate restitution for harm suffered by Njoy due to the defendants’ unfair competition.
“We want to protect harm reduction and the opportunity for the 30 million smokers in the U.S.,” said Gifford. “We really need to have enforcement where the smokers can make informed choices as they are moving across categories. I think that there’s an underlying positive is that we see adult smokers moving over, so they’re ready to have potentially reduced harm products. We just need them to be regulated and based on science to be in the marketplace.”
Sal Mancuso, Altria’s chief financial officer, said that traditional cigarette volumes continued to decline in the third quarter of 2023. He said that the decline is impacted by the number of illegal products on the market; however, because illicit products are largely distributed through nontraditional untracked channels, the company has had to refine its ability to estimate the illicit product impacts on the legal vaping industry.
“With the information we have today, we believe that there is more cross-category movement than previously assumed. And we now estimate that growth of illegal flavor[ed] disposable e-vapor products contributed to industry, cigarette industry declines in the range of 1.5 percent to 2.5 percent and over the last 12 months,” said Mancuso. “We will continue to monitor this dynamic trend and are actively pursuing better data sources to enhance our estimates in this space.”
“We believe the FDA has good tools necessary to bring order to the market.”
Amplifying Actions
Altria Group completed its acquisition of Njoy Holdings in May. In 2022, Njoy Holdings received marketing orders for its Njoy Ace device along with several tobacco-flavored pods. At the time of writing, Njoy Holdings had received six of the 23 marketing orders granted by the FDA for the entire vaping product category, including pods, disposables and open systems. The regulatory agency is still reviewing Njoy’s premarket tobacco product applications for several Njoy menthol-flavored e-vapor products.
Gifford said that the company executed Njoy’s business plans with “speed and focus,” adding that the goal is to grow the Njoy brand responsibly and sustainably. To set the foundation for success, Altria first strengthened Njoy’s supply chain. He said the company successfully solidified the entire Njoy supply chain from sourcing direct materials through the shipment to retail.
“As a result, we do not anticipate capacity constraints as we execute our initial expansion plan. Next, during the third quarter, our teams prioritized closing inventory gaps at retail and expanding distribution of ACE,” said Gifford. “Prior to the acquisition, Njoy had a small-scale sales force, which resulted in inventory volatility and significant distribution gaps at retail …. Upon completion of the Njoy transaction, we immediately unleashed our sales force to focus on closing the inventory gaps in stores that already had distribution. We improved inventory conditions in stores and are actively working to close remaining gaps at retail.”
Pamala Kaufman, a financial analyst with Morgan Stanley, asked Gifford if he believed Njoy could be successful and grow in a marketplace dominated by illegal products. Gifford said that the FDA still needs to get through its authorization process, and the agency’s actions will translate to the marketplace.
Since its acquisition by Altria, distribution grew to approximately 42,000 stores during the third quarter of 2023 for the Njoy Ace, the company’s flagship device. The product is now distributed in all the top 25 U.S. convenience store chains by vaping product volume, according to Gifford. The company has also started to amplify visibility with new point-of-sale and fixture signage at retail.
“During the fourth quarter, we continue to expect ACE expansion to reach a total of 70,000 stores by year end, representing approximately 70 percent of e-vapor volume and 55 percent of cigarette volume sold in the U.S. multi-outlet and convenience scanner,” said Gifford. “As we continue to expand distribution and close inventory gaps, we expect to further enhance visibility and product fixture space at retail.”
Last month, Njoy unveiled its first retail trade program. The program allows retail partners to sign up for the program at various levels with merchandising options designed to position Njoy “strategically and responsibly” to current combustible tobacco consumers while boosting the awareness of the Njoy brand. Gifford said the company is beginning to test various promotional plans and anticipates more disruptive execution at retail in the fourth quarter. Moving into 2024.
“We will continue to refine our promotional plans, implement Njoy’s retail trade program, further expand distribution and evolve our consumer engagement strategy. Our strategies will focus on informing adult vapors and smokers of the attributes of ACE, such as battery capacity and pod size, relative to other leading brands, generating trial and growing brand loyalty,” said Gifford. “In addition, plans for a new brand equity campaign are well underway. We expect the equity campaign to further amplify the brand’s presence at retail and drive consumer engagement.”
Jacob de Klerk, an analyst for Redburn Atlantic, asked Gifford what the impact would be on Njoy’s projected market growth if the FDA doesn’t approve any flavors other than tobacco. Would only allowing tobacco flavors create enough demand for Njoy to remain profitable? Gifford said he believes there is room, and he wouldn’t rule out the potential for an authorized menthol product.
“I wouldn’t rule out menthol. We feel good about the application—the current application in front of the FDA from a menthol standpoint. I think if you look at some of the recent marketing denial orders, it was related to ‘new following,’” he replied. “When we made the Njoy transaction, there was virtually no new following. As far as additional flavors are concerned, we’re excited and currently looking forward to being able to file [marketing applications] in the near future. We believe that [flavor] allows for adult consumers to have it as an offramp but not an on-ramp for underage users. So, we still see the potential for flavors.”
Tobacco harm reduction (THR) took center stage during this year’s GTNF conference in Seoul.
By VV staff
Nearly 300 delegates from around the world gathered in Seoul for the annual Global Tobacco and Nicotine Forum (GTNF) from Sept. 19 – 21. The delegates encompassed a variety of backgrounds including public health professionals, consumer advocates, financial analysts, and prominent regulators such as Brian King, the director of the Center for Tobacco Products at the U.S. Food and Drug Administration. This year’s theme was “Change the Conversation, Change the Outcome” which promoted the open exchange of information and ideas between public health experts, government representatives, the industry and investors.
Attendees of GTNF discussed several issues currently confronting the nicotine industry, with a special focus on lessening the harms brought on by tobacco use. Behind the success of the GTNF is a strong belief that deepening the conversation about tobacco, nicotine and public health can lead to more informed views and decisions by all stakeholders. Previous events took place in Washington DC (2022 and 2019), London (2018); New York (2017); Brussels (2016); Bologna (2015); West Virginia (2014); Cape Town (2013); Antwerp (2012); Bangalore (2010); and Rio de Janeiro (2008). The following stories are a small selection of the keynote speakers and panels presented during the GTNF 2023 event.
Keynote: Eve Wang, executive director of Smoore International and vice president of Shenzhen Smoore Technology Co.
The vaping industry is young at only 20 years old. However, Eve Wang, executive director of Smoore International and vice president of Smoore Technology, said the industry isn’t going to get much older if it doesn’t find a way to balance innovation and social responsibility. Wang should know. She has been in the industry for more than 17 years.
“We are at a very critical path for the vapor industry,” she said. The vapor industry has grown rapidly over the past 20 years, with large growth in the first 10 years followed by the past 10 years seeing more regulation in markets like the U.S., Europe and China as products have evolved to be more compact and portable, usability has improved with technology evolution, open systems have evolved to pod mods and disposables have grown in variability.
Wang cited Frost and Sullivan data from March of this year, which showed that as of last year, the vapor industry made up a $52 billion dollar market, nearly double what it was in 2018. “There is no doubt the market is fast growing with huge potential,” she said.
With large growth comes media attention, as Wang noted, highlighting headlines that called for bans and restrictions, overwhelmingly regarding disposables.
She then posed the question “What can we do for sustainable growth?” She broke this up into two categories that Smoore uses to address this issue: consumer experience and environmental impact, what she called “vaping efficiency.”
“Vaping is not perfect,” she said. “It’s far from being perfect. Yes, it’s new, it’s complex.”
To address this, Wang explained that Smoore looks at it as two major aspects—atomization efficiency and power efficiency, and each aspect has a different approach. Without going into minute detail, she described atomization efficiency as improving the utilization of e-liquid and power efficiency as increasing energy density and reducing battery size.
“Do we have answers to all the challenges?” she asked. “I’m afraid it’s too early to tell. And if I may be the real Eve, I would say, no, we don’t have the answers.” She urged the industry to keep innovating and for every player to take their responsibility seriously.
“As long as the conversation goes on, we are confident that together we can make the best outcome. It could be this year; it could be next year; it could be in the next five years.”
Keynote: Brian King, Director of the U.S. Food and Drug Administration’s Center for Tobacco Products
GTNF 2023
When Brian King speaks, people come to listen. The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) director’s keynote address was easily the most attended session of GTNF 2023. King’s speech served as an overview of the current state of the CTP and an outline of the center’s main priorities over the next few years.
King said that the CTP has made considerable progress in reducing combustible cigarette smoking in the United States, which he contends as one of the most remarkable public health achievements of the past century. He hopes that those declines continue, given that “we do know” that combustible smoking is responsible for the overwhelming burden of death from using combustible tobacco.
Tobacco use continues to cost the U.S. government a considerable amount of money—to the tune of $600 billion per year from both direct healthcare costs and lost productivity, according to King. He said there are important human health benefits as well as financial benefits for regulators to continue to focus on reducing combustible use in the United States. As a part of this focus, the CTP is continuing to make inroads when it comes to premarket tobacco production application review.
“As folks are aware, we do have a new director of our office of science who has jumped in headfirst to continue to fiercely lead our 550-plus scientists on application review …. We have processed 99 percent of those and continue to finalize the remaining 1 percent. I’m hopeful that in the coming months and years, we will get back to what was intended to be a premarket approval process,” said King. “In the meantime, we have authorized 23 e-cigarettes, all tobacco flavored. So, it is possible. We have had successful authorizations. But again, I can’t reinforce enough the importance of providing that sound and robust science to inform on potential authorization.
“And it is possible, as you can see. There will be more authorizations in the future, but it’s important that we have that science to support those decisions. As I noted earlier, we also continue to fold in the nontobacco nicotine work into our broader portfolio around regulation. We did receive a million applications, which I don’t think anyone anticipated. I will say that we are making great numbers. We are 99.9 percent through with the review of those. I will say that 100 percent is very imminent.”
King said that when it comes to products that are illegally on the market (having received a marketing authorization and are not currently under review by the CTP), the CTP is mindful of the importance in exercising all authorities that it has to ensure that people are complying with the law. He said that the FDA has given retailers the information they need to comply with the law through a list of authorized products (the 23 products that have been authorized for sale). The CTP also continues to ramp up efforts in terms of training, education and outreach across the supply chain, particularly to retailers.
“We also continue to do surveillance inspection investigations. This is something that occurs on a daily basis. We have arrangements with all 50 states and territories to continue to do investigations. We have issued many warning letters for flavored disposable e-cigarettes, which we know are particularly popular for youth,” said King. “There’s been a variety of blitzes that have occurred monthly throughout the summer. I will say there are more to come. We are going to continue to conduct those blitzes and making sure that we are routinely monitoring, particularly with a focus on those products that we know have high youth appeal.
“On balance, we are also continuing to do work around issuing import alerts. I was a little tickled by all the attention that the import alert on Elf Bar got. That’s nothing new, folks. We’ve been doing that for many years. It was suggested it was something seismographic, but we’ve been doing import alerts for quite some time. And we do use those as, again, another tool in our toolkit to make sure that we are addressing not only the products that are already in the country but preventing illegal products from entering the country.”
As of Sept. 31, the FDA has issued over 1,200 warning letters for online investigations. For manufacturers, the CTP has sent more than 800 warning letters, with more than 750 letters for e-cigarettes. Beginning earlier this year, the FDA also issued the first civil money penalties against manufacturers for violations for illegal e-cigarette sales. He said civil money penalties will remain a part of the CTP’s tools to combat illicit sales.
“We also issued the first six injunctions in coordination with the Department of Justice. I got a lot of flak for that as well about enlisting the Department of Justice. And I will remind folks that the FDA doesn’t have an independent litigation authority. If folks do not comply with the law, we will escalate further as has been evidenced by these actions, which again are going to be part of our broader portfolio moving forward,” said King. “Everyone is going to be held accountable across the supply chain. We do want to make sure that we address the bad actors in a meaningful way. We also continue to pursue no tobacco sale orders among retailers as well. This has traditionally been issued for underage sales. But again, we’re committed to using the full scope of our authorities granted through Congress.”
King added that education is also a priority for the CTP. The center is ramping up efforts to address misinformation in the continuum of risk for nicotine products. He mentioned that he recently wrote a commentary where he highlighted the importance of opportunities and considerations for addressing misperceptions in nicotine. “There is science that exists in that there are misperceptions around the continuum of risk and also nicotine. And so, we do have opportunities that are present, but we have to follow the data-driven pandemic-based approach,” he explained. “That said, I’m putting my money where my mouth is …. We’re working with the National Institutes of Health for a funding opportunity to get more data on public health communication messaging about the continuum of risk.
“And as noted in that funding announcement, we’re looking for data both for the target population, which is called smokers, but also unintended populations, particularly youth. This is several million dollars on an annual basis, and we look forward to that kickstarting and getting data to inform our work.”
King said the CTP will also continue to gather input from the industry and the public. The CTP is creating a new office within the Office of the Center Director and is looking to hire a new director for Policy and Partnerships. “That posting is public,” he said. “And I’m looking forward to seeing those who have applied and getting someone in that seat to meaningfully oversee the product regulation portfolio across the center, particularly as we get that strategic plan in place.”
During the closing of his address, King said that he continues to be big on communication and stakeholder engagement. He expects to provide the industry with more opportunities for communication with the CTP. “I know that you’ll see in the future an evolution of our messaging. Both through our press releases, our social media and our [overall] messaging to make sure that we are clearer, simpler and more digestible,” he said. “I’ve been a bureaucrat for many years, but that doesn’t mean that I can’t communicate effectively with the general public. I think we can do better. I know we can do better.”
Panel: Innovating Products for the Future
GTNF 2023
Discussing the future of innovation in nicotine products is complicated. The industry is innovating at lightning speed, especially in batteries and atomization. However, manufacturers don’t often want to discuss innovations in progress because competition in the next-generation nicotine-delivery segment is fierce. It’s not uncommon for a company to launch a new innovative design only to see its IP stolen and used in counterfeit products.
During the panel “Innovating Products for the Future,” moderator Eve Wang, executive director of Smoore International and vice president of Shenzhen Smoore Technology Co., questioned five industry experts about how they imagine the future of the vaping industry. The participants agreed that innovation would continue boosting the harm reduction potential of next-generation nicotine-delivery products. Surprisingly, they all willingly shared interesting insights into new product innovation.
Tao Cui, director of innovation, strategy and compliance at Innokin Technology, said that future vaping products will likely be more individualized, more efficient and more intelligent. He also said that products will continue to become less harmful. He said the heating element is especially an area that will see more innovation.
“In a perfect scenario, you can control the temperature as low as possible and also precisely control it. And, if you have a much, much less harmful substance, we combine both together, then we have a less harmful product,” he said. “In the future, I would say the products will be more individualized because no one product fits 1 billion people. In the future, your product may adapt to your habits. The product may know if you need more [puffs] in the morning, in the afternoon, today or tomorrow.”
Cui outlined some potential solutions for sustainability-related issues, including the use of research and development. He proposed that countries that have successfully controlled youth usage could offer insight; they could accomplish this by better regulating flavor names and packaging.
James Kuang, chief scientist and head of the Life Science Institute at ICCPP, parent to Voopoo vaping products, stated that the innovation of products is needed to balance user experience, harm reduction and environmental protection. “Yes, we should develop some [better batteries] and [e-liquid bases] for that. “We talk about the effective battery …. Can we do something for our environment by developing different [e-liquids]? I say if we can develop some new type of [e-liquid base] … for example, can we use some nature-sourced alcohol? …. Another solution, I think, is a water-based solution. In my opinion, a water-based [solution] may be the best product for the future.”
Fadi Maayta, president and co-founder of Alternative Nicotine Delivery Solutions (ANDS), stated that the next stage of innovation should be aimed at protecting consumers—especially nonsmokers and ex-smokers—and youth. He noted that it was the responsibility of the industry to ensure it was on the right path to responsible growth. He said that artificial intelligence (AI) could play for both the industry and regulators by helping to better analyze data concerning consumers and product use.
“I know many companies that invested in applications to link [AI] to the device to tell the consumer how many puffs they took, what’s the health risk. All these apps failed. I don’t see consumers really using it, to be realistic,” said Maayta. “It will help consumers to get more data. It will help companies and factories [know where] to locate and know how to get the right product for the consumers through using that engine but also externally for the regulators and policymakers to get data about these products. It might help in tracking as well, track and trace for the product.”
When it comes to eco-friendly products, Maayta claimed that a rational vision of environmental sustainability involves four distinct pillars. The first pillar is the product. Manufacturers should use the right elements … cardboard, biodegradable silicon and biodegradable plastics. The second pillar is showing that your claims of eco-friendliness are provable—that they can be substantiated.
“If you want to claim that your product is recoverable and recyclable, and your product can be recycled to 99 percent, whatever—you [had] better be careful. You are in a very controversial industry, and every word will be tracked,” he said. “You better [be able] to substantiate every word, every percentage, everything you say about the recyclability and the probability of the product.”
The third pillar is that if you market an eco-friendly product, you need to have a program to support recycling. The collection of these products is important. “Make it simple … because consumers need simplicity,” he said. “You used to have a cigarette and a lighter. That’s it. You are giving them an electronic device. They don’t want to have a headache there.”
The fourth element is regulation. Maayta said regulators should be involved in investing in approving sustainable products and possibly incentivizing recycling programs. He criticized manufacturers that aggressively market products that appeal to youth. He criticized regulators for not doing more to remove the “bad players” from the market because it’s leading to good manufacturers being replaced by the black market.
Cherry Pan, managing director of consumer and marketplace insights at Altria, said that as the industry moves toward more “eco-friendly” products, the term needs to be better defined. Pan said that the environment should be a concern for all manufacturers. She also suggested that manufacturers could play a more innovative role in the design of eco-friendly products.
“First, how to define eco-friendly … that means you’re 100 percent recycled or 50 percent recycled or 30 percent? …. Or does it mean that we use vaping products that are less harmful than cigarettes? This also means it’s eco-friendly,” Pan explained. “We will make about 150 to 200 new products every year [not necessarily that make it to market] with our army engineers. We have about 150 engineers. So we also must make products which we [consider] eco-friendly because we can recycle it, maybe 70 [percent] to 80 percent. We use some degradable materials. The percentage we use is higher [than many other products]. We want to make removable batteries.”
Ryan Selby, CEO of Generative AI Solutions and executive chairman at The Modern Nicotine Co., said that innovation will not bring about a one-size-fits-all solution for consumers. It’s going to take a comprehensive approach to create choices for consumers through innovation. However, he doesn’t know what the next best thing is.
“I do think we need to keep our eyes on the future and look at there’s some big changes coming down in terms of the virtual and augmented reality experiences,” Selby said. “In the oral space, looking at opportunities for creating more personal nicotine experiences that have a lower [third-party] impact as well as lower the impact on the environment.”
Selby also said that AI could be beneficial in providing consumer insight and in helping find innovative ways to restrict youth access. He said AI can aid the nicotine industry by helping to reduce harm by analyzing data. Regulators may even be better able to understand the consumer experience.
“I think this is a tremendous opportunity for AI in this space to help feed in massive amounts of data set and tease out some of these interactions between devices … looking at opportunities for combining substances and devices in a way that can reduce the harms associated with [use],” said Selby. “I think there is tremendous promise with large data sets and the ability of AI to tease out some hidden secrets in there that can help us to continue moving in the right direction.”
Panel: Talking Nicotine: Perception vs. Reality
GTNF 2023
From a public health perspective, the misperceptions and misunderstandings surrounding nicotine are incredibly frustrating, according to David Sweanor, adjunct professor of law at the University of Ottawa, who moderated the GTNF panel on the public perception of nicotine. Science has proven that it is the delivery system [combustible cigarettes], not the nicotine itself, that causes the deadly diseases suffered by cigarette smokers.
Sweanor said Sweden was an excellent example of a country where the use of different delivery systems, such as snus, led to massive decreases in the number of combustible cigarette smokers. Sweanor said it would be a major benefit to public health if the industry would or even could do more to educate consumers, public health groups and legislators about the facts. He emphasized that people can only make as good a decision as the information available to them allows.
“We already knew from the work of Michael Russell that people smoked to get nicotine, but they died from the smoke. Nicotine wasn’t the problem. It was the delivery system that was the problem,” Sweanor explained. “We’ve known that for 50 years. And we’ve seen examples from places like Sweden where people can move to an alternative product and have disease rates that are massively lower than what you see elsewhere. In fact, looking at the long-term users of a product called snus, it is very hard to find anything to distinguish their disease risks from those people who don’t use any tobacco or nicotine product at all.”
The first speaker was Carolyn Beaumont, a general practitioner, educator and founder of SmokerHealth Telehealth and Medical Nicotine Scripts who for the last three years has been prescribing vaping products to cigarette smokers in Australia. She said that there is an outpouring of need and frustration and even fear from the many smokers that she works with. Under Australia’s strict vaping rules, vaping products are only allowed through prescription, and there are only a few products legally allowed to be prescribed. She presented several quotes from former smokers showing how vaping had changed their lives for the better.
“They really want their stories to be heard …. Smokers want to be heard—not judged—supported, and advocated for. And as I said before, they’re also very fearful that if they can’t get their vape, they will return to smoking, and that seems true as well,” said Beaumont. “I guess for those of you who are not sure how successful vaping is in [supporting] smoking cessation, it’s very effective.”
There were several quotes presented, including one from a patient who said there was a history of cancer in their family. “I am very reluctant to take up smoking again. I haven’t touched a cigarette in close to three years now, and I feel wonderful,” the patient stated, according to Beaumont. “My sense of taste and my smell has returned. Fitness has improved. So, I thank you for the service you provide for us ex-smokers to be able to vape instead of [smoking] those dirty cigarettes.”
The next speaker, Delon Human, president of Health Diplomats, a healthcare advocacy group, said that misperceptions surrounding nicotine were causing people to die. “At the heart of nicotine misperception lies an issue that we are wasting unnecessary lives,” Human told attendees. “We are allowing the misperception of nicotine to lead to disease. And that is a time that we absolutely have to take hold of the stakeholders, who can change those perceptions.”
He also stated that the World Health Organization’s failure to differentiate between tobacco and nicotine, combustibles and noncombustibles, has caused the spread of misinformation among the organization and government and nongovernment organizations it influences. “If you read WHO documentation …. On the one hand, nicotine is part of the WHO list of essential medicines. Nicotine as part of nicotine-replacement therapy as prescribed by physicians and health professionals for smoking cessation,” said Human. “And on the other hand, there’s an all-out war on nicotine. What has happened over the years, over the last 50 years, is that the so-called war on tobacco has changed into the war on nicotine.”
Human also noted that there is a serious amount of misperception surrounding nicotine among physicians and consumers. He mentioned a recent study from the Foundation for a Smoke-Free World that found that on average, nearly 77 percent of doctors mistakenly believe nicotine causes lung cancer, and 78 percent believe it causes atherosclerosis. While on average 87 percent of doctors at least moderately agree that helping patients quit smoking is a priority, lack of training and nicotine knowledge adversely impacts quitting and harm reduction advice, according to the study.
“It found that 58 percent of those respondents thought that [nicotine] caused cardiovascular or heart disease, which again shows you that the level of misconception is not only dangerous, it’s sick …. It’s 2023 and so simple of a situation, but suddenly physicians have a complete misconception of what nicotine is,” he said. “In our own study in 5 countries, we [found that among] GPs [general practitioners], there was a persistent belief that nicotine is the most awful aspect of smoking. Nicotine causes cancer, and nicotine causes heart and lung disease.”
Human pointed out the positive outcomes of correcting misconceptions about nicotine, including improved health for smokers and lower smoking rates. He proposed that medical professionals should receive new training on the effects of nicotine and the advantages of tobacco harm reduction. Human said that companies should also refrain from marketing to youth and keep up with the research and development of new reduced-harm products.
“In terms of physicians, what can they do for misperceptions to be corrected? No. 1, training needs to be updated to the 21st century. Doctors need to know that nicotine does not cause cancer. It’s a crime for doctors to think that nicotine causes cancer or heart disease or lung disease in a way that they perceive it now, so correct the training,” he said. “No. 2, make sure that doctors understand what harm reduction is. Harm reduction is really part of everyday medical life. That’s what we do in medical practice. You’re trying to reduce the harm.”
Hiroya Kumamaru, cardiovascular surgeon and vice director of AOI International Hospital in Japan, said that in his country, there is also a wide misperception among physicians that nicotine is harmful. He argued that the industry needs to think about how best to educate regulators on understanding the effects of nicotine and the risks of different delivery systems. “Many, many … GPs are thinking that nicotine is quite harmful itself [in Japan], and we have to educate them somehow. Thinking about how we can [address] this issue, I tried to have a small meeting in the Swedish embassy about four years ago to educate not only physicians but also media and governmental officers to understand the concept of harm reduction in tobacco, in smoking,” explained Kumamaru. “But it was still difficult because some of the physicians, even [ones that] were working in a university hospital or working in the Ministry of Health, were saying that smoking is a sin …. They didn’t care about the difference [between] vapor and cigarette smoking. Because they say nicotine drug dependency is a very bad agent. We have to think once more to educate these people to understand.”
Kumamaru said Japan has seen a historic decline in the number of combustible smokers because of the rise of heated-tobacco products. He said more than half of the combustible market has disappeared in just a few years. He also agreed that the industry could accomplish more if more were done to battle misinformation.
“We’re still stuck with this problem of it. People and regulators can only make as good a decision as the information available to them allows us. And people believe that using nicotine is about sin rather than about health. If people don’t understand that [combustible cigarettes, not] nicotine causes cancer, what can you do? …. Millions of Americans who are able to move between the [various harm reduction] products never had the information that one product is very likely to kill you and [that] the alternative product is massively less hazardous.”
Mohamadi Sarkar, a fellow of scientific strategy and analysis and regulatory affairs at Altria Client Services, told attendees that the science on nicotine is not new. He said that even though many mistakenly believe that vaping is just as dangerous or even more so than smoking combustible cigarettes, there is a plethora of evidence to show that vaping contains fewer harmful chemicals than cigarette smoke.
“We often hear that ‘Well, these products have not been on the market long enough, so there is no long-term epidemiology.’ We don’t need it. What we do know is that cigarettes have 70,000 chemicals. Seventy of them are carcinogens and linear, cardiovascular and respiratory toxins,” he explained. “On the other hand, smoke-free products like e-vapor or [heated-tobacco products] are nicotine-positive and have far fewer chemicals.”
In the end, all the speakers agreed that the industry could do more to battle the misinformation surrounding reduced-risk products. The vaping industry needs a unified voice. “We need unified goals for all the stakeholders to communicate …. We know that education works. Education has changed perceptions,” said Sarkar. “We need immediate action.”
Panel: Reasonable Responsibility
GTNF 2023
Youth use is everyone’s responsibility. It’s also the name of the GTNF panel that focused on how to balance preventing youth use with helping combustible cigarette smokers move toward less risky nicotine products. The panel’s moderator, Stacy Ehrlich, partner at Kleinfeld Kaplan and Becker, encouraged panelists to debate whether abstinence is a realistic or appropriate goal when attempting to combat youth use.
“Hopefully, speakers will address that and whether and how to communicate with youth and children about relative risks and progress. I think an interesting question is: Are youth an unintended population for these communications?” said Ehrlich, referring to the U.S. Food and Drug Administration’s acknowledgment that e-cigarettes are less harmful than combustible cigarettes. “Should we be communicating with underage individuals about consumer risk?”
All the panelists were given the opportunity to make a short presentation. Jasjit Ahluwalia, professor of behavioral and social sciences and professor of medicine at the Center for Alcohol and Addiction Studies at the Brown University School of Public Health and Alpert School of Medicine, said that tobacco addiction is a pediatric disease and noted that many diseases resulting from tobacco use were effectively human caused, such as chronic obstructive pulmonary disease, as 95 percent of cases were the result of tobacco use.
He also stated that youth use of tobacco and nicotine was unethical as young people are uninformed consumers. However, he noted that communicating risk to this group was complicated. He said that tobacco prevention campaigns are key.
“This is something that we know [is] important to effectively educate youth,” said Ahluwalia. “I’m mindful of the importance of the issue of spillover … this is, again, a careful area where I think it’s important that we’re mindful of what the impact is on the intended population and mitigating risk for the unintended population, which in this case, I believe is adult smokers that you want to make sure that they’re not scared away from using an e-cigarette that could potentially be beneficial for them to transition completely from combustibles.”
Ahluwalia also highlighted the vast amount of misinformation that had been communicated through anti-vaping/smoking campaigns, noting the role of the media in misrepresenting the science behind vaping products. He stated that the industry needed to focus on innovating safer and better products. He also called for the FDA to approve new smoking cessation medications. Lastly, Ahluwalia stated that a goal of zero youth use was unrealistic and unreasonable.
Brian King, director of the FDA Center for Tobacco Products, explained that youth prevention continued to be a critical part of the FDA’s portfolio since nine out of 10 adult smokers started smoking below the age of 18. He noted that the youth were using a variety of different products, with the use of e-cigarettes being particularly prominent.
“Youth prevention is a key component of FDA’s portfolio … we do see kids using a variety of different products. But right now, the focus is primarily on e-cigarettes,” explained King. “We’ve seen an evolution within even that product class as well, which I think is important for us to consider as we talk about what the inherent risks of these products are, particularly when it comes to dependency. That said, although we’ve seen declines in e-cigarette use, which again, we’ve noticed, is a good thing, among the kids who are currently using e-cigarettes, we’re seeing increased signs of dependency.”
King said the FDA is held by the standard of being “appropriate for the protection of public health.” This is not like the other centers at the FDA, such as the Center for Drug Evaluation and Research (CDER), which has a “safe and effective standard.” In therapeutics, the CDER wants products to be safe for people to use but also effective at treating the ailment.
“When it comes to tobacco products, the U.S. Congress has given us appropriate for the protection of public health, where we have to weigh the benefits and the risks. That said, the risks are typically focused on youth initiation. And we have made decisions based on that,” King told attendees. “The primary reason you’re seeing a variety of negative actions that have been taken on e-cigarettes is because of the prominent youth use of these products. It certainly is possible to mitigate that risk. For example, we know that youth have very little [interest in] tobacco-flavored e-cigarettes, which are the products that have been authorized to date because that benefit of adults has been able to outweigh the risk of kids.”
Colin Mendelsohn, general practitioner and founding chair of the Australian Tobacco Harm Reduction Association, said that current vaping policy is largely driven by fears over youth vaping. The scientific evidence of vaping is being overlooked. He stated that children should not vape or smoke; however, he acknowledged, it is inevitable that some will. Mendelsohn argued that most youth vaping was experimental, with frequent vaping being rare.
“I think policy around e-cigarettes is largely driven by youth [and] flavor. And I think it should be driven by the evidence, not by emotion and moral values,” he said. “What I’m going to talk about is actual evidence, or at least the best evidence we have today. Kids shouldn’t vape or smoke. They shouldn’t be using alcohol or useless drugs. Of course, they do lots of things they shouldn’t do.”
Mendelsohn said his research showed that only 3 percent of children who had vaped were frequent vapers, with half of those also being smokers. This evidence, he said, showed that vaping was not a gateway to smoking. He said that the opposite was true, and vaping was diverting kids away from smoking combustible cigarettes.
“I think we all agree that vaping is not a significant gateway to smoking. If there were a significant gateway, we would expect to see smoking rates going up. And of course, they’re going in the opposite direction. In the U.S., when vapes became popular, smoking rates continued to decline. In fact, they declined faster than they ever had compared to the historical period before 2013 since vaping became available.”
Stefanie Miller, vice president of external engagement at Juul Labs, said one of the reasons why she wanted to join Juul Labs is that she gets to say that Juul has a problem with youth use. “We don’t need to skirt around that. So I’m going to talk to you about what this company has done to successfully deal with youth using the product,” she said. “We took what we consider a three-pillar approach … it has been a productive initiative that we’ve taken …. It’s limiting underage appeal, restricting underage access and enforcing against third parties, enforcing against illicit products.”
Miller said Juul Labs is also using technology and innovation to help in the company’s fight against youth use. However, Juul Labs is also looking at how initiatives that are put in place to prevent youth use impact adults making the switch from combustible cigarettes. “We’re also considering what these interventions would do to make it potentially more difficult for an adult smoker to have access to a less harmful product, which is not the goal of our company,” said Miller. “We’re trying to walk this really careful line, both from the innovation but also the point-of-sale intervention along these three lines.”
Many of the questions coming from the audience were directed at King concerning the FDA premarket tobacco product authorization process. For example, Fadi Maayta, the CEO and co-founder of Alternative Nicotine Delivery Solutions (ANDS), a Dubai-based vaping product manufacturer, asked King to explain why the agency does not do more to incentivize law-abiding players. The FDA’s current penalty framework, he argued, penalizes good and bad players alike.
King said he understood Maayta’s frustration. There are numerous good players in the vaping industry that don’t have the issues of youth uptake, he acknowledged. The reality, however, is that the U.S. Congress wrote the Tobacco Control Act and prescribed very specific processes that the agency is required to do by law, said King.
“That said, the intent is not to penalize everyone … but we do have to follow the law in terms of implementing the regulations that have been required by us. And that includes a premarket tobacco product process and a rigorous scientific assessment …. We also have to enforce the law, and we are a free market paradigm. So there’s no safe harbor. If you don’t have authorization, your product is subject to enforcement compliance,” explained King. “That said, are there opportunities to streamline those processes? Absolutely. And that’s what we’re looking at. There are efficiencies that I think we can gain by looking at our processes to make it more streamlined moving forward.”
Panel: Research and Innovation Update
GTNF 2023
Regulations in the nicotine industry should change as products become more innovative and less harmful. Unfortunately, that is unlikely to happen in many markets. During a panel discussion updating attendees on research and innovation, moderator Mohammed Agrabawi, senior director of corporate affairs and communications at ANDS, discussed approaches in the Middle East where governments have imposed high taxes on vaping products.
“I want to take you to the reality where I come from, from the Middle East, where most of the countries are imposing taxes that are 100 percent and 200 percent on vaping products. You can buy a pack of cigarettes [for one-fifth the cost of a disposable vape] …. Don’t you think that governments are part of suppressing innovation and investment in that part because of fiscal and regulatory frameworks?” Agrabawi asked. “Yes, absolutely. And the reason for this is clear. One of the things that Sweden did really, really well is price taxes on a continuum of risk. The lower the risk, the lower the tax.”
For Agrabawi, this clearly demonstrated that government regulation can suppress innovation.
Also on the panel, Tim Andrews, director of Consumer Issues at Americans for Tax Reform and the Tholos Foundation, cited several historic examples of innovation being demonized that would later go on to save lives—he suggested next-generation nicotine products are another example of this. He also stressed the need to better communicate the scientific research on nicotine products and their benefits.
Andrews believes there are better ways to deal with the uptick in youth vaping. “There’s an old saying that goes, ‘Children see and children do,’” he said. “A simple switch or a simple button to activate this product will not prevent [youth use].” Andrews suggested that youth prevention can’t just be simple, such as technology requiring a user to push a button three times. And future solutions will probably incorporate AI or Bluetooth. However, an immediate impact could be made if more was done to fight the black market.
“I would say that unethical retailers … they sell illicit products, and they sell to minors as well. So illicit vaping is a gateway to smoking and vaping rather than legal companies. And if we look into the illicit market, they don’t check IDs, they don’t use [legitimate sales] practices because they’re an illicit company,” explained Andrews. “If you shut down all of the legal products and move it to the black market, it’s going to be worse because we’re unregulated; we don’t know what’s in there; they’re going to sell to kids. You don’t have any safeguards.”
Kang Yu, head of the Research Institute at Hangsen International Group, outlined how her employer has been establishing a framework of harm reduction that will help test new products and produce safer ones. She delivered a comprehensive presentation outlining Hangsen’s strategic evolution within the realms of scientific research and innovation. Yu underscored the organization’s steadfast dedication to enhancing consumer safety by elaborating on their initiatives pertaining to harm reduction.
Yu pointed out that the industry is still young and has a promising future. Yu also commented on the potential of nicotine salts. She emphasized that nicotine salts are a critical component of e-liquid formulations and have a decisive impact on product taste and feel.
“Pure and high-quality nicotine salts can significantly enhance the overall sensory experience, providing consumers with a superior user experience. While benzoate salts have gained popularity in the market, they have limitations in reproducing certain specific taste profiles, such as sour fruits, non-sour fruits, toasted and tobacco flavors,” she said. “Other acids that can be used for salt formation, such as acetoacetate, lactic acid and citric acid, offer unique and rich flavor characteristics once they form salts. For example, acetoacetate can enhance the authenticity of fruit flavors.”
Shawn Long, president of the Zinwi Research Institute, Yunnan, and director of Zinwi Tobacco, said his company has been focused on reducing the harm of their e-liquid products. He said the company has set up advanced safety assessments and a tobacco flavor evolution platform that allows conventional tobacco smokers to find an e-liquid flavor that mimics the brand of combustible cigarettes they are trying to transition away from.
A major reason that Zinwi’s e-liquid has an enhanced flavor profile is the company’s Atomization Technology Research Center, which has self-developed nicotine salts and the sweeteners used in the e-liquids to ensure the highest quality of those components of the e-liquid formula, according to Long. The company also requires each component of its e-liquids to have the highest levels of quality and purity.
Marlen Nazarov, chief technology officer at Alfabet Labs, identified two main challenges in the e-cigarette industry: sustainability and youth access to vapes. On youth access, he suggested the solution is to make the product look less attractive with minimalist packaging, minimal colors and no flavors. He also agreed that additional solutions to challenges with youth use will likely involve AI.
“Innovation should be directed toward the key challenges in the market. So basically, there is no one solution for everything. It’s a really big challenge,” said Nazarov. “For youth use, it’s two parts. The first part is to make the colors less attractive, use conservative packaging without any fruits, etc. For the devices, it’s the same, just a simple white or black device without any images.”
Rex Zhang, strategy director at Shenzhen Smoore Technology Co., discussed what he sees as the two main challenges to the vaping industry: user experience and sustainability. On youth vaping, he outlined how child protection must be more advanced to stop children from using vapes. Zhang detailed Smoore’s advancements in sustainability and vaping efficiency. The company, he said, had reduced the amount of lithium materials in its vaporizers and increased the lifespan of its products, thus fewer products will be discarded.
Zhang also added the drive behind Smoore’s innovations. “I think the solution of best fit for society is a balance solution between regulations and user experience,” he said. “Smoore’s mission ‘Atomization Makes Life Better’ aligns very well with this objective to continue to work on the R&D, improving it for bettering people’s life.”
Time has not been used effectively to lower smoking rates using proven THR policies.
By George Gay
No truer statement about tobacco harm reduction (THR) could ever have been made than this: “Too much time has been wasted.”
This blunt assessment was attributed to Jacek Olczak, CEO of Philip Morris International, in a September press note heading that had him challenge “governments across the globe to embrace smoke-free alternatives to end cigarettes faster.”
I take it that what Olczak was referring to is the time that has not been used by societies to good effect to bring down tobacco smoking rates using proven THR policies. But he might well have had in mind, too, the cumulative time cut from the lives of individuals said to have died “prematurely” from smoking-related diseases—diseases that could have been avoided by employing THR strategies.
The press note includes much that is interesting, but my eye was particularly drawn to a passage where it was said that, according to a new international survey conducted by independent research firm Povaddo for PMI, 82 percent of respondents agreed they would be somewhat or very angry, frustrated or upset to learn that a breakthrough that could help address a societal issue was not made available to the public due to government inaction.
Even very angry doesn’t cut it for me, partly because we are not talking only about government inaction but about government action in undermining such breakthroughs. Later in the press note, Sweden was said to have one of the lowest smoking rates in the developed world, at just 5.8 percent, largely due to the availability of snus, which Swedish men began switching to decades ago. “… The Swedish Snus Commission (SSC) estimates that more than 350,000 smoking-attributable deaths among men could have been avoided each year if the other EU countries had matched Sweden’s tobacco-related mortality rate,” the note said.
If the SSC is correct, and given that the EU has banned snus outside Sweden since 1992, we must reluctantly accept that about 10,500,000 men have, because of the action of the EU authorities in banning snus and then their subsequent, continuing inaction in not unbanning it, died prematurely in about a 30-year period.
OK, so 10,500,000 might be something of a stretch because the EU was smaller in 1992 than it is now, and I don’t know whether the 350,000 annual figure is an average or is based on a single year. But it is clear that we are talking about a big number and that no such number would have been allowed to have occurred in a 30-year war. A truce would have been called long ago and compromises made. But not in respect of the war on snus, and yet nobody will be called to account over what has occurred in the EU because of the ban on snus.
And the question arises as to whether such a calamity, such an outrage, would have been allowed to go almost unnoticed, unremarked in any other field. I think not, but I struggle to understand why this is the case, and the only reasons I have managed to come up with so far are that 1) smokers tend to be financially less well-off than the average person and to have little or no public voice or power, and 2) smokers have been deliberately denormalized by anti-tobacco activists. They have been placed beyond societal norms, so the problems they face are not regarded as being societal issues. People will not be very angry, or even upset, if governments don’t take the problems of smokers seriously.
These are not wholly convincing arguments, are they? And I must be concerned when I cannot even convince myself. I mean, individuals, companies, organizations and governments do worry about smokers, don’t they? At the first opportunity, everybody with the closest or flimsiest connection to tobacco or nicotine will lament that, according to the World Health Organization, 8 million smokers die prematurely each year because of their habit. Ask yourself how many times you have seen that statement written or heard it articulated.
PMI says it used WHO data, estimates and methodologies, along with third-party data, to calculate the potential public health impact of the world’s smokers switching from cigarettes to less harmful, smoke-free products.
“The hypothetical model shows that if smoke-free products are assumed to be 80 percent less risky than cigarettes and if people who currently smoke were to switch to them completely, then over their lifetime, there’s a potential for a tenfold reduction in smoking-attributable deaths compared with [those that would have occurred under] historical tobacco control measures alone,” the press note said.
This is impressive and worthy of note, but the problem here is that in using and, dare I say it, extolling the data and, especially, the methodologies of the WHO, PMI rather shoots itself in the foot.
“For over a decade, PMI has championed a smoke-free future,” Olczak is quoted as saying. “Having invested more than $10.5 billion to scientifically research, develop and commercialize smoke-free products—which today account for more than a third of our total net revenues—we are living this future. Yet, inexplicably, there are countries stuck in the past where smokers can easily access cigarettes—the most harmful form of nicotine consumption—but not the better option of smoke-free alternatives.”
This situation is not universally inexplicable. Imagine for a minute that you are the health minister in a country whose economy does not allow major investments to be made in nation-specific health research. When the WHO comes knocking and tells you that your country has a smoking problem that is draining its finances and that THR is not the way to address it, what are you going to do?
You might notice that PMI is advocating THR, but you also notice that it is relying on WHO data and methodologies. That is, the methodologies are the same, the only difference is the interpretation of the data, so who are you going to believe, the international health organization or the international tobacco/nicotine company? It’s a no-contest.
I don’t want to seem to be an anti-expert or a conspiracy theorist, but I believe that we need to rely less on numbers, which are impersonal and which can be, intentionally or not, highly misleading, and more on values when it comes to addressing the problems caused by smoking. There is certainly something wrong with the ways that health data are manipulated by some, and the situation is getting worse by the day. Let me provide a current example from the U.K.
The ruling Conservative Party, nervous of a general election due next year, is reverting to type and aligning with a former prime minister’s reported policy of cutting the “green crap,” supposedly to help it appeal to its older voter base. And as part of this strategy, some are opposing certain policies aimed at cutting outdoor pollution by pointing out that the word ‘pollution’ has appeared only once as a cause of death on a death certificate.
I cannot say whether this is correct, but it wouldn’t surprise me because it could be argued that, for instance, people don’t die of heart attacks caused only by the inhalation and ingestion of pollutants, which is perhaps one factor—one major factor—among others that might include lifestyle choices.
But in conceding this, I must ask myself why people are so ready to attribute deaths to smoking. By the same reasoning, I take it, people don’t die of heart attacks caused only by the inhalation of tobacco smoke, which will be one factor—one major factor—among others that might include lifestyle choices and pollution.
Of course, we know the answer to this. It’s because of the way the system is set up to focus on smoking but not on pollution. There are certain diseases that are defined as smoking-related, and if a smoker dies of one of these, her death is recorded as having been caused by smoking.
The fact that these diseases could also be defined as pollution-related diseases seems to be glossed over. To get an idea of the contribution of pollution to disease and deaths, it is necessary to listen to the information provided by people such as the U.N. secretary-general, Antonio Guterres, who is not afraid to speak out.
Interestingly, Sept. 7 was International Day of Clean Air for Blue Skies, and if you look at the U.N. website, you will see that air pollution is described as a twofold problem:
“Health impact: Tiny, invisible particles of pollution penetrate deep into our lungs, bloodstream and bodies. These pollutants are responsible for about one-third of deaths from stroke, chronic respiratory disease and lung cancer as well as one quarter of deaths from heart attack. Ground-level ozone, produced from the interaction of many different pollutants in sunlight, is also a cause of asthma and chronic respiratory illnesses.”
“Climate impact: Short-lived climate pollutants (SLCPs) are among those pollutants most linked with both health effects and near-term warming of the planet. They persist in the atmosphere for as little as a few days or up to a few decades, so reducing them can have … almost immediate health and climate benefits for those living in places where levels fall.”
It is good to see this emphasized because air pollution, which is generally invisible and is visited upon everyone, even those, such as children, who don’t cause it directly, is a more insidious risk factor than tobacco smoke, which is visible and largely affects only those who consume it. In fact, my newspaper this morning, Sept. 21, has a heading: “Almost all Europeans breathing toxic air.”
Clearly, the figures of one instance of pollution being recorded on a death certificate and 8 million smoking-related deaths annually are both misleading, but they are allowed to guide us because they point us in the direction that we have already determined we want to go. They provide the comfort of confirmation bias. But what we should be doing is determining that direction based on values, not suspect figures, even though such a quest might lead us into difficult places.
And one of those places is, of course, environmental pollution, which, in my opinion, is still not taken seriously enough by the vaping industry, especially when it comes to disposables. I fail to understand how we might be able to justify the proliferation of disposables on the grounds of values.
How can we justify disposables when, clearly, the conversion of all smokers to the consumption of disposable vapes would not be something we could defend—would not, if you like, be something we would wish to become a universal law unless we are seeking to accelerate the end of humanity. And neither can they be justified on the grounds of the good of most people.
In fact, up to a point, I think the same might be said for nondisposable vapes, and so perhaps the time has come for THR advocates to start winding back on vaping devices and concentrating more on products such as snus and nicotine pouches, which are much easier to justify on the grounds of nicotine-user health, the environment and society at large.
A lot of people, including, probably, most of the readers of this magazine, will not agree with this, and they may well be right in not doing so. But I think it is important to have these discussions. THR fails, in my view, if it does not comprise a progressive signpost.
I said at the start of this piece that, in my opinion, Olczak had made what is possibly the truest statement about THR in saying that too much time had been wasted. But he said something even more important that I quoted above and part of which I shall repeat here: “… We are living this future ….”
He’s right: We need to look to the future, not the past, which can be a guide only for those reactionaries not wanting to face the future.
Tobacco companies often get blamed for things only because they are tobacco companies.
By George Gay
Wow! U.S. tobacco companies—just how bad are they? Well, I’ll give you an idea. I received in September an email with news of a study that “… shows food from tobacco-owned brands more ‘hyperpalatable’ than competitors’ food.” The study, by researchers at the University of Kansas, was published in the peer-reviewed journal Addiction.
Addiction, tobacco companies, hyperpalatable—you get the drift.
Hyperpalatable food is apparently what most of us refer to—inconsiderately given the level of hunger in the world—as “junk food”: “… kind of salty, sweet and high-fat fare,” according to the email announcing the publication of the study, which quoted the lead author as saying, “… [h]yperpalatable foods can be irresistible and difficult to stop eating.” Hmm.
U.S. tobacco companies apparently invested heavily in the U.S. food industry during the 1980s, and the researchers found that “… between 1988 and 2001, tobacco-owned foods were 29 percent more likely to be classified as fat-and-sodium hyperpalatable and 80 percent more likely to be classified as carbohydrate-and-sodium hyperpalatable than foods that were not tobacco-owned.”
However, the tobacco companies apparently divested from the U.S. “food system” between the early to mid-2000s, so by now, you would have expected that junk food would be almost off the menu and U.S. citizens brimming with health and vitality. But not so fast! The Kansas University study found that the availability of fat-and-sodium hyperpalatable foods and carbohydrate-and-sodium hyperpalatable foods was still high in 2018, regardless of prior tobacco ownership, “showing these foods have become mainstays of the American diet.”
So, I suppose we must conclude that some food companies not associated with tobacco companies are equally as bad as those associated with tobacco companies when it comes to dishing out junk food? But no; in fact, the researchers have another suggestion to make: “… perhaps the shadow of Big Tobacco has remained,” they say.
Talk about giving a dog a bad name. This has nothing to do with a shadow; it has to do with something called competition. I really hate to state the obvious, but this is down to “market forces.” When one company puts on the market a product that is more useful, shinier or, yes, more palatable than that offered by other companies, its product sells well, and other companies notice this and, wanting to stay in business, start marketing similar products if they can (you won’t read marketing insights like this every day).
The “market” has some advantages and some disadvantages; the latter crop up, for instance, where a product is hyperpalatable to individuals while making public health officials hyperventilate. However, the tobacco industry did not invent the market.
Having said that, I would not seek to defend tobacco companies, whether in the U.S. or elsewhere, in respect of all they have done, but to me, what is important is to look forward rather than backward and realize that many of them seem to have the potential and the willingness to address some of the harms they have caused in the past. It seems to me to be absurd not to take advantage of whatever expertise they can bring to the table.
But, clearly, not everybody thinks this way, and at this point, I would like to switch my attention to the U.K., where, also in September, the U.K. Vaping Industry Association (UKVIA) announced that “the membership of [BAT], Imperial Brands, Japan Tobacco International and Philip Morris International has come to an end.”
“This means that the UKVIA will no longer include any tobacco companies within its membership,” the announcement said. “Following a member-wide consultation, the association will not be accepting any new applications for membership by vaping businesses wholly/part-owned or acquired by tobacco companies in the future. As a result, it will not be accepting any tobacco company funding in the future.”
Two main reasons were given for the change. Firstly, there was said to be a misperception that the association was largely financially supported by tobacco firms, and even though funding from tobacco-owned vaping brands for the most recent membership year amounted to less than four percent, this misconception had given the impression in some quarters that the association was synonymous with combustible tobacco.
Secondly, the association says that it had underestimated the drag on engaging with some key stakeholders, particularly those in public health, that was caused by restrictions placed on tobacco companies.
In one respect, I don’t blame the UKVIA for what it has done because, I assume, it has decided that it can advance the cause of its members and tobacco harm reduction (THR) more effectively if it is not associated with tobacco companies. It would argue, no doubt, that it will help prolong the healthy lives of more current smokers if its untainted members go it alone.
But its stance does worry me because it seems to be giving in to, and aligning with, the irrational views of others. If we want to solve the problems caused by smoking, we, and “we” includes public health folk, need to be taking advice from anybody who can provide insights into smoking and quitting, and there can be little doubt that tobacco companies can provide such insights.
In fact, much against my better instinct, I shall provide a little history here. The first time I heard about the continuum of risk and THR was at a meeting called by one of the major tobacco manufacturers that has now been ejected from the UKVIA. And that meeting was called some years before the arrival on the scene of the electronic cigarettes now advocated by the association. It should be remembered that tobacco companies have been in the vanguard of some important initiatives when it comes to THR.
Given this, I believe that those THR stakeholders not part of the tobacco industry should not give in to intellectual cowardice. It is possible to listen to the ideas of tobacco companies and then reject them. There is no obligation. I do not accept as right everything that tobacco companies do, and I’m certain those companies would not endorse much of what I have to say.
It is also worthwhile mentioning something that might seem a little perverse: the fact that if it were not for smokers and the tobacco industry, the UKVIA and all its member companies would not exist. Nor would all the jobs in tobacco/nicotine public health and the universities where many people make a decent living out of researching often pointless aspects of tobacco and nicotine consumption to come up with excruciating ways of making life unpleasant for those who choose to smoke.
It used to be said of the tobacco industry that it needed to keep addicting new generations of people to tobacco products in order to keep its operations going. So, since we are told that most vapers are recruited from the ranks of smokers, the UKVIA, all its members, the numerous other vaping associations, public health officials, academics, researchers, those of us commenting on these matters in the media, etc., are all dependent on a “healthy” tobacco industry, something we need to keep in mind before we get too holier-than-thou—before we start tut-tutting about smokers over our gin and tonics at yet another THR conference.
Perhaps I’m being unfair, but I sometimes get the feeling that it is only smokers who live authentic lives aligned with their values while the rest of us have at least associate membership to the hypocrisy institute. There is an interesting piece posted by Clive Bates on his Counterfactual website in which he describes 10 ways in which tobacco control advocates have commandeered the methods of Big Tobacco.
I was particularly taken with his point six, “aggressive economic actors. Big Tobacco was an economic interest group threatened by evidence of the dangers of smoking tobacco,” Bates points out. “Tobacco control activism is an economic interest group threatened by evidence of the safety of smoke-free nicotine use,” he added. (I should point out that at the end of his piece, Bates says that his comments are aimed only at certain sections of tobacco control activism and that he acknowledges that many in this field are sincere in what they do.)
But let’s widen that idea out a little. To my way of thinking, the vaping industry has become a fairly aggressive economic actor while many people within the vaping community are involved in what I would describe as tobacco control activism, though it is difficult to be sure whether they would be seen as being on the acceptable side or the other.
Bates indicates that the World Health Organization is one of the agencies he sees as exhibiting the “awful attitudes and behaviors” of mainstream global tobacco control, so I would suggest that though it might be wrong to lump the vaping industry into the mainstream of tobacco control, it must be conceded that it seems ready to get into bed with the WHO when that agency’s questionable figures might help advance vaping’s cause.
Of course, it could be argued that marching to the tune of 8 million premature, smoking-related deaths a year is just fine when under the THR banner, but not when under the banner of quit-or-die, but it makes me feel uncomfortable. If you believe something is not right, you are not acting authentically to pretend it is right for what you might think is the right reason.
As Bates well catalogues, both Big Tobacco and Big [not his word] Tobacco Control have got things badly wrong at times. But is there a danger that Big Vaping is going down a similar route? Currently, a lot of noise is being made about calls for banning disposable vapes, and it is true that a lot of that noise is coming from people deliberately distorting the picture by linking what they say is a rise in vaping by young people with the arrival of disposable products.
Once again, the figures are highly questionable, and, in any case, vaping among young people is a policing issue, not a product issue; and from this point of view, it is right to challenge the conclusions being drawn.
But there is something else going on here that I don’t think reflects well on the vaping industry. In part, the calls for bans on disposables are about environmental issues, which cannot be dismissed. As far as I have seen, the industry defends its position opposing bans on disposables with four main arguments.
One argument has it that a ban will not work. The second says it is encouraging consumers to dispose of their used products at points from which they can be collected and disposed of properly. The third claims that it is improving its disposable products so that they are easier to dispose of in an environmentally friendly manner. And the fourth states that because disposable products require a lower initial outlay than nondisposable products, they help financially poorer smokers transition to a less risky product.
If I were somebody promoting bans on disposables, I would dismiss the first and second arguments as being: 1) something for the imposing authorities to worry about and 2) little more than wishful thinking. While accepting the possibility that the third might prove feasible, I would suggest that any ban could be reconsidered when an acceptable level of improvement had been reached.
And in respect of the fourth argument, I would suggest that the industry involves itself in a little introspection. Is its concern really about impoverished smokers or about sales and profits? Indeed, could it instead of selling disposables sell its nondisposables for less than is currently the case and accept that its profits will fall? In what other ways do the people working in the industry, and especially those at the top of industry, show concern for impoverished people? Do they, for instance, advocate the redistribution of wealth?
I think these questions and more are worth considering. Otherwise, in the future, it might be the case that somebody—possibly an alien visiting Earth after the demise of humanity—will revisit Bates’ piece and add point 11. Big Tobacco failed to deal with the environmental harms caused by its cigarettes. Big Tobacco Control failed effectively to oppose Big Tobacco’s environmental shortcomings. Big Vaping knowingly and wilfully contributed to the Earth’s environmental breakdown.
Australia’s proposed crackdown on vaping is unlikely to achieve its objectives.
By Stefanie Rossel
As a vaper in Australia, you basically have two choices. The first option is to behave like a good citizen, go to your doctor, get a prescription and convince a pharmacist to sell it to you. The alternative is to be not so good and do what 92 percent of Australian vapers do—source your e-cigarettes on the black market. Vapes have been regulated Down Under since October 2021 but so poorly that Australian health professionals speaking at the Warsaw Global Forum on Nicotine in June apologized for the legislation.
Getting a prescription is more difficult than one might think, according to Carolyn Beaumont, an Australian general practitioner (GP) who advocates for the right of adult smokers to access vaping products. As Beaumont explained during her presentation, among the many barriers is the challenge to find a doctor who is not only familiar with vaping products but also believes in their potential as smoking cessation tools. But Australia is a huge country, where most of the population—and doctors—live along the Eastern Seaboard. In other regions, there are fewer physicians. Additionally, clinics may not be open daily, wait times are getting worse, and more GPs are charging privately. An estimated 20 percent of Australians have no regular GP; Beaumont said it could be even 35 percent.
Doctors often lack product knowledge and have an inadequate understanding of smoking, vaping and nicotine dependence. Tobacco harm reduction is not taught in Australia, according to Beaumont, and the medical guidelines are not supportive of vaping. Doctors also face an administrative barrier: They need to be registered as an authorized nicotine prescriber. However, the prevailing negative media narrative in Australia makes many GPs reluctant to register. In April 2023, the Australian Department of Health and Aged Care listed 1,963 authorized prescribers nationwide, which equals one in 20 practitioners.
Once vapers have secured a prescription, they need to find a pharmacy that sells vapes. But few establishments do so, and often, they have only limited stock. Vapes can also be ordered online and imported for personal use under the Therapeutic Goods Administration’s (TGA) personal importation scheme. With a valid prescription, Australians may legally import a three-month supply per order. “It remains illegal for other Australian retailers, such as tobacconists, vape shops and convenience stores, to sell you nicotine vaping products, even if you have a prescription,” the TGA stresses on its website.
At present, merely 8 percent of vapers have a prescription, and only 2 percent purchase from pharmacies, according to a Roy Morgain survey in February 2023.
Additional Restrictions
Colin Mendelsohn
Things are unlikely to get easier for smokers seeking less hazardous alternatives to combustible cigarettes. In May 2023, Health Minister Mark Butler announced a further crackdown on recreational vaping. He claimed that vaping had been advertised to the public as a therapeutic product meant to help smokers quit but instead spawned a new generation of nicotine users, particularly young people. At press time, details on the new rules were unavailable, but tobacco harm reduction advocates were bracing for restrictions on disposable vapes, flavor options and nicotine concentrations, along with a requirement to package vaping products in pharmaceutical-style packaging and an end to the personal importation scheme, with sales permitted only through authorized pharmacies.
Writing on his blog, professor Simon Chapman, a determined opponent of vaping, suggested that Butler might ban refillable vaporizers as well. The planned legislation will require federal authorities to seize products at the border and states to police retail sales, but so far, it has not allocated any funding to enforcement.
The proposed plan is de facto prohibition, according to Colin Mendelsohn, a former GP who has been helping smokers quit for more than 30 years. “It is a doubling down on a failed highly restrictive model that has been rejected by vapers and prescribing doctors and has created a thriving black market, which sells freely to underage users,” he says. “The history of prohibition and the war on drugs shows consistently that it does not reduce long-term illicit drug supply, and there is no reason to believe that this will be different. Bans are effective short-term political strategies but are bad public health policy. The Australian Border Force (ABF) does not have the resources or interest in intercepting vapes and is correctly more focused on dangerous illicit drugs, such as heroin, cocaine, ice, etc., or weapons.”
In an interview in May, ABF Chief Michael Outram warned that banning vapes at the border wouldn’t be enough to stamp out a rampant black market, as his organization managed to intercept barely 75 percent to 80 percent of illicit drugs making their way into Australia “on a good day.” Of the 8 million containers coming into the country each year, only 1 percent to 1.5 percent are scanned.
The proposed crackdown, cautions Mendelsohn, will likely have many unintended consequences. “Criminal networks will continue to find ways to import vapes,” he says. “This is a high-profit and low-risk crime, and it is accompanied by stand-over tactics, such as firebombing of retail outlets, gang wars and violence, and corruption of officials. The proceeds fund other, more serious criminal activities. There will be continuing sales to youth and more difficult legal access for adult smokers. Some vapers will relapse to smoking. It will be harder for current smokers to switch to vaping.”
According to Mendelsohn, the planned law will criminalize otherwise law-abiding citizens who simply want to improve their health, and cause the government to lose revenue from taxes, licensing and vape shops while shouldering increased cost of policing, enforcement, the justice system and prisons. “We will continue to see dodgy, mislabeled, unregulated products with high nicotine levels,” he says. “The harm from unregulated black market products was demonstrated during the EVALI [e-cigarette or vaping product use-associated lung injury] outbreak. There will also be higher prices, increased drug potency [and] stockpiling of nicotine e-liquids prior to the change. All legal, legitimate vape businesses will be closed. It’s a violation of the human right to access a safer alternative to smoking.”
Unsuccessful Measures
Low-income and otherwise disadvantaged people, among whom rates of smoking and smoking-related death and disease are significantly higher than in the rest of the population, will be disproportionately affected, according to Mendelsohn. “Australian research has shown that vaping may help to reduce health inequalities,” he says. “Smoking is a leading cause of financial stress in disadvantaged populations, especially at a time of sluggish wage growth, high interest rates and a high cost of living. Spending is diverted from food, clothing, etc., to smoking.”
Australia has the highest cigarette prices in the world, with a pack of 20 retailing at AUD40 ($25.60). Based on a consumption of 13 cigarettes a day, the average cost of smoking is AUD11,850 per year. Vaping, by comparison, costs AUD500 to AUD1,500 per year, depending on the device used.
“At the current high levels, further tax rises are no longer effective due to the law of diminishing returns,” says Mendelsohn. “Many addicted smokers are simply unable to quit no matter how high the price. Smoking rates in Australia have not declined over the last four years in spite of high prices, plain packaging and other tobacco control strategies.”
So where’s the consumer in all of this? Mendelsohn says that the lack of a consumer voice is a big problem. “We had a New Nicotine Alliance AU, which disbanded about five years ago. Recently, the Australian Smokefree Alternatives Consumer Association was formed but is still very quiet. Legalise Vaping is a part of the Australian Taxpayers Association and is the most active advocacy group. I believe they have had some indirect tobacco company funding in the past, but they are focused on legalizing and regulating vaping and the rights of adults to make their own choices. Overall, they do an excellent job with limited resources. All anti-vaping groups are subject to great scrutiny and are smeared and undermined by anti-vaping advocates if there is any potential opportunity.”
Ideology Instead of Science
Butler’s plan has attracted criticism from several institutions. On July 8, internal confidential e-mails sent by members of the Australian National Advisory Council on Alcohol and Other Drugs (ANACAD) expressed concerns about further restrictions, saying it would exacerbate the black market problem, criminalize more people and make smoking more attractive. On July 18, Mendelsohn and a group of more than 40 experts from Australia and New Zealand urged lawmakers to listen to the ANACAD ahead of Butler’s proposed vaping crackdown. At the time of this interview, they had not received a response to their letter.
Mendelsohn is not optimistic that Butler will change course. “Butler has committed himself to this crackdown, and there is no indication that he will soften his approach,” he says. “He is taking advice from a small group of ideologically driven tobacco control academics and health bureaucrats with extreme anti-vaping views.” According to Mendelsohn, Butler operates in a bubble and is ignoring the pro-vaping arguments. “He has refused to meet with Dr. Wodak [a fellow tobacco harm reduction proponent] and me, although we met with his adviser, who was clearly committed to a predetermined position,” says Mendelsohn. “He is under considerable pressure from Australian health charities, medical associations, public health organizations and state governments that are almost universally opposed to vaping. The media is also hostile to vaping. Any turnaround will be very difficult politically.”
Vaping policy in Australia, says Mendelsohn, is driven by ideology rather than science. “Australia’s peak health and medical research organization, the National Health and Medical Research Council (NHMRC), prepared an anti-vaping position paper on vaping. The NHMRC is very influential in guiding national health policy. The NHMRC document was critiqued in a peer-reviewed article in Addiction by leading Australian and international experts and found to be riddled with serious scientific flaws and misinformation. However, it remains unchanged.”
For sensible regulation of vaping, says Mendelsohn, Australia should look to its neighbor, New Zealand, which in August 2020 legalized and regulated vaping. “Over the next two years, there was an unprecedented 33 percent decline in the adult smoking rate among those aged 15 and over—from 13.7 percent to 9.2 percent. In Australia during the same period, the smoking rate increased by 4.5 percent. In that time, there have been no major smoke-free policy interventions, almost no mass media spend on quit campaigns and no tobacco tax increases in NZ.”
Lessons From Drug Policy
Alex Wodak
Alex Wodak, Mendelsohn’s ally in the battle for harm reduction-based legislation, is more confident that Australia will eventually change its stance on vaping. Wodak has dedicated his career to drug harm reduction and was instrumental in reforming drug law in Australia. Together with colleagues, he created the country’s first needle exchange program in 1986 and its first medically supervised injecting center in 1999. At this time, both were pre-legal.
He observes parallels with his country’s current crackdown on vaping. “The World Health Organization opposed drug harm reduction, including needle and syringe programs for a few years in the 1990s, apparently relenting to intense U.S. pressure,” says Wodak. “The default policy for communities, governments and the WHO for new drugs, new forms of drug administration and new forms of drug harm reduction is generally negative. It seems sensible to be initially cautious about changing situations regarding drugs, but we have a problem when the opposition to a new form of drug harm reduction is maintained long after the evidence of effectiveness and safety has become compelling, especially when the costs of delay are so substantial as they are with needle and syringe programs and tobacco harm reduction.
“The case in favor of vaping and other forms of tobacco harm reduction is now overwhelming. Smokers increasingly prefer to continue to use nicotine but prefer to consume it in safer ways. Many traded tobacco companies are transforming from combustible cigarettes to safer products, some faster than others, but they are changing. Investors pay higher prices for tobacco companies transforming more rapidly. Unfortunately, tobacco control, governments and the WHO are still resisting change, which now seems inevitable. This change is an enormous opportunity for public health, similar to the scale of the benefits from vaccination.”
Wodak remembers the time when harm reduction was refused in favor of an abstinence-only approach in drug policy circles. “The political debate lags behind the scientific debate,” he says. “There are many lessons from this experience. It is important to continue improving the quantity and quality of evidence. It eventually does make a difference. Being polite and respectful to harm reduction opponents matters. So does persistence. There are no shortcuts. Harm reduction involves consequentialism—that is, making an assessment of both the benefits and costs of a policy or intervention. Opposition to harm reduction often involves deontology—that is, following a set principle, such as aiming for a tobacco-free—or nicotine-free—outcome rather than a smoke-free outcome. The net effect of the policy or intervention is not a concern.”
Staying Power Needed
The current approach of the Australian government to vaping is unsustainable, Wodak emphasizes. “It is destined to collapse sooner or later,” he says. “Opponents of harm reduction are unable to justify why a far safer option is severely restricted while a deadly option remains readily available. Despite dominating politics, mainstream media and medical and health publications, 73 percent of Australians support vaping being regulated like cigarettes and alcohol while only 20 percent support prescription-only regulation of vaping.”
The new approach announced by Butler on May 1 requires legislation to be passed by the House of Representatives and the Senate. “This legislation will most likely be passed by the House of Representatives but is unlikely to be passed by the Senate,” says Wodak. “The black market currently meets 92 percent of the demand from a rapidly growing number of adult Australian vapers, now estimated to number 1.3 million. Although the government asserts it will strengthen law enforcement border efforts to reduce the number of illegal vapes entering Australia, now estimated at about 10 million per month, no additional funds have been provided for this purpose. Heroin was prohibited 70 years ago in Australia. However, in 2022, a survey of people who use drugs found that 87 percent said that obtaining heroin was ‘easy’ or ‘very easy.’ When demand for a good or service is strong and controls are easy to subvert, as is the case with vaping, other sources of supply almost invariably emerge.”
Wodak views the battle for vaping reform in Australia through the lens of drug harm reduction rather than from a perspective of tobacco control. “I have been involved in battles for drug law reform in Australia over about 40 years. We have won almost all of these battles, although it has often taken more time and effort than we would have preferred. I am very confident that tobacco harm reduction will prevail in Australia. Taking a bet against drug harm reduction is very brave as harm reduction almost always wins.”
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
“The more things change, the more they stay the same,” is an expression that has been around for almost two centuries, and it speaks to the fact that the small picture(s) of life may change, but the larger one does not. The vape industry and all the challenges and changes that have happened in the past decade are totally contrary to that famous saying.
A decade ago, the vape industry was the epidemy of the Wild, Wild West, full of vape shops springing up on every corner, and any/everyone creating e-liquids in their bathtubs at home. Regulation and competition changed all that and brought some semblance of “orderliness” to the market, but as state and federal regulations bombarded the industry, and with the FDA creating onerous and unattainable guidelines, the vape space has truly become one of survival.
I recently attended a vape event in Phoenix which brought together several dozen top manufacturers, distributors, and buyers, and universally everyone lamented the same concern: business is down.
Why is business down?
The reasons are many, including strict regulations, and now, even more enforcement of those regulations, but overall, the cause was much simpler. The huge COVID-19 rebound in 2020-22 put more money in consumers’ pockets and more time on their hands. Those issues combined created an artificial bubble that many thought would last. But time has passed. Add in the inflation that has pushed up food and other cost of living expenses, and some former necessities are now becoming unaffordable luxuries.
“It’s a balancing act between the addictive nature of some nicotine products and the limitations of buyer’s budgets,” said Jamie Reed with Simple Vape Supply from Orange County California. “I’ve been in the industry for over ten years, and this is evolution in its purest form and based around ’survival of the fittest.’”
Simple manufactures and distributes over 100 different assortments of nicotine cartridges, including disposables, including various iterations of CBD, Delta-8 and Kratom.
“It’s interesting,” Reed added. “When I got hired, I was told that there was an ‘expiration date,’ and we all knew that this industry might not last, and that the cream would rise (to the top). We planned to be one of those surviving companies, and we’ve been able to adapt to the times.”
Her company, along with many that are still around, were mostly run by rebels, radicals, and envelope pushers; and many have in fact changed accordingly, but some have merely learned how to “play the game” and outwardly appear to be toeing the line, but the reality may be different.
“We were aware that the COVID blip was a one-time event. People were home, they had government money to spend, and no one was checking in on them or requiring any urine tests. The Delta (8,10) boom really added to that, and everyone jumped on that bandwagon,” she said excitedly.
That line of CBD was an example of how the industry has and continues to push back. The FDA says you can’t do this, so the industry says, “F-you, then we’ll do that.”
With regulation eliminating or reducing product selection, almost any industry will do the same thing: adapt; repurpose, or reposition.
Of the dozens of people I spoke with at the event, the numbers (from shop owners and manufacturers) were pretty consistent, and most of them were down 20 to 30 percent. Many were saying that purchase sizes were lower than normal and a typical ten-thousand-dollar order was now half that. They saw some shops closing, but most were working on smaller revenues.
Manager J-K Thorne holds some of the flavored products that are no longer available at Wild Impulse vape shop. (Shane Hennessey/CBC)
Meanwhile, on the other side of the equation, vape liquid manufacturers who are trying to “play the game” right and submitting premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration are frustrated at the amount of time it takes and how much money is being thrown into a (seemingly) dark hole.
I spoke with one of the owners of a large vape manufacturing business and distribution company in Idaho, and he shared some facts and figures about their process of trying to make their products “legal.” Legal, in the eyes of the FDA, has caused his company to squander over $5 million in the past few years trying to get authorization.
Mike Larsen is a detailed and focused vape guy who has been in the industry for over a decade and is with Lotus Vaping Technology, which started in 2011. As a partner and director of sales, he is on the front line of everything the company does to stay legal and compliant and is riding the roller coaster ride on a daily basis.
“Disposables have really changed the game,” he said, “and they have reduced the role of vape shops where people used to come for education and guidance. Consolidations and closures have also reduced the shop numbers by 30 to 40 percent, and now you have larger conglomerates doing the work of the multitude of shops.”
We spoke about a possible flavor ban nationally, and he said he was skeptical.
“The PMTA process has already reduced or eliminated flavors, so it may not be necessary to go to that length. There have been between six and seven million submissions by thousands of companies, and so far, just 23 have been approved. I know of a few companies that submitted over a million applications themselves. And here’s the irony: everyone approved has been a Big Tobacco company, and they make up just a fraction of the total vaping market.”
The second irony on top of that, is that those so-called approved products are ones that no one wants.
We talked about whether those approvals were fair or were the result of favoritism and bias, and he smiled since we both knew the answer.
“When you look at the PMTA process and the rigid requirements, it seems pretty obvious that they were written to the advantage of the larger, established companies, and the “small guy” had very little chance in this skewed game. You can’t even budget for something like this,” he continued. “The original filing costs over a million dollars, and I know several companies that have put another ten million in, only to get denied. Who has deep pockets like that? In 2016 I could have named over 150 liquid companies doing good business; today I can name about three dozen.”
And that is why the number of companies manufacturing tobacco and vape products is half what it was and is getting smaller every year. The FDA changes the rules of the game continually.
“There’s something happening here, but what it is ain’t exactly clear,” is the beginning line of a song that speaks to changes going on in society. That song by Buffalo Springfield may have nothing to do with vape, but the message says the same thing: there is something happening here although it may be clearer than we realize. We all knew this would happen; it was predicted a decade ago.
In the vape space, the more things change…the more things change.
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.
By Jean Gonnell, Christina Sava and Nicholas Ramos (Troutman Pepper Hamilton Sanders Tobacco and Cannabis Team)
Across the United States hemp products seem to be everywhere. From corner stores to spas, one can find a hemp- or CBD-infused version of almost anything. Hemp and its derivatives are found in foods, cosmetics, hand-rolled cigarettes and vape pens. A new category of “intoxicating hemp products,” such as delta-8 THC products, have taken the hemp industry by storm. Although the market is vast, the regulatory landscape contains many pitfalls. Potential market entrants must carefully research the applicable laws, and take into account any federal-level risks, before deciding to invest in a hemp or hemp-derived products venture. This article reviews the legal status of hemp-derived products, including smokable hemp products, at the state and federal levels.
Marijuana and Hemp
Marijuana and hemp come from the same plant: Cannabis sativa L., or “cannabis” for short. Cannabis has a long history of industrial and medicinal uses, and only a short history of prohibition, which we now see unraveling. “Hemp” is the common term for cannabis with a concentration of delta-9 tetrahydrocannabinol (“THC”) of .3% and under, while “marijuana” is used to mean cannabis with a delta-9 THC concentration over .3%. Marijuana remains a Schedule I substance under the Controlled Substances Act (“CSA”). Hemp production, on the other hand, was legalized by the Agricultural Improvement Act of 2018, or 2018 Farm Bill. At that time, Congress removed “hemp” and “tetrahydrocannabinols in hemp” from the CSA’s definition of “marijuana.” Specifically, the 2018 Farm Bill defined “hemp” as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3% on a dry weight basis.” 7 U.S.C. § 1639o.
So, although they are technically the same plant, hemp and marijuana fall under completely different regulatory regimes, with a single cannabinoid – delta-9 THC – determining whether a cannabis plant or product is hemp or marijuana.
THC, CBD, and Other Cannabinoids
There are over 100 cannabinoids found in cannabis. Perhaps the most well-known of these are cannabidiol, or CBD, and delta-9 THC. CBD is considered non-psychoactive and generally prized for its therapeutic potential. Delta-9 THC has long been recognized as the cannabinoid that causes users to feel “high.” Since the 2018 Farm Bill, however, other psychoactive THCs, such as delta-8 and delta-10 THC, have been identified in cannabis. The “high” produced by delta-8 THC has been described as partway between THC and CBD, with relaxing body effects and a less-potent “head-high,” while delta-10 has been described as producing a more cerebral high akin to sativa strains of marijuana.
So why the boom in delta-8 and delta-10 THC products now? They can be derived from hemp. Although found in much lower quantities in hemp than other cannabinoids, manufacturers have found ways to chemically convert hemp-derived CBD into delta-8 and delta-10 THC. Even delta-9 THC is being converted from CBD, and manufacturers are adjusting product ratios to remain within the .3% limit. The Cannabis Regulators Association has called this the “0.3% loophole” and stated: “While the threshold of 0.3% delta-9 THC (tetrahydrocannabinol) by weight is a small amount of THC in a hemp plant, when applied to hemp-derived products (e.g., chocolate bars, beverages, etc.) which can weigh significantly more, 0.3% by weight can amount to hundreds of milligrams of THC. For example, a 50-gram chocolate bar at 0.3% THC would have around 150 mg of THC (30 times the standard 5 mg THC dose established by the National Institute on Drug Abuse).”[1]
The Drug Enforcement Administration (DEA) more or less gave the hemp-derived delta-8 industry a green light in a September 2021 letter to the Alabama Board of Pharmacy. The Board of Pharmacy inquired as to the control status of delta-8 THC under the CSA. DEA concluded that “cannabinoids extracted from the cannabis plant that have a [delta-9]-THC concentration of not more than 0.3 percent meet the definition of ‘hemp’ and thus are not controlled under the CSA.” Thus, so long as delta-8, delta-10, and other extracts are derived from a cannabis plant with less than 0.3% delta-9 THC, they constitute “hemp,” which is federally legal.
Notably, “synthetic tetrahydrocannabinols” remain a schedule I substance under the CSA. Some argue that because delta-8 and delta-10 are produced through a form of synthesis, they are Schedule I “synthetic tetrahydrocannabinols.” Regardless of this argument’s merit, this is not the position DEA has taken thus far, and we do not see any indication that they will suddenly take this position in the near future.
FDA Enforcement and the Future of CBD Regulation
Nonetheless, hemp-derived CBD and THC products are still not legal to be sold as a drug, dietary supplement, or food, according to the Food and Drug Administration (FDA). To the extent a manufacturer markets its delta-8 (or CBD) products as intended to affect the structure or any function of a consumer’s body, FDA’s position is that the product is an unapproved drug. In addition, “food” (almost anything edible that is not an approved drug or lawful dietary supplement) may not contain unapproved additives. Any form of CBD and THC are not approved food additives.
FDA has also concluded that THC and CBD products cannot be marketed as dietary supplements, because the definition of “dietary supplement” excludes active ingredients that have been approved as drugs or have been authorized for investigation as a new drug. THC and CBD are both active ingredients in at least one FDA-approved drug. Other parts of the hemp plant that do not contain THC or CBD might be available for use as dietary supplements, so long as manufacturers abide by related requirements, including notifying FDA.
And, FDA is watching the marketplace closely and taking enforcement action where it sees fit. FDA has issued numerous warning letters to companies selling hemp-derived CBD and THC products with impermissible health or therapeutic claims; for misbranding, such as lacking adequate directions for use; and for using these cannabinoids as an unapproved additive in foods, such as gummies, chocolate, caramels, chewing gum, and peanut brittle. The agency has also published a general health warning for delta-8 products.
Industry and regulators alike have been anticipating some kind of regulatory action by FDA, but it appears this is yet far off. In January of this year, FDA determined that it does not have the appropriate regulatory pathway to regulate CBD products and called on Congress to pass legislation creating a new pathway separate from the food, drug, or dietary supplement pathway. Despite this regulatory uncertainty, sales of CBD products in the U.S. continue and could reach as high as $20 billion by 2025.
States and Hemp-Derived Products
Given the lack of federal standards and delta-8 and delta-10 (and likely other THCs’) psychoactive effects, state lawmakers are taking action to regulate products containing these extracts. At least 22 states have restricted or banned the sale of delta-8 THC products, while others are in the process of reviewing the cannabinoid’s status. One common way states are doing this is by limiting the total concentration of THC a product can have, rather than mirroring federal law and limiting only delta-9 THC concentrations. In Colorado, lawmakers have passed SB23-271, which goes further and actually classifies nonintoxicating cannabinoids, potentially intoxicating cannabinoids, and intoxicating cannabinoids. Products will be regulated according to which category of cannabinoids they contain.
In many states, a “ban” actually means that these products will only be available in licensed cannabis dispensaries where regulators can more easily track their production and sale, ensure that the products pass required contaminant testing, and prevent the products from being sold to minors. Retailers and manufacturers of hemp derived products, especially those wanting to sell nation-wide, must be diligent in tracking state by state restrictions on hemp-derived products.
Smokable Hemp
Smokable hemp, although it receives less attention than other forms of hemp products, is a major driver of hemp product sales. Smokable hemp is hemp flowers after they have been manicured and dried. Smokable hemp can be sold as “buds” or in pre-rolled hemp cigarettes. This hemp looks and smells a lot like traditional marijuana but is not psychoactive. While some users may feel a mild mellowing effect, most do not feel “high” after smoking hemp. This may be why smokable hemp is the only hemp product category that has experienced wholesale price increases over time.
The legal status of smokable hemp, however, also varies from state to state. Smokable hemp is illegal for sale in a handful of states, including Idaho, Iowa, Kentucky and Massachusetts. Other states do not place any restriction on its sales.
New York has banned hemp flower products that are “clearly labeled or advertised for the purpose of smoking or in the form of a cigarette, cigar or pre-roll.” California does not currently permit the sale of any “inhalable hemp” products, however labeled, having passed a law that prohibits the sale of such products until a tax on the products has been enacted. No such tax is yet in effect.
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Given the above, it is not safe to assume that your hemp product is legal for sale because hemp is federally legally. It is important for retailers and manufacturers to be aware of the laws that apply to the types of hemp products they are selling. Although the DEA has been hands-off since the passage of the 2018 Farm Bill, FDA oversees all foods, drugs, and dietary supplements in the U.S. and maintains that THC and CBD, even though hemp derived, may not be added to foods and dietary supplements, or marketed as drugs. FDA does not oversee inhalable substances generally, and thus has not released statements related to the legality of smokable hemp. Smokable hemp may be a good market entry point, especially for manufacturers and retailers already familiar with highly-regulated inhalable products.
Troutman Pepper’s Cannabis Practice provides advice on issues related to applicable state law. Cannabis remains an illegal controlled substance under federal law. Its attorneys are available to provide more information about these opportunities.
For 15 years, Haka Korea has been making innovative strides in the fast-growing global vaping market.
By Timothy S. Donahue
E-cigarettes are a less risky way to use nicotine. If they were more harmful than combustible tobacco products, the U.S. Food and Drug Administration would not have authorized 23 vaping products for sale. Likewise, the U.K. would not be promoting vaping products as tools to help cigarette smokers quit if they were not less harmful than traditional cigarettes. E-cigarettes and other vaping products are tools for harm reduction, and there’s plenty of research to confirm this.
According to a Statista survey conducted in South Korea in 2021, around 33 percent of men smoked cigarettes. However, cigarette use in the country has steadily declined. This can mostly be attributed to the rise of e-cigarettes and other less risky products, such as heated-tobacco devices, taking a more prominent place in the market. In 2020, KAMJE, the journal of the Korean Medical Association, published an article citing medical experts advocating for wider availability and softer regulations regarding e-cigarette use because of vaping’s potential to help smokers quit or switch to less risky products.
“There is an ongoing debate within the public health community about e-cigarettes on whether they have a potential role in smoking cessation. ‘Quit or die’ is no longer the only option for those who cannot quit,” the article states. “Safer nicotine products offer another way. There is substantial international and independent evidence that these products are safer than cigarettes.”
Haka Korea was founded in 2013 and has been widely recognized in the vaping industry for its advancements in technology and consumer-orientated services. Haka leadership said the company strives to improve the lives of both smokers and nonsmokers, and it endeavors to offer the best products and services with its customer-focused approach. However, the Korean market presents its challenges.
“Right now, the Korean e-cigarette market lacks a concrete regulatory framework. Furthermore, taxes imposed on the product are incredibly high. It’s an unbalanced system,” said a Haka representative. “These laws and rules are handled by different governmental departments, leading to difficulties in implementation. Additionally, taxes must be paid in a variety of ways, making it hard to manage.
“Given that there is no powerful group yet spearheading this cause, it will be a challenge to change preexisting laws to fit current circumstances. Nevertheless, our team believes that if these laws can be modified and adjusted through sustained struggle, the possibilities for growth in the e-cigarette sector in Korea would be massive, and competition could be sustained. It won’t be easy, but we think it’s worth taking on.”
Haka is focused on providing safe and reliable products and services. The company works at these goals in a socially responsible manner and is dedicated to developing and maintaining ethical standards, according to the representative. Haka products have been tested and certified by several regulatory bodies in several countries, including the European Union.
In 2016, Haka Korea was honored with the Product Safety Commendation by the Korea Standards Association, a branch of the Korean government. The commendation served as confirmation of the product’s safety, according to Haka’s spokesperson.
During the following years until 2023, Haka has been awarded the Best Brand Award Selected by Consumers at an event co-hosted by the newspaper JoongAng Ilbo and Forbes Korea. The awards were sponsored by Korea’s Ministry of Science, ICT and Future Planning and the Ministry of Trade, Industry and Energy.
Haka has made several industry advances. For example, the company has been granted a patent for an adaptable charger that is compatible with mobile phone chargers. After introducing Haka Premium in 2013, it sold over 2 million units and became legendary among early e-cigarette users in Korea.
During the vaping sector’s early years, which were plagued by defective devices, the company also implemented one of the industry’s first warranty programs to guarantee customer satisfaction. In 2013, the company also found fame in the development of its micro five-pin charging method. It has also excelled at creating several safety protocols, better batteries and two safety protection circuits that are installed on all of Haka’s hardware.
“In 2015, we registered our most groundbreaking product yet—an automatic system that was powered by minuscule currents from the human body without the need for buttons. This caused quite a stir within the industry. Haka Korea strives to continue innovating and researching new concepts,” the Haka representative said. “Despite being one of the leading domestic electronic cigarettes on the market, external pressure due to regulations has been mounting. Nevertheless, we did not give up and released the CSV pod system, known as Haka Signature, in 2019, setting ourselves up for a new successful leap forward.”
Haka is taking a proactive approach to protect the health of smokers who have quit combustibles using its products. For instance, Haka Korea has implemented a “no smoking” policy in all its stores, which prohibits the use of any tobacco-based or nicotine-based products. Haka Korea also offers a wide range of smokeless tobacco products, such as heat-not-burn devices, to provide customers with options that are less harmful than traditional smoking.
In addition, Haka Korea provides information and resources to its customers on the potential health risks associated with smoking. “Haka Korea provides quality customer service and strives to create a safe and comfortable shopping experience for all customers. Haka Korea has established a customer service center to assist customers with any queries related to the company’s products and services,” explains the spokesperson. “In addition, Haka has created a website that allows customers to easily find information about products and services as well as to place orders online.”
Haka has applied for and registered over 30 patents in areas such as trademarks, designs and technology. Furthermore, they have received several mandated certifications, such as CE (European Commission certification), RoHS (Restriction of Hazardous Substances Directive), KC (South Korean standards) and SGS (South Korean Assessment, Auditing and Certification).
To comply with various regulations globally, the company works to ensure that all authorized retailers of Haka products comply with domestic laws and regulations and are effectively managed. In addition, Haka has established an authorized retailer training program to ensure that staff are knowledgeable about the company’s products and services.
Haka says it is making great strides to expand its presence in the domestic electronic cigarette market. Currently, Haka Korea has 50 directly managed stores located nationwide, and the company plans to open more than 100 directly managed stores by 2023. In addition, Haka Korea is actively working to increase its presence in the online market, with plans to launch an online marketplace for its products soon.
There are currently over 700,000 former smokers using Haka Signature, according to company data, and more than 3 million products have been sold. The company states that more than 50 million pods have been produced, and those numbers keep growing day by day.
Haka saw the opportunity in the Korean pod vape market and teamed up with FEELM, a leading closed-pod atomization company, to produce Haka Signature—a closed pod system powered by FEELM’s innovative ceramic coil heating technology. Retailers said after the release that Haka Signature’s space-like design helped it stand out from the competition, differentiating itself from most conventional USB drive-like and cig-a-like products on the market. Closed pod system products account for over 90 percent of total revenues for Haka.
Haka decided to collaborate with FEELM by introducing Signature’s ceramic coil vape pod to the Korean market for the first time. Not only did this solve several familiar complaints from e-cigarette users (e.g., spitback and burnt taste), but it also reduced the leakage rate to an unprecedented 5 percent, which is far lower than the cotton coils used in competitive products, according to FEELM data.
Moving forward, Haka leadership intends to continue making significant strides in research and development to create products dedicated to health. The company is investigating different facets of the healthcare industry and brainstorming progressive solutions that it could potentially offer to not only its current clients but to the broader global market. In the end, Haka Korea hopes to establish continuous growth.
“This shift toward healthcare-focused brands shows our dedication to spreading the message of healthier choices. It is a lofty goal, but with our proficiency, commitment to introducing new ideas and focus on quality, we feel prepared to bring this vision into fruition,” the Haka representative said. “Ultimately, Haka Korea’s long-term ambition is consistent growth within both the e-cigarette and healthcare industries while providing excellent products and services for consumers.
“We wish to assist those who want to quit smoking by giving them accessible options and helping people lead more healthy lives with a diversity of products. This expresses our dedication to establishing healthier lifestyles and choices among consumers. It’s an ambitious aim, but with our expertise, dedication to advancing the field and focus on quality, we know we can achieve it.”
The market share of open pod systems on the Korean market is much higher than in other regions.
By VV staff report
Korea Vape Show 2023 (KOVAS) is the best launching point for entering the Korean market, according to a Wingle Group report of the show. Wingle is a Hong Kong-based business platform company founded in 2010 that facilitates mutually beneficial cooperation between consumer electronics, healthcare and e-consumer companies.
KOVAS is a vaping business exhibition that connects domestic and overseas distribution buyers and companies from more than 20 countries. The dynamic event exhibits the latest technologies from the vape industry, and more than 50 companies were given the opportunity to promote their products to more than 15,000 visitors. KOVAS was held in late July at the Korea International Exhibition Center, commonly known as KINTEX, located in Ilsanseo-gu, Goyang, Gyeonggi Province, South Korea.
Listed below are 10 takeaways from the Wingle report:
The Haka brand showcased its Haka Q (Metex Melux) heated-tobacco system with Bluetooth connectivity for consumption tracking. Haka also promoted its new disposable e-cigarette Haka S, Haka Glow with the FEELM Max ceramic heater. Haka is completely powered by Shenzhen Smoore Technology.
Aspire launched its prefilled pod system Gotek S. The next planned market is the U.K. The company also showcased its new Peboo pod mod.
Geekvape presented the Geekvape & PAX Vape pod mod with VPU technology for an improved vapor performance.
Daddy’s Vapor promoted the Pyro 6000 disposable powered by Smoore’s Topower battery solution, which claims to have 30 percent more capacity compared to mainstream batteries with the battery size remaining unchanged.
Korean wholesaler Dragon Vapes promoted Uwell’s upcoming releases: Valyrian Air, Valyrian Pro and Valyrian Max pod systems.
Pura presented two new products: Pura Legend pod system and the Pura MyBox 5000 disposable.
Smok showcased its new Spaceman SP7000 disposable with battery and e-liquid indicators.
Innokin launched Klypse Mecha and Innobar R2 open pod systems.
Several new high-capacity disposables with a display were highlighted: Vapengin Nimmbox 8500, Orca Air 7500, Yooz BC8000, Mosmo VD8500, Mosmo SO7500, Mosmo Jucy Punk II 7000, Oukitel Aqua 12000, Oukitel 9000, Sanyeah C290 5000, Firerose IN7500 and Nasty DX 8.5i.
There were also several new compact-size pod systems: Aspire GoTEK Pro, Smoant Levin, Pura Legend, Viento Magnum, Innokin Klypse Mecha, Innokin Klypse Zip, Innokin Innobar R2, Rincoe Jellybox V1, Rincoe Jellybox V2 and Rincoe Jellybox V3.
Most of the presented and marketed devices at KOVAS have futuristic electromechanical designs with transparent bodies, according to the Wingle report, which also detected a trend toward making pod systems less expensive. Additionally, the market share of open pod systems on the Korean market is much higher than in other regions.
Heat-not-burn players on the Korean market include Smoore (Haka Korea), Shenzhen SMY (Pluscig, Morex) and Shenzhen Yunxi Smart (UWOO), according to Wingle. Smoore, the world’s largest atomization company, seemed to also attempt to generate new leads and establish new relationships for the expansion of its FEELM-powered devices. Disposable vaping products had a strong presence, and the segment continues to grow globally.
KOVAS 2023 was a success, according to Wingle. That may be due to South Korea’s next-generation tobacco market showing a booming trend in recent years, according to data from Euromonitor. The country’s heated-tobacco market was valued at KRW2 trillion in 2021 and is expected to reach nearly 2.5 trillion won by 2025. And according to a survey by the South Korean Ministry of Strategy and Finance, the share of the entire tobacco market held by the e-cigarette segment in Korea rose from 2.2 percent in 2017 to 14.8 percent in the first half of 2022.
The vaping industry is young at only 20 years old. However, Eve Wang, executive director of Smoore International and vice president of Smoore Technology, said the industry isn’t going to get much older if it doesn’t find a way to balance innovation and social responsibility. Wang should know. She has been in the industry for more than 17 years.
Heat-not-burn players on the Korean market include Smoore (Haka Korea), Shenzhen SMY (Pluscig, Morex) and Shenzhen Yunxi Smart (UWOO), according to Wingle. Smoore, the world’s largest atomization company, seemed to also attempt to generate new leads and establish new relationships for the expansion of its FEELM-powered devices. Disposable vaping products had a strong presence, and the segment continues to grow globally.