Tag: regulation

  • Innovative Focus

    Innovative Focus

    TabExpo returned to the nicotine show circuit in Bologna, Italy, in May with innovative industry insights.

    By VV Staff

    TabExpo is back. Since the inception of TabExpo in 1994, the industry trade show has provided exhibitors and visitors with interests in the nicotine industry an elite opportunity to showcase their products and network among contemporaries. This year, TabExpo was held at the BolognaFiere in Bologna, Italy, May 10–11, and visitors and exhibitors alike said the show exceeded their expectations.

    In November 2019, TabExpo was acquired by U.K.-based Quartz Business Media, owner and organizer of the largest network of tobacco and nicotine-related exhibitions and conferences in the world. This year’s event was attended by over 100 exhibitors and more than 2,000 visitors representing all aspects of traditional and next-generation nicotine products from leaf suppliers to e-liquid manufacturers.

    TabExpo is much more than a typical tobacco tradeshow. One highlight of TabExpo 2023 was its Innovations in Tobacco conference. The sessions mainly focused on the future of the nicotine industry and the roles sustainability and modernization will play. The congress sessions were often standing room only. Below is an overview of the sessions and the insights shared by the numerous speakers.

    Keynote: Flora Okereke, head of global regulatory insights and foresights at BAT

    Conversations on the regulatory environment in the nicotine industry can be complicated. During her keynote, Flora Okereke, head of global regulatory insights and foresights at BAT, told attendees that regulation is important because many of the industry’s tobacco harm reduction goals can be enhanced by the policy environment. However, regulation can also create an obstacle.

    Okereke said that beyond regulatory policy, innovation is driving the transformation from both within the manufacturing supply chain and the retail sector. “In the past year, there has been a huge upheaval as a result of innovation, as a result of acquisitions, as a result of what we are doing in a journey to transform our industry,” she said. “You can see this in the amount of products that are new and coming to the markets, and the technologies that are coming up, and the kind of ways that we are monitoring environmental issues.”

    Additionally, the nicotine industry is no longer made up exclusively by major tobacco companies. Most of the innovations, such as e-cigarettes, were developed by entities outside the traditional tobacco sector. When considering the regulatory environment for next-generation products, Okereke said that regulators should not regulate blindly and must take the time to consider the impacts regulation can have on harm reduction goals.

    “I will say that because of the transformation, because of the eagerness for us to move from smoking tobacco to our newer products, expectations that are being made without proper milestones are going to create problems,” she explained. “I can [also] tell you regulation, while it is not something that you do daily, it’s a critical accelerant—a critical catalyst for our industry. It can derail what we are doing, but also, it can support a moving forward. This is why we have to not ignore it and put our head under the table but to face it squarely and be constructive as to how we look at it.”

    One of the potentially most impactful regulatory decisions being considered that could affect nicotine is environmental policy. Okereke said that environmental protection is now at the top of everyone’s agenda: many governments, many nongovernmental organizations, and it’s a public policy priority. There is even an environmental meeting at the global level being held by the United Nations trying to formulate a treaty similar to the World Health Organization Framework Convention on Tobacco Control  that, when it comes to plastics, is probably going to change our industry, she said.

    “The tobacco control advocates are calling on the prohibition of filters, on disposables, on the treatment of waste,” said Okereke. “This is happening not just at a global level; it is happening in most of the markets. So the sector needs to work together in a constructive manner to agree and determine how it responds to what is coming,” she said. However, if governments can put in place a regulation that permits companies to give clear communications to consumers to help them understand the relative risk of various products, that kind of regulation would be a catalyst that should work for everyone.

    “If the regulator would look at some of these new products … and understand that the relative risk means that they could be incentivized, maybe in a fiscal way, that will enable adults who would like to move away from smoking to make that movement because we all believe that what they want, what society wants and to some degree what some smokers want, or our consumers, is to have the choice to move to a reduced-risk product,” said Okereke.

    Another major issue driving regulation is concern about youth access, especially in relation to next-generation products such as disposable vaping devices. “It’s almost the underpinning reason that justifies why regulators are taking very extreme measures,” said Okereke. “And I think it’s important that we look at it. I think it’s important that we find a solution that addresses this issue,” she said. “It is also because of this, the regulators say, [that] issues like flavors are being treated negatively. Whether you are a manufacturer or a person in the supply chain, [it] is important that we find the right solution to address [youth access].”

    Okereke also discussed the latest regulatory trend: tobacco “endgame” legislation, which is a tool to end the use of tobacco. Unfortunately, some countries are looking beyond tobacco and using that concept to call for an end to nicotine in any form. “Please don’t ignore the endgame scenario and think that it refers only to cigarettes,” she cautioned. “It doesn’t.”

    In the end, Okereke said that all sectors of the nicotine industry must join together to fight for sensible harm reduction policies that drive consumers away from combustible tobacco products. Now is the time to work together to give the government a single message that less risky nicotine products have a role to play in smoking cessation, she insisted. “We need to defend and protect that space for all of us, especially during the upcoming COP10 in Panama later this year,” she said.

    Okereke also urged the industry to stress to regulators the value of harm-reduction products ahead of the WHO gathering. “I think it is time for you to use your access to your government,” she said. “Remember, the parties are the ones mandated to make decisions at this meeting. Countries have the mandate to raise their voice and their opinion.”

    Keynote: Patrick Basham, director of the Democracy Institute

    Communication is a problem in harm reduction circles. During his keynote address, Patrick Basham, director of the Democracy Institute, said that many medical professionals, consumers and anti-nicotine campaigners believe the narrative that all nicotine products are dangerous. Furthermore, many of these people wrongly believe that nicotine rather than the chemicals released during combustion causes cancer. They believe this, said Basham, because anti-tobacco harm reduction lobbyists have told them so.

    “These lobbyists have told them [these misconceptions] are true because they don’t trust tobacco and nicotine consumers with the truth, so they must alter it for them,” said Basham. “Now, it’s indeed true that most well-funded public health institutions and stakeholders are rabidly anti-tobacco harm reduction. The World Health Organization is the most clear-cut example. You’ve got billionaire philanthropists funding global campaigns that, in concert with the WHO, incentivized national governments and their public health agencies to ignore or to disparage tobacco harm reduction’s demonstrated ability to improve public health.”

    Many consumers, meanwhile, are either uninformed or ill-informed about tobacco harm reduction, and the specific products central to its implementation. Basham said that the ignorance is deeply frustrating because prohibitionist politicians, philanthropists, regulators, public health organizations and academics have consciously erected barriers to better consumer understanding of harm reduction products.

    Even more frustrating is that the governments of many smaller-sized and medium-sized nations look to organizations such as the WHO, the U.S. Food and Drug Administration and the EU for case studies, regulatory models, bureaucratic signals and political cover regarding tobacco harm reduction. However, what “our rulers and rule regulators say and what people believe about tobacco harm reduction and reduced-risk products is neither the actual truth nor the entire truth,” said Basham. “The good news about tobacco harm reduction is that the bad news is wrong.”

    According to Basham, the tobacco harm reduction experience is a positive story. Although it’s hard to be fair and balanced about tobacco harm reduction politics, the reality is that some steps taken by governments and public health bodies have empowered tobacco harm reduction while other steps have retarded its progress, he said.

    A good many countries, international institutions and public health organizations are employing and advocating for tobacco harm reduction policies and proven strategies to reduce cigarette consumption. Many governments have adopted quite sophisticated harm reduction strategies and policy prescriptions. To date, nearly 70 countries have adopted regulatory frameworks on reduced-risk products, and an enormous number and variety of electronic nicotine-delivery system products are in the marketplace, with nearly 16,000 flavors available and global sales rising to more than $15 billion. Heated-tobacco products are available in over 50 markets worldwide.

    “Only one Western democracy—Australia—still illogically and irrationally requires its citizens to possess a nicotine prescription to vape,” according to Basham. “Snus is legally bought in 81 countries. Reduced-risk products are already being used by 112 million people worldwide, with approximately 82 million vapers, 20 million heated-tobacco users and 10 million smokeless tobacco users,” he said, citing statistics from a Democracy Institute study. “The evidence in favor of tobacco harm reduction as a complementary intervention to help drive down death and disease from smoking is, I suggest to you, robust.”

    All the countries that adopted a regulatory framework for less risky nicotine products subsequently reported a dramatic decline in smoking prevalence. Countries that embrace vaping have witnessed a decrease in smoking rates that is twice as fast as the global average. “We now have extensive international evidence that vaping is the world’s most effective smoking cessation tool. Snus’ extensive contribution to improvements in Swedish public health is well documented,” he explains. “Let me just highlight that over the last 15 years, Sweden slashed smoking rates from 15 [percent] to 5.6 percent. The EU’s average smoking rate, meanwhile, is 23 percent, 4.5 times higher than Sweden.”

    When Norway allowed snus products to be more widely available, cigarette smoking fell by half in just 10 years. Japan’s tobacco harm reduction policies have led to a remarkable drop in cigarette smoking. In October 2020, the smoking rate in Japan dropped to a record low of 16.7 percent. Between 2016 and 2021, domestic combustible cigarette sales in Japan declined by 43 percent. This decline was directly attributable to the availability of heated-tobacco products, according to Basham.

    “So, tobacco harm reduction truly is a refreshingly good news story. That’s the reason governments around the world are increasingly placing tobacco harm reduction at the heart of their anti-smoking strategies. Governments should legalize the import, export, sales, possession and use of reduced-risk products,” said Basham. “Reduced-risk products should be as widely available as tobacco products and available without a prescription.”

    Panel: Reinventing for Sustainability

    Solutions to environmental concerns are not individual contributions but are built upon a series of interlocking breakthroughs and tweaks. That presents an almost composite picture of progress in the nicotine industry. Chris Greer, CEO of TMA, expressed this notion as moderator for the panel “Reinventing for Sustainability.” The discussion centered on how innovations are at the forefront of producing sustainable nicotine products from packaging to production to distribution to consumption.

    Everyone touched on new product innovation and that it will take the entire nicotine industry to work together to achieve many sustainability goals. Packaging, for example, transcends all consumer products. Innovations in packaging can help nearly all consumer product companies achieve a percentage of ESG goals. “In packaging, we have to react and change because of the pressure from the government or the environment,” said Michael Pierse, sales director at IRPLAST. “In 2018 and 2019, in the plastics industry, in our company, we all of a sudden realized that sustainability and environmental impact was no longer just something difficult we’re talking about, but it had to be enacted.”

    There is no cigarette company that would allow cigarettes to be sold unpackaged without wrapping film to guarantee the consumer receives the product in the same state it was when it came out from the factory (although they cannot prevent retailers in many developing countries from selling cigarettes by the stick to smokers with low disposable incomes).

    “We were faced with a challenge. Our product is fossil-based. Every kilogram of polypropylene film made from fossil fuels emits between 3.5 [kg] and 4 kg of carbon dioxide into the environment. That’s a very heavy fossil footprint to be addressed,” said Pierse, who highlighted his company’s NOPP (natural oriented polypropylene) tape, a new generation of high-performing and eco-friendly adhesive tapes manufactured with 50 percent recycled materials.

    There has been progress, too, on the front of filters, which remain one of the most commonly littered items on the planet. Filtrona CEO Robert Pye said his company has 10,000 future filter designs in a storage facility at its innovation center. He said that Filtrona is committed to more degradable and sustainable products. The higher degradability and nonplastic options of its ECO range is clear evidence of this commitment, he said. At TabExpo, Filtrona debuted its latest plastic-free innovation, the ECO Tube Triple Carbon Filter.

    “We’re all on the journey together,” said Pye. “So even in our traditional filters, we have very good partners that we also develop traditional cigarette filters with reduced carbon effects and increased sustainability. A real game changer is the ECO range. This is something that we can see that can definitely transform the industry.”

    ECO range is born out of partnerships with Filtrona’s customers and suppliers. There are many different forms that Filtrona can move forward with its filter technology, but Pye said the ECO range will help both his company and the traditional cigarette manufacturers it supplies meet ESG goals.

    “I know from our sales and through China we’re seeing probably half of our developments now based in sustainable products within our range. Our customers are driving us that way,” said Pye. “We are seeing different sorts of materials supplies and equipment supplies which will help us progress further in the journey to supply more of the ECO range. Of course, to get all of these plans together in the [necessary] scale is something we need to work through as well.”

    Schweitzer-Mauduit International (SWM), too, has been working to improve the sustainability of its products. Last year, the company launched Evolute, a fiber-based filtering media. Alice Jaussaud, product manager in the engineered papers division at SWM, said that the company has observed an acceleration of the demand for alternative solutions that is reinforced by societal trends toward sustainability. “We can say that, in terms of innovation, we do whatever is possible or in our control to make it happen,” she said. “And then it is about working together; it is a lot about partnerships.”

    Also discussing filters, Luis Sanches of Greenbutts said that of the more than 5 trillion cigarettes produced globally each year, the majority end up in the environment after consumption. Cigarette butts are the most littered plastic item on earth. While most of a cigarette’s components quickly disintegrate when smoked or disposed of, the filter will stick around for some time. Around 98 percent of cigarette filters comprise cellulose acetate (CA), a polymer that is slow to degrade in the environment. It can take up to 14 years for a CA filter to degrade, depending on the conditions of the environment where it has been discarded.

    One challenge, according to Sanches, is ensuring that a better biodegradable filter doesn’t change the user experience. “We want the consumers to have the same or even better experience that they have currently,” said Sanches. “This is pretty much our mission.”

    Greenbutts spent almost a decade designing and developing filters that provide comparable taste and filtration properties as current CA filters but will disperse in water within several minutes with agitation and begin to degrade in compost within several days, according to Sanches. “You don’t want your wine to be affected by the glass that you’re drinking. And you don’t want your pasta or your lasagna to be affected by the plate it’s served on. The same thing for a cigarette,” he said. “Nobody wants the filter to alter their taste of the cigarette.”

    The machinery producing the filters is integral to helping companies meet their ESG goals. Montrade has led the way in making machines for sustainable products with production speeds of 5,000 filters per minute. It is also creating sustainable packaging solutions, according to Antonella Giannini, co-founder and sales director of Montrade.

    “Montrade always strives to develop for the ever-changing and fast-approaching future,” she said. “We work to provide the means for the industry to transition into the next generation of environmentally focused products, including biodegradable filters and plastic-free alternatives for multiple product categories,” she said when discussing her company’s partnership with Greenbutts. “When designing for the ocean and environmental sustainability, our innovations in paper filter technology along with novel plant-based technology, such as the Greenbutts’ water-dispersing substrate, will work together to meet the requirements of the European Union’s Single-Use Plastics Directive.”

    Summarizing the session, Greer stated that, fundamentally, meeting ESG goals is about trust. “The most important ingredient in all of the things that you are doing is trust; the trust that you have between yourselves and your clients, the trust that you have with your internal teams,” he observed.

    Keynote: Tim Phillips, managing director of Tamarind Intelligence

    The global e-cigarette is worth more than $50 billion. There are also now more than 100 million vapers worldwide, according to Tim Phillips, managing director at Tamarind Intelligence. This year marks the 10th anniversary of Wells Fargo Managing Director Bonnie Herzog’s famous prediction that vaping products would overtake the combustible cigarette market. Herzog’s prediction was bold, said Phillips, adding that she could not have imagined the regulatory firestorm suffered by vaping products.

    Phillips noted that in another 10 years, Herzog could prove to be correct, however. “I was doing some very back-of-the-envelope calculations this morning, but I think if you give it another 10 years, we might well get there,” he said. “We’ve got combustible cigarettes slowing down in pretty much all Western markets. We’re seeing growth rates in some of these novel nicotine products in the 10s or many more percent points per year. And over a period of 10 years, I think we may well see [combustibles] replaced. I think my message to you is just be really careful of that. I think we’re going to see a massive acceleration of alternatives for nicotine products, and we will see a replacement of combustible tobacco over time. It’s just a matter of time.”

    Next-generation nicotine products come in three dominant varieties: nicotine pouches, heated-tobacco products and vaping products. Phillips said the segment is growing fast but at different rates in different areas of the world. It’s also very fragmented. “It’s completely different to traditional combustible cigarettes,” he said. “The market is growing in all sorts of different ways, and there are enormous opportunities to benefit from some of that growth. Consider nicotine pouches … we’ve got a fragmented market in a similar kind of format to vape about seven [years] to 10 years ago. There are more than 50 brands in some of the markets, including in European markets. And we’ve got more than 500 products in each of these markets. That’s a huge amount of fragmentation.”

    Phillips said his organization, which provided the data for his keynote address, originally thought the nicotine pouch would be an interesting product for consumers who are already using chew tobacco products in the U.S. or a snus product in the Nordic countries. “What we’re seeing is this product category is really of interest to consumers in all sorts of markets, and we see lots of crossover with other types of products,” he said.

    According to Phillips, the data shows a lot of multi-usage with next-generation nicotine products, especially pouches. “Consumers have moved from a mono market where the only way to have nicotine was to smoke cigarettes or another type of combustible tobacco,” he said. “We’re moving into a world where that’s completely different, where there are multiple ways of using products. And what we’re finding is the consumers are faced with a huge choice of different types of products and using many of them at the same time.”

    Such fragmentation is less evident in the market for heated-tobacco products. According to Phillips, the data shows huge growth in the number of compatible products. Many of them are hardware, and many of the vape companies’ manufacturers in China are now also manufacturing compatible heating tobacco hardware.

    “We’ve seen a massive growth in the number of compatible heat sticks, and many of them are nontobacco-containing—made out of tea, made out of various other products,” said Phillips. More products are competing with the major tobacco companies’ heated-tobacco brands, and Phillips said one of the reasons this is happening is regulation.

    “In Europe, as many of you know, we’ve got a directive banning flavors for heated-tobacco products. It needs to be implemented in European member states, and it is brought into their local law by July this year, and it should be implemented from October,” he said. “We’ve got a couple of countries that have implemented the flavor ban, but there are plenty of countries that have [not].”

    In the world of vaping, Phillips said that massive growth is happening in the disposable products segment. This started in the U.S. After the FDA banned vape shops from selling flavored prefilled pods, disposables began to take over the market. Today, there are thousands of new disposable products in the market. It is also the segment most blamed, after the fall of Juul, for the rise in youth vaping. Phillips said disposables drove the youth uptick, not flavors as most regulators would claim.

    “What I’m saying is it’s not really flavors that are driving this. But it is something where youth are using disposable products much more than an older age group,” he said. “We’re seeing those that initiate with vaping; we’re starting to see a younger age group come through and initiate into vape. Of course, that’s going to happen as the sector grows … the predominant product that those age groups are using is the disposable product,” said Phillips. “There is a correlation, if you like, between disposables and youth. And there’s no getting away from it. I think the industry just needs to face up to that.”

    Keynote: Simon Clark, director of FOREST

    If people want to smoke, they should be allowed to smoke. It’s not illegal to smoke cigarettes or vape or eat a giant cake. Today, even when there are consumer panels, every speaker tends to be an advocate of vaping. Current and former smokers in defense of smoking are conspicuous by their absence. Simon Clark, director of FOREST, explained that during a tobacco conference last year, one of the first speakers got a round of applause when he told the audience that it had been six years since he had successfully quit smoking.

    “Now, just think about that for a moment. A keynote speaker at a tobacco industry event is applauded for having stopped smoking. Now, for a moment, I thought I’d stumbled into a meeting of addicts anonymous,” said Clark.  

    FOREST, the Freedom Organization for the Right to Enjoy Smoking Tobacco, was founded in 1979. Clark said that the organization fully accepts the health risks of smoking but insists that the debate is not just about health. It’s also about freedom of choice, personal responsibility, risk and the infantilization of society.

    “We therefore represent adults who know about the health risks of smoking but choose to smoke and don’t want to quit,” said Clark. “We also represent former smokers like myself. People who are tolerant of smoking believe that smokers are unfairly discriminated against and are opposed to excessive regulations on consumer products such as alcohol, tobacco and sugary drinks. I’m often asked why, as a nonsmoker, I defend the rights and interests of confirmed smokers. By this, I mean smokers who don’t want to stop. I try to explain that I genuinely think smokers are treated appallingly these days, whether it’s comprehensive smoking bans, punitive taxation, creeping prohibition or the general denormalization of a perfectly legal habit.”

    Clark said that even at tobacco industry events, the thinking appears to be that anti-smoking campaigns and legislation don’t affect nonsmokers. Or people believe it’s impossible to win the battle, so just ignore the war. The problem with that attitude is that it invites advocates of the nanny state to move on to issues such as alcohol and food. “Some call this the slippery slope,” said Clark. “We’ve been warning people about this for more than 20 years. I think you’ll appreciate [that] it’s actually happening because alcohol is under increasing attack, as is the type of things that we choose to eat.”

    Twenty years ago, no government and relatively few politicians enjoyed being pigeonholed as a supporter of the nanny state. Public smoking bans changed the narrative because although they didn’t join most of the public support at the time of their introduction, smoking bans are now talked about as an allegedly popular example of the nanny state and action, said Clark.

    “A narrative has also developed suggesting that smoking bans have been an enormous success. We’re told that cafes and bars are no longer the horrible smoky environment of old, that smoking rates fell [because of] smoking bans. And public health has dramatically improved. Although there is relatively little evidence to support that thesis,” said Clark. “Nevertheless, the so-called success of public smoking bans around the world has clearly encouraged public health campaigns and governments to press on with other restrictive measures. Many anti-smoking policies are presented as examples of a benign nanny state that wants to help people make the right choices. However, there is nothing benign about it. We are increasingly living in a bully state in which education has been replaced by coercion and compulsion.”

    According to Clark, there is nothing fair or benign about the current rates of taxation on tobacco. The current rate of tax on an average pack of cigarettes in the U.K., for example, is about 86 percent. The aim is to force smokers to quit, but it discriminates against those on low incomes. Sometimes if people don’t quit, it can force fervent poverty. Again, this is the mark of a police state.

    “In my view, tobacco control is no longer about public health,” said Clark. “Nicotine is a drug; so is alcohol; so is caffeine. But people choose to consume these products. No one is forced to smoke tobacco, drink alcohol or consume caffeine. The anti-smoking campaigners also argue that the tobacco industry targets children. The truth is that many teenagers like to experiment. Many [youth] experiment with alcohol, some with tobacco, and more recently, e-cigarettes. I don’t condone it, but it’s called growing up. In my experience, most of the attacks on the tobacco industry have nothing to do with health. It’s politics, pure and simple.”

    PANEL: Next-Generation Products: Delivering Innovation

    Innovation isn’t a light switch. It isn’t a process that happens suddenly. During a panel discussion on the topic, Jackie Zhuang, president of Macau Chongva Tobacco Factory, said that an easy way to understand innovation is to look at patents. As of the end of April, the estimated accumulated patents for vaping products from the four largest manufacturers in Europe plus Juul Labs was 69,500 patents, according to Zhuang. The number for the top 15 Chinese factories combined is an estimated 24,239.

    “The Chinese e-cigarette industry is working very hard to catch up in the fields of patent,” said Zhuang. “And the number we have from last year will be Chinese e-cigarette companies combined; we have 60 to 100 patents applied last year. And outside China, only 2,800,” explained Zhuang. “The innovation came from the manpower invested in Chinese e-cigarette companies (where an estimated 6,000 researchers are working in the e-cigarette industry).”

    China has long been the epicenter of e-cigarette manufacturing. Modern e-cigarettes were born there, and Shenzhen is home to 90 percent of all e-cigarette manufacturing worldwide. Zhuang said that Chinese manufacturers don’t often create new products; they specialize in making innovative products better. Zhuang said that for Chinese manufacturers, innovation is driven by their customers. “The customer wants something, and we offer a lot of [options] for the consumer,” he said. “When international brand owners try to develop their brands, they are [surprised at the types of innovations we can offer] their customers.”

    Phoebe Dong, regional marketing manager for Heaven Gifts, a major vaping industry manufacturer based in Shenzhen, agreed with Zhuang that most innovation is driven by the consumer. She said it is also driven by the maturation of research and development. She said that the end user doesn’t often know how technology in materials improves the function and the performance of vaping products. The consumer only sees the finished product and not the progressive innovations.

    “Competitive pressure can also drive companies to innovate to maintain their market position,” said Dong. “The emergence of new products and technologies … industry trends, technology trends, market trends and consumer trends all make an impact on innovation.” There are “two forces pulling there …. It’s competitive pressure and then it’s also your internal passion. You want to make a better product; you want to improve things.”

    Regulation also has an impact on innovation. Ian Fearon from McKinney Regulatory Science Advisors said that when creating new products, innovators must understand what the product’s potential impact on public health is. Then they need to look at the regulatory environment and which markets they want to go into.

    “Is it a permissive environment, such as the U.K. or some of the European countries? Is it a market that is very difficult to get into, such as the United States? And then with both of those aspects together, developing a rigorous assessment framework with which you can assess that innovation, generate the data which the regulators require for you to place that product on the market and then conduct those studies,” explained Fearon. “Use scientific experts to interpret the data, to translate that data into something that the regulator can understand and will want to approve for the market. Conduct those studies and then push the data out to the regulator.”

    Fearon said that to get new products through the regulatory process, innovators need to tell the story of a product so that the regulator understands the product and its potential impact. He said much of McKinney’s work is in creating that narrative, which takes complex scientific data and translates it into something tangible that the regulator can understand.

    “It comes from taking the clinical data, the TOPS data, the chemistry, taking any clinical data, nicotine absorption studies, taking any behavioral data, such as intentions to use studies,” said Fearon. “And integrating all of that into a narrative, which gives FDA information on the public health imperative of the innovator, which is really what FDA is looking for. If you market this product in the United States, will it improve public health? And it’s an unusually complex area, and it takes great expertise to integrate all of those very different and complex scientific disciplines into a single story. And I think the other thing you have to bear in mind as well with FDA is that they are looking, as far as I can tell, for you to provide words that they can put in their authorization letter … it’s almost like you have to help FDA make the decision that you ultimately make with the narrative and provide them with a sub-narrative that they can tell to the American public.”

    While innovation may be easier in countries with less stringent paths to market, bringing products to market in the U.S. is only getting more complicated and expensive. After spending billions of dollars on developing a product, in a country with a regulatory regime like the U.S. there is no guarantee that the product will ever make it to market.

    “You don’t know how long it’s going to take before we go [to market or the] innovation starts making money or starts improving public health. It could be three years, five years, nobody really knows,” said Fearon. “I think then, the contrast there is in a country that may contribute [to innovation in the vaping industry] like the U.K., which is open to innovation. It’s actively advising smokers to start vaping. Which is very different to what happens in the United States. Even to the point where we are seeing innovation within the U.K. government in that they are spending a million pounds in April, giving e-cigarettes to pregnant women—I mean, that’s just unheard of when you think about it. That’s an example of the regulator innovating to help the manufacturers innovate, which I think is an incredible example of the two different contrasts we have.”

    Fireside Chat: George Cassels-Smith, CEO of Tobacco Technology Inc.

    Flavorings in nicotine products are interesting. Most consumers think it’s just about taste. The reality is that few understand tobacco product flavorings and how they are produced. George Cassels-Smith, CEO of Tobacco Technologies Inc. (TTI) and eLiquiTech, said that TTI separates itself from its competition by tailoring each of its flavors to the customer’s application.

    “I don’t have a library, even though I’ve done 300,000 flavors. I don’t pull anything off the shelf,” said Cassels-Smith. “I innovate new flavors in the direction of my customer’s request. I might [have] several iterations in a portfolio first … and we then choose the direction that we would want to continue to develop. And ultimately, that becomes a unique flavoring system that is only for that particular customer.”

    Consumer testing and the evaluation of the product are at the heart of what TTI does for its clients. When a TTI salesman goes out to visit the customer and receives a project, he takes back all those requirements and works with the individual flavors within the profiles requested by the customer. TTI then has a team of sensory pros to help evaluate the different creations.

    “It’s usually three, four, five weeks for one single flavor,” said Cassels-Smith. “We save that company all that development time internally, and we give them the turnkey operation. And we call it joint development because it always has the input of the customer.”

    When the U.S. Food and Drug Administration began its crackdown on flavors in e-liquids, Cassels-Smith feared it would create a perception that TTI would stop innovating, which the company does constantly. However, TTI and eLiquiTech only had one facility, located in the U.S. state of Maryland, serving its global client list. He said the solution to that issue was to build a second facility in Assisi, Italy. There, he says, the TTI team is combining art and science.

    “Initially, it was just to have a second facility that was located close to product development. But with the advent of Covid and the disruption in supply chains, we found that the bifurcation of manufacturing greatly assisted us in our delivery and time. And that became very critical,” explained Cassels-Smith.

    Cassels-Smith also discussed how his company was the global supplier of synthetic nicotine produced by U.K.-based Zanoprima Technologies. According to him, the problem with extracting nicotine from tobacco is that it delivers an impurity profile that would contain potential carcinogens. “We find them mainly in two forms—tobacco-specific nitrosamines [TSNAs] and heavy metals. The virtue of the synthetic nicotine is that it doesn’t have a plant-root system that can absorb heavy metals, and since the starting material is a vitamin, it’s clean and it has no heavy metals, and I cannot develop TSNAs,” he said.

    Synthetic nicotine is not new. Nicotine was first synthesized in 1904. Molecules such as nicotine may exist in mirror-image forms with identical chemical makeup but sometimes differing biological activity. The nicotine molecule possesses chirality, meaning it exists in two mirror-image versions called enantiomers or stereoisomers. Nicotine comes in left (S) and right (R) forms. The (S)-isomer of nicotine greatly predominates in tobacco leaf, which contains only small amounts of the (R) variant (0.1 percent to 1.2 percent). Most synthetic nicotine has equal parts of both the (S)-isomer and (R)-isomer. Zanoprima’s product, SyNic, only has the (S)-isomer—the one that holds all the psychotropic effects that nicotine consumers want, according to Cassesls-Smith.

    When dealing with unique products in the nicotine industry, such as flavor profiles or synthetic products, competition can be fierce. There are also regulations that boost black markets and counterfeit goods. On the flavoring end, if you make a profile that does well in the market, it becomes a target. And other people might try and imitate it. And through reverse engineering, you can usually get fairly close, not exactly, he said.

    Cassels-Smith said some of the same issues are being experienced by the synthetic nicotine he distributes for Zanoprima. They developed an enzymatic process to create it, and when you’re the first to develop new technology, you can get a broad patent to prevent anybody else from imitating your product. Zanoprima has patents in 48 countries for its synthetic nicotine process.

    “If anybody is using an enzymatic nicotine and selling it in the market, Zanoprima is the sole patent holder in that market. But unfortunately, when it gets published, people can imitate,” said Cassels-Smith. “What we’re seeing right now is in the disposable market, which is the dominant global player, every one of them is using synthetic nicotine from an enzymatic process. And they’re selling them in markets that are violating the Zanoprima patent.”

    Cassels-Smith said he is in the process of taking legal action. “The legal process begins, but if anybody has ever been in the lawsuit, it’s the biggest nightmare in the world. Litigation costs are high,” he said.

  • Executive Experience

    Executive Experience

    Eve Wang, vice president of the world’s largest atomization company, shares her vision for vaping.

    By Timothy S. Donahue

    The largest atomization company in the world is Shenzhen Smoore Technology Co. Based in Shenzhen, China, the company has maintained its position as the global leader in the atomization technology market since the beginning years of the vaping industry.

    Smoore has seen significant growth since its establishment in 2009 and operates three atomization businesses: nicotine delivery (including vaping and heat-not-burn), medicinal applications and healthcare.

    Within the nicotine-delivery business, Smoore’s technology brand, FEELM, holds a prominent position as one of the industry’s leading closed-system vaping solution providers. This diverse business structure allows Smoore to deliver innovative solutions across multiple industries to meet several varied consumer needs.

    Earlier this year, the international ESG rating agency Sustainalytics awarded Smoore International Holdings, parent of the FEELM and Vaporesso brands, the top position among global electronic atomization companies. Smoore consistently ranks first among global electronic atomization companies in the ESG ratings published by MSCI, the world’s largest index company.

    Vapor Voice invited Eve Wang, vice president of Smoore, to share her vision for the vaping industry and her insights into how Smoore will move forward as atomization technology continues to improve and develop into various marketplaces beyond the vaping industry.

    Vapor Voice:As an atomization technology solution provider, how important are Smoore’s investments in R&D?

    Eve Wang: Centered on Smoore’s mission of atomization makes life better, we have a long-term approach to everything we do and believe that continuous technological innovation is the only approach to develop the atomization industry. Last year, Smoore invested £160 million ($199.5 million) in R&D, which accounted for 11.3 percent of the total revenue in 2022. This investment has resulted in 2,254 new patent applications worldwide, including 1,125 invention patents.

    Our commitment to continuous technological advancement is best shown by the fact that we employ 1,500 R&D personnel, which accounts for more than 40 percent of our entire nonproduction workforce.

    As a young and developing industry, constant R&D in both technology and manufacturing is vital to drive growth and ensure the highest quality standards. Our professional testing facilities feature more than 700 different types of testing equipment, valued at over £23 million, and we have many partnerships with leading research institutes and analysis laboratories to complement our already comprehensive testing capabilities. We have developed the world’s first fully automation pods production line, and our ceramic coil disposable automation line is not only the world’s fastest but also allows our products manufactured by FEELM to achieve a first pass yield of over 99.5 percent.

    Looking toward the future, Smoore is exploring how to apply vape atomization technology within the healthcare sector, and our dedication to cutting-edge research and development, regulatory compliance and superior consumer experience supports our commitment to the longevity and sustainable growth of our business.

    Is Smoore seeking to invest beyond the vaping industry?

    We keep exploring the boundaries of innovation and the application of atomization technology in new application scenarios, such as medicinal and healthcare sectors. For example, last year in China we registered a ventilator in combination with an atomization drug delivery device and successfully obtained the production license for this technology.

    We have also set up a team in the United States which has developed two drug delivery devices targeting asthma and chronic obstructive pulmonary disease and started the development of relevant medicinal preparations.

    How do you see the vapor industry developing, and what will be the biggest growth areas in terms of technology and geography?

    According to a report by Frost and Sullivan, the global retail market for e-vaporization is expected to reach $122.2 billion by 2027. It is expected that in the long run, companies that prioritize regulatory compliance and harm reduction while also focusing on consumer experience will emerge as the ultimate winners.

    However, as an emerging industry aimed at assisting smokers toward a smoke-free society, e-cigarettes are still in their infancy and face a range of challenges which makes it crucial for all stakeholders in the industry to collectively provide the best possible harm reduction solutions for current adult smokers.

    Therefore, we have developed and launched a new 2 mL e-liquid compliant disposable solution to provide 800 puffs with the innovative technology FEELM Max, where conventional products typically provide around 600 puffs.

    How is the FEELM Max technology different from that used in conventional products?

    As the world’s first ceramic coil disposable solution, FEELM Max benefits from a cotton-free design that, with a compliant e-liquid volume of 2 mL, can provide 800 puffs whilst current solutions offer 600 puffs. This is a significant step toward setting a new industry compliant benchmark for 2 mL.

    In addition to more puffs, this innovative heating technology is designed to bring cleanness and silkiness, ensuring a satisfying experience for consumers. Our constant power technology provides a vapor and taste consistency, and together with a transparent e-liquid tank design offers an enhanced consumer experience.

    The ceramic coil is like an electric car, symbolizing a more advanced technology. Several major brands have already adopted our new technology, recognizing that differentiation is key in a competitive market. We are committed to providing superior vaping experiences that meet the evolving needs of consumers around the world.

    What is the largest market for Smoore and its subsidiary’s products?

    In 2022, Smoore’s global enterprise customer business revenue was £1.22 billion, with the U.S. market ranking first, accounting for 35.4 percent. The revenue share of Europe and other markets increased from 24.1 percent in 2021 to 43.6 percent in 2022, up by 19.5 percentage points. Smoore will continue to provide technology solutions and products worldwide, all tailored to fully comply with all local regulations.

    What are Smoore’s concerns about the growth of noncompliant products in the marketplace?

    We believe that effective regulation is vital for sustainable growth and that proportionate regulation can support the industry’s evolution.

    However, the presence of noncompliant or counterfeit products entering the U.K. market is a significant concern for us. These products not only pose potential health risks to consumers but also bring negative effects on the long-term development of the vaping industry. These illicit products can discourage innovation and deter potential investments in research and development, hindering the industry’s ability to evolve and improve.

    Like any industry, there are always those who operate illicitly. However, it is vital that the responsible majority within our sector, together with government, regulators, enforcement bodies, trade associations and partners, collaborate on initiatives and share intelligence to eradicate illegal and noncompliant vapes. This collective effort is necessary to ensure that the sector’s reputation is not only maintained but also improved.

    We believe in maintaining the very highest product standards whilst also being fully compliant in all local markets in which we operate. That’s why we have developed and launched the 800-puff compliant disposable vape: FEELM Max. FEELM Max represents a commitment to both technological innovation and regulatory compliance, moving the vaping industry forward in a responsible and sustainable way.

    Eve Wang, VP of Smoore

    Many vapor products that have been authorized for marketing in the U.S. were developed by Smoore. What is the secret behind Smoore’s high share of Food and Drug Administration marketing orders?

    Smoore is always committed to full regulatory compliance and product quality. In 2022, out of over 6.7 million e-cigarette product listing applications, the FDA only approved eight from JTI, nine from R.J. Reynolds Tobacco and six from Njoy. Smoore, as the atomization technology manufacturer, has aided the most clients in the ENDS [electronic nicotine-delivery system] category to pass the PMTA [premarket tobacco product application] process.

    Last September, Smoore had the distinction of being invited to an industry meeting convened by the commissioner and director of the Center for Tobacco Products. We actively engaged in explorations and discussions regarding the future of a more compliant and sustainable vaping industry.

    Smoore’s achievements stem from the long-term focus on the improvement of atomization technology and the commitment to innovation, compliance and product safety; we always deliver user-centric and user-friendly technologies and products to clients, consumers and industry.

    As the FDA commented when approving one of the closed-system pod vaping products: “It met the standard because, in several key considerations, chemical testing is sufficient to determine that the levels of harmful and potentially harmful constituents in the aerosol of these products are lower than those in the smoke from combusted cigarettes.”

    What is Smoore/FEELM’s strategy for the disposable market?

    The disposable vape has been a widely accepted product in the e-cigarette market. Even as far back as 2018, when closed-system vapes dominated the industry with a 72 percent market share, it was predicted that disposables would account for more than 70 percent of the closed-system market over the next five years.

    However, such rapid growth inevitably leads to challenges, and the market has seen a proliferation of noncompliant products and counterfeits, coupled with problems such as the illegal overfilling of e-liquids and the quality issues from the black market, as reported by the BBC. These issues have sounded alarm bells across society, calling for superior, compliant and healthier solutions.

    How will Smoore confront the challenges associated with disposable products, such as environmental concerns?

    As the first Chinese e-cigarette company to be included in the Dow Jones Sustainability Index, Smoore aims to minimize any environmental impact from our operations and products as much as possible.

    In May 2022, we officially launched our carbon neutrality plan, setting a net-zero target by 2050. We will continue to increase the use of renewable energy in our operations, aiming for 50 percent energy consumption from renewable sources by 2030.

    Whenever I come across a discarded disposable vape on the ground, I will pick it up and bring it back to the company, where my colleagues can professionally process and recycle it. But more needs to be done to encourage active participation by consumers in recycling their vapes. Therefore, we have launched the industry’s first end-to-end whole-chain recycling scheme, including manufacturers, brands, retailers, the Royal Mail and waste management specialists, Waste Experts.

    Working closely with our clients, we have created a household collection service whereby consumers who return 10 or more old disposable vapes for recycling will receive a free disposable product incorporating our latest technology as a reward.

    What do you consider to be Smoore’s greatest industry innovations?

    The cotton coil is widely adopted within the vaping industry, and there are many challenges that affect the consumer experience.

    Smoore drew inspiration from traditional Chinese ceramic making to develop the ceramic technology. We discovered that, compared to the cotton coil, the ceramic coil has advantages such as high thermal efficiency, leakage prevention and the ability for planned automated production as well as delivering strong taste consistency.

    Therefore, in 2014, Smoore initiated research into ceramic heating technology, and in 2016, Smoore’s ceramic coil technology brand FEELM was officially launched in the market, aiming to “feel the moment of vaping” and representing our long-term commitment to vaping sensory and technology. Today, FEELM has already become a very well-recognized tech brand by the industry, especially for ceramic coil technology. Since 2018, we have shipped over 3.5 billion pod products worldwide, and we cover more than 50 different countries and regions.

    We remain devoted to our mission of improving public health through the advancement of atomization technology.

    What are the greatest challenges facing the global e-cigarette industry, and how is Smoore helping solve those challenges?

    Smoore recently commissioned a survey, which was conducted by One Poll, among 2,000 adult smokers. The results revealed that 42 percent of respondents had little or no trust in e-cigarettes. Meanwhile, nearly two-thirds (62 percent) believed that e-cigarettes were more harmful or at least as harmful as traditional cigarettes whereas evidence from the Office for Health Improvement and Disparities highlights that e-cigarettes are at least 95 percent less harmful than smoking.

    That’s why we have established an independent panel of experts in science, smoking cessation and compliance to look at creating a new rating system that will allow adult smokers and vapers to make informed decisions about their choice of vapes based on their harm reduction profile.

    We are committed to innovating alternatives to traditional smoking, to reducing harm and to benefit public health. We strongly believe in the potential of e-cigarettes to provide a viable and less harmful alternative for smokers who struggle to quit.

    Smoore hopes to fulfill our mission: Atomization makes life better—better for our clients and consumers. We aim to achieve this by providing better technological solutions and products in the future in novel tobacco, medicinal and healthcare fields.

  • Understanding Synthetic

    Understanding Synthetic

    Credit: Nitiphol

    A nicotine industry veteran answers some common questions concerning the rise of synthetic nicotine.

    By Chris Howard

    Since President Biden signed the fiscal year 2022 Consolidated Appropriations Act into law on March 15, 2022, questions surrounding the U.S. Food and Drug Administration’s Center for Tobacco Products’ (CTP) handling of enforcement with respect to products containing nontobacco-derived (NTN), or synthetic nicotine, have been pervasive. While the CTP has indicated that it is not engaging in enforcement discretion to address the exceptionally short compliance timeline Congress provided in the bill, the center’s actions and public statements provide insight into its enforcement priorities and how the industry can assess the position the center takes. In this article, I will answer some frequently asked questions formulated from an extensive review of public statements and enforcement actions.

    What does the Consolidated Appropriations Act have to do with tobacco products containing synthetic nicotine?

    The act provided the CTP jurisdiction over NTN products beginning April 14, 2022. It also established a period for compliance with the Federal Food, Drug and Cosmetic Act’s premarket review requirements for NTN on or introduced to the market by April 14, 2022.

    The legislation provided that for a manufacturer to continue marketing NTN products after May 14, 2022, they must submit a premarket tobacco product application (PMTA) for such products by that date. In the event a manufacturer complied with this requirement, they were permitted to continue to market such a product through July 13, 2022 (provided the FDA didn’t previously deny the PMTA, refuse to file the PMTA or withdraw a marketing order for a previous version of the product at issue that utilized tobacco-derived nicotine). Just like tobacco-derived products that remain the subject of pending PMTAs beyond Sept. 9, 2021, NTN products that are the subject of pending PMTAs after July 13, 2022, technically must have received market orders to be legally marketed today.

    Are tobacco products containing synthetic nicotine illegal?

    Just like tobacco products containing tobacco-derived nicotine that are subject to pending PMTAs, all current tobacco products containing synthetic nicotine on the market in the United States are illegal. It is important to note, however, that this doesn’t mean that CTP intends to expend its limited enforcement resources to remove all such products from the market. Rather, the center has expressed its intent to move forward in accordance with a discrete set of priorities outlined more particularly below.

    Does the FDA intend to treat enforcement of tobacco products containing synthetic nicotine differently than enforcement of tobacco products containing tobacco-derived nicotine?

    No. CTP leadership has made it clear that it will apply its enforcement priorities identically with respect to both categories of products.

    The CTP has been explicit that both tobacco products containing nicotine derived from tobacco (marketed after Sept. 9, 2021) and tobacco products containing nontobacco-derived nicotine (marketed after July 13, 2022) without premarket authorization (marketing orders) are considered by the FDA to be noncompliant and that manufacturers of both categories of products are subject to the same public health standards. The CTP’s position is set forth clearly in the below public statements:

    Tobacco Products Containing Nicotine Derived from Tobacco

    On Sept. 9, 2021, the FDA issued a statement entitled “FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90 Percent of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted,” which you can review at the following link: https://www.fda.gov/news-events/press-announcements/fda-makes-significant-progress-science-based-public-health-application-review-taking-action-over-90. In this release, former Acting Commissioner Janet Woodcock and former CTP Director Mitch Zeller indicated: “All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion” (emphasis added).

    Tobacco Products Containing Nontobacco-Derived Nicotine

    On Oct. 14, 2022, the FDA issued a statement entitled “FDA Completes Initial Review of 95 Percent of Nontobacco Nicotine Product Applications; Agency Has Issued Over 60 Warning Letters to Manufacturers, Including for Products with a Submitted Application and Negative Action,” which you will find at https://www.fda.gov/tobacco-products/ctp-newsroom/fda-completes-initial-review-95-non-tobacco-nicotine-product-applications-agency-has-issued-over-60. Upon review, you will note that the FDA is speaking about tobacco products containing nontobacco-derived nicotine. As we discussed, the FDA used nearly the exact same language employed by Woodcock and Zeller in September 2021 to describe the agency’s views with respect to tobacco products containing nicotine derived from tobacco. In particular, the FDA states, “To date, the FDA has not authorized any NTN products. Therefore, all NTN products on the market are marketed unlawfully and risk FDA enforcement action” (emphasis added).

    In a Feb. 3, 2023, email to the executive director of the National Association for Tobacco Outlets from a director in the CTP’s Office of Compliance and Enforcement, FDA leadership provides even more clarity:

    “FDA is fully committed to implementing the new federal law clarifying its authority to regulate tobacco products containing NTN, including synthetic nicotine. Manufacturers of these products are now held to the same public health standards, including premarket review, as tobacco-derived nicotine (TDN) products. Irrespective of whether the product contains TDN or NTN, it is illegal to sell or distribute tobacco products that the FDA has not authorized. On Aug. 8, 2016, all deemed tobacco products, including e-cigarettes, became subject to FDA’s tobacco authorities.

    “As a matter of enforcement discretion at the time, the agency stated that it intended to defer enforcement for a period of time of the premarket authorization requirement for certain deemed new products on the market as of Aug. 8, 2016. However, in light of later data on youth use and other information, FDA revised this policy in its 2020 enforcement priorities guidance. That guidance described how the agency intended to prioritize its limited enforcement resources regarding certain ENDS [electronic nicotine-delivery system] products. It also noted that all deemed new tobacco products on the market without authorization are illegally marketed and that the agency ‘retains discretion to pursue enforcement action at any time’ against such products.   

    “The same principle applies to NTN products; specifically, all illegally marketed NTN products are subject to enforcement ….”

    Director Brian King has made similar statements in several open forums indicating that tobacco products without market authorization (regardless of whether they contain nicotine derived from tobacco or nontobacco-derived nicotine) are noncompliant. Based upon these ubiquitous public statements, it appears the FDA will continue to prioritize enforcement against manufacturers with products (a) not covered by timely filed pending PMTAs or (b) that are the subject of marketing denial orders—with an emphasis on products that are particularly attractive to youth.

    What is the significance of the Aug. 8, 2016, effective date of the deeming regulation with respect to tobacco products containing synthetic nicotine?

    The FDA did not have authority to regulate tobacco products containing synthetic nicotine upon the effective date of the deeming rule. Rather, the FDA obtained authority to regulate such products following the effective date of the Consolidated Appropriations Act. The relevant timelines established by the act did not include a period for continued marketing of unauthorized new products containing synthetic nicotine beyond July 13, 2022. As such, all tobacco products containing synthetic nicotine on the market without premarket authorization are illegal and subject to FDA enforcement.

    What are CTP’s priorities when enforcement against tobacco products containing synthetic nicotine without market orders?

    Regardless of whether a product without market authorization contains synthetic or tobacco-derived nicotine, the FDA has indicated its intention to prioritize its enforcement efforts with respect to certain deemed tobacco products (1) not covered by timely filed PMTAs, (2) that have been the subject of marketing denial orders or those covered by PMTAs subject to negative determinations, including those rejected on procedural grounds (i.e., refuse-to-accept letters or refuse-to-file letters), and (3) that raise youth use concerns.

    As we are all aware, even though the continued compliance policy for certain deemed new tobacco products ended on Sept. 9, 2021, and those products were subject to immediate enforcement action, the CTP has not, as of the date of the publication of this article, brought enforcement action against any of those products covered by still pending PMTAs. Based on the center’s handling of these products combined with the CTP’s recent public statements, it seems likely that the CTP will exercise a similar approach to NTN products covered by PMTAs that remain pending after July 13, 2022. Moreover, the CTP is likely to refrain from taking enforcement action against such products while it reviews the pending applications.

    Chris Howard is the executive vice president of external affairs and new product compliance for Swisher International.

  • My Journey in Nicotine

    My Journey in Nicotine

    Kim Hesse shares her insight into the ignition of the ENDS industry and the attempts of regulators to manage it. 

    By Kim Hesse

    After years of working in the U.S. medical industry, life threw me for a loop and took me to Germany in late 2007. After going through a six-month language course, I learned enough Deutsch to get by in my new country and felt ready to enter the workforce. Fortunately for me, I had a friend in the employment office who secured me an interview with a company that needed someone who could speak fluent English. Ironically, this required me to stammer through a three-hour interview in German. I only understood about 10 percent of that conversation, but still got the job.

    In January 2008, I began my journey in the tobacco industry working at Eurofins Dr. Specht Laboratorien in Hamburg-Harburg, Germany. There I was trained, at a very high level, in the analysis of pesticides in tobacco. I learned about the various instruments in the laboratory and why some are used over others.

    For instance, a gas chromatography-mass spectrometry instrument can detect and analyze compounds that a liquid chromatography instrument might miss. Before working at Eurofins, I knew zilch about instrumentation, chemistry or tobacco. Today, I can rattle off many reasons why you might choose to use a GC over an LC, including the polarity and volatility of the item being analyzed.

    I spent four years becoming proficient in German and learning about the tobacco industry while performing customer service duties, which acquainted me with a variety of industry people. Since my brain ticks in a business manner, I began assessing the client base and pondering ways to reach out to gain more.

    One day, I took a phone call from a company called Contraf-Nicotex Tobacco. They were interested in having their products tested for nicotine concentrations and heavy metals. This was the first time the lab had received such an inquiry. A few weeks later, I received a similar call from a company called Red Kiwi. These two companies were my introduction to what is now called the electronic nicotine-delivery system (ENDS) industry.

    While Eurofins Dr. Specht chose to stay focused on their core business of testing for pesticides, my interest in this blossoming segment of the tobacco industry grew. I began researching these companies and grew excited about the potential of these emerging technologies.

    My desire to expand the business for Eurofins did not wane, and I eventually convinced my boss to exhibit at TabExpo Prague in 2011. For me, this was the first of many trade shows in the tobacco industry. While TabExpo was a good experience for me, it may not have been such a great one for my boss. While at that show, a man came to our booth and asked why I was living in Germany and if I would ever consider moving back to the U.S.

    Credit: Pudiq

    Going home

    Little did he know I had a family issue that had me wanting to return. Through him, I met Richard Higby, former president and managing director of Arista Laboratories and Microbac Laboratories, who recruited me to help build business for the newly formed smoke lab at Microbac Laboratories.

    Once back in the States, I was told about the new regulations affecting the tobacco industry there. I was surprised by the sweeping changes facing the industry as I never thought regulations like this would come into effect nor did I think they would be so stringent. I was amazed at the speed with which third-party laboratories had to develop and validate new testing methods for up to 93 compounds.

    Additionally, I was astonished by the absence of clear instructions that could effectively guide the process of keeping a product on the market. I began a deep dive into the abyss of the internet to learn what regulators expected and why. This task was overwhelming, and the Food and Drug Administration websites were hard to navigate. At times, it was like trying to find a needle in a haystack.

    My colleagues and clients were all scrambling to become educated. Clients needed assistance from many angles, and I assisted on the laboratory front and connected clients with potential partners. Clients found themselves in need of comprehensive guidance, not only for determining the appropriate testing procedures but also for seeking expert advice on navigating the intricate web of regulatory compliance and understanding the legal considerations associated with their testing practices. This multifaceted support was and still is crucial in enabling clients to meet regulatory standards and mitigate potential legal risks effectively.

    Finally, in January 2011, the FDA Center for Tobacco Products issued guidance on demonstrating substantial equivalence for tobacco products. This sent tobacco companies scrambling to find laboratories to complete the needed work for their submissions on deadline.

    During this time, I was at Microbac Laboratories, where smoke analysis was a brand new addition to its scope of work. This was an exciting time to be in the tobacco industry because of the new regulations and the opportunity to learn and help clients navigate their new environment. Combustible cigarettes were still the focus from 2011 to 2014, but slowly the ENDS industry began making noise.

    Credit: Sezerozger

    Global outlook

    In 2014, I was recruited again and went to work at Global Laboratory Services (GLS). There I was tasked with growing the smoke side of the business. I got my copy of Tobacco Reporter (sister publication to Vapor Voice) and scoured it for advertisers. I saw a large number of e-liquid companies advertising and began reaching out to them.

    Then I started looking at the trade shows and saw how many were turning more toward ENDS products. While at GLS, I helped the lab grow from a predominantly pesticide analysis laboratory into a lab offering a significant diversification of analysis, including e-liquid and ENDS testing.

    During the beginning years of testing ENDS products, most laboratories worked on method development and validation on their own. For anyone who doesn’t understand that process, it’s kind of like baking a cake without having a recipe. You try to put in a little bit of flour, baking soda or powder, eggs and other ingredients. However, you are not sure exactly which ingredients to use or the correct amounts. So you try and try again until you get it right. This is method development. But then you have to prove you can do this same thing and produce the cake exactly as it was the first time you got it—that is method validation.

    Most testing performed in those early years focused on propylene glycol, vegetable glycerin and nicotine concentrations. As we saw increasing interest in the testing of e-liquid and ENDS, third-party labs began developing more methods to meet the expanding scope of testing demands. Eventually, the demand for sound science and broader scopes of testing began being heard, and Coresta (the Cooperation Centre for Scientific Research Relative to Tobacco) became involved.

    The Coresta E-Cigarette Task Force (now called E-Vapour Sub-Group) began in 2013. This group has worked together for years now and has provided published methods, guides and reports, all with the intent of improving the science surrounding the testing of ENDS products.

    While the scientists were busy ensuring methodology was sound, the ENDS industry was busy expanding and innovating. One of the first organizations focusing on vapor products, the Consumer Advocates for Smoke-Free Alternatives Association began in 2009. I remember meeting Julie Woessner at a meeting of the Smoke-Free Alternatives Trade Association (SFATA) in Chicago.

    It was the first time I really learned about the organization and was impressed by Woessner’s passion. In addition to consumer advocacy groups, we saw the introduction of trade organizations like the American E-Liquid Manufacturing Standards Association (AEMSA), which began in 2012. Lou Ritter, on behalf of the AEMSA and Cynthia Cabrera from the SFATA were showing up and talking at many events to help educate regulators and the industry. I spent time with both Ritter and Cabrera at many events and eventually sat on the board of directors of the SFATA in 2015.

    Credit: Adobe

    Trading places

    Alongside the trade and consumer organizations growth, we all had front row seats to an amazing number of trade shows. The first ones began popping up around 2011. I had the pleasure of being at possibly one of the largest ENDS-specific trade shows I have ever attended. It was ECC 2015 at the Fairplex in Pomona, California. The line to get in was at least a mile long, and we all stood outside in the heat.

    Luckily for me, Norm Bour spotted me and helped get me in a little faster. Nearly every inch of the 543 acres was covered with exhibitors. New players with fun names—SpaceJam, VaporShark, Cosmic Fog—came to play with massive displays, loud music and some flashy cars. Little did people know that a small booth on the outside of buildings in a relatively nondescript white tent contained one company that would alter the industry.

    After hours of walking and talking, I saw a smaller tent outside with a comfortable-looking white sofa. My feet needed a rest, and the booth was not busy, so I stopped. There I met Gal Cohen and Adam Bowen for the first time. I tried their product, Juul, and was immediately impressed. To me, this product mimicked the experience of a combustible cigarette extremely well. I told them I felt their product would be a game changer because I believed it could help smokers quit.

    ECC was just one of many vape trade shows during that period—so many that one could literally go to a vapor trade show nearly every week. The industry was booming, full of young entrepreneurs daring to create innovative products. We saw the inception of cloud chasers: people experimenting with their devices to create the largest clouds of vapor.

    There’d be one group eagerly trading tips on enhancing mods, another learning how to blow vape rings and a third creating such a thick cloud that you couldn’t see through them. The indoor areas at ECC were enveloped in a thick haze of vapor, carrying intense fragrances of artificial fruit, vanilla and sweets. After spending several hours in this environment, I developed a headache and had to retreat to the outdoor booths, where the heat was equally unbearable.

    Unfortunately, as the industry was rocking and rolling, it started gaining more attention from the media and additional focus from regulators. By 2009, the FDA already had its eye on the vapor industry. In May 2016, the FDA deeming regulations were issued. This was the beginning of changes to come.

    During this time, I visited multiple vapor companies, many of which only produced e-liquids. When talking to those companies, I often asked what their plans were if the FDA began regulating and requiring routine testing. Many of these energetic entrepreneurs said they planned to make their money and exit the industry. Others planned to follow the regulations but faced an increasingly uphill and difficult course due to the slew of regulatory challenges.

    Those ranged from navigating through login to the FDA portal, discovering some information was missing or was constantly moving, changes in the process occurring frequently and sometimes even after deadlines and filings were complete. One of the most frustrating early events happened during what was supposed to be a seemingly small, relatively simple task that turned out to shut down the FDA’s portal for multiple days … registering and submitting ingredient listings.

    After that major bump in the road, companies faced challenge after challenge. Today, those companies that still exist must decide whether to enter the long, painful premarket tobacco product application (PMTA) pathway or to simply sell their products abroad where regulations are more clear, concise and defined. For those who choose to stay in the precarious U.S. game, a strategy to speed and strengthen their existing PMTA and the wise allocation of resources are imperative. Those who complete the obstacle course to market authorization will see big payoffs in dollars and saved lives.

    Looking back, I am amazed at how far the manufacturers have come with their quality control systems, which for some were initially nonexistent. The marketers have also grown, and focus has been more conscientious not to appeal to youth. The laboratories participating in the CORESTA studies have grown and made great strides in methodology.

    It was fascinating to watch the growth of ENDS technologies from initial rumblings to exploding into the massive industry this has become. For some, this industry has enabled them to live the American dream of doing hard work to get ahead.

    We saw small shop owners become millionaires, innovators create products that could help people transition off combustible cigarettes, laboratories and organizations grow and thrive, and the American economy prosper. And the ride is not over yet …. I am excited to see what the next 15 years will bring.

  • New Deadline for South Africa Vape Rules Comments

    New Deadline for South Africa Vape Rules Comments

    Credit: Sharaf Maksumov

    The Portfolio Committee on Health in South Africa has announced that public consultation on the new Tobacco Products and Electronic Delivery Systems Control Bill will end on July 28.

    In a media statement from Parliament, the government said that written submissions on the bill must be emailed to tobaccobill@parliament.gov.za or submitted online at https://forms.gle/FLrhnvThDk8ccLG97.

    As reported on June 22, the submission period was originally between June 21, 2023, and August 4, 2023.

    The bill aims to regulate not only traditional tobacco smoking but also electronic cigarettes, such as vapes which have become immensely popular not only as a means to stop smoking normal cigarettes but as a gateway into nicotine consumption.

    In broad terms, the bill aims to regulate the sale and advertising of both tobacco products and electronic delivery devices, reports Business Tech.

    Parliament stated that: “the bill will also focus on legislating electronic nicotine and electronic non-nicotine delivery systems; introduce plain packaging with graphic health warnings and pictorials; introduce a total ban on display at the point of sale; introduce 100% smoke-free areas – indoor public places and certain outdoor areas; and a total ban on vending machines for tobacco products.

    At the start of the month, the Portfolio on Health briefed Parliament on the new bill with mixed reactions. Many stakeholders were concerned as to the severe knock-on effects the new bill could have on the tobacco/smoking industry, which is a key driver of economic growth in South Africa.

    Members of Parliament said that the bill could lead to more people turning to the already budding illicit tobacco industry and lead to job losses.

    Speaking specifically regarding vape products, Asanda Gcoyi, the chief executive of the Vapour Products Association (VPASA), said that combustible alternatives to traditional cigarettes should form the backbone of tobacco harm reduction in South Africa and be seen more as a solution to a problem rather than a new problem.

    She said that the government has managed to demonize vaping, marking it as more damaging than traditional cigarettes.

    Vapes are not only getting regulated by the new bill but are also being drawn into the ambit of excise taxes, as provided in the updated Tobacco Product Excise.

    Barry Buchman, the managing director of Vaperite, said that the newly imposed excise duty on vaping products has taken its toll on retailers, with many arguing that the tax has had the adverse effects of driving consumers towards the illicit market.

    Buchman added that the tax is pushing consumers to purchase the highest and most addictive nicotine-content-e-liquid as it is a cheaper option, negating the original aim of the National Treasury to tackle health-related issues.

  • Challenging Times

    Challenging Times

    As tobacco harm reduction continues growing in influence, it is also facing many obstacles.

    By Stefanie Rossel

    Regulatory policies, industry standards and medicinal licensing were among the themes tackled during the May 23–24 ENDS Europe Conference in Amsterdam.

    Many countries, including New Zealand and England, aim to be “smoke-free” by 2040, a term generally defined as less than 5 percent of the population lighting up. However, according to speakers at the event, most of these countries are unlikely to achieve their goals due to prohibitionist policies, such as incremental increases in purchase age, reductions in tobacco sales outlets or ultra-low-nicotine requirements.

    The country most likely to achieve smoke-free status is Sweden, according to the conference participants. By helping smokers switch to less harmful alternatives, such as snus, it is living proof that tobacco harm reduction (THR) is a more effective strategy than prohibition to reduce tobacco-related illnesses.

    Noting that millions of smokers don’t want to quit, Christopher Snowdon, head of lifestyle economics at the Institute of Economic Affairs in the U.K., presented an alternative, pragmatic and realistic smoke-free plan that includes a wide range of reduced-risk products (RRPs), such as snus, nicotine pouches, e-cigarettes and heated-tobacco products (HTPs), and focuses on educating consumers and fostering innovation. To put an end to misinformation about RRPs, Snowdon proposed the introduction of public information campaigns and cigarette pack inserts informing consumers in a band-neutral manner about the benefits of switching to less risky products.

    He also asked for better regulation, including advertising, tank and bottle sizes and nicotine limits. For HTPs and nicotine pouches, Snowdon proposed proportional tax and regulation and independent research. He warned policymakers against overregulation, naming e-cigarette taxes, flavor bans or indoor vaping bans as examples. Anything that makes vaping, HTPs, snus or nicotine pouches less appealing will make smoking relatively more appealing, he cautioned.

    More Challenges Ahead

    Regulations, however, continue to mount. Ciprian Boboi, founder and board member of the Independent European Vape Alliance, provided an overview of upcoming EU laws that will affect the nicotine sector. The Battery Regulation, which will be adopted in June or July this year, stipulates that the batteries in portable devices must be removable and replaceable by the user. For disposable vapes, the new rules mean a de facto ban from January 2027. The Tobacco Products Directive (TPD), which is in revision until 2025/2026 and projected to be implemented by 2027/2028, may encourage the spread of flavor bans (which are already in force in five member states), plain packaging and advertising bans.

    The Tobacco Excise Duty Directive (TED), to be implemented by 2025, is expected to include vaping. The Packaging and Packaging Waste Regulation requires all packaging to be recyclable by 2030. Plastic must contain a minimum percentage of recycled material. Provisions are likely to apply to packaging used by the vaping industry, including e-liquid bottles.

    The upcoming TED, which aims to harmonize taxation of combustible cigarettes among member states based on the purchasing power parity index, was also the subject of a panel discussion. According to leaked information, the revised TED will tax e-liquids with a nicotine content of below 15 mg/mL (including zero nicotine liquids) at 20 percent, or €0.10 ($0.11)/mL, and those above 15 mg/mL at 40 percent, or €0.30/mL. HTPs will be taxed at 55 percent, or €91 per 1,000 sticks, nicotine pouches at 50 percent, or €120/kg, and other nicotine products at 50 percent, the latter two gradually over four years.

    Panelists questioned the objective of the directive, arguing that if it was about health or nicotine, it was illogical to also tax non-nicotine liquids. By failing to follow the risk continuum, tax differentials would merely protect the cigarette trade and worsen the public’s already poor understanding of THR, according to panelists.

    The global novel nicotine market is currently worth an estimated $56 billion, according to Marija Obradovic, head legal analyst at ECigIntelligence. Vape products are the predominant category in North America whereas HTPs are leading in Europe, the Middle East and Africa region and the Asia-Pacific region.

    Nicotine pouches are steadily growing but face a fragmented regulatory framework in the EU. In several countries, among them Estonia, the Czech Republic and Sweden, they are regulated, with some states imposing packaging restrictions and requiring health warnings. In Bulgaria and Austria, there is a tax on modern oral nicotine products. For HTPs, a flavor ban will enter into force this October. Obradovic said the regulation will likely lead to more illicit markets, especially in eastern European countries bordering non-EU countries where flavors are not banned. Meanwhile, the number of herbal consumables for HTPs with or without nicotine, a totally unregulated market, has been growing.

    Regulatory Approaches

    When it comes to regulatory policies for RRPs, there are three approaches, as independent consultant Patricia Kovacevic explained. Regulatory science-based policies rely primarily on premarket notification with some elements of product science or standards. The EU TPD notification scheme is an example of this approach. Advantages of this stance include faster and more accessible market entry and a more diverse range of manufacturers, importers and products. Due to distinctions among national legislation, however, consistent success of electronic nicotine-delivery systems (ENDS) as a consumer product is impeded, and the approach does not include an element of scientific communication of the risk continuum. As flavor bans show, it is not always science-based.

    By contrast, regulatory policies based on product science authorize market entry upon scientific review, including a comparative risk profile of products. The unit-by-unit review prevails in the U.S. under the Tobacco Control Act. While the approach is protective of the individual and, to some extent, public health, and robust science will eventually lead to a favorable outcome, it is a time-consuming, prohibitively complex, expensive and anticompetitive process that results in a limited number of products concentrated with a few large players, likely resulting in deceleration in harm reduction, according to Kovacevic.

    The third approach—no effective premarket requirements—is followed by a dwindling number of countries. It allows easy market access but is not protective of public health. There are no standards and no oversight of product ingredients or functionalities. A regulatory approach that best serves THR, Kovacevic summarized, would include proportional and science-based product design, ingredients and manufacturing standards, reasonable liberties to communicate with adult consumers and would consider distribution, retail and age verification.

    Regarding the future of global ENDS regulation, this November will see the 10th conference of the parties (COP10) to the World Health Organization Framework Convention on Tobacco Control (FCTC), to be staged in Panama. Jeannie Cameron, CEO of JCIC International, told the audience about the mechanisms behind the gathering’s decision-making, which takes place by consensus, not vote, and what to expect from the meeting. As the COP10 Bureau, the body that will be writing the agenda, consists of representatives of six countries, most of which have banned vaping, a pro-THR approach is unlikely.

    Key issues on the FCTC agenda will likely include bringing novel nicotine products into the FCTC remit, a redefinition of smoke that includes aerosols, restriction of nicotine delivery and bans on nicotine salts in vaping products. COP10 will also discuss nicotine addiction, environmental issues and illicit trade.

    As only governments have a say at the meeting, they will have to determine their views beforehand. Cameron recommended that to prepare for Panama, business and consumer advocates should contact small business and health committee members of Parliament, respectively, while political advocates should coordinate with like-minded countries.

    Making Adjustments

    In a presentation, Marina Murphy, director of scientific and medical affairs at ANDS, demonstrated that nicotine is not the evil substance anti-THR advocates make it out to be.

    There is evidence that nicotine, an alkaloid like caffeine, could have a neuroprotective effect, she noted. Murphy pointed out that in nicotine product regulation, lawmakers apply widely varying standards, with cigarettes being regulated based on what comes out and e-cigarettes being regulated on what comes in, for example. With the WHO promoting nicotine flux—the rate at which nicotine flows from the mouth end of an e-cigarette per puff second—as a new regulatory target, she said it is time for the industry to reframe nicotine.

    Righting misperceptions derived from flawed science can be helpful in this regard. Rosalia Emma, assistant professor at the Department of Clinical and Experimental Medicine at the University of Catania, reported on the Replica project at the Center of Excellence for Acceleration of Harm Reduction (COeHAR), in which researchers between 2019 and 2022 replicated the most relevant international studies and unequivocally demonstrated the reduced toxicity of e-cigarettes and HTPs. With Replica 2.0, a new phase of research has started this year, which repeats a study by Fetterman that suggested that flavorings in tobacco products induce endothelial cell dysfunction.

    In contrast to the Fetterman study, COeHAR’s preliminary results show no significant differences in cell viability between PG/VG and PG/VG with vanillin. Reviewing recent literature about emission characterization, Sebastien Soulet, an engineer at Ingesciences, concluded that the contested studies used devices with high power and low airflow. He said that the condition of use should be investigated by researchers as there was a lack of information in many commissions and committees, including those that put together the FCTC’s nineth report, or the SCHEER report.

    Compared to other age-restricted consumer products, such as combustible cigarettes or alcohol, vape products face a stronger regulatory, often prohibitionist stance, mainly because of the flavors involved—although these are also common in alcoholic beverages, according to speakers at the Amsterdam event. To make their products less prone to attack, panelists argued, the industry should behave more responsibly in the design and description of their products to prevent them from attracting youths. It should also develop a nomenclature to rule out violations, they suggested.

    Rather than raising taxes on vape products, regulators should step up enforcement against retailers selling to youth, according to speakers. No longer subject to EU requirements, the U.K. should also consider allowing larger tank sizes, they suggested. This would make vapor products less appealing to youth due to higher prices.

    The Flavor Issue

    The conference also tackled the issue of flavors. In her Tobacco Products Prevalence Study, Andrea Patton, behavioral epidemiologist and head of prevalence research at the Centre for Substance Use Research, modelled the impact of an ENDS flavor ban on U.S. youth and adult users, developing two scenarios. Under the first, the U.S. Food and Drug Administration would ban all flavors except tobacco; under the second, the agency would ban all flavors except tobacco and menthol.

    According to the study, the first scenario would result in a 31 percent reduction of vaping among current adult cigarette users while the second scenario would yield a 21 percent reduction. In both scenarios, participants stated that they would start using tobacco. Flavor, Patton concluded, was the main driver for quitting cigarettes. By contrast, only 5 percent of youths said that they vaped only because of flavors; the main reasons cited for vaping were anxiety, stress or depression. A flavor ban would thus not affect youth use as intended, according to Patton, who also stressed the importance for studies on youth use to look beyond the brand level.

    Citing research by Konstantinos Farsalinos, Michael Landl, director of the World Vapers’ Alliance, explained the importance of flavors. Most vapers, Farsalinos’ work showed, use flavors other than tobacco. Over time, they will get “flavor fatigue” and hence need a variety of flavors. Flavor bans, he argued, won’t work as they make vaping less attractive to smokers, imply a never-ending “war on drugs” mentality and drive consumers to the black market.

    In Estonia, where flavors have been banned since 2020, 58 percent of vapers still use flavors, he said—a real-life experience the Netherlands should have considered before enacting a similar ban. A flavor ban wouldn’t prevent youth uptake either, Landl argued, as most adolescents consumed nicotine for relief of psychological stress. To solve this problem, he asked politicians to improve the socioeconomic conditions and create better opportunities for disadvantaged adolescents.

    Richard Young, principal toxicologist at Bibra Toxicology Advice and Consulting, identified aspects that vape manufacturers need to consider when carrying out assessing their products under TPD rules. He recommended getting a toxicologist involved early in the process—doing more extensive toxicity assessments, comparing acceptable levels or thresholds of toxicological concern for each ingredient to appropriate consumer exposures and documenting hazard and risk assessment clearly.

    What THR Also Means

    Credit: Smithers

    Three speakers shared their personal experiences with THR. Tom Gleeson, trustee of the New Nicotine Alliance Ireland, related how he, a smoker of 35 years, successfully quit within two days 12 years ago by trying an early vape product. 

    Flora Okereke, head of global regulatory insights and foresights at BAT, said that to her, a better future is to use and enjoy nicotine with little or no health impact, which she described as an achievable goal. Okereke made clear that leaving cigarettes, the cash cow for the tobacco industry, to an uncertain future was a bold step for a cigarette manufacturer. She called on the industry to unite and send a unified message to policy regulators. The industry, Okereke said, needed to use COP10 as an opportunity to shape where the industry will be heading.

    Liam Humberstone, technical director at Totally Wicked, described his company’s strategy to deal with the waste created by disposable vapes. According to Nielsen, the U.K.’s single-use vape market was worth £1.12 billion ($1.38 billion) in May 2023, corresponding to 200 million pieces sold each year. In addition, there are an estimated 300 million illegal products.

    Totally Wicked promises consumers it will take back any device of any brand, even illegal vapes. Products are recycled through some of the country’s few authorized treatment facilities, as their batteries are hazardous waste that needs separating. He pointed out that reducing, reusing and recycling makes sense—a lithium-ion battery, for instance, can be recharged 150 times to 300 times—but is not yet widely practiced. Concrete steps and appropriate regulations are needed to improve the situation, he claimed.

    New Technologies

    One way to accelerate THR is to offer licensed e-cigarettes on prescription. According to Ian Fearon of WhatIF? Consulting, doctors could prescribe vapes instead of less effective nicotine-replacement therapies. The best places for the medical licensing pathway, according to Fearon, are the U.K. and the U.S. Pete Lomas, managing consultant of product realization at Broughton, explained in detail what it takes to develop an ENDS product for medicinal licensing.

    The ENDS Conference also highlighted innovative technologies. Stefanie Scheffler, scientist at the Fraunhofer Institute for Toxicology and Experimental Medicine, presented a novel device for standardized e-liquid testing. Capable of producing a defined and adjustable temperature, the prototype eliminates the influence of the vaping device on aerosol emissions and creates more safety for the user, independent from the e-cigarette used.

    Scientific Horizons Consulting launched a new puff-recording ENDS that allows researchers to assess real-world user behaviors in real time. According to the company’s principal scientist, Xiang Gao, a two-month observation study revealed that users had vastly varying, complex and nonlinear puff behavior patterns.

  • New Louisiana Vape Law May be Defacto Flavor Ban

    New Louisiana Vape Law May be Defacto Flavor Ban

    Credit: Jet City Image

    Louisiana passed a law that raised taxes on nicotine e-liquids. However, the new rules could result in most vape products being taken off the shelves.

    The legislation, Act 414 by Rep. Paul Hollis, started out as a bill to increase the tax on vapes, with Hollis saying he wanted to discourage their use. But it quickly morphed into a broader law that dramatically scales back what vapes can be sold, after wholesalers, major tobacco companies and legislators concerned with youth use got involved.

    The law Edwards signed triples the tax on vape liquid from 5 cents per milliliter to 15 cents per milliliter and earmarks the revenue the tax will generate for pay raises for state troopers, according to NOLA.com.

    But the bigger impacts have to do with a new registry pushed by the major tobacco companies and large wholesalers.

    The law, which goes into effect in November, will require any vapes sold in Louisiana to be authorized by the U.S. Food and Drug Administration to be marketed in the U.S.

    Some other products could be sold if litigation is ongoing, but the state Office of Alcohol and Tobacco Control will be able to fine retailers for unapproved products.

    The new rules allow for only a handful of companies to sell vaping products in Louisiana, including R.J. Reynolds and Altria, major tobacco companies that sell Vuse and NJoy products, respectively.

    Both companies lobbied significantly on changes to the bill, including the registry.

    Effectively, the law could ban the vast majority of flavored vapes being sold in Louisiana. A wholesaler testified in a committee hearing that the list would tamp down on popular disposable vapes such as EscoBars, Puff Bars and Elf Bars, which have drawn the ire of regulators and lawmakers across the country.

    The FDA has cracked down on Elf Bars recently, telling retailers to stop selling them and halting imports.

    Hollis said Altria and Reynolds, along with wholesalers who argued the state was missing out on tax revenue by allowing retailers to bypass it and buy products from vape manufacturers, were among those who negotiated the final law.

    The new law now requires products to go through wholesalers.

    The law could also mean a de facto ban on flavored vapes because the FDA has not approved any flavored products other than tobacco. Reynolds, with its top-selling Vuse brand, only sells tobacco and menthol-flavored products.

    A Reynolds spokesperson said in a statement that “illegally marketed disposable” vapes, often imported from other countries, have “subpar regulatory oversight,” and that getting such products off the shelves will protect youth while allowing adult smokers options beyond combustible cigarettes.

    “The creation of a marketing order registry, and the state tax increase which will fund it, will help the public and retailers in assessing the legitimacy of vapor products before hitting the store shelves,” the company said. “Reynolds also urges the FDA to put together a list of products that can be legally sold in the US.”

    iMiracle, the maker of Elf Bars, said it was “concerned that the true objective of this law has been obscured from both the general public and Louisiana voters.”

    “Louisiana legislators should take a careful look at who promoted and who benefits from this legislation, and whether they want to limit their adult constituents’ access to harm-reduction products,” a company spokesperson said, adding it is evaluating the law’s “applicability and legality.”

    The state Office of Alcohol and Tobacco Control will be tasked with enforcing the new law by fining retailers who sell products not authorized by the FDA.

    ATC chief Ernest Legier said he hasn’t yet had time to closely review which products will be allowed, but that industry representatives have suggested as much as 60 percent of the products currently on the shelves could be removed.

  • UK Motor Group Calling for Ban on Vaping While Driving

    UK Motor Group Calling for Ban on Vaping While Driving

    Credit: Monkey Business

    A motoring group in the United Kingdom is calling for the government to change laws on vaping and driving. With vaping at record levels, motoring experts at LeaseCar.uk are calling for an urgent ban on smoking e-cigarette devices when behind the wheel, according to an emailed press release.

    In the UK, it is a legal requirement to drive with due care and attention, and the experts at LeaseCar.uk say there is no way people can adhere to this standard of driving while vaping. Aside from causing drowsiness and dizziness, the devices emit vast clouds of smoke, which restricts vision, making it impossible to be aware of surroundings, the release states.

    “Drivers not in complete control of their vehicle could receive penalties such as an unlimited fine, 9 points and a discretionary disqualification,” the release states. “In extreme cases, if someone is injured or killed due to careless driving, they could be jailed.”

    In the UK, the only current law around smoking and driving is that it is illegal to smoke with someone under 18, but this doesn’t apply to vaping. Tim Alcock from LeaseCar.uk said that it is only a matter of time before there are more fatalities on the road due to vaping.

    “There has been growing concern over the effects of vaping, but we do know that there are high levels of nicotine in the devices, which is highly concerning from a driving point of view,” he said. “E-cigarettes that contain nicotine cause dizziness and lightheadedness, which is highly dangerous, putting both the driver and other road users at risk.

    “It is appalling that drivers are still allowed to vape with children in the car given the immediate dangers on the road and long-term medical side effects which are still being researched. Not only that, as people puff at the devices, the vast clouds of smoke create a massive hazard as it blocks and restricts vision. We are calling for the government to make urgent changes to current motoring offenses and consider just how dangerous vaping at the wheel is.”

  • FEELM’s Topower Brings More Puffs, Better Battery Life

    FEELM’s Topower Brings More Puffs, Better Battery Life

    A new disposable vape battery solution was showcased during the World Vape Show Dubai, held from June 21-23.
    The pioneering power technology developed by FEELM, a subsidiary of the world’s largest atomization technology company Smoore, is intended for markets that allow higher puff counts and has been designed to increase the endurance of single-use devices.

    When compared to mainstream batteries, the new Topower offers 30 percent more capacity with the battery size remaining unchanged and can deliver over 6,000 puffs without needing to be recharged.

    Topower also provides a constant power output that reduces the loss of taste caused by voltage drop.

    FEELM says the new innovation also boasts the “longest shelf life in the industry,” according to a press release, promising just 1 percent power attenuation over six months and 3 percent over a year – which the brand says is 1/10th the level seen in traditional batteries.
    “This is our new battery technology customized for higher puff disposable vape, with large puff vaping without charging, ultimate-low discharge, ultimate-high energy density,” said Rex Zhang assistant president of FEELM. “The end goal for our industry is to create a smoke-free future and unburden adults from the harms of deadly cigarettes – technology is going to play a leading role in achieving this.”

    Zhang said the no-charge element of Topower was beneficial not just for brands, but for consumers as well. He said the battery solution eradicates the need for additional charging cables, which eliminates the necessity for internal charging devices and consequently saves on production costs.

    He also said consumers would no longer need to “worry about when and where they could next plug their disposable, which can reduce user anxieties and create a more convenient vaping experience,” according to the release.

    Topower has been incorporated into two solutions – FEELM Max’s ceramic coil disposable solution and Power Alpha‘s mesh coil solution.

    FEELM Max and Power Alpha have already been extensively commercialized and have achieved considerable success in multiple countries.

  • July 1 is Start Date for New Louisiana Vaping Tax

    July 1 is Start Date for New Louisiana Vaping Tax

    Credit: Summer

    A new law that increases the tax on vaping products in Louisiana takes effect on July 1.

    But some vape shop owners say it is not the tax hike that bothers them the most about the new law.

    Rep. Paul Hollis, from St. Tammany Parish, authored the bill that Governor John Bel Edwards signed into law.

    “Basically, what we’ve done, we’ve increased the excise tax placed on vape products. Currently, it’s 5 cents, on July 1 it will go to 15 cents per milliliter,” said Hollis.

    Hollis said revenues from the higher tax will benefit La. State Police. “We put this vape tax and we dedicate it to the state police salaries and the legislature obviously believes are long overdue. I’m embarrassed by what we currently pay state police, especially new officers,” said Hollis.

    Landon Naquin said he owns Gotta Stop in Houma and is in the vape product business, according to FOX8Live.

    “I’m actually not opposed to a tax increase within reason and I find that it’s in reasonable amount because frankly, the state has been losing money recently because so many people within my own business are transitioning from cigarettes to E-cigarettes and the state’s not collecting that revenue from the cigarettes they used to collect,” said Naquin.

    Under the new law, beginning on October 1, vape product manufacturers and makers of alternative nicotine products that are sold in Louisiana will have to execute and deliver the certificate to the commissioner of the La. Office of Alcohol and Tobacco Control stating the product was on the market in the U.S. as of August 2016.

    Naquin thinks that will have a significant impact.

    “It pretty much only legally allows for three remaining products to remain on the market,” he said.

    And the law calls for the ATC commissioner will have to develop and maintain a directory listing all vape and alternative nicotine product manufacturers that have provided certifications that comply with that law.