Ispire Technology and IKE Tech announced a successful pre-premarket tobacco product application (PMTA) meeting with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for their age verification technology for electronic nicotine delivery systems (ENDS).
According to an e-mailed release, the technology aims to prevent youth access while expanding adult market access to flavored PMTA-authorized products. IKE Tech is a joint venture among three leading technology and research companies Ispire and Touch Point Worldwide d/b/a Berify and Chemular Inc.
IKE Tech will submit a component PMTA, which would allow ENDS manufacturers to incorporate their blockchain-based age-gating solution if authorized. The FDA indicated potential priority review consideration and acceptance of a component PMTA. The company plans to complete the required studies in Q1 2025.
This critical regulatory milestone marks an essential step in the journey to provide an innovative, secure universal solution aimed at preventing youth access to ENDS and expanding the market for adults who choose to use flavored PMTA-authorized products, according to the release.
“The IKE Tech identity and age verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage,” the release states.
Due to its innovative design, reliance on blockchain technology, and partnership with leading identity and age verification providers, the IKE Tech system is an advanced component that could be used — in any ENDS device — to ensure only authorized adult users can access vaping products.
FDA alignment on key points:
Component PMTA: IKE Tech will submit a PMTA for a component, as opposed to a finished tobacco product to be sold to consumers, and the FDA indicated it will accept such a component PMTA if all statutory requirements are met. Additionally, due to the fact this component employs novel point-of-use technology, the FDA indicated it will consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTAs, as a plug-and-play age-gating solution, which may allow for the approval of a variety of flavored ENDS products.
Creation of Tobacco Product Master File (TPMF): IKE will create and file a TPMF for the IKE component. Once authorized, the component and TPMF can, subject to agreement, be available to ENDS device manufacturers for incorporation into products.
IKE Tech anticipates completing the required studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component in Q1 2025.
“Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire’s mission,” said Michael Wang, Co-CEO of Ispire. “We are proud to introduce technologies that are designed to responsibly support adult consumer choice while significantly reducing youth access. This technology represents our dedication to aligning with regulatory guidance and setting new standards for safer
Vapes are a powerful tool for adult smokers making the transition from cigarettes to reduced-risk products (RRP). The category is governed by market-specific regulation, often influencing public perception and, therefore, uptake.
Last week, following an extensive scientific review, the U.S. Food and Drug Administration authorized the marketing of four menthol-flavored e-cigarette products for Altria-owned vaping company Njoy. This is a watershed moment for the sector and one which will have a huge and significant impact on the global RRP market.
This announcement signifies the FDA’s acknowledgment that menthol vaping products have the potential to be an important and effective tool for adult smokers looking for reduced-risk alternatives. This is significant for the wider sector in a number of ways; above all, it sets a precedent for other markets, paving the way for other regulators, particularly those looking at bans, to consider flavors in the context of public health.
Across the globe, we are seeing an increasing number of markets introduce bans on flavors on a precautionary basis in a bid to mitigate youth uptake. At Plxsur, we have long advocated against the ban of flavors on vape products, arguing that it has the potential to negatively impact those making the transition from conventional cigarettes, who often are drawn to vapes for their flavor, amongst other factors such as price and convenience. There are also arguments and emerging evidence that flavor bans drive the black market sale of unregulated, dangerous products.
There will be many that, understandably, say this decision is “too little, too late,” but it is nonetheless encouraging to see the FDA, with its extensive science and evidence-based review, validating that with effective regulation and enforcement, flavored vape products are “in the interest of public health.” Those countries that have considered flavor bans should look to the U.S. and conclude that it can’t be justified from a scientific review perspective.
While this is the first authorization of a “characterizing flavor” by the FDA for vaping products, two of the major regulatory influencing bodies, the FDA and the Medicines and Healthcare Products Regulatory Agency (MHRA), now acknowledge that there is value in non-tobacco-flavored vaping products.
This decision has the potential to impact the world. The U.S. has long influenced international markets, so it sets a benchmark that we expect other, less vape-supportive governments and regulatory bodies will follow.
Rob Burton
In Italy, tobacco-flavored vapes constitute 40% of the vape market, while menthol represents 21%.[1] This demonstrates the significance of flavored products in the market as a whole. If such flavors were to be banned, this would act as a barrier for smokers to move to reduced-risk alternatives and potentially lead vapers to return to cigarettes.
In some geographies, it is great to see that vapes are being accepted as an effective alternative to conventional cigarettes, even this week’s news from Australia announcing that vapes – which until now have only been available through prescription – will soon be available for sale within pharmacies without the need for a prescription, offering an effective pathway to end the smoking epidemic in the country.
As we anticipate the potential revision of the Tobacco Product Directive Review next year, the justification for banning flavors, from a scientific point of view, simply isn’t there. In the case of Njoy, this has been shown through closed-system pod-based devices, which offer a more cost-effective avenue for existing smokers and disposable systems while incorporating child lock systems that will restrict access to children, as is already applied by a Plxsur company, ProVape, in its SALT and KUBIK brands.
While the FDA’s authorization is specific to these four products made and sold by Njoy and does not apply to any other menthol-flavored e-cigarettes, our expectation is this will open a channel for other such products to achieve authorization by providing the necessary framework and the potential for knowledge-sharing and guidance. With the weight of data-led evidence, the category can advocate for the democratization of this framework, enabling further regulatory authorizations for products produced by responsible vaping companies in the interest of the adult smoker.
At Plxsur, we have a clear purpose – to facilitate adult smokers to make positive health decisions by transitioning away from cigarettes to reduced-risk products. Flavor is a key factor in supporting smokers moving completely to such alternatives, and we look forward to seeing a more science and data-led approach being adopted across all markets as we work to save the lives of those impacted by smoking, mitigate the risk of youth uptake, and do so sustainably and responsibly.
We view this FDA decision as a significant step forward in broadening the pathway for adult smokers, and previously lacking “off-ramp” for U.S. menthol smokers looking to make the switch, which, according to Public Health England, is 95% less harmful and, therefore, undeniably, “in the interest of public health.”[2]
Robert Burton is Group Scientific and Regulatory director for Plxsur.
Examining the impact of flavored e-cigarettes on adult smokers: insights from a three-month experimental study
By Jessica Zdinak
Much ink has been devoted to the dichotomy presented by electronic nicotine-delivery systems (ENDS)—are they a friend or a foe?
For several years now, we have seen a surge of a variety of different e-cigarette products, overrunning the U.S. commerce both legally and illegally. The question remains for some, including our regulator: Do they serve as an alternative to traditional combustible cigarettes, or do they serve as an initiator for youth and young adults? This dichotomy revolves heavily around the authorization of and use of flavored e-cigarette/e-liquid products.
Continuously, and in my opinion, rightfully so, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) presents manufacturers with marketing denial orders that state things like “… your PMTA lacks sufficient evidence demonstrating that your flavored ENDS will provide a benefit to adult users that would be adequate to outweigh the risks to youth.” To demonstrate this, a reliable and robust study must be conducted. “Reliable and robust” means different things with each of the different scientific areas contained within an application. For the behavioral sciences, it means using a design that inherently has a level of methodological and statistical control, such as a randomized control trial, known in our scientific area as a “between-subjects experimental design.”
To address the CTP’s concerns and gain a better understanding of the effects of flavored e-cigarettes, the research team at Applied Research and Analysis Company (ARAC) conducted a three-month randomized experimental study. This study was sponsored by Accorto Regulatory Solutions, in conjunction with Freenoms, an e-liquid manufacturer and subsidiary of Lotus Vaping Technologies, creator of the Nomenons e-liquid. In this article, we will explore the key findings and insights from this study, shedding light on how flavored e-cigarettes may influence adult smokers’ habits and vapes’ potential as a smoking cessation tool.
Study Context
The study, conducted by a team of experts led by ARAC Chief Research Officer Jessica Zdinak, was designed to provide evidence related to the public health impact of flavored e-cigarette products on adult smokers. The study’s design played a crucial role in ensuring the validity and reliability of the results. Expertise in behavioral science and research methodologies were instrumental in crafting the study’s plan, design and analysis. After a recent meeting with the CTP, it is acknowledged that ARAC’s key behavioral science framework meets the mark from a scientifically rigorous perspective. Here are just a few key aspects of ARAC’s study designs that underscore the importance of such expertise:
Statistical power: The study’s design took into account statistical power, ensuring that there were enough participants to detect significant effects should differences or effects exist and not to detect such differences or effects should they not exist. (Think, “Can you generalize your results?”)
Effect size considerations: Researchers considered effect size, an important factor in determining the practical significance of findings. (Think, “How generalizable are your results?”)
Hypothesis generation: The study involved the formulation of hypotheses that guided the research, enabling a systematic investigation of the impact of flavored e-cigarettes on smoking behaviors.
Awareness of behavioral factors: Researchers were keenly aware of the behavioral factors at play behind nicotine consumption, adding depth to the study’s approach.
Study Design
The study was conducted using a between-subjects randomized experimental design, which involved two conditions: one with flavored e-liquids and another with tobacco-tasting e-liquids. The primary dependent variables were cigarettes per day (CPD) and candidate product usage. The use of a randomized experimental design is a rigorous and reliable approach to investigate the effects of flavored e-cigarettes on smoking behaviors, as it minimizes bias and allows for causal inferences.
Following Institutional Review Board approval, participants were recruited from several locations across the U.S. They were then randomly assigned to one of two conditions: flavored candidate e-liquids or tobacco-tasting candidate e-liquids. Over a three-month time period, participants returned to facilities each month to select additional products as needed and to complete follow-up surveys. The follow-up surveys asked participants to specify their CPD over the past 30 days and the past 24 hours as well as their use of the candidate e-liquids. These responses were used for the primary analyses in which reduction and cessation were defined and analyzed as:
computed reduction of 50 percent or more of cigarette stick usage from baseline to follow-up
complete elimination of cigarette sticks
Results: Descriptive Insights
At the end of the three-month study, a total of 382 participants completed the final follow-up survey (n=181 in flavor condition; n=157 in tobacco-tasting condition). Using this data, we conducted both descriptive and inferential statistics. Coupled together, but with a focus on the inferential statistics, this study’s results offer valuable insights into the impact of flavored e-cigarettes on smoking behaviors.
Flavors over time: The study tracked how participants’ preferences for specific e-liquid flavors did (or did not) change over the three-month study period.
2. CPD between conditions over time: The results show the descriptive differences in cigarettes smoked per day between the flavored and tobacco-tasting conditions over the course of the study.
3. CPD between conditions over time: The results show the inferential statistics assessing the experimental effect of flavors on CPD compared to tobacco-tasting. Specifically, the study found that the portfolio of flavored e-liquids led to a significant reduction in CPD compared to tobacco-tasting products. This suggests that flavor plays a role in encouraging smokers to cut down on their cigarette consumption.
4. Switching rates: The research examined the rates at which participants switched from smoking cigarettes to using e-cigarettes, with specific attention to the flavored e-liquids, which led to a higher quit/cessation rate than tobacco-tasting e-liquids.
5. Individual flavor assessments: The study explored how individual flavors affected CPD reduction and cessation, providing insights into the specific flavors that had the most significant impact. Specifically, different flavors had varying effects on CPD reduction and cessation, with some flavors showing statistically significant differences. This highlights the complexity of the relationship between flavor and smoking behaviors, such as reduction in CPD and cessation of combustible cigarettes.
Summary of Findings
In summary, the study found that flavored e-liquids had a positive impact on smoking behaviors among adult smokers. Specific findings include:
CPD reduction: The portfolio of flavored e-liquids were associated with a statistically significant reduction in cigarettes smoked per day compared to tobacco-tasting products, suggesting that flavors encourage smokers to cut down on their cigarette consumption.
Variability among flavors: The impact of flavored e-liquids on CPD reduction and smoking cessation varied among different flavors. Certain flavors had a more pronounced effect, highlighting the need to consider the specific flavor profiles when evaluating their impact on smoking behavior.
Preference changes over time: Some participants’ preferences for specific flavors changed throughout the study, indicating that flavor appeal may evolve and influence its effectiveness in encouraging smokers to switch to e-cigarettes.
Qualitative insights: Open-ended questions provided valuable qualitative insights into how flavors influenced participants’ perceptions and decisions to quit or reduce cigarette consumption. These insights offer a more comprehensive understanding of the relationship between flavor and smoking behavior.
Overall, the study’s findings underscore the complex interplay between flavored e-cigarettes and smoking behaviors among adult smokers. While some flavors show promise in reducing cigarette consumption and promoting switching, there is no one-size-fits-all approach, and individual preferences and perceptions play a significant role.
One of the most powerful aspects of science is replicability. If industry is serious about getting new products, including flavors, authorized for market, replicability of studies such as this one is fundamental to success. Let’s hope this study is just the first of many at building that library of rigorous scientific evidence that the CTP has been looking for.
Jessica Zdinak is a U.S. Eastern Shore Virginia native with almost 20 years’ experience leading psychological research across a variety of domains, including a decade of which serving in tobacco harm reduction. She leads a team focused on product development and behavioral science consumer research supporting innovation, “next-generation” products and regulatory applications, including investigational tobacco products, premarket tobacco product applications, modified-risk tobacco product applications and substantial equivalence applications. Zdinak has substantial experience within the U.S. federal government sector, leading research evaluation teams with a focus on the Centers for Disease Control and Prevention, the National Institutes of Health, the National Science Foundation, the Food and Drug Administration, and other large-scale grants and projects.
Interested parties can now register for the Jan. 12 U.S. Food and Drug Administration seminar covering the ban of menthol flavors in tobacco products. “The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars” is the first FDA tobacco-related seminar of the year.
The presentation will provide an overview of the scientific evidence that informed the development of these proposed rules, with an explanation of the external peer review process the FDA utilized for review of the highly influential scientific assessments for these proposed rules.
Bridget Ambrose, director of the Division of Population Health Science in the Office of Science at the FDA’s Center for Tobacco Products, will be the speaker. Ambrose has over 20 years of experience in tobacco control and regulatory science, with specialized experience in longitudinal analyses of tobacco use.
The idea that e-cigarette flavors hook kids is simple, compelling—and false.
By Clive Bates
In a fact sheet titled “Flavored E-cigarettes Hook Kids,” the U.S.-based Campaign for Tobacco-Free Kids asserts that “Flavored e-cigarettes are undermining the nation’s overall efforts to reduce youth tobacco use and putting a new generation of kids at risk of nicotine addiction and the serious health harms that result from tobacco use.” Let us call this “the activist proposition.”
The challenge with simple but false activist propositions is that refuting them can require a lengthy embrace of more complex arguments. Brandolini’s law, also known as the bullshit asymmetry principle, can be expressed: “The amount of energy needed to refute bullshit is an order of magnitude larger than to produce it.” In this article, we shall demonstrate Brandolini’s law by addressing the simple but false activist proposition about flavored e-cigarettes through a series of questions.
First, do flavors cause youth tobacco or nicotine use? The activist proposition builds in an assumption that flavors cause e-cigarette use. Lots of young people use flavored e-cigarettes. Therefore, it is claimed, flavored e-cigarettes must cause young people to use e-cigarettes. But how likely is that? We know from the past that a high proportion of young people can use tobacco if they choose to, mostly without flavors. According to the Monitoring the Future survey, for most of the 1990s, U.S. 12th-grade past 30-day cigarette smoking prevalence was at or above 30 percent. By 2021, teenage cigarette smoking had fallen around 4 percent, but nicotine vaping had reached 20 percent. Perhaps there is a persistent demand for nicotine or tobacco, regardless of whether it is flavored. Also, let’s look over time. In the United States, high school past 30-day vaping was 11.3 percent in 2016, rose to 27.5 percent in 2019 but fell to 14.1 percent by 2022. Yet there was very little change in the availability of flavored e-cigarettes to explain these swings. There are also countries where flavors are widely available but youth vaping is relatively low. Take the U.K., for example, which takes a positive approach to tobacco harm reduction and vaping. Thousands of flavored products are available, but according to a recent official evidence assessment, youth vaping remains below 10 percent. And the U.K. offers us a further important insight: “[D]ata showed that most young people who had never smoked were also not currently vaping (98.3 percent).” This tells us that vaping is highly concentrated in adolescents already open to tobacco use.
Second, so what does cause youth tobacco or nicotine use? Most of the evidence points to characteristics of the individual and their circumstances not tobacco product features. Tobacco use is driven by a complex mix of psychosocial factors, including genetics, parental smoking, poverty, delinquency, rebelliousness, low self-esteem, peer group, etc. A 2016 literature review identified 98 conceptually different potential predictors of smoking onset. A 2019 study looked at stated reasons for e-cigarette use and concluded there were two main drivers: “alternative to cigarettes” and the “larger social environment.” For some young people, tobacco or nicotine use may have functional benefits. It may modulate stress or anxiety, improve concentration or help control conditions such as attention deficit hyperactivity disorder(ADHD). For others, it may be just frivolous and experimental. In 2019, the U.S. Centers for Disease Control and Prevention asked young people why they vaped; the top reason was, “I was curious about them.”
Third, what would teenage vapers do if they were not vaping? Implicit in the activist proposition is the idea that removing flavors will remove the reason to vape and stop the user from vaping. At one level, there is some truth in this. If the products are bland, unpleasant or tasteless, perhaps no one will use them. But here is the problem: What if the demand for tobacco and nicotine has deeper psychosocial causes, such as those discussed above? Removing the flavored products does not make the demand go away. Would the teenage vapers just give up vaping and do more homework and piano practice instead? If the underlying demand remains, that is unlikely. Teenagers interested in nicotine might revert to cigarettes, cigars or other tobacco products. We have some evidence for this: When e-liquid flavors were banned in San Francisco in 2019, there was an increase in teenage smoking compared to other areas where flavors had not been banned. This is hardly a surprise—in one study, young adults were asked what they would do if e-cigarette flavors were banned. About one-third said they were likely to switch to cigarettes.
In 2022, Boston-based public health scientists Mike Siegel and Amanda Katchmar reviewed the body of evidence on youth smoking and vaping, concluding that it “suggests that youth e-cigarette use has instead worked to replace a culture of youth smoking.” Economic analysis also backs this idea—when prices of e-cigarettes increase, youth vaping falls, but youth smoking rises. That tells us that e-cigarettes and cigarettes function as substitutes. If regulators ban e-cigarette flavors, then they should not be surprised if more smoking is the result. For that reason, Siegel and Katchmar concluded “[W]e propose a reevaluation of current policies surrounding e-cigarette sales so that declines in e-cigarette use will not come at the cost of increasing cigarette use among youth and adults.” That is very troubling for the activist proposition—it means policies to address youth vaping cannot be evaluated without concern for their effect on youth smoking. It also means that some youth vaping may be a diversion from smoking and is beneficial. It follows that regulation discouraging vaping could easily be harmful.
Fourth, how would a ban on flavors work? The logic of the activist proposition is that a ban on flavored products would remove flavored products from the market, thus removing the reason for young people to vape. But that is not how prohibitions work in practice. A prohibition does not cause the prohibited product to disappear. But in practice, a prohibition causes the perturbation of a market. It causes changes to the behavior of consumers, legal and illegal suppliers, prices and availability. Foreseeable consequences include switching to cigarettes or other tobacco products; switching to other substances; switching e-cigarettes to the permitted flavors; illicit trade in flavored liquids; home mixing and informal selling; cross-border trade or internet sales; stockpiling and workarounds such as sales of flavors for aromatherapy. Prohibitions change the supply side, and rarely for the better. There should be no mystery about this: Despite longstanding prohibition, the Monitoring the Future survey shows that U.S. 12th-grade past 30-day cannabis use has been around 20 percent and daily use around 5 percent for about the past 25 years. Some of these responses to flavor prohibition will clearly increase harm compared to vaping. Because smoking is so much more harmful, it would only take a slight uptick in smoking to offset any benefit of significantly reduced teenage vaping. But there are also hazards arising from informal manufacturing and workarounds. Illicit supply will bring adolescents into contact with criminal networks as consumers and potentially as low-level participants.
Fifth, what is really going on with youth vaping? I believe there are two broad patterns of youth vaping and two distinct behaviors at work, but these are often conflated. The first is frivolous and experimental use, where young people try new things. This has characteristics of a frothy fad: infrequent use, transient and unpredictable. The second is more determined nicotine use: frequent, intense and entrenched. But this group is more likely to be the adolescents who would otherwise be using cigarettes or other tobacco products. The first group contributes to the “youth vaping epidemic” narrative but is not really a cause for great public health concern. The second group represents the migration of nicotine use in society to far safer technologies and is likely beneficial for public health. The activist proposition, however, requires policymakers to believe there is no latent demand for nicotine use and that removing products will eliminate nicotine from society. But it is much more plausible to think of the demand for nicotine in similar terms to alcohol, caffeine, cannabis and other recreational substances. People use nicotine for a reason, and there will be a long-term demand for it. The task for policymakers and regulators is to make that acceptably safe and to resist simplistic activist propositions that are likely to do more harm than good.
In November 2022, the Campaign For Tobacco Free Kids celebrated the success of a mass activist campaign to secure Proposition 31, a ban on flavored products in California. They may have won their political battle, and their aggressive promotion of the activist proposition has again prevailed. But nowhere in its advocacy literature does this powerful coalition level with California’s voters about the underlying drivers of youth nicotine use, the linkages between smoking and vaping, and the risks of unintended consequences. They can deny this real-world complexity, but policies built on bullshit have a nasty tendency to go wrong, to do more harm than good and to call into question the credibility of their advocates.
Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
Like many people who smoke, Doug Halterman wanted to quit. “I tried other ways, even prescription drugs, and nothing worked.” When he decided to try vaping, “At first, it was a research and development stage. I had to figure out what ones best acted like a cigarette,” he recalled. “I started with menthol tobacco. I then liked the fruit flavors because it helped stay clear of cigarettes. After vaping fruity flavors, cigs tasted absolutely disgusting.”
Halterman’s story of switching is one of several dozen generously shared via emails from members of the Consumer Advocates for Smoke-free Alternatives Association (CASAA). This exploration of what drives change was triggered by anecdotes and research suggesting that encountering and trialing a range of alternative nicotine products, or rotating among an engaging mix of options, can be key to ditching smoking. The typical successful quitting journey seems less like a thruway and more like a meandering river. The U.S. Food and Drug Administration’s Center for Tobacco Products’ approach to researching switching, described in its Final Rule guidance, assumes simple choices and straight lines.
The Wrong Framework?
Premarket tobacco product application (PMTA) behavior studies are supposed to describe likely changes (and related health risks) created by the marketing of a single novel tobacco product of a particular flavor and nicotine strength. This is not unlike studies the FDA’s Center for Drug Evaluation and Research (CDER) reviews, comparing effects of a new drug to a placebo on particular symptoms or endpoints.
In a September 2021 PMTA Technical Review Summary available online, the FDA laid out a new standard that flavored electronic nicotine-delivery system (ENDS) products must meet. Balancing concerns about youth uptake demands “acceptably strong evidence that the flavored products have an added benefit relative to that of tobacco-flavored ENDS in facilitating smokers completely switching away from or significantly reducing their smoking.” What kind of evidence? “Most likely product specific evidence from a randomized controlled trial (RCT) or longitudinal cohort study.”
Again, it’s like testing whether a medicine to treat gout or acne is superior to the current standard therapy, except it casts tobacco flavoring (the taste of cigarettes) as the standard and mango or vanilla as the unproven alternative.
Does an approach that may work for “safe and effective” prescribed drug authorizations make as much sense for a balance-of-risks consumer product standard? Does the CDER mindset serve well the end goal of moving people off combustibles? This pharma-influenced standard may be the wrong tool to address tobacco product effects.
Comments from people’s real-world switching experiences (see sidebar) suggest that a test-in-isolation model fails to capture a lot of key information that could accelerate the move away from smoking and its unacceptably high risks of disease and death.
Unlike pharmaceuticals and devices approved by other FDA centers, nicotine consumer products are not prescribed as a course of treatment. Tobacco users looking to switch aren’t making comparisons among two (or three) options. They meander through shops and gas stations, picking up nicotine products at will and whim. Many use multiple products to suit situations or prevent boredom. They learn through trial and error: How does this product work? What does it do for me? How does it fit into my life? And they choose again.
Another problem: As Neil McKeganey of the Center for Substance Use Research pointed out recently, it’s not clear by how much the FDA values youth vaping prevention over adult smoking cessation. How obviously better would a flavored product need to be at helping smokers switch, compared to a tobacco flavor, to offset concerns about youth appeal? The recent longitudinal study of Juul, where over half of participants switched completely from cigarettes at one year, found that what flavor smokers chose did not significantly affect success.
Missing Variables
Most studies aren’t designed to address the power of choices. Even large surveys that support the importance of flavors in switching tend to collapse flavors into categories (like “sweet” for fruit and candy) and ask about main flavor used, obscuring the paths taken by individual quitters. But there are tantalizing hints. For example, a six-week switching study of tobacco-free pouches found a link between trying more flavors and fewer daily cigarettes smoked. A 2018 study of MarkTen found that smokers who switched completely used more flavors.
Based on her experience researching oral and vapor product behaviors (including MarkTen), “Most smokers don’t successfully switch and sustain their switching through one product category,” said Jessica Zdinak, chief research officer at Applied Research and Analysis Consulting. She notes that academic studies of smoker transitions often leave out important variables, such as previous quitting experiences or stressful changes in life circumstances.
Adding Real-World Evidence
FDA Commissioner Robert Califf has been quoted repeatedly as supporting greater reliance on real-world evidence to support drug regulation decisions. During his first stint as FDA head, Califf said at the 2016 Food and Drug Law Institute conference that “In the past, so-called ‘regulatory trials’ tended to focus on high-quality studies with detailed study procedures, restrictive inclusion and exclusion criteria and have been conducted in special study sites.” By contrast, he noted that “pragmatic clinical trials,” studies that look at treatments and outcomes in actual medical practice settings, “may be the most important source of knowledge in the future.”
Another difference from pharmaceutical products: Many alternative nicotine products have been on the market for several years. Why not consider real-life evidence, as in natural choice situations over time, for tobacco product switching behavior? Don’t throw away tried-and-tested tools but see how they fit in a new context.
Zdinak would like to see long-term randomized trials that incorporate this approach, showing the effect of having or lacking a range of options. To demonstrate the effects of flavors on switching, “What does the world look like if I’m a smoker of 30 years who enters a vape shop, and I have tobacco-flavored vapes as my sole option? Or what happens if I see citrus, mango, cinnamon, coffee and caramel?” She is currently in the design and review phase for one such realistic study.
To quote prominent researchers Dorothy Hatsukami and Dana Carroll, “Most in the tobacco control community would agree that an immediate main goal is to rapidly eliminate tobacco-related death and disease.” If regulators agree, let’s look at what obstacles are preventing smokers from switching more rapidly. That includes tailoring methods and assumptions borrowed from pharma research to suit appropriate for the protection of public health (APPH) standards and goals.
The Power of Choices: Stories from CASAA
Founded in 2009, the Consumer Advocates for Smoke-free Alternatives Association (CASAA) is a 501(c)(4) consumer nonprofit organization that aims to “ensure the availability of a variety of effective, affordable reduced-harm alternatives to smoking.”
In response to an emailed request from CEO Alex Clark, a number of former smokers took time to share their experiences of switching to vaping or other smoke-free products. One question posed by Clark was whether the variety of products was helpful in staying engaged with smoke-free options and reducing the temptation to return to smoking.
Clark himself recently switched from vaping to using pouched snus. Along with a concern that overconsumption of stimulants, such as coffee and rapid-delivery nicotine products, were triggering heart palpitations, he said, “The hands-free nature of snus fits more with my needs. And I can still get all of the different flavors when I order from Sweden.”
Here are excerpts from CASAA member comments, edited for length and clarity. No doubt, people who smoke have a range of goals and preferences that evolve in sometimes surprising ways through product exploration.
Nancy S.: “I started vaping because I was unable to stop smoking tobacco cigarettes because I am so addicted to nicotine. And I don’t want to die from lung cancer like my father did. The products I tried were exactly what I was looking for. I wanted something that tasted like a real cigarette. No funny flavors.”
Roger M.: “I love the variety of products—both hardware and e-juices. My favs are black licorice, almond and bubble gum. They say only the kids like these flavors, but I have loved them since I started vaping 12 years ago. I am now 61.”
Sara C.: I liked trying new flavors in the beginning then found my favorite [strawberries and cream] that I’ve stuck with for years.”
Marc C.: I’ve tried the patch, the gum, hypnosis, as seen on TV products, medications and counseling. Nothing worked or works for me except vaping. I want my vape to taste like an authentic tobacco vape. But I’m okay with some flavor of tobacco, like coffee, vanilla, apple or maple. Almost like a pipe tobacco assortment.”
Sean O.: “The first product I tried wasn’t all that good. Eventually, I found that using what’s called a ‘box mod,’ which takes two high-powered batteries … gave the great sensation in your throat of inhaling the same way a cigarette did. The large clouds of vapor that you can produce using these mods and tanks is incredible. [And] the variety of flavors is exactly what has kept me away from cigarettes.”
Joni L.: “The device was key for me. I chose a Vaporesso Swag because of the size. It felt close enough to a pack of cigarettes for me, and a lot of my habit was actually reaching for my smokes. My first e-juice was a house-made vanilla custard tobacco; I was afraid to go too far away from tobacco flavors because I actually believe I liked the flavor of a cigarette. After three or four days, I went back to the vape shop and bought some mixed berry-flavored juice. That was it. It didn’t take long for my cigarette cravings to go away.”
Kelly P.: “I did try a different device but went back to Juul. I liked the mint and found it better than the menthol cigarettes I had smoked. Also, Juul wasn’t one of those devices that you would blow out a cloud of smoke.”
Glenn N.: “I believe that the first ‘e-cigarette’ I bought was the first Blu. I vaped that for a couple months, but it was missing something, and I thought I would go back to cigarettes. So I started looking online. With that ProVari, I knew that I would never smoke again. I found what I needed. I started with 36 mg liquid and went down to 12 mg in about a year.”
Steve T.: “I will be 68 this year and feel I made a great decision with vaping. Access to flavors is a critical component necessary to transition away from cigarettes. I have reduced the nicotine levels from 18 mg to 3 [mg], and my Kona e-juice was replaced with dessert and blueberry flavors.”
Jessie C.: “NRT [nicotine-replacement therapy] options like snus and nicotine gum/lozenges never worked for me as more than a way to avoid smoking at an event or during a long work shift. I’m very much a tech-oriented person, so the idea of having many options was stimulating for me. At the time, CE4 atomizer [tanks] and little pens were the most accessible items on the market [and did not meet expectations]. When the Kangertech Subox Mini hit the market, I was satisfied and stuck with that.”
Cindi K.: I started vaping in 2014 not because I was looking to quit smoking but because I was avoiding convenience stores; I had just entered AA [Alcoholics Anonymous] and that is where I’d bought alcohol. Two doors down was a vapor store. I bought an eGo Tank and some tobacco-flavored e-liquid in 24 mg. I made friends in AA that were also vaping and noticed their liquids smelled much better than what I was using. I continued to be what I labeled a dual user for a few more months and decided to use flavored e-liquid and willpower to quit smoking. I also learned how to make my own flavors. I had about 12 I used in rotation and loved.”
Tanya L.: “The first product I tried was in 2013: a vanilla-flavored vape liquid, Kanger T3S tank and coils, which I still use. I like vanilla. I just had to find the best vanilla.”
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.
Increasingly popular, crushable filters may very well breach the confines of their niche status.
By Stefanie Rossel
Even as global cigarette volumes continue to contract, one product segment is enjoying considerable success—flavor-capsule filter (FCF) cigarettes. First introduced in Japan in 2007, FCF cigarettes have seen impressive growth around the globe since.
“The segment is still relatively small but has doubled in penetration between 2012 and 2015,” says Shane MacGuill, head of tobacco research at Euromonitor International. According to the market research firm, FCF volume grew from 30.91 billion, or 0.6 percent of the global cigarette market (excluding China), in 2012 to 63.18 billion, or 1.2 percent, in 2015.
“Penetration is very high in some markets, particularly Latin America, Japan and the U.K., but there is much lower to negligible penetration in very large markets such as Russia, Indonesia and China, which means that at a global level the category is still niche,” says MacGuill.
FCF products are most popular in Chile, where they accounted for 32 percent of the tobacco market in 2015, followed by Peru (22.8 percent), Guatemala (19.3 percent), Argentina (15.6 percent) and Mexico (13.7 percent). In Sweden, they represented 13 percent. Other important FCF markets are Ireland (10 percent), Slovakia (9.3 percent), Japan (8.4 percent) and the U.K. (7.9 percent). Japan is the largest global market for FCF cigarettes in absolute terms; its FCF volume grew from 9.87 billion sticks in 2012 to 15.4 billion units in 2015.
MacGuill estimates that, on a pro rata basis, the global FCF segment would be worth about $8.4 billion. “However, given the geographic concentration, the true tax-inclusive retail sales price value of the segment could be more like $15 billion,” he notes.
Having started as a feature for premium brands, FCFs have now reached the cigarette mainstream. Increasingly, manufacturers are using the technology as a “premiumizing” tool for their economy and value brands, and in some cases even for localized cigarette brands.
Opportunities ahead
FCF technology allows consumers to customize their smokes by crushing one or more flavor capsules integrated into the filter. Basically, there are two variants: double-mentholated or menthol-to-menthol capsule filters, which allow the smoker to vary the strength of the menthol flavor, and hybrid capsule products, which enable the smoker to turn a regular cigarette into a mentholated version.
While the focus has been on adding a menthol or minty taste, FCF technology is increasingly used to deliver other flavors, too. “We’ve seen a huge increase in combination capsules in the form of products like Pall Mall Double Click and several others,” says MacGuill. “Many of these are launched in Japan, but also in Latin America and Europe, particularly Central and Eastern Europe. Flavors are also becoming more exotic, with grape, berry, even whiskey, as in Winston in Japan, appearing in capsule form.”
The future of the segment will depend largely on regulations. The EU, for example, will ban menthol cigarettes from 2020. Concern about regulation appears to have held up FCF launches in some markets, such as Brazil, but Euromonitor has failed to detect a similar impact in Europe.
For the time being, FCF products remain tremendously popular. Anecdotally, the industry even credits capsule products with luring smokers back from illicit cigarettes, particularly in Latin America. MacGuill expects tobacco companies to sell FCF products for as long as they legally can. There are also large markets with low penetration, he notes, which are unlikely to introduce flavor regulation in the short to medium term. In such markets, there is clear scope for FCF cigarettes to expand.
MacGuill is confident FCF products present further opportunity for the industry. To some extent, he says, the flavor-on-demand option addresses the competition combustible cigarettes face from e-cigarettes, which rely heavily on flavors. Due to its sophistication, FCF technology also makes cigarettes harder to counterfeit.
And then there is China. “We are just beginning to see the emergence of capsule products in China, for example with green tea flavor,” says MacGuill. China, of course, remains off-limits to foreign cigarette manufacturers, but the rise of FCF products there could benefit suppliers. “If the segment achieves only a fraction of share of the Chinese market, it would be bigger than the entire global volume currently,” says MacGuill.
A hard nut to crack – flavored capsules present formidable manufacturing challenges
Hauni’s MCAP detecs missing or surplus capsules. It also monitors filling level and position.
While the commercial potential for FCF products is promising, the manufacturing process is full of challenges. Based on gelatin, the delicate capsule beads need careful handling, not only during production and insertion but also during the reclaiming of tobacco from rejected FCF cigarettes. Too much pressure on the capsule and the flavorant will contaminate equipment and tobacco.
Tobacco machinery manufacturers offer a variety of FCF solutions. In November, Hauni Maschinenbau introduced Flexport-CI, an enhanced version of HCI, the company’s first capsule inserter. According to Hauni, Flexport-CI is the market’s first customer-accepted high-speed capsule inserter.
After thoroughly analyzing the inserting process and its HCI experience, Hauni completely redesigned the vacuum system and the shape of the capsule holding area. The revisions resulted in “a very precise and reliable inserting process,” says Arne Klisch, product consultant at Hauni.
The Flexport-CI can be integrated into Hauni’s KDF 5 and KDF 6 filter makers. To ensure gentle treatment, the beads are transferred by vacuum and sophisticated drum technology. A modified sampling device can eject filters out of the mass flow for immediate quality analysis.
By making many small but effective changes, Hauni was able to nearly double the insertion rate. With a more flexible design, Flexport-CI allows customers to reduce their time to market, according to Klisch.
To test capsules in finished products, Hauni developed MCAP, an online sensor. Based on microwave technology and used in the Max filter assembly unit of a Protos-M cigarette maker, MCAP offers high- quality detection, according to Hauni. “The system offers color-independent detection of missing or surplus capsules and also monitors their filling level and position,” says Klisch.
The MCAP is the only sensor of its kind in series production, according to Hauni. Because the instrument tests every capsule cigarette at the end of the production process, it ejects only individual defective cigarettes, not complete filter rods with four or six capsules each, as happens in the filter rod production process.
Speed with precision and efficiency
Witek Bialas
Capsule filters require a high degree of accuracy during handling, especially as far as the capsule position is concerned. Another factor is flexibility; tobacco companies like the freedom to design a variety of products that will appeal to consumers.
In September, International Tobacco Machinery (ITM) introduced the Capsule Insertion Module (CIM) for its filter maker. “The capsule distribution process is controlled mechanically without centrifugal and gravity force support, transporting each capsule in a gentle way,” says Witek Bialas, director of filter technologies for ITM Poland.
Thanks to specially designed insertion cams, forks and vacuumless servo-drive technology, each capsule is safely transported and placed into the rod without any damage, guaranteeing precision and quality, while ensuring full repeatability of production, according to Bialas.
ITM says that its new capsule insertion technology does not limit the nominal speed of the filter maker when inserting capsules into the rod. It guarantees a speed of 500 meters per minute for the insertion of one or two capsules into the filter on its Polaris single-rod filter maker, with the highest product quality and minimum waste.
Capsule efficiency, Bialas says, is up to 40,000 pieces per minute, with waste of under 2 percent. The CIM can handle filters with lengths of 60 mm to 150 mm and diameters of 5.3 mm to 9.0 mm. Capsule diameter can be from 3 mm up to 3.5 mm, while the capsule position in the filter can be symmetrical or asymmetrical.
“Not only speed is unprecedented in this technology, but also the capsule position in the rod,” says Bialas. “The minimum 10 mm distance between capsules is unique.” The CIM is of modular design, enabling easy implementation to the ITM Polaris filter maker and flexibility to quickly meet the required filter specification, he adds.
To maintain and measure performance, ITM offers MOMS2, a microwave system that monitors the characteristics of the filter material, capsule condition and position.
Each rod is analyzed during the production process. Out-of-specification products are identified and rejected automatically.
Recycling made easy
Heinen Koehl’s ReclaimAir minimizes the risk of tobacco contamination while processing cigarettes with capsule filters.
FCF products present an additional manufacturing challenge in that they make it more difficult to reclaim tobacco from rejected cigarettes. If damaged during the recovery process, a capsule full of menthol or other flavors will contaminate the tobacco that is meant to be recycled. To prevent this scenario, Heinen Koehl has developed ReclaimAir. Depending on the filter type processed, the unit works with one of two different principles. Both start with cigarettes being discharged via a separation belt into a cigarette hopper, where they are buffered and collected piece by piece from the transport belt. With the help of sensors, all cigarettes are orientated with the filter toward the processing side.
For the separation of flavor capsule filters, the tobacco is then blown out of the cigarette tube with compressed air. The flavor capsule remains undamaged inside the filter. Even if the capsule was already faulty when entering the reclaim unit, its contents will not leak into the tobacco to be reclaimed.
When handling charcoal filters, the machine separates the filters from the tobacco rods to avoid the risk of charcoal particles entering the process. This is achieved with circular knives that cut the cigarettes in front of the filter; a vacuum then sucks off the segregated filter.
With its filter removed, the tobacco rod moves to a splitting unit. An additional circular knife opens the enclosed tobacco rod, and the paper and tobacco is discharged onto a separating conveyor.
Heinen Koehl has optimized the ReclaimAir since its introduction at TABEXPO 2015 in London. After successfully completing a long-term test, the machine has been available to customers since Jan. 1. “It’s a booming market, especially in Asia,” says Stefan Hahn, sales manager of tobacco processing technology at Heinen Koehl. “We already have a lot of requests for the ReclaimAir.”
More recovery solutions
ITM, too, offers tobacco reclaiming technologies suitable for FCF products, including the Delphi 2 reclaimer, the Oculus visual sorting system and the Elph filter plug removal machine.
Integrated in-feed separation, a new aligning system and a new gentle opening process allow retrieving tobacco from the capsulated cigarettes with a reclaim efficiency of 95 percent, according to the company.
“The intuitive design of Delphi 2 ensures that no filter plug components are released during the reclaim process, preventing any contamination of the recovered tobacco,” states Bialas. “Oculus can identify a variety of colored capsules within recovered tobacco and automatically reject them from the production flow.”
An adjustable and flexible detection system enables users to determine not only the color but also the size of the capsule. “Sorting accuracy is extremely high—proven at 95 to 100 percent, depending on the color—and precisely controlled rejection gates discard the contamination accurately with the minimal amount of collateral tobacco,” says Bialas. Oculus can be also incorporated into previous Delphi reclaimers.
Elph features a first-stage in-feed separator, which selects single cigarettes from the total waste and transfers them to the positioning module, where accurate identification and location take place before the filter plugs are removed completely. According to ITM, the precursory positioning and cutting system guarantees that even the most complex filter plugs are removed with great precision.
“Reclaimed tobacco contamination is avoided, and efficiency is proven in excess of 99.5 percent,” says Bialas.—S.R.
