Month: March 2024

Versatile Verification

Fluxcode’s solution has been designed to be flexible so that both small and large companies can comfortably operate it.
German software supplier Fluxcode has developed a track-and-trace solution for all needs.
By Stefanie Rossel
The illicit cigarette trade has reached a disturbing level: According to Euromonitor International, it accounted for just under 12 percent of global cigarette sales, excluding China, in 2022. Driven by higher taxes and consumers’ greater price sensitivity, it is expected to increase to just below 14 percent by 2027. The World Bank estimates that illicit tobacco trade causes tax collectors to miss out on $40 billion to $50 billion in revenues per year. Authorities have also identified it as a primary source of revenue for organized crime and terrorism.
Among the strategies aimed at combatting the problem are track-and-trace (T&T) protocols. Using serialization technology, these systems monitor the manufacturing and distribution of tobacco products.
The governing body of the World Health Organization Framework Convention on Tobacco Control (FCTC) adopted the Protocol to Eliminate Illicit Trade of Tobacco Products in 2012. Having entered into force in 2018, the treaty mandated the creation of a global tracking and tracing regime within five years to closely control and monitor the legal supply chain of tobacco products.
By September 2023, all 68 parties to the protocol had to have their T&T systems deployed. The required global information exchange mechanism, however, had not been established at that time, and the deadline for implementation is likely to be postponed further as such a global system requires international standards and guaranteed interoperability, and solutions to technical and regulatory challenges. The current generation of T&T systems hence remains limited to national or regional jurisdictions.
In the EU, which was the first to officially introduce a track-and-trace system, T&T has been mandatory for cigarettes and fine-cut tobacco under the Tobacco Products Directive (TPD2) since May 2019. As of May this year, other tobacco products such as pipe tobacco, chewing tobacco or nasal snuff must also be tracked and traced.
The process requires a highly developed IT infrastructure, as the example of the EU experience has demonstrated. The system mandates that each tobacco package carry a unique identifier (UI) code that has to be requested by European manufacturers or importers of tobacco products for each individual pack from an independent organization appointed by EU member state authorities.
The UI code must be scanned and recorded all along the distribution chain and transmitted to both the manufacturer’s and the EU database, thus enabling authorities to trace and authenticate tobacco products. Manufacturers and importers must install and integrate a database, a so-called primary repository, to store all data related to each individual package. This information is copied into a secondary repository that is operated by another independent third party appointed by the European Commission.
Mitja Carstensen
Outside the tobacco sector, T&T has long been used by many other highly regulated industries. The scope of functions offered by T&T solution providers is generally quite similar, according to Mitja Carstensen, managing director of Fluxcode. Unlike other companies in this field, however, his Lubeck, Germany-based business has more than 30 years of experience in the tobacco industry. “We are acquainted with many of the problems or pitfalls of technology a tobacco company may encounter when implementing and conducting track and trace and can support them in advance with our experience,” says Carstensen. “In addition, we always keep production staff in mind when developing the software—it must be easy and intuitive to use for all users and work reliably. We are very close to our customers during the entire implementation process and also help with marginal issues, such as the registration for ID Issuers or the optimization of processes.”
Industry Independent
Carstensen founded Fluxcode together with his former colleague, Rene Petton. The two met when they were working as software developers at the IT department of a medium-sized German tobacco products manufacturer.
“In general, we always tried to develop all production-relevant software for our former employer ourselves, particularly because a medium-sized enterprise can’t be handled according to the book and because history has shown that there are various special cases for which standard solutions would have become difficult,” Carstensen explains.
At that time, in 2016, the only T&T solution available for tobacco products was Codentify, a system developed by Philip Morris International and licensed to BAT, Imperial Tobacco Group and Japan Tobacco International. Today the product is marketed by Inexto. “There were no other providers,” says Carstensen. “Since the Codentify solution would also have been very cost intensive, we decided to develop the required software ourselves. With a project scope like TPD2, this was of course a complex endeavor. After we had completed our software solution and it became known within the tobacco industry that we had a functioning alternative to Codentify, we were approached by several smaller and mid-sized companies who acquired the solution we had then, which was called Red Carpet.”
As T&T gained importance, Carstensen and Petton decided to take their software to a broader, more professional level, and in 2020, they established Fluxcode. The Red Carpet software was resigned to history. In its place, Carstensen and his team developed a completely new solution in such a way that it can also be used to track products in other sectors. The company is already negotiating with manufacturers of drinks and tires.
Fluxcode developed the Fluxcode Suite, which is independent from the tobacco industry and divided into five core modules—one for ordering and downloading of the UI, one to create a globally unique identifier with included additional customer information, one to provide the correct UI to the production line printers, one to connect to the aggregation system and one for sending previously elaborately processed data to a repository. Modules can be purchased individually, depending on the requirements of the customer. Security against piracy is provided by encryption of the most important Fluxcode Suite codes, which users can only access by deploying a license key to unlock them.
Fluxcode also provides storage for the considerable amount of data generated, says Carstensen. “Many of our competitors rely on cloud hosting of the database. This means that the track-and- trace data of a manufacturer are being stored on the server of a service provider, to which the manufacturer himself potentially has no access. He will be able to retrieve a part of the data through various sighting processes but won’t have administrative sovereignty over the data. We don’t think that this is very practicable, as from our point of view, the data belong to the customer.”
Therefore, Fluxcode offers data storage on the manufacturer’s server. “This goes down well with our customers,” says Carstensen. “We have optimized the amount of data so that a small enterprise can produce several years with our software, and its data storage will remain in the low double-digit gigabyte zone.”
The company supplies only the software part of the track-and-trace system, but it has long-term partners from the respective hardware areas, including aggregation systems, printer manufacturers or external repositories. “At the request of the customer, there is also the option that one party acts as the general contractor,” says Carstensen. “This way, the customer has only one contact person and one contracting party without having to negotiate with each provider individually.”

Flexibility is Key
Fluxcode’s solution has been designed to be flexible so that a small manufacturer of handmade cigars can use it just as well as a multinational company, says Carstensen. Most of the company’s clients are medium-sized companies with between five and 50 production lines. They are highly diverse, ranging from cigarette and roll-your-own manufacturers to moist snuff, cigar and cigarillo makers. With T&T becoming mandatory for other tobacco products in the EU starting this May, the company has witnessed increased demand for its offerings. “Many companies, especially smaller ones, are very insecure and have no concrete idea what this obligation will mean for them,” says Carstensen. “Apart from software, this requires a lot of educational work.”
Despite its complexity, Fluxcode is easy to use and stable, according to Carstensen. “Principally, there are very few cases where support is needed since our software enables the customer to solve many issues himself with a simple click. Besides, it runs reliably and provides the user with information before a potential data error occurs.”
Should support be required, response times are low compared to other companies, stresses Carstensen. “In most cases, issues can be solved within hours.”
Currently, the majority of Fluxcode’s customers have their manufacturing sites inside the EU, but the company is in advanced talks with clients in Asia and South America. The system is highly compatible with the various T&T requirements of individual regions, according to Fluxcode. Differences can be found not only in international tobacco markets but even within the EU. “Registration with an EU ID issuer is not standardized, hence each country has its own system and interface for this,” says Carstensen. “Registration can be more or less demanding—in Italy, for example, the process takes several weeks. In other countries, registration takes place with a few mouse clicks.”
Production outside the EU may require other parameters, such as the obligation to print two codes on the packaging. The different product categories also present different challenges. “Cigarettes have a faster production speed than cigars or shisha tobacco, hence there is more motion along the entire production line,” says Carstensen. “This can cause print images to blur or smudge. This requires precise interaction of speed adjustment, production line design and print control. Cigars, on the [other] hand, will have to be printed and labeled individually. If sold in wooden boxes and stored, they require a label that will stick to the box for years and a code that will still be legible [after that time].”
With a majority of countries committed to tracking and tracing tobacco products in accordance with FCTC requirements but only a few having introduced T&T products yet, Carstensen sees vast potential for his solution. “Tobacco products are only the beginning. In Russia alone, several sectors are required to track and trace, such as milk, baby food or alcohol. Here, new markets will emerge in the future.”
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

March 1, 2024
Tobacco Control’s Nervous Breakdown
Photo: Xalanx
Innovation in the recreational nicotine market is revolutionizing the tobacco industry and disrupting tobacco control.
By Clive Bates
In his groundbreaking 1997 book, The Innovator’s Dilemma, Clayton Christensen defined the concept of “disruptive innovation.” The term is often used carelessly, but disruptive innovation has several characteristics that apply in today’s tobacco and nicotine market. In essence, it is a theory of how entrants to a market can challenge incumbents by focusing on unmet needs using novel business models exploiting simple enabling technologies.
In the nicotine market, the lithium-ion battery provided a critical enabling technology with sufficient power and energy density to replace combustion with electrical heating to create an inhalable aerosol in a compact and convenient form. Once the concept took off in the early 2010s, the technology rapidly evolved through at least four major generations during the decade. The disruption has never stopped, and the emerging incumbents in the vape industry now face disruption from disposable single-use vape products. It isn’t just technology; the business model has changed and adapted over time, embracing user-driven innovation, new retailing models such as specialized vape shops and international e-commerce, and a pro-health marketing proposition spread through social media.
A new wave of innovation is now breaking with the rapid rise of oral nicotine pouches. This newer trend may prove even more disruptive—a low-tech, low-cost nicotine delivery with negligible health consequences, no intrusion on others and none of the stigma attached to tobacco. Through vaping, consumers have deconflated tobacco and nicotine use and are now primed to adopt this technology.
The regulatory environment also played a critical role, but more for what it didn’t do than what it did. In the United States in 2009, the U.K. in 2010 and the European Union in 2013, there were failed attempts to classify and regulate vaping products as medicines. Several core pharmaceutical regulation concepts are hostile to vaping. Vaping products are not smoking cessation therapies but pleasurable consumer alternatives to smoking that require nicotine delivery equivalent to cigarettes. Medicine regulators are not at ease with pleasure, or what they would call “abuse liability,” yet pleasure is integral to their success as consumer products.
Let’s delve deeper and ask who is disrupted and how.
First, the incumbent tobacco companies. In the standard model of disruptive innovation, these giants would be caught off guard by fast-moving entrants bringing new technology to a vanguard of early adopting consumers, rapidly changing the market dynamics. This would be felt most keenly as a loss of “pricing power” (the ability to raise prices to compensate for declining cigarette volumes) and a squeeze on margins and revenue in the profitable incumbent cigarette business. This should happen as the existing customer base of people who smoke is exposed to a wide range of low-cost alternatives without many downsides. So far, I don’t think this squeeze on the cigarette business has happened to anything to the extent it might have and still could, even though the companies have entered these markets and developed heated-tobacco products. The reason is that regulators are slamming on the brakes in response to activist and political pressure—disrupting the disruption. Regulatory excess has combined with activists and academics working tirelessly to nurture false risk perceptions and reinforce doubt about the wisdom of stopping smoking by switching to a reduced-risk product. The tobacco industry has been protected from the most severe disruption with the unintentional help of the tobacco control mainstream.
Second, disruption has wrong-footed regulators and legislators. In response to rapid changes in the market, regulators and legislators have blundered in without first understanding (or perhaps without caring about) the complex adaptive system in which their rules would be applied. Because the new products function as economic substitutes for cigarettes, we expect three primary responses to excessive regulation: more smoking than there otherwise would be, more illicit trade in the new products, and consumers adopting risky workarounds, such as mixing their own flavored e-liquids. For example, limiting nicotine strength in the European Union made it harder to bring to market the pod devices that have been successful in reducing smoking in the United States. Flavor bans in the United States made vapes less appealing and caused more people to smoke, in some cases including young people. The prescription-only availability of vapes in Australia has led to a chaotic, lawless mess, with more than 90 percent supplied via informal, illegal channels. With their mission to protect the young from vaping, regulators forgot that in a world without vaping, many young people would smoke and, therefore, are benefiting from vaping.
Third, the rise of the confident consumer. Consumers are the primary beneficiaries of the radical reduction in health and welfare detriments of smoke-free products. We are used to smokers burdened with regret, challenged with stigma and punished by anti-smoking policies. But all of that is driven by the health implications of smoking and the policy response that started in the early 1960s. How does the recreational nicotine consumer change if they are no longer troubled by the health and welfare implications of nicotine use and related policies? Simple economic theory suggests that if the costs and nonmonetary detriments of nicotine use fall, then demand will rise. It is likely, in my view, that there will be new users of nicotine who would never have become smokers in the absence of much safer products. For some, that is profoundly disturbing. For me, it is almost an inevitable consequence of having far lower risks and there being a latent demand for the real or perceived hedonistic, functional and therapeutic benefits of nicotine. Public morality may be shocked, but more people (of any age) using much safer products should not cause a public health crisis—we would be moving to substance use more like drinking coffee.
Fourth, the existential threat to the tobacco control complex. The public discussion of the emerging landscape of low-risk consumer products seldom focuses on the interest group that is most vulnerable to disruption: the mainstream of tobacco control. It is a complex of interests comprising nonprofit activists, academics, medical and health societies, major institutions (such as the World Health Organization or the U.S. Food and Drug Administration), philanthropists and research-funding bodies. The problem for the mainstream of tobacco control is that without serious harm, the whole movement loses its purpose and its reason to exist. When it comes to low-risk alternatives to smoking, this complex is profoundly confronted by the threat of having nothing to control, no case for intervention and no reason to be. It is a powerful incumbent interest group challenged by new technology, new suppliers and new consumer confidence.
As a result, the mainstream of this interest group has rejected tobacco harm reduction as a strategy for addressing its own notional goals of reducing death and disease from tobacco use. Instead, it has mounted a rear-guard defense based on a range of strategies, including the following:
Falsely implying that noncombustible products are no less risky than cigarettes, that data is too uncertain or short-term, or asserting that reduced risk is no more than a marketing claim of tobacco companies.
Asserting that harm reduction is merely a commercial strategy of tobacco companies. The aim here is to attach the reputational baggage of “Big Tobacco” to these new developments. Yet, many independent experts support tobacco harm reduction, and it is good if tobacco companies adopt a business model aligned with reducing health impacts.
Excluding or stigmatizing contrarian opinions and creating sealed bubbles open to groupthink. The WHO Framework Convention on Tobacco Control has taken this to new extremes.
Shifting emphasis to problematize nicotine rather than the “tar” of cigarette smoke that is the cause of nearly all tobacco-related disease. We are hearing more about “addiction” and less about cancer. Yet, a dependence only meets the definition of addiction if there is serious net harm to the user.
A relentless focus on the supposed interests of children without recognizing that would-be smokers among adolescents also benefit from low-risk products and that the demand for nicotine has persisted across generations for hundreds of years. Young people have an interest in the health of the significant adults in their lives as carers, breadwinners and role models.
Pressing for prohibitions or equivalent regulation to cigarettes, often with manipulation of language to imply equivalent risk, for example, by stating that heated-tobacco products produce “smoke” or that all tobacco products should be treated the same even though they have very different risks.
A blunt refusal to face trade-offs (for example, between the interests of youth and adults) or unintended consequences (for example, increases in smoking) arising from favored policy positions.
I have watched on in horror as the leadership in tobacco control, albeit with many honorable exceptions, has dogmatically denied and suppressed the opportunity to radically reshape the recreational nicotine market to cause vastly reduced harm and avoid hundreds of millions of premature deaths. It looks like a nervous breakdown is developing in tobacco control in response to profound disruptive innovation. I doubt they will survive it.
Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
March 1, 2024
After Disposables

Photo: Image: Viktoria Ostroushko
It is opportune for the industry to revisit the fundamental purpose of vaping—harm reduction and providing a superior consumer experience.
By Douglas Ming Deng
Pro or against? It is undeniable that disposable e-cigarettes have been the most popular format in the market over the past four years. Despite earlier predictions of their imminent disappearance, recent events like TPE24 and Champs in February suggest that manufacturers and distributors are still committed to showcasing elaborate disposable models. With features such as increased puff capacity, larger screens and vibrant colors, there seems to be no limit to the innovations of the disposables they’re introducing.
However, changes are on the horizon, especially since the British government announced a ban on disposable e-cigarettes. The ban has sparked growing concerns among industry stakeholders regarding the life cycle of this category. While compliance has always been a central issue, the heightened emphasis on enforcement in the past months has prompted industry-wide apprehension. Yet, for those familiar with the evolution of vapor products, the shift in exterior designs should not be surprising given the industry’s history of transitioning from closed systems to open systems then to pods, pod-mods and now disposables within the past two decades.

At the TPE24 and Champs Trade show, numerous disposable products were exhibited with minimal differentiation among them. Instead of specifying their current preferences for an ideal e-cigarette, both distributors and shop buyers voiced their anticipation for what would become popular six months down the line. To predict the future trends of products, it becomes essential to unravel the reasons behind the success of disposables.
The affordability of disposables lowers the threshold, allowing for a smoother transition for those seeking to switch from combustibles to risk-reduced products (RRPs). Disposables possess clear advantages over device-based systems, particularly in terms of portability, while retaining key features such as noncompatibility of fake cartridges and adjustable coil voltage. In addition, they contribute to relative environmental protection with the increasing volume of liquid filled. However, the downsides of disposables are apparent. Firstly, their disposability sparks significant environmental protection debates, necessitating solutions that incur additional costs and subsequently leading to a general rise in the price of vapor products. Therefore, the next-generation vapor products will be sold at a higher price margin than the current disposables.
Recently, solutions like paper-based bodies with biodegradable plastic components have been introduced to disposable e-cigarettes. In the EU, regulations mandate the rechargeability of batteries in vape products, establishing a reusable device as the minimum standard for the next generation of e-cigarettes. Moreover, the widespread use of disposables among underage individuals has cast a shadow over the entire category since its inception. While recent reports suggest a decline, with some teenagers deeming vaping immature, the issue remains pertinent. If even a single producer persists in designing disposable vapes with toy-like appearances and cotton candy flavors targeting underage kids, the entire industry could face consequences. This negative externality has become more critical than ever, emphasizing the need for the industry to unite and reach a consensus on addressing these public enemies. It is the right time to reconstruct the value of the whole industry and shape a new image of vapor.
Noteworthy Changes
Since the beginning of 2023, the evolution of disposable e-cigarettes has undergone a remarkable surge. For many, the exterior appearance of these products has transformed so swiftly that some manufacturers express concern that their latest models could become outdated before even hitting the market. The size has shifted from compact to large, the weight from light to heavy and the e-liquid tank from small to enormous. The rapid evolution of disposables suggests that the category is approaching the culmination of its development.
One noteworthy change, above all, is the incorporation of screens on these products. While screens have appeared on vapor products before, recent developments significantly differ, particularly from those on open systems. Within just one year, screens have evolved from simple black-and-white displays to color ones then to TFT-LCD, and some brands have now introduced new products with LED touch screens. The on-screen features change from display of battery life and e-liquid contents to fancy animations ranging from alien UFOs shooting off to fireworks blasting, and they seem to emerge one after another. One might question: Are these high-end features really necessary for a disposable vape product priced at $30?
As a scholar closely studying the industry over the past two decades, I strongly believe that the integration of screens on disposable vapes marks a significant breakthrough in vape products and could mean the evolution of vapor toward an advanced step. Interactivity is poised to become the defining characteristic of next-generation e-cigarettes. This interactivity fosters a dialogue between end users and other stakeholders in the industry chain.
Currently, a major obstacle hindering the expansion of vapor to those who seek RRPs is the lack of communication among manufacturers, sellers, end users and regulators. When end users visit a shop, they often lack knowledge about why they are buying an e-cigarette and what product suits their needs. Shop assistants, with varying levels of expertise, recommend products, and some may lack technical knowledge about flavor differences. Neither end users nor sellers often realize that tobacco harm reduction (THR) is the real selling point of vape products. However, a smart device could facilitate communication between end users, manufacturers and sellers, allowing real smoking experiences to be reported to manufacturers for them to conduct consumer-oriented innovation. During my keynote speech at GTNF 2023 in Seoul, I emphasized the concept of a regulatory sandbox. Such a sandbox would only be viable with the presence of a smart vape device. It would enable vape products to be regulated in a closed loop, fostering innovation by allowing regulators to monitor real-time product testing. Enterprises would receive regulatory feedback promptly, adjusting their research and development accordingly. This approach enhances regulatory efficiency and ultimately builds trust among regulators, enterprises and consumers. Thus, the transition will be achieved from “wait and improve” to “test and innovate.”

In 2022, the introduction of the Lil Aible by KT&G was groundbreaking. This smart device seamlessly integrates the use of heated-tobacco products (HTPs), incorporating both granular and reconstituted tobacco, along with vape technology. The exterior of Lil Aible mirrors the trend observed in disposables today—a robust device featuring a high-definition touch screen. However, the interior features of Lil Aible offer a glimpse into the future of vapor products: the incorporation of an AI function powered by a robust digital CPU. This function not only empowers the e-cigarette to optimize the smoking behavior of each individual user, enabling them to control the total puffs consumed every day, but also enhances harm reduction capabilities. Moreover, the implementation of facial recognition on a smart vape device, when used with due consideration for privacy, can effectively prevent usage by minors. This technology alleviates the burden on regulators for monitoring purposes.
Furthermore, an AI-empowered device would revolutionize the flavoring process. Currently, manual flavoring is often considered an art, with the addition of various flavor chemicals relying on the blender’s personal taste and experience. However, in the era of digital flavoring, the process resembles coding basic substances through chromatographic fingerprints. The flavor can be precisely replicated on an AI smart vape device, a concept known as decoding. It’s crucial to recognize that e-cigarettes possess a natural electronic endowment, making them inherently suited for digital flavoring. In comparison to substances like alcohol or perfume, e-cigarettes have a distinct advantage in executing digital flavoring. This advantage is particularly pronounced in tobacco-flavored e-liquid, where manual methods may fall short of achieving promising results. The inherently possessed electronic capabilities of e-cigarettes may facilitate more straightforward communication between producers and users.
Computer Chips Vs. Potato Chips
Instead of dwelling on the next exterior appearance of e-cigarettes after disposables, it is opportune for the entire industry to revisit the fundamental purpose of vaping—harm reduction and providing a superior consumer experience. Shenzhen, China, renowned as the “Vape Valley,” possesses the capability to spearhead the creation of the next generation of e-cigarettes. During GTNF 2023, we delved into discussions about the future trends of vapor products. Moving forward, professional and technical forums like CORESTA or the Tobacco Science Research Conference serve as valuable platforms to gauge the direction of the next generation of vape products. It is in these forums that the industry can collectively shape the future while staying true to the core principles of harm reduction and delivering an enhanced user experience.
In the years to come, e-cigarettes will embody characteristics of both fast moving consumer goods and more advanced, versatile electronic durable goods. Rather than opting for radical change, the transition from disposables to next-generation devices will be gradual. Like I said during a 2023 industry conference in Shenzhen, involution might only lead to the production of “potato chips” instead of “computer chips.” While potato chips can satiate basic appetites, aiming for the sophistication of computer chips elevates the vape industry to a higher standard. It is crucial for the industry to recognize this potential, as failure to do so may result in being confined to the low-end recycling sector.
In conclusion, the narrative of disposable e-cigarettes mirrors the industry’s dynamic spirit—a story of adaptation, innovation and a relentless pursuit of excellence. The application of screens on disposables might disclose the future of vapor. Standing at the precipice of evolution, the industry is not merely chasing trends but actively shaping a future where harm reduction, end user-centric experiences and technological advancements harmoniously coexist. The tale of disposables is but a chapter in a grand saga, with each exhale marking a step into a future where vaping transcends boundaries and emerges as a beacon of possibilities.
Douglas Ming Deng is a professor of next-generation products industry studies at Yunnan University.

March 1, 2024
Chilling Effects

Image: Jolita Marcinkene
Is a menthol ban appropriate for the protection of public health? Hopes, concerns and a reality check
By Cheryl K. Olson
Is a U.S. menthol ban finally coming? The 2009 Tobacco Control Act exempted menthol cigarettes from its blanket ban on candy and fruit flavors. Menthol was left out, according to CNN, due to “serious lobbying from the industry.”
As the Washington Post reported, plans to finalize the rule have been made—and postponed—multiple times by the Biden administration. The announcement of a finalized rule was planned for this month.
The Food and Drug Administration first announced its “proposed product standards to prohibit menthol as a characterizing flavor in cigarettes” back in April 2022. The stated purpose? To reduce appeal to and experimentation by youth that will lead to regular smoking addiction and to reduce disease and death among adults via fewer cigarettes smoked and more quitting. A ban is also “expected to reduce tobacco-related health disparities.” The ban would target making and selling not individual possession or use.
Concerns that banning menthol could exacerbate waning enthusiasm for Biden among Black voters appears to be one factor behind the delay. (Hoping to capitalize on this, one conservative group is reportedly testing menthol-focused ads on Black South Carolina primary election voters.) Four in five Black adults who smoke report choosing menthols.
The National Association for the Advancement of Colored People, a venerable advocacy organization for Black Americans, supports a federal menthol ban. In a Jan. 12 press release, its senior vice president of global policy called out “the relentless predatory marketing of menthol-flavored cigarettes, [which] has inflicted devastating consequences on Black communities.” This included ads in Black-oriented media, such as Ebony magazine, and sponsored events, such as the Kool Jazz Festival.
Other organizations, such as Reverend Al Sharpton’s National Action Network, have argued against singling out menthol for a ban. Sharpton has expressed concern that a menthol focus could increase over-policing of Black communities, pointing to the New York City police killing of Eric Garner, who was suspected of selling “loosie” untaxed cigarettes.
“The illicit market is always open and doesn’t check IDs.”
Why Menthol?
In the U.S., menthol has been added to cigarettes for at least 100 years, at times promoted as throat-soothing for coughs and colds. National government surveys find that, as smoking rates overall trend down, the proportion of menthols smoked has crept up.
These surveys show that menthol smoking is disproportionately higher among subgroups of people regulators consider disadvantaged or vulnerable. This includes Black and Hispanic adults who smoke, young adults, women and persons reporting serious psychological distress.
Concern that menthol may be a drag on cessation rates has boosted support for a ban. Because it reduces irritation, menthol may make it easier to start smoking. It’s used more often by people who smoke intermittently or experimentally. Researchers have called for more studies to parse and prove a causal role for menthol in increasing smoking and deterring quitting.
In this century, smoking rates have been stagnant among African-American adults who smoke. A 2020 analysis of U.S. studies did not find an overall effect of menthol on smoking cessation but did find that among African-Americans who smoked, use of menthol was linked to 12 percent lower odds of quitting.
Can bans help people quit smoking? To some degree, yes. Pooled results from a 2024 systematic review and meta-analysis of English-language menthol ban studies found that 24 percent of those who smoked menthols had quit cigarettes a year or two later. But results varied widely; bans took place under a variety of conditions, and most of the studies included had small or unrepresentative samples.
For example, a survey of San Francisco’s ban of menthol and other flavors in all tobacco products found decreased flavored e-cigarette and cigar use and a slight uptick in smoking. The study used a small convenience sample of 247 young adults. Even rigorous economic studies of bans admit to trouble tracking illicit and cross-border sales and other workarounds.
Regulators are aware of the need for better research. The FDA recently awarded a $3.6 million grant to researchers at the Medical University of South Carolina to study whether banning menthol in cigarettes (and e-cigarettes) would increase quitting or switching. Meanwhile, Rutgers University received two grants totaling $7 million via the National Institutes of Health to study anticipated “disinformation” from industry, aimed at Black and Hispanic young adults, that could “undermine the impact of a ban on menthol cigarettes and flavored cigars.”
What Could Go Wrong?
The FDA expects minimal illegal trade in event of a ban. Richard Marianos disagrees. He is a retired assistant director at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and a faculty member at Georgetown University. Marianos says banning products creates crime.
Illicit sales of individual cigarettes and contraband packs are already problematic, in part because taxes have driven up costs. Marianos showed me photos of several men, one with a gun in his waistband, at an illegal sales spot outside of a Washington, D.C., Metro station.
“People come off the train, buy four loosies from the spot, then ration them out during the day,” he says. “You can get your marijuana, your cocaine and your Newports.”
The flavor ban in California has sparked increased robberies of convenience stores across the border in Arizona, according to Marianos. “A pack of menthol cigarettes that they can steal and sell for $2 apiece at the spot derives a greater profit than a cash register robbery,” he says. “I have videos of crews hitting a Circle K or Wawa, jumping over the counter, sticking up the clerk and—like Santa—putting the cigarettes into a gigantic tarp and taking off.”
A Canadian study of intended and unintended effects of their menthol ban found that many people purchased menthols on First Nations reserves, where the ban did not apply. Marianos expects that Native American reservations in the U.S. would similarly help meet demand.
The practical path forward for advocates of an enforceable menthol cigarette ban is to actively promote harm reduction.
Menthol Workarounds
The assumption by many tobacco control advocates that Big Tobacco will sabotage menthol bans overlooks the likely ingenuity of individuals. Marianos described one case he ran across: “A guy was going on eBay and buying menthol crystals, spraying regular cigarettes in his basement and then selling them on the corner as menthols.”
Noting that products to alter cigarette characteristics are illegal under the proposed rule, “FDA does not anticipate a substantial number of individuals would utilize such products.”
Researchers have documented sales of flavor cards and menthol drops in Canada and various flavor accessories in the European Union to circumvent their menthol bans—predictably leading to calls to ban those items too.
“The illicit market is always open and doesn’t check IDs,” notes Nicholas “Grimm” Green, a YouTuber and tobacco harm reduction advocate. “As long as $10 ‘menthol injectors’ exist on Amazon, the idea of a menthol ban is silly.”
That’s not to say that companies won’t do their part to circumvent a menthol ban. “Tobacco companies have already introduced nonmenthol-menthol cigarettes into the market in California,” says Green. Further, enforcement is lax. “Menthol disposable vapes are available at almost every gas station and head shop in the state,” he adds.
The California ban, approved by voter referendum, went into effect in December 2022. It covers not just menthol cigarettes but nearly all flavored nicotine products. Researchers have found synthetic cooling agents that give menthol-like effects in cigarettes sold in that state. A journalist from STAT News found widespread sales of flavored products, even in cities that had their own longstanding flavor bans.
Legal Hurdles
If the menthol rule comes to pass, store shelves aren’t immediately cleared. Flavor bans enacted by states can take effect within months. Because the proposed federal ban comes out of the FDA’s complex rule-making process, it could take years.
“If they publish that rule on a Monday, the next day, you’ll see a legal challenge filed to prevent it from ever going into effect,” says Jeffrey Weiss, partner at Flagstaff Ventures and formerly chief engagement officer and general counsel at Njoy.
He predicts a dead-end fate for the menthol ban, similar to that of the final rule requiring graphic health warnings on cigarette packs. Why?
U.S. law requires that adoption of tobacco product standards must be appropriate for the protection of public health. In supplementary information to the proposed menthol rule, the FDA cites research, including population models and expert opinions, on what is expected to happen after a menthol ban.
“They model that a certain percentage will switch to tobacco cigarettes, a percentage will buy black market menthol cigarettes, a percentage will quit and a percentage will switch to an e-cigarette, primarily menthol,” Weiss says. “But that model doesn’t actually exist—in the sense that there are no authorized menthol e-cigarettes for smokers to switch to.”
Post-ban, more menthol users are expected to switch to menthol e-cigarettes than to quit using tobacco. In sum, much of the health benefit from banning menthol is supposed to come via unauthorized product use. Products that are themselves banned in a growing number of states and localities.
Regulators are not unaware of this conundrum. FDA Commissioner Robert Califf has publicly expressed concern about the difficulties that people dependent on menthol cigarettes will face if the products are taken away. For example, he remarked at a 2023 Congressional budget hearing, “[W]here do they [menthol users] go to get help, coming off of a terrible addiction? Our healthcare systems are not set up to deal with that right now.”
What about evidence for a menthol ban preventing harm to youth? The respected nationally representative Monitoring the Future study found that past-month menthol and nonmenthol cigarette use by non-Hispanic black teens is now less than 1 percent. It’s fallen so low in recent years that “prevalence levels approach a floor effect.” Moreover, today’s Black adolescents use menthol cigarettes at lower levels than non-Black youth.
A Better Way?
Given the high risk of unintended effects and the limited certainty of benefits, is a menthol ban our best plan? “It would be best if the government would think first in the direction of ‘how can we affirmatively help people make positive change?’” Weiss says. “Because prohibitions are hard and costly to enforce.”
The lack of authorized reduced-harm menthol or mint products is just part of the problem. Another is the FDA’s limited and ambivalent reduced-risk communications.
Weiss points to the FDA’s routine tweeting of its one-page list of 23 authorized e-cigarette products. At the bottom of the page is a disclaimer: Being authorized “does not mean that these products are safe nor are they ‘FDA approved.’ All tobacco products are harmful.”
“If you want a current menthol smoker who can’t completely quit to switch to a regulated reduced-harm product—how are they going to do that when you’re telling them that none of these products are safe?” says Weiss. “If it’s an unsafe product, why is that a better choice for me” than a tobacco-flavored cigarette or an illicit menthol one?
Active promotion of reduced-harm menthol alternatives seems a sensible way to limit ban backfires. A rigorous laboratory study of adults who smoked menthol cigarettes daily found that menthol-flavored e-cigarettes outshone tobacco-flavored ones in reducing cigarette cravings—including urges to smoke for pleasure. According to the authors (affiliated with prominent universities), this is a known strong predictor of successful smoking cessation.
The practical path forward for advocates of an enforceable menthol cigarette ban is to actively promote harm reduction. “Encourage FDA to start authorizing menthol e-cigarettes, among other things, so that these smokers would have something to switch to,” says Weiss. “And to make it more likely that a menthol ban could withstand a legal challenge.”
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.

March 1, 2024