Tag: behindtheheadlines

Stronger Together
The European Tobacco Harm Reduction Initiative demands rules that consider the relative risk of various tobacco-related products.
By Stefanie Rossel
Times are getting tougher for tobacco harm reduction in Europe: The recent outbreak of vaping-related lung illnesses and deaths in the U.S. have negatively impacted sales in Europe’s leading e-cigarette markets. The EU is currently reviewing its Tobacco Products Directive (TPD2). In 2020, the Netherlands will host the World Health Organization’s ninth Conference of the Parties.
To promote safer nicotine use and sensible regulation of reduced-risk products (RRPs) across Europe, a group of consumers launched the European Tobacco Harm Reduction Initiative (ETHRA) at the end of September 2019. The group demands regulation that considers the considerably lower risks of reduced-risk products. It wants RRPs to become affordable and untaxed products.
Twenty partners from all over Europe have already joined ETHRA, including the French consumer association SOVAPE, the New Nicotine Alliance (NNA) and EU for Snus. Tobacco Reporter spoke with Martin Cullip, chair of the NNA, who was involved in setting up ETHRA, about the organization’s next steps.
Tobacco Reporter: What was the idea behind establishing a pan-European consumer initiative?
Martin Cullip: The treatment of reduced-risk products around the world varies region by region. In discussions with fellow advocates from different continents at conferences such as the Global Forum on Nicotine, it was clear that we were facing different challenges based on where we lived. In Europe, the Tobacco Products Directive has meant that our region is comparatively sensible in this area of policy, although obviously there are things that could be improved. It was felt that—especially with new regulatory challenges on the horizon—a consumer-led association to deal with specifically European issues could deliver benefits to the harm reduction approach in our region and amplify the voice of the many hard-working grassroots associations operating across the continent. In just a couple of months, we have enlisted 20 partner associations and are organizing to effectively move the consumer voice forward.
What will be your next steps?
We have seen a couple of positive developments in states where our partners have an interest but also negative ones. We hope to raise awareness across borders to what is happening around us and learn from each other how to best engage with policymakers and ensure that consumers are heard.
What are the most pressing issues at the moment as far as vaping in the EU is concerned?
An imminent threat is the EU’s upcoming review of TPD2, implemented in 2014. Earlier this year, the EU health commissioner’s office claimed that “E-cigarettes may be less harmful, according to some reports, but they’re still ‘poison,’” so it appears that despite EU regulations presenting some of the most progressive and effective public health protections in the world around e-cigarettes particularly, some in the EU are still intent on turning back the clock and trying to implement damaging and counterproductive restrictions on safer nicotine products. With the extremely vaping-skeptic World Health Organization due to hold their Conference of the Parties in The Hague, Netherlands, this year, Europe could be a crucible where future regulations will be formed. We in ETHRA hope to ensure that consumers are central to that debate when it comes.
What is your organization’s response to the current challenges for vaping following the events in the U.S., which have also cast a shadow on vape sales in the EU?
Currently, there is a lot of alarm and false information in Europe following events in the USA. We have seen a number of countries taking this as an opportunity to propose restrictions and bans on vaping products. Our partner organizations will be working to correct this by engaging with policymakers to dispel the many myths that surround harm reduction.
It is important to highlight that e-cigarettes, as regulated under the current TPD, do not present hazards such as [those that have] happened with illegal THC cartridges in the U.S. It is clear that the panic in the U.S. is being orchestrated to some extent by those who claim to be a force for good in public health but who are instead working to an ideological agenda regardless of the harm it will cause to millions of people.
We must reiterate that no good can come from banning safer products and creating a huge black market in Europe to match the one in the U.S., which is the source of all the illness and deaths over there.
Which role does snus play in your concept of tobacco harm reduction?
We think the U.S. FDA [Food and Drug Administration] granting one company license to make reduced-risk health claims around snus is a very positive development and one which should embarrass the EU.
There are decades of evidence from Sweden that snus is vastly safer than smoking, and there is no valid reason for a ban being inflicted on EU member states. With the U.S. government accepting officially that snus reduces harm—and allowing manufacturers to display this on their packaging—we have a perfect example of how good regulation of snus could be beneficial for public health in the EU.
Evidence from countries such as Sweden and Norway shows that snus could play a vitally important role in attracting many smokers away from lit tobacco. It is long past time that the ban on snus in the EU was overturned, and we hope to make that case repeatedly going forward.
Where will funding for ETHRA come from?
Currently, ETHRA has no funding whatsoever except for a seed donation from Vapers in Power, a former pro-vaping political party in the U.K., which had a credit balance left from its vaping members when it disbanded. This was used to set up the website, but apart from that, funding isn’t currently an issue. As a collective of autonomous consumer associations across Europe, ETHRA relies on input from passionate volunteers from self-funded partners who give their time and expertise for free. It may be that we need to crowdfund in the future for certain projects, but that will be considered as and when the circumstances arise.
The European Citizens’ Initiative Vaping is NOT Tobacco is gathering signatures to make the European Commission treat vapor products differently than tobacco (see “A Call for Common Sense,” Tobacco Reporter, December 2019). Would it make sense for ETHRA to cooperate with them?
We understand that some partner organizations are optimistic about the initiative, but others are not. We have five main principles, which all our partners have signed up to. Apart from that, it is up to each partner to decide their own course. As an entity, ETHRA has no mandate to offer a view either way.
February 13, 2020
Record Highs

Photo: KuyaAndy from Pixabay
Malaysia struggles with unprecedented volumes of illicit cigarettes.
It’s one of those rankings no one wants to lead. With 59 percent of total tobacco sales, Malaysia in 2018 had the world’s largest illicit cigarette market, easily outdoing the next four countries, Brazil (50 percent), Ecuador (41 percent), Panama (34 percent) and the United Arab Emirates (33 percent).
The data stem from a study published by Oxford Economics last June, which had been commissioned by British American Tobacco (BAT). The report estimates that the number of black market smokes sold in the Southeast Asian country totaled the equivalent of 598 million packs of 20 cigarettes each, compared to an estimated consumption of about 417 million legal packs.
According to the study, Malaysia’s contraband problem caused the country’s treasury to miss out on MYR5.1 billion ($1.24 billion) in tax revenues in 2018. This equates to more than 2.9 percent of the country’s total tax receipts during that period and is almost twice the tax revenue Malaysia’s government collected from legal cigarette sales, which Oxford Economics estimated at MYR3 billion that year.
The situation has worsened since, as a more recent report, the long-term Illicit Cigarettes Study (ICS), carried out on behalf of the Confederation of Malaysian Tobacco Manufacturers for the past 15 years, suggests. Between June and August this year, an estimated 3.1 billion sticks (64.6 percent of the total market) were smuggled into the country, contributing to a record 12 billion illicit cigarettes to be consumed this year and an estimated loss in tax revenue of MYR6 billion, according to ICS. With approximately 66 percent of cigarettes sold in the market being smuggled, Malaysia reached a new high in July.
While the size of Malaysia’s illicit tobacco sector has been considerable for years, it exploded after the government introduced an excise tax hike of almost 40 percent in 2015. In 2015, 22.8 percent of Malaysia’s roughly 32.77 million population smoked, with males having a significantly higher prevalence than females, according to the country’s National Health and Morbidity Survey. Since the Oxford Economics study, overall cigarette consumption, however, has increased by another 5 percent. The country ratified the World Health Organization’s Framework Convention on Tobacco Control in 2005, but has not signed the associated Protocol to Eliminate Illicit Trade in Tobacco Products.
Between 2012 and 2018, the specific excise duty on cigarettes nearly doubled to MYR400 per 1,000 cigarettes. The government also implemented a minimum price of MYR10 per pack. In late 2019, the health ministry proposed to raise the minimum price to MYR15, a suggestion met with harsh criticism by the local tobacco industry in light of the country’s unabated increase in contraband cigarettes.
Large price differences
In 2018, the average price of a pack of 20 legal cigarettes stood at MYR15.87, the Oxford Economics report says, compared to MYR4.50 for the illicit equivalent. The vast price differential makes illicit cigarettes particularly attractive to households in the bottom 40 percent of Malaysia’s income distribution. In 2016, they had to spend more than 17 percent of their daily income to buy a pack of legal cigarettes, whereas a pack of illegal smokes at the average illicit price would have cost them only 4.8 percent of their daily income.
The combination of affordability and easy availability of contraband tobacco products largely contribute to the thriving of the black market. Malaysia, whose territory is separated into two similarly sized regions by the South China Sea, has long coastal lines, isolated jetties and long, porous borders that facilitate smuggling. The country’s peninsular part shares a land and maritime border with Thailand and maritime borders with Singapore, Vietnam and Indonesia, whereas its eastern part neighbors Brunei, Indonesia, the Philippines and Vietnam. Almost three-quarters of illegal cigarettes come into Malaysia from its nearest neighboring countries, where weighted average prices of legal cigarettes ranked between $0.80 (Vietnam) and $2.40 (Thailand) in 2017, according to the Oxford Economics report. The notable exemption among source countries is Singapore, which boasts the region’s highest cigarette prices by a considerable margin. Of Malaysia’s 13 states and three federal territories, Sabah, Sarawak, Pahang, Kelantan and Terengganu are most affected by illegal cigarette sales, which in these regions account for up to 83.5 percent of the market.
Illicit whites, i.e. cigarettes produced legally abroad for the explicit purpose of selling in a target market, in 2018 dominated the Malaysian tobacco sales with a share of 43.9 percent, followed by smuggled kreteks—Indonesia’s characteristic clove cigarettes—with 10.1 percent and cigarettes with fake tax stamps (4.9 percent), the study finds. The practice of equipping legitimate packs with counterfeit tax stamps, is a relatively new phenomenon, which, according to the report, has occurred for the first time after the excessive 2015 excise hike.
Action needed
In the face of policy loopholes, weak law enforcement and corruption, the smuggling of cigarettes in Malaysia continues to gather momentum. The country ranks 61st of 180 countries on the most recently published Corruption Perception Index, with Transparency International Malaysia estimating that 4 percent of the country’s gross domestic product has been lost annually to corruption since 2013. In the absence of political financing laws and corporate liability, Malaysia has seen numerous corruption scandals over the past years. The high level of corruption also makes the country less attractive to foreign direct investment.
The increase of illicit cigarette trade is closely related to Malaysia’s corruption problem, the Oxford Economics report states, quoting sources that indicate that the large-scale smuggling in Malaysia relies heavily on the ability of traffickers to bribe officials to overlook contraband shipments. With hurdles for smuggling being low, the often transnational syndicates have been able to generate substantial profits, which they use for further contraband activities, attempts at wider corruption and other criminal activities, potentially even terrorism.
The situation in Malaysia, which, according to Japan Tobacco International (JTI) Malaysia’s managing director, is now surpassing crisis levels, has also impacted on the legitimate cigarette industry. In 2017, British American Tobacco and JTI closed down their manufacturing facilities as a consequence of their business shrinking amid the growing illegal cigarette trade. According to the Oxford Economics study, which takes all tobacco supply-chain related occupations into account, the closures represented the loss of an estimated 5,750 jobs throughout Malaysia’s workforce, as well as a loss of 0.1 percent of the government’s total tax revenue annually. And there is more to come: In September 2019, JTI announced that under its transformation plan [see also article on page xx], the company would permanently close its shared service center for Asia-Pacific in Kuala Lumpur and lay off about 40 percent of 170-strong workforce.
Malaysia has taken notice. Recognizing that the illicit cigarette trade and its association with criminals, contraband and cross-border syndicates is becoming a national threat, the government has announced plans to tackle cigarette smuggling to recover at least MYR1 billion. The tobacco industry has proposed a number of measures that would enable the government to curb contraband, including a multi-agency approach and a three-year moratorium on further excise duty hikes.
Experts also recommend the creation heavier penalties for cigarette smuggling, including mandatory imprisonment terms. A special task force set up under the country’s home ministry should focus exclusively on illicit cigarette trade, thereby spearheading more effective coordination and collaboration among key law enforcement authorities.
Technological equipment at customs checkpoints at ports and other borders and high-risk posts should be upgraded, while law enforcement agencies should prevent corruption by rotating officers in given jobs. Quick action is needed as the next challenge already looms on the horizon: According to JTI Malaysia, the country’s illegal vapor market stands already represent 10 percent of all sales and is growing rapidly.

Stefanie Rossel
tefanie 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.
February 13, 2020
Too Little, Too Late
Michael B. Siegel
Michael B. Siegel reflects on the great vape scare of 2019.
By Stefanie Rossel
Michael B. Siegel is a professor of community health sci- ences at the Boston University School of Public Health. He has 32 years of experience in the field of tobacco control, previously spent two years working at the Office on Smoking and Health at the U.S. Centers for Disease Control and Prevention (CDC), published nearly 70 papers related to tobacco and testified in the landmark Engle lawsuit.
In his tobacco and alcohol news analysis blog, “The Rest of the Story,” Siegel was one of the first to hint at the fact that illegal e-liquids containing tetrahydrocannabinol (THC) are likely to be the true cause of the recent vaping-related illnesses and deaths in the U.S. He has criticized the CDC for its late warning against these vapes and is asking health authorities to stop ignoring “the other youth vaping epidemic”—the vaping of marijuana.
Tobacco Reporter: E-cigarettes have been on sale in the U.S. for more than a decade. How do you explain the sudden proliferation of vaping-related illness?
Michael B. Siegel: The proliferation of vaping-related illness is not being caused by e-cigarettes but by THC-containing vape cartridges. Late in 2018, a new thickening agent began to be used as a diluent for THC concentrate—vitamin E acetate oil. Vitamin E acetate oil is a viscous oil. The vitamin E acetate destroys the surfactant in the lungs, blocking their ability to work properly. In addition, vitamin E acetate when heated can form a toxin that is toxic to the respiratory tract. This explains why there has been a sudden proliferation of this illness.
Why do you think marijuana vaping has become so popular among youth during the past year?
For two reasons. First, because vaping has become so popular. Second, because the legalization of marijuana in many states has led to a decreased perception of harm.
In your blog, you criticized the CDC for waiting two months after the first vaping-related illnesses and deaths before issuing a warning against vaping THC e-liquids. Why do you think the CDC took so long?
I think the CDC had a preexisting bias against e-cigarettes and therefore its thinking was clouded. I also think that the CDC did not do enough to talk to vapers in order to understand the benefits of vaping to so many smokers—and ex-smokers—across the country. I think the CDC wanted to tell the story of how e-cigarettes were causing severe illness and death. When the evidence didn’t fit this story, they were very reluctant to change the story to fit the evidence. It wasn’t until the evidence became too overwhelming to deny that they finally admitted the role of THC vaping. However, they still cling to the faint hope that somehow e-cigarettes are involved in the outbreak.
How has the number of cases developed since the CDC’s official warning? Has the warning been taken seriously?
The number of cases has finally started to wane, not because of any action by the CDC but because of enforcement actions by the Food and Drug Administration, the Drug Enforcement Administration and a number of police departments that have begun to crack down on the illicit production and distribution of THC vape cartridges. Also, excellent reporting by Leafly played a role as they investigated the outbreak and quickly pinned it to vitamin E acetate oil being used as a thickening agent by several large illicit manufacturers in Los Angeles. When these producers became aware, they did discontinue its use. This is why the cases are declining—not because of any effective warnings from [the] CDC. If anything, the vagueness of [the] CDC’s warnings led to more cases of the outbreak than we would have experienced had they simply told the public the truth from the beginning.
Which measures have health authorities taken since they first admitted that the vaping-related illness is linked to THC that is potentially contaminated with vitamin E acetate, and how useful do you think they have been in tackling the problem?
The major action by health authorities in most states has been to warn the public not to vape at all and in some states taking e-cigarettes or at least flavored e-cigarettes off the market. Both of these actions probably made the problem worse not better. To be sure, taking e-cigarettes off the market did nothing to curtail the outbreak because these products were not involved in the first place. However, taking e-cigarettes off the market and hiding the true role of THC vaping probably did lead to more people continuing to vape THC and therefore to more cases of the illness.
Most of the implicated THC e-liquids were illegal products. In your opinion, which immediate and which long-term strategies should be taken to address the problem?
The problem is clearly the fact that there is a large and unregulated market for THC products. The only way to address this effectively is to legalize the use of cannabis but to accompany that with stringent regulations that include [the] testing of all cannabis products for chemicals like pesticides, metals and solvents/diluents such as vitamin E acetate.
In the U.S., we now have the situation that flavored e-liquids except those with tobacco flavor have been banned in some states. Moreover, in early January, the Trump administration announced plans to bar sales of flavored e-cigarette cartridges except for menthol and tobacco flavors. The move will exclude refillable e-liquid flavors and will go into effect within 30 days. In Massachusetts, one of the states that already implemented a ban, vapers have returned to smoking in great numbers, which is an indicator of what the present policy on vaping illness is doing to the entire vape sector.
The outbreak of lung injuries has scared many vapers and prompted authorities to take drastic measures such as the recently announced ban on all cartridge-based flavors except tobacco and menthol. Can the vapor industry recover from this blow?
Unfortunately, I think there are multiple policies that are going to decimate the vape sector. The more existential challenge is that the PMTA [premarket tobacco product application] system is still in place. As of May 2020, all products that have not submitted a PMTA will have to come off the market. The PMTA process is so burdensome and expensive that only the largest companies will be able to afford it.
This will result in the decimation of the industry as only a small number of products have a decent chance of being able to remain on the market, and the vape shop model is simply not going to survive. What is truly needed for the vape sector to survive and continue to thrive is legislation that prevents the FDA from implementing the PMTA process and instead forces the agency to actually promulgate a set of safety standards for these products.
How do you see the future of tobacco harm reduction in the U.S. against this background?
I would like to emphasize that both flavored e-cigarette bans and the PMTA enforcement are going to have the adverse effect of forcing many ex-smokers back to smoking. I see this as a tragic and preventable public health outcome. There are at least 3 million ex-smokers who quit [by] using e-cigarettes. Taking these products off the market makes absolutely no sense. These vapers have accomplished the most difficult task imaginable: quitting smoking. Why punish them by removing the products that enabled them to quit?
Unless we change course, we will have squandered the opportunity for one of the greatest public health miracles in history: the elimination of the combustible tobacco market by transitioning the market over to an array of much safer nicotine-containing products. The industry is ready for it. Smokers and vapers are ready for it. Sadly, the only ones not ready for it are the anti-tobacco groups who have for decades purported that their goal is to [make] smoking history. This is the great irony of the vaping story.

Stefanie Rossel
February 4, 2020
Keeping Track
An overview of track-and-trace technologies
By Michael Butterworth
Track-and-trace solutions in all their various forms are currently all the rage. Retailers are increasingly looking to use metrics to demonstrate supply chain efficiencies and provide transparency over things like delivery times and sustainability information.
In this article, we take a look at some of the different technologies deployed in traceability schemes, key strategic questions to consider when structuring your contracts and some of the different legal aspects to the data generated in the process.
Technology
Bar codes or QR codes feeding into a centralized database
Retailers may want different partners to input data or scan an item at various stages in the production process. By maintaining a centralized data repository, the retailer can use the data to oversee the various stages in the production process.
However, the production line needs to be updated to apply the codes, and manufacturers will need to think through the impact on the production process: If supply chain partners need to apply or generate a code (potentially from a third-party source, such as the ultimate retailer), how will this new “raw material” fit into the production timeline?
The European Commission imposed this type of solution for verifying the authenticity of medicinal products and tobacco products under the Falsified Medicines Directive and the Tobacco Products Directive, requiring the industry to establish data repository systems allowing data to be generated and tracked at all stages from manufacture to point of sale.
Interestingly, the commission decided not to use this solution for medical devices where the requirement is simply to apply a unique ID number to each device and log that number with the regulator, but there is no end-to-end tracking system in place.
Similarly, for customs tracking purposes, shippers only need to provide their container status messages (an existing code used in the shipping industry) to the European Anti- Fraud Office (OLAF), which itself maintains a directory.
Connected devices/internet of things
These are used for tracking larger assets (e.g., shipping containers or delivery vehicles). A connected internet of things solution can provide real-time data on the location of products or other key status indicators, like temperature or shock. This type of solution can be used to provide data streams to end users where the design and functionality of the user interface will be important for establishing a brand and recognition.
Organizations purchasing this type of solution may therefore want to own or have exclusive rights in the user interface. They will then need to make sure that the connected devices meet the technical requirements to operate with the user interface and that the contract with the hardware vendor includes the necessary rights for interoperability if the user interface is procured from a separate vendor.
If you’re tracking devices using a global connectivity solution, you will also need to check that your solution is suitably “future-proofed” for countries switching off their 2G and 3G networks and those with more plans to do so (www.emnify. com/blog/global-2g-phase-out).
Blockchain
Distributed ledger technology has been generating a lot of excitement for a while and has been developed for track-and-trace applications in a number of situations, often for tracking high value or unique assets, such as diamonds, jewelry or artwork.
The key advantage of a blockchain is that each transaction is verified across the blockchain, so there is no single authority that could manipulate the transaction records. For many track-and-trace scenarios, that is not necessarily a concern. However, for high value or unique assets, there is a clear vulnerability that a blockchain could help address.
The difficulty then is linking up the asset to the blockchain. This would also require a system of unique IDs. Then the vulnerability shifts from ensuring the integrity of the single authority to the various players seeking to first register a unique ID on the blockchain.
Whatever the relationships between the players in the particular market, there will need to be a comprehensive system of contractual relationships to set out what the legal effect of a particular transaction would be and how that relates to activities on the blockchain.
Structure
Third-party integrations
It’s important to consider the key stakeholders in the ecosystem. The real value from track-and-trace solutions often comes from integrations with third parties—for example, if a retailer provides a platform for suppliers to input their data or if a logistics company allows customers to access and view data on their deliveries.
Centralized authority
If you’re tracking delivery vans, containers or other items where the real interest is in what’s inside them, who will have access to the manifest data? If you’re tracking larger or more valuable assets, do you need verification that the manifest matches the contents? If so, who will do this?
Ownership of the solution
One of the key strategic questions to consider before embarking on a track-and-trace project is whether you require exclusive use of the solution to establish a brand name—for example, if you want to differentiate your core product by providing a unique data service on top, or, alternatively, if you simply want something off the shelf that can be more easily swapped out for a competing product further down the line. A hybrid strategy could be to use different vendors for different components, which can prove more challenging from a contractual/operational risk perspective as a systems integration role may be required.
Data
Commercialize and exploit
Track-and-trace solutions generate vast amounts of data. It’s key at the outset to consider what value you want to derive from the data. What rights will you give customers and business partners to access the data? Will you generate any analytics using the data, and what sort of data products do you want to generate? You should make sure you have license terms in place with any third parties accessing the data, making sure you retain the rights you need for any future commercial exploitation.
Your supply contracts should make clear who owns the rights to the data, who backs up the data and whether you need any support with data portability on termination.
Personal data
If you’re tracking people, such as delivery drivers, then you will need to think about your EU General Data Protection Regulation (GDPR) obligations. Have you checked if you need to do a data protection impact assessment? Even if you’re not tracking people, the GDPR is likely to be engaged given most solutions will collect personal data for the users logging into the system. Have you thought about how the GDPR will affect the contracting structure and transfers of personal data overseas?
Nonpersonal data
You may have missed it, but there’s now a regulation on the free flow of nonpersonal data (https://ec.europa.eu/digital-single-market/en/free-flow-non-personal-data). Initially, this will mainly impact buyers in the public sector who need to think carefully before imposing any restrictions on the territory of data storage. Look out for the codes of conduct envisaged under this regulation, which the commission will encourage service providers to develop by Nov. 29, 2020, and implement six months later.

Michael Butterworth
Michael Butterworth is senior associate of technology, outsourcing and privacy at Fieldfisher, an international law firm headquartered in London.
February 3, 2020
The Tastemakers
Who’s who among supplies of tobacco and vapor flavorings
TR Staff Report
Tobacco and e-liquid companies use flavorings to produce consistent, high-quality products and set their brands apart from the competition. In today’s heavily regulated tobacco manufacturing environment characterized by a dwindling number of approved ingredients, superior skills and know-how are in high demand. The professional flavorings supplier must be highly experienced not only in new technologies and smoke chemistry but also in patent protection and other legal issues. And because flavorings are keys to brand identity, the importance of confidentiality cannot be exaggerated.
Alternative Ingredients
Established in 2014, Alternative Ingredients is fully dedicated to next-generation products and electronic nicotine-delivery systems. the company has a state-of-the-art creation center and an ISO 7 production clean room. Alternative Ingredients develops special flavors designed for next-generation products and electronic nicotine-delivery systems. It offers customized finished e-liquids and a variety of nicotine solutions.
Borgwaldt Flavor
Borgwaldt Flavor, part of Hauni Maschinenbau, develops and produces flavors and casings for cigarettes, pipe tobacco, cigars, water pipe tobacco, RYO/MYO, chewing tobacco, moist snuff, kreteks, heated-tobacco products and filter capsules as well as flavors and liquids for e-cigarettes. Borgwaldt Flavor also offers tobacco additives such as anti-mold agents, burn additives and humectants as well as insect control and monitoring material. Borgwaldt Flavor works in close collaboration with customers by offering consulting services in product development, blending, processing and manufacturing technology.
Curt Georgi
Founded in Germany in 1875, Curt Georgi is a traditional flavor and fragrance house—and still family-owned. Located in Boblingen, Germany, the company has more than 11,000 square meters of production facilities. With subsidiaries in many countries and professional partners around the world, Curt Georgi is able to offer its products globally. Curt Georgi offers flavors for cigarettes, cigars, shisha and other products as well as a complete service package, including professional, free consulting on all aspects of tobacco product manufacturing. The product range consists of burley casing, flue-cured casing, stem casing, Virginia casing, top flavors, full-blend casing (for blended, Virginia and kretek cigarettes) and irritation “improvers” in ready-to-use or concentrated varieties. The company also specializes in flavors for water pipe tobacco, pipe tobacco, cigars, snuff and chewing tobacco.
Hertz & Selck
Hertz & Selck develops and produces high-class flavors for the international tobacco industry. Its wide-ranging portfolio covers flavors from classic natural extracts through exclusive top flavors to the latest fashionable flavors. Applications comprise cigarettes, cigarillos and cigars, rolling tobacco, pipe tobacco, chewing tobacco, snuff and water pipe tobacco, filters, cigarette papers and e-liquids plus regional products such as khaini, kreteks, bidis and snus. With its focus on tobacco industry products, a network of distribution partners and representatives on four continents, Hertz & Selck is well established today. Thanks to its extensive experience on the international market and its familiarity with the requirements of end consumers, Hertz & Selck supports its customers throughout all phases of product development, from the initial idea to market launch. Hertz & Selck aims for excellent quality in all areas of activity. The company attributes its success to its passion for tobacco, which has shaped Hertz & Selck for more than 80 years.
Hertz Flavors
Dedicated to the tobacco industry, Hertz Flavors has established itself as Europe’s leading supplier for unique flavors of premium quality made in Hamburg, Germany. The company’s philosophy is simple: to provide tailor-made solutions for superior taste. Together with its customers, Hertz Flavors creates flavors for tobacco products with character, including top flavors, casings or other tobacco additives for cigarettes, shisha, kretek, RYO/MYO, heat-not-burn, cigars/cigarillos, pipe, snus/snuff, capsules/filter, e-liquids or any other innovative product category.
Mane Flavors
Headquartered in Vouvry, Switzerland, Mane’s tobacco business unit offers the following products to the tobacco industry: top flavors, top casings and casings, natural extracts, essential oils, absolutes, menthol, microencapsulated flavor systems for capsule/molecular encapsulates, development, consulting and tobacco blend formulation. Worldwide, the company has 21 production facilities, and its tobacco business unit has five tobacco flavor development units. Most recently, e-liquids and reduced-risk product applications have been at the forefront of new Mane technology developments. The tobacco business unit has secured a global network of partnerships to ensure a seamless development and supply line for e-flavors and e-liquids, guaranteeing the current and future regulatory compliance of products while also ensuring the traceability of all raw materials.
Mother Murphy’s Laboratories
Founded in 1946, Mother Murphy’s Laboratories is a privately owned flavor manufacturer located in Greensboro, North Carolina, USA. the company began working closely with the tobacco industry in the late 1980s and is currently selling tobacco flavors in more than 15 countries. Its offerings include complete casings, flavor for casings, top dressings, top flavors and functional ingredients—all designed and tested for applications like cigarettes, cigars, water pipes, smokeless tobacco products, filters, etc.
Taiga International
Offering more than just flavoring, Taiga International’s services range from tobacco selection to blend development and cigarette design. Based in Breendonk, Belgium, Taiga International’s products include flavors, casings, enhancers and other ingredients for cigarettes, cigarillos, kreteks, shisha, pipe tobacco, RYO/MYO, snuff and snus. The company also offers flavors for e-cigarettes, e-liquids and e-hookahs. To mimic the smoking sensation of a traditional cigarette as closely as possible, Taiga International has developed a special series of e-liquid flavors. Different varieties are available, from traditional or brand-type cigarette flavors to food flavors. These flavors include blended-type top flavors, burley flavor, chocolate, menthol and Virginia top flavor types.
Tobacco Technology Inc.
Founded in 1975 in Maryland, USA, Tobacco Technology Inc. (TTI) develops customized flavors for smoking products, including casings, cigarettes, water pipes, snuff, snus, chew, kreteks, RYO, pipe tobaccos, hemp and dissolvables. TTI also offers consulting services to facilitate flavor, process and product development. TTI subsidiary E-LiquiTech is dedicated to e-liquids, bottling and cartomizer filling. TTI Flavors s.r.l. will open in Assisi, Italy, in 2020 and is a manufacturing facility for flavors, casings and e-liquids, bringing faster delivery to customers in the Middle East, Europe, Africa and Russia.

January 22, 2020
TABEXPO Impressions
The global tobacco and nicotine industries gathered in Amsterdam, Nov. 12-14, to learn about the latest products and services.

January 17, 2020
Trader Versus Critter
Proper pest infestation control remains an essential issue in tobacco warehousing and logistics.
By Stefanie Rossel
Tobacco leaf feels like home to a number of insects, and that continues to be a challenge during transport and storing of the costly base material for combustible cigarettes. In stored raw tobacco, the dreaded cigarette beetle, also known as Lasioderma serricorne, and the similarly destructive tobacco moth (Ephestia elutella) find the perfect conditions to hatch the next generation—or rather, generations as the insects are prolific: In ideal circumstances—for example, in tobacco bales where there are no natural enemies—the female cigarette beetle can produce up to 32 billion descendants per year. The insects thrive in warm and humid warehouse environments in which the larvae feed on dried tobacco, pressed lamina or cut rag, contaminating the commodity with their excretions and thus making it unusable.
The creatures are also hard to extinguish. The design of their respiratory systems allows the beetles to survive a long time with little gas exchange and low levels of oxygen. In each stage of its lifecycle—beetle, egg, larvae, pupae, cocoon—the insect has special characteristics that allow it to survive.
Moth and beetle infestations are responsible for annual losses of between $400 million and $800 million globally, according to industry estimates.
Needless to say, infestation control is essential in the transportation and storage of tobacco. To fight the parasites, Coresta recommends three treatments. An efficient but rarely employed method is freezing the tobacco to below 20 degrees Celsius. The technology is expensive and not apt for handling the high volumes common to cigarette production, hence it is applied only to high-value leaves used for cigars.
According to the fourth edition of Coresta Guide No. 2: Technical Guide for Phosphine Fumigation Parameters for the Control of Cigarette Beetle and Tobacco Moth from August 2019, phosphine gas (PH3), which has been used for decades, is still the main tool for management of infested tobacco. It requires low initial investment and involves low long-term cost. As warehouses can be completely sealed for fumigation, the process allows for high-volume treatment. If protocols are followed, it leaves no chemical residues after the treatment. However, because the treatment isn’t always applied, cigarette beetles are becoming increasingly resistant to phosphine.
The third accepted standard, controlled atmosphere (CA), is a relatively new method in the tobacco industry. While the technology has been in use for more than 100 years for other commodities, it became an option for tobacco infestation control only 15 years ago. The process consists of a specially constructed, gastight chamber in which a commodity is treated in an artificially engineered atmosphere. In the case of infested tobacco, the oxygen level is reduced to below 0.5 percent to ensure a 100 percent mortality rate in all life stages of the insects. While requiring an upfront investment to set up the gastight chamber—which can even be created in a tent—CA offers a number of benefits. Next to the 100 percent mortality guarantee, it can be used for all types and varieties of leaf tobacco without affecting taste and color. Besides, it can be employed for treatment of tobacco products. It is not suitable for high-volume treatment, though.
As with the other methods, procedures must be strictly followed to make CA effective. In 2013, Coresta published its Guide No. 12, which recommended CA technology for infestation control and set up the technical standards for successful use. The guideline, which has been updated several times since its launch, has contributed to the increasing popularity of CA technology. “The industry was already aware of the issues regarding the PH3 resistance of the beetle and was waiting for solutions,” says Rene Luyten, director and owner of b-Cat in the Netherlands. “Since the guideline is out, the market is open for the controlled atmosphere system. Companies who face issues will make the investments in CA.”
B-Cat offers CA systems that can be attached to any hermetically sealed space, such as a storage room, container, silo, tent or bag. The system will then filter out the oxygen inside by using a nitrogen (N2) generator.

Uphill struggle
Of course, the tobacco landscape has changed significantly since 2013. Sales of traditional cigarettes have declined considerably, and many next-generation products are made without leaf tobacco. That development has yet to impact Luyten’s business, however.
“Up to this moment, these changes haven’t had any influences on our market; there is still tobacco, and the cigarette beetle is still present,” he says. “We don’t have an overview if the volumes are getting down. With our system, it’s still a small part of the total volume that is getting treated. We are still building new projects to support our clients with the fight against the PH3-resistant cigarette beetle.”
Luyten notes that demand for CA continues to grow with more companies taking the step using the technology to ensure a clean product and keep the beetle counts down. For b-Cat at this stage, demand for CA is still the highest in Europe, the Middle East and Asia. “It’s not really a fixed region,” says Luyten. “The cigarette beetle travels along with all the movements of the tobacco. We see a slight move from factories to other areas. There is a decrease of infestation in the European Union regions and a move toward [the] Middle East and Asia. For the cigarette beetle, this is a much better climate considering the higher temperatures, so the fight against the beetle isn’t over yet. In the colder climates, the beetle counts aren’t as high as in the warmer climates, but the issue is the same. We notice that between the leaf dealer and clients, the controlled atmosphere isn’t really going on, but at the factory site, which is the last stage, the [number of] projects increase.”
While Luyten is hesitant to put an exact figure on the share of global tobacco production lost to infestation—estimated by some at 1 percent—he says the concern extends beyond the lost volumes. “In the end, it’s all about getting the counts down in the factory and making sure the cigarette beetle will never be found in one of [the] manufacturers’ finished products on the market,” he says.
Luyten is encouraged that customers are increasingly aware of the need to keep their products clean after infestation treatment. “By using controlled atmosphere, we are able to ensure a 100 percent mortality of all life stages of the cigarette beetle, but once that’s performed, we have to protect the materials to keep them clean, something we pushed from the beginning but which wasn’t picked up directly. Nowadays, clients are more aware of this and are more willing to investigate the possibilities.”
Preventing a new invasion
Re-infestation remains an important risk, not only for CA but for all treatments. “Once the treatment is performed, re-infestation is always possible,” says Luyten. “We always discuss this topic with our clients and try to find the best solution in this scenario. Each project is different, and we have to decide whether we will treat the product just before shipment, i.e., export, or whether we treat the incoming product. We also need to assess what the flow of the product is after treatment and in which area the location is—is it colder or in a tropical climate? There are many possibilities on the market, but it always has to be clear that optimum conditions need to be created to avoid re-infestation. Unlike with CA systems, however, a 100 percent mortality rate can’t be guaranteed.”
To help avoid re-infestation after CA treatment, b-Cat’s subsidiary vQm a few years ago developed a method to vacuum-pack tobacco. The technology has since been refined. A patented valve enables flushing the vacuum-packed plastic with N2 or CO2 in a process called modified atmosphere packaging. It ensures insect-free packaging from the moment of packaging to arrival at the end user, according to vQm. Additionally, modified atmosphere packaging reduces oxidation, conserves the product and keeps moisture levels stable.
“VQm packaging is a great solution for cut rag and expanded tobacco,” says Luyten. “Advantages of the method include its effectiveness against insects in all life stages and protection against re-infestation. Furthermore, it enables savings in logistics of at least 25 percent. Weight and moisture loss are minimized, flavor and color preserved, [and] the tobacco freshness is retained. We have a stabilization during shipment and transportation, and the method does not impact tobacco-specific nitrosamines.”
B-Cat has more innovations in the pipeline. “There are always opportunities and improvements to be made—certainly when you think about the complete chain,” says Luyten. “All are related to each other and all are facing the same issue. The purchaser of the leaf is buying hopefully clean products. Many of these products are stored in the warmer climates and not always under the best circumstances. Here is the challenge: how to get the product clean and how to keep it clean from insects before sending it out. The challenge is to be able to ship the materials guaranteed insect-free to the client. However, the sources are limited, and there are many factors which have an influence.”

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.
January 17, 2020
Europe’s Conflicted Stance
Vaping, yes, snus use, no—the European Union has failed to craft a coherent tobacco harm reduction policy.
By Stefanie Rossel
It’s a curious situation: In terms of vaping and snus regulation, the EU is like a distorted reflection of the United States. While in October 2019 the U.S. Food and Drug Administration (FDA) authorized Swedish Match to advertise eight of its General snus smokeless tobacco products as less harmful than cigarettes, the European Court of Justice (ECJ) in December 2018 reaffirmed the EU ban on snus sales, arguing that all tobacco consumption should be reduced and that snus could be a gateway to combustible cigarettes. In the EU, snus can be consumed only in Sweden, which enjoys an exception on cultural grounds.
In contrast, e-cigarettes are largely tolerated across the EU; in the U.K.—the EU’s largest vapor market—health authorities even actively promote e-cigarettes as quit-smoking aids. In the U.S., meanwhile, vapor products are increasingly demonized following an outbreak of vaping-related deaths and illnesses linked primarily to black market THC products.
Europe’s vaping landscape appears relaxed by comparison. The EU has thus far been spared the vaping sickness that has caused least 2,400 injuries and 50 deaths in the U.S. Although e-liquids are available throughout the EU in many flavors—including the sweet dessert-like tastes that have been termed “child-appealing” in the U.S.—there seems to be less concern that vaping is a gateway drug luring otherwise uninterested teens into a lifetime of nicotine use.
Studies published by the German e-cigarette trade association Verband des eZigarettenhandels in June 2019 show that only 0.9 percent of 14-year-old to 17-year-old Germans use e-cigarettes—down from 2.8 percent one year earlier—despite the rapid growth of the segment and the continuously expanding availability of products.
In the U.K., a mere 1.6 percent of 11-year-olds to 18-year-olds use vapor products more than once a week. Only 0.6 percent use them daily. This compares to 28 percent of high school students in the U.S. who reported using nicotine e-cigarettes in the past 30 days in 2019, up from just over 20 percent in 2018, according to a study published in JAMA in November 2019. Among middle schoolers, that rate rose from 5 percent in 2018 to 11 percent in 2019.
When U.S. President Donald Trump called for a ban of all nontobacco flavored e-liquids in the wake of the vaping scare, Public Health England (PHE) reiterated its stance on vaping, which it considers to be 95 percent less harmful than traditional smoking, as a cessation tool.
While the U.K. remains a forerunner in terms of vaping policies, PHE’s approach is nevertheless symbolic of the different attitudes on both sides of the Atlantic. In the U.S., numerous tobacco lawsuits over the past decades have contributed to the perception of e-cigarettes as a potential gateway to smoking combustible cigarettes. Conversely, the EU has embraced vapor products as a tool to discourage smokers from consuming the significantly more hazardous combustible cigarettes. By doing so, the economic community acknowledged the continuum of risk concept. It also drew inspiration from harm reduction initiatives in other areas, such as HIV prevention. Instead of embracing prohibition, many EU countries sought to limit infection by providing drug users with clean needles and sex workers with condoms.
Regulated market
Contrary to the U.S., the EU admitted e-cigarettes to the market under strict regulations. Article 20 of the EU’s Tobacco Products Directive (TPD2) sets safety and quality standards for vapor products and refill containers. Among other things, it restricts the amount of nicotine to 20 mg per mL of e-liquid. By comparison, the most popular vapor product in the U.S., Juul, contains 59 mg per mL of nicotine.
Furthermore, the TPD2 limits the capacity of e-cigarette tanks to 2 mL and the maximum volume of cartridges to 10 mL. The directive prohibits the use of certain ingredients, including taurine, colorings and caffeine in e-liquids. Vaping liquids that contain THC, the psychoactive constituent of cannabis, or vitamin E acetate, the two substances that have been singled out as likely culprits for the vaping-related illnesses in the U.S., are hard to find in Europe.
The TPD2 also regulates the packaging and labeling of vapor products. For example, mandatory health warnings advise consumers that they contain nicotine and should not be used by nonsmokers. Packaging must include a list of ingredients and disclose the product’s nicotine content.
The legal age for purchasing vapor products is 18. E-cigarette advertising in print, on television and radio is limited, and vapor companies are prohibited from targeting teens. Before marketing their products in the EU, manufacturers and importers must register them electronically. In general, it is the responsibility of the producer to ensure that their products comply with the TPD2.
“Due to the characteristics of e-cigarettes, and in particular their nicotine content, it was deemed appropriate to consider them as tobacco-related products and to include them in the scope of the directive,” says Vivian Loonela, spokesperson of DG Sante, the European Commission’s Directorate-General for Health and Food Safety. “Given the lack of conclusive evidence related to the long-term health effects of e-cigarettes, their use patterns and potential to facilitate smoking cessation, Article 20 of the directive adopts a careful approach to their regulation, allowing these products to remain available to consumers.”
Thanks in part to this cautious regulatory approach, vaping has become increasingly popular across the EU and contributed to a decline in smoking, most notably in the U.K. According to an annual population survey, smoking prevalence among adults aged 18 and over in England declined by 5.4 percentage points from 2011 to 2018. In 2011, 19.8 percent of adults smoked, falling to 14.4 percent in 2018, equivalent to a drop from 7.7 million smokers in 2011 to 5.9 million in 2018. Action on Smoking and Health (ASH) estimates that around 7.1 percent of Great Britain’s adult population, or 3.6 million people, currently use e-cigarettes. Although the decrease in smoking came at a time when stricter tobacco control measures, such as plain packaging for combustible cigarettes, were implemented, e-cigarettes are believed to have played a significant role in the decline.
The snus phenomenon
The European Commission has managed to regulate new nicotine-delivery devices without full scientific evidence about the long-term health effects of the new products. While not claiming that vapor products are harmless, the commission proceeded on the assumption that they were a less hazardous alternative to traditional cigarettes. In this light, the EU’s negative attitude toward snus is difficult to comprehend. Snus is pasteurized oral tobacco that is available as loose products or in small pouches and has been used in Sweden for about 200 years. When Sweden applied for EU membership in 1995, it was exempted from the snus ban on cultural grounds.
Sweden stands out internationally because of its low smoking rates. According to Statista.com, 7 percent of Swedes smoked in 2016. Across the EU, the figure was 25 percent during that period. Sweden also has remarkably low rates of tobacco-related illnesses among men, low smoking-related mortality rates and the lowest risk of lung cancer among industrial countries—even though the country’s overall tobacco consumption is comparable with that of other European countries.
This paradox is widely attributed to Swedish tobacco users’ preference for snus over cigarettes. In contrast to the young e-cigarette category where little is known about the long-term risks of vaping, the long-term health effects of snus have been documented by a plethora of epidemiological studies over the past decades. While not risk-free, using snus is associated with lower risks of cardiovascular diseases and cancers than smoking. Studies have shown that the change from combustible cigarettes to snus brings about a drastic decline in health risks and that snus use is not related to oral cancer. According to research, using snus is about 90 percent to 95 percent safer than smoking, which puts the product basically on par with e-cigarettes.
Incoherent approach
Despite this scientific evidence and the similarities between the e-cigarettes and snus in terms of their potential for harm reduction, the ECJ endorsed the snus ban last year. “There should be no confusion between use of snus and use of electronic cigarettes,” says Loonela. “With regard to the latter, the commission continuously monitors developments related to e-cigarettes, including emerging scientific evidence. This information will contribute to the implementation report on the directive that the commission is required to submit in 2021.”
The snus ban, she says, is appropriate considering the directive’s objectives—to facilitate the functioning of the internal market and protect human health. “It is undisputed that oral tobacco is addictive and has adverse health effects,” says Loonela. “The negative health effects of snus and other types of smokeless tobacco were confirmed by the Scientific Committee on Emerging and Newly Identified Health Risks in 2008. The committee concluded that all smokeless tobacco products contain carcinogenic substances, albeit at different levels, and are associated with a number of adverse health effects. It was further concluded that smokeless tobacco in all its forms can cause cancer, increases the risk of death after myocardial infarction and is addictive.”
That argument is remarkable considering that the sale of combustible cigarettes and other smokeless tobacco products remain legal in the EU. Loonela acknowledges that there is no harmonized EU approach on harm reduction. “The commission has consistently given the message that e-cigarettes pose a risk to health and snus is banned in the EU, with the exception of Sweden,” she says.
The EU stance on snus resembles the “quit-or-die” attitude advocated by the World Health Organization. In upholding the snus ban, the ECJ followed a line of reasoning strikingly similar to that put forward by proponents of an e-liquid flavor ban in the U.S. The court argued that if snus products were introduced to the EU market, they would be novel compared with already available combustible products and smokeless products, and they would accordingly be attractive to young people.
By upholding the ban on snus, the EU has missed a chance to implement a consistent tobacco harm reduction policy. A 2017 study by the Swedish Snus Commission found that if every EU member state had the same tobacco-related mortality rate as Sweden, around 355,000 lives would be saved each year.

Stefanie Rossel
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.

January 17, 2020
Taking Charge

To prevent a regulatory overreaction, the vapor industry needs to self-regulate its use and marketing of flavors.
The use of flavors in e-cigarettes is the hottest topic in this disruptive industry. Manufacturers’ use of flavorings in e-cigarettes has come under intense scrutiny and is a piece of ammunition often used by those looking to impose stringent regulation on the industry. As we enter 2020, it is perhaps an opportune time to look back at the tumultuous happenings of the past couple of years to examine where the flavor debate has taken us and what we might expect to see in the future.
The inclusion of flavors in e-cigarettes poses many challenges for the industry. Broadly speaking, these challenges fall into three categories: the toxicological impact, the effects on vaper behavior and nicotine delivery, and perhaps most importantly, the impact on population level use among different user cohorts. It is the latter that poses an existential threat to the e-cigarette industry and to its ability to provide a reduced harm alternative to deadly combustible cigarettes.
The potential toxicological impact of flavored e-cigarettes is a relatively simple issue to address. By utilizing robust product stewardship procedures assessing the inclusion of flavor ingredients, utilizing literature and computational approaches to ingredient assessment and utilizing rigorous testing of e-cigarette emissions, manufacturers can easily provide reassurance to consumers that their products are safe. The impact on vaper behavior is another relatively simple issue to consider, and we are now beginning to see scientific evidence showing that flavorings in e-cigarettes can cause differences in nicotine delivery, likely secondary to effects on human puffing behavior (topography).
The greatest challenge comes with assessing the population level impact of e‑cigarette flavors. It is often stated that flavored e-cigarettes are beneficial in assisting adult smokers who want to quit smoking. There is good evidence for this—for example, research carried out by the Centre for Substance Use Research in U.S. adult vapers concluded that those who have completely switched from smoking cigarettes to using e-cigarettes are increasingly likely to have initiated e-cigarette use with nontobacco flavors and to have transitioned from tobacco to nontobacco flavors over time.¹
More recent longitudinal data from the same group similarly demonstrated that the use of Juul “characterizing” flavors (e.g., mint and mango) was associated with greater odds of quitting combustible cigarette smoking. The U.S. Food and Drug Administration (FDA) acknowledges the support that flavored e-cigarettes provide to smokers; in warning letters sent by the FDA in September 2018 to a number of U.S. manufacturers, the agency describes the “emerging evidence that some adults may potentially use certain flavored tobacco products to transition away from combusted tobacco use.”² Analyses of the FDA’s own Population Assessment of Tobacco and Health data have shown an association of nontobacco-flavored e-cigarette use with smoking cessation.³
The concern, though, is not this “off-ramp” for adults, a term used by the former FDA commissioner, Scott Gottlieb, to describe transitioning away from cigarette smoking, but the “on-ramp” for youth use of e-cigarettes and the potential for teens initiating nicotine use through flavored e-cigarettes.⁴ Action from the FDA on flavored e-cigarette use has arisen due to data from the U.S. National Youth Tobacco Survey (NYTS) showing an escalation of youth use of e-cigarettes, something the FDA terms an “epidemic.” While the use of such a term is perhaps an overstatement of the scale of the issue as recent analyses of NYTS data show very little frequent use of e-cigarettes by teens and particularly by those who have never used other nicotine-containing products,⁵ it is difficult to argue against the need for action against what is an escalating concern, regardless of its current scale.
The recent publication of further NYTS data fueled the crisis and has led to stronger calls for regulation of the industry and for the curbing of flavored e-cigarette availability. However, there are no easy solutions, perhaps evidenced by the ever-changing nature of the regulatory measures being discussed and recent data that suggests that even when some flavors are removed from store shelves and online marketplaces, switching to other flavors takes place. Even with the recent U.S. presidential intervention, we still do not have clear sight of what the future marketplace for flavored e-cigarettes will look like or as to what regulatory interventions will take place. And even in the absence of reactionary regulatory measures, the FDA will soon have greater discretion over which flavors are allowed to be sold in the U.S. through its premarket tobacco product application approval procedure.
Clearly, the industry needs to self-regulate since regulatory action, and especially knee-jerk regulatory action, often comes with unintended consequences that may do more harm than good. Many manufacturers have taken such proactive approaches, but there still remains on sale a vast number of e-cigarettes with flavor names and marketing materials that can be seen as targeted toward youth. If such marketing practices are not curbed by manufacturers themselves, regulators will perform this function for them—and with a potentially poor outcome.
It is worth noting that the impact of the U.S. flavor debate is being felt elsewhere. Some Canadian provinces, for example, have outlined their proposals to regulate flavored products. Importantly, we must remember that in the European Union, the Tobacco Products Directive (TPD2), a union-wide directive that regulates e-cigarettes, is due for revision soon. As in the U.S., it is expected that regulatory measures in TPD3 could involve restrictions on flavored e-cigarettes.
Undoubtedly, e-cigarettes have the potential to help reduce the global burden of death and disease caused by combustible tobacco smoking. Further, without doubt, they are a greater tool in helping smokers quit than licensed pharmaceutical products. However, improper regulatory measures may stifle the good that e-cigarettes are doing by limiting smokers’ access to the very products that are helping them quit. But perhaps with some sensible industry self-regulation, as a proactive measure to curb youth use and appease regulators, the widespread reductions in smoking prevalence caused by e-cigarettes will continue for the benefit of smokers and for global public health.

Ian Fearon
Ian Fearon is the director of whatIF? Consulting. He contributed this article on behalf of Broughton Nicotine Services .
January 17, 2020
Correcting the Narrative
The nuances in the vaping debate have been drowned by the media hype.
By Dan Marchant
In the past months, vaping has been under an unprecedented attack from the media, politicians and “health professionals.” Headlines have been filled with stories about a deadly lung disease, an “epidemic” of youth vaping and potential bans of flavored e-liquids.
But why the sudden media furor?
Last August, stories began to emerge from the U.S. regarding a mysterious lung disease that had started to affect multiple people. Information was sparse, but fairly quickly, both the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) began to warn that this disease, which had by now killed more than one victim, was in some way vaping related. They advised that all vaping should cease—and thus the touch paper was lit.
However, it became clear early in these investigations that there was a conflation between vaping as an alternative to smoking and vaping as a delivery mechanism for illicit drugs. Many experts had already identified black market THC (the psychoactive ingredient in marijuana) vapor products as the likely culprit, specifically products that contained a substance called vitamin E acetate.
Yet both the FDA and the CDC continued to warn against the use of all vapor products because not all the patients had reported using THC. At this stage, something like 70 percent to 80 percent had admitted drug use, but many had not.
What could have stopped this confusion? It would be normal in such circumstances for the CDC to advise medical practitioners to take a urine sample from all the cases, allowing them to determine beyond a doubt whether patients had been using THC (or other drugs). But for some reason, this was not done, and they had to rely on people, who for many reasons may not be forthcoming, being honest.
As time went by, unfortunately, growing numbers of people were hospitalized with the illness, and the death toll was rising. By Sept. 11, President Donald Trump gave a speech in which he combined concerns about this outbreak with concerns about the much-reported youth vaping “epidemic” in the U.S. He said that his administration was worried about vaping and would consider a nationwide ban on vapor flavors to “protect the children.”
So now vaping was doubly under attack; both the mysterious vaping illness and the teen vaping problem were front page news, and the U.S. vapor market suffered a huge decline. Some reports estimate it to be down by 80 percent to 90 percent, putting thousands of small businesses at risk. Even the U.K. vapor business declined by an estimated 30 percent despite the fact that it didn’t experience a spike in youth vaping or an outbreak of vaping-related illnesses.
As the story unfolded, evidence piled up that black market THC products were behind the outbreak of lung disease. The illicit products contained vitamin E acetate, which is used to “cut” the product so that it vaporizes more easily and requires less THC distillate. Unfortunately, vitamin E acetate has oil-like properties and when inhaled, it can cause lipoid pneumonia. Oil deposits in the lungs and impairs their function, which can be fatal.
To the outside world, it was clear that this was a U.S. problem; no cases of this illness were reported outside of America. If the injuries were caused by legitimate vapor products used by consumers as a less harmful alternative to cigarettes, then vapers would have been falling ill all over the world—but they haven’t been.
By Oct. 4, the FDA realized the same and updated its warnings to say that consumers should avoid THC vapes. But the CDC waited to update its advice until December. Now both organizations are suggesting that consumers who vape as an alternative to smoking should continue—but it’s too little, too late. The damage has been done, and the headlines have moved on before health experts could correct the narrative.
Unfortunately, the U.S. seems to have a big problem with youth access to vaping. The situation in the U.K. is quite different. The latest statistics from Action on Smoking and Health show that just 1.6 percent of 11-year-olds to 18-year-olds vape regularly (once a week or more) and 1.5 percent were previously smokers. And note that these figures include 18-year-olds, who are legally allowed to buy and use the products in the U.K.
In the U.S., by contrast, 20.8 percent of U.S. high school students are classified as “current” e-cigarette users. The U.S. figures cannot be compared directly to those of the U.K., however. For starters, the FDA defines a “current” user as somebody who has vaped in the past 30 days. It is also rumored that the U.S. statistics include any type of vaping, including that of THC, so there could be some confusion on the actual numbers. Nonetheless, there has clearly been a much bigger uptake of vaping in the U.S. than in the U.K. But why?
The answer is regulations. The U.K. and the U.S. have very different rules for vapor products. The U.K. implemented the EU Tobacco Products Directive in 2016, and this brought strict regulations for electronic cigarettes. These laws ensure the quality and safety of the nicotine-containing products on the market. They ensure that devices and e-liquids are tested for safe emissions, do not contain banned ingredients (ones we know could be harmful) and impose nicotine limits.
The U.S. does not have anywhere near the same level of regulations. In August 2016, the country implemented its “deeming regulations” on vapor products. This meant no new product could be brought to market after Aug. 8, 2016, but those already available could continue to be sold until May 2020, by which time they must submit to the FDA a premarket tobacco product application. As of June 2019, all products on the market should have submitted information such as ingredients listings. However, there is as yet no list of banned ingredients or any testing requirements.
Most importantly, the U.S. does not restrict the amount of nicotine in vapor products. The EU and the U.K., by contrast, limit nicotine to 20 mg per mL of liquid. While some have argued that this may be too low to help the heaviest smokers switch from combustible cigarettes, the limit ensures that consumers don’t receive too much nicotine in one go.
In the U.S., there has also been a huge rise in the popularity of small “USB stick” devices, which use pre-filled pods containing 50 mg to 60 mg of nicotine per mL. This is too much for many adults, let alone for a teenager with smaller body mass who has not built up nicotine tolerance. Such a dosage essentially gives them a brief high. And this is a major contributing factor toward the youth access issues in the U.S.
Another big problem is caused by retailers who illegally sell these products to minors. It is right to be outraged by so many youngsters getting their hands on vapor devices, but the outrage should be directed at the illegal sellers not the products. After all, vapor products have saved the lives of millions of adults who would otherwise have succumbed to one of the many smoking-related illnesses that kill 50 percent of all smokers.
It’s been a hard year for the vapor industry and its customers. What’s worse, amid the media hype and confusion, many vapers have returned to smoking combustible cigarettes; 2019 might be the first year in decades that smoking rates have increased in the U.K. Needless to say, this is a disaster for public health and for tobacco control.
On the bright side, throughout the uproar, Public Health England has maintained its stance that vaping is 95 percent less harmful than smoking. It has defended flavors as playing a vital role in helping people switch from smoking combustible cigarettes, and it has cited regulations as a reason that the U.K. has been spared an outbreak of vaping-related illnesses.
This gets little coverage, unfortunately. We need the media to help get this message out to the hundreds of thousands of vapers who have been scared by these stories and reassure them that vaping is still far less harmful than smoking.

Dan Marchant
Dan Marchant is the owner of Vape Club and a founding member of the U.K. Vaping Industry Association
January 17, 2020