Category: Also in TR

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Unfit for Purpose

HPHC testing is an unreliable, misleading comparative measure for premium cigars.
By Gerald Long
An understanding of what scientific content is reliable, meaningful and necessary for the substantial equivalence (SE) reports that tobacco manufacturers are required to submit to the U.S. Food and Drug Administration (FDA) for certain products is much needed and long overdue. The industry will not have an answer until FDA issues the final SE rule currently under review, but the proposed SE rule released last April indicates that data on harmful and potentially harmful constituents (HPHCs) will be required as a comparison point in all SE reports ¹ The Family Smoking Prevention and Tobacco Control Act (TCA) requires the industry to report levels of HPHCs in individual products ². Importantly, however, the TCA does not require HPHC test results to be included in SE reports. Unfortunately, FDA decided to include such results in SE reports as part of the proposed SE rule. This is both unnecessary and misleading when applied to premium cigars, as the industry has explained in extensive comments filed with the agency.
Further, while there is no statutory requirement that SE reports include HPHC data, doing so will not further any legitimate agency objective. FDA plans to use HPHC data as a metric to determine if the subject of an SE report (the “new” product) is substantially equivalent to a predicate product. For premium cigars, however, such test results will be meaningless as a comparative measure, will be crushingly expensive for the industry and will not provide FDA useful information furthering public health. FDA would be making a serious mistake by requiring such test results for premium cigar SE reports.
The problem
The TCA requires new tobacco products to undergo premarket review by FDA before introduction into interstate commerce. Section 910(a)(1) of the Food Drug and Cosmetic (FD&C) Act defines a “new tobacco product” as any tobacco product not commercially marketed in the United States as of Feb. 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after Feb. 15, 2007. The SE pathway, one of three premarket review pathways for a new tobacco product, is designed to demonstrate that the new tobacco product is “substantially equivalent” to a predicate tobacco product (i.e., one on the U.S. market as of Feb. 15, 2007)
FDA’s attempt to rely on HPHC data in SE reports for premium cigars is misguided. For one, it ignores difficulties in determining what “comparison criteria” to use for such testing and whether such criteria are reliable. Further, it is unclear what testing methodology to use. There is no internationally recognized, validated method for testing hand-rolled large cigars. Simple t-test data comparisons—a type of inferential statistic used to determine if a difference exists between the means of two groups—when applied to highly variable data collected with unvalidated methods, could lead to the incorrect conclusion that two identical products are different or that two different products are the same. Testing methods and comparison procedures that might solve this problem do not exist.
In addition, the paired designed testing comparisons favored by FDA are not available for premium cigars. Instead, the industry must rely on historical method capability data, such as repeatability and reproducibility, in order to establish what acceptable HPHC differences are between products for SE purposes; however, little, if any, such data exist for premium cigar HPHC methods. In any data comparison approach, allowable differences are critical factors in establishing product equivalence. Further complicating matters, differences in analytes other than nicotine (where the new product has a significantly lower yield than the predicate product) are considered by FDA to “not raise additional questions of public health.”
The absence of utility and reliability of HPHC data is even more glaring for premium cigars. HPHC data for premium cigars as a comparative measure is not reliable or meaningful, given the unique nature and variability of cigar tobacco and the handmade process used to make premium cigars. Also troubling is that, unlike for cigarettes, there are no reference products for premium cigars. This poses an issue with respect to scientific validation of testing methods and data resulting from any premium cigar testing.
To evaluate the usefulness of HPHC testing on premium cigars as a comparative measure, Tabacalera USA (TUSA) performed extensive HPHC testing of premium cigars from its portfolio. Results demonstrate that HPHC testing “data” is more likely to mislead FDA than help it make informed and scientifically sound comparative decisions⁴.

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TUSA’s HPHC testing efforts
TUSA tested 91 products from its commercial inventory. The 91 cigars comprised 43 different sizes and 18 different blends, all of which, like nearly all premium cigars, were comprised entirely of dark air-cured tobaccos. TUSA tested for certain physical measurements (i.e., conditioned weight, length, circumference and pressure drop) using 40 replicates; six individual HPHCs in cigar tobacco using seven replicates; 18 individual HPHCs in cigar smoke using seven replicates; and for TNCO in cigar smoke using 20 replicates (total particulate matter, tar, nicotine, carbon monoxide and water). “Replicates” refers to a “repeat measurement” and gives statistical power to conclusions based on the data. These tests measured HPHCs on FDA’s “abbreviated” list for cigarettes since FDA has not published a list for premium cigars.
TUSA utilized Coresta testing methodology, though it is not validated for large hand-rolled cigars. In fact, there is no internationally recognized, validated smoking methodology for testing large hand-rolled cigars. One problem, for example, is that cigars, especially large cigars, smoked under the Coresta methodology tend to extinguish and need to be relit, altering HPHC results.
One threshold issue in testing HPHCs in cigar tobacco is how to process samples for testing. One option is to combine all cigar tobacco from a sample, grind the tobacco and test samples from the combined composite tobacco, a method typically used with cigarettes. Another option is to grind each cigar separately and test the tobacco from each individually ground cigar. The former option produces consistently low variability within composite samples that can be considered a measure of analytical method variability while the second option provides a measure of the variability between the cigars themselves.
In the testing, TUSA collected more than 36,000 points of data. Such a large pool of data points might superficially lead one to believe the data are reliable and usable as a means to compare cigars. As set forth below, however, these data points confirm that HPHC testing on premium cigars—and the corresponding data—should not be a benchmark for comparative analysis by FDA⁵
The HPHC test data
Data from TUSA’s HPHC testing confirmed that it does not provide a useful metric of premium cigar comparison for equivalence purposes.
Most critically, 18 out of the 91 tested cigars had the same blend of dark air-cured tobaccos (“Blend A”). Any differences in tobacco HPHCs for the Blend A cigars revealed by testing is attributable only to the natural variability of tobacco. A naive statistical comparison might lead to the conclusion that the cigars are different, but they are not.
As an example, TUSA tested for the HPHC N-nitrosonornicotine (NNN) in cigar tobacco. Test data revealed that the variability of NNN among Blend A cigars was even larger than the variability between completely different cigar blends. In other words, test results identified cigars of the same blend as potentially “more different” from one another than cigars with completely different tobacco blends. Figure 1 shows this in a graphic form, making the huge variability apparent.
Figure 1
Box plot of tobacco NNN (µg/g cigar) for 91 samples tested segregated into 18 samples with Blend A and the other 73 samples
The data was also concerning with respect to the testing of cigar smoke. Notably, at present, smoke testing methodologies that yield reliable, reproducible and scientifically valid results for HPHCs in large hand-rolled cigars do not exist. The data from TUSA’s smoke testing makes it clear that such testing is meaningless as a comparative measure. With the exception of certain “extreme” cigar sizes, the range of HPHCs in the smoke from Blend A cigars (comprising only 18 different cigar sizes) was just as large as the range of smoke HPHCs in the entire study set of 91 cigars, covering 18 different blends and 43 different cigar sizes. There was also no real consistency or discrimination for smoke yield between cigars of different diameters. Figure 2 shows an example using only data for carbon monoxide (CO). The variability, between both sizes and blends, is clear.
Figure 2
Box plot of smoke carbon monoxide (mg/cigar) for 91 samples segregated into the Blend A samples with 18 different sizes and the other 73 samples in 34 sizes
Statistical comparisons of this data would conclude that, excluding extremely large or small sizes, all smoke CO results for the entire study set fall within the range of 200 mg/cigar to 1,100 mg/cigar defined by the 18 sizes from the Blend A group. The variabilities in fundamental design characteristics like cigar weight and size, inherent to handmade cigars and the uncharacterized variabilities in premium cigar smoking methods directly influence the observed variabilities in smoke HPHC deliveries.
The takeaway
HPHCs, in tobacco or smoke, are simply not viable metrics for comparing premium handmade cigars. Unlike cigarettes, produced by a high-speed, mechanized manufacturing process, premium cigars are handmade, artisan products with significant natural variability in the tobacco. Further, natural variability in tobacco means that the same cigar may vary in ways HPHC testing cannot account for, making the HPHC data of no utility as a comparative measure. Other variabilities in fundamental design characteristics, such as cigar weight and size, also directly influence observed variabilities in smoke HPHC deliveries.
A comparison of cigars based upon HPHC results could lead to the erroneous conclusion that the cigars have different characteristics when they do not or that they do not have different characteristics when they do. For premium cigars, different HPHC levels in the tobacco or in the smoke do not allow for conclusions on whether or not the cigars are “substantially equivalent.”
FDA cannot and should not look to differences in HPHC results for premium cigars because of a high likelihood of erroneous conclusions in equivalence comparisons. HPHC results for premium cigars are confounded by inherent variability of cigar tobacco, variability resulting from handmade construction and uncharacterized variabilities in cigar smoking methods.
The industry has raised this issue with FDA, including in comments on the proposed SE rule. The bottom line is that HPHCs are simply and clearly not a viable metric for distinguishing between premium cigars. As Albert Einstein said, “Not everything that can be counted counts, and not everything that counts can be counted.”

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References

¹See Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports, 84 Fed. Reg. 12,740 (proposed April 2, 2019) (to be codified at 21 C.F.R. pt. 16, 1107).

²Tobacco Control Act, 21 U.S.C.A. § 387 (2009). FDA published a preliminary list of 93 HPHCs in March 2012 and then identified product-specific subsets of HPHCs for which manufacturers and importers are to test and report to FDA. Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug and Cosmetic Act, March 2012.

³See Tobacco Control Act, 21 U.S.C.A. §905(j)(1)(A).

⁴TUSA defines a premium cigar as a cigar with the following characteristics: is wrapped in whole leaf tobacco; contains a 100 percent leaf tobacco binder; is made by manually combining the wrapper, filler and binder; has no filter, tip or nontobacco mouthpiece and is capped by hand; and weighs more than 6 pounds per 1,000 units. TUSA has proposed this definition of premium cigar to FDA on multiple occasions.

⁵Recent work published by the Center for Tobacco Products and other researchers confirms the variability in any testing among cigars of like brands and sizes. This work did not attempt smoke testing; rather, it examined only product size, dry nicotine content and tobacco pH, and the study found a “wide variation in product size and nicotine content within the domestic cigar market.” Further, the study found that “cigar size does not necessarily correlate with nicotine or free nicotine content.” Critically, the study found that it was not possible to replicate results, noting, “in the two large cigar and cigarillo brands analyzed a second time, there was considerable within-brand variance in nicotine content and concentration between the first and second analyses.” See Koszowski, et al. Nicotine Content and Physical Content of Large Cigars and Cigarillos in the United States. Nicotine and Tob. Res. 20(3) 393-398 (2018).
Gerald Long is manager, scientific affairs, product integrity and compliance at ITG Brands, on loan to Tabacalera USA (TUSA). TUSA, through its Altadis USA subsidiary, is a leading premium cigar manufacturer, making iconic brands such as Montecristo, Romeo y Julieta, and H. Upmann. It is also, through its JR Cigar subsidiary, a leading premium cigar retailer and, through Casa de Montecristo, the operator of premier, modern cigar stores. As such, TUSA is a leading supporter of the premium cigar industry, devoting significant internal and external resources to protecting the rights of those who make and sell premium cigars, and the adult consumers who enjoy them.

March 1, 2020
Busy Times Ahead

Stephane Colard (left) and Pierre-Marie Guiton
Coresta’s new secretary general shares his plans for the organization.
By Stefanie Rossel
At the end of last year, Stephane Colard took over as Coresta’s secretary general. Before joining this “cooperation center for scientific research” in Paris, he worked for Altadis and Imperial Brands where his last position was head of scientific research and harm reduction. Colard has been involved with Coresta since 2000 as a presenter of several papers and as a working group member and coordinator. From 2014 until 2018, he also served on the organization’s scientific commission. Colard holds a doctorate in science and last year obtained a Master of Business Administration with a specialty in corporate and social responsibility. Tobacco Reporter spoke with Colard about his plans for Coresta.
Tobacco Reporter: You’ve been at the helm of Coresta since November 2019. What is your vision for the organization?
Stephane Colard: The vision of Coresta is “to be recognized by its members and relevant external bodies as an authoritative source of publicly available, credible science and best practices related to tobacco and its derived products.” This vision is mine too, and in addition, I have a personal ambition for Coresta: to meet the fast-changing stakeholders’ expectations by translating and embedding, with the cooperation of all members, the vision into an extended scientific scope. With “stakeholders,” I mean all people or organizations impacted by or impacting the tobacco sector; for example, regulators, NGOs, suppliers, manufacturers or investors.
I am convinced that the scope of Coresta’s activities should not only cover the science of the products but also environmental, social and economic sciences. By considering large and multidisciplinary scientific domains and decreasing the granularity of specific areas of expertise, one can reduce the distance between scientists and stakeholders. This is a pre-requirement for meeting new product, environmental, social and economic expectations; this is my ambition.
The tobacco industry is in a state of transformation. What are the most pressing issues for Coresta?
Organizations are being asked to be more responsible than ever, and this is particularly true for the tobacco sector. Ignoring or underestimating this responsibility would be a trap reinforcing the strategy of “demonization.” This sector should therefore behave responsibly today, and because there is no doubt that more changes will occur, it should prepare responsibly for the future to make sure that value is sustainably created and shared. Investments in innovative new technologies and products like heated tobacco or oral nicotine-delivery products are interesting signs of industry transformation and of alternative levers of value creation.
Obviously, it is not the role of Coresta to influence business decisions and strategies. However, I am personally convinced that science can support value creation by developing new consensual tools for measuring the performance and the positive impacts of business adaptations and transformations. So, in my view, the most pressing issues for Coresta are to understand the expectations of stakeholders, to anticipate the needs for new broad scientific cooperation and tools, and to address them consensually and efficiently.

Among the things the tobacco industry will have to deal with are the United Nations’ Sustainable Development Goals (SDGs). They recognize that ending poverty and other deprivations—for instance, of tobacco farmers—must go hand-in-hand with strategies that improve health and education, reduce inequality and spur economic growth while tackling climate change and working to preserve the world’s oceans and forests. Developing and developed countries are supposed to work in partnership to turn the 17 goals into a reality. What role can Coresta play in accomplishing the SDGs?
Last year, I completed an MBA specializing in the assessment of the corporate and social responsibility performance of organizations. In that context, I undertook a project to better understand the impact of tobacco and alternative product sectors on the United Nations’ SDGs—the full report is available on the Coresta website—and to identify methods for performance assessment and improvement. Even if some specific goals are more impacted than others, this project showed that all goals were interrelated and that synergies and antagonisms should be carefully evaluated before any decisions of action for mitigation are taken. It is then important to take a global and multi-angle approach. Coresta is an international association composed of 160 member organizations spread all around the world and covering a wide range of expertise; this collaborative platform offers great opportunities to create strong and long-term partnerships for addressing issues globally.
During our conferences held last October in Hamburg, Germany, and Victoria Falls, Zimbabwe, the president of the board of Coresta, Huub Vizee, confirmed that sustainability topics were nowadays one of the strategic priorities for Coresta and that new cooperations should be initiated rapidly. I am currently working hard to make this multidisciplinary cooperation a reality from 2020; everything will then be in place to develop the consensual tools needed for performance and impact assessments.
Electronic nicotine-delivery systems, increasingly used to quit smoking around the world, suffered a severe blow after an outbreak of vaping-related lung injuries in the U.S. Although it turned out that the disease was caused by illicit THC products, consumers of legitimate products have also been scared away. With its science-based approach, can Coresta help restore the products’ reputations?
The purpose of Coresta is not to defend the reputation of a certain product category, whatever the product. The purpose of Coresta is to promote cooperation, to do good science and to make it publicly available. Scientists believe that facts are more important than opinions and feelings. I believe that continuing to produce credible science and to educate people will contribute to having an environment where rational facts continue to prevail.

The U.S. also made headlines when the Food and Drug Administration (FDA) announced plans to reduce nicotine in cigarettes to “minimally addictive” levels. What impact have these plans had on the work of your organization?
Challenging regulatory perspectives automatically trigger new scientific work. Several initiatives [were] launched by Coresta when the FDA announced its intention to regulate nicotine levels in tobacco leaves.
In 2017, two task forces were created to investigate the biosynthesis of nicotine and new biotechnologies. The objectives of the first task force are to understand the genetics that control alkaloid formation in tobacco plants; to understand the feasibility of conventional and nonconventional breeding techniques to modify alkaloid formation; and to understand the impact of tobacco alkaloid levels on leaf production and quality. The second task force’s objectives are to describe and summarize publicly available literature on biotechnology and omics techniques and to prepare clear and concise definitions of nomenclature and techniques.
In addition, a new task force, the Collaborative Study of Low Nicotine Tobacco Agronomic Production Practices, was created in 2019 to determine the impact variety selection has upon nicotine levels and to determine the impact of modified cultural practices on nicotine levels.
So, yes, Coresta monitors the changing environment [and] priorities and revises rapidly its scientific program accordingly.
Heated-tobacco products are another growing category. What are Coresta’s current and future tasks in this field?
Last year, nearly 50 international scientists participated in an open forum organized by Coresta with the aim to identify scientific needs and priorities for this new product category. They came to the conclusion that a working group should be created with the objective to establish standardized terminology and definitions that encompass all categories of heated-tobacco products, to define one or more specific approaches and regimes for the generation and collection of emissions, to define and agree on priority compounds to be analyzed, and to revise or develop recommended methods. Three months after the open forum, this new working group was created and held its first meeting. Work is progressing fast now.
Coresta will hold its annual congress in Vienna from Oct. 11–15. Which topics can we expect?
The theme of the 2020 congress is “Integrated Science: Opportunities and Challenges.” Science should not be seen as a set of different domains of expertise ignoring each other. Like the United Nations’ Sustainable Development Goals, areas of expertise are interrelated. Agronomists, geneticists, physicists, chemists, toxicologists, behaviorists, clinicians … all scientists should meet and work together to develop product, social, environmental and economic science. It is a bit early to provide the details of the scientific program as it is based on the abstracts that will be submitted for oral or poster presentations. However, considering the congress theme, we can expect a rich and “integrated” scientific program demonstrating that a unified [scientific] approach is the best way to meet expectations.
Where can stakeholders access information on Coresta’s current projects?
Information on Coresta activities are published on our website, www.coresta.org. This is the first source of publicly available information as it gives access to thousands of documents. Our annual congress also offers the opportunity to network with our members, to interact with experts, to exchange more detailed information, to participate in workshops, to listen to the latest reports of the working groups and to hear a whole range of high-level scientific presentations. The congress will be held Oct. 11 to 15 in Vienna, Austria—make a note in your diaries and register as soon as possible!

Reflecting on an exciting time
Pierre-Marie Guiton, who led Coresta as secretary general from January 2010 to late 2019, takes stock of his decade with the association.
Tobacco Reporter: How do you look back on your time with Coresta?
Pierre-Marie Guitton
Pierre-Marie Guiton: It was an exciting time. Coresta has this extraordinary purpose and capacity of making an array of tremendously smart and committed people cooperatively work on issues raised by the rapidly evolving tobacco-related world for the benefit of science on a noncompetitive basis. Moreover, I have been impressed with the international and friendly spirit of Coresta.
What do you consider the greatest accomplishments of your tenure?
I am not sure about “great accomplishments,” but I am glad I brought the vape world into Coresta—or the other way around—in 2012 with a working group launched [in] early 2013. I contributed, as a speaker [at] many events, in demonstrating to more and more stakeholders that Coresta is a unique platform to develop solid analytical methods that can become international standards.
In the 2019 membership, there are now almost as many independent labs and consultants as there are tobacco and vape producers; the ratio was 50 percent in 2010. Lastly, and although not a personal accomplishment, I am also proud that Coresta was granted the Most outstanding service to the industry Golden Leaf Award in 2018.
What will be the greatest challenges for the organization in the near future?
After the vape disruption, heated products and low-nicotine tobacco will surely keep scientists very busy. Widening the scope of Coresta is also a challenge, and the growing interest worldwide in sustainability will need support from an experienced organization such as Coresta. And I know my successor is the man to handle that task. —S.R.
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, 2020
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
Hoffman Buys CM Packaging
Hoffmann Neopac, a global provider of plastic and metal packaging, has acquired CM Packaging in Dronten, Netherlands, for an undisclosed sum.
As of Jan. 1, 2020, the company intends to operate as a single entity.
Hoffmann Neopac is also investing in a three-piece can making line at CM Packaging. Andreas Geiger, former CTO of Hoffmann Neopac, will assume leadership of the metal packaging division as managing director. The overall sales team will be led by Tomas Pivko, currently the head of sales for tins at Hoffmann Neopac. The three owners of CM Packaging will remain with the company.
“The team at CM Packaging has been a tremendous partner through the years, and with them joining the Hoffmann Neopac family, we now have a production site in the EU in the metal sector and can also successfully implement our internationalization in this area,” said Mark Aegler, CEO of Hoffmann Neopac.
“The acquisition of CM Packaging by Hoffmann Neopac will combine the clear strengths of both companies and improve our position in an increasingly challenging market,” said Herbert van de Beek, sales and marketing director of CM Packaging. “It will also further strengthen our service and development power, which is a benefit to our customers.”
January 23, 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
A rhetorical gambit
The absence of long-term risk assessments does not justify stifling the development of new, potentially less harmful nicotine products.
By Clive Bates
It’s a common refrain: “We just don’t know the long-term risks of vaping.” Those who oppose the transition of the consumer nicotine market from combustible to noncombustible products will often argue, correctly, that there are no long-term studies of the safety and health impacts of vaping or heated-tobacco products. What is wrong is to assume this is a slam-dunk clincher and that the argument should end there. Let us examine this claim in more detail.
First, it is a statement of the obvious. We have not yet invented time travel and cannot venture forward to 2050 to find out what happened to life-long vapers. There will be no long-term studies until the long term has elapsed and the studies have been done. We have had about 10 years of science on vaping, and the story is positive so far, but we will not have 40 years of studies until 2050.
Second, at least for now, almost everyone who vapes or switches to a heated-tobacco product is currently or has recently been a smoker. For that reason, long-term data on vaping will be “contaminated” with health consequences of prior smoking, and this will be difficult to untangle. It will be possible to follow cohorts of those who never smoked prior to vaping, but at present, these are a small fraction of the total user population. I hope that share will grow (there should be no need to go to a safer form of nicotine via the most dangerous) but that is not something the authorities wish to encourage.
Third, some activists argue that it took years for us to discover the health risks of smoking. Smoking took off in the early 20th century, but it was not until the 1960s that the U.K. Royal College of Physicians and the U.S. Surgeon General issued their blockbuster reports on smoking and health. Surely, we should expect discoveries to emerge over decades. But this perspective ignores the march of scientific progress over the past 60 years. Today’s field of systems toxicology would be unrecognizable to the boffins of the 1950s. If cigarettes were invented today, a modern lab would need about half a day to establish the extraordinarily high risk, and that includes writing up the paper. We would not need to wait 40 years to declare that a hypothetical newly introduced cigarette would be very harmful to health.
Fourth, it is true that we do not have long-term epidemiology for vaping, but that does not mean we know nothing. There is a lot of data that helps us assess what long-term risks are likely to be. These come from chemical analysis of the vapor aerosol and measurements of toxins in the blood, saliva and urine of users of the products. We are also seeing more measurements of improving indicators of health in users who have switched from smoking to smoke-free products. The totality of what we do know is impressive, and it all points toward much lower risks over the long term.
Fifth, some analysts advocate a “precautionary approach” to address long-term but uncertain risks. This would mean some mix of prohibition, taxation, regulation and off-putting communications to deter use until someone can prove that the products are safe—or safe enough. The precautionary principle is perhaps the most shamelessly abused concept in all of policy-making (though it is a crowded field). The precautionary principle is not a free pass to ban anything with uncertain risks. It is really a sophisticated form of risk assessment that requires taking account of the consequence of both action and inaction and the consequences of being wrong. Given that smoke-free products are alternatives to smoked products, and we know beyond doubt that these are harmful, then there is every possibility that obstructing access to what looks like a much safer product will do more harm than good. In what I regard as the most important passage in its 2016 report, Nicotine without smoke: tobacco harm reduction, the Royal College of Physicians captured this challenge:
“A risk-averse, precautionary approach to e-cigarette regulation can be proposed as a means of minimizing the risk of avoidable harm, e.g., exposure to toxins in e-cigarette vapor, renormalization, gateway progression to smoking, or other real or potential risks.
However, if this approach also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer-friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking. Getting this balance right is difficult.”
Generally, the precautionary principle is most applicable where the risks are novel, systemic, irreversible and cause uncontrollable destabilization—for example, introducing new species or pathogens into an ecosystem or increasing the heat in the atmosphere. Vaping risks are not like this.
Sixth, it is often assumed that “no long-term studies” implies there are bound to be risks but we just haven’t found them yet. However, it may turn out that the risks are negligible or well within the range of voluntarily accepted risks associated with living a normal enjoyable life. It is even possible that there may be health-protective effects that go beyond ameliorating the risks of smoking. It is possible, for example, that nicotine may have protective effects against some forms of neurodegenerative disease.
Seventh, it is possible that unexpected risks will emerge. But it is likely that many plausible risks can be dealt with through regulation. For example, a recent study by Farsalinos and Lagoumintzis investigated the toxicity of flavor compounds used in e-liquids. It found that “one chemical (methyl cyclopentenolone) was found at a maximum concentration 150.7 percent higher than that needed to be classified as toxic.” There is an obvious regulatory response: Stop the use of this compound or ensure it is used only in concentrations well below the toxic threshold. This response is possible with vapor products because the vapor aerosol is more or less a heated version of the e-liquid, so controlling ingredients and contaminants in the e-liquid will also control human exposure. The same is not true for cigarette smoke. Vapor products generally operate below 300 degrees Celsius, but the temperature in the burning tip of a cigarette can exceed 900 degrees Celsius. At these higher temperatures, there is much more energy to break chemical bonds and to create thousands of new “products of combustion,” which can react with each other to create still more compounds. The combustion process of cigarettes is far more complex and chaotic than the heating process of vapor products and leaves the cigarette designer with only limited options to control toxic exposures. This is one reason why industry engineers have struggled to make a “safer cigarette.”
Eighth, a common variant on the “we just don’t know” argument is that public health was badly caught out with “light and mild” low-tar cigarettes. These appeared to be safer and even had some public health endorsements as a harm reduction approach. These products appeared to be safer only when smoked by machines with fixed smoking regimes. It turned out that real humans adjusted their smoking behavior by blocking filter ventilation holes or drawing more frequently and deeply on the cigarette. Smokers adjusted their behavior—a process known as compensation—to achieve their desired dose of nicotine. And with the nicotine, they got the exposure to toxins in the smoke and were no better off. The situation with smoke-free products is very different. Low-tar cigarettes mostly just diluted smoke with air—the ratio of toxins to nicotine barely changed. Vapor products work by dramatically reducing the ratio of toxins to nicotine in the aerosol. So for a given dose of nicotine, a vaper will receive a much lower exposure to toxins than a smoker. The “light and mild” argument is misusing an analogy that does not hold true in reality. We should not use a mistake in the understanding of light cigarettes to justify a mistake in the understanding of smoke-free products.
My concern is that the argument about the lack of long-term studies is essentially tactical: a rhetorical gambit designed to create an insurmountable evidence hurdle that will apply indefinitely. I do not believe it is a sincere attempt to grapple with inevitable uncertainties and to make the best decisions possible with the available evidence. To test the sincerity of those making this argument, I have devised what I call “the snus test.” Snus is a form of oral tobacco popular in Scandinavia. So my question is: Do you accept that the long-term evidence for snus use in Scandinavia shows it has reduced smoking prevalence and the burden of disease? If the answer is “no” and some other justification is offered, it is clear you are not dealing with a sincere truth seeker.
The theme of this year’s Global Tobacco and Nicotine Forum (GTNF) is “More choice, less risk.” The GTNF will be held Sept. 24–26, 2019, in Washington, D.C. See www.gtnf.org for more information.
Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).

September 1, 2019
Filling the void
Producing some 95 percent of the world’s vapor devices, China has at last started regulating its domestic market.
By Stefanie Rossel
It’s a curious situation: Even though it is the birthplace of the modern e-cigarette and the epicenter of vapor product manufacturing, China’s domestic e-cigarette market is miniscule. According to Euromonitor International, the value of the global vapor market increased from $3.7 billion in 2013 to $15.8 billion in 2018. Of that, China represented only $750 million last year. Insight Solutions estimates that the country produces about 95 percent of the world’s electronic cigarettes, exceeding 1.6 billion units in 2017. Of those, 90 percent are exported to the United States and Europe whereas domestic sales account only for about 5 percent.
Growth of the category has accelerated rapidly in recent years. A Market Watch report reveals that sales of vapor products in China increased from less than rmb1 billion ($142 million) to more than rmb4 billion between 2013 and 2017. Nevertheless, vapers are still an uncommon sight in China. While there is no official data, Guanyantianxia, a Beijing-based consultancy, estimates that there are currently only between 1.5 million and 2 million vapers in the country.
This compares with 300 million to 350 million smokers of combustible cigarettes—an enormous untapped potential for China’s e-cigarette industry. If only 10 percent of Chinese smokers switched to vaping, the market value would exceed $15 billion.
Due to its small size and value, the Chinese vapor market had long been overlooked by supervisory bodies, allowing it to develop in a regulatory vacuum. Access to and consumption of vapor products is hardly regulated apart from a ban of e-cigarette sales to minors issued in August 2018. There are no rules covering the production, manufacturing standards and oversight of e-cigarettes. In 2018, a joint circular published by China Tobacco, the country’s state monopoly, and the State Administration of Market Regulation (SAMR) warned that vapor products on the market varied widely in quality, and some might pose safety risks, such as liquid leakages or use of substandard batteries.
Government drafts standard
To fill the regulatory void and permit the sale of regulated e-cigarettes, China recently took a major step. On May 1, 2019, the country submitted plans for a set of e-cigarette standards to the World Trade Organization (WTO). The standard, to be finalized on a yet-to-be-determined date, is comprehensive: It specifies the levels of nicotine, the types of additives and other components allowed in battery-powered devices as well as definitions, technical requirements and test methods. The standard also covers packaging, identification, instructions, storage and transportation.
Although the standard was published by the SAMR and the Standardization Administration of China, the agency responsible for drafting and maintaining it will be the State Tobacco Monopoly Administration (STMA).
The new standard is expected to have a significant impact on the manufacturing, sale and import of e-cigarette products in China. The law firm Keller and Heckman expects Chinese authorities to release the standard later this year.
The announcement of the new standard followed another joint measure by the SAMR and the STMA. In August 2018, they announced a ban on the sale of electronic cigarettes to minors. As in the United States, teenage vaping has increased sharply in China. The ban covers both physical stores and online platforms.
Passing the renminbi
One factor contributing to the longstanding lack of regulation in China was that none of the country’s agencies were willing to take on responsibility for the new ill-defined product category. For more than a decade, China’s regulatory authorities passed the buck to each other, as detailed in a 2016 study by the University of Pennsylvania Law School.
The report cites the introduction of RuYan, one of the first e-cigarette brands, to the Chinese market in 2006. Proposals were made to assign regulatory responsibility to the State Administration for Work Safety, the State Administration for Industry and Commerce and the health ministry. China Tobacco argued that the e-cigarette should be regulated under the State Council’s dangerous chemicals regulations.
The State Food and Drug Administration was also considered as a potential regulator, but that agency argued that, due to their use for eliminating nicotine withdrawal symptoms, e-cigarettes did not fit under the regulatory framework developed for medical devices in China.
Due to policymakers’ reluctance to define e-cigarettes as medical devices, pharmaceutical or tobacco products, vapor products became ordinary consumer products in China, which is reflected in companies’ advertising and promotion efforts. Unlike their counterparts in Europe and the United States, e-cigarette manufacturers are allowed to make health claims and promote their products as lower risk alternatives to conventional cigarettes in China.
Increasing investments
In the absence of legislation and related pressure to consolidate, China’s vapor market has become highly fragmented. Insight Solutions estimates that there are nearly 4,000 e-cigarette companies in China. About 80 percent employ fewer than 50 people. China Tobacco has also joined the game. In 2014, its provincial subsidiary, Hubei Tobacco Co., launched its first e-cigarettes in Wuhan.
There are indications that the country’s competitive landscape for e-cigarettes is about to heat up. In 2018, dozens of e-cigarette startups collectively raised tens of millions of dollars in venture capital, according to Bloomberg. The growing market has also attracted players from other fields, such as electronics and software. And then there is Juul, the U.S.’ leading vapor brand, which in July 2019 was rumored to be entering the Chinese market with plans to spend more than $100 million over 15 months on branding and marketing operations. Reportedly, the company is teaming up with JD, one of China’s largest e-commerce platforms, which saw e-cigarette sales grow about 600 percent during the country’s 2019 Mid-Year Shopping Festival.
New supervisory agency
As Chinese startups strengthen their financial muscle to make inroads into the blossoming category, their products will likely take a greater share of the country’s enormous cigarette market. This may explain in part regulators’ more active stance toward e-cigarette regulation.
As the world’s largest producer of traditional cigarettes and leaf tobacco, China Tobacco provides the government with massive tax revenues. According to a Channel News Asia report, the monopoly contributed rmb1 trillion in taxes and profits in 2018, representing more than 5 percent of the central government’s revenue.
China Tobacco operates under the STMA, which in turn is part of China’s Ministry of Industry and Information Technology. China’s Tobacco Monopoly Law gives the STMA control over the production, import, export and distribution of tobacco products in China. This means the entity is regulator and market player at the same time. The tobacco industry is also a significant employer in China. More than 20 million people, including farmers and retailers, are linked to the tobacco industry. An estimated 510,000 people work directly for China Tobacco, according to the Pennsylvania Law School.
In this context, tobacco control has proven to be difficult. While China joined the World Health Organization’s (WHO) Framework Convention on Tobacco Control in 2006, it has yet to implement many of the treaty’s measures. The country has enacted indoor smoking bans in specified public places, including hotels and restaurants, but it must still pass a comprehensive tobacco control law at the national level.
To separate regulatory and commercial functions, in March 2018, China assigned responsibility for tobacco control to the newly created National Health Commission (NHC), which will also oversee the vapor industry. The advisory body is expected to put more WHO rules into effect. At a press conference in July 2019, the NHC announced “severely strengthened” supervision of electronic cigarettes.
Regional regulation enacted
While national laws are still up in the air, several Chinese cities have taken steps to regulate e-cigarettes. On Jan. 1, 2019, Hangzhou became the first city to ban vaping in public. It did so through upgraded anti-smoking legislation that formally regulates e-cigarettes as tobacco products. As a consequence, vaping is now banned on specified indoor and outdoor premises, including bars, restaurants and public transport. Violators of the ban will face fines of up to rmb20,000.
Shenzhen, Macao and Nanning have enacted similar e-cigarette bans. Hong Kong went a step further. In February, the city’s health authority proposed to ban the import, manufacture, sale, distribution and advertising of alternative smoking products altogether. Under the draft law, anyone who imports, makes, sells or promotes such products could face a hkd50,000 ($6,373) fine or six months in jail.
If passed, the bill will prohibit visitors from bringing in any reduced-risk products (RRPs). Authorities fear resale of such products and the development of a black market in Hong Kong. Dedicated boxes for the collection of visitors’ cigarette alternatives are to be placed at borders; visitors voluntarily giving up their RRPs will not be considered violating the law.
The measure reflects the city government’s intention to stifle vaping before it becomes entrenched in the former British crown colony. The bill has sparked a debate about its effects on smoking cessation efforts. In contrast to mainland China, Hong Kong already has a low smoking prevalence of 10 percent among people aged 15 and older. By 2025, the government aims to reduce this to 7.8 percent.
September 1, 2019