Author: Staff Writer

Crossing the Divide

Photo: es0lex
When scientists work for a tobacco company
By Cheryl K. Olson
Carlista Moore Conde never expected to work for Big Tobacco. A chemical engineer by training and a former NASA scholar, her career had focused on R&D for multibillion-dollar brands of household name consumer goods at Procter & Gamble.
“I spent 20 years working on products that improved people’s lives,” she told me soon after we’d met at the 2021 Global Tobacco and Nicotine Forum in London. “Now I’m working on products that can save lives.”
Carlista Moore Conde
As group head of new sciences at BAT, Conde is part of a trend among tobacco companies to hire from outside the fold—industries that often have nothing to do with nicotine, as well as academia and government—to work on reduced-harm products that lower the health risks to people who are already addicted to combustible cigarettes.
“I have family members, dear aunts and uncles, who spent a lifetime smoking and suffered the [health] consequences,” she continued. “So I never even considered working for a tobacco company, honestly. I misperceived the harm of alternative nicotine products as being the same as traditional smoking.”
Mohamadi Sarkar took a different path to working in the industry. He’d been a professor of clinical pharmacology at the Medical College of Virginia at Virginia Commonwealth University where he’d done research on smoking-related diseases. He was approached by scientists from Altria about joining them after he’d presented at a conference run by the Society for Research on Nicotine and Tobacco.
“And my first reaction was ‘Heck no!’” he said. “I was a tenured professor. Never in my wildest dreams had I thought I’d work for corporate America, let alone work for a tobacco company!” He’s now a fellow in scientific strategy at Altria Client Services. Sarkar has been at the company and its predecessors for 19 years. He maintains a faculty appointment at VCU and teaches three courses there per year.
Brian Erkkila was a neuroscientist at the National Institutes of Health before joining the then-new FDA Center for Tobacco Products in 2011. He was a lead toxicologist there for more than six years. After a three-year stint at the Foundation for a Smoke-Free World, he moved to Swedish Match in 2021, where he is director of regulatory science.
“It was certainly comforting to see how ‘all-in’ everyone I work with at Swedish Match is about tobacco harm reduction,” he said. “Looking out from inside the industry, there is a magnified sense of uncertainty concerning the regulatory environment. It’s very difficult to know what the nicotine marketplace will look like even one or two years from now.”

Looking past the cliches: While the tobacco industry engaged in questionable and even spurious research a generation or two ago, its recent approach has been quite different.
(Photo: Seventyfour)
New Scientists, Old Beliefs
Mohamadi Sarkar
A generation ago, the tobacco industry was largely an old boys’ network. Tobacco was “in your blood.” As the health effects of combustible cigarettes became apparent, many scientists from outside that industry saw joining it as a career killer.
But Big Tobacco has moved on. In response to public health findings, combined with social, regulatory, and economic pressures, it’s shifting away from combustible tobacco and focusing on alternative, less harmful nicotine-delivery systems. Still, scientists who are recruited from outside the industry often respond with healthy skepticism about whether this new focus is sincere. Conde shared that skepticism until she spoke with BAT employees who had come from outside tobacco and took a close look at the company’s operations.
“You hear stories about big bad tobacco from the past,” she added. “But what I found is that the science done here is done in a very transparent and rigorous way and is shared, even with our competitors.”
Erkkila added, “Sadly, I feel that some former colleagues will simply write me off for joining [the] industry. However, they need to understand that this is not the same industry from decades ago. FDA regulation of tobacco products has ensured that the research being done by companies is vetted and carried out in a robust manner.”
Sarkar admits that he struggled a bit with the reactions of some people at his university when he started at what was then Philip Morris USA. “Folks I knew from my past experience in academia who were my friends and colleagues started distancing themselves,” he recalled. “They were not happy with my decision to work for a tobacco company. But we do good science with the right rigor. I take great pride in the work we do.”
For Sarkar, as well as other scientists who’ve worked previously as professors, one of the strong advantages of corporate research is the consistency of funding. Another is the speed with which a novel idea can be pursued. Research grants to university laboratories often require months of detailed paperwork. The success rate of scientific research grant applications to the federal government—the largest funder of such research—is notoriously low. (In 2020, the National Cancer Institute rejected six grant applications for every grant that it funded.)
“At PMUSA, I was just amazed at the resources available to do the research, and the commitment not only to conduct the research but to publish and share it with the scientific community,” Sarkar continued. “Unfortunately while we are keen on publishing and sharing our research, some journals don’t accept industry funded research for peer-review consideration. In this situation, nobody wins—not science, not good policy, and certainly not adult smokers.”

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A Caste System for Researchers?
Brian Erkkila
There’s a paradox to the resurgence of suspicion and even outright rejection of industry-conducted science on tobacco harm reduction and alternative nicotine products. While the tobacco industry engaged in questionable and even spurious research a generation or two ago, its recent approach has been quite different.
“In this age of rampant misinformation, certain groups ignoring quality science because they don’t like the source strikes me as a hindrance to public health,” said Erkkila.
Recently, the editorial board of Nicotine & Tobacco Research, the journal published by the Society for Research on Nicotine and Tobacco, announced that “In order to continue the journal’s policy of alignment with the SRNT, which owns the Journal, N&TR will no longer allow tobacco industry (TI) employees to submit work to the journal in any format. TI employees include those individuals who work for companies owned in part or in whole by manufacturers of commercial tobacco products.”
This concern flies in the face of one of the fundamental tenets of scientific research: that it should be judged solely on its rigor not on the provenance of the researchers. That is the purpose of anonymous peer review. Preemptively excluding all research from the industry (or academia or government or pharmaceutical companies) is naive at best and will likely do harm to the public health.
All researchers who publish should cite both their affiliations and their sources of funding as well as other potential conflicts of interest. This encourages readers to employ a gimlet eye when considering conclusions and recommendations. It’s a pretty safe bet what the National Pork Producers’ Council will recommend for dinner. But does that mean I should automatically reject its nutritional analyses or its studies of African Swine Fever risk and prevention?
The new policy draws some bizarre distinctions. I’m a former academic researcher. During my career, I’ve worked on tobacco harm reduction and youth smoking prevention projects that were funded by government, nonprofits and industry. Am I a “good guy” or a “bad guy?” Is there a formula by which a certain amount of government-funded research cancels the stigma of industry-funded research, the academic equivalent of buying carbon offsets? (I’m only being slightly facetious.)
Note that the SRNT definition of “tobacco industry” does not include e-cigarette makers, except those linked to traditional tobacco product companies. (It also does not exclude consultants to tobacco companies from its conferences or journal, only industry employees.)
We run the risk that some of the “bad actors”—companies that have shown scant interest in harm reduction and youth use prevention—will have access to communications channels being denied to “good actors” that currently or have previously manufactured tobacco products. Under these rules, researchers for companies side-stepping Food and Drug Administration regulation by using synthetic nicotine could have their work considered for publication while scientists who crossed from government and academic posts to Juul (which is partially owned by Altria) would have their work summarily dismissed.
Simplistic approaches such as this may feel righteous, but they elevate form over function. We lose sight of the ultimate goal—a goal more likely to be achieved by sharing data and resources. Many scientists who have entered the industry believe that they can do more to block the dangers of combustible tobacco from the inside than from the outside.
“My moves from regulator to the Foundation and ultimately to Swedish Match have all been about reducing the public’s harms from tobacco,” said Erkkila. “Others’ view of me may have changed, but these moves have allowed me to appreciate the issue from many sides.”

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Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.

November 1, 2021
A Greene Niche

Despite its considerable profit margin, U.S. organic tobacco is likely to remain a marginal crop.
By Stefanie Rossel
Across all areas of life, sustainability has become an ever more important issue for consumers. Global sales of organic food, for example, have increased between nearly $18 billion in 2000 to $106 billion in 2019, according to Statista. Cigarettes made of organically grown tobacco, however, continue to remain a rarity. Many smokers are likely to be aware now that the combustion of tobacco leaves, a process that releases more than 7,000 chemical substances—among them more than 70 linked to cancer—makes cigarette consumption a hazardous habit regardless of whether the leaves have been cultivated in a certified organic way or conventionally. Thus, the unique selling proposition of organic cigarettes is not their comparative health risk but their lower impact on the environment.
Only a handful of tobacco companies offer organic smoking products, with Santa Fe Natural Tobacco Company being the most prominent player. According to Nielsen, the manufacturer’s American Spirit brand had a share of around 2 percent of the U.S. market in August 2021.
William Snell
“Sustainability is the buzz with most companies today, including tobacco companies, but, at this point, I just don’t see organic tobacco capturing much of the market,” says William Snell, professor of agricultural economics at the University of Kentucky. “Keep in mind, even with the massive escalation of organics in our food markets, they still only comprise around 6 percent of today’s [U.S.] food market.”
That organic tobacco will likely remain a niche is also reflected by the amount of U.S. farmland dedicated to that crop.
“Demand for organic tobacco seems to have peaked, if we are basing it off of current acreage in the U.S. Data are limited, but we know that the bulk of organic flue-cured tobacco is produced in North Carolina, and our state’s organic-certified tobacco acreage has not increased since around 2017,” says David Suchoff, alternative crops Extension specialist and assistant professor at North Carolina State University. “Compared to conventional tobacco, certified organic tobacco still represents a very small percentage of the total crop produced. However, the general increase in North Carolina’s certified organic acreage can be attributed to tobacco as it tends to result in higher profit margins than many other organic field crops, making the transition from conventional to organic easier on the farmer.”

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Decreasing Production
According to the U.S. Department of Agriculture (USDA) National Agriculture Statistics Services, 181 farms cultivated 13.08 million pounds of organic tobacco in 2019, representing a value of $39.13 million. This compares to 467.96 million pounds of conventional leaf. With 18.62 million pounds, organic tobacco production was higher in 2018 but so was the conventional leaf crop, which stood at 628.72 million pounds in 2016. Of the 2019 U.S. organic tobacco crop, the majority was flue-cured Virginia. In 2019, 6.04 million pounds came from North Carolina and 2.28 million pounds from Virginia. Kentucky grew 1.14 million pounds of organic burley that year.
In the first part of the last decade, Kentucky witnessed a rapid rise in interest in organic burley, followed by a steep drop, according to Robert C. Pearce, Extension professor at the College of Agriculture, Food and Environment at the University of Kentucky. “I assume [that happened] because they built an inventory of organic leaf that was not used as quickly as anticipated,” he says. “I only know of a handful of growers in Kentucky still cultivating organic burley. I don’t anticipate much increasing demand for organic burley. Burley tobacco is used in smokable products to absorb flavoring components. Since many natural/organic tobacco products do not utilize flavorings, burley is not needed in large amounts.”
In North Carolina, production of organic leaf has almost halved from 11.91 million pounds in 2016. The future of the segment is difficult to predict, says Matthew Vann, associate professor and Extension tobacco agronomist at North Carolina State University. “Obviously, we have the capacity to produce more organic leaf, but this is all dictated by the market. We do not foresee the organic leaf production to drop considerably, but we also do not expect demand to skyrocket. We do see opportunities for commercial farmers with serious interest in producing this style of tobacco, and we also want to make growers aware that organic production must be taken seriously due to the stringent regulations in place by the USDA National Organic Program and the standards outlined by leaf purchasers.”

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Greater Efforts, Higher Profits
Matthew Vann
For farmers, the higher profits associated with organic tobacco tend to be the major motivator for cultivating such crops. “Many of our farmers have organic certified land and conventional land based on the crops they grow and the economics of producing one crop organically versus the other,” says Vann. Pearce observes that for some farmers, it is a lifestyle choice: “There are some that have tried to do both, but those who are most successful are full-time organic producers for their entire operation. In order to be successful, a grower must have sufficient land area in organic rotation to be able to rotate their crops. Growers must understand that organic production is a system-wide commitment.”
In any case, going organic is one way to keep charging premium prices. While cultivating organically costs more and yields a slightly less marketable product, farmers are able to make up for more than the difference—their organic tobacco will command double the price of the conventionally grown, chemical-laden variety.
Extension experts stress that organic is not to be conflated with sustainability. “Just because a farmer is organic does not necessarily mean that their system is sustainable, and, conversely, just because a farmer uses conventional practices does not imply that their system is not sustainable,” Suchoff points out. “We want to make that distinction, as we are working very hard to ensure the sustainability of both production systems. While organic growers can improve the health of soils and local environments through the practices they employ, the same can be said for conventional farmers, thus we do not make any blanket statements about organic being better for the environment.”
To become a certified organic tobacco farmer, the farm or business needs to adopt organic practices and apply to a USDA-accredited certifying agent. An inspector conducts an on-site inspection of the applicant’s operation; the certifying agent reviews the application and the inspector’s report to determine if the applicant complies with the USDA organic regulations. If the application meets the required standards, the farmer will receive an organic certificate. To maintain certification, the farm or business must submit to an annual review and inspection. Certification costs may range from a few hundred to several thousand dollars.

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More Challenges
When committing themselves to growing organic tobacco, farmers restrict themselves in the use of fertilizers, herbicides and pesticides, which can be a challenge for the cultivation of a crop as complex and susceptible to pests as tobacco. “Typical pests are a problem for organic growers—weeds, insects, diseases, etc.,” says Pearce. “Typically, organic growers wind up substituting extra labor and tillage for herbicide to control weeds and use cultural practices to assist with insect and disease control. There are two areas that we have found to be particularly challenging for organic tobacco production. One is growing the transplants in a float system. Getting the appropriate balance of nutrients with only water-soluble organic fertilizers has been difficult. The other challenge has been controlling suckers after topping. There is one organically approved fatty alcohol for sucker control, but its approval has had several challenges along the way.”
In managing common pests, farmers can choose from a number of Organic Materials Review Institute (OMRI)-certified products. “One of the biggest challenges organic tobacco farmers face is weed management,” says Suchoff. “While there are a few OMRI-certified herbicides, these products are very expensive, require multiple applications, are generally not very efficacious, would require precision application to prevent injury to tobacco and aren’t approved for use by buyers of organic leaf. Consequently, organic tobacco farmers are left with only routine field cultivation and hand removal to manage weeds. Producers sometimes struggle with disease management. We are fortunate that most approved varieties have good or excellent resistance to black shank and/or Granville wilt, but there’s no host resistance to target spot or tomato spotted wilt virus. Management for these diseases (and a few others) relies heavily upon cultural practices, such as transplanting date, avoiding areas of a field with a known history of certain diseases and even harvest timing, for example. Another issue organic tobacco farmers face is determining which crops should be placed in rotation with tobacco.”
The goal of his university’s Extension program, he says, is to conduct applied field research to answer their farmers’ questions and address any production issues they have in an organic system. “For example, we continue to look at organic crops such as sweet potato, hemp, sunflowers and other grains that may fit within an organic tobacco rotation. Additionally, we have conducted work looking into alternative weed management strategies that promote soil health. From this research, we develop grower recommendations to share with county extension agents, farmers and the industry as a whole through field day events, publications and online posts. Ultimately, our Extension programs are designed to address real-world problems through basic and applied research.”
The University of Kentucky’s Extension program supports growers of organic tobacco mostly on a case-by-case basis, explains Pearce. “We have so few organic growers that most just come to us with questions. During the organic ‘boom’ of a few years ago, we did several trials on float system fertilization to help answer grower questions.”
Although the future of the segment remains unclear, Vann believes that the emergence
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.

November 1, 2021
Stepping Up

Tim Liddicoat
(Photo: Hall Analytical)
Hall Analytical is investing in reduced-risk product analysis to meet growing demand driven by innovations and regulatory requirements.
By George Gay
Hall Analytical’s sponsorship of the recent GTNF in London represented the company’s first participation in this annual conference, and Tobacco Reporter was keen to discover why it had decided to take part this year. Did its participation represent, for instance, a vote of confidence in the future of the nicotine industry?
Given the chance of an email exchange with managing director Tim Liddicoat, Tobacco Reporter started off by asking whether he believed Hall Analytical’s nicotine industry business would increase or decrease in the future.
Tim Liddicoat: We are convinced that our nicotine industry business will significantly increase in the next five years. With our investment in reduced-risk product analysis at Hall Analytical, we believe that client requirements for our analytical expertise will substantially increase in the next several years. The recent report in Research and Markets predicts the global ENDS [electronic nicotine-delivery systems] market to reach $84.43 billion in 2025, and we have the infrastructure and expertise to service this market with high-quality scientific data.
Tobacco Reporter: Why this optimism? Do you believe the nicotine industry regulatory environment will become more demanding in the future?
As the burden of proof required to prove APPH [appropriate for the protection of public health] increases incrementally in the U.S. and as European legislation develops, along with the need to support new innovations in the space, we see the analytical testing requirements becoming more demanding. This drives us to develop even more sensitive, precise, accurate and robust analytical methods.
In addition, as regulatory frameworks continue to be strengthened in established markets around the world and client demand for high-quality product characterization, emission analysis, stability and E&L [extractable and leachable] studies will only increase. The recent publication of the U.S. FDA’s final rule for the PMTA [premarket tobacco product application] pathway has established the minimum data requirements for a deemed tobacco product to enter substantive review. This certainty has been welcomed by the RRP [reduced-risk product] sector, enabling product regulatory compliance strategies to be reviewed and re-engaged. The published final rule, and limited market authorizations of tobacco-flavored ENDS to date, strongly suggest the agency’s burden of proof to demonstrate APPH is substantial. The European TPD [Tobacco Products Directive] regulatory review is imminent, and there’s every indication that a tightening of regulation around flavored ENDS products is favored by the majority of member states. This will potentially increase the requirements for analytical services from our European TPD clients.
Client requirement for our services will not only be fueled by regulatory compliance but rapid innovation in product technology with safety and user experience at the heart of new product development.
ENDS clients are also looking to emerging markets for growth, with national regulators examining established markets for guidance on appropriate regulatory frameworks. Tobacco companies traditionally focused on combustible cigarettes are rapidly diversifying their product portfolios toward reduced-risk alternatives for a sustainable business future. Growth in global markets for the next generation of nicotine-containing products will progress rapidly, and our ability to respond to clients’ needs will enable Hall Analytical to attract new business servicing the RRP sector.

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Who owns Hall Analytical?
Hall Analytical is owned by Element Material Technology, a leading global provider of testing, inspection and certification services on a wide range of products, materials, processes and services for a diverse set of end markets, where failure in service is simply not an option.
Headquartered in London, U.K., Element’s scientists, engineers and technologists, working in its global network of over 200 laboratories, support customers from early R&D, through complex regulatory approvals and into production ensuring that their products, materials, processes and services are safe, compliant and fit for purpose.
Is ownership about to change?
Hall Analytical was acquired (along with VR Analytical, Crawford Scientific, Anatune and APEX Scientific) in July 2021, and ownership is not about to change again.
What, in layman’s terms, are the main methods you use and the main pieces of equipment you use, especially in respect of testing e-cigarette and heat-not-burn products and vapors?
When testing ENDS products, we focus on the analysis (testing) of the e-liquid and resultant vapor emissions, which are inhaled by the user. E-liquid testing can be more straightforward than analyzing ENDS vapor. The e-liquid samples received from clients are prepared in the laboratory and tested using analytical instruments, which employ either liquid chromatography (LC) or gas chromatography (GC) to separate the complex mixture of chemicals. The LC or GC is connected to a detector, such as a mass spectrometer, which can detect, identify and accurately quantify trace levels of chemical compounds. To unequivocally quantify trace chemicals in complex e-liquids and vapor emissions, we use tandem mass spectrometry for extremely sensitive and specific chemical detection. Trace metal quantities in e-liquid and vapor emissions are determined using a technique called inductively coupled plasma mass spectrometry.
For vapor emission analysis of both ENDS and heated-tobacco products (HTPs), we employ the same analytical instruments but need to generate vapor emissions from the test devices in a standardized procedure. To do this, we use an automated e-cigarette/HTP vaping machine specifically designed to be compliant with international testing standards. The test device emissions are generated by the machine, collected, prepared in the laboratory and then analyzed by the techniques previously discussed.
You mention above quantifying “trace chemicals in complex e-liquids.” How would you explain to a layman what complex trace analytical chemistry is?
Many chemicals can be found in complex mixtures at very low “trace” concentrations in different matrices, such as pharmaceutical products, environmental samples, physiological samples (blood, urine, etc.) and e-liquids used in e-cigarettes. Most of these trace chemicals were not detectable for many years due to limitations in analytical instruments and methods. With modern advances in instrumentation and techniques, laboratories can detect and precisely determine the amount of trace chemical present in a complex test sample.
What are the main services you offer, apart from those already mentioned?
Hall Analytical delivers industry-leading scientific expertise that supports our customers’ ability to ensure product safety. We do this in support of a number of industries: tobacco (to support both product development and regulatory submission for reduced-risk products) and pharmaceutical and medical device supply chain and manufacturers. Our main services are in support of chemical analysis of RRPs and E&L testing for all aforementioned industries.
Do you offer any services in respect of traditional tobacco products?
We have recently moved into analytical testing of HTPs but currently do not analyze traditional tobacco products.
Where is your company based?
Hall Analytical is based at a 25,000-square-foot facility in Wythenshawe, Manchester, [U.K.]. This is the only Hall site, but the wider Element organization has a global network of over 200 laboratories, some of which support reduced-risk product testing similar to that carried out at Hall Analytical.
How many people work for Hall Analytical?
Hall Analytical currently has 50 staff. There are about 200 people in the wider Element Life Sciences EMEAA [Europe, Middle East and Africa] organization split over five companies (Hall Analytical, VR Analytical, Crawford Scientific, Anatune and APEX Scientific), with the Element Material Technology business working in a global network of over 200 laboratories.
Are they mainly chemists and technicians?
Hall Analytical employees are split between the operational team, quality, science (study direction, R&D and subject matter experts, E&L specialists), commercial and supporting functions (project management, HR, HSE [health and safety], admin and IT) with the majority directly supporting our customers by delivering industry-leading scientific expertise that supports our customers’ ability to ensure product safety.
In which countries are your main customers based?
Our customer base is primarily European and North America[n], but we have customers based worldwide. Many customers are large multinational organizations, and we have supported them from Australia to South America and beyond.

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Which industries provide the bulk of your business?
Tobacco companies, pharmaceutical companies, medical device organizations and their supply chain partners make up the bulk of our business.
You expressed confidence earlier, so would it be fair to say that your business is growing?
We have a strong business that is well placed for future support of all of our customers. We fully expect the business to sustainably grow in the coming years and to further expand its services and offerings in tobacco RRPs, pharmaceutical E&L and medical device E&L. We see fantastic opportunities with our acquisition by Element and will continue to work in partnership with our customers to meet their needs as their businesses develop.
Does this mean you invest significantly in the business?
In recent years, we have been well supported with significant investment in infrastructure (£2 million), instrumentation and data systems (£1 million), business leadership and our quality management system to reflect changing customer needs and maintain our commitment to state-of-the-art, high-quality analytical services.
Has your business been affected by Brexit and, if so, how?
The only impact we have had from Brexit has been with supply of chemicals from the EU. With changing REACH [Registration, Evaluation, Authorization and Restriction of Chemicals] regulations, it has become more difficult to predict which reagents and standards will be available, but we have mitigated well with increased stock of hard-to-get chemicals.
Has your business been affected by the Covid-19 pandemic and, if so, how?
Covid has impacted our business in ways that we would not have predicted. On the one hand, we saw a slowdown in the responsiveness of the FMCG [fast-moving consumer goods] markets we serve due to the restrictions of working on-site for many of our customers, but, in contrast, supporting vaccine development, ventilator production and a general acceleration of pharmaceutical and medical device projects accelerated.
Operationally, we flexed well to a hybrid work model where some activities could be done remotely, and there was little impact. We also moved facility at this time, and this was delayed a little.
George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.

November 1, 2021
Flooding the Market

Photo: Lezinav
The U.K. vaping industry sounds the alarm over noncompliant products.
By George Gay
Earlier this year, the U.K. Vaping Industry Association (UKVIA) called for “tough action against resellers of noncompliant disposable vape products,” which were said to be on sale widely across the U.K. and online. Indeed, a UKVIA investigation was said to have found that “illegal and counterfeit products” were “flooding into the market,” posing “a potential health risk to customers.” Inappropriately branded products were being purposely marketed toward children, the release said.
The situation is clearly concerning, but care needs to be taken here because it could be lethally counterproductive if reports about the need to combat the problems caused by the arrival of noncompliant disposable vapes were seized upon and used by those opposed generally to the use of vapor products as harm reduction tools proven to help smokers switch from traditional cigarettes to e-cigarettes. It is important to note that there is nothing inherently wrong with the harm reduction credentials of disposable vape products, given that they are registered with the relevant authorities. In fact, such products can act as a handy entry point for those smokers who have yet to make up their minds about the switch to vaping because disposables do not require a significant capital outlay and they are, relative to traditional cigarettes, inexpensive.
But while this is all well and good when it comes to licit products, things start to fall apart when unregistered products become available, though even here it is not necessarily the case that an illicit product will be more risky or less effective than other products. The problem arises because it is not known under what conditions illicit products have been manufactured and because of the way that such products distort the market. In the eyes of consumers who buy unregistered disposables unwittingly, these products do reputational damage to the legitimate industry and the whole concept of harm reduction if they underperform. And the very existence of unregistered disposables causes reputational damage to the legitimate industry in the eyes of society at large.
Add to this the fact that under-enforcing regulations on a strictly regulated market, as is currently happening, puts the suppliers of licit products at a disadvantage to the suppliers of illicit products in respect of such matters as costs and speed to market. To place a vape product on the U.K.’s market, a company is required to have that product tested by independent, qualified companies in respect of requirements laid down by the Medicines and Healthcare Products Regulatory Agency (MHRA). It has to submit a registration application complete with the results of the required tests to the MHRA, which then has up to six months to approve the application, request more information or reject the application—a service for which it charges a fee. No product may be placed on the market until it has been approved and that approval has appeared on the MHRA’s website.

John Dunne
Facilitating Enforcement
It is hardly surprising then that, while the industry welcomes robust, appropriate regulation, it can lead to frustration when a parallel, nonregulated market opens up and grows, as has happened and is happening in the U.K. While the UKVIA can and does monitor the market and call out where illicit products are on sale, it cannot enforce the regulations. And this is why John Dunne, the UKVIA’s director general, said in the press note that his organization was “calling upon regulators and the online marketplaces to robustly enforce current regulations and do much more in order to ‘clean up’ the disposable vapes market.”
At this point, a question arises, and I asked Dunne during a telephone conversation why the regulations were not being enforced robustly. The reality, he said, was that Trading Standards, which is responsible for ensuring businesses are compliant with regulations governing the sale of vape devices and e-liquids, was under-resourced. This is a common problem in austerity in the U.K. and is unlikely to go away given the current government’s policies, so I asked Dunne whether there were ways in which the UKVIA could help ameliorate the situation. “We are trying to work out some creative ways in which, as an industry, we could help,” he said. The industry was considering the provision of funds for further enforcement if resources comprised the issue. And it had offered to provide training to enforcement officers if product knowledge was the issue.
Dunne added that the UKVIA had recently published a one-page comprehensive guidance on the compliant retailing of disposable vape products in the U.K. And one idea that was in the pipeline was the provision by the UKVIA of one-page documents that include the images and information necessary for Trading Standards officers to easily tell a counterfeit product from a legitimate one, at least in respect of high-profile brands.

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Unfair Competition
One problem is that such initiatives take time to implement, especially given that Trading Standards offices operate independently in the various counties and countries that make up the U.K., and, in the interim, those interested in scamming the system have a relatively free hand.
Another important question that arises concerns the ways in which products appearing on the market are noncompliant: Why haven’t they been registered with the MHRA? There are two basic answers to this question. One is that while the product in question conforms to U.K. regulations, its supplier has not, for whatever reason, put the product through the registration process or because the process has not been completed and the supplier has jumped the gun.
The other answer as to why a product does not conform with the regulations is obviously more problematic. In some cases, it might be an e-liquid’s nicotine strength that makes its sale on the U.K. market illegal. Dunne said that some of the illicit products that had been identified had nicotine strengths two-and-a-half times the maximum allowed in the U.K. and were clearly marked “For sale in the U.S. only.” In the case of others, it was the tank size that broke U.K. market regulations, something that could be determined from the number of puffs that the device was credited with delivering. Yet other products were noncompliant because of failure to meet packaging requirements, which, as is spelled out in the guidance document issued by the UKVIA, are extensive.
On the positive side, Dunne said that none of the e-liquids in the illicit disposables the UKVIA had tested contained any substances that raised concerns, and while some e-liquids were of a higher strength than was permitted, those strengths were as indicated on the packaging.
Nearly all of the noncompliant products originate in China, but then so do nearly all of the compliant products, a geographical monopoly that has at least one advantage. When factories producing counterfeit products are located in China, the authorities act quickly to close them down. There is, after all, no reason to suffer reputational damage as a harborer of counterfeiters when you can sell the genuine product just as easily.

One of the ways in which consumers can take to protect themselves against illicit products, according to the UKVIA, by consistently buying from a reputable source.
(Photo: VPZ)
Know Your Source
What, for people such as me, is particularly galling about the arrival on the U.K. market by air and by sea of a growing number of illicit vaping products is the fact that this is happening at a time when so many other products are in short supply due, we are told, to Brexit, the Covid-19 pandemic, the Suez snafu and a lack of lorry drivers—when water companies are unable to access all the chemicals they need for treating sewage.
But while illicit disposables arrive with near-impunity, once in the country, it should be another matter. Dunne said it should be possible to identify how counterfeit products were getting through the distribution system because all the manufacturers were supposed to be able to track their products from manufacture through to the consumer. So if they were doing things correctly, it should be possible to take a picture of a pack code and send it to the apparent factory of manufacture for verification or not. That is the theory. In reality, the system is so far not operating fully, so there is room for improvement.
In any case, while the information garnered from such systems can be used to good effect in examining the workings of distribution channels and, in retrospect it has to be said, tighten them up, they do little directly for the consumer. For a consumer to discover, post-purchase, that a product is a fake or not registered merely leaves her in the position of having to decide whether she takes the unknown risk of consuming the product or takes the financial hit of throwing it away. It takes only a few seconds’ thought to realize that this situation is not in the interests of consumers or the industry.
There are, however, some basic precautions that consumers can take to protect themselves. “The advice I always give is that you should buy from a reputable source,” said Dunne. “You buy from your local vape store whose business it is. They know these devices; they know where they come from. And for the most part, they sell only products that are registered correctly or that come from a known supplier.”
Even so, vapers can be misled, especially, for instance, when they buy online. Dunne said he had contacted a number of platforms, including eBay and Amazon, neither of which, to his way of thinking, controlled the vape products displayed on their websites robustly enough. Amazon claimed it didn’t sell any products that contained nicotine, he said, but during the morning of the day I spoke to him, he had quickly identified 10 different high-capacity vape devices on offer on the platform, all of which contained nicotine. Some of them were displayed under a headline that indicated “No nicotine,” yet nicotine strengths could be seen on the pictures of the products. “So,” he said, “my question to Amazon is: How are you policing the products that are being put on your site? Some of these devices are not sold nicotine-free anywhere in the world.”
Finally, picking up on a part of the press note in which it was said that disposables had a major role to play in the vape market, I asked whether it wasn’t the case that they also comprised a potential environmental problem. Dunne readily admitted that this was a concern for the industry. “And that is one of the reasons why the association as well as several manufacturers are looking at how these products can be recycled,” he said. “If we can find recyclers here in the U.K. that can deal with volume, there is an appetite within the industry to set up some sort of pick-up and recycle program.”

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George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.

November 1, 2021
TMA Announces Virtual Annual Conference
TMA will hold a virtual annual conference on Nov. 16-17, TMA 2021: From Chance to Change. As the industry has been challenged in many ways this year, TMA believes it is important to share insights among all stakeholders to equip its audience and members with the understanding and information necessary to successfully navigate the changes that lie ahead. TMA 2021 will feature two half-day interactive virtual sessions with keynotes from regulatory leaders and panel discussions from industry and stakeholder thought leaders that covers everything from Food and Drug Administration policy, marketing denial orders, product authorization pathways (PMTA, SE, MRTP, exemptions) and global trends that may surface in the U.S. and vice-versa.
“For this year’s TMA Annual Conference, we felt it was important to capitalize on the breadth and depth of speakers and expertise that only TMA can bring and condense that into the most important topics for our attendees who have also spent the last 24 months living virtually. We are very proud of our lineup for TMA 2021 and the information that it brings to the people doing the work on the front lines. You simply cannot get this anywhere else but from TMA,” said TMA President and CEO Chris Greer.
The program includes live keynote presentations with Q&As by FDA CTP Director Mitch Zeller and CTP Office of Science Director Matt Holman followed by these panel discussions:
An Applicant’s Perspective: Reflections on Where We Stand – Moderated by Jim Solyst, industry consultant
The Marketplace Perspective: Adjusting to Change – Moderated by Mary Szarmach, Smoker Friendly
Early and Often: Navigating Your Path to Market – Moderated by Jennifer Smith, Altria Client Services
Connecting U.S. and Global Trends – Moderated by Jeannie Cameron, JCIC International Consultants
“2021 was another challenging year for in-person events; following feedback from our members and guests, TMA elected to hold our annual conference virtually and will host our annual meeting and conference in 2022 as an in-person and virtual event,” said Greer.
For this year’s TMA Annual Conference, we felt it was important to capitalize on the breadth and depth of speakers and expertise that only TMA can bring and condense that into the most important topics for our attendees who have also spent the last 24 months living virtually.
Chris Greer, president and CEO, TMA
TMA 2020 | Digital was TMA’s first virtual only event and featured an expansive program of hour-long discussions and keynotes spread over several months. TMA 2021 takes the best of that format along with a super-charged program aimed directly at those most active in the industry and stakeholder community.
Registration will open on or about Nov. 1 and run up through the conference commencement. Registered attendees will have the ability to view content for 30 days following the end of TMA 2021 and TMA members will have access for longer still. Registration is $299 for non-members and $199 for TMA members.
For more information, please see tma.org or send inquiries to tma@tma.org.
October 29, 2021
Voopoo Launches Drag Nano2

Photo: Voopoo
Voopoo has launched its new Drag Nano2 internationally.
The product features a striking design and multiple advanced technologies, such as three gears of output and top e-juice filling.
“The Drag Nano 2 is not only the flagship product of Voopoo in the pod category but is also the strategic product of the company for this year, with a leap forward in performance from previous similar products,” said Voopoo CEO Everest, who goes by only one English name, in a statement.
Infinite airflow and adjustable power technologies were originally exclusive to mod products, but after multiple trials Voopoo researchers have successfully applied it to the Nano 2.
Founded in 2017, Voopoo has rapidly grown and is now selling worldwide. Integrating R&D, design, production and brand operations, the company has four flagship products: Drag, Vinci, Argus and V Series.
October 29, 2021
England Paves Way for E-Cig Prescriptions

Photo: goodmanphoto
Doctors in England may soon be prescribing e-cigarettes to help people stop smoking tobacco, according to a news story published by the Department of Health Social Care and the Office for Health Improvement and Disparities. The Medicines and Healthcare products Regulatory Agency (MHRA) is publishing updated guidance that paves the way for medicinally licensed e-cigarette products to be prescribed for smoking cessation.
Manufacturers can approach the MHRA to submit their products to go through the same regulatory approvals process as other medicines available on the health service.
This could mean England becomes the first country in the world to prescribe e-cigarettes licensed as a medical product.
If a product receives MHRA approval, clinicians could then decide on a case-by-case basis whether it would be appropriate to prescribe an e-cigarette to NHS patients to help them quit smoking. It remains the case that non-smokers and children are strongly advised against using e-cigarettes.

This country continues to be a global leader on healthcare, whether it’s our Covid-19 vaccine rollout saving lives or our innovative public health measures reducing people’s risk of serious illness.
Sajid Javid, Health and Social Care Secretary
If a product receives MHRA approval, clinicians could then decide on a case-by-case basis whether it would be appropriate to prescribe an e-cigarette to NHS patients to help them quit smoking. It remains the case that non-smokers and children are strongly advised against using e-cigarettes.
E-cigarettes contain nicotine and are not risk free, but expert reviews from the U.K. and U.S. have been clear that the regulated e-cigarettes are less harmful than smoking. A medicinally licensed e-cigarette would have to pass even more rigorous safety checks.
Smoking remains the leading preventable cause of premature death and while rates are at record low levels in the U.K., there are still around 6.1 million smokers in England. There are also stark differences in rates across the country, with smoking rates in Blackpool (23.4 percent) and Kingston upon Hull (22.2 percent) poles apart from rates in wealthier areas such as Richmond upon Thames (8 percent).
E-cigarettes were the most popular aid used by smokers trying to quit in England in 2020, according to the Department of Health and Social Care. E-cigarettes have been shown to be highly effective in supporting those trying to quit, with 27.2 percent of smokers using them compared with 18.2 percent using nicotine replacement therapy products such as patches and gum.
Some of the highest success rates of those trying to quit smoking are among people using an e-cigarette to kick their addiction alongside local Stop Smoking services, with up to 68 percent successfully quitting in 2020 -2021.

We fully welcome the news that the NHS in England is exploring opportunities to prescribe vaping products to help people quit smoking.
Doug Mutter, director, VPZ
“This country continues to be a global leader on healthcare, whether it’s our Covid-19 vaccine rollout saving lives or our innovative public health measures reducing people’s risk of serious illness,” said Health and Social Care Secretary Sajid Javid.
“Opening the door to a licensed e-cigarette prescribed on the NHS has the potential to tackle the stark disparities in smoking rates across the country, helping people stop smoking wherever they live and whatever their background.”
Vapor industry representative welcomed the prospect of e-cigarettes on prescription.
“We fully welcome the news that the NHS in England is exploring opportunities to prescribe vaping products to help people quit smoking,” said Doug Mutter, director of VPZ, the U.K.’s largest vaping retailer with 157 stores throughout the country.
“The pandemic has triggered an increase in smoking rates and the public health problem has been compounded by funding cuts for NHS stop smoking services and local support groups.
“However this progressive and innovative approach being considered by the NHS in England has the potential to reverse this damage and bring new momentum to our ambitions of becoming a smoke free nation by 2030.”

The government deserves huge praise for taking this bold decision to look more closely at the use of vaping when it comes to smoking cessation and for taking an evidence-based, science-led approach.
John Dunne, director-general, UKVIA
“The government deserves huge praise for taking this bold decision to look more closely at the use of vaping when it comes to smoking cessation and for taking an evidence-based, science-led approach rather than the nonsensical anti-vaping, anti-harm reduction stance of some countries,” said John Dunne, Director General of the U.K. Vaping Industry Association.
“This announcement by the Department for Health is just the latest in a long line of breakthroughs for those of us who for years have advocated vaping as the best and most effective method for people looking to quit smoking.”
October 29, 2021
India Slashes Penalty for Overproduction

Photo: Tobacco Reporter archive
India’s Ministry of Commerce and Industry has cut the penalty on “excess” tobacco produced during the 2021-2022 cropping season by 50 percent to help growers compete on the world market, reports The Hindu.
To prevent overproduction, Indian regulators set a crop size target prior to each production season. Growers who exceed the authorized volume must pay a penalty.
Following the penalty reduction, authorized growers must pay INR1 ($0.01) per kg and 5 percent of the value of their excess production during the 2021-22 cropping season. However, unregistered growers have to pay the old rates.
Tobacco growers welcomed the decision. “We can confidently raise the crop without fearing the penalty to achieve the economies of scale,” said B. Ramaanjaneyulu.
The Tobacco Board authorized production on 27,818 hectares in the Southern Light Soils region and 22,014 hectares in the Southern Black Soils region of Andhra Pradesh.
October 29, 2021
JT Group ups Forecast on Robust Nine Months

Masamichi Terabatake
(Photo: JT Group)
The JT Group reported year-to-date revenue of ¥1.77 trillion ($15.5 billion), up 10.9 percent over those in the first nine months of 2020. Adjusted operating profit at constant currency increased 21.9 percent to ¥538.1 billion. On a reported basis, adjusted operating profit increased 23 percent to ¥542.9 billion. The group’s operating profit was ¥480.7 billion, up 23.2 percent over last year’s period. Based on its performance, the JT Group increased its financial forecasts for the full year.
“The JT Group reported a robust year-to-date performance, driven by strong momentum across the tobacco businesses. Our volume performance continued to be strong, driven by market share increases and stable industry volumes from longer than expected travel restrictions,” said JT Group President and CEO Masamichi Terabatake in a statement.
“We revised our full year forecasts upward, reflecting the robust results delivered in the first nine months of 2021 and also favorable currency trends. Following the upward revisions of our forecast, we are pleased to inform our plan to raise our annual dividend guidance by ¥10 to ¥140 per share.
“In Japan, we have received very encouraging feedback from consumers on Ploom X. However, the global semi-conductor shortage is impacting production of heated tobacco devices, so for the remainder of the year, we will prioritize the device supply in the Japanese market where we have already launched Ploom X. We will continue to strive to secure share growth.
“In addition, with our one tobacco business new operating model from January 2022, we will further strengthen our business foundation as well as build a more agile and consumer-centric organization.”
October 29, 2021
Farmers Rally Against Contracting Plan

Photo: Tobacco Reporter archive
A plan to introduce tobacco contract farming has run into fierce opposition among leaf growers in India, reports The Times of India. During a massive gathering in Guntur on the occasion World Tobacco Growers’ Day, farmers demanded that the central government abandon its proposals, saying that contracting would put growers at risk of exploitation.
“It’s going to have a disastrous effect on the livelihood of millions of growers,” predicted Gadde Seshagiri Rao, former vice president of the Tobacco Board.
Virginia tobacco farmers association president Karatam Venkata said the existing auction system works well because it provides growers with assured payment though the Tobacco Board while contract farming results in delayed payments. In contract farming, he added, farmers’ livelihoods would be at the mercy of traders.
Growers also praised the fairness and transparency of the auction system, which they said provided greater market stability than contracting. The tobacco farmers were particularly incensed that the government had made its proposal without consulting them.
Contract farming has been gaining momentum globally at the expense of auction sales as leaf traders faced with ever-stricter compliance requirements seek greater control over the production process.
October 29, 2021