Category: Print Edition

Great Expectations

Photo: ktsdesign
Brexit has given the United Kingdom freedom to expand its progressive tobacco harm reduction approach.
By Stefanie Rossel
Ever since the Royal College of Physicians (RCP) recognized the case for tobacco harm reduction (THR) in a 2007 report and Public Health England concluded that e-cigarettes were at least 95 percent less harmful than combustible cigarettes in 2015, the United Kingdom has been a forerunner in including reduced-risk products in its tobacco control strategy. The country’s 2017 Tobacco Control Plan (TCP), published by the department of health, stresses the importance of innovation and less harmful alternatives. Most anti-smoking and public health organizations as well as medical institutions in the U.K. support vape products as a reduced-risk alternative to cigarettes.
Data prove that the country is heading in the right direction: Smoking prevalence is at a record low level, down from around 20 percent in 2011 to between 13.8 percent and 16 percent now, depending on the survey, according to the U.K. government. This equates to 6 million to 7 million smokers. On the other hand, the number of vapers has steadily increased, from 700,000 in 2012 to 3.6 million users in 2021, The Guardian writes. In 2020, the newspaper says, e-cigarettes were the most popular smoking cessation aid.
Despite this obvious success story, the U.K. still has a long way to go to meet its goal of becoming smoke-free by 2030, which, according to the World Health Organization definition, means that less than 5 percent of the population smokes. Brexit has provided the country with the opportunity to shape comprehensive, proactive and progressive THR policy—the U.K. will no longer have to comply with the European Union’s Tobacco Products Directive (TPD), which, critics claim, contains several provisions hindering tobacco harm reduction.
Following its departure from the common market, the U.K. has been reviewing its Tobacco and Related Products Regulations, which represent the transposition of the 2014 TPD, the 2003 Tobacco Advertising Directive and the 2011 Tobacco Excise Directive rules into the U.K.’s national law. The review, required to take place five years after implementation, coincides with the four-year interval stipulated for review of the TCP, a new version of which is scheduled for introduction by the end of this year.

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Expectations among stakeholders are high, as the TCP stated in 2017 that the government would consider whether the “current regulatory framework strikes the right balance and whether there is more we can do to help people to stop smoking.” In the past months, internationally respected academic institutions in the U.K., among them the RCP and the Cochrane organization, have emphasized their continuing support for vaping products as safer alternatives.
In July 2021, the All-Party Parliamentary Group (APPG) for Vaping released a report based on the results of an inquiry into U.K. tobacco harm reduction and opportunities post-Brexit. By gathering cross-parliamentary input, the APPG for Vaping hoped to help Parliament channel the voice of the community to ensure the next TCP will accelerate the U.K.’s push toward a smoke-free 2030.
Recommendations from the report include an extension of the current regulations for vaping to other noncombustible alternatives to cigarettes and the establishment of a new category in legislation that treats all noncombustible products as distinct from combustibles. This category should incorporate nicotine pouches, which are currently largely unregulated; heated-tobacco products, which are presently not afforded the same treatment as vapes; and snus, which to date has been illegal in the EU, except in Sweden, despite its significant success in helping reduce the number of smokers in the Nordic country.
The report also suggests that the rules for vaping be amended to ensure they cater to the needs of both existing vapers and the smokers who have tried them but not stuck with them—i.e., allowing for increased tank sizes, bottle sizes and higher nicotine strengths—and to allow for sensible and direct communications to smokers and vapers about the products available to them, either through inserts in cigarette packs or through digital means.
A Missed Opportunity?
Mark Pawsey
Mark Pawsey, a conservative member of Parliament who set up the APPG for Vaping in 2014, hesitated to speculate on which recommendations would be taken up in the legislation. “I wouldn’t want to preempt what may be in the new TPC, but what I hope to see is a much more positive approach regarding the efficacy of vaping from a harm reduction and smoking cessation perspective,” he said. “The U.K. has adopted an evidence-based, pragmatic and yet progressive approach to vaping and harm reduction, and this should be reinforced. I would also like to see some of the transposed EU legislation from the Tobacco Products Directive removed from domestic legislation, such as restrictions on vape juice bottle sizes and the maximum nicotine strengths allowed for vape juices. The latter is crucial in enabling heavy smokers to make the switch to the much less harmful alternative of vaping.”
Gerry Stimson, public health social scientist and a director of Knowledge-Action-Change (KAC), a private sector agency working in public health and harm reduction, was less optimistic. “There has been a change in ministerial lead, and I detect that Maggie Throup, the parliamentary under-secretary of state for vaccines and public health who is now responsible, may be unfamiliar with this field and therefore unwilling to take risks. I don’t expect major changes. This will be disappointing because the U.K. won’t reach the goal of being smoke-free without increasing access to safer nicotine products.”
Stimson said he’d like to see snus regulated under the new TCP but didn’t expect it to happen. “The Department of Health and Social Care takes the view that all tobacco is harmful,” said Stimson. “The halfway position would be the regulation of nicotine pouches, currently available but unregulated in the U.K., but some regulation might help to assure consumer confidence.”
Vaping on Prescription
Gerry Stimson
As in many developed countries, smoking is increasingly a problem among the vulnerable in society, such as people with low income or mental illnesses. The Guardian notes that there are “alarming differences” in smoking rates in the U.K. Smoking prevalence in Blackpool, for instance, which in the 2019 Indices of Multiple Deprivation was rated the most deprived area out of 317 districts and unitary authorities in England, stands at 23.4 percent. This compares to only 8 percent in the wealthier area of Richmond on the Thames.
“The impact of smoking on those with lower incomes can be devastating,” Pawsey said. “We must do more to help those smokers on lower incomes make the switch to vaping where they are unable to quit completely. It is better for their health, and it is considerably cheaper.”
Vaping on prescription might be a solution to this problem. In late October, the Medicines and Healthcare Products Regulatory Agency published updated guidance that paves the way for medicinally licensed vape products to be prescribed for tobacco smokers who want to quit smoking. Thus, the U.K. could become the first country to prescribe medicinally licensed e-cigarettes. Stimson says this is extremely unlikely to happen in the short term, though: “Far simpler would be for the National Health Service to provide vape shop vouchers for people on low incomes in order to get them to try e-cigarettes. Smoking cessation—by switching to lower risk products—is crucial in mental illness and substance misuse treatment settings and populations but is often ignored,” he said. “In my view, it is unethical to enforce abstinence from nicotine, especially in situations of enforced confinement, so the route must be to provide e-cigarettes in those settings for those populations.”
New International Role
While Brexit has freed British THR policy from the bonds of the TPD, it has also given the U.K. a new status on the international stage: For the first time, the country was not obliged to join the EU’s position at the WHO’s Framework Convention on Tobacco Control (FCTC) Conference of the Parties (COP9), which took place virtually in November. In the run-up to the meeting, THR advocates, among them the APPG for Vaping and KAC, had urged the U.K. to tout the health benefits of e-cigarettes during the next summit. On March 31, 2021, the APPG on Vaping published an inquiry into the COP9, in which it called for the U.K. delegation, which usually comprises health officials, diplomats and activists, to be strengthened with experts with real-world experience and former smokers who can attest to the benefits of RRPs. The U.K. delegation, it said, should consist of committed proponents of vaping. Furthermore, the inquiry requested a meeting with the public health minister and asked the U.K.’s COP9 delegation to establish a working group to look at the science and evidence for new and emerging products.
At the time of writing, shortly before COP9, it was clear that few of these proposals would make it into the virtual get-together. “Sadly, as the health minister has confirmed in recent responses to written parliamentary questions from my colleagues, the U.K. delegation will not be calling for a working group on harm reduction at COP9,” said Pawsey. “However, the minister has been forthright in her confirmation that the U.K. delegation will advocate for our pragmatic and evidence-based approach to harm reduction and the important role that vaping has to play in it.”
The KAC had called on the U.K. to use its significant financial contributions to the FCTC as a lever to question the direction of travel on safer nicotine products, call for improved transparency and accountability at COP meetings and be prepared to veto poor decisions affecting users of safer nicotine products in the U.K. and around the world. With payments of almost $10 million since 2006, the U.K. is the fourth-largest sponsor behind Japan, Germany and France.
“Over the last few years, the U.K. has provided around 70 percent of the regular and project funding for the FCTC secretariat,” Stimson pointed out. “This puts it in a strong position, so it is bizarre it has not made this funding contingent on the WHO and the secretariat pursuing a more positive approach to tobacco harm reduction in line with U.K. policy. The COP operates on consensus, so, theoretically, the views of a single country can be very significant. Unfortunately, I don’t see the U.K. being willing to ‘rock the boat’ at this COP.”
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.

December 1, 2021
Clouded in Confusion

Photo: Prostock Studio
Confusion persists even as the U.S. Food and Drug Administration approves an ENDS product for marketing.
By Timothy S. Donahue
The U.S. Food and Drug Administration has created quite the mess. The regulatory agency’s handling of premarket tobacco product applications (PMTAs) has left many in the nicotine industry bewildered. It started with numerous refuse to accept and refuse to file letters. Then the agency began sending out marketing denial orders (MDOs). After publicly rescinding one of the MDOs—and with rumors circulating about additional rescissions—the agency is now being sued by at least 28 companies for making “arbitrary” decisions in reviewing PMTAs. The MDOs of least four companies have been granted a temporary stay through the courts or by the FDA itself.
As of this writing, the FDA has granted the Vuse Solo device and two tobacco-flavored pods produced by the R.J. Reynolds Vapor Co. (RJRVC) the first-ever marketing orders for a vapor product. The decision shocked many because the Vuse Solo is an unpopular and outdated device, according to some observers. RJRVC’s main e-cigarette product, Vuse Alto, which accounts for the vast majority of the company’s market share, has yet to receive a marketing order. The Alto PMTA was submitted an estimated two years after the Solo PMTA, according to media reports.
Sam Salaymah, president of AMV Holdings, parent to Kure CBD and Vape, called the FDA action a historic win for adult smokers that confirms e-cigarettes have been scientifically proven “appropriate for the protection of public health.” “[This] verifies that adult users are exposed to significantly fewer toxic aerosols and less harmful or potentially harmful constitutes than found in combustible cigarettes,” he says. “The science has spoken, and this is a great public health win for countless adult smokers looking to transition from deadly cigarettes.”

Vuse Solo received the first-ever marketing orders for an ENDS product.
(Photo: RJRVC)
But while approving Vuse Solo tobacco-flavored pods, the FDA rejected five of RJRVC’s flavored products. The agency is expected to only approve tobacco flavored pod systems; however, the outlook for open systems (alongside bottles of flavored e-liquids) is anyone’s guess. James Xu, president and founder of Avail Vapor, says that eventually he expects the FDA to approve an open system and some bottled tobacco-flavored e-liquids. He says that studies have shown that very few youths use an open system to vape, and the FDA is likely considering that factor. “I think it is just a matter of time,” he says. “In light of the many lawsuits and confusion in the vaping industry, the FDA is now likely taking more time to review the PMTAs before making any more decisions either for or against a product. I think we will have an open system with a marketing order at some point.”
Chris Howard
As of Oct. 19, the agency had announced 323 MDOs, accounting for more than 1,167,000 flavored vaping products (there may be more unannounced). Many vaping industry representatives and public health researchers believe the removal of all flavored products would negatively impact harm reduction efforts in the United States. “Some vapers will undoubtedly return to smoking combustible cigarettes,” says Chris Howard, vice president, general counsel and chief compliance officer of E-Alternative Solutions. “And smokers who might have transitioned to ENDS [electronic nicotine-delivery system] products may now elect not to do so.” The current state of the ENDS industry is what many industry observers predicted as far back as 2016, according to Howard. Given the entry of ENDS products into an already highly regulated space, manufacturers would need to be “significantly capitalized and possess material expertise to navigate the requirements” to survive FDA regulation, he says.
“Unfortunately, despite a near universal view that flavored ENDS products present a tremendous harm reduction opportunity to smokers seeking to quit or reduce their combustible cigarette intake, cost-saving shortcuts during the premarket approval process are very unlikely to meet FDA’s threshold regarding the quality, quantity and type of data required to obtain market orders,” says Howard. “In the short term, this will have a significant impact on consumers as they will now have significantly fewer choices of both devices and flavors available. That said, I remain confident that given time, the industry will obtain more clarity, and a path for the return of flavored vapor options will materialize. FDA is the biggest proponent of harm reduction when it comes to tobacco and recognizes that providing adult smokers with options is important.”

Jamex Xu
In the meantime, MDO recipients are fighting back. Pursuant to Section 912 of the Tobacco Control Act, companies who receive PMTA denials have 30 days to petition for a judicial review of the decision. Days after it received its MDO, Turning Point Brands (TPB) filed a petition for review with the United States Court of Appeals for the 6th Circuit, followed shortly thereafter with a motion to stay the MDO. Just days later, the FDA rescinded Turning Point’s MDO. The FDA admitted that after “further review of the administrative record,” it made an error in TPB’s PMTA review, and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said Larry Wexler, TPB’s president and CEO, in a statement following the rescission. “It is important that the PMTA process is transparent, purposeful and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance.”
Azim Chowdhury
The FDA has set an extremely high bar when it comes to authorizing e-liquid flavors, explains Azim Chowdhury, a partner at the law firm Keller and Heckman who specializes in vapor, nicotine and tobacco product regulation. According to Chowdhury, the MDOs essentially created a new standard for flavors: Applicants must demonstrate an “added benefit” of a nontobacco flavor that outweighs the known risk to youth use through the use of either a randomized controlled trial (RCT) or a longitudinal cohort study (LCS).
“[The] FDA clearly jumped the gun with at least some of these companies in the way that they issued the MDO without giving the PMTAs a full scientific review as required by the statute. That being said, even if some of these lawsuits are ultimately successful, the outlook for flavored ENDS, to me, looks pretty grim,” says Chowdhury. “Even if we’re successful in these lawsuits and the MDOs get vacated and the PMTAs go back into review—which is good—the FDA is ultimately going to have the final say in what science is required and what is going to be enough for them to believe a flavored product is appropriate for the protection of public health.”
Whatever data Vuse submitted for its flavored PMTAs hasn’t been disclosed publicly. Chowdhury says that it was likely robust and exceeding anything that most small manufacturers submitted for their flavors. “Right now, no one can tell you what it takes scientifically to get a flavor through,” he says. “Even in the best-case scenario, if we get the courts to say that FDA did this wrong, they should have done a hard look at the PMTAs, that they should have given companies fair notice about this requirement for RCTs and LCSs, they should have perhaps even gone through a notice and comment rulemaking period … even if one of those arguments win in court, it’s still only going to result in the PMTAs going back into scientific review.”

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TPB’s stay motion (which the company dropped after the FDA rescinded its MDO) stated that the agency had moved the goalposts for data needed to receive a marketing order based on what the agency “learned” from the “review [of] PMTAs for flavored ENDS so far.” Nearly every MDO/PMTA lawsuit filed has followed TPB’s blueprint and is asking the courts to review the FDA order “on the grounds that it is arbitrary and capricious.” The FDA has already had MDOs for Triton Distribution, My Vape Order and Gripum LLC placed on hold by the courts, and the agency has told at least two other companies that received MDOs that it would rescind the orders or “not enforce” them, according to sources.
Chowdhury said that technical project lead reports concerning PMTA reviews obtained through Freedom of Information Act requests revealed that the FDA performed a “box checking” exercise to see if an application contained an RCT or LCS instead of an actual scientific review of the application. “The first thing they have in these decision memos is, literally, a table where it says, ‘Do you have an RCT?’ No. ‘Do you have an LCS?’ No … then that’s it. If you said ‘no’ to both of those responses, they didn’t look at the rest of the application. This is mind-boggling because the statute, guidance and final PMTA rule, etc., all make clear that the APPH standard is a complex, multifactor standard. It requires all sorts of evidence and data, and it doesn’t require any one particular type of study. FDA avoided considering any of the other information contained in the PMTAs, including marketing restrictions and youth access prevention measures.”

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Chris Allen
The FDA’s rationale for banning flavored products is its desire to address what the agency has long described as an “epidemic” of youth vaping. However, recent evidence seems to show that the overall youth use of e-cigarettes in the U.S. is declining. According to the 2021 National Youth Tobacco Survey (NYTS), the FDA and the Centers for Disease Control and Prevention (CDC) found that youth use of e-cigarettes fell sharply in 2021. It’s the second consecutive year of major declines.
Many in the industry say the FDA’s negligence in the PMTA review process and its single-minded focus in preventing youth uptake is going to create additional issues, further clouding the vapor industry’s outlook. Chris Allen, chief scientific officer at Broughton, a contract research organization (CRO) delivering analytical, scientific and regulatory services for the ENDS industry, says that the FDA might well be using the NYTS to justify the “flurry of MDOs” issued for flavored e-liquids. He also said the majority of the companies that have fallen foul of the recent MDOs are responsible manufacturers supporting tobacco harm reduction.
“I completely accept that youth use is unacceptable; however, the issue doesn’t appear to lie primarily in open systems but a product that is currently outside the jurisdiction of FDA: a disposable containing synthetic nicotine,” says Allen. “Regardless of the product, or the source of nicotine, there’s no place for irresponsible marketing and distribution practices that keep adding fuel to this fire. I fear that the latest action is simply going to lead to a seismic shift into the black market and unregulated (synthetic nicotine) products, which will be near on impossible for the U.S. government to control. From my personal perspective, this doesn’t seem an appropriate way to support THR [tobacco harm reduction].”
Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.

November 1, 2021
The Fork in the Road

Photo: Malcolm Griffiths
Following the virtual conference in 2020, which had been forced online by the coronavirus pandemic, the GTNF was pleased to once again welcome delegates in person in 2021. The Rosewood Hotel in London hosted 162 delegates Sept. 21–23, with an additional 720 participants following the speeches and discussion panels online.
The event attracted both industry representatives and stakeholders from other sectors, including government, civil society and the legal profession. In addition, GTNF 2021 generated considerable interest among the media, with representation from prominent outlets such as The Wall Street Journal, Bloomberg and Le Monde.
Below is a sampling of the 2021 GTNF keynotes and panel discussions. For additional coverage of the event, please click here.
To read what delegates had to say about the ninth Conference of the
Parties to the Framework Convention on Tobacco Control that is scheduled
to take place this month, please click here.

Matt Ridley: The importance of innovation
Matt Ridley, who is a member of the U.K. Parliament’s upper house, ended his presentation by saying the All-Party Parliamentary Group for Vaping, of which he is a member, had recently urged the U.K. government to attend this year’s Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control and, while there, use its relatively independent post-Brexit voice to argue strongly against the e-cigarette prohibitionists and in favor of scientific evidence and the harm reduction argument. “I don’t know whether we will be listened to by the U.K. government on this, but we are going to try and get this point across because I think it’s … it’s a moral one, and I think we have a duty to try to win the point,” he said.
This will have gone down well with many of the conference participants, who will have agreed with Ridley’s earlier comment that the WHO’s war on vaping was “positively unhinged” and flew in the face of evidence that it reduced smoking. And here he illustrated his point by quoting Chris Snowden of the Institute of Economic Affairs as saying the WHO had doubled down on its hostility to vaping even as real-world evidence continued to show smoking rates declining as vaping rates increased.
Ridley’s was the first keynote presentation of the event, and, while it did not contain much else that was new, it ran through most of the underlying issues causing concern to the vaping industry, and it did so with panache. He covered, among other subjects, the assessment of relative risk and its relationship with the concept of harm reduction, innovation and the main ideas that motivated some people, including some public health professionals and politicians, to want to ban the technology underpinning vaping.
The first motivation, he said, was down to the inappropriate application of the precautionary principle in answer to the question, “What if this technology turns out to have unknown risks?” While that question was valid, he added, in the case of vaping, the answer was that it would be better to take the small risk that there were unknown hazards than the known risks that there were large hazards. The second motivation was a general hatred of all things related to nicotine, which was deeply ingrained in the culture and underlined by the involvement of tobacco companies in the vaping industry.
The third motivation was self-interest. The pharmaceutical industry had a nice little earner called nicotine-replacement therapy, and since its patches and gums didn’t work very well, the market for them remained limitless. And the fourth motivation was simply down to the urge to ban. Some people loved to disapprove, and they were able to come up with all sorts of specious arguments about why they disliked e-cigarettes and why, therefore, they should be banned.
Ridley, an author whose books have sold more than a million copies and been translated into 31 languages, added to his output in 2020 with the publication of How Innovation Works, and part of his presentation looked at the way in which innovative products often initially meet with considerable opposition. Margarine, he said, had been opposed by dairy producers, refrigerators by natural ice suppliers, tractors by the people who went under the name of the Horse Association, umbrellas by hansom cab drivers, coffee by vintners and the telephone by what sounded like an old curmudgeon worried that this then-new contraption would destroy private life if it were not restricted. (Of course, with most of us now suffering daily from the debilitating effects of vacuous, secondhand mobile conversations, it might be worthwhile revisiting the old curmudgeon’s complaint.)
The audience, I think, will have been struck by two things in relation to these examples. One, obviously, is that they are all from the distant past. The other is that whereas nearly all of them involve people trying to protect their self-interests, those self-interests comprised their livelihoods and none of their actions threatened to cause direct harm to others. So while the opposition to these products and services can be likened to the opposition to vaping, there is an important difference because unjustified opposition to vaping does directly threaten the well-being of others: current smokers.
Given that this session report starts with Ridley’s last words, it might be appropriate if it ends with his first words: a gentle plug for his latest book. It had been co-authored by a brilliant molecular biologist at Harvard, Alina Chan, he said, and it was called Viral: The Search for the Origin of Covid-19. “You can buy it in all good bookstores from the middle of November,” he added helpfully.

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Stefan Bomhard: Putting the consumer first
Across all industries, the Covid-19 pandemic has been one disruptive force, which drove government intervention, accelerated consumer trends and, as a result, spurred further innovation. The tobacco and nicotine industry, which finds itself in a period of rapid change, has been no exception: Controversial policy led to bans on combustible cigarettes as seen in South Africa, but at the same time, growing health consciousness has led to an increased interest in reduced-risk alternatives.
Stefan Bomhard, who previously worked in the alcohol industry and joined Imperial Brands as CEO in July 2020 from Inchcape, a global distribution and retail leader in the premium and luxury automotive sectors, shared his views on the longer term transformation of the tobacco and nicotine industry, looking at how stakeholders could collectively be best at making a reality of a healthier future. He observed parallels between the vaping sector and the automotive industry, where manufacturing for many years had been seeking to improve the efficiency of the 160-year-old technology of the combustible engine. “Then climate change became the climate crisis, and the e-engine meant a complete turnaround,” he said.
Innovation, Bomhard emphasized, can happen only if supported by private sector efforts. As regulation of reduced-risk products (RRPs) edges toward prohibition, unintended consequences such as illicit trade arise. “The industry has to step up and present continuously better choices for consumers,” Bomhard said. “Smokers need to be perceived as informed people who want to make informed choices. There is no single route to tobacco harm reduction, but a billion individual paths.”
Imperial Brands, which in the past 25 years developed from a domestic player into an international player, sees its role in this development in delivering a better experience for consumers. “From my experience, small players can flourish with the right mindset,” he said.
While keen to transform the tobacco industry, Bomhard insisted Imperial Brands remains 100 percent committed to combustible cigarettes. “They are the core business for building a harm-reduced company, as they finance the investments in tobacco harm reduction,” he noted.
To transform Imperial Brands, he explained, additional capacities have been built, including increased research of consumers’ needs. The company hired its first consumer product officer earlier this year. Products will be improved based on the findings of consumer studies. At this point in time, consumers have chosen heated-tobacco products over vaping, according to Bomhard, so Imperial Brands focuses on offering products in that segment.
Furthermore, a number of new executives have joined Imperial Brands, bringing in new capabilities and contributing to the development of a new, more innovation-headed mindset in the organization. The focus is on the question of how employees can play a practical role in driving innovation, Bomhard pointed out.
In addition to harm reduction, he went on, the industry had other important challenges, inclusive of supporting better lives for farming communities, transitioning to a lower carbon business model and reducing waste. “The future of the industry will without doubt have twists and turns,” he said. “For me, having enjoyed a career in a variety of fast-moving industries, each one of them facing major structural changes, the year with Imperial has enforced my first impression that right now, there is no more dynamic sector than tobacco and nicotine.”

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Panel: What is Next for Tobacco and Nicotine
The vaping industry faces many challenges. The road to a viable future for these products must pass through sensible regulations based on science. In the current environment, unfortunately, this will be challenging, according to speakers on the GTNF plenary panel The Fork in the Road: What is Next for Tobacco and Nicotine. Misperceptions surrounding nicotine and vaping products, the panelists agreed, are furthered by the mass media’s “wonton disregard” for the science behind the tobacco harm reduction potential of electronic nicotine-delivery systems (ENDS).
One speaker noted that in addition to many countries banning or erecting insurmountable barriers to vaping products, well-funded anti-nicotine activists are attacking the people who are bringing reduced-risk products to adult combustible cigarette smokers trying to quit smoking. These groups are opposed to the tobacco harm reduction that science and innovation can bring.
All of these activities together only serve to enhance the vaping industry’s problem: the massive public misperception that vaping is as deadly as smoking cigarettes. The fact that a significant number of physicians mistakenly belief that nicotine, rather than combustion, is responsible for smoking-related illness, bodes ill for the perceptions among the general population. “If physicians believe this, imagine the views of the average smoker in Kenya or Chicago, Illinois, or in Australia,” one speaker said.
While anti-nicotine activists have done their share to misperceptions, the vaping industry too is partly to blame, according to one panelist. The ENDS industry can do a lot more than feel helpless or complain, this speaker noted. Innovation in harm reduction cannot occur without the vaping industry’s support. That means responsible marketing, combating illicit trade, limiting youth access and making sure that the ENDS industry is doing what it can to prevent underage use.
Panelists also expressed concern about the direction of the vapor market in the wake of the U.S. Food and Drug Administration’s marketing denial orders (MDOs), with some describing a “Wild West” scenario. After receiving MDOs, some companies have turned to synthetic nicotine because that product currently is outside of the agency’s jurisdiction. A panelist said that the FDA’s “scorched earth” approach to flavored products is only creating bigger problems in the market, adding that if a market isn’t regulated, there is still going to be an unregulated illicit market that has the potential to be more deadly than that for combustible tobacco.
“Nobody wants kids to take up the products … it’s a very significant responsibility that we in industry be there to be the stewards of that concept in generating science and evidence,” a panelist said. “We should all be proud of the good science that is being generated … that is our responsibility: to generate and publish and participate in the scientific debate and pursue reasonable regulation. What is reasonable? I don’t know. It’s not going to be nothing. We all have to get over it and figure out what is the right way forward so we can go back to helping the consumer and making sure we’re only serving smokers who are looking for alternatives to combustibles.”

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Amanda Wheeler: Continuing the fight
Amanda Wheeler got involved in the vapor business after a personal tragedy. Despite a cancer diagnosis, she was unable to quit smoking for years—until she discovered vapor products. Eager to share her success with others, Wheeler and her husband, Jourdan, opened JVapes, an e-liquid manufacturer and retail store in Prescott, Arizona, USA, in 2012.
The business was successful, quickly expanding to multiple locations across three states. Wheeler was helping her customers quit smoking combustibles and became increasingly involved in advocacy.
In October of 2020, Wheeler and fellow business owner Char Owen created the American Vapor Manufacturers Association (AVM) to help small businesses navigate the U.S. Food and Drug Administration’s onerous premarket tobacco product application (PMTA) submission process. The organization also engaged in federal lobbying and sought to provide reduced-cost scientific testing and expert regulatory compliance advice to members preparing PMTAs.
The deadline for submitting PMTAs to the FDA was Sept. 9, 2020. Wheeler submitted timely applications and was allowed to keep her products on the market for up to one year while the FDA reviewed her submissions. But on Sept. 9, 2021, Wheeler received a marketing denial order (MDO). The regulatory agency appeared determined to put the company she and her husband had built, along with the industry she passionately defended, out of business.
That day, the FDA issued MDOs to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The bloodbath continued in the following weeks. At press time, the FDA had issued 323 MDOs accounting for more than 1,167,000 flavored electronic nicotine-delivery systems (ENDS). As of Sept. 28, not a single ENDS had been approved.
“[The] FDA knew that they didn’t have the time or the resources to give our products fair consideration, but instead of asking for help, they let the 9/9 deadline pass and left the more than 500 companies subject to their decision in an unstable and probably untenable position,” Wheeler explained. “The FDA’s arbitrary ruling effectively criminalizes thousands of long-standing businesses in communities all across the country. Those entrepreneurs now have to junk their inventory, fire their employees, stiff their investors, and defer their dreams.”
Wheeler said she was standing up for the “little guy”—the thousands of small business owners who manufacture, distribute and retail open system products in vape shops all over the United States. She explained that her business and other AVM members made every attempt within their means to comply with the FDA regulations. It was an expensive process. It was also a system designed for small businesses to fail from the very beginning, she said.
“My company personally submitted several hundred thousand pages of documents to the FDA in an attempt to comply with this one premarket tobacco application standard. The [FDA’s] decision doesn’t just make a mockery of that earnest work. It also makes the more than 10 million Americans who made the switch to vapor products—in our vape shops, with our liquids—into outlaws, too,” said Wheeler.
Wheeler said the FDA, in an act of “regulatory arson,” was creating a tobacco-led monopoly over the vaping industry, as only the companies with the deepest pockets stand a chance to survive the agency’s cumbersome PMTA process.
She also focused on what she perceived to be one of the biggest challenges facing the industry today: misinformation. “There is one other group I want to address with my time here. It’s the activists and the press who—whether because they are misguided or malicious—spread the falsehoods and distortions that directly led to this tragic outcome,” she said.
The biggest victims of the FDA’s actions, according to Wheeler, are the vapers who will now struggle to acquire the products that have helped them stay off of cigarettes. Wheeler vowed she would continue to fight for her customers and fellow business owners. “Even through their dismay, I am hearing a constant refrain: We are not going to stand for it,” she noted.
“We will be at the FDA’s doorstep demanding answers or forcing them through Freedom of Information Act laws and the courts. We are not surrendering our business or abandoning vapers to cigarettes,” she said. “As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”

Joe Murillo and Todd Cecil: The regulator’s view
When the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for vapor products, the industry was understandably shocked. Many companies that had submitted timely premarket tobacco product applications by Sept. 9, 2020, had expected to first receive a deficiency letter and not immediately an order to remove their products from the market. Some MDO recipients complained the agency had “moved the goalposts” by suddenly requiring studies that it had previously said were not required.
At least three companies have filed lawsuits over their MDOs. All are accusing the agency of making “arbitrary” decisions and not reviewing the submitted data according to the statutes. In a “fireside chat” between Joe Murillo, chief regulatory officer for Juul Labs, and Todd Cecil, deputy director of the Office of Science for the FDA’s Center for Tobacco Products, during the recent GTNF in London, Cecil acknowledged the missing data that caused the flurry of MDOs is not required by the statutes that regulate tobacco products.
When asked what the “level of expectation” the FDA had in deciding whether to issue a deficiency letter or an MDO after a premarket tobacco product application (PMTA) was moved into scientific review, Cecil said that the agency followed “a randomized approach” to choose the applications the FDA would work on.
“The randomized approach identified a number of manufacturers’ products that went into this scientific review, and we … evaluated them from top to bottom,” he said. Cecil noted the agency began to see in some applications that “tended to have problems or missing materials that we needed in terms of benefits [of flavors]; that we learned we have to have that benefit piece … that evaluation that we spent several months working on taught us what we had to look for to be able to [conduct] a full scientific review.”
Cecil said that the agency just figured “if we know going right in that there are pieces missing, why will they go through a deficiency process and with a very short turnaround expecting to get back a full study that wasn’t completed previously?” So, instead of issuing a deficiency letter as required by statute, the FDA just handed out MDOs because the agency knew that it would take a company a significant amount of time and expense to conduct the new required longitudinal and cohort studies. Cecil was then asked why the agency filed the applications in the first place.
“We had to make a determinant how can we streamline this evaluation and determine those products that have at least the bare minimum for us to do a real and complete evaluation,” Cecil said. “This evaluation is not a standard. It is not a de facto standard or anything else. This is information that we need to see, but it’s not a requirement. An RTF [refuse to file] are those things that are required by the statute. And these studies are not necessarily required by the statute.”
The FDA has also been facing an unprecedented amount of scrutiny on how its handling of regulation of electronic nicotine-delivery system (ENDS) products and the PMTA process. Numerous health groups, anti-nicotine groups, states attorneys general and even members of Congress have criticized the FDA and demanded action. When asked if the FDA’s actions were influenced by these groups, Cecil said the agency focuses on science.
“We’re science-based,” he said. “We need look at what is presented to us in the application and in the laboratory. That is what we’re most focused on. If there is new data out there and that new data is brought to our attention through one of these [groups], then that’s fine. We would be happy to get those up and understand the bigger picture, all of the data … We need to evaluate those as scientifically or make a determination based upon that science.”
Only 100,000–200,000 products remain under FDA review. Of the 6.7 million submitted PMTAs, all others have received either a refuse-to-accept, an RTF or an MDO response. Cecil denied the agency was making a “categorical policy decision as opposed to an application-by-application decision” about flavored products. “We are stating that we understand that there is a significant youth initiation risk that comes from flavored ENDS products,” he said. “We are, in fact, reviewing all of those, and what we have found as we’ve done our reviews is that none of the literature is sufficient to demonstrate that there is not a youth initiation risk for individual flavors.
“We see that tobacco has a lower initiation risk. We see that menthol has some issues with it, and we are going to be evaluating that as we go forward. However, all of the data points to the flavored products as having significant youth initiation concerns. So what we’re looking for is an adequate indication that there’s a benefit on the other side of the equation. This is not a decision that we aren’t going to accept flavored products. Absolutely opposite. We need to ensure that there is concrete and robust data that demonstrates that there is an existing user benefit for those products.”
Cecil declined to say when more MDOs would be issued or when the agency would rule on major products, such as Juul, NJOY, blu and Vuse. “We continue to work diligently,” is all he would say. “There are a number of products that are well along. But no, I can’t tell you how many are those ones, but there are some that we’re hoping to move forward in the short term.”
The FDA’s recent action against flavored e-liquids does not mean that the FDA will never approve a flavored e-liquid, according to Cecil. He said that the rejected applications just lacked the required information that those products met the agency’s “appropriate for the protection of public health” standard. “You are welcome to reapply once you have addressed the issues that we provided to you,” he said. “And we will reevaluate that at a future date.”

Investment Panel: A New Case for Tobacco
Despite the rough ride for tobacco stocks in recent years, the investment case for tobacco and nicotine remains strong, according to the participants in the Global Tobacco and Nicotine Forum (GTNF) 2021 investors panel. Under the direction of Eric Bloomquist, four prominent tobacco analysts—Jonathan Fell of Ash Park Capital, Rupert Wilson of Strategic Business Consulting, Pieter Vorster of Idwala Research and Gaurav Jain of Barclays—debated the outlook for tobacco in a rapidly changing business environment. Even as the industry suffered from Covid-19-related fallout, its legendary pricing power remained intact and continued to deliver profit growth and cash flow. With supply chain disruptions affecting many sectors, tobacco has even become a safe hiding place again, one panelist ventured.
That said, some companies have clearly done better than others. Those with greater exposure to noncombustible products are attracting higher valuations than those with a lower portion of their revenues coming from that business, and the panelists debated whether that discrepancy would prompt investors to pressure the underperformers to “get their act together.” Not everybody was convinced. As one participant pointed out, shifting the world’s 1.1 billion smokers to noncombustibles is a very long-term project. “Realistically, there is time for the companies who don’t have the right strategy to eventually get there,” he said. A word of caution was also uttered against compromising the cash flow machines: The transition to less risky nicotine products requires lots of investment, and many of those funds are still generated by sales of traditional cigarettes.
Speculating on possible mergers and acquisitions, the panelists considered a reunification of Altria Group and Philip Morris International unlikely in the near future. As one participant pointed out, PMI has publicly committed to deriving more than 50 percent of its net revenues from smoke-free products by 2025. Because Altria currently receives a smaller share of its earnings from such offerings than does PMI, it would be harder for the combined entity to meet PMI’s target. What’s more, many PMI investors like the fact that they can currently choose whether or not they want exposure to the uncertain U.S. market—an option that would no longer be available after any merger.
One panelist suggested Swedish Match as an acquisition target for PMI. After the recently announced separation of its cigar business, Swedish Match would offer PMI attractive complementary smokeless businesses, such as snus and modern oral, the panelist said. Others contemplated the possibility of spinoffs by Imperial Tobacco, which has announced greater focus on its core markets. The problem here, noted one panelist, would be the buyer: With all large tobacco companies keen to reduce their dependence on combustibles, there is no obvious taker for such a business—at least not among the publicly listed firms. This, in turn, led to speculation about the designs of China’s State Tobacco Monopoly, which is not accountable to shareholders—but the panelists quickly agreed it was futile to figure out “what is happening in China.”
The discussion then turned to the impact of environmental, social and governance (ESG) initiatives on investors. Would tobacco companies’ efforts to transition smokers away from deadly combustibles prompt investors who might otherwise have shunned the sector to take another look? Panelists agreed that the Foundation for a Smoke-free World’s Tobacco Transformation Index, which evaluates tobacco manufacturers on efforts and actions relating to tobacco harm reduction, could prove to be a valuable tool for investors. Companies that are doing the most in this area are already enjoying the best valuations, one panelist pointed out. They also pointed to the entrance into the market of new nicotine companies that offer no combustibles, such as RELX and SMOORE, which have broadened the options. PMI’s recent acquisitions of pharmaceutical companies, such as Vectura, could also generate interest from a new class of investors, the analysts ventured.
At the same time, the panelists acknowledged the challenges facing tobacco companies in escaping the tobacco “taint.” Many financial websites offer investors a dropdown menu with the option to exclude “tobacco”—a broad label that includes both companies wedded to traditional cigarettes and firms at the forefront of transitioning smokers away from such products.
One panelist detected a marketing opportunity. Its premise would be simple: Rather than pretending tobacco companies don’t exist, such a fund could offer to invest in their depressed stocks and help them change. “That would be a useful approach for the world and an interesting proposition for investors,” he said.

Open Mic: Tackling the Hard Questions
One of the panelists at the final session of the Global Tobacco and Nicotine Forum (GTNF) 2021, the Open Mic, indicated that he and his colleagues were spending a lot of time trying to validate innovative ways of substantiating tobacco harm reduction. He was responding to a question about whether breaking through to those so far unconvinced about the harm reduction credentials of new-generation tobacco/nicotine products would require more research or whether a different approach was needed. It was obvious that regulators would want to see the results of high-quality studies, he said, but what was not so obvious was what kinds of studies were needed. It was known, however, that if somebody stopped smoking tobacco, they benefited from a whole world of physical improvements that could be measured; the problem was how to measure those changes effectively and in a timely manner.
The Open Mic session lasted one-and-a-half hours and provided event participants with the opportunity to ask some challenging questions, one of which touched on the fact that in some tobacco markets, up to 35 percent of smokers are occasional or nondaily smokers, most of whom don’t use other nicotine products on days when they don’t smoke. Given this, what was the role of nicotine in moving people away from combustible products?
One response suggested that the issue of addiction or dependence was oversimplified, as though all smokers were the same and all were addicted, an idea that was not entirely true. There had been overexposure of the problem of addiction and dependence, especially in relation to young people, when, in fact, some people were able overnight and without withdrawal symptoms to quit a smoking habit that had lasted up to 40 years. It was time for the book of addiction and dependence to be rewritten.
Another panelist took the view that the issue of the spectrum that took in addiction, dependence and pleasure was complex, and focusing on it as if it were the main moral question that had to be grappled with was not helpful. Having such a focus was to miss the target. The target should be to reduce risk and to reduce disease. In fact, the important moral question was do physicians and members of the scientific medical community give smokers an additional option or not? Do they provide them with proper guidance on how to quit but give them the right to choose, or do they condone only the methods of which they approve?
Broadly speaking, the Open Mic session included three panelists from the world of science and healthcare and three from the world of business, one of whom appeared remotely from China. The session started, however, with a comment from one of its two moderators, who said the 2021 GTNF was the first conference she had been at where the consumer was front and center. But there was a sting in the tail. Some consumers, she added, those who still used traditional tobacco products, were not at the center except in the sense that they were the subject of discussions on how to get them to move to one of the many new-generation products coming onto the market. In a way, the suggestion seemed to be: Where was the “T” in GTNF?
A corollary to this question came up later when it was asked whether committed traditional tobacco users should be continually bombarded with information by those wanting them to quit or switch to less risky products or whether, at some point, it should be accepted that since they were determined to continue with their habit, they should be left alone to enjoy it. Nobody got to grips with this question, perhaps because it was too raw or because this “hard core” of smokers would make up the 5 percent who would still exist in countries that had “eliminated” smoking. Although one panelist made the point that in a relatively free world, people should be allowed to do what they wanted to do with a legal product, most merely suggested that new-generation products and the messages around them should be improved, presumably until even the hard core of smokers came on board.
There is clearly a problem with such communications, however. One simple but insightful question asked where a smoker looking to quit should go for advice. This presents a conundrum because the tobacco/nicotine and pharmaceutical industries have financial interests in the outcome, many healthcare professionals are ill-informed and social media is crawling with conspiracy theories. One panelist made the point that it could turn out that your friend who had already benefited from switching from consuming traditional tobacco products to using new-generation products could prove to be the most important medical adviser you would ever consult.

November 1, 2021
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
A Better Treaty

Photo: Malcolm Griffiths
GTNF panelists offer suggestions for transforming the FCTC.
TR Staff Report
The recent Global Tobacco and Nicotine Forum (GTNF) included a well-timed panel discussion on the Ninth Conference of the Parties (COP9) to the World Health Organization’s Framework Convention on Tobacco Control (FCTC). Scheduled to take place Nov. 8–13, 2021, COP9 originally planned to convene in the Netherlands but moved online due to the persisting coronavirus pandemic.
While the delegates are unlikely to make major decisions during the virtual gathering, the shift in format could have negative implications for the nicotine business. Rather than adopting or rejecting important reports, the delegates will merely “note” them this year.
Unfortunately, experience suggests that many COP participants will treat noted reports—including those based on poor science—as adopted and start transposing their recommendations into national legislation. The result could be more counterproductive prohibitions and restrictions on potentially reduced-risk nicotine products, especially in low-income and middle-income countries (LMICs), by the time COP10 rolls around.
Moderated by Flora Okereke, BAT’s head of global regulatory insights and foresights, the GTNF discussion panel brought together top experts on the FCTC, including Derek Yach, a leading architect of the treaty and current president of the Foundation for a Smoke-Free World; Ming Deng, head of NGPs Industry Study at Yunnan University; Michiel Reerink, international corporate affairs director and managing director of Alliance One International; and Chris Snowdon, head of lifestyle economics at the Institute of Economic Affairs.

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Okereke reminded her audience of how much had changed since the creation of the FCTC 20 years ago. In 2000, she recalled, there was no iPhone. The U.S. Food and Drug Administration had no authority to regulate tobacco, and the EU Tobacco Products Directive was not even on the horizon.
While the WHO claims there are 100 million fewer smokers today than there were in 2000, the FCTC and its related procedures have attracted considerable criticism from industry and tobacco harm reduction advocates, who complain about a lack of transparency and mission creep, among other shortcomings. Over the years, its detractors contend, the FCTC’s purpose of mortality reduction has evolved into a war on nicotine.
Snowdon contrasted the FCTC COP with the United Nations’ Climate Change Conference (COP26) scheduled for Oct. 31–Nov. 12 in Glasgow. The Scottish event, he predicted, will get lots of coverage. Politicians will be scrambling to get in the limelight and lining up to take credit or pass blame. Business, including fossil fuel and renewable energy companies, will be present—not only to learn what regulations governments have in store but also to show how they can be part of the solution. This, said Snowdon, is hugely different from the FCTC COP, which explicitly bans the industry it oversees from taking part in its deliberations.

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While activists often justify industry exclusion by pointing to the FCTC’s infamous Article 5.3, Snowdon noted that the original objective of that section was merely to prevent the tobacco industry from interfering in health policies; it was never meant as a blanket ban on interaction. Yach recalled how the WHO in the early days of the FCTC even invited leading scientists from the tobacco industry to share their views on the direction of harm reduction. “That was the first and the last time they were ever allowed in the building,” he lamented.
The GTNF panelists also expressed concern that the FCTC has gone beyond its remit, looking to restrict not just tobacco but also products that contain no tobacco and are helping millions of people to stop smoking. As Snowdon pointed out, the treaty defines tobacco control as being “a range of supply-demand and harm reduction strategies that aim to improve the health of a population by eliminating or reducing the consumption of tobacco products and exposure to tobacco smoke.” Products such as e-cigarettes clearly do all of these things, he said—yet the WHO remains firmly opposed to such products.
Yach noted that while the FCTC text has stood the test of time relatively well, it has not properly considered innovation and intellectual property. Contrary to their counterparts in the fight against HIV/AIDS at the turn of the century, the drafters of the FCTC did not expect many technological developments to take place in their field; tobacco was generally viewed as a staid legacy sector. “How wrong we all were,” said Yach, referring to the tremendous technological advancements that have disrupted the tobacco industry in recent years.
Not all players have been equally forward thinking, however, and Yach said it was no longer appropriate to speak of “the tobacco industry.” Instead of an industry with a homogeneous view, he noted, there is now one group of players, led by publicly traded companies, making serious changes to their business, and another group, led by state monopolies, resisting change. Unfortunately, the latter group accounts for a far greater share of cigarettes sales than the first. “Many COP delegates are unaware that if you add up the sales of PMI, BAT and JTI, Imperial and Altria, they come to less than the sales of China Tobacco,” he said. However, being owned by their respective governments, the state tobacco firms are indirectly represented at COP, even as their more progressive counterparts are excluded. Deng said it was the secretariat’s job to develop a better mechanism to deal with this issue.
Yach said the industry should come together and show authorities it was willing to push the change process collectively by having a joint plan to end youth smoking, for example. Reerink reminded his audience that the industry had attempted exactly that 20 years ago, but the development got lost in other news. “I cannot blame Derek for missing it,” he said, “because it was announced on Sept. 11, 2001.” With the FCTC finances one of the few items certain to be decided at this virtual COP9, Reerink shared his insights into the budget, which he said is probably one of the treaty’s least read documents. The FCTC has a biannual budget of about $20 million. Half of that—$9 million—is reserved for “activities.” Reerink detailed how the U.K., Australia and Norway provided millions of dollars for the FCTC 2020 Project. This project, he said, is about the FCTC secretariat telling a handful of LMICs that they have to fully implement the FCTC, with bans on reduced-risk products and plain packaging. “None of these are obligations from the FCTC, but that’s the message to the LMICs,” said Reerink.

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The GTNF discussion wrapped up with an audience question-and-answer session, and one delegate asked about the opportunity for the U.K., with its comparatively pragmatic approach toward new nicotine products, to influence the debate at the FCTC now that it is outside of the European Union. Yach said both the U.K. and U.S. governments have an obligation to be more vocal in the FCTC process. Even though the U.S. is not a full signatory to the FCTC, its representatives can still participate in the debate as registered observers. The U.K., he noted, is currently the world’s gold standard in reducing smoking rates. The FDA for its part, should share the scientific logic that went into its deliberations for approving marketing applications for Swedish snus and IQOS. That insight is important; due to the FDA’s unrivaled investment in regulatory science, its decisions tend to become global norms.
Asked about the path forward for reform, Yach recalled the dark days of apartheid in South Africa, when a research paper examined what would happen to the economy if the system continued on its current track versus how the economy would fare in an open democracy. That research helped galvanize the population and encouraged reforms. He encouraged the industry to present simple studies detailing how many lives could be saved if regulators integrated tobacco harm reduction, better cessation and treatment into its programs. “It’s not that difficult to give some reasonably good predictions,” he said. Such studies could be used to spur delegates into action. “You can ask them: Are you not willing to save x number of lives? What is the cost of inaction in lives lost because you are sitting around twiddling your thumbs?”
Flora Okereke
Flora Okereke, who moderated the GTNF panel on the Framework Convention on Tobacco Control, is head of global regulatory insights and foresights at BAT. In this role, she is responsible for analyzing and forecasting regulatory developments across BAT’s 180-plus global markets.
She previously held a number of senior country, regional and global roles at BAT, including legal, corporate and regulatory affairs director for West Africa; head of regulatory affairs for Africa, the Middle East and Eastern Europe; and global head of regulatory strategy and engagement.
Most recently, she served as senior director of government affairs and international policy at Reynolds American Incorporated Services, a subsidiary of RJR Tobacco based in Washington, D.C. In this role, she led engagements with U.S. government agencies, foreign embassies and global institutions on international trade, anti-illicit trade, tax and regulatory issues on behalf of Reynolds American Inc. and BAT. Prior to joining BAT, Flora was a commercial litigation solicitor in the City of London.
October 25, 2021
Troubled Waters

A flat corporate hierarchy and short lines of communications helped Glatz Feinpapiere cope with the coronavirus pandemic disruptions. (Photo: Glatz Feinpapiere)
The cigarette paper sector is coping with rising costs for raw materials, energy and transportation.
By Stefanie Rossel
Paper manufacturers have learned to cope with the pressure brought about by slumping global cigarette consumption and the simultaneous rise of paperless next-generation products. Since 2013, worldwide sales of combustible cigarettes have decreased every year, with consumption standing at 5.06 trillion cigarettes in 2020, down 3.7 percent from 2019, according Euromonitor. In 2019, the combustible cigarette category accounted for an estimated 95 percent of the global tobacco market, down from 94 percent one year previously.
As if this hadn’t been enough, Covid-19 presented a range of further challenges for paper suppliers. “On top of [the shrinking global combustible cigarette market], the situation this year has been exacerbated by container shortages, resulting in higher raw material prices and delivery delays,” says Omar Rahmanadi, CEO of Indonesian cigarette paper maker BMJ. “Nonetheless, like Albert Einstein once said, ‘In the middle of difficulty lies opportunity.’ The global crisis has forced many buyers to revisit their sourcing strategy, which has subsequently opened new business opportunities.”
Katrin Hanske
“Security of supply is even higher on the agenda since the Covid-19 crisis,” says Katrin Hanske, vice president and general manager of SWM’s Tobacco and Alternative Solutions division. “The cigarette paper manufacturers have to ensure a high level of service and quality and must be even more agile in a rapidly changing environment. Having a global footprint and a strong global supply chain is a true advantage to serve our customers located all around the globe.”
“Like the whole world, we were also not prepared to face the challenges of a worldwide pandemic,” says Nina Ritter-Reischl, CEO of Glatz Feinpapiere in Germany. “However, we were able to quickly adapt to the new situation, especially due to our flat hierarchy and short lines of communication. Particularly during the first months of the pandemic, we were faced with high demand for our papers, so we quickly increased our capacity by adapting flexible working hours or shift systems. In combination with the new sanitation and distance regulations, this was a challenge of its own.”
Coping with Costs
Rising prices for raw materials and energy, too, are impacting cigarette paper producers. “The global cigarette paper market in 2021 is dominated by a rapid increase in the costs for pulp,” says Ritter-Reischl. “From January to August, the costs for short fibers have increased over 70 percent and the costs for long fibers over 50 percent. This rapid increase is joined by rising costs for transportation, energy, chemicals and additives in general. Worldwide logistics and workflows still suffer from lockdowns of the Covid-pandemic. Therefore, the cigarette paper industry, just as the paper industry worldwide, is struggling with unexpected high costs, transportation challenges and the consequences of Covid.”
As a consequence of this development, SWM raised prices by up to 15 percent across its engineered papers portfolio on July 1, 2021. The increases, the company said in a press release, were a direct result of sharp rises in raw material prices, with market wood pulp costs up by 50 percent in the past six months. “Largely because of the Covid-19 pandemic, 2020 saw a lower than expected demand for wood pulp and higher inventory levels,” SWM commented. “Since Q4 2020, demand in Asia has recovered strongly, driving inflation and a fast decrease in global inventory levels. Supply levels have turned toward Asia, leading to one of the sharpest price increases in recent history. In addition, polymer prices and packaging material costs remain highly volatile. At the same time, shipping companies are capitalizing on high demand following periods of congestion to leverage their pricing power as well as providing limited visibility on freight rates and special surcharges.”
Although heated-tobacco products represent less than 2 percent of global tobacco retail volumes, according to Euromonitor, they will likely have an impact on the paper business, predicts Rahmanadi. “Heat-not-burn [HnB] products have disrupted the conventional cigarette industry,” he says. “This will undoubtedly disrupt cigarette papers as well. This development requires us as a specialty paper manufacturer to intensify our innovation to support the growth of HnB products.”
Trend Toward Sustainability
Despite current challenges, cigarette paper manufacturers remain optimistic. New business opportunities, they agree, are about to arise from tobacco companies’ focus on sustainability. “This is a trend and customer need we can serve, as it is in our genes,” says Reischl. “As a family-owned company with more than 135 years of history, we are sustainable in more than one way. Not only do we live and work carefully with the resources that nature is giving us—from water quality, emission reduction to energy savings, we [also] yearly reduce our footprint. We are also a sustainable partner for all our business partners, suppliers as well as customers.”
Rahmanadi sees big opportunities in developing a paper-based material that can replace single-use plastics, not necessarily exclusive to the cigarette industry. “The global pandemic has demonstrated that people have the capability to tolerate changes more than what they thought they could. This could mean that people might be willing to sacrifice convenience for environmental sustainability by using paper-based materials instead of plastics, among others,” he says.
“With the EU’s 2019 single-use plastics directive, paper filters made from cellulose fibers represent a great sustainable alternative for the industry,” notes Hanske. “They provide many benefits being an efficient plastic-free solution made with 100 percent renewable raw material, leaving no trace thanks to its faster degradation. We also observe that the industry is looking to use more natural materials for their packaging. It is again an opportunity for SWM to put decades of know-how at the service of the market.”
According to Hanske, SWM is ready to serve its customers no matter where the market takes them. “Beyond cigarette papers, the priority at SWM today is to offer the technical solutions needed by our customers to adapt and grow their business, be it in the traditional cigarette market or in the developing spaces like heated-tobacco products, smokeless or cannabinoids.”
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.

October 1, 2021
Shaking off the Shackles

Photo: prakasit khuansuwan/EyeEm
The Philippines is rebuffing outside forces seeking to derail its tobacco harm reduction policies.
By Stefanie Rossel
The Philippines is about to become the first country in the Asia-Pacific region to introduce risk-proportionate vaping legislation. By doing so, it is defying the World Health Organization, which has been skeptical about tobacco harm reduction (THR). The Philippines is part of a small group of nations that have started scrutinizing the influence of big WHO donors on national tobacco control policies.
In December 2020, two Filipino congressmen called for a congressional investigation into the Philippines Food and Drug Administration’s (PFDA) acceptance of funding from the International Union Against Tuberculosis and Lung Disease, which is popularly known as The Union. The Union is a major beneficiary of Bloomberg Philanthropies, a foundation created by U.S. billionaire Michael Bloomberg, that is known for its anti-vaping agenda. By accepting funding from Bloomberg, the representatives argued, the PFDA violated a number of critical regulations in the public sector. These include the Anti-Graft and Corrupt Practices Act, the Code of Conduct and Ethical Standards for Public Officials and Employees, the Tobacco Regulation Act, the Lobbying Act and the Foreign Agents Registration Act. The PFDA’s director general had previously admitted during a public hearing that the agency had received more than $150,000 from The Union, essentially to hire employees to outline the Philippines’s tobacco control policy.
Since 2006, Bloomberg Philanthropies has invested $1.1 billion to advocate for tobacco control policies worldwide. These policies are largely based on MPOWER, a set of demand-reduction strategies derived from the WHO Framework Convention on Tobacco Control (FCTC). A substantial portion of Bloomberg Philanthropies’ work has advanced tobacco control in many countries. However, support for adult smokers to quit—a component of MPOWER—has been completely ignored by the organization and its partners, according to Derek Yach, founder and president of the Foundation for a Smoke-Free World (FSFW). “These organizations see THR as a ploy of the tobacco transnationals,” he says. “With this perception, they ignore the vast benefits of THR and its potential to end smoking in this generation.”
Bloomberg Philanthropies and its partners are not investing to develop research and capacity in low-income and middle-income countries (LMICs) on THR and the safety of associated products, notes Yach. “By continuing to ignore the growing evidence, including from the Royal College of Physicians, showing e-cigarettes and other reduced-risk products are much less harmful than combustibles, Bloomberg and others are impeding important progress in the fight to end smoking,” he says.
Far-Reaching Influence
Around 80 percent of the more than 5 trillion cigarettes smoked globally each year are consumed in LMICs. By its own reckoning, Bloomberg Philanthropies is present in 110 LMICs through its Bloomberg Initiative to Reduce Tobacco Use. These include India and China, which together account for nearly 40 percent of the world’s smokers. The initiative, Bloomberg Philanthropies claims on its website, “is helping cities and countries implement measures that are proven to reduce [tobacco] use and protect people from harm.”
Michelle Minton
The initiative’s influence extends through all levels of society, media and government. According to an analysis by Michelle Minton, senior fellow at the Competitive Enterprise Institute (CEI), it seems to be aimed at imposing its will on the developing world. Minton’s findings are based on a leaked document obtained by CEI, which detailed the 2017 LMIC strategy of the Campaign for Tobacco-Free Kids (CTFK), Bloomberg Philanthropies’ largest beneficiary. The CTFK is part of a complex network of Bloomberg Philanthropies-funded organizations, all of which pursue a zero-tolerance approach to all tobacco use.
For these organizations, the term “tobacco” includes reduced-risk products (RRPs)—essentially, anything containing nicotine that is not a pharmaceutical nicotine replacement-therapy product. The CTFK has attempted to influence political processes and key players in various countries with the help of partnerships and often financial collaborations with activists, think tanks, professional associations, media, universities and governments. According to Minton, the CTFK and its grantees pay to manipulate news coverage. She calls the CTFK’s strategy “a highly synchronized chorus of interdependent interest, coordinated from afar.”
Lacking the funds to conduct their own THR research, most LMICs follow the WHO’s guidelines unquestioningly. In recent years, their delegates have continued to confirm the WHO’s anti-THR stance during the FCTC Conference of the Parties (COP) sessions. The next summit, COP9, which was postponed due to Covid-19, will now take place in November 2021 and presents another opportunity for delegates to make a change.
The influence of Bloomberg and his fellow WHO sponsor, Bill Gates, has also been brought to light by a number of recent articles. A study by Mitsuru Mukaigawara et al., published by Wellcome Open Research, examines the extensive use of media and academic influence by Bloomberg and the Gates Foundation to drive the global tobacco control agenda. “Highlighted by their influence over the World Bank and WHO, the authors show that the two organizations have been able to create a multilayered approach that touches many of the key stakeholders and undermines national sovereignty in tobacco control,” Yach explains. “Their broad and tight grip on various tobacco control activities will be tough to overcome. What may well happen, though, is that the weight of scientific evidence favoring THR will in time break through into the corridors of future WHO COP sessions.”

Due to the travel restrictions, the ninth Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control will be a virtual event. Discussions about tobacco harm reduction have essentially been tabled until COP10 in 2023. (Photo: olrat)
THR Discussions Postponed
Yach is less optimistic that such evidence will change minds among participants in the upcoming COP. “Unfortunately, due to the travel restrictions, FCTC-COP9 will be a virtual event with limited technical discussions, essentially tabling THR discussions until COP10 in 2023,” he says. “Even before this announcement, the WHO’s lack of transparency in its reports on novel products reveals a prohibitionist stance on THR.”
Over the past decade, Yach observes, media access to the FCTC has been constrained, and documents are published by the secretariat without formal member state input. “In fact, for the upcoming COP9 meeting, documents containing serious implications for THR are presented to be ‘noted’ without being subject to the usual United Nations practice of being thoroughly discussed and revised,” he says. “Many LMICs may well be persuaded by Bloomberg grantees to go ahead with bans and prohibitions of THR products supported or encouraged by WHO documents. These decisions will undermine the long-term health of their smokers.”
Derek Yach
In the run-up to the conference, the FSFW has started a campaign to inform COP9 delegates on the potential of THR. “Our goal is simple: Ensure that all involved directly or in advisory roles to member states engaged in COP9 are equipped with the best scientific data and information,” says Yach.
The FSFW’s new Commission Report: Reignite the Fight Against Smoking, created by an international team of experts, highlights the opportunities to reduce the death and disease caused by smoking through use of THR and, in time, more effective cessation, Yach says. “The report provides member states with up-to-date data and insights about the value of innovation in driving changes in some companies. It spotlights which countries are making the most progress and which are badly lagging.” The report also highlights the need for doctors to take a more supportive role in advancing use of cessation and THR in LMICs, and the need for industry to be more aggressive in addressing youth access and marketing, according to Yach.
The Commission Report, available at www.fightagainstsmoking.org, is complemented by the Patent Landscape Report, which is available on the FSFW website and presents an overview of current patents for THR technologies. “The FCTC failed to recognize importance of intellectual property and technological innovation,” says Yach. “Both are now driving change in the industry and further exacerbating the advantages developed countries have over LMICS as patenting activities in developing and least-developed countries are not comparable to those in the developed world.”
Progressive Stance
The Philippines is not the first country to reject the influence of Bloomberg Philanthropies on its tobacco control policies. In 2017, the government of India prevented two not-for-profit organizations funded by Bloomberg Philanthropies from carrying out tobacco control work in New Delhi after they failed to disclose their financial backers. In March 2021, a Mexican activist revealed that a proposal to prohibit the import, distribution and sale of vaping products had been formulated by CTFK’s legal advisor for Latin America.
THR proponents hope that the Philippines will become a model for other Asia-Pacific countries where smoking prevalence is high and RRPs are currently either banned or restricted. After years of opposition to RRPs, the Philippine House of Representatives in early 2021 proposed House Bill 9007, which will regulate electronic nicotine-delivery systems (ENDS). If approved, the Philippines Department of Trade and Industry, in consultation with the PFDA, will be assigned oversight of ENDS regulation.
Among other things, the bill stipulates that only retailers will be allowed to sell electronic nonnicotine delivery products and heated-tobacco products (HTPs). Retailers will be required to check buyers for a valid government-issued ID. Manufacturers, importers and distributors will need to comply with certain packaging and health requirements. Use of RRPs will be allowed only in designated areas, and the sale or distribution of these products will be prohibited within 100 meters of schools, playgrounds and other facilities frequented by minors. (Currently, the minimum age for purchase of ENDS and HTPs in the Philippines is 21.) Bill 9007 passed the House in May with a comfortable majority of votes; the Senate was expected to vote on it this fall.
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.

October 1, 2021