Author: Staff Writer

  • TPB Announces Third-Quarter Results

    TPB Announces Third-Quarter Results

    Turning Point Brands reported net sales of $109.9 million in the third quarter of fiscal 2021, up 5.5 percent over that of the previous year’s third quarter. Gross profit increased 12.3 percent to $54.3 million and net income increased 49.3 percent to $13.4 million.

    “Our third quarter performance fell within our expectations with sales growth of 11 percent in our core business despite facing the headwind of Covid-related consumption and other benefits we experienced in the prior year period,” said TPB President and CEO Larry Wexler in a statement.

    “Zig-Zag had another robust quarter driven by our strategic initiatives and growth within our Canadian business. Stoker’s saw double-digit growth in our Moist Snuff Tobacco (MST) business which drove growth in the overall segment. Regarding capital deployment, we continued to repurchase our shares during the quarter and today announced an increased share repurchase authorization. We also maintain a strong balance sheet to pursue a healthy pipeline of investment opportunities. Overall, we remain optimistic about the growth prospects in our core business.”

    NewGen Products gross profit increased 22.4 percent to $13.5 million for the quarter. The segment gross margin expanded 760 basis points to 36.2 percent with the improvement partially driven by industry pricing pressure ahead of the PMTA submission deadline in the previous year comparable period.

    Wexler said he was encouraged by the U.S. Food and Drug Administrations recent decision to reconsider and place back into review the premarket tobacco product application for TPB’s proprietary vapor products, which the agency had earlier rejected.

    “I am confident that we submitted a robust application and look forward to engaging with the FDA in its review,” he said. “We continue to believe that robust regulatory oversight is a positive for the industry and we believe we are favorably positioned to leverage our strong regulatory and logistics capabilities to capitalize on an attractive long-term opportunity.”

  • Minister: Tobacco Will Remain Cash Crop

    Minister: Tobacco Will Remain Cash Crop

    Workers at a Malawi leaf processing facility prepare to unload a fresh shipment of tobacco.
    (Photo: Taco Tuinstra)

    Tobacco will remain Malawi’s cash crop for the foreseeable future, according to Minister of Agriculture Lobin Lowe. Speaking after touring Japan Tobacco International Leaf Malawi Factory, Lowe urged farmers continue their commitment to the crop, according to Malawi24.

    Citing JTI’s recent $1 million investment in maintaining its Malawi factory, Low said it is pleasing that companies consider Malawi as a leading processing country. The investment, he said, is evidence that tobacco has a bright future in Malawi.

    “If we talk of other crops, we are talking of complementing tobacco and not getting away from tobacco. This alone shows that we are still relying on tobacco in the short, medium and long term,” said Lowe.

    As global demand for cigarettes has stagnated, Malawi growers have increasingly been eying alternative crops. In May, Malawi’s president, Lazarus Chakwera, urged a switch to high-growth crops like cannabis, stating that tobacco, the country’s leading foreign exchange earner, was in terminal decline.

    While expressing confidence in tobacco, Lowe lamented farmers’ low earnings. Growers, he said, retain little money after repaying the inputs they got from tobacco companies. He also complained that the ministry did not get enough forex from tobacco sales.

    Low urged discussions between buyers, processors and the regulator to make sure that farmers are attracted to tobacco.

    JTI Managing Director John Gauna called on government to remove non-value costs in order to make Malawi’s processing facilities financially appealing.

    Gauna said that a number of tobacco processing factories have closed in the neighboring countries, and this has created an opportunity for Malawi to position itself as a competitive alternative.

    But taxes and levies in commodity processing are making Malawi unattractive, according to Gauna.

    “We boast capacity to process up to 240 million kilograms of tobacco leaf here in Malawi. But at the moment we aren’t achieving anywhere near this,” said Gauna.

    The JTI factory can process up to 50 million kg of leaf but is currently processing around 40 million kg, up from 28 million last year.

  • Tobacco Smuggling Route Used For Humans

    Tobacco Smuggling Route Used For Humans

    Seven Moroccan and Malian nationals were apprehended after using former tobacco smuggling routes for illegal immigration between Spain and France.

    A joint investigation by Spain’s Civil Guard and the French National Gendarmerie, supported by Europol, led officers to dismantle an organized crime group involved in migrant smuggling. The group is believed to have moved irregular migrants from their country of arrival to another destination within the European Union.

    “The organized crime group would firstly seek newly arrived irregular migrants in southern and eastern Spanish coastal areas such as Murcia, Alicante, Vizcaya, Guipuzcoa, Navarra and Barcelona,” Europol wrote in a press note.

    “The migrants arrived by boat from destinations in North and West Africa. Those irregular migrants would then be taken by road to France via former tobacco smuggling routes in Guipuzcoa and Navarra. The main destination point from there would be Bordeaux, France, with the organized crime group facilitating further illegal immigration from Bordeaux to countries across the European Union.”

  • FDA Rescinds Another Marketing Denial Order

    FDA Rescinds Another Marketing Denial Order

    The U.S. Food and Drug Administration has rescinded another marketing denial order (MDO), placing Fumizer’s flavored vapor products back under review, reports Filter. Fumizer received its MDO in September.

    This recission comes just weeks after the agency withdrew an MDO issued to Turning Point Brands (TPB).

    In a letter to Fumizer’s, the FDA stated that “upon further review of the administrative record, FDA found relevant information that was not adequately assessed previously.”

    “Specifically,” the letter states, Fumizer’s “application did contain randomized controlled trials comparing tobacco flavored ENDS [electronic nicotine-delivery systems] to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use and perceptions in current smokers, current ENDS users, former tobacco users and never users, which require further review.”

    The FDA has indicated that it “does not intend to initiate an enforcement action” on Fumizer’s flavored vapor products returning to the market during the new review.

    Many MDO recipients have complained that the FDA has been “shifting its goal posts,” during the review process, demanding certain studies that it did not appear to require before the PMTAs were filed.

    According to industry insiders, the most recent MDO recission demonstrates that TPB’s successful petition for review and motion for a stay wasn’t a one-off, resulting from the legal jurisdiction it was filed in.

    “A rescission in California for Fumizer is evidence of the systemic failure of the agency to ‘adequately assess’ the science and data of a wide range of small- and mid-sized applicants while giving all of their time and attention to the large companies like Juul and Reynolds,” a source told Filter

    Multiple companies have challenges their MDOs. Triton, Bidi and Gripum recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.

  • Leadership Transition at Smoke-Free Foundation

    Leadership Transition at Smoke-Free Foundation

    From left to right, Derek Yach, David Janazzo and Heidi Goldstain

    Foundation for a Smoke-Free World today announced that Derek Yach will no longer serve as president and board director. Heidi Goldstein, general counsel, and David Janazzo, chief financial officer and executive vice president of operations and finance, will serve as interim co-presidents, effective immediately, while the board conducts a search for a new president to lead the foundation and its vital mission forward.

    “After careful consideration, the board has determined that now is the right time for a new leader to guide the essential efforts of the Foundation, its team and its work with partners around the world,” said Pamela Parizek, chair of the Foundation’s board of directors, in a statement. “As we continue to take urgent action to accelerate progress toward ending smoking in this generation, we look forward to this opportunity to take the Foundation to the next level of achievement.

    “The Foundation remains squarely focused on its mission to improve global health by reducing death and disease caused by smoking, and Heidi and David, together with the rest of our talented team, will continue advancing our global research grantmaking, range of innovative programs and powerful public health collaborations without interruption.”

    Parizek continued, “On behalf of the board, I want to thank Derek for helping to establish and build the Foundation. We deeply appreciate the contributions he has made to this team’s work and to communities around the world through decades of ground-breaking efforts in tobacco control and public health. We wish him all the best.”

    “The Foundation’s ongoing work to end the world’s largest single preventable cause of death could not be more needed today,” said Yach. “I leave the Foundation with deep satisfaction that we now have an emerging cadre of hundreds of researchers, advocates and industry scientists dedicating themselves to this goal. My future efforts aim to complement them.”

  • CDC awards $35 million in contracts

    CDC awards $35 million in contracts

    Photo: Katherine Welles

    The U.S. Centers for Disease Control and Prevention (CDC) has awarded global consulting and digital services provider ICF three contracts with a combined value of $35 million to provide digital transformation, health surveillance, data management, technical assistance and communications services to its programs.

    The agreements include a $9 million task order with the Office on Smoking and Health to provide communications, marketing and partnership engagement services, as well as research and technical assistance support on issues related to tobacco control, including the development and implementation of campaigns and the release of Surgeon General reports.

     “ICF has partnered with CDC programs for over 30 years, and we have the right people and the right skills in place to meet their complex needs—from public health research to data analytics and IT modernization to communications and citizen engagement,” said Mark Lee, ICF executive vice president and public sector lead, in a statement. “We look forward to continuing to help CDC advance the critical public health missions of its programs.”

     ICF brings together public health, health technology and technical support services to help organizations solve complex challenges. ICF’s approach combines advanced analytics, industry expertise and enterprise technologies.

  • A Better Treaty

    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.

  • Mexico: Nearly One in Five Cigarettes Illicit

    Mexico: Nearly One in Five Cigarettes Illicit

    Photo: Hassan

    Illicit products account for 18.8 percent of Mexico’s cigarette market, reports Mexico Daily, citing a report released by the Confederation of Industrial Chambers of Mexico (Concamin). The figure is up from just 2 percent in 2011.

    The illicit trade has cost the government an estimated MXN13.5 billion ($667 million) in uncollected excise and VAT taxes. The report added that the illicit sales create unfair competition for legitimate sellers and noted that the black market was helping to fund criminal activities, which negatively affect public security.

    Concamin said that two-thirds of illegal cigarettes do not carry the security code that proves compliance with tax regulations “Illegal cigarettes are a multidimensional problem that has become sophisticated in recent years,” it noted.” Although before there was no local production of illegal cigarettes, today we can see in the market many brands do not have the security code that the government requires through the [tax regulator] SAT. This dynamic represents two-thirds of the problem.”

    The Federal Commission for Protection Against Health Risks reported that there are more than 245 brands of illegal cigarettes in Mexico, mainly of Chinese origin, with the brands Win and Brass standing out as leaders in the cigarette contraband market, with 6.7 percent of total cigarette sales.

  • Mi-One Brands Launches Pod Nic-Salt Device

    Mi-One Brands Launches Pod Nic-Salt Device

    Photo: Mi-One Brands

    Mi-One Brands has launched its Mi-Pod 2.0, a sleek refillable liquid pod-based system with a larger battery, laser-cut mesh coil pods and robust flavor production. According to Mi-One Brands, the device is one of the few sub-OHM pod systems on the market. It is designed for use with nicotine salt-based e-liquids.

    “We have always designed products with attention to detail of all the five senses to create the ultimate user experience,” says Geoff Habicht, co-founder of Mi-One Brands, in a statement. “With Mi-Pod 2.0, we not only incorporated the five sense and years of customer feedback into the design, but we also added sacred geometry designs to symbolize the ‘connection to self,’ which we have found so vitally important on the journey to live a smoke-free life.”

    Headquartered in Phoenix, Arizona, USA, Mi-One Brands started in 2008 as Smoking Vapor, providing alternatives to combustible tobacco cigarettes before the term “vaping” was coined. Co-founders Amir Hakak and Geoff Habicht created Mi-One Brands to help eradicate the harm caused by smoking and improve the lives of adult smokers with simple, efficient designs and convenient, high-quality devices.

  • Roya Ghafele

    Roya Ghafele

    The Importance of Intellectual Property

    I figured I’d drawn the short straw when I was told I had to cover the GTNF session on intellectual property (IP), so I probably wasn’t paying as much attention as I should have been until I heard the presenter say she wanted to share her “passion for patents.”

    At that suggestion, my ears pricked up. I had never heard the phrase “passion for patents,” and I had assumed I never would, given that it seemed to encapsulate the ultimate oxymoron. And, as it turned out, what was being spoken about wasn’t a passion for patents only but a passion for IP, which, in turn, wasn’t only about patents, trademarks and copyrights. Roya Ghafele, managing director of the law and economics consultancy OxFirst, told her audience that IP was about ownership, knowledge, creativity, new views, new perspectives and new ways of seeing the world and about how we were going to organize and manage property rights, private property or what’s in our brains. “I can’t think of anything more revolutionary and more exciting than that,” she said.

    But then Ghafele, who is also a visiting professor of IP law and economics at the School of Law at Brunel University, London, went on to speculate about whether we were taking capitalism to the next step, leaving the audience to ponder, I guess, whether such a step would be up, down or sideways or, indeed, whether it would be revolutionary, not a word normally associated with capitalism. But there again, we are living in interesting times. The theme of the GTNF was “Continuing Change: Innovation and sSustainability,” and continuing change seems to speak more to concepts of anarchy than capitalism.

    This is not to get away from the subject. Ghafele made the point that considerations of IP went beyond our normal understandings into the territory of how we perceive politics and also into the areas of organizing business, economics, society and beyond. “Would emotional property follow on from intellectual property?” she wondered.

    Who knows? Currently, we’re apparently at the stage where everybody wants to lead by harnessing innovation. Though, one problem here is that the IP underpinning such innovation is the elephant in the boardroom. IP tends to be left in the hands of legal teams and, in extremis, the judiciary, which is concerned with the law and is not democratically accountable, while those who are accountable, politicians, do not have IP, nor potential policy governing it, in the forefront of their minds. Ghafele said that, in her view, even CEOs lacked adequate understanding of business strategy around IP. In fact, there was a way of looking at IP that she found conservative and paradoxical. The thinking behind governance structures that helped frame the basis of innovation was not itself innovative. It was rather cautious and backward looking.

    Patents, it turns out, are not, or, certainly, were not, in the DNA of tobacco corporations, which, in the past, were solely part of an industry tied up with consumer brands and trademarks. Patents came to the fore with the introduction of novel products in reaction to the major governance change brought about by the coming into existence of the World Health Organization’s Framework Convention on Tobacco Control. We know this because Ghafele’s presentation was based on research carried out into IP in the tobacco space, with sponsorship from the Foundation for a Smoke-free World—research she described as being one of the first projects to start thinking seriously about patents and new technologies in the context of fighting the smoking pandemic.

    But while patents might not have been in the industry’s DNA, the industry hasn’t done too badly during the past 10 years. The research turned up 70,000 patents in the fields of nicotine vapor products, smokeless nicotine products and heated-tobacco products, broadly describing technologies aimed at reducing the harm of smoking. This level, which was boosted somewhat by nontobacco/nicotine industry players, was described as indicating a good level of investment.

    Now for the bad news. Ghafele said she had been shocked by the massive gap between developed and developing countries when it came to patent filing. It was a good rule of thumb that companies did not intend to sell their products in countries where they were not filing patents, and they were not filing them in large numbers in developing countries where the smoking pandemic was particularly pronounced. While acknowledging that patent systems in some developing countries were unsophisticated, Ghafele said the current situation was wrong. “There is nothing else to say but that is wrong,” she said.