Year: 2023

  • Filling the Gaps

    Filling the Gaps

    Image: boldg

    As it seeks to reduce its reliance on tobacco, Zimbabwe is investing in cannabis research.

    By Daisy Jeremani

    In a bid to bridge the knowledge gap in Zimbabwe’s burgeoning cannabis industry, the Zimbabwe Industrial Hemp Trust (ZIHT) has identified 63 medical doctors for training to equip them with skills to conduct medical and clinical research on cannabis.

    They are in a flexible 12-month online program that was designed in Australia by the International College of Cannabinoid Medicine. Students can study at their own pace but are expected to finish the course within 12 months.

    Nesisa Ncube, a junior resident medical officer at Mpilo Central Hospital in Bulawayo, Zimbabwe’s second biggest city, views her selection to participate in the course as an honor and an opportunity to learn more about the new medicinal cannabis sector.

    She hailed the training as “insightful” as it delves, among other modules, into pharmacokinetics of medicinal cannabis and also what to consider when planning to prescribe medicinal cannabis to a patient.

    “It has been interesting to learn how some conditions which don’t have clear and effective treatments are now being treated with medicinal cannabis, and there have been some good outcomes,” she said in an interview with Tobacco Reporter.

    The southern African nation, which is also the continent’s biggest tobacco producer, has been working to diversify that sector amid the intensifying campaign against the golden leaf over environmental and health concerns. Zimbabwe identified cannabis production as among the possible pathways to diversification.

    In April 2018, it became Africa’s second country (after Lesotho) to issue licenses for production of cannabis for medicinal and scientific use. Thereafter, the government created a licensing and enforcement desk to administer the relevant statutory instrument on behalf of the health ministry. The desk’s mandate covers applications for licenses of sites, applications for renewal, variation or amendment of licenses for sites or persons, the production, handling, import and exportation of controlled substances and all compliance issues relating to controlled substances.

    Locally produced cannabis is largely for export purposes only, with domestic use restricted to research and development purposes.

    In its 2022 annual report, The Medicines Control Authority of Zimbabwe (MCAZ) says that it has issued 59 licenses for production of cannabis for medicinal and scientific use. Fifty-eight licenses were active with 56 of them being for cultivation and production and two for cultivation and research.

    Last year,, the MCAZ received two applications for production of hemp-based cannabidiol products as complementary medicines. It issued one of the applicants with a pharmaceutical manufacturer’s license restricted to complementary medicines manufacture.

    Among the major licensees is Swiss Bioceuticals, which launched a $27 million medicinal cannabis farm just outside Harare in May 2022.

    ZIHT CEO Zorodzai Maroveke said most of the ZIHT’s activities are to fill gaps and needs in the hemp industry, and one of the gaps it has identified is the lack of knowledge among local medical health professionals. It is against this background that the ZIHT has facilitated the year-long training program.

    “It is the study of a very huge biological system called the endocannabinoid system,” she said.

    The local medicinal cannabis industry has not developed as fast as expected since the first license was issued five years ago due to what Maroveke describes as tight compliance requirements by the regulator and failure to comply by most players. The enormity of resources required for entry is the biggest hurdle, she observed.

    ZIHT is worried over these challenges, which are frustrating more effective participation into this specialized area by local investors.

    “The industry remains capital-intensive, the market dynamics present a market access challenge, [and] lack of localized expertise have all affected the participation of local investors,” said Maroveke.

    Although ZIHT’s primary area of interest is industrial hemp, she said, their support for medicinal cannabis is because there was no active representation of the sector by its major stakeholders.

    Ncube is optimistic that the training she is undergoing will advance her career as it covers an area that is not yet part of the curriculum at local medical schools. The increase in the number of health professionals who are conversant with this novel treatment system, she observed, will add diversity to the medical fraternity.

    “The training will help advance my career by educating me on the mechanisms of action and prescribing considerations for medicinal cannabis, which is not really a subject that was covered in med school, and this will benefit the medicinal cannabis sector because this increases the number of health professionals who have knowledge on the subject, which enables expansion of the sector into other countries like mine,” Ncube said.

    “I see expansion of the industry with distribution centers all over the world with safe prescription and monitoring of patients by properly trained health care professionals on the subject.”

    Zimbabwe is battling an increase in psychiatric cases due to abuse of various illicit substances, cannabis included. Up to 80 percent of all admissions to Ingutsheni Psychiatric Hospital in Bulawayo are due to drug and substance abuse, including marijuana, officials say.

    Percy Mukwacha, who is also training in psychiatry at the University of Zimbabwe and is also undergoing training under the ZIHT scheme, said he was mostly impressed by the potential of cannabinoid not only to treat a number of illnesses but to also ease the burden on local healthcare.

    “In mental health, we get a lot of morbidity from cannabis use. That’s what interested me to join this training where cannabis can have positive effects on the society,” he told Tobacco Reporter.

    “I guess an understanding of this ubiquitous substance with problematic consequences has to be helpful in my career.”

    Treatments derived from cannabis, said Admire Machongwe, a medical doctor in private practice in Harare, have potential to revolutionize patient care in the country.

    “We were notified of the scholarship but were already intrigued by the way cannabinoid medicines were being used to treat chronic pain and other ailments,” he said.

    “It [training] will be quite beneficial,” he added. “We expect cannabinoid medicines to be licensed in Zimbabwe in the near future. Treatment of otherwise difficult-to-treat conditions like chronic pain and depression might be achievable.”

  • A Shot in the Arm

    A Shot in the Arm

    CME explores opportunities in packaging solutions for midsize and small tobacco companies and in areas like format changes, spare parts and mechanical and electrical upgrades with larger tobacco players. | Photo: CME Automation Systems

    Boosted by a significant private equity investment, CME Automation Systems is strengthening its offerings to the tobacco industry and other sectors.

    By George Gay

    Paul Knight

    In October, Tobacco Reporter had the opportunity of speaking with Paul Knight, the CEO of CME Automation Systems, which, two months earlier, following the receipt of what it described as “significant backing from private equity,” had announced in a press note that it would be looking to invest in strengthening its offering to its international customers in the pharmaceuticals, cannabis, tobacco and other fast-moving consumer goods (FMCG) sectors. Following are excerpts from our conversation.

    Tobacco Reporter: Is there overlap as far as you are concerned in the concepts underlying the technologies and performances of the machines used by the pharmaceuticals, cannabis, tobacco and other FMCG sectors, if not in the machines themselves?

    Paul Knight: The overlap is in some of the underpinning technology, not in the specific machine platforms. Some of the technology overlap is in our concepts for product handling, filling and packing. Our passion is for helping drive industries forward by improving production optimization.

    Will the investments specifically in tobacco machinery technologies form a significant part of the overall investment?

    We will definitely be expanding our offerings to the tobacco sector as part of our investment program, much of which will be around life extension and aftermarket support products.

    Does this mean that you have confidence in the longevity of the tobacco industry? Or do you think that with the right developments CME can increase its share of a decreasing market for tobacco packaging equipment?

    Yes, we do have confidence in the longevity of the tobacco industry, and we have confidence in our ability to increase our share of the marketplace with our new investments in mind.

    When you talk of the FMCG sector, do you include vaping products, or do they comprise a sector that you do not serve or intend to serve?

    Yes, we do work in both vaping and heat-not-burn sectors and anticipate strong growth as consumers move in bigger numbers toward these products from combustibles.

    Where will the overall investment be targeted mainly—at taking on more engineers, perhaps, obtaining new design tools, or investing in artificial intelligence (AI)?

    The investment is being targeted in several areas, particularly marketing, sales channels, new product development and existing product enhancement.

    In what areas, if any, does AI play a part in your overall operations or will play a part in the future?

    AI is starting to make an impact in the administrative areas of our business, and over the next several years, we will see it start to make its way onto machine platforms for predictive maintenance and self-diagnosis.

    Will you be investing in new facilities, perhaps outside the U.K., given the challenges thrown up by Brexit?

    Yes, we will be looking to move elsewhere within the U.K. over the next one [year] to two years. But in all honesty, Brexit has not been an issue for CME outside of customs-related administrative changes.

    Is this a brave time for an international player to be looking to expand, what with the various challenges facing manufacturing, including raw materials supply chain difficulties, inflation and rumblings about the demise of globalization?

    Yes, it is; there are many risks in the macroeconomic and global political environment, but we believe counter cyclic investment is a good play for CME at our current stage of development.

    In the August press note, CME said the new investor had identified “the potential to build on CME’s expertise and reputation for innovation, especially given the company’s recent success in developing new solutions for growth markets such as cannabis and clinical trials.” Could you describe briefly what form these successes took?

    For clinical trials, we have developed a system called PACE, which is designed to automate clinical trial provisioning for multinational pharma companies. Our first customer is a consortium including Astra Zeneca and GSK. This is a huge opportunity for CME’s future. In the cannabis market, we now have our widest product portfolio and plans to put a footprint in North America.

    Would you describe CME as a medium-sized player in the tobacco packaging field?

    Yes.

    How else would you describe CME?

    CME is a business that is passionate about innovation, solving problems for our customers and markets, adding value to their businesses and ensuring their future success. 

    The press note mentions bespoke machinery. Do you regard this as one of your main strengths in the tobacco packaging field?

    Bespoke machinery design and build is a strength of CME’s, but we do relatively little of this in the tobacco packaging sector.

    What are your other strengths in this field?

    A broad range of high-quality standard and flexible machinery products that cover the range of needs from small independent producers to multinationals up to 400 packs per minute.

    Do you see change coming in the environment in which tobacco packaging machinery companies compete?

    Change in our sector is already well underway! I think in terms of new packaging machinery, demand is moving toward higher speed equipment, particularly in the multinationals. We are not in the high-speed segment, so this leaves us to explore lower speed packaging in mid-size and small tobacco companies globally and in areas like format changes, spare parts and mechanical and electrical upgrades with larger tobacco players. There is also clearly a geographical demand shift away from developed economies to developing economies for combustible tobacco products and a shift toward vape/HEBB-style products in developed economies.

    The press note does not mention who is providing the investment funding. Is there a reason for this?

    The funder wishes to remain anonymous.

    The press note does not mention the level of the funding either. Are you able to provide a rough figure?

    It is a seven-figure number.

    Is there anything else you would like to say about the new investment funding and how it will affect CME’s future?

    The investment represents a new dawn for CME and our ability to focus significant investment capital on our target markets via new product development and product enhancement. We could not be more excited to have a committed investor that believes in our ability to grow into the future.

  • PCA Debuts Advocacy Grant Program

    PCA Debuts Advocacy Grant Program

    Image: Olivier Le Moal

    The Premium Cigar Association (PCA) of the United States announced a new state advocacy grant program aimed at investing in state associations and their boots-on-the-ground lobbying capacity for the 2024 legislative cycle.

    The resources in the program approved by the PCA board of directors will be spent much like a match grant program where the state association agrees to match funding by the PCA, going toward hiring contract lobbyists to advance positive legislation or fight back against erroneous regulations. State associations must have a basic infrastructure in place and must meet certain criteria to be eligible for funding, including having an incorporated state association and agree to accountability and transparency with the PCA about where the funds will be spent. 

    “This is not only a way for us to support existing state associations and their advocacy capacity, but it also establishes a baseline for starting a brand new state association with the prospective of seed funding. This criterion is a blueprint to get started and to receive funding. Our staff will continue to support individual associations and retailers with strategy and logistics, and this is a new tool to help maximize that effectiveness,” says Scott Pearce, executive director of the PCA.

    Grant criteria include: having an incorporated and active state association; having an elected board of directors; having a designated treasurer with authority over accounts; agreeing to comply with PCA reporting requirements; agreeing to PCA involvement in consulting lobbyist selection process; agreeing to disclose any and all issues for which funds are used and for which lobbyist is engaged; and providing the PCA with the operating budget and amount and source of funds raised by the state association.

    “This year, our team has been extremely effective in the states and is reflective of retailers stepping up to defend their businesses. This state grant program is aimed at spurring this level of activity and, frankly, success moving forward. Each year, our team must evaluate our priority area, and in the past, our Vision 50 strategic plan focused on litigation or international outreach. Make no mistake, this is the year of the states,” says Joshua Habursky, the PCA’s head of government affairs.

    Applications can be submitted to the PCA online portal and will be reviewed by appropriate advocacy staff and the PCA Legislative Affairs Committee. Applications will be reviewed on a rolling basis and will reflect legislative/regulatory necessity in the state. 

  • Shifting Sands

    Shifting Sands

    Image: Givaga

    Under pressure from the IMF, Egypt’s government reduces its share in Eastern Co.

    By Stefanie Rossel

    On Oct. 29, 2023, Egypt’s House of Representatives approved a long-expected tax hike on tobacco products. The amendment to the 2016 VAT law will expand the price ranges of taxed cigarettes by raising the minimum and maximum limits of each segment by 12 percent annually for five years. In addition, the draft law will increase the fixed tax by EGP0.50 ($0.02) on the three segments of cigarette prices, resulting in EGP4.5 for cigarettes retailing at less than EGP31, EGP7 for the mid-price cigarette range (those costing between GDP31 and GBP45) and EGP7.5 for cigarettes priced above EGP45.

    The bill also increases the tax on tobacco products by 75 percent, raising the minimum from the present EGP30 to EGP60 per kilogram. Imported and local molasses products will see a 25 percent tax hike whereas the tax on heated-tobacco products will rise from EGP1,400 per kilogram to EGP1,800 per kilogram. Under the new law, e-liquids will be taxed at EGP4 per milliliter instead of the current EGP2 per milliliter.

    The amendment will allow cigarette manufacturers, who have been facing increasing production costs and a plummeting Egyptian pound, to adjust prices without moving into higher tax brackets. The tax hike is expected to generate up to EGP8 billion annually in additional revenues for the state budget.

    According to the head of the House’s Planning and Budget Committee, the move is also designed to encourage tobacco companies to increase production in a way that will stem the rise in cigarette prices, thus putting an end to the country’s cigarette crisis. Since May, the Egyptian cigarette market has been in turmoil. According to observers, the problem emerged after the minister of finance called for an amendment to the 2023–2024 budget to increase its tax revenue from EGP81 billion to EGP87 billion. The government, however, was slow to implement the tax hike. What followed was a shortage of tobacco products, particularly cigarettes, and the rise of an informal, parallel market in which a pack of the country’s most popular brand, Cleopatra, sold at EGP50 instead of EGP24.

    As soon as they got wind of the tax increase, tobacco traders seized the opportunity to make additional profits by hoarding cigarettes. The artificial scarcity caused cigarette prices to soar, forcing smokers to buy unknown, adulterated or smuggled cigarettes, which in turn reduced tax revenues. After Egypt’s tobacco monopoly, Eastern Company, increased production by 40 percent and stepped up vigilance against illicit sales, cigarette prices decreased to EGP40 in September.

    In the short term, [the deal] is clearly positive,” says Vorster, “but the potential for more adverse excise and regulatory regimes could detract from that significantly.” 

    Foreign Currency Crisis

    “Other than for the traders exploiting the situation, it is clearly an unfavorable environment, albeit one caused by tax increases telegraphed well ahead of their implementation, exacerbated by weak enforcement and currency shortages,” says Pieter Vorster, managing director of Idwala Research. “The tax hike helps to reduce margins in the parallel market, but stockpiling will likely continue if potential disruptions to production owing to currency shortages are viewed as possible.”

    Egypt was hit hard by Russia’s invasion of Ukraine in February 2022, which caused many foreign investors to abandon emerging markets. Consequently, the country has been struggling with rising global wheat and energy prices. According to a report by the U.S. Department of State, Egypt’s external debt reached $164.7 billion in June 2023.

    In December 2022, the International Monetary Fund (IMF) approved a 46-month $3 billion loan for Egypt to overcome its economic crisis under the condition that the government undertake several structural reforms. It insisted that Egypt adopt a flexible exchange rate, lift of import restrictions and privatize state-owned companies.

    Despite the government’s efforts to create a more favorable business environment, foreign investors continue to face challenges such as bureaucracy, lack of transparency, uneven enforcement, corruption, intellectual property issues and a shortage of skilled labor.

    Egypt’s sale of a major stake of Eastern Co. on Sept. 3, 2023, was part of its commitment to sell shares in 35 state-owned firms. Global Investment Holding (GIH) of the United Arab Emirates paid EGP19.3 billion for a 30 percent stake of the 50.9 percent stake that the state-owned firm Chemical Industries Holding Co. had previously held—a price that Vorster deems steep. “It seems a high multiple for a noncontrolling stake without the synergies that a tobacco company might have been able to extract,” he says. According to Daily News Egypt, both Japan Tobacco International and United Tobacco Co., in which Philip Morris International controls most shares, also submitted offers for a stake in Eastern Co.

    Following the deal, 20.9 percent of Eastern Co. remains with Chemical Industries Holding Co., 35 percent is freely traded on the Egyptian Stock Exchange, and the remaining 15 percent is owned by various private stakeholders. GIH announced that it would invest $150 million to rejuvenate Eastern Co.’s raw material supplies. Whether it will be allowed to use its funds to import tobacco, however, remains unclear. Egypt prohibits tobacco cultivation and taxes leaf imports at 75 percent. According to Mada, an Egyptian media organization, the Emirati firm will work with banks to facilitate Eastern Co.’s access to foreign currency for imports. “In the short term, [the deal] is clearly positive,” says Vorster, “but the potential for more adverse excise and regulatory regimes could detract from that significantly.” 

    A Growing Market

    The deal might still prove to be a win-win for both parties. Egypt is in dire need of U.S. dollars to pay for imports. Eastern Co. accounts for 70 percent of tobacco sales in Egypt, which is one of the world’s few remaining growth markets for cigarettes. Statista anticipates the market to generate $6.3 billion in 2023 and projects it to enjoy an annual growth rate of 9.65 percent by 2028. According to Alternative Policy Solutions, a public policy research project at the American University in Cairo, around 18 million Egyptians over the age of 15 are smokers. Overall cigarette consumption increased 7 percent in 2022. Smoking is a male habit: The World Health Organization projects that by 2025, 63 percent of the country’s male population will be smokers, up from presently 41.8 percent. Only 0.3 percent of women currently smoke.

    According to Forbes Middle East, Eastern Co. is worth $1.2 billion. The company reported a net profit of EGP5.29 billion in the first nine months of fiscal year 2022–2023– 24 percent higher than in the comparable prior-year period. Its revenues rose to EGP14.6 billion from July 2022 to March 2023 compared to EGP12.78 billion in the comparative period of the previous fiscal year. The company supplied 88 billion cigarettes to the Egyptian market in 2022–2023.

    With the acquisition of its stake in Eastern Co., GIH will have effectively established control over 40 percent of the Egyptian tobacco market as the investment firm’s founders also hold shares in UTC, according to Mada. How their acquisition will impact on the overall market remains to be seen. Citing Turkiye as an example, Vorster points out that there are several examples where the excise tax and regulatory environments became significantly less favorable when the state exited former monopolies. “It also seems plausible that the market could become significantly more competitive with PMI now manufacturing themselves, and others potentially following in future,” he says.

    PMI Starts Local Production

    In its domestic market, Eastern Co. is rivaled by only JTI and UTC. BAT exited the Egyptian market last year, claiming a lack of economic viability. Its withdrawal came shortly after PMI in April 2022 had reached a licensing agreement with Eastern Co. to manufacture cigarettes in Egypt. More than a year earlier, Egypt’s Industrial Development Authority had invited companies to bid to become the country’s second tobacco company. However, the agency was forced to relaunch the tender after bidders complained that its conditions gave unjust advantages to Eastern Co. In the renewed tender, UTC was the only company to bid. Under the agreement, Eastern Co. acquired a 24 percent stake in UTC.

    Although meant as a first step toward privatization of the tobacco monopoly, the agreement stipulates that UTC manufactures only products owned by PMI, thus protecting Eastern Co.’s market share by preventing the newcomer from producing cigarettes in the same price category as Eastern Co.’s bestseller, Cleopatra.

    In September 2022, UTC started producing cigarettes at the manufacturing site of its predecessor Philip Morris Misr, the licensee for PMI products in Egypt established in 2013. PMI’s flagship brand Marlboro has been manufactured by Eastern Co. since 1985. Following the agreement, PMI products in Egypt are marketed under the label “Made by UTC.”

    UTC also has permission to manufacture e-cigarettes. In April 2022, Egypt legalized the import and commercialization of vape products. Statista estimates that the revenue generated in the country’s e-cigarette market will reach $400 million in 2023.

    The recent sale of the stake in Eastern Co. could also pave the way for more ambitious tobacco harm reduction in Egypt. To date, Eastern Co.’s portfolio has offered only high-risk products, such as cigarettes, shisha and cigars. Vorster is less optimistic. “In theory, it is slightly positive, but with cigarette prices below $2 per pack, it is hard to see reduced-risk products gaining significant traction,” he says.  

  • Canada Targets Zonnic Marketing ‘Loopholes’

    Canada Targets Zonnic Marketing ‘Loopholes’

    Image: Imperial Tobacco Canada

    Canadian Health Minister Mark Holland announced that the health department will address “loopholes” surrounding Zonnic, a flavored nicotine pouch product from Imperial Tobacco Canada, reports the Canadian Broadcasting Corp.

    Health Canada previously approved the sale of Zonnic without any advertising or sales method restrictions.

    According to Holland, “the behavior and intentions of the tobacco industry have raised serious concerns as they appear to want to addict new young people to nicotine, which is appalling, and we want to address this issue.”

    In November, six national health organizations called on the government to immediately regulate the advertising and sale of flavored nicotine products; Zonnic is not included in any existing federal or provincial tobacco or e-cigarette legislation as it does not contain tobacco, contains less than 4 mg of nicotine and is not inhaled.

    Holland reportedly takes responsibility for the oversight and plans to review the approval process for nicotine products.

    Imperial Tobacco Canada must conduct annual self-reports and “identify any appeal or abuse of their products among young people,” Health Canada stated.

    “Marketing targeted at young people will be considered deceptive advertising and may trigger post-listing compliance action,” the Canadian Ministry of Health stated. Decisions regarding product sales locations and age restrictions are determined by individual provinces and territories, according to Health Canada.

    In response to earlier criticism, Imperial Tobacco Canada said that it has already taken measures to prevent youth access to its products.

  • Taming the Cowboys

    Taming the Cowboys

    Image: JEANNE

    Altria has declared war on the illicit disposable devices that are impacting its bottom line.

    By Timothy S. Donahue

    The illicit e-cigarette market is soaring. Illicit products are estimated to account for more than 60 percent of the $8.3 billion U.S. vaping industry. Statista expects the U.S. electronic nicotine-delivery system (ENDS) market to grow at a compound annual growth rate of 3.93 percent from 2023 to 2028. If the illicit market continues to go unchecked, however, companies that market legal vaping products fear many consumers will simply switch back to combustible products.

    “It is very much worth noting that this rapid apparent substitution is happening in an environment where half the vapor market is illicit; the FDA [U.S Food and Drug Administration] has hugely hampered vaping products making it onto the legal market, and consumers are hugely misled on relative risks,” said David Sweanor, an adjunct law professor at the University of Ottawa and a longtime tobacco harm reduction advocate. “As with other markets seeing similarly historic drops in cigarette use as alternative sales soar, it raises the question of just how rapidly cigarette sales could fall if policies were aimed at facilitating that rather than doing things to stymie it.”

    Altria, parent to Njoy, a leading brand of legal vaping products in the U.S., according to Nielsen, told investors during a recent conference call that the current state of the market is “intolerable” for both legitimate manufacturers and consumers. Altria CEO Billy Gifford said the regulated market is being overrun by illegal flavored disposable products manufactured and distributed by companies violating the rules and guidance laid out by the FDA. He said that regulation not enforced is indistinguishable from no regulation at all.

    “Illegal e-vapor products circumvent the actions of regulators, responsible manufacturers and retailers by evading scientific review, quality manufacturing controls, marketing oversight and legal aids or purchase restrictions. Despite recent actions by the FDA, enforcement has been inadequate and ineffective,” explained Gifford. “We believe the FDA has good tools necessary to bring order to the market. For our part, we are actively engaged with regulators, state and federal lawmakers, and trade partners and other stakeholders to build awareness of these serious issues and drive marketplace enforcement.”

    According to Gifford, the lack of enforcement has forced Altria to take a “targeted but necessary action.” The company filed a lawsuit in the District Court for the Central District of California against 34 organizations. Njoy alleges that the defendants are manufacturing, marketing, distributing, selling and/or marketing their flavored disposable ENDS unlawfully for three primary reasons:

    • They are not authorized pursuant to FDA marketing granted orders as part of the premarket tobacco product application process.
    • California bans the retail sale of flavored ENDS.
    • The defendants do not comply with the Prevent All Cigarette Trafficking Act’s delivery sale age verification, registration and filing, record keeping, tax payment and labeling requirements.

    Altria is asking for the court to provide appropriate restitution for harm suffered by Njoy due to the defendants’ unfair competition.

    “We want to protect harm reduction and the opportunity for the 30 million smokers in the U.S.,” said Gifford. “We really need to have enforcement where the smokers can make informed choices as they are moving across categories. I think that there’s an underlying positive is that we see adult smokers moving over, so they’re ready to have potentially reduced harm products. We just need them to be regulated and based on science to be in the marketplace.”

    Sal Mancuso, Altria’s chief financial officer, said that traditional cigarette volumes continued to decline in the third quarter of 2023. He said that the decline is impacted by the number of illegal products on the market; however, because illicit products are largely distributed through nontraditional untracked channels, the company has had to refine its ability to estimate the illicit product impacts on the legal vaping industry.

    “With the information we have today, we believe that there is more cross-category movement than previously assumed. And we now estimate that growth of illegal flavor[ed] disposable e-vapor products contributed to industry, cigarette industry declines in the range of 1.5 percent to 2.5 percent and over the last 12 months,” said Mancuso. “We will continue to monitor this dynamic trend and are actively pursuing better data sources to enhance our estimates in this space.”

    “We believe the FDA has good tools necessary to bring order to the market.”

    Amplifying Actions

    Altria Group completed its acquisition of Njoy Holdings in May. In 2022, Njoy Holdings received marketing orders for its Njoy Ace device along with several tobacco-flavored pods. At the time of writing, Njoy Holdings had received six of the 23 marketing orders granted by the FDA for the entire vaping product category, including pods, disposables and open systems. The regulatory agency is still reviewing Njoy’s premarket tobacco product applications for several Njoy menthol-flavored e-vapor products.

    Gifford said that the company executed Njoy’s business plans with “speed and focus,” adding that the goal is to grow the Njoy brand responsibly and sustainably. To set the foundation for success, Altria first strengthened Njoy’s supply chain. He said the company successfully solidified the entire Njoy supply chain from sourcing direct materials through the shipment to retail.

    “As a result, we do not anticipate capacity constraints as we execute our initial expansion plan. Next, during the third quarter, our teams prioritized closing inventory gaps at retail and expanding distribution of ACE,” said Gifford. “Prior to the acquisition, Njoy had a small-scale sales force, which resulted in inventory volatility and significant distribution gaps at retail …. Upon completion of the Njoy transaction, we immediately unleashed our sales force to focus on closing the inventory gaps in stores that already had distribution. We improved inventory conditions in stores and are actively working to close remaining gaps at retail.”

    Pamala Kaufman, a financial analyst with Morgan Stanley, asked Gifford if he believed Njoy could be successful and grow in a marketplace dominated by illegal products. Gifford said that the FDA still needs to get through its authorization process, and the agency’s actions will translate to the marketplace.

    Since its acquisition by Altria, distribution grew to approximately 42,000 stores during the third quarter of 2023 for the Njoy Ace, the company’s flagship device. The product is now distributed in all the top 25 U.S. convenience store chains by vaping product volume, according to Gifford. The company has also started to amplify visibility with new point-of-sale and fixture signage at retail.

    “During the fourth quarter, we continue to expect ACE expansion to reach a total of 70,000 stores by year end, representing approximately 70 percent of e-vapor volume and 55 percent of cigarette volume sold in the U.S. multi-outlet and convenience scanner,” said Gifford. “As we continue to expand distribution and close inventory gaps, we expect to further enhance visibility and product fixture space at retail.”

    Last month, Njoy unveiled its first retail trade program. The program allows retail partners to sign up for the program at various levels with merchandising options designed to position Njoy “strategically and responsibly” to current combustible tobacco consumers while boosting the awareness of the Njoy brand. Gifford said the company is beginning to test various promotional plans and anticipates more disruptive execution at retail in the fourth quarter. Moving into 2024.

    “We will continue to refine our promotional plans, implement Njoy’s retail trade program, further expand distribution and evolve our consumer engagement strategy. Our strategies will focus on informing adult vapors and smokers of the attributes of ACE, such as battery capacity and pod size, relative to other leading brands, generating trial and growing brand loyalty,” said Gifford. “In addition, plans for a new brand equity campaign are well underway. We expect the equity campaign to further amplify the brand’s presence at retail and drive consumer engagement.”

    Jacob de Klerk, an analyst for Redburn Atlantic, asked Gifford what the impact would be on Njoy’s projected market growth if the FDA doesn’t approve any flavors other than tobacco. Would only allowing tobacco flavors create enough demand for Njoy to remain profitable? Gifford said he believes there is room, and he wouldn’t rule out the potential for an authorized menthol product.

    “I wouldn’t rule out menthol. We feel good about the application—the current application in front of the FDA from a menthol standpoint. I think if you look at some of the recent marketing denial orders, it was related to ‘new following,’” he replied. “When we made the Njoy transaction, there was virtually no new following. As far as additional flavors are concerned, we’re excited and currently looking forward to being able to file [marketing applications] in the near future. We believe that [flavor] allows for adult consumers to have it as an offramp but not an on-ramp for underage users. So, we still see the potential for flavors.”

  • Canary Islands to Revise Tobacco Tax Law

    Canary Islands to Revise Tobacco Tax Law

    Image: Comugnero Silvana

    The Canary Islands plans to revise its tobacco products tax law in 2024, according to 2Firsts.

    Beginning next year, e-cigarette products and e-cigarette juices will be subject to a tax of €0.10 ($0.10) per milliliter with the revenue being incorporated into the 2024 budget proposal.

    Implementing this tax will make the Canary Islands the first Spanish autonomous community to impose a specific tax on tobacco products.

    The tax will affect e-cigarette devices and liquids regardless of nicotine content.

    A Ministry of Health report titled E-Cigarette Tax Review: European Regulations and Potential Scenarios in Spain predicts that the impending tax could increase national public revenue from €7 million to €48 million.

    The revised bill will also increase the tax rate for cigars and small cigars to 4 percent from 2 percent and increase the tax rate for other tobacco products to 10 percent from 5 percent.

  • Elf Bar Removing Some Flavors from U.K.

    Elf Bar Removing Some Flavors from U.K.

    Image: Tobacco Reporter archive

    Vaping brands Elf Bar and Lost Mary will remove dessert, candy and soft drink flavored disposable vapor products from the U.K. market, according to Vaping360.

    The brands make up more than half of the U.K.’s disposable vape sales, according to data firm NielsenIQ. They are owned by the Chinese firm Shenzhen iMiracle Technology, and it is unclear if the Chinese company will remove these flavors from other markets.

    Elf Bar has already ended U.K. sales of Bubble Gum and Cotton Candy flavors and renamed Gummy Bear “Gami,” according to the BBC.

    The decision is meant to help curb claims that the popular vapes are marketed to youth following a panic over youth vaping that has seen an uptick in the past couple years.

    Prime Minister Rishi Sunak proposed changes to the vaping laws in October. There is currently a public consultation to determine what actions to take.

    “The introduction of such a regime would mitigate children’s access to vapes and make it easier for the authorities to regulate the sale of vaping devices better. Furthermore, we believe it would help combat the growing illicit vape market and drive increased rates of vape recycling,” an Elf Bar spokesman said.

    Clive Bates of The Counterfactual questioned whether the move would silence the company’s critics. “Their detractors will take it as an in-principle admission of culpability and then build outward from that principle,” he said.

  • The Potential of Pot

    The Potential of Pot

    Photo: Konrad

    Despite regional setbacks, global cannabis sales are still getting higher.

    By Stefanie Rossel

    Global cannabis sales continue to grow, albeit at a slightly slower pace than before, facing headwinds in comparatively mature markets, such as Colorado or California. Euromonitor International expects the value of the global legal cannabis market to grow from $41 billion in 2022 to $98 billion by 2027. Despite increasing access and acceptance, the stigma around cannabis remains and regulatory uncertainty prevails.

    The main growth drivers are innovation, investments from tobacco companies and consumer perception. Cannabis caters to the needs of consumers unnerved by economic, environmental and political uncertainties along with the spread of armed conflicts. Indeed, data from Israel’s ministry of health shows a spike in demand for a medical marijuana program one month into the war with Hamas. Meanwhile, the government of Ukraine—another country at war—is preparing to legalize medical cannabis.

    Euromonitor expects noncombustible cannabis products to gain share as consumers become more concerned about their health. Further legislation of adult-use cannabis would have significant implications for other fast-moving consumer goods, according to the market intelligence providers, with innovations in cannabis involving topicals, beverages or edibles.

    Alert to opportunity, the major tobacco players have already ventured into the sector. Philip Morris International has invested in Vectura Fertin Pharma, a contract development and manufacturing organization specializing in gums, pouches, tablets and other solid oral systems for the delivery of active ingredients. According to news reports dated July 2023, PMI is also planning to take over Syqe Medical, an Israeli company, which manufactures a metered-dose inhaler for pain reduction using medical marijuana.

    BAT, for its part, has stakes in 13 cannabis startups. In April, the company entered a joint venture with Charlotte’s Web Holdings, a cannabidiol (CBD) producer based in Denver, Colorado, USA. Since 2021, it also holds a minority stake in Organigram, Canada’s second-largest licensed cannabis producer. In early November 2023, BAT boosted its interest in the company through a cad124.6 million ($90.15 million) investment. Last year, it invested $37.6 million in a leading German cannabis company called Sanity Group.

    Imperial Brands acquired a stake in Auxly in 2019, while Altria is represented in the cannabis market through Cronos of Canada.

    Despite the growth of the market, Canadian companies are struggling to profit from legal cannabis.
    (Image: JHVEPhoto)

    Successful Experiment

    Presently, two markets are of particular interest for investors in the cannabis space: Canada, which in October celebrated the fifth anniversary of legal recreational cannabis; and Germany, which was supposed to legalize cannabis in November.

    Canada’s government had committed itself to reviewing its Cannabis Act after three years, but the Covid-19 pandemic delayed that exercise. In October, the government published a summary of feedback provided by industry, healthcare and community groups. Its conclusions were sobering. Despite the growth of the market, companies across the supply chain are struggling to profit from legal cannabis. Legal producers are burdened by significant regulatory fees, distributor markups and taxes in a hyper-competitive market. The illicit market, meanwhile, still represents 40 percent of the business.

    In their rush to compete with illegal products, sellers of legal cannabis have dropped their prices dramatically, selling products for as low as cad3 per gram instead of the cad10 per gram originally envisaged by the government. Due to advertising and packaging restrictions, communication with consumers, even to inform them about different varieties of cannabis and their effects, is nearly impossible. As a result of such challenges, several first players have exited the market or reduced manpower.

    Legalization has also impacted public health: The Canadian Institute for Public Health noted that cannabis-related emergency department visits and hospitalizations increased 14 percent between 2019 and 2021. Despite its shortcomings, Deepak Anand, principal of Vancouver-based ASDA Consultancy Services, deems legalization a success. “Legalization has resulted in about a 50 percent reduction in illicit market sales,” he says, quoting a recent survey in which 48 percent of cannabis-using respondents stated that they purchased all their products at a licensed retailer.

    “Retailer availability and proximity is an important metric in increasing overall market penetration and facilitating access,” says Anand. “No one expected the illicit market to disappear on day one or year five of legalization. The fact that we are at almost 50 percent reduction says a lot about the progress made.”

    Altogether, 64 percent of Canadians supported legalization, according to the probe. The survey also showed that people aged 45 and older increased their cannabis intake the most of all age groups following legalization, whereas those under 17 reduced their consumption.

    Legalization has resulted in about a 50 percent reduction in illicit market sales.

    Lessons to be Learned

    Anand emphasizes that legalization is a process rather than an event and that the experiences of Canada show other countries what works and what doesn’t. Lessons, he says, include the importance of avoiding over-taxation and overregulation of a nascent industry, particularly when one of the goals of legalization is to transition consumption from illicit to licit channels.

    What’s more, tax earnings derived from legalization must not be used solely to fill government coffers. “Revenues must be reinvested by providing the industry with data, research and tools to support the nascent industry and transition supply from criminal and illicit channels.”

    Governments must also guard against setting the age of access too high or the THC limits too low, according to Anand. Furthermore, they should make sure that social justice reform is baked into any legalization programs.

    Anand expects the final report on Canada’s Cannabis Act, which will be tabled before Parliament in March 2024, to take into account industry suggestions on taxation and THC levels, concerns from academics about the lack of research and a call for an overhaul of the medical system.

    The Canadian cannabis market, he predicts, will see only the fittest companies surviving. “Strong business fundamentals and financial discipline will be rewarded,” says Anand. ”Companies and teams that focus on the plant and the consumer will thrive as we are seeing in the market currently. Cannabis isn’t going anywhere; it is an industry that is here and will not only stay but also thrive in the future.”

    Disappointing Move

    Meanwhile in Germany, legalization appears to have lost some of its momentum. Hopes were high when, in 2021, a new coalition government announced it would permit licensed shops to sell recreational cannabis to adults, i.e., those from the age of 18. The move would have made Germany the biggest EU cannabis market by far. With the legalization, the government aimed to starve the illegal market, decriminalize occasional users, lower criminal justice expenditures and protect public health. The expected cannabis tax, experts predicted, could contribute up to €1.8 billion ($1.92 billion) annually to the state treasury.

    Two years on, all that remains of the lofty plans is a watered-down version. After realizing that full legalization of recreational cannabis would interfere with the U.N. Single Convention on Narcotic Drugs (1961) and EU legislation, the cabinet on Aug. 16, 2023, approved a bill that would allow adults to possess up to 25 grams of the drug, grow a maximum of three plants and acquire weed as members of nonprofit cannabis clubs. The government said it would also launch a pilot project to test the effects of a commercial supply chain for recreational cannabis over five years—a proposal for which it will need to present separate legislation.

    The legislation was scheduled to pass Parliament on Nov. 16, 2023, making cannabis legal from Jan. 1, 2024. However, after meeting fierce opposition from numerous parties, among them conservative policymakers who warned that legalization would encourage cannabis use and create more work for authorities, industry associations and consumer advocacy groups, the final reading was delayed to mid-December.

    In a Nov. 6 parliamentary hearing, the German Cannabis Association (DHV) pointed out that the possession cap of 25 grams per year made home cultivation impossible, as it referred to fresh flowers, which tend to lose weight after drying. “Under these conditions, no one will take the trouble to cultivate cannabis,” says DHV Managing Director Georg Wurth. “The limit would be a promotion scheme for the black market.”

    DHV also advocates to allow private growers to cultivate more than three plants and criticizes the distance rule, which stipulates that consumption will neither be allowed in cannabis clubs nor within a 200-meter distance of schools, kindergartens, playgrounds or cannabis clubs. “Such a distance—or any obligatory distance—would mean that in populated areas there would be no space left for legal consumption,” he says. “The idea to completely prohibit consumption on the premises of clubs whose only aim is to cultivate cannabis is unrealistic and makes no sense. The envisaged distance rule for cannabis clubs is similarly absurd, as it does nothing for youth prevention.”

    Furthermore, the punishments for violations described in the proposed legislation are too harsh, according to Wurth. The bill stipulates imprisonment of up to three years for the possession of 26 grams of cannabis or the cultivation of four plants. Consumption-related offences involve high fines. Smoking pot in a 190-meter radius from a school, for example, could cost the user up to €100,000. The DHV also calls for a legal opportunity to consume self-cultivated cannabis with friends. “After all, the goal is to deprive the black market of as much consumed cannabis as possible,” Wurth says. The association also calls for equal treatment of cannabis and alcohol in road traffic and an alignment of sanctions.

    At press time, an amended version of the bill that takes into account stakeholders’ input had not been released. The first part of the planned cannabis reform in Germany is now expected to become effective on April 1, 2024, at the earliest.

  • A Widening Gap

    A Widening Gap

    Image: WindyNight

    Tobacco harm reduction for people with mental health needs

    By Cheryl K. Olson

    “I firmly believe a lot of us, people like me, are self-medicating, pure and simple,” says Skip Murray. A Minnesota-based tobacco harm reduction specialist, Murray began smoking at age 10. She was diagnosed initially with autism and attention deficit/hyperactivity disorder (ADHD) and later with depression, anxiety and post-traumatic stress disorder (PTSD) as well. She vapes to manage her symptoms.

    Brian King, director of the U.S. Food and Drug Administration’s Center for Tobacco Products, has called for greater focus on health equity. One group he cited as disproportionately affected by smoking is people living with mental health conditions. If you’re among this crowd, you are more likely to smoke (and smoke heavily) and less likely to quit compared to the general population.

    Plenty of research details this serious disparity. Among U.S. adults scored as having serious psychological distress (SPD) in the National Health Interview Survey, nearly 40 percent smoked. That’s compared to 13 percent of people without SPD. Of all cigarettes consumed by U.S. adults, nearly one-third are smoked by someone with a mental illness.

    A new analysis of Population Assessment of Tobacco and Health survey data found that among adults ever diagnosed with psychosis, 41 percent had used any kind of tobacco in the past month, and 31 percent had smoked. Having multiple mental health conditions is linked to higher smoking rates.

    The disparity is growing. U.S. national surveys find that smoking rates for those with mental health diagnoses are either stagnant or are declining more slowly compared to the general population. In particular, smoking rates for black and Hispanic adults experiencing serious psychological distress have not budged in years.

    What stands in the way? How can we better support tobacco harm reduction for people with mental health needs and persuade mental health professionals to take smoking seriously?

    A Culture of Smoking

    Historically, mental health care systems tolerated or even encouraged a smoking culture. Smoking breaks helped build relationships between patients and providers. Cigarettes were used as rewards for “good” behavior or for complying with treatment.  

    Studies find that mental health professionals frequently believe that their patients who smoke aren’t interested in quitting. Or that giving up cigarettes is too much to take on when also dealing with mental illness. Many therapists view smoking as not part of their turf but belonging to the physical health side of things.

    Amid the stresses and crises of mental health practice, granting lower priority to smoking cessation may seem practical. But ignoring cigarettes costs their patients years, even decades, of life. A recent editorial in the British Journal of General Practice called smoking the single biggest contributor to the seven-year to 25-year reduced life expectancy for people with mental health conditions.

    “To ignore their smoking, and only focus on their mental health, in the long run harms their overall health,” says Murray. “Why aren’t we looking at why they smoke? Do they not have healthcare, a home, enough food?”

    “I’m more than my mental illness,” she continues. “We need to treat the whole person.”

    Another barrier to encouraging smoking cessation has been lack of research on, and provider knowledge about, effective interventions. People with schizophrenia are at highest risk for earlier death, and their rates of smoking are especially high. Randomized trials suggest that smoking cessation medications are not risky for them to use. The issue is not safety but effectiveness.

    For example, a large Canadian community-based smoking cessation study found that many people with schizophrenia who smoke want to stop. They were as able as others to reduce their smoking but much less successful at quitting altogether.

    For people living with mental health conditions, as with the general population of people who smoke, there is an urgent need for more effective cessation approaches. A 2002 commentary titled “Smokers with Schizophrenia Will Benefit From More Flexible Treatment Approaches” put it this way: “New and creative NRTs [nicotine-replacement therapies] and pharmacological and psychosocial interventions are needed to compete with the high reinforcement value of smoking.”

    Today, we have nicotine alternatives undreamed of in 2002, including e-cigarettes.

    A Role for Vaping?

    In a 2017 review on Smoking, Mental Illness and Public Health, Stanford researchers wrote that “Additional data are needed to more fully understand the long-term potential of [e-cigarettes] for harm/harm reduction, particularly in vulnerable groups of smokers, including those with mental illness.”

    Six years later, many in public health are unfortunately still on the fence about whether vaping causes or reduces harm. We now have high-certainty evidence from a respected Cochrane review of research that vaping works better than NRT to help people quit smoking.

    But what evidence do we have for persons with mental illness in particular? The studies summarized in the Cochrane review either didn’t mention mental health or specifically excluded people with conditions such as depression, anxiety and psychosis from participating.

    More often than not, even the newest studies on helping people with mental illness quit smoking ignore the existence of vaping and other non-NRT nicotine options. However, evidence from recent population surveys that give results for people with mental health conditions suggests that vaping merits a closer look.

    A 2023 report analyzed data on people reporting depression and anxiety from the 2018 and 2020 Four Country Smoking and Vaping Surveys. The authors state, “It appears that smokers with depression are motivated to quit smoking but were less likely to manage to stay quit and more likely to be vaping if successfully quit.”

    A 2020 English population survey report by Brose and colleagues found that smokers with mental health problems were just as likely as others to successfully quit smoking if they tried. People who had ever had a mental health diagnosis were nearly four times more likely to choose vaping over nonprescription NRT (37 percent versus 9.8 percent) when making quit attempts—more than the sample overall. The authors suggest that “e-cigarettes used in quit attempts currently are more likely to positively affect inequalities than other smoking cessation interventions,” especially if their reach among people with mental health problems can be increased.

    Wanted: Better Studies

    Caponnetto and Polosa have summarized the results of some small but promising studies, involving first-generation or second-generation e-cigarettes, to help people with schizophrenia spectrum disorders stop smoking. Vaping showed potential as an acceptable substitute even among people with severe mental illness who don’t intend to quit smoking. Are larger studies in the research pipeline?

    A 2021 research letter in JAMA Psychiatry describes registered clinical trials looking at e-cigarettes to reduce or stop smoking. Just eight of the 66 ongoing or completed trials recruited individuals who smoke who have a psychiatric condition. The authors note that very few studies (and no completed ones) tested “newer e-cigarette devices that are designed to deliver nicotine more similarly to cigarettes.” They call for more, higher quality studies. We’ll keep an eye out.

    Ways to encourage harm reduction after inpatient mental health treatment also need more study. A 2023 U.K. study by Shoesmith and colleagues in Nicotine & Tobacco Research describes the development of a complex behavior change intervention to follow discharge from a smoke-free mental health stay. You have to dig into the supplemental material to find that mental healthcare worker training in use of e-cigarettes is part of the recommended intervention.

    We need more research to better understand what may block or encourage people with mental health conditions from trying and switching to vaping. A 2017 study analyzed discussions on Reddit by people with mental illness about motivations and limitations associated with vaping. Self-medication was a common theme.

    One person who reported PTSD and anxiety wrote, “For me, vaping is pretty much the same as smoking, in terms of how it helps me calm down and handle stress.”

    Many wrote on Reddit about the importance of education about and support for vaping from friends, family and online communities. Informed mental health professionals could likely play a critical role in saving lives. A U.K. study found that among people who have used tobacco, those with serious mental distress are more likely to have inaccurate harm perceptions of nicotine and nicotine products, including vaping.

    “A Clear and Definite Message”

    A U.K. government-funded community interest company, the National Centre for Smoking Cessation and Training, just released a much-needed guide to vaping for health and social care professionals. The guide states that “some people from disadvantaged groups may vape for temporary abstinence (e.g., at work or while in a mental health inpatient setting) before deciding to switch completely.” Also, “it is important that people from disadvantaged groups receive a clear and definite message that vaping is much less harmful than smoking.”

    Some mental health professional associations have endorsed vaping, however grudgingly or conditionally. For example, the Royal Australian and New Zealand College of Psychiatrists issued a sensible e-cigarette position statement in 2018 (due for updating soon). Acknowledging the high smoking prevalence and low quit rates among people who live with mental illness, they say that “e-cigarettes and vaping devices may provide a less harmful way to deliver nicotine to those who are unable or unwilling to stop smoking tobacco.”

    The college would like more data on vaping’s long-term health effects and on switching success. However, “This does not justify withholding what is, on the current evidence, a lower-risk product from existing smokers while such data is collected.”

    The position of the U.K. Royal College of Psychiatrists is similarly pragmatic. Vaping devices, they note, have become the most popular real-world quit-smoking aid. Although using neither is preferable, “using an EC [electronic cigarette] is always better than smoking a cigarette.”

    By contrast, a 2022 position statement on vaping products from the American Psychiatric Association does not mention harm reduction. They focus only on potential risks to youth.

    Knowledge can flow the other way, from patient to mental health professional. Murray received counseling for a year from a therapist who was initially highly skeptical of vaping. “She was one of those who believed that nicotine causes cancer and depression,” Murray recalls.

    After seeing the difference in Murray’s focus when she had forgotten her vape at work and gone without nicotine for hours, the therapist became curious. “That’s when we figured out that nicotine helps my ADHD,” Murray says. Upon request, she shared published studies on nicotine and mental health with her therapist.

    Adds Murray, “It was cool to meet somebody who was willing to look at information and think about if what they believed was actually true.”