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  • Exploring ‘Belated’ Mortality

    Exploring ‘Belated’ Mortality

    Photo: Nopphon

    How did the 1980–2020 fall in U.S. smoking incidence impact smoking-related deaths?

    By George Gay

    I have a question. What proportion of smokers die “belatedly,” a word I shall use to mean later than predicted or expected, the opposite of “prematurely”? What I am getting at is, if, as I am told, 50 percent of smokers die prematurely from smoking-related diseases and, as I assume, X percent of smokers die prematurely from nontobacco-related causes, unless X is equal to 50, there must be a proportion of smokers who either die on their allotted day or after their allotted day, either from a tobacco-related disease or other causes. But you rarely hear of these people outside of the odd sensational newspaper story that tells how Joan Naughtie has just celebrated her 105th birthday with a cigarette, a glass of whiskey and a bout of raunchy, unprotected sex.

    There are probably a number of reasons why you rarely hear about these people, one of which is that they are an embarrassment, especially in the case of the Joan Naughties of this world who have clearly been having too much fun.

    But firstly, it is necessary to be clear what we mean by a smoker dying prematurely, on time or belatedly. Although it is difficult to impossible to prove a negative, experience tells me that none of us comes into this world tattooed or otherwise marked with a use-by date, so the day on which we are “supposed” to die must be predicted in some way by people who dabble in necromancy, I assume on the basis of past years’ age-related death statistics. I don’t know how sophisticated longevity figures are, but what I see usually are nationwide figures, stated separately for men and women. I trust the breakdown is more intricate than this, however, because, in a country such as the U.K., for instance, where inequality is rife, longevity varies hugely by region, so judging whether a smoker died prematurely against a national average would lead to overestimations.

    Given such concerns, I think that, in the cause of balance, the percentage of smokers who die belatedly should from now on always be stated whenever the percentage of smokers who die prematurely of smoking-related diseases is given.

    I wrote above that the number of smokers who died on their allotted day or after was an embarrassment, and one reason is that they, especially those who die not of a smoking-related disease, give the lie to the general statement that “smoking kills.” Smoking might be the indirect cause eventually of the deaths of a proportion—even a high proportion—of smokers, but, if I am correct in my assumptions above, given that people smoke and live beyond their allotted lives, it cannot be stated, without caveat, that smoking kills.

    One other embarrassment concerns whether, given that it is claimed that smokers who die before their allotted time die because of their smoking unless there is clear evidence to the contrary (they were hit by a bus, perhaps), it can be said that smokers who die after their allotted time live longer because of their smoking, unless there is clear evidence to the contrary (they were genetically modified, perhaps).

    Cause and Effect

    I started to think about such things after reading what struck me as a strange story in The Hill titled “Despite drop in popularity, cigarette smoking continues to be a leading cause of U.S. cancer deaths.” The story was based around some figures from the oddly named U.S. Centers for Disease Control and Prevention (CDC) and new research from the American Cancer Society. The CDC input was that the cigarette smoking rate in the U.S. dropped from 33 percent in 1980 to a little above 12 percent in 2020.

    The story followed up these figures by saying, in part: “But new research from the American Cancer Society shows smoking is still taking a huge toll on American life expectancy and the economy. According to a new study published in the International Journal of Cancer, nearly 123,000 U.S. cancer deaths were caused by cigarette smoking in 2019, making up close to 30 percent of all cancer deaths for that year. Cancers associated with smoking included cancers of the oral cavity, pharynx, esophagus, stomach, lungs and bronchus, among others.”

    This is interesting as far as it goes, but it was what was not revealed that I found frustrating and interesting. Nowhere in the story does it say whether the fall in the incidence in smoking between 1980 and 2020 was mirrored by a fall in smoking-related deaths. Clearly, this is the critical point because if the fall in the incidence of smoking-related deaths has mirrored or closely followed, at a certain time remove, the fall in the incidence of smoking, then many of the claims and assumptions that have been made surrounding smoking and its effects will have been confirmed. However, if there is a largish variation, then questions need to be asked. We certainly need to know if the fall in the incidence of smoking-related deaths in the U.S.—I take it there has been one, though you wouldn’t know from the story—has fallen behind or raced ahead of the fall in the incidence of smoking. And, in either case, we need to know why what has occurred has occurred. Could it be, perhaps, that smoking between 1980 and 2020 became more or less dangerous?

    It might be an uncomfortable truth for politicians and those who refuse to cut back on car journeys, but if the fall in the incidence of “smoking-related” deaths has not kept up with the fall in the incidence of smoking, it would be fairly obvious where to start investigating—the incidence of pollution exposure. I am not a medical person, but some of the smoking-related cancers listed above could seemingly be caused wholly or partly by pollution.

    None of this is meant to support tobacco smoking. On the contrary, it is meant to help us understand what the facts—rather than the myths—are surrounding “smoking-related” deaths and in this way lessen those deaths.

  • Survey Details Advocacy for Safer Nicotine

    Survey Details Advocacy for Safer Nicotine

    Image: Andrii Yalanskyi | Adobe Stock

    Knowledge-Action-Change (KAC) has released a global survey investigating the role and activities of consumer organizations advocating for access to safer nicotine products (SNPs) and tobacco harm reduction.

    Carried out by KAC’s Global State of Tobacco Harm Reduction project, the research was published in Public Health Challenges.

    It reveals that there are 54 active consumer advocacy groups working around the world to raise awareness about, and promote the availability of and access to, SNPs, which include nicotine vaping products (e-cigarettes), Swedish-style snus, nicotine pouches and heated-tobacco products.

    The authors of the survey found that the vast majority of organizations (42) were operated entirely by volunteers, most of whom had successfully quit smoking with the help of SNPs.

    Only seven of the groups had any contracted or paid staff (13 people globally), and for the last full year, the total funding for all organizations surveyed amounted to $309,810. This is in stark contrast to the millions of dollars spent on campaigns by actors, such as Bloomberg Philanthropies, seeking to limit access to SNPs, such as nicotine vaping products. The paper also notes that none of the consumer advocacy organizations reported receiving funding from tobacco or pharmaceutical companies.

    This paper starkly demonstrates the major imbalance in resources available to consumer organizations advocating for access to safer nicotine products and those opposed to tobacco harm reduction, unfairly skewing the debate.

    Many of these organizations are members of four regional umbrella organizations covering Latin America (ARDT Iberoamerica), Africa (CASA), Europe (ETHRA) and Asia-Pacific (CAPHRA).

    “This survey offered a unique opportunity to map these advocacy organizations for the first time and provide valuable insight into how they are operating all over the world,” said Tomasz Jerzynski, lead author and data scientist for the Global State of Tobacco Harm Reduction project. “The sustainability of these organizations is one of the main concerns that has come out of the data. All of these groups face challenges due to their small numbers of core workers and their dependence on volunteers.”

    “This paper starkly demonstrates the major imbalance in resources available to consumer organizations advocating for access to safer nicotine products and those opposed to tobacco harm reduction, unfairly skewing the debate,” said Gerry Stimson, report author, director of KAC and emeritus professor at Imperial College London. “It also highlights why consumer groups must be recognized as legitimate stakeholders in the policy sphere.”

  • PMI, BAT Recognized for Gender Equality

    PMI, BAT Recognized for Gender Equality

    Image: melita | Adobe Stock

    Philip Morris International and BAT were included in the 2023 Bloomberg Gender-Equality Index (GEI).

    PMI made the index for the third year running, achieving an overall score of 80.6 percent.

    “Achieving gender balance at all levels of the company is one of our top priorities, and I am delighted that our efforts are recognized again in this year’s index,” said Silke Muenster, chief diversity officer at PMI. “While we are making significant progress, we know we need to keep our foot on the acceleration pedal. An inclusive workplace that leverages the full talents of both women and men is crucial to our smoke-free vision, making our organization more innovative, resourceful and engaged.”

    In 2022, PMI achieved its target of ensuring at least 40 percent female representation in managerial roles and announced a new target to achieve 35 percent of women in senior roles by the end of 2025, among other targets.

    BAT, which participated in the index for the first time, received a score of 75 percent. BAT was recognized for creating an inclusive culture for women via its recruiting initiatives, adoption of family-friendly policies, sponsoring programs dedicated to educating women, and support of community programs. Inclusion in the index follows BAT being named as a Global Top Employer for a sixth successive year.

    “Recognition in this year’s Bloomberg Gender-Equality Index demonstrates our commitment to addressing gender diversity and highlights our concerted global efforts to provide transparent reporting,” said Hae In Kim, BAT’s director of talent, culture and inclusion. “With more than 50,000 employees worldwide, our diversity and inclusion strategy is truly global, and I continue to be incredibly proud of the collective efforts made by all our employees.”

    The GEI measures gender equality performance globally across five pillars as set by Bloomberg: leadership and talent pipeline, equal pay and gender pay parity, inclusive culture, anti-sexual harassment policies, and external brand. The 2023 Bloomberg GEI comprises 485 companies from 45 countries and regions.

  • Trade Group: Cigar Flavor Ban Harmful

    Trade Group: Cigar Flavor Ban Harmful

    Image: pureradiancecmp

    Banning flavored cigars would do more harm than good, according to David Ozgo, president of the Cigar Association of America, reports The Center Square.

    “The economic impact is one thing, but just as important is the fact that what you’re doing is taking away an adult’s right to choose,” Ozgo said. “When President [Barack] Obama passed legislation in 2009 regulating tobacco, he stressed the idea was not to take away an adult’s right to use tobacco if that’s what they choose.”

    In 2021, flavored cigars made up 47 percent of the market, so banning them would have a huge economic impact, according to Ozgo. He projects losses of about $4 billion in retail sales, 16,000 jobs, $840 million in wages and an estimated $750 million in federal, state and local tax revenue.

    “The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” Health and Human Services Secretary Xavier Becerra said in a statement on the U.S. Food and Drug Administration’s website. “Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities.”

    Ozgo countered that it’s already illegal for a person under 21 to purchase tobacco. Government data shows less than 1 percent of youth use flavored cigars, he noted.

    “This is a solution in search of a problem,” Ozgo said. “When you look at indicators of nicotine addiction, they’re not the same as, say, cigarettes. Really, people smoke cigars for different reasons. With cigars, it’s just something you do to relax and enjoy. We always say cigars are more of a hobby than a habit; you don’t even smoke one every day.”

  • KT&G Refuses Ginseng Spinoff

    KT&G Refuses Ginseng Spinoff

    Photo: KT&G

    KT&G has refused to spin off its ginseng business as requested by activist investor Flashlight Capital Partners, reports The Korea Herald.

    “The spinoff will have little to no benefit to the company’s corporate value and shareholders from a long-term perspective,” KT&G Senior Executive Vice President Bang Kyung-man said.

    Bang expressed concern that KT&G would potentially lose “synergy” in the event of the ginseng unit’s separation.

    Flashlight Capital Partners has been putting pressure on KT&G to increase dividends and spin off its ginseng unit into a separate listing, among other things. 

    KT&G plans on initiating a share buyback program and aims to increase its overseas sales to over half by 2027. To raise the needed capital, KT&G can sell property assets and borrow from banks, according to Bang.

  • U.S. Cigarette Sales Down in 2020-2021

    U.S. Cigarette Sales Down in 2020-2021

    Photo: www.akolosov.art

    The number of cigarettes that the largest cigarette companies in the United States sold to wholesalers and retailers nationwide decreased from 203.7 billion in 2020 to 190.2 billion in 2021, according to the Federal Trade Commission’s most recent Cigarette Report. The report also states that in 2021, menthol flavored cigarettes comprised 37 percent of the market among major manufacturers, more than double the 16 percent market share they held in 1963.

    The amount spent on cigarette advertising and promotion increased from $7.84 billion in 2020 to $8.06 billion in 2021. Price discounts paid to cigarette retailers ($6.01 billion) and wholesalers ($917 million) were the two largest expenditure categories in 2021. Combined spending on price discounts accounted for 86 percent of industry spending.

    According to the Smokeless Tobacco Report, smokeless tobacco sales decreased from 126.8 million pounds in 2020 to 122 million pounds in 2021. The revenue from those sales rose from $4.82 billion in 2020 to $4.96 billion in 2021. Menthol flavored smokeless tobacco products comprised more than half of all sales and fruit flavored smokeless tobacco products comprised 2.7 percent.

    Spending on advertising and promotion by the major manufacturers of smokeless tobacco products in the U.S. increased from $567.3 million in 2020 to $575.5 million in 2021. As with cigarettes, price discounts made up the two largest spending categories, with $308.2 million paid to retailers and $81.3 million paid to wholesalers in 2021. Combined spending on price discounts represented 67.7 percent of all industry spending.

    Smokeless tobacco manufacturers also reported selling $804.8 million of nicotine lozenges or nicotine pouches in 2021, not containing tobacco, up from $422.7 million in 2020.

    The Commission has issued the Cigarette Report periodically since 1967 and the Smokeless Tobacco Report periodically since 1987.

  • Altria Group Reports 2022 Results

    Altria Group Reports 2022 Results

    Photo: Altria Group

    Altria Group reported net revenues of $6.11 billion for the fourth quarter of 2022 and net revenues of $25.1 billion for the full year, down 2.3 percent and 3.5 percent, respectively, from the comparable periods of 2021. Revenues net of excise taxes were down 0.1 percent for the quarter and up 2 percent for the full year, to $5.08 billion and $20.69 billion, respectively.

    “It was an exciting year for Altria as our businesses delivered strong financial performance, and we continued to strategically invest toward our Vision,” said Altria CEO Billy Gifford in a statement. “We generated strong adjusted diluted EPS growth of 5 percent and made meaningful progress in several areas of our smoke-free portfolio.”

    “Our plans for 2023 include a continuation of our strategy to balance earnings growth and shareholder returns with strategic investments toward our Vision. We expect to deliver 2023 full-year adjusted diluted EPS in a range of $4.98 to $5.13, representing a growth rate of 3 percent to 6 percent from a base of $4.84 in 2022.”

    Like other tobacco companies, Altria was impacted by high rates of inflation in 2022, which reduced adult tobacco consumers’ discretionary income and spending. “As a result, our businesses and the industry experienced elevated volume declines, and we observed accelerated share growth in discount cigarettes. Despite these factors, our leading tobacco brands remained resilient and we continued to observe significant brand loyalty in the tobacco space overall,” the company wrote on its website.

    While Marlboro’s retail share of the total U.S. cigarette category dropped 0.4 points to 42.5 percent in 2022, the brand gained 0.5 points in the premium segment, claiming 58.2 percent of that category.

    Altria Group also revised the valuation of its stake in Juul Labs, which has faced considerable regulatory and legal challenges. As of Dec. 31, 2022, the investment was worth $250 million, according to Altria.

  • A Blunt Tool

    A Blunt Tool

    Photo: MichaelJBerlin

    Unless properly structured, Europe’s tobacco and vapor tax plans may not achieve their public health objectives.

    By Stefanie Rossel

    The European Commission’s (EC) December 2022 proposal for an update to the 2011 EU tobacco excise directive came with a first: In addition to a significant hike in cigarette excise rates, the draft also calls for a bloc-wide vaping levy.

    According to the proposal, the current minimum EU excise tax rate of €1.80 ($1.92) should increase to €3.60 per pack of 20 cigarettes. This would double excise duties in member states with low cigarette taxes (in eastern European countries, a pack of cigarettes can currently sell for under €3) and affect excise duties in countries such as Luxembourg and Austria, where cigarette prices are low relative to income. The EU hopes to generate an additional €9.3 billion in revenue from the tax harmonization, which would be a welcome windfall for pandemic-struck and inflation-struck member states. If enacted, the proposal would also increase taxes on hand-rolled tobacco.

    E-cigarettes with less than 15 mg of nicotine per milliliter of liquid would attract a 20 percent excise duty, and stronger products would be subject to a duty of at least 40 percent. In the EU, nicotine content of e-liquids is limited to 20 mg per milliliter. According to the draft proposal, heated-tobacco products (HTPs) would attract a 55 percent excise duty, or a tax of €91 per 1,000 items sold.

    The proposed legislation would harmonize the fragmented EU vapor market, where each member state taxes vapor and HTP products at its own rates. It is part of a push aimed at accelerating the reduction of smoking rates throughout the EU. As part of the common market’s Beating Cancer Plan, introduced by the EC in February 2021, health officials seek to lower the current EU smoking prevalence of 26 percent to 20 percent by 2025 and achieve a “tobacco-free generation”—that is, a smoking rate of below 5 percent—by 2040.

    The draft was released only weeks after the EC imposed a ban on flavored HTPs to cut the growth in demand among younger consumers. Responses were mixed. While some argued that union-wide taxes are necessary because less harmful products still present risk, tobacco harm reduction advocates warned for unintended consequences.

    Too High, Too Complex

    David Sweanor

    “Simply increasing cigarette taxes is a blunt instrument when trying to reduce the health toll from cigarette smoking,” says David Sweanor, adjunct professor of law at the University of Ottawa in Canada. “It is far more powerful than other standard anti-smoking measures but has limitations and constraints that are often overlooked. Price sensitivity is real, but many people who smoke cigarettes will seek to deal with increased costs through access to contraband, the cross-border trade, simply changing the way they smoke without achieving health improvements, or further diminishing their overall well-being by redirecting expenditures from healthier purchases to the purchase of cigarettes.”

    Taxing low-risk alternatives reduces the incentive to switch from cigarettes and can make illicit cigarettes more competitive, according to Sweanor. In his view, it is akin to making alcoholics who give up drinking by taking up jogging pay a tax on running shoes. “It misses the point of how taxes can be justified due to the relative health impact of certain behaviors,” he says.

    Dustin Dahlmann

    Dustin Dahlmann, president of the Independent European Vape Alliance, believes that EU policy should be guided by scientific evidence. “Science around the world agrees that vaping is significantly less harmful than smoking,” he says. “E-cigarette taxes that are too high [to] prevent socially disadvantaged groups in particular from switching to e-cigarettes. In the first instance, there should not be excise duties for electronic cigarettes, as they are a means for smokers to switch to less harmful alternatives. If further harmonization of excise duties is considered, legislators should take into account the significant differences in risk profile between tobacco cigarettes and electronic cigarettes and apply the excise duties methodology accordingly, i.e., proportionality to the harm reduction benefits brought about by tobacco replacement products.”

    In practice, this would mean a maximum excise duty of €1 per 10 mL or €0.10 per 1 mL of e-liquid, and it should be applied only to e-liquids with nicotine, according to Dahlmann. “The EU draft imposes a combination of an ad valorem and a specific volume base excise that would be an administrative burden for small and medium enterprises and fiscal authorities due to the additional complexity. Giving two options will lead to uncertainty, defeating the purpose of a harmonization of excise rates.”

    Illicit Trade Could Increase

    The question about how the EU’s revised tobacco tax directive would impact the illicit cigarette market is justified. The experience of France provides a cautionary tale. Following a tax increase of almost three times the EC’s minimum level, the illicit market in that country more than doubled, from 13.7 percent in 2017 to 29.4 percent in 2021, leading to an estimated loss of €6.2 billion in tax revenues in 2021, according to a KPMG report. In general, the study found, illicit consumption in the EU increased by 3.9 percent, or 1.3 billion cigarettes, in 2021, which corresponds to a loss of €10.4 billion in taxes.

    How the suggested excise duty increase would impact markets with relatively low income and high smoking levels, such as Greece (42 percent smoking prevalence) and Bulgaria (38 percent), is anybody’s guess. “I have worked globally on illicit trade issues for decades,” says Sweanor. “There is much we can do to limit the trade, but the economics makes [illicit cigarette trade] so lucrative that it is hard to imagine bringing it under control so long as there remains a significant market for cigarettes. Markets meet needs, including illicitly. Cigarettes are extraordinarily inexpensive to make, and taxes and the huge profit margins of Big Tobacco create a business opportunity many people can be expected to see as a money spinner. The real answer is to facilitate disruptive technology that makes cigarettes as undesirable to consumers as unsanitary food or leaded petrol.”

    To achieve the latter, the EC would have to acknowledge the harm reduction and smoking cessation potential of novel tobacco products. In February 2022, the EU Parliament became the world’s first elected chamber to endorse THR when it adopted a resolution on cancer prevention and treatment that notes that e-cigarettes “could allow some smokers to progressively quit smoking.” Dahlmann praised the move as a “landmark declaration” that would help reassure smokers of the benefits of switching to vaping. “All other EU institutions—and in particular the European Commission—should take this on board and ensure that policy follows science, not the other way around,” he said at the time.

    Sweanor is less upbeat. “The taxation of low-risk products reflects an understanding of differential risks. But it fails to come to terms with the full magnitude of the harm from cigarette smoking and the enormous potential to dramatically reduce it. When we are looking at hundreds of thousands of annual deaths, surely it is a public health emergency—and policies should reflect that. Language such as “could allow some smokers…” and policies that limit the relative acceptability of low-risk alternatives indicate that the extent of the public health opportunity is not fully grasped.”

    Differentiated Approach Required

    Whether the EU is prepared to part ways with anti-novel nicotine product sentiment of the World Health Organization Framework Convention on Tobacco Control (FCTC), which the common market has ratified, remains to be seen.

    “The EU is obligated to support tobacco harm reduction as a signatory to the WHO’s FCTC as stipulated in the introduction, article 1 (d) of the treaty,” says Dahlmann. “The FCTC requires the EU to not only allow reduced-risk products but to actively promote them. However, this definition is not actively supported by the WHO. The rule here is much more ‘quit or die.’”

    “The WHO’s FCTC process has followed in the footsteps of narcotics protocols in being hijacked by ideologues who seek an abstinence-only approach on drugs where total abstinence is simply not a viable nor a humane goal,” Sweanor adds. “As with those narcotics protocols, caring governments that follow the Enlightenment principles of science, reason and humanism will either creatively skirt such guidelines or simply ignore them. This is something we are now seeing unfolding globally with cannabis policies.”

    The goal of the new tax directive to create a smoke-free European society, he says, is noble and achievable—and far more quickly than envisioned in that 2040 goal. “But it requires bold rather than tentative steps. Policymakers should act in ways consistent with cigarette smoking being a public health crisis of enormous importance,” says Sweanor. “The best way to tackle this is by use of cross-elasticities, of empowering and facilitating people who smoke cigarettes to make healthier choices. This is accomplished by measures such as the widest possible cost differential between lethal cigarettes and low-risk alternatives. Given the horrendous death and disease tool from cigarettes, this should be a huge priority.”

    “E-cigarettes need to remain accessible and affordable to smokers from all socioeconomic backgrounds who wish to quit smoking,” says Dahlmann. “E-cigarettes offer smokers an alternative that is 95 percent less harmful than smoking. Switching from tobacco to vapor has positive individual, social and economic implications and should be encouraged, not penalized by the tax system. If taxes make vaping more expensive than smoking, many smokers will lose an incentive to switch to the much less harmful alternative. We therefore would see no chance of achieving the EU’s ambitious goals.”

    Before it is enshrined in law, the proposal will have to be agreed on by all EU member states. BAT already noted that this is merely the beginning of a long legislative process. “I assume there will be amendments, but we do not yet know their likely nature,” says Sweanor. “The proposal could be changed to help facilitate a rapid public health breakthrough as people abandon lethal cigarettes in huge numbers. Or it could be amended to make that a pipe dream.”

  • A Teaching Moment

    A Teaching Moment

    Photo: Darren415

    Nicotine’s lessons for cannabis regulation

    By Cheryl K. Olson and Willie McKinney

    From the industry perspective, regulation of tobacco products by the U.S. Food and Drug Administration went from impatient foot-tapping to a lurching roller-coaster ride. The recently released “operational evaluation” of the FDA’s tobacco program, requested by Commissioner Robert Califf, lays out in sedate but clear terms some causes of industry’s frustrated exhaustion: years of delay in establishing requirements. Sudden major shifts in policy. Cycles of litigation and reprieve.

    Based on feedback from FDA employees, and people from industry and public health, the independent Reagan-Udall Foundation for the FDA made recommendations to start repairing the regulatory mess. After “observ[ing] that CTP [Center for Tobacco Products] has been forced to operate primarily in a reactive mode, moving from one challenge to the next,” the first recommendation to the agency is to get proactive. The Reagan-Udall panel encouraged the CTP to make time now to “think strategically about where it is today and where it needs to go in the next several years.”

    This advice might apply equally to whatever future the FDA faces with regulation of cannabis products. The FDA has authority over cannabis and its dozens of biologically active chemical compounds, including CBD and THC. Although marijuana falls under the federal Controlled Substances Act, the 2018 Farm Bill removed hemp (a low-THC cannabis plant and its derivatives) from that definition.

    Principal Deputy Commissioner Janet Woodcock recently announced in a press release that existing regulatory frameworks for food and supplements are not appropriate for CBD. “The agency is prepared to work with Congress” on a new pathway, she stated.

    What might we take from the U.S. tobacco experience to ease headaches for future cannabis regulation? Below are some points to ponder in three areas: regulatory structure, medical versus recreational use, and the effects of misinformation on regulation.

    What Should a New Structure Look Like?

    First, what regulatory structure makes sense: Should the FDA create an all new one for cannabis products, or should it employ some existing channels? Consider the tobacco parallel.

    “Safe and effective” is the FDA’s traditional standard for evaluating drugs and medical products. In the 1990s, then Commissioner David Kessler tried to assert the FDA’s authority to regulate nicotine as a drug—intended by industry to affect the body’s structure or function—and cigarettes as delivery devices. A 2000 Supreme Court ruling found that the “s and e” standard left no room for regulation of tobacco.

    In 2009, when Congress chose to place tobacco under FDA jurisdiction, a novel department was created. But this promising, fresh science-based regulatory approach for tobacco faced headwinds. This Center for Tobacco Products was largely staffed by people rotated from elsewhere in the FDA. The “appropriate for the protection of public health” (APPH) tobacco standard was a difficult departure from their accustomed ways and views. The combination of suspicion from past industry misbehavior and the political uproar over youth vaping fostered an “us versus them” mindset. The founding legislation’s focus on cigarettes, the most deadly of tobacco products, affected attitudes toward emerging alternative nicotine products with the potential to greatly reduce disease risks for people who smoke.

    Perhaps there is light at the end of the tunnel. The FDA appears to recognize that shoehorning cannabis into existing structures has its own problems. Each type of intended use must find a fit in an existing department, such as human food, veterinary products, cosmetics or drugs. Under the Federal Food, Drug and Cosmetic Act, a drug is any product (including marijuana or hemp) intended to affect the structure or function of the body or intended to diagnose, cure, mitigate, treat or prevent disease.

    What factors will influence staff mindset about cannabis in these various departments? How will that affect regulation?

    Medical vs. Recreational Pathways

    Another issue: How best to regulate cannabis for medical versus recreational use? Like tobacco, cannabis has been used historically for medical purposes, such as treating pain. Both nicotine and cannabis are reportedly used to self-medicate for mental health disorders. Use of marijuana to manage mood disorders is reportedly higher in states with medical marijuana laws. But there currently is no such thing as “medical” marijuana. (This is not unlike the confusion over what constitutes “natural” food.) The FDA drug pathway would create medical cannabis. A standardized product would be evaluated for quality, safety and efficacy for a particular medical indication.

    We lack randomized, controlled clinical trial data on whether cannabis effectively treats disorders such as depression. However, such studies could be done by industry and submitted to the FDA’s Center for Drug Evaluation and Research. Several specialty products containing THC or CBD (e.g., for chemotherapy-related nausea or severe forms of epilepsy) have emerged from this path.

    But what regulatory pathway might recreational cannabis take? And what complications arise from product format and route of administration: smoked, vaped, applied to skin or eaten? Where would combusted flower fit?

    Nicotine is regulated by the FDA as a drug and as a recreational product. Two paths for cannabis also make sense. Although there is overlap (to get technical: Gum bases that contain nicotine are regulated as both pharmaceuticals and recreational tobacco products), combusted tobacco products that contain nicotine are only regulated by the Center for Tobacco Products.

    We propose that Congress modify the 2009 Tobacco Control Act to give the CTP authority over combusted and vaped cannabis. Such products are very unlikely to pass the “safe and effective” drug standard, but the APPH standard may be applicable to recreational cannabis. And the CTP has built up expertise in combusted and vaped products.

    Keep Moral Panic Out of Regulation

    A third issue deserving of thought is how to prevent moral panic and misinformation from derailing the potential benefits of cannabis. One lesson from nicotine is how these can fog the ability of regulators, politicians and the public to see data clearly.

    Research shows that youth use of nicotine and cannabis (as well as alcohol and other substances) overlap. A 2022 analysis of Population Assessment of Tobacco and Health study data found that more than half of e-cigarette users aged 15 to 24 had vaped cannabis. At the population level, teen cannabis youth has been fairly stable for the last quarter century. However, there will be concerns that the spread of state laws legalizing cannabis for adults could ease access for youth.

    Once it takes hold, misinformation is hard to uproot. Witness stubborn rates of misbelief that the outbreak of vaping-related lung injuries (e-cigarette or vaping product use-associated lung injury, or EVALI) were caused by e-cigarettes instead of THC vapes adulterated with vitamin E acetate.

    We see signs of a potential moral panic over cannabis. When the Centers for Disease Control and Prevention noted that marijuana vaping was most often linked to EVALI, the Wall Street Journal editorial board decried the “risky social experiment [of] legalizing and especially destigmatizing cannabis”—a drug that “could be damaging young brains for a lifetime.” News reports tout studies suggesting higher potency cannabis could mean higher risks of addiction and health harms.

    Research to clarify the specific nature of cannabis risks to youth is needed. We also need research on the current state of cannabis misinformation, including overly rosy views of risk that could create a backlash when problems are publicized. Using the results of this research for outreach ASAP, before the pot panic gets rolling, could soften the impact.

    Scrutinize and Enforce

    To avoid repeating mistakes of the past, we also need rigorous oversight. The FDA has been criticized for reluctance to use its powers to remove illegal nicotine vapes from the market. Some companies continue to sell despite warning letters. We need to study what cannabis products drive youth use and proactively target those makers and distributors.

    Products likely to attract underage users deserve particular scrutiny. Although no deaths were reported, a study in the journal Pediatrics2 documented a worrisome increase in child poisonings from edible cannabis products. To protect both adult access and child well-being, it’s common sense to require that edibles come in clearly marked, child-resistant packaging with no resemblance to candy.

    We have tools to unmask the bad actors. Youth will tell us in surveys what products they buy. The FDA’s own National Youth Tobacco Survey identified products not legally on the market, such as Puff Bar and Hyde, as favorite brands (Hyde was identified through write-in responses).

    With nicotine, regulatory delays and gray areas (such as regulation of synthetic nicotine) were abused by companies willing to skirt the law for quick profit. We see analogous situations with cannabis. One example is hemp-derived delta-8 THC products, said to produce a milder high similar to that from marijuana-derived delta-9 THC. Sales are rising fast. So are concerns. There are safety risks from impurities created during delta-8 manufacturing. And public confusion over delta-8’s legal status could complicate marijuana legalization efforts.

    The Reagan-Udall Foundation review of the CTP highlighted the need for “truthful and accurate information to help adult consumers make informed decisions about the role of nicotine” and product-specific risks. This applies equally to cannabis.

  • Enduring Legacy

    Enduring Legacy

    Packing and pressing station for tobacco | Photo: Godioli & Bellanti

    Celebrating 100 years in business, Godioli & Bellanti attributes its success to offering “quality machines at truly unbeatable prices.”

    By George Gay

    Lorenzo Curina | Photo: Godioli & Bellanti

    After three years of subdued demand for tobacco industry primary processing equipment, interest is picking up, according to Lorenzo Curina, chief executive officer and sales director at the primary machinery designer and manufacturer Godioli & Bellanti.

    There was now increasing demand for complete processing lines that were compact and uncomplicated, a demand that was being driven by a growing interest in the production of cut rag, he said in an emailed reply to questions.

    At the same time, there was a trend by major cigarette manufacturers to require the relocation and/or the refurbishment of existing equipment, projects for which Godioli & Bellanti, with its 100 years of experience in the business, was well qualified to undertake. The company’s engineering skills and experience enabled it to repair, rebuild, recondition or upgrade all types of primary equipment while its organizational skills and flexibility meant it could navigate the necessary logistics involved.

    In fact, an indication of the engineering and logistical skills the company can call on was demonstrated when, in 2018, it shipped and delivered what was believed to have been one of the tobacco industry’s biggest direct conditioning cylinders, which was 14 meters long, 3 meters in diameter and capable of processing flue-cured Virginia tobacco at a rate of 20 tons per hour.

    A Pioneer

    Godioli & Bellanti was established in 1923 by Gino Godioli and Angelo Bellanti, whose initial focus was on making agricultural implements, especially those aimed at helping the mechanization of tobacco production, since the Umbria region, where they were based, was one of the most important areas in Europe for the cultivation of flue-cured tobacco.

    After the passing of the founders, Godioli & Bellanti was, in 1963, turned into a limited company, which was the beginning of a transformation. Under its new designation, Godioli & Bellanti SpA, the company moved into new and challenging areas. It developed new technologies for the tobacco industry, becoming Italy’s first supplier of tobacco machinery to the tobacco manufacturing sector, which later included the multinational companies that established operations in Italy and elsewhere in Europe.

    The transformed company specialized in turnkey projects, which meant that it supplied, as well as machinery, services such as heating and lighting systems. And this breadth of operation allowed it to gain considerable expertise in machine and whole-factory design.

    Initiatives such as these have been continued and are continuing. Although the company is known for its tobacco industry services, it operates in other industries, most of them natural outcrops. It offers machinery and processing lines for medicinal herbs and other plants, including mechanized equipment for the cultivation of these plants, along with machinery for drying and dehydrating; cutting, threshing and classification; and mixing and blending. It offers, too, continuous drying plants for food products.

    Entering New Fields

    Processing line for medical herbs | Photo: Godioli & Bellanti

    Meanwhile, the company’s experience in the field of herbs was adapted to allow it to enter the field of industrial hemp processing, where its processing lines provide for the separation of the plant’s fiber, hemp, seeds, flowers, leaves and stems. This is an important and growing side of the business because the products that are generated are used in a wide range of industries, including those concerned with pharmaceuticals, textiles, foodstuffs, veterinary products and bio-building. Less well-known, perhaps, is the company’s work with tree seeds. It was the first company to develop a tree seed extraction system, and it now offers complete, custom-designed turnkey plants for the extraction and selection of tree seeds.

    Aside from its interests in food and related products, the company offers biomass driers that function with recovered thermal energy, including driers for woodchips and sawdust. And it offers machines and complete processing lines for producing glass-reinforced pipes and sleeves, using continuous filament winding technology.

    Custom Offerings

    Drying lines for tobacco | Photo: Godioli & Bellanti

    But a large part of its business is concerned with tobacco, for which it can supply equipment for auxiliary plants, threshing lines and, of course, primaries. For auxiliary plants, where the leaf tobacco process begins, Godioli & Bellanti is able to offer, among other items, conveyor belts, picking lines, feeding and blending tables, tipper feeders, tipping machines, weighing belts, vibrating conveyors, vibrating sieves, pneumatically operated pad looseners, sand reels, blending silos and ordering cylinders along with test shakers, stem testers, laboratory mills and laboratory cutters.

    For many years now, it has been a goal of most leaf processors to implement changes aimed at increasing packed-tobacco quality, costs and yields, and, to this end, Godioli & Bellanti offers custom-designed threshing lines and plants, including, among a host of other equipment, high-efficiency threshers operating over a wide range of speeds and compact classifiers with low energy requirements. It provides, also, compact, high-efficiency re-driers with steam recycling systems that reduce steam consumption. Being custom designed, the re-driers provide for a wide range of adjustments in such areas as, but not limited to, drying temperatures, humidifying steam pressures and apron conveyor speeds. Finally, Godioli & Bellanti offers complete, automatic, programmable leaf tobacco packing lines for cartons, wooden boxes, zipper bags and bales.

    Meanwhile, it is probably the case that the company is best known for its primary machinery and plants—particular plants at that. Curina told Tobacco Reporter that companies that contacted Godioli & Bellanti were those who preferred “traditional primary processing—I would say almost artisanal.” Such equipment includes automatic handling systems for cartons and bales, automatic de-cartoners, automatic vertical slicers, pneumatic conveying systems, weighing belts, dosing feeders, tipping feeders, blending and storage silos, toasters, sauce and flavor kitchens, casing and flavoring cylinders, drying cylinders for cut rag, and customized supervision software to render whole lines automatic.

    Finally, Curina further defined his company’s approach to business. “We don’t presume to compete with the big primary machinery manufacturers for the very big projects,” he said, “but we modestly offer quality machines at truly unbeatable prices.”

    This strategy seems to have paid off, not surprisingly, perhaps, given that the recent past has seen an increasing trend—at least outside China—toward shorter cigarette-manufacturing runs, a trend that has been reflected in primaries as a need to produce smaller batches of cut rag. There has been a rise, too, in the number of small, independent primary operators catering to multiple end users that need to run low-cost, highly flexible operations from small footprints. Certainly, Curina, and his brother Cesare, president of the board and technical director, who have steered the company’s direction in recent years, have made much progress—modestly expressed. A note on the company’s website describes how “Godioli & Bellanti works in several areas of the world,” before going on to list almost 60 countries and every continent.