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Year: 2023

  • Half-Baked

    Half-Baked

    Photo: vchalup

    Germany’s comparatively high smoking rate shows that cessation-only policies are insufficient to end cigarettes.

    By Stefanie Rossel

    Alexander Nussbaum | Photo: PMI

    Germans, it appears from anecdotal experience, are a stubborn species when it comes to smoking cessation. During a recent holiday at the French Riviera, we had a heavily smoking couple from the Lower Rhine as neighbors at our resort. Out of professional interest, I asked them whether they had ever tried to quit. The husband showed me a scary-looking scar on the side of his ribcage and said, yes, he had stopped for two years after his surgery but then relapsed to smoking what looked like at least a pack per day. Quitting again was clearly not on his agenda nor on his wife’s. At the mention of less hazardous alternatives to combustible cigarettes, they gave me a skeptical look.

    That smokers like these are the rule rather than an exception confirms a survey commissioned by Philip Morris Germany (PMG) that looked at the barriers to quitting. Carried out first in 2021 and updated in 2022, the research found that last year, 51.3 percent of the 1,000 participating German adult smokers representing all age groups, genders and federal states did not want to give up smoking—only slightly less than in the first edition of the study (53.5 percent).

    The German Survey on Smoking Behavior (DEBRA), a bi-monthly representative, face-to-face household survey on the use of tobacco and alternative nicotine-delivery systems (ANDS) conducted by Heinrich Heine University Duesseldorf, measured an even lower motivation to quit smoking in Germany, relates Alexander Nussbaum, head of scientific and medical affairs at PMG. “Almost three-quarters of the nearly 19,000 smokers surveyed did not express the intention to quit smoking,” he said. “Our own survey from 2022 confirms what we already measured in 2021: More than half of German smokers do not currently express the intention to quit smoking. Even those who are motivated to quit smoking are rarely specific in their plans: Only 3 percent to 5 percent of them plan to quit in the next month.”

    At 64.4 percent, it’s particularly smokers over 65 years who are uninterested in stopping. In addition, the PMG study found, every third smoker over 50 years of age has never seriously tried to quit. There’s a pronounced correlation between motivation and actual quitting attempts; 76.4 percent of smokers who never tried to stop smoking were also unmotivated to quit.

    Motivation for smoking cessation also varied between socioeconomic groups: 64.5 percent of participants in the lowest income group said they had no intention to quit whereas in the highest income group, the figure was 43 percent. “Even among smokers with the highest educational level in our survey—‘college, university without/with degree’—almost half were not motivated to quit smoking in 2021,” said Nussbaum. “However, this proportion increased to 61 percent for smokers with the lowest educational level—i.e., ‘elementary school with/without completed apprenticeship.’ The motivation to stop smoking is not solely dependent on education. Rather, our results from 2022 show a strong correlation with income.”

    Beyond Smokers’ Reality of Life

    Depending on the sources, between 23 percent and 34 percent—that is, between 17 million and 18.9 million of the more than 83 million Germans—currently smoke. Smoking prevalence in the country is significantly higher than in other European nations. Germany, which ratified the World Health Organization’s Framework Convention on Tobacco Control (FCTC) in 2005, has repeatedly been criticized for being too lax in implementing tobacco control measures, most recently by Ruediger Krech, the WHO director for health promotion. On the occasion of the publication of the ninth WHO Report on the Global Tobacco Epidemic on July 31, 2023, Krech noted that the country’s ban on indoor smoking was inconsistent, advertisements against the harmful effects of smoking in public spaces were poorly enforced and inflation had little impact on the affordability of tobacco products.

    Whether higher prices or expanded smoking bans would significantly reduce prevalence is questionable when looking at the reasons people named for continuing to smoke, however. According to PMG’s survey, 50.1 percent of participants stated that they enjoy smoking, making this the biggest barrier to smoking cessation. That share was particularly high among older smokers (58 percent) and those with no motivation to quit (62 percent). More than half of the people surveyed had been smoking for more than 20 years, making habits and learned behavior another major barrier to quitting smoking. “Lack of discipline” was quoted as a further hindrance. Only 12 percent named “cost” (of offers or products to support quitting cigarette smoking) as keeping them from stopping smoking.

    It’s not that there weren’t any smoking cessation programs or initiatives available. Since 2014, for example, the S3 guideline, “Smoking and tobacco dependence: screening, diagnosis and treatment,” has provided healthcare professionals with recommendations on how to help smokers quit. S3 means that the guideline has undergone all elements of a systemic development, including decision and outcome analysis and assessment of the clinical relevance of scientific studies. The recommendations of the current S3 guideline include low-threshold tools such as short motivational counseling and envisage nicotine-replacement therapy (NRT) only as a last measure after education and psychotherapeutic support. The guideline advises explicitly against using e-cigarettes as a smoking cessation aid.

    “A medical smoking cessation guideline is primarily effective among smokers who are already motivated to stop smoking and who seek advice from their family doctor or pharmacist on how they can completely give up tobacco and nicotine, which is always the best option,” says Nussbaum. “However, it is also a fact that the majority of smokers in Germany are currently not motivated to quit smoking, and this is reflected in the stable or even increasing smoking rate. This in turn suggests that the measures taken to date, including the smoking cessation guideline, are missing the needs of the majority of smokers.”

    This is also evident from the fact that e-cigarettes are now used by 10 percent of smokers to wean themselves off of cigarette smoking, according to the DEBRA study. This makes vapor products the most frequently used form of cessation support in Germany, despite the fact that they are not recommended in the guideline and despite the prevailing misperceptions about comparative health risks. According to a survey by the German Federal Institute for Risk Assessment (BfR), 63.3 percent of smokers consider e-cigarettes to be at least as risky as combustible cigarettes.

    “The results [of the PMG survey] clearly show that the best measures, such as the gold standard of NRT and behavioral therapy recommended in the medical smoking cessation guideline, are of little use if they do not reach the smokers’ reality of life, for instance, because the motivation to stop smoking is lacking,” says Nussbaum. “That said, alternative nicotine products, such as e-cigarettes, heated-tobacco products or nicotine pouches, are not cessation tools but rather consumer products for adult smokers who for whatever reason are not quitting cigarette smoking.”

    Wanted: Clear Communication

    Nussbaum calls for support of measures that promote complete smoking cessation. “This includes education among medical professionals and their adequate remuneration, e.g., by health insurances, for smoking cessation treatment as well as low-threshold access to therapeutics,” he says.

    For adult smokers who would otherwise continue to smoke, alternative noncombusted nicotine products could better address their barriers and significantly reduce exposure to harmful substances from cigarette smoke as intended by the concept of harm reduction, he adds. The German government, he insists, should invest more in education campaigns to help smokers properly assess the relative risks of cigarettes versus noncombusted alternatives and make better choices than continued smoking if they do not quit nicotine use altogether.

    Nussbaum calls for a clear, unambiguous education. “For example, as in the U.K., simple-worded flyers that say: ‘The harmfulness of cigarette smoking is primarily related to the toxicants from tobacco combustion’ and: ‘Alternative nicotine products such as e-cigarettes, heated-tobacco products, or nicotine pouches are not risk-free and still contain the addictive nicotine, but, for all we know today, have considerably less potential for harm than cigarettes,’” he says.

    The sole focus on the protection of young people is obviously not having the intended effect, notes Nussbaum. On the contrary, according to the DEBRA study, cigarette smoking—by far the most harmful form of nicotine consumption—is currently rising among young people while the smoking rate among adults continues to stagnate.

    “I believe that all stakeholders in the healthcare system who are interested in differentiated risk communication have a responsibility, including the Federal Drug Commissioner and authorities such as the Federal Center for Health Education and the BfR,” he says. “The same applies to medical societies and health insurance companies—many of which, however, have not treated smoking, smoking cessation and the scientific evidence for harm reduction with the necessary focus.”

    For its study update, PMG also surveyed former smokers who had switched to e-cigarettes or tobacco-heating products. Interestingly, they cited similar barriers to quitting smoking in retrospect. “What surprised us: Many aspects, such as ‘enjoy smoking,’ ‘can’t see it through’ or ‘don’t want to cut down,’ were even more pronounced in this sample in retrospect than among current smokers,” said Nussbaum.

    “Nevertheless, they have managed to abandon cigarette smoking. We are currently investigating whether the level of information about alternative nicotine products was decisive for the switch. Overall, this shows us: Alternative nicotine products without tobacco combustion have the potential to open a pathway away from the by far most harmful form of nicotine use, cigarette smoking, for a large group of smokers with no motivation to stop smoking and with barriers such as ‘I enjoy smoking.’” Due to misperception, this potential remains largely unused, according to Nussbaum.

    U.K. Leads the Way

    To reach this base of smokers unwilling to quit, both manufacturers and regulators have a responsibility, stresses Nussbaum. “Alternatives developed by the industry must […] address the needs of the many smokers who are not motivated to quit smoking,” he says. “In addition to the development of alternative products, their regulation in comparison with cigarettes regarding tax/price, communication options, product testing in specialist shops, etc., plays a decisive role in ensuring that they are attractive to adult smokers who would otherwise continue to smoke, without attracting nonsmokers. To achieve the ideal solution of quitting all tobacco and nicotine products, NRTs remain a valid option, especially for motivated smokers willing to use them. NRTs are most effective when used in combination with behavioral therapy or adjunctive support.”

    Nussbaum points to the U.K. as an example for Germany to follow in its efforts to reduce smoking prevalence. “Alternative nicotine products are an important pillar in the strategy to curb cigarette smoking in the U.K., which is part of the FCTC. Remarkably, this is in line with the FCTC, which lists ‘harm reduction’ as one of several pillars of tobacco control,” he says.

    “At the same time, the U.K. applies a very strict regulatory framework around cigarettes. It is precisely this differentiation based on the scientifically supported differences between nicotine products—the ‘risk continuum’—that seems to account for the success of the British approach. The consequence is a very low smoking rate by international standards of just over 10 percent.”

    The U.K.’s success has also been bolstered by differentiated risk communications about alternative nicotine products and cigarettes through easily understandable messages such as “Clearing up some myths around e-cigarettes” by the U.K. Health Security Agency or the recently published fact sheet “Addressing common myths about vaping” by the U.K. public health charity Action on Smoking and Health (ASH).

    “One looks in vain for something like this from German health authorities,” laments Nussbaum.

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • A Captivating Compound

    A Captivating Compound

    The role of nicotine in tobacco harm reduction

    By Grant Churchill

    As a pharmacologist, I remain perplexed that most people, including scientists and doctors, are under the misconception that the harms of tobacco come from nicotine. Indeed, they believe that tobacco and nicotine are equivalent and that nicotine is carcinogenic. All not true. The thesis of this article is that the vast majority of the known harms of tobacco come from chemicals other than nicotine. Using the best current scientific evidence, I will first outline a few background concepts, including the scientific process, chemical terminology and a central concept of pharmacology. I will then cover the harms from tobacco and the harms from nicotine itself and compare them on a risk-benefit basis. I conclude that, based on the objective risks, nicotine is an excellent option for achieving tobacco harm reduction.

    Another common misconception is that science is a list of facts. Science is a process in which there is never absolute proof but rather a continuum of probabilities of belief. As Benjamin Disraeli said, “When the evidence changes, I change my mind, what do you do?” Therefore, if the scientific evidence changes, the conclusions of this article will also change. The experimental evidence also has degrees of strength and is often debatable and controversial, especially where results from studies using isolated chemicals on cells and animals in the lab are extrapolated to humans.

    In common parlance when we say something contains “chemicals,” it means artificial additives or synthetic compounds and comes with a negative connotation. Moreover, “organic” is taken to mean natural, no additives and “chemical-free,” which is impossible as everything is made up of chemicals, including us humans. Often, “synthetic” is associated with toxic and “natural” with harmless. From a pharmacologist’s point of view, a chemical is never given a binary classification of toxic or nontoxic but has a degree of harm related to the dose, as stated by Paracelsus that “the dose makes the poison,” which forms a central concept in pharmacology. So, stating that nicotine is toxic, in a certain sense, is very true, but so is water, as about 4 liters will kill a person. Conversely, botulinum toxin is both natural and one of the most toxic substances known, yet it is used safely at low doses for removing wrinkles. The proper question is not whether nicotine is toxic but rather: What is the exposure dose relative to the toxic dose?

    With the above as background, I now address the relationship of nicotine to tobacco through the lens of harm reduction. In terms of epidemiological data, smoked tobacco carries extensive harms in terms of cancers, lung disease and lost lives and shortened life expectancy. As a pharmacologist, it is patently obvious that tobacco, especially smoked tobacco, is not nicotine and that nicotine is not tobacco. As professor Michael Russell stated, “People smoke for nicotine, but they die from the tar.” Definitions vary, but tar is particulate matter made up of a very complicated mix of only partially known chemicals. Indeed, tobacco smoke is estimated to contain up to 7,000 chemicals, and around 100 are known toxins and/or carcinogens at exposure levels experienced by smokers.

    Most of the harmful chemicals form when tobacco burns (combustion). During combustion, tobacco provides the fuel in the form of chemicals composed mainly of linked carbon and hydrogen (akin to the chemical cellulose in wood fueling a log fire) that split apart and combine with oxygen to form carbon dioxide and dihydrogen oxide (water!). Total conversion is complete or clean combustion, but tobacco combustion is incomplete and results in carbon monoxide rather than dioxide and soot and tar, which are carbon-based chemicals created by the heat, which facilitates a process whereby the bonds that hold atoms together are rearranged to produce a bewildering complex array of new chemicals.

    One major class of chemicals in tar is polyaromatic hydrocarbons, which are large, flat molecules composed of six-membered rings (chicken wire) that insert between the stacked bases of DNA and cause errors when it replicates. Some chemicals are volatile organic compounds, such as aldehydes (formaldehyde and acetaldehyde), which are highly chemically reactive and modify DNA bases. Changes in DNA bases result in mutations, the genetic equivalent of spelling mistakes, and can cause cancer. Other harmful volatile chemicals have acute effects, such as carbon monoxide, which displaces oxygen from hemoglobin in blood.

    Some of these so-called toxic chemicals in tobacco smoke are natural metabolites produced in our bodies enzymatically, such as carbon monoxide and formaldehyde. All aldehydes are highly reactive and can be harmful, including glucose, but in low amounts, those produced or consumed are detoxified through metabolism. This further illustrates that it is not the chemical or its origin (natural or synthetic) but the dose that makes the poison. From an evolutionary perspective, we evolved consuming many toxic chemicals from our environment and have methods to detoxify and excrete these. Tobacco smoke is exceptionally harmful not due to the presence of a given chemical but crucially the dose to which a smoker is exposed.

    It seems perverse for humans to smoke, that is, to create a large and unknown mixture of chemicals through burning and then inhale them. Yet, humans have inhaled the smoke from plant material for millennia and continue to do so to get a fast rush from psychoactive drugs in them. It is interesting to examine the possible origins of this behavior. It has been suggested that this began with the use of fire to cook our food, which destroys pathogens and toxins, and the use of smoke, which preserves food from microbial spoilage. Evolutionarily, fire and smoke had health benefits over the short term (to enable us to pass on our genes through reproduction), but evolution does not select against long-term harms. We are the products of this evolutionary pressure and have a strong preference for the charred and caramelized flavors and “tobacco” notes in food and drink. Unfortunately, the desirable aromas and flavors are part of a large mixture of chemicals formed upon combustion, so with the antimicrobial chemicals also come, most unfortunately, irritants and carcinogens.

    The discussion above outlines why tobacco, particularly when burned, is harmful, but what about nicotine itself? Theoretically, nicotine could be harmful based on its chemical reactivity as carcinogens such as nitrosamines modify DNA or through pharmacological means with nicotine interacting with its biological target, the nicotinic acetylcholine receptor. Nicotine itself is unreactive, and although metabolic reactions in the body in the liver oxidize it and can make it into reactive metabolites, the dose is very low and not considered meaningful. Nicotine is commonly thought to be a carcinogen, but there is no scientific evidence supporting this. In some literature, the term “cancer promoter” has been conflated with carcinogen. In some studies, with cells in the lab, nicotine has been shown to be a cancer promoter. Promoters are compounds that stimulate cell growth and sensitize cells to chemical carcinogens that damage DNA. Any substance that enhances cell growth can potentially be a cancer promoter, such as glucose or even certain vitamins. So, while technically true in cells in culture, in intact humans, there is no evidence that this is a concern, and nicotine is not considered a carcinogen. These data illustrate a specific challenge in studying the potential effects and harms of nicotine as much of the research into the potential harms of nicotine comes from studies in cells and animals where the doses used are often very high, leading to results that are controversial and difficult to extrapolate to humans.

    Do the pharmacological effects of nicotine on the three subtypes of its receptor result in any toxicity? For acute toxicity, the lethal dose is between 60 mg and 600 mg (30 cigarettes to 300 cigarettes), with toxicity resulting from stimulation of the least sensitive subtype of receptor (neuromuscular) that is present on nerves that stimulate skeletal muscle. The most sensitive subtype are the brain receptors, which elicit the cognitive and mood effects of nicotine and have been suggested to underlie neurological developmental problems, but the data are correlative rather than causal. The third receptor subtype (ganglionic) resides in nerves controlling the “flight or fight” adrenaline response and mediates the most investigated and substantiated potentially harmful effects of nicotine per se and give rise to cardiovascular effects. For example, nicotine has been shown to increase blood pressure, heart rate and cause blood vessels to become atherosclerotic. However, the effects are not large and are currently not considered a concern except possibly for those with cardiovascular disease. Indeed, professor David Nutt has noted that the size of the effect is similar to watching a scary movie.

    The disconnect between the cellular/animal studies and human studies is not unique to nicotine and has been well documented for bacon, coffee and even vegetables. In bacon cured with nitrate salts, cooking results in the formation of nitrosamines, which are highly carcinogenic in rats but not humans because humans metabolize nitrosamines differently than rodents. In humans, there is an epidemiological risk from eating bacon, but it is far less than suggested by the rodent studies. Roasted coffee beans contain 826 volatile chemicals, and of the 21 tested, 16 are rodent carcinogens, but, paradoxically, drinking coffee has health benefits in the human population. Professor Bruce Ames’ work has shown that many chemicals from vegetables test positive in rodent carcinogenicity tests, but consuming vegetables in our diets is protective, illustrating that the results from individual chemicals at high concentrations cannot be reliably extrapolated to their effect on humans. The take-home message from these studies is that human epidemiological data are the ultimate test and trump any lab-based results, be they on DNA, cells or animals. Overall, the well-conducted studies that can separate the effects of nicotine from those of other chemicals, such as in tobacco smoke, have revealed minimal effects and harms from nicotine itself, but this area remains controversial.

    In regard to nicotine, the most informative studies are those done in humans. Somewhat ironically, the best evidence for the effects of nicotine itself come from use of a particular form of tobacco called snus. Snus is used in a packet placed between the gums and lips, and nicotine is absorbed through oral mucosal membranes. Snus is not burned nor does it contain high amounts of nitrosamines, which are carcinogens present in unburned tobacco at amounts dependent on the drying and curing process. If snus use were associated with health harms, it would be impossible to disentangle the chemical cause being nicotine or another chemical. Specifically, prevalence statistics and epidemiological data indicate that the use of snus confers a significant harm reduction benefit, which is reflected in the comparatively low levels of tobacco-related disease in Sweden when compared with the rest of Europe. The available scientific data, including long-term population studies conducted by independent bodies, demonstrates that the health risks associated with snus are considerably lower than those associated with cigarette smoking. By extension, one can infer minimal or no harm with nicotine use. But, as you might have guessed, interpretation of these data is controversial.

    To conclude, in regard to tobacco harm reduction, the question is not whether nicotine has any harm but rather how harmful is nicotine relative to tobacco. Given that tobacco smoke is exceptionally harmful, anything that can reduce smoking will have health benefits to both the individual and society. Nicotine, the chemical itself, is addictive, but from a pharmacological perspective, when used as intended through properly regulated means, the balance of evidence shows that it has minimal harm. Therefore, nicotine is an excellent means for tobacco harm reduction as it can combat smoking, the largest cause of preventable deaths worldwide.

    Grant Churchill is a professor of chemical pharmacology at the University of Oxford.
  • Brazil: Most of Crop Already Planted

    Brazil: Most of Crop Already Planted

    Image: Tobacco Reporter archive

    Brazil’s tobacco crop for the 2023/2024 season is mostly planted already, according to Kohltrade.

    Transplanting began earlier this year than in previous years and is being finalized in most of the southern Brazil properties. Farmers are hoping to avoid excessive summer heat and to grow more quality leaf. 

    Traditionally, the majority of planting took place in August. Recently, however, farmers have been planting early to harvest earlier to avoid issues created by lack of rain and excessive heat, which have been constant in recent seasons.

    The Department of Mutuality of the Brazilian Tobacco Growers Association stated that recurring droughts have forced farmers to start their work earlier in the season. Planting early has risks as well, though, with the potential for some of the plants to die after a winter frost.

  • Innokin Partners with Bahrain Duty Free

    Innokin Partners with Bahrain Duty Free

    Image: Tobacco Reporter archive

    Innokin is partnering with Bahrain Duty Free (BDF), a retailer in the Middle East.

    BDF will help introduce Innokin’s Innobar vaping products to Bahrain Duty Free’s premium stores, catering to the increasing demand for e-cigarettes in the region, according to a press release.

    The new partnership began with a pilot project launched in April 2023. Within two weeks, the entirety of the trial stock had sold out.

    “Building on this remarkable success, the collaboration has now expanded to provide customers with greater access to Innokin’s award-winning vaping solutions,” Innokin wrote in its announcement. “Innokin’s Innobar devices, in particular, have garnered significant interest for their exceptional performance and flavors, which are tailored to suit the preferences of the Bahrain market.”

    Currently, the Innobar 3500, 6000 and V7000 models are available at BDF locations. A key element of the partnership has been the knowledge-sharing and training provided by Innokin’s experts to the management of BDF.

    “We are thrilled about our partnership with Bahrain Duty Free. This collaboration signifies not only our dedication to the growing Middle East market but also our commitment to fostering responsible practices in the industry,” said George Xia, co-founder of Innokin. “With our decade-plus experience and the shared values of both organizations, we are confident that this partnership will set new standards of excellence for vaping.”

  • Philippine Growers Urged to Plant More

    Philippine Growers Urged to Plant More

    Photo: Philip Morris Fortune Tobacco Co.

    Philippine Agriculture Undersecretary Deogracias Victor Savellano urged tobacco-producing provinces in Northern Luzon to increase production for export, according to the Philippines News Agency. The request followed a meeting with the governing board of the National Tobacco Administration (NTA).

    Savellano said that the NTA and farmers should boost tobacco production without sacrificing production of other crops, like rice, corn and other high-value crops.

    If the Philippines increases tobacco for export, the country can engage in barter-to-barter with Indonesia, which produces low-cost rice and fertilizer.

    In 2022, the Philippines exported 53 percent of tobacco produced while 47 percent was supplied to local tobacco manufacturers.

    “Aside from our aim to increase our tobacco production for export, we are also looking at the other alternative products from tobacco and its commercialization, like the tobacco dust,” Savellano said.

  • Cambodia: Police Shut Down Illegal Tobacco Factory

    Cambodia: Police Shut Down Illegal Tobacco Factory

    Image: Derek Brumby

    Tboung Khmum police shut down an illegal tobacco factory producing counterfeit Esse brand cigarettes, in collaboration with Cambodia’s provincial military police and mobile customs officers, reports the Khmer Times. The factory was located in the Memot District, near the border with Vietnam.

    The factory was allegedly owned by a Cambodian tycoon, according to Tboung Khmum Provincial Economic Police Officer Major Long Sambath. Police were investigating and monitoring the factory for a month before the raid, said Sambath.

    The alleged owner was not present during the raid and has not been located, though his identity is known.

    “This factory has operated without any authorization from relevant provincial authorities. We discovered recently that it was producing unlicensed, counterfeit Esse cigarettes,” Sambath said.

    “The authorities have already cracked down on the factory, and we will take legal action to locate and prosecute the owner of the factory,” he said.

    Several tons of counterfeit cigarettes were seized along with other tobacco-related materials, including new cigarette manufacturing equipment.

  • Coalition Campaigns Against Menthol Ban

    Coalition Campaigns Against Menthol Ban

    Image: National Coalition of Justice Practitioners

    The National Coalition of Justice Practitioners, a group of Black and Hispanic law enforcement executives and experts, hosted the “When Good People Write Bad Policy” National Press Club panel event to educate people about the racial and criminal implications of a menthol ban, according to a PR Newswire release. The panel met before the U.S. Food and Drug Administration’s anticipated menthol ban announcement.

    “There are many groups who still do not understand the unintended consequences of this proposed ban,” said Benjamin Chavis, president and CEO of the National Newspaper Publishers Association and panel moderator. “For leaders in Washington to consider this ban without consulting Black and Brown officers is disastrous. Let’s sit down with the proponents and first conduct a Racial Impact Study. Targeting in the past doesn’t justify targeting now. We are against racial targeting and profiling. All of it.”

    Panelists Jiles Ship, Neill Franklin, Elliot Boyce, Corey Pegues, Sonia Pruitt, David Daniels III, John I. Dixon and Ron Hampton asked that President Joe Biden and Vice President Kamala Harris pull back on this menthol ban until further studies, like a Racial Impact Study, are done and more experts are heard.

    The Aug. 10 panel event urged lawmakers to study the effects of a menthol ban by launching a Racial Impact Study that gathers input from law enforcement, health experts and Black and Latino communities.

    The law enforcement experts listed these unintended consequences: Anything you ban becomes illegal, and it is a policing issue; enforcement of the menthol ban will be in more urban and Latino communities and used as a tool in racial profiling, stop-and-frisks and arrests; and the police do not need another reason for a stop-and-frisk that leads to life-threatening casualties in the Black community.

    Former Law Enforcement Action Partnership Executive Director Franklin stated, “Illicit markets breed violence. This menthol ban will flood the streets, especially Black and Latino communities, with unregulated products, and if you think the products are unhealthy now, wait until the unregulated products are pushed into our communities. You don’t want to see substances like fentanyl added to a street cigarette.”

    Overall, adult and youth smoking rates in the U.S. are at record lows, according to the coalition. Since over 80 percent of African Americans and 48 percent of Latinos who choose to smoke prefer menthol cigarettes, a proposed FDA ban is racially discriminatory since cigarettes preferred by white smokers will not be banned, they argue. There is no scientific basis to regulate menthol and nonmenthol cigarettes differently. Health concerns are more effectively managed through education, treatment and counseling, not by police, they state.

  • ‘FDA Botched Review’

    ‘FDA Botched Review’

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration failed to conduct a proper analysis before rejecting premarket tobacco product applications (PMTAs) submitted by Fontem U.S. for certain vaping products, the U.S. Court of Appeals for the D.C. Circuit found on Aug. 29.

    The court upheld the regulatory agency’s denial of Fontem’s application to market flavored vaping products but rejected the FDA’s denial of Fontem’s application for unflavored products.

    “While the FDA identified multiple ‘deficiencies’ [in Fontem’s application], it failed to analyze the trade-offs necessary to make a public health finding,” the judges wrote in their ruling. “Nor did the agency explain how the specific deficiencies relate to its overall conclusion that Fontem failed to demonstrate its unflavored products were appropriate for the protection of public health. The agency’s denial therefore failed to comport with the requirements of the Tobacco Control Act.”

    The FDA’s failure to correctly apply the public health inquiry to Fontem’s unflavored products led it to make another serious error, according to the court. In its initial deficiency letter, the FDA requested certain information from Fontem, thereby indicating such information would be sufficient for the agency to approve Fontem’s products.

    But in its denial order, the agency changed its tune, reproaching Fontem for failing to provide information that the agency had never explicitly sought.

    “Shifting the regulatory goal posts without explanation is arbitrary and capricious,” the judges wrote. “By indicating in its deficiency letter that Fontem could resolve issues with its applications by providing specific information, the FDA represented such information would be sufficient to secure approval.”

  • Russia Blames Illicit Trade for Tax Losses

    Russia Blames Illicit Trade for Tax Losses

    Photo: Ivan Semenovych

    The Russian government lost more than RUB46 billion ($481.33 million) in tax earnings in the first half of 2023 as a result of the illicit trade in cigarettes, reports Interfax.

    “According to the latest study, which ended this month, the share of illicit cigarette trafficking was 13.3 percent in terms of smokers,” said Vladislav Zaslavsky, director of the Russian Industry and Trade Ministry’s department for the system of digital marking of goods and the legalization of the circulation of products.

    “The minimum amount of losses, according to the NNCC [National Scientific Center for Combating Illicit Trafficking in Industrial Products], is estimated at RUB46.5 billion,” Zaslavsky said on Aug. 24 during a retail round table in the Volga region.

    According to Zaslavsky, each percent of the share of illicit cigarette trafficking costs the federal budget about RUB7 billion in excise taxes alone.

    The NNCC will conduct a study on “nicotine-containing products” in the second half of 2023. As of the end of 2022, the market share of illegal nicotine-containing products was 79 percent, including 93 percent in illegally sold nicotine-containing liquids.

  • Sampoerna Announces Executive Changes

    Sampoerna Announces Executive Changes

    Photo: Taco Tuinstra

    Sampoerna has appointed Johan Bink as the operations director, succeeding Dina Lombardi, and Gunnar Beckers as marketing director, succeeding Francisca Rahardja.

    Previously, Bink served as director of manufacturing at Papastratos, an affiliate of Philip Morris International in Athens, with over 33 years of experience in supply chain management and production planning.

    Beckers previously served as PMI global head of consumer experience in Lausanne, Switzerland, with over 20 years of experience in marketing.

    “Johan’s extensive experience in operations, from production floor to central functions, and his strong communication and leadership skills will continue to be great assets in his new role,” said Sampoerna President Director Vassilis Gkatzelis in a statement.

    “Meanwhile, Gunnar is a well-rounded executive, who has consistently created value across diverse assignments at global, regional and market levels. His strategic perspective, wide international experience, strong collaborative spirit, focus on consumers, and ability to build brands will be great assets in his new role.”

    Gkatzelis also expressed his gratitude to Lombardi and Rahardja for their contributions and leadership at Sampoerna. Both will assume new responsibilities within the PMI organization.

    “Ibu Dina has always prioritized the safety and development of our people, thus role-modeling the Sampoerna and PMI values during the very challenging pandemic period. She guided Operations in reaching monumental milestones, including the establishment of the manufacturing facility for innovative smoke-free tobacco products,” said Gkatzelis.

    “Meanwhile, Ibu Francisca has been leading the Marketing organization through very challenging times in a forward-looking way. In addition, she built solid foundations for the Consumer-Centric Organization. At the same time, she also contributed to the early journey of the innovative smoke-free tobacco products that Sampoerna introduced to adult consumers in Indonesia,” said Gkatzelis.