Tag: Germany

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.

Deepak Anand, principal, ASDA Consultancy Services

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.

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

December 1, 2023
Bubbles of Bliss

Splash’s objective was to develop a smoke-free and vape-free product that would integrate enjoyment and ritual.

A German startup deploys foam to deliver nicotine.

By Stefanie Rossel

Klaus Hagen
Until recently, users of noncombusted products had two ways of consuming nicotine: through an aerosol generated by e-cigarettes or heated-tobacco products (HTPs) or through direct absorption by the mucous membrane of the mouth, as is the case when using modern oral nicotine products. The Splash platform works with an entirely different medium: foam. According to its eponymous manufacturer, a startup company based in northern Germany, Splash is the fastest delivery system on the market, delivering the desired nicotine “hit” within seconds.
The stimulants carrier is not an aerosol but a glycerin-free fine foam, similar to the froth on a cappuccino, which is consumed through a mouthpiece. The Splash device comprises a bottle filled with nicotine-containing liquid. A separate department at the top of the unit holds a mix of natural ingredients, including phospholipids and a vegetable emulsifier, that turn the liquid into a stable foam when released.
“We wanted the particles to stay in the mouth longer than aerosols and be absorbed sublingually,” explains Klaus Hagen, chairman of Splash. “Foam moves slowly and remains in the mouth long enough for ingredients to be absorbed quickly. This way, it takes only a few seconds until the active ingredient arrives in the brain. In addition, the foam allows the aromas to spread in the mouth and create an intense taste experience.”
To manage the air pressure within the bottle, the device is equipped with coated pills and a filter. “With Splash, we have found a way to substantially shortcut the road that stimulants usually have to take through the body via the stomach and the bloodstream,” says Hagen.

Smoke-Free and Vape-Free

Splash is a hybrid: a modern oral nicotine product in the form of a handheld device that mimics the hand-to-mouth motion associated with smoking or vaping.

Hagen, who boasts a long career in the tobacco industry, most recently as head of next-generation products at a leading multinational, founded Splash in 2021. Development of the Splash platform, however, started as early as 2019. Hagen had just successfully exited his first startup, which had developed a battery-powered shisha.
“A few weeks after the sale of our company, my team and I were contemplating what to do next,” says Hagen. “We knew that whatever we would develop now would only become relevant to consumers, the industry and regulators in three [years] to four years. When we started with Splash, vaping was already very popular, and it was all about generating big clouds of steam. Oral nicotine products at that time were either tiny niche or locally limited, such as snus in Sweden. The same was true for batteries and their potential hazard for the environment. Nevertheless—or because of that—we decided to create a natural alternative to aerosols and batteries.”
The objective was to develop a smoke-free and vape-free product that would integrate enjoyment and ritual. “We aimed to be way ahead of a consumer trend we were anticipating,” says Hagen. “At that time, it was a mere gut decision, but it has turned out to be the right one.”
The idea of using foam was inspired by the detergent capsules used in dishwashers. “We were immediately aware of the enormous potential ‘effervescent tablets’ would have as an energy source for use in inhalers,” says Hagen. “So we decided to develop a method to turn a liquid into a solid foam.”

Facilitating Switching

The result is a hybrid—a modern oral nicotine product in the form of a handheld device that mimics the hand-to-mouth motion associated with cigarettes, HTPs or vapes. Hagen calls it a vape 2.0 or “no heat, no burn.” The product can be offered with various nicotine strengths. Once activated, the device generates 25 puffs to 30 puffs.
The company tested user acceptance at different points in the development process. “In the U.K., we had the product tested by many consumers in London, Birmingham and Manchester this May,” says Hagen. “They all immediately understood what Splash was about, which is on the one hand to maintain an essential ritual known from smoking or vaping and on the other hand to be discreet—i.e., not to emit smoke or vapor. We live in a fast-paced time where social acceptance of smoke[-generating] and vapor-generating products is getting ever more limited. Besides, for smokers or users of HTPs or vape products, the switch to a nicotine pouch is too big a step—they need certain key elements, including habits and satisfaction.”
In researching the market, the company paid particular attention to two aspects: How do consumers experience the absorption of active ingredients, and how do they like foam as an administration tool? “We were surprised how well both were received,” says Hagen. “Consumers described the uptake of active ingredients as ‘very fast and effective.’ The foam, albeit a novelty, was experienced as extremely pleasant. We had numerous conversations with smokers who confirmed that nicotine absorption through Splash is not only exceptionally fast but also lasts for a long time so that the total consumption of nicotine—spread across a day—is lower than with the usual nicotine-containing products.”

Splash is not only fast, but it also lasts a long time so that the total consumption of nicotine is lower.

Klaus Hagen, chairman, Splash

Low Risk Profile

Splash’s comparatively low risk profile should help the product gain acceptance in a heavily regulated industry. The foaming agents contain emulsifiers that have been approved for use in the food industry. As a modern oral product, the device is not subject to the EU Tobacco Products Directive (TPD) yet; for the time being, member states can decide for themselves whether to permit the product category. Hagen is confident that the TPD will embrace new products such as Splash in the future.
Being made of nicotine, the liquid in Splash does not contain harmful substances common in tobacco, such as nitrosamines. The product is also free from heavy metals. Since Splash works without heating or pyrolysis, it doesn’t create any byproducts, such as formaldehydes. What’s more, the absence of a battery means there is no risk of fire or malfunction. Other risks, such as leakage or accidental swallowing of the whole product, are ruled out as well, according to Hagen.
In addition to equipping its device with a child-safety lock, Splash adheres to strict voluntary standards to prevent youth appeal. “Of course we stick to the legal caps for nicotine, but we also refrain from using sugar-loade[d] flavors or giving our flavors fancy names that are targeting children or youths,” says Hagen. “We don’t do lifestyle marketing, and we focus on age verification for online trade and retail.”
Splash is a disposable product, planned to retail at $2 per unit and appealing to a mass market with its simplicity of use. However, sustainability has played an important part in its development. “We were motivated to make things better than existing products,” says Hagen. “In contrast to vape products, Splash contains no electronic components. Almost all its parts are made of recyclable plastic, hence the product can be returned into the recycling loop. With this, we are anticipating what is already imminent in some regions: the legally enacted ban of batteries in disposable products.”

Platform with Potential

The company believes its platform has potential beyond nicotine delivery. “Splash could be used for the administration of substances that provide users with new energy or a feeling of well-being and deceleration,” Hagen says. “It is also apt for administration of medicines. Our technology has a big advantage for beverage and pharma: the speed of absorption. While it takes about 10 [minutes] to 20 minutes for an energy drink or a painkiller to release its effect, Splash will take only a few seconds. We have already carried out respective tests in our labs, and there’s interest from the industries. Here, our technology could be licensed.”
The company, which comprises a network of 14 people spread across several cities and continents, aims to become an expert in the administration of substances rather than an expert in the distribution of nicotine products, according to Hagen. For the time being, though, Splash is focusing on nicotine, which currently engages the majority of its staff. A second division, however, is working on other mood enhancers.
The Splash device is developed in Germany and manufactured in China. For regulatory reasons and to distinguish it from use in other industries, the company in November rebranded the nicotine part of its platform under the name Voam.
The company started to commercialize its patented technology as a nicotine product in the late summer of 2023, testing the product in several stores in close contact with consumers to be able to potentially make last adjustments. “We intend to keep this panel that exceeds traditional market research to test innovations, such as new flavors, in the future,” says Hagen.
According to him, the industry has already shown significant interest in the product. The company has been in talks with representatives of the traditional tobacco business as well as the nicotine industries and leading distributors in several countries. “We are already negotiating the first larger volumes,” says Hagen. “In the selection of potential partners, it is especially important to us that the player shares our mission: to enable a smoke[-free] and vapor-free world with our product without forgoing enjoyment and rituals.”

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

November 20, 2023
Industry Leaders Call for Regulatory Restraint

Photo: WavebreakMediaMicro

Representatives of the nicotine industry called on regulators to develop policies that respect adult consumers, strengthen the protection of minors in a targeted manner and take into account the concerns of the companies and employees of a diverse industry.
Speaking during the opening day of the InterTabac trade exhibition in Dortmund, industry leaders cited mounting regulations in Germany, where manufacturers, retailers and consumers have had to adjust to multitude new restrictions in short succession.
Meanwhile, the EU Commission is preparing amendments to the EU Tobacco Tax Directive and the EU Tobacco Products Directive, which threaten to tighten the rules even further. In Berlin, politicians are calling for additional advertising bans and a ban on flavors in e-cigarettes.
Managing Director Michael von Foerster of the German Smoking Tobacco Association urged lawmakers to return to the model of the responsible consumer.
“An informed adult who rolls a cigarette, enjoys a cigar, smokes a pipe or consumes snuff has the right to do so without government paternalism through new harassment and restraints,” he said. “Instead of continuing to turn the regulatory screw, greater trust in informed consumer decisions is urgently needed—not only in the tobacco sector.”
The calls for new advertising restrictions in Germany are driven in part by a recent DEBRA study that revealed an increase in smoking. However, according to Jan Muecke, managing director of the German Association of the Tobacco Industry (BVTE), the results of this study are contradicted by the significant decline (8 percent) in cigarette sales in 2022. Cigarette sales in Germany fell to 65.8 billion units in 2022, according to the BVTE—a historical low.
“Far reaching political decisions cannot be discussed on the basis of a survey which, given the small sample size, has no validity and does not stand up to scrutiny,” said Muecke. “We support a targeted strengthening of the protection of minors, for example through more intensive control of the ban on the sale of these products to minors. Arbitrary bans, on the other hand, would not add any value to the protection of minors and would ultimately be counterproductive. Banning flavors in e-cigarettes does not keep young people away from nicotine, but only prevents adult smokers from switching to these low-emission alternative products.”
Bodo Mehrlein, managing director of the Federal Association of the Cigarette Industry, demanded an end to what he described as the strangulation of the tobacco business in Germany, pointing to the sector’s economic contributions at a time of hardship. The tobacco industry, which directly and indirectly employs some 350,000 people in Germany, is already drowning in regulations and requirements, he said. For example, it is currently facing the challenge of installing a costly traceability system to monitor the supply chain.
Torsten Loeffler, president of the Federal Association of Tobacco Retailers, said the mounting regulatory burdens threaten the viability of many retailers, who are already struggling with skyrocketing cost and low profits.
“Those who demand a ban on tobacco advertising in shops want a ban on communication for legal products, prevent competition as well as diversity, and thus endanger the existence of businesses and the jobs of employees,” he said.

September 15, 2023
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.

September 1, 2023
Beco Launches Two Products in Germany

Image: BusinessWire

BecoVape has launched two new products in Germany: Beco Beak600 and Beco Mate, according to BusinessWire.
Beco Beak600 has an ergonomic mouthpiece design that follows the curve of the mouth and is specifically designed to provide a stable one-hand grip. Beco Mate is said to offer a new alternative for cigarette users.
“We are very excited to introduce these two new products in Germany,” said Beco’s CEO. “We have worked hard to develop products that are not only innovative but also practical and useful for our customers. The specialized heating system and airflow design direct the airflow to deliver smooth inhales. Beco made 10,000 designs to find the perfect fit of the mouthpiece and combine it with a compact design.”
The brand plans to expand its product line. However, the issue of how to become more environmentally friendly is top of mind for the brand. To address this issue, Beco has developed a recycling program.

April 13, 2023
German Cigarette Sales at Historic Low

Photo: Tupungato

Cigarette sales in Germany fell 8.3 percent to 65.8 billion units in 2022, according to tobacco tax stamp figures published by the Federal Statistical Office on Feb. 8.
German cigarette volumes have been declining steadily for years. In 2012, smokers bought 82.4 billion cigarettes. As a result of tobacco tax increases and inflation-related adjustments, a pack of 20 premium cigarettes became more than 5 percent expensive in both 2022 and 2023—which is still below the average rate of inflation in those years.
In response to the price hikes, some smokers have switched to fine-cut tobacco, which is taxed at lower rates. Sales of roll-your-own and make-your-own cigarettes remained stable in 2022 at 25,080 tons.
Sales of cigars and cigarillos declined 8.9 percent compared to the previous year. The pipe tobacco tax category, which in 2021 still included classic pipe tobacco, water pipe tobacco and tobacco heaters, now only reflects sales of classic pipe tobacco, which reached 324.5 tons in 2022. The volume for water pipe tobacco was 962.6 tons.
The share of untaxed cigarette sales in Germany declined from 19.1 percent in 2019 to 17.3 percent in 2022, likely as a result of coronavirus-related travel restrictions. According to the German Association of the Tobacco Industry and New Products (BVTE), this means that lower legal cigarette sales were not fully offset by sales of products purchased abroad or on the black market.
In July 2022, Germany started taxing e-liquids at a rate of €0.16 ($0.17) per milliliter. The government taxed 226,018 liters that year, earning €42.6 million from the segment. The impact of the tax increases will become visible only after the old, untaxed stocks may no longer be sold after Feb. 13.
By 2026, Germany’s Ministry of Finance expects e-cigarettes to generate revenues of €1 billion, a figure that the BVTE in a statement described as unrealistic.
Despite the tax increase, the federal government collected €14.23 billion in tobacco taxes in 2022, 3.4 less than in 2021.

February 8, 2023
Lifting the Fog

Photo: Andrii

An official acknowledgement of nicotine pouches’ comparatively low risk clears the way for appropriate regulation in Germany.
By Stefanie Rossel
The news was a minor sensation given German authorities’ reluctance to acknowledge the reduced harm potential of novel tobacco products. On Oct. 7, 2022, the Federal Institute for Risk Assessment (BfR), a scientific institution of the German government, published a statement in which it confirmed that tobacco-free nicotine pouches could reduce the health risks compared to smoking.
Jan Muecke | Photo: German Association of the Tobacco Industry and Novel Products
The risk profile of modern oral nicotine products, as they are also called, is comparable to that of medical nicotine-replacement products such as nicotine patches, the institute wrote in its evaluation, which was published in several scientific journals, including Tobacco Control. Carried out by BfR scientists in August 2022, they study showed that aside from nicotine, the pouches contain no substances that present health concerns. In some samples, researchers detected traces of tobacco-specific nitrosamines, which are also found in medical nicotine-replacement products. According to Jan Muecke, chief executive of the German Association of the Tobacco Industry and Novel Products, this problem is solvable, however.
To protect consumers, the BfR recommended regulation of the manufacture, presentation and sale of nicotine pouches. Tobacco harm reduction advocates hope the findings will prompt German authorities to finally regulate modern oral nicotine products as tobacco products.
Nicotine pouches comprise small sachets with a mixture of cellulose fibers, flavorings, water, humidifying and gelling agents along with preservatives and artificial sweeteners. Since their introduction in Germany, they have existed in a regulatory gray area. Because the products contain nicotine, authorities decided that sales require monitoring. However, since the products are tobacco-free, the German tobacco product law does not apply.
Following several assessments and court rulings, German regulators classified modern oral nicotine products as food, making it subject to European food law. However, the European Union prohibits the use of nicotine as a food, food ingredient, food additive or food flavor, which means nicotine pouches classified as food may not be sold in the trade bloc. In March 2021, the administrative court in Hamburg confirmed that the sale of modern oral nicotine products was illegal. Other German courts have followed suit.
According to Muecke, the classification of nicotine pouches as food has been problematic because it misleadingly implies that the products are being eaten. “This is nonsense,” he says. “The products are consumed by putting the pouch between the upper lip and gum and leaving it there while the nicotine and taste is being released. After use, the complete pouch is disposed of. This makes them comparable to toothpaste or floss—no one would think of declaring these products as food.”

Regulation Protects Consumers

By classifying nicotine pouches as food, Germany is an outlier. In the 16 EU member states where modern oral products are available, they are regulated either as tobacco or as a consumer product. Demark and the Czech Republic have even created a new product category for nicotine pouches, defining them as tobacco surrogates and allowing the sale to adults.
Muecke welcomes the opportunity that the BfR assessment offers Germany to change its classification. “The BfR statement contains all data that are required for appropriate regulation of nicotine pouches,” he says. “Scientific studies have confirmed that if nicotine content is limited to a maximum of 20 mg per pouch, nicotine blood levels will not be higher than when smoking a combustible cigarette. We therefore hope that the government will take the request of the consumer protection conference of the federal states seriously who in 2021 had called for regulation of nicotine pouches under tobacco law.
“In the current state of legal uncertainty, modern oral nicotine is nevertheless on the German market—consumers buy their nicotine pouches online from abroad. These products often do not stick to nicotine limits, and child and youth protection cannot be efficiently controlled. Adequate regulation of nicotine pouches as tobacco products would hence protect consumers and youths.”
A chance for a change is already in sight: Under a delegated directive from the European Commission, the German government has until July 2023 to revise the country’s rules for heated-tobacco products (HTPs). “HTPs will be more strictly regulated in Germany in the future,” Muecke explains. “Therefore, it would make sense to find legal regulation for nicotine pouches during the same legislative process, which for HTPs will have to be concluded in the first half of 2023. To wait for a new version of the EU Tobacco Products Directive (TPD) that won’t be translated into national law until 2025 or 2026 would be wrong as unregulated online purchases of modern oral nicotine products with excessive levels of nicotine would continue to endanger consumers.”
The European Commission intends to publish a draft of the revised TPD in 2024. While the wording is still unknown, the public has an opportunity to share its views through a consultation. Muecke encourages all stakeholders to take part, for example through the German-language website dein-ding.de.
While it would technically be possible to regulate nicotine under the revised TPD, this is not Muecke’s preferred solution. “The products are on the market right now and available in 16 EU member states, especially in most of our neighboring countries, hence Germany shouldn’t be an island of prohibition,” he says. Muecke suggests regulators use the TPD’s e-cigarette regulations as guidelines for modern oral nicotine products.
Muecke is confident that appropriate regulation for the novel oral nicotine products will be implemented in Germany. “A ban of nicotine pouches would not be in accordance with the principle of risk minimization,” he says. “The government must create a possibility for consumers to buy such reduced-risk products at retailers—it’s an absolute necessity.”

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.

February 1, 2023
German Trade Group Blasts Call for Vape Ban

Jan Muecke
(Photo: German Association of the Tobacco Industry and Novel Products)

Recent calls to ban e-cigarettes lack a scientific basis, according to the German Association of the Tobacco Industry and Novel Products (BVTE).
In a recent interview with Deutsche Presse-Agentur, Manne Lucha, minister of social affairs, health and integration for Baden-Württemberg, said that e-cigarettes should be treated the same as combustible cigarettes and that flavored vapor products should be banned.
“It is a scientific consensus that the intake of harmful substances when vaping e-cigarettes is much lower than when smoking tobacco. With his ‘post-factual’ statements, the minister is causing consumer uncertainty with counterproductive consequences for health policy,” said BVTE CEO Jan Muecke in a statement.
Muecke cited a 2020 statement by the German Cancer Research Center, which acknowledged that a complete switch from smoking to vaping reduces the consumer’s exposure to harmful substances. He also quoted Public Health England’s finding that e-cigarettes are at least 95 percent less harmful than smoking.
According to the BVTE, e-cigarettes are the most frequently used smoking-cessation tool in Germany, ahead of less effective methods such as medical nicotine replacement products. The wide choice of flavored liquids, meanwhile, is a significant factor for adult smokers to switch to vaping, the organization wrote.
“Instead of fueling fears with false claims and misguided demands for bans, e-cigarettes should finally be promoted in Germany as an opportunity to minimize risks for smokers,” Muecke said.

January 31, 2023
Trade Group: Germans Smoking Less

Photo: Rene Van Den Berg | Dreamstime.com

Contrary to what the recently conducted German Survey on Smoking Behavior (DEBRA) suggests, Germans are smoking less, writes the German Association of the Tobacco Industry and New Products (BVTE) on its website, citing figures from the Federal Statistical Office (FSE).
According to the FSE, sales of taxed cigarettes will decline in 2022 for the fourth year in a row, falling well below the 70 billion unit threshold for the first time.
“People are smoking less and less in Germany. That is a fact that cannot be disputed,” says Jan Muecke, chief executive of the BVTE. “If more smoked, we would have to see that in the sales statistics. The opposite is the case.”
Conducted at the University of Duesseldorf, the DEBRA found that the proportion of smokers in the total population increased from 25.4 percent in 2020 to 37.6 percent in July 2022. Among underage tobacco users, the prevalence had even almost doubled within one year, showing an increase from 8.7 percent in 2020 to 15.9 percent in 2022. According to the DEBRA, several million adults and around 200,000 minors have (re)started smoking.
The BVTE noted that such a significant increase in smoking prevalence should have been reflected in government sales statistics, even if the new smokers were only occasional users.
However, fewer cigarettes have been sold in Germany every year since 2019. From 2019 to 2021, cigarette sales fell by 3.6 percent to 71.7 billion units. This trend continued in 2022. The FSE reported tax stamp purchases for 60.7 billion units from January 2022 to November 2022. This means that 8 percent fewer cigarettes were produced for the German market than in the same period of the previous year.
For 2022 as a whole, the agency expects sales of around 67 billion units.

“People are smoking less and less in Germany. If more smoked, we would have to see that in the sales statistics. The opposite is the case.”

Jan Muecke, chief executive, BVTE

According to the BVTE, the discrepancy between official sales statistics and the DEBRA data points to methodological weaknesses in the survey. For example, the alleged increase in the proportion of underage consumers is based on a sample of only about 50 young people—apparently including eight people who reported smoking. Based on this data, says the BVTE, any estimate of smoking prevalence is highly uncertain.
Muecke lamented the fact that the dubious DEBRA results were used to justify misguided demands for regulation. “Tobacco is fully regulated,” he said. “Adult smokers in Germany already feel unduly patronized and are not reached even with ever new bans and restrictions.”
At the same time, German policy fails to expand the range of new alternative products for smokers and to create more opportunities and greater acceptance for potentially risk-reduced nicotine consumption, according to the BVTE.
For example, the Federal Ministry of Agriculture is delaying the regulation of tobacco-free nicotine pouches, which are still not available to smokers in German shops despite the fact that the Federal Institute for Risk Assessment has acknowledged that switching from cigarettes to nicotine pouches could represent a reduction in the health risk for a person who smokes.”

January 22, 2023
Institute: Pouches Safer Than Smoking

Photo: Swedish Match

In the statement published on Oct. 7, 2022, the German Federal Institute for Risk Assessment (BfR) confirmed that tobacco-free nicotine pouches can reduce health risks compared to smoking. To protect consumers, the BfR recommends regulation of the manufacture, presentation and sale of nicotine pouches.
In a detailed study on the material composition of tobacco-free nicotine pouches performed in August 2022, BfR scientists found that aside from nicotine, the pouches contain no substances presenting health concerns. In some samples, however, they detected traces of tobacco-specific nitrosamines (TSNA) similar to those found in medical nicotine-replacement products.
The BfR scientists did express concern about inadequate labeling and missing warnings on some products.
“These critical comments can be resolved in principle,” said Jan Muecke, CEO of the German Association of the Tobacco Industry and Novel Products (BVTE), in a statement. “It would make a lot of sense to set appropriate limits for nicotine and TSNAs and to introduce binding regulations on warnings and labeling obligations. A high level of consumer protection must be guaranteed.”
Muecke said the BVTE would welcome regulation of nicotine pouches under tobacco laws. Contrary to their counterparts, other European countries, German regulators treat nicotine pouches as food products. As a result, they are illegal in Germany.
Muecke said he hoped the BfR assessment would prompt regulators to rethink. “We want tobacco-free nicotine pouches to provide consumers of tobacco and nicotine products with another potentially less harmful alternative,” he said.

October 13, 2022