Press Release | 27.11.2024 | Nicotine pouches regulation: The importance of educating regulators about their benefits in smoking control

The importance of educating regulators about the benefits of vaping and nicotine pouches in smoking control

Nicotine pouches are the newest oral, smokeless tobacco harm reduction product with a safety profile very similar to pharmaceutical nicotine formulations. Their availability in a variety of strengths and flavours represents a potentially important tool in the arsenal of the tobacco cigarette-alternative options that smokers, particularly those unable or unwilling to quit with currently approved methods, might need in order to partially or completely substitute for smoking. However, as with all harm reduction products, appropriate regulation is key in determining whether pouches will become a valuable addition to the smoking control strategy or a wasted opportunity.

Konstantinos Farsalinos, MD, MPH, Senior Researcher University of Patras, Greece; School of Public Health, University of West Attica, Greece; Data & Media Lab, University of Peloponnese, Greece, moderator to the webinar held on November 27th, titled "Nicotine pouches regulation: Questions, uncertainties, and ways to maximize public health benefit," introduced the speakers: Karl Fagerstrom, Tim Phillips, and David Sweanor, and presented the topics to be discussed: the current situation and trends in international legislation concerning nicotine pouches; exploring the appropriate pathway to find the balance between exploiting all intended benefits and avoiding unintended harms on an individual and population level.

Karl Fagerstrom, Professor Emeritus; President, Fagerstrom Consulting, Sweden, addressed an introductory presentation discussing the regulation of nicotine pouches, highlighting Sweden's historical context with tobacco products and recent government support for harm reduction.
He stressed that non-tobacco nicotine pouches are probably the least harmful of the nicotine containing consumer products. He presented data from the Nordic countries that use alternative tobacco products, such as snus, to support this. In Sweden, up until very recently, governments regarded all tobacco products equally harmful. It is the last government that endorsed harm reduction for nicotine products; as a consequence, the tax on snus was lowered by 20% while it was increased on the more dangerous cigarettes by 10%. Very recent statistics on use of nicotine and tobacco show that Sweden has reached endgame with at most 5% prevalence of smoking with the help of snus and nicotine pouches.
Professor Fagerstrom presented findings on tobacco attributable deaths among males in the European Union showing that all the countries that are using snus—Sweden, Norway and Iceland—are enjoying less tobacco attributable deaths. He commented that this is the result of the use of snus on the smoking prevalence that lowers the tobacco related harm. He presented details on the ingredients and composition of nicotine pouches and noted that the non-tobacco nicotine pouches need to be regulated e.g. according to legal age for buying, packaging, advertising and amount of nicotine in the pouches to ensure good quality products that can contribute to improved public health. Countries could learn from Sweden’s success, he concluded, for example by considering increasing taxes on cigarettes and lower them on less harmful products.

Tim Phillips, Managing Director, Tamarind Intelligence, UK, highlighted the rapid growth of nicotine pouches and their current market value. Nicotine pouches estimated global worth is around $65 billion, he noted, with a significant portion concentrated in the U.S. He pointed out that many governments are still unfamiliar with these products, resulting in a lack of specific regulations. That, together with concerns over youth use and the illicit vape market has led to defensive government reactions and bans in countries such as Russia, Germany, and the Netherlands. Mr Phillips commented that the next Tobacco Products Directive (TPD) in the European Union is going to be crucial for how novel nicotine products are treated, not just in Europe, but around the world.

David T. Sweanor J.D., Chair of the Advisory Board, Centre for Health Law, Policy & Ethics, University of Ottawa, Canada, provided insights into the regulatory landscape, arguing that the opposition to low-risk alternatives is often poorly reasoned and serves to protect high-risk products.
He drew parallels to historical resistance against innovations, suggesting that societal fears can overshadow the dangers of established risks. "Claims about the promise of a new technology are at times greeted with skepticism, vilification, or outright opposition, often dominated by slander, innuendo, scare tactics, conspiracy theories, and misinformation," he said, quoting Calestous Juma. Prof. Sweanor emphasized the conflict between public health objectives and moralistic agendas, which can hinder efforts to reduce health risks. He stressed the importance of addressing nicotine use through a public health lens, advocating for the promotion of safer alternatives rather than attempting to eliminate nicotine entirely. He likened the situation to the consumption of coffee, suggesting that society should focus on reducing risks rather than imposing bans. Despite regulatory bans, he noted, there is a persistent consumer demand for these products, and paralleled the situation to past struggles for individual rights and access to contraception.

At the discussion that followed, K. Farsalinos stressed the importance of providing accurate health information, citing Moldova's restrictive policies on harm reduction products as a significant issue, as access to health-related information is a human right. He questioned the rationale behind focusing on nicotine dependence, which does not equate to the harms associated with substances like alcohol or opioids. "Is it a failure of public health to explain that dependence is not harm," Farsalinos said. "Dependence is a repetitive behavior and if it's not associated with health harm, why should we care?" he added. Tim Phillips agreed, suggesting that public perception is heavily influenced by the association of nicotine with smoking-related deaths. Both speakers emphasized the need for a rational, evidence-based approach to nicotine regulation that acknowledges the historical persistence of stimulant use and promotes safer alternatives.
The discussion also touched on the dangers of limiting public choices without viable alternatives, which D. Sweanor believes erodes trust in authorities and he urged public health officials to reflect on their trustworthiness rather than questioning why the public does not trust them. K. Farsalinos highlighted the political dimensions of the issue, pointing out that censorship attempts by authorities fail to address the underlying reasons for public distrust.
Tim Phillips noted that politicians use the issue of nicotine dependence to garner public support, often overlooking the potential for increased illicit markets. The need for a better understanding of how regulation affects market dynamics was emphasized, and how attention should be paid on the effects that novel products like nicotine pouches can have in low- and middle-income countries, such as India, or countries of Southeast Asia.
The conversation concluded with a focus on the need for educating regulators about the public health implications of smoking and the potential benefits of alternatives like nicotine pouches, as well as the ethical questions surrounding government bans on such products.
"Smoking is the number one preventable risk factor for a number of disease conditions in several organ systems. And the public health impact, not only in terms of health, but also in terms of financial burden of smoking globally is tremendous. So, there are many benefits in accelerating the smoking decline", Konstantinos Farsalinos concluded.

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ABOUT SCOHRE

SCOHRE is an International scientific Association of independent experts on Smoking Control & Harm Reduction, who seek an open and constructive dialogue to help come up with a new approach to smoking control policies.

Our purpose is to provide stakeholders with science-based balanced information. Tobacco harm reduction debate is still at an early stage and more research and publications are needed.

We need to raise awareness on existing knowledge, benefit from already existing solid expertise in many countries, and create more opportunities for education of health policy experts, regulators, and the public.

We will work to generate more evidence that harm reduction in smoking should be implemented along with smoking prevention and smoking cessation to counterfeit the detrimental effects of smoking.

We will establish new research to generate more evidence to cast out all doubt.