Sweden is today the only EU country that has stopped smoking. Fewer than 5% of the population smoke cigarettes there. For the World Health Organization (WHO), this is both a success and a failure. A success because Swedes have effectively extinguished smoking and achieved „smoke-free” status. But a failure because they did so using methods that the WHO neither recommends nor approves of. Swedish smokers replaced cigarettes with snus and nicotine pouches – about 19% of Swedes currently use them, the highest rate in the EU. The WHO wants to fight this form of nicotine, including by introducing a flavour ban on these products. The European Commission and Poland have announced similar directions. According to Brian Erkilla, former toxicologist at the U.S. Food and Drug Administration, such regulations are a dead end.
On May 25, the Swedish Council for Information on Alcohol and Other Drugs (CAN) reported that in 2025, the number of smokers in Sweden had fallen below 5 percent. No other EU country has achieved this.
A few days earlier, the WHO called for restrictive regulations on nicotine pouches. The WHO’s idea fell on fertile ground in Brussels: the European Commission has just launched consultations on the revision of the EU Tobacco Products Directive (TPD). One of the ideas in the directive is to equate the legal status of nicotine pouches with cigarettes.
Poland is also working on regulations that would effectively ban nicotine pouches. The Ministry of Health proposes, among other things, eliminating all flavour variants except one: tobacco flavour. The thing is, nicotine pouches do not contain tobacco, and tobacco-flavoured ones are already virtually impossible to find on the market.
Brian Erkilla, former toxicologist at the U.S. Food and Drug Administration (FDA), now Principal Regulatory Specialist at the Swedish company Swedish Match (one of the world’s largest producers of nicotine pouches and snus), assesses that such bans could cause more harm than good. The rise of the illegal market, smokers returning to cigarettes, or lack of control over sales to minors – these are just some of the consequences he points out.
We interviewed Brian Erkilla after a scientific conference in Stockholm. In a conversation with Industry Alarm, the expert pointed out that the WHO report on nicotine pouches omits the issue of their significantly lower toxicity compared to cigarettes. In the opinion of the former FDA toxicologist, the WHO demonises nicotine pouches, presenting only one side of the coin and focusing solely on potential risks, rather than on the fact that pouches could prove a pragmatic solution to the smoking problem – just as happened in Sweden.
– The authors of the report completely ignored the aspect of reducing the negative health effects caused by smoking. In my opinion, this report also ignores scientific evidence that several public institutions, such as the U.S. FDA, have assessed and considered in their actions – says Brian Erkilla.
Research shows that smokers who switched from cigarettes to smokeless products, including nicotine pouches, significantly reduced their exposure to harmful substances, which occur at much lower concentrations than in cigarette smoke. The key difference lies in the combustion process of tobacco. That is when most carcinogenic and harmful substances are produced, generating smoke. Nicotine itself, as the WHO notes, is not carcinogenic, although it is addictive.
– In smokeless products, there is no combustion process. That is a key fact that should be known to decision-makers in individual countries. This information should also reach adult cigarette smokers – adds Brian Erkilla.
The Swedish model: fewer bans, fewer Diseases, and fewer deaths
The truth is simple and inconvenient: Sweden is today the only „smoke-free” country in the EU. But this is not thanks to the WHO, but to Sweden itself.
For years, Sweden has pursued a nicotine policy that contradicts key WHO and European Commission guidelines. Despite repeated pressure from Brussels, the Swedes did not decide to ban the sale of traditional smokeless nicotine products like snus – moist tobacco portioned into cellulose pouches placed between the gum and lip. Nicotine is released into the bloodstream through contact with the oral mucosa and saliva. In 2014, the sale of snus was banned throughout the European Union – except for Sweden.
– The case of Sweden shows that pursuing a balanced regulatory policy, based on scientific research and resulting from actual consumer behaviour, can lead to positive changes in public health. The market here naturally shifted towards oral nicotine products, such as snus, and later nicotine pouches – explains Brian Erkilla.
As recently as 2000, nearly 20% of Swedes smoked cigarettes. In recent years, thanks in part to consistent regulatory policy (contrary to WHO recommendations), the percentage of smokers has radically declined, and in 2025 it was less than 5%. At the same time, about 19% of Swedes today use snus and nicotine pouches. However, the WHO today only talks about the first percentage. The second remains an inconvenient truth that the organisation omits in its reports.
Changes in nicotine consumption patterns in Sweden have led to a radical improvement in public health over the last 20 years. According to the latest OECD report, Sweden has one of the best population health outcomes in the EU, with a life expectancy in 2024 reaching 81.4 years (the highest in the EU) – more than two years above the EU average.
The Swedish government, in addition to allowing the sale of snus and nicotine pouches, also introduced sales restrictions and levied taxes on nicotine products proportional to the risk level associated with each product category. For example, recently the Swedes increased the excise tax on cigarettes by 9%, but reduced the excise tax on snus by 20%.
FDA vs. WHO. A Dispute between Pragmatism and idealism
The Americans share a similar approach to the Swedes. In 2009, they entrusted a key role in regulating tobacco and nicotine products to the U.S. Food and Drug Administration (FDA).
The FDA employs a model based on solid scientific evidence – a manufacturer seeking to introduce a new tobacco or nicotine product to the market must provide millions of pages of chemical and toxicological analyses, which the Agency meticulously verifies. The FDA then assesses whether the introduction of such a product would benefit public health. If so, the product may be sold. If not, it does not reach the market. The FDA also places the product on a health risk scale: the highest risk is assigned to cigarettes. The lowest – to nicotine pouches and snus. Nicotine replacement therapy is rated even lower.
The WHO and the European Commission have chosen a different path. The WHO does not recognise any health risk scale. It believes all nicotine products are equally harmful. The EU Commissioner for Health, Olivér Várhelyi, has recently spoken in a similar tone.
– The American approach is unique. All tobacco and nicotine products are subject to strict FDA regulations. This approach ensures the creation of independent, research-based laws backed by a respected state institution – explains Brian Erkilla, who himself previously worked as a toxicologist at the FDA.
From a scientific perspective, the difference between cigarettes and nicotine pouches is, in his view, simple and fundamental: cigarettes release nicotine through the combustion of tobacco, whereas nicotine pouches cannot be lit – they release nicotine upon contact with the oral mucosa. What does this mean from a toxicologist’s perspective?
– Nicotine pouches release on average about 99 percent fewer harmful or potentially harmful chemicals compared to smoking cigarettes. From a toxicologist’s point of view, the choice is obvious – Erkilla tells us.
When authorising the marketing of alternative products, the FDA issues so-called Modified Risk Tobacco Product (MRTP) authorisations, which confirm that the Agency has positively verified scientific research on such products.
Regarding nicotine pouches, the FDA has stated that they can play a positive role in protecting public health by helping people quit smoking cigarettes. It also confirmed that they are associated with a significantly lower oncological risk than smoking cigarettes.
At the same time, the FDA noted that such products are hardly used by people who have not previously used nicotine, nor by young people. The Agency approved them for sale on the U.S. market, openly indicating them as products with the lowest risk profile in the category of nicotine and tobacco products.
The approach of the WHO and the European Commission is radically different.
– It’s a philosophy that can be summed up as: „This seems wrong, so it should be banned,” without delving into scientific analysis – the expert sums up.
Therefore, both the WHO and the European Commission are announcing a tough course on pouches – either a total ban or significant restrictions.
Prohibition Strengthens the grey zone, and the grey zone means no control over the market or sales to minors
Experiences with bans from other countries that have introduced prohibitionist anti-nicotine policies (e.g., the Netherlands or France, which have already banned nicotine pouches) show that a banned product does not completely disappear from the market. It only changes its sales channel: from legal and state-supervised to illegal, where only organised criminal groups profit.
– Prohibition leads to the development of an illegal market. In the grey zone or black market, there is no regulatory oversight, so the consumer does not even know the composition and quality of the purchased product – the expert warns.
Obviously, in the illegal market, there are no mechanisms protecting minors from access to such products. Entities operating outside the law are also not interested in complying with legal age-of-sale regulations. For them, the key goal is only profit maximisation – and avoiding law enforcement.
– I believe that bans can bring a number of negative side effects for public health. Such actions can also harm adult cigarette smokers because they deprive them of access to a better alternative to continued smoking – adds Erkilla.
