Following the opening remarks from the SCOHRE Board Members, Prof. Ikonomidis, D. Sweanor, Prof. Fal, Prof. Farsalinos, and F. Mili, in his keynote speech on the “History and future of nicotine, plus some learnings from the Swedish end-game”, Karl Fagerstrom presented the history of nicotine replacement treatment (NRT).
History of nicotine replacement treatment
The starting point was 1967, when two Swedish physicians doing research on the atmospheric pressure effects on submarine crews observed that many of the men were using a very old product, snus, as they were not allowed to smoke in the submarine. Recognizing that nicotine delivery rather than smoking ritual drove tobacco use behavior, the two physicians contacted a small pharmaceutical company in Sweden, Niconovum. While it was exceptional at the time to suggest to a pharmaceutical company to sell nicotine –as it was classified as “poison”– research was taken on and the first product that came out was a chewing gum.
The first approval of an NRT product took place in 1978 in Switzerland; the first approval in the US came a little bit later. In 2009, Niconovum registered the first nicotine pouch as an NRT. In 2014, the EU TPD (Tobacco Products Directive) enabled the development of nicotine consumer products beyond pharmaceutical restrictions.
Swedish tobacco control model and its outcomes
In the second part of his speech, Mr. Fagerstrom referred to the Swedish tobacco control model and its outcomes, starting with some numbers: Sweden has a smoking prevalence of 5%, the lowest among the EU countries, despite the fact that Sweden ranks 21st on tobacco control measures. This low prevalence, he explained, can be attributed to the wide use of snus, which has traditionally been very common among Swedish workers. In 1964, when it started to become known that smoking is very dangerous, the Swedish government tobacco monopoly allocated money to an anti-tobacco clearinghouse; at the same time, they also started to advertise snus as a way of enjoying tobacco without irritating your bystander. As a result, as snus sales went up, cigarette sales went down.
Mr. Fagerstrom pointed out that three Nordic countries (Sweden, Norway and Iceland) that support the use of smokeless tobacco, particularly the old-fashioned snus, occupy the three lowest tobacco-related mortality positions in Europe, for males; females do not use snus very much and they do have a different picture.
He also highlighted an FDA statement supporting this approach, that was released when the new nicotine pouch, ZYN, was approved: “Nicotine is what keeps people using tobacco products; however, it is the thousands of chemicals contained in tobacco and tobacco smoke that make tobacco use so deadly. The toxic mix of chemicals –NOT nicotine– cause the serious health effects among those who use tobacco products.”
Comparison between product’s compositions and safety profiles
Comparing different products’ composition and safety profile, Mr. Fagerstrom said that the content of nicotine pouches is very similar to the content of NRT products. Both ZYN nicotine pouch and ZONNIC nicotine pouch (registered as an NRT) contain pharma grade nicotine; the only difference is that the consumer products have a stronger nicotine strength and more flavorings. The other excipients are also very similar and the same stands for the Nicorette nicotine gum. So, if the content is very similar, it is to be expected that the adverse effects would also be similar. A couple of studies found 84 harmful or potentially harmful compounds (HPHC) in cigarettes, 19 in snus, 9 in nicotine gum, 5 in nicotine pouches, and 2 in a nicotine lozenge.
Then, Mr. Fagerstrom presented a dependence analysis comparing nicotine users and caffeine users, which challenges conventional nicotine addiction concerns. He commented that, if dependence is the main problem of our societies, the different nicotine products are not an effective solution, because they are also associated with dependence. But if the main problem of our societies is suffering, death and disease, he said, the heat-not-burn (HnB) products, the vapes, and the pouches can drastically reduce the problem.
The speaker added that the objective of tobacco policy in Sweden is a smoke-free Sweden by 2025. The Secretary of Health endorsed the harm reduction perspective and the government lowered the tax on snus by 20% and increased the tax on cigarettes by 10%; as a result, the least harmful tobacco product has the lowest price.
In a nutshell, according to Mr. Fagerstrom:
- Smoking prevalence can be reduced with the help of alternative products.
- Convincing data demonstrate the reduced harm in Sweden.
- Harm reduction can be achieved without resource-demanding government policies.
Finally, Mr. Fagerstrom expressed his concern about future challenges; it is troubling, he said, that governments and pressure groups want to ban the least harmful products (e.g. the new nicotine pouches) and keep cigarettes on the market. He suggested, If the worst-case scenario prevails, that nicotine pouches may need to be registered and approved as medicines (i.e., as nicotine replacement products), which would of course require some extra activities and costs.