Gli esperti del MOHRE scrivono una lettera aperta al Ministero della Salute belga: “approccio alla riduzione del danno palesemente ignorato”.
29 marzo 2023 – Il Governo federale del Belgio ha deciso di vietare le bustine di nicotina (oral pouches), come comunicato lunedì nella Gazzetta Ufficiale. “Riteniamo che questo sarà un passo indietro per i fumatori che cercano un’alternativa praticabile alle sigarette ma che potrebbero non essere in grado di smettere completamente di usare la nicotina, e ora renderà più difficile per il Belgio raggiungere il suo obiettivo senza fumo, che approviamo pienamente” dichiara Fabio Beatrice, Direttore del Board scientifico di MOHRE, primo firmatario della lettera aperta inviata alle istituzioni del paese cuore dell’UE.
“I sacchetti, non contengono tabacco (a differenza dello snus), ma un mix nicotina e aromi e la somministrazione avviene tramite la mucosa orale. Si tratta di una diversa modalità di somministrazione della nicotina che potrebbe rientrare in un approccio alternativo al consumo di sigarette tradizionali, specie per i soggetti con una lunga storia di fumo alle spalle che desiderano allontanarsi dalla combustione e dai danni correlati” sottolinea Johann Rossi Mason, Direttore dell’Osservatorio e della testata giornalistica Mohre.it.
“I prodotti a base di nicotina senza fumo, come i sacchetti di nicotina, offrono un enorme potenziale per ridurre il fumo, proteggendo così la salute pubblica. I sacchetti di nicotina non contengono tabacco e non c’è combustione quando vengono utilizzati. Sebbene la nicotina crei dipendenza e non sia esente da rischi, è ampiamente accettato che la maggior parte dei danni associati al tabacco provenga dalla combustione. La nicotina è disponibile da anni nei medicinali autorizzati per la terapia sostitutiva, ma questo prodotto non è per tutti. È però importante sottolineare che le popolazioni minorenni non devono usare sacchetti di nicotina.
Mentre l’approccio alla riduzione del danno è stato palesemente ignorato dal Piano Europeo di lotta contro il cancro, le istituzioni mediche di tutto il mondo lo considerano un’opportunità strategica. Nonostante sia responsabile di mantenere la dipendenza, la nicotina non è cancerogena: l’Agenzia Internazionale per la Ricerca sul Cancro afferma: “La nicotina provoca il cancro? No. La nicotina è un composto chimico comune che si trova nelle piante di tabacco, e il suo effetto è quello di creare dipendenza dal tabacco piuttosto che provocare direttamente il cancro”.
A seguire il testo integrale della lettera:
The new MOHRE Observatory ( www.mohre.it) was born from the will of a group of scientists and experts in health communication, which wants to emphasize the strategies that can be implemented in all the medical fields in which it could be possible to avoid public health damage and deaths. From addictions to sexually transmitted diseases – in which the strategies are now consolidated – to the ‘third way’ to help individuals and communities reduce the damage deriving from incorrect lifestyles and behaviours, the Observatory will deal with oncological and cardiovascular diseases, andrological, infectious with a focus on Covid-19 and eating and behavioural disorders.
Quite recently, our Observatory wrote an open letter to Health and Food Safety Commissioner Stella Kiriakydes aiming to sensitize the European Community not to miss the opportunity to effectively intervene on avoidable smoking-related mortality. While the harm reduction approach has been blatantly ignored by the Beating Cancer Plan, medical establishments around the world are looking to it as a strategic opportunity.
As a group of EU and international public health advocates and academics, we are writing to encourage your government to continue taking advantage of the harm reduction concept when it comes to tobacco control. We believe harm reduction is vital to tackle tobacco-related morbidity and mortality in Belgium, particularly amongst the more vulnerable smoker groups, as recently reported in Belgium.
Smoke-free nicotine products, such as nicotine pouches, offer huge potential to reduce smoking in Belgium, thereby protecting Belgian public health. Nicotine pouches do not contain tobacco, and there is no combustion when used. Whilst nicotine is addictive and is not risk-free, it is widely accepted that most of the harm associated with tobacco comes from the combustion. Nicotine has been available in licensed medicinal products for years, but this product is not for everyone. Pregnant and/or breast-feeding women or people with diabetes, severe hypertension, or unstable heart conditions are strongly advised to abstain from nicotine use in any form. It is also important to recognise that underage populations must not use nicotine pouches.
We are deeply disappointed to hear that the Federal government has now decided to implement the ban on nicotine pouches, as communicated in the Official Gazette. We believe this will be a step backwards for smokers looking for a viable alternative to cigarettes but who might not be able to stop using nicotine completely, and will now make it more difficult for Belgium to reach its smoke-free target, which we fully endorse.
In many countries in the EU, governments have regulated rather than banned nicotine pouches, and introduced provisions to control how the products are displayed and sold to prevent underaged access. Banning them completely, as Belgium now intends to do, means smokers will have less options to help them quit cigarettes. For those who still want to use nicotine pouches, they will now have no option but to turn to purchase from illegal, and potentially unregulated, sources. Such a prohibition perversely risks making nicotine pouches more accessible to the underaged, as sellers in unregulated channels do not check any ID.
Despite tobacco control measures implemented by governments across Europe, smoking rates in the region remain stubbornly high. A recent report published by the European Cancer Inequalities Registry, a flagship initiative of the EU’s Beating Cancer Plan, found that whilst cancer mortality rates in Belgium are among the lowest in the EU and decreased significantly between 2011 and 2019, there were an estimated 75,000 new cancer cases in 2020. The report, which aims to identify trends, disparities and inequalities between member states and regions, suggests that whilst Belgian smoking rates have decreased substantially in recent years, important disparities across socioeconomic groups persist. Moreover, behavioural risk factors for cancer such as smoking and alcohol consumption are contributing to Belgium’s cancer risk profile. 9a976db3-en.pdf (oecd-ilibrary.org)
We would like to take this opportunity to highlight several critically important thought pieces and evidence to be considered in the discussion of nicotine pouch policies in Belgium:
- When a cigarette is lit the tobacco will combust at temperatures in excess of 950°C, creating a complex and dynamic chemical mixture (composed of over 6,500 compounds including nicotine). Rodgman, A., Perfetti, T.A. (2013) The chemical components of tobacco and tobacco smoke. 2nd Ed. CRC Press, Boca Raton, FL, USA.
- When puffing on a cigarette a smoker inhales the smoke into the respiratory tract, where it passes the upper airways into the lungs of the smoker. Here, in the alveoli, nicotine is rapidly absorbed into the bloodstream and transported directly to the brain within 20 seconds after each puff of a cigarette. https://www.ncbi.
- The UK Royal College of Physicians has concluded that: “the harm of smoking is therefore caused not by nicotine, but by other constituents of tobacco smoke. Non-tobacco nicotine products that reproduce the nicotine delivery and behavioural characteristics of smoking, without the many other toxins in tobacco smoke, therefore have the potential to allow smokers to continue to use nicotine and avoid the significant harm to themselves and others that smoking causes”. https://www.
rcplondon.ac.uk/projects/ outputs/nicotine-without- smoke-tobacco-harm-reduction
- Nicotine is not a carcinogen, and it has not been established as cause of cancer. The International Agency for Research on Cancer states: “Does nicotine cause cancer? No. Nicotine is a common chemical compound found in tobacco plants, and its effect is to make tobacco addictive rather than to cause cancer directly”. https://cancer-
code-europe.iarc.fr/index.php/ en/ecac-12-ways/tobacco/199- nicotine-cause-cancer
- The German Ministry of Food & Agriculture commissioned the Bundesinstitut fur Risikobewertung (BfR – the German Federal institute for Risk Assessment) to provide a health risk assessment of oral nicotine pouches to help inform future policy. This report is an update of earlier, preliminary BfR opinions from March 2021 and December 2021 and the publication in August 2022 of an article in Tobacco Control. Levels of nicotine and tobacco-specific nitrosamines in oral nicotine pouches | Tobacco Control (bmj.com). Among other things the German institution recognises that nicotine pouches have the potential as a harm reduction tool to reduce the “health risks for those individuals switching from cigarettes”. This risk assessment also “closes several knowledge gaps”, stating that it “seems to be a reasonable approach to implement quality control via standardisation and regulation measures to achieve harm reduction through nicotine pouches”. Finally, the report cautions that smokers who switch to nicotine pouches should not be exposed to higher levels of nicotine compared to smoking, while never smokers/nicotine users and at-risk groups should avoid pouches. For that reason, they recommend regulators should apply precaution to set maximum nicotine strength not exceeding 16.6mg / pouch.
- Recently in Italy the government introduced a specific excise level for nicotine pouches. Six other Members States across the EU have also done the same.
We know that some of the views mentioned above are shared by similar organisations, such as ETHRA https://ethra.co/
We would be pleased to share with you more information about how other countries are successfully regulating nicotine pouches, to provide options for adults while protecting against use by the underaged, and to discuss this matter with you further.