Saving lives in Sweden, banned by the EU: experts call for change to smokeless tobacco policy

Spreadsheet data, charts and sources and look at this too.

One of the greatest public health successes in Europe is due to… tobacco

According to the 2012 Eurobarometer survey, adult smoking prevalence has fallen to 13% in Sweden: far below the EU average of 28% and an outlier from the next lowest, Portugal, at 23%.  The use of smokeless tobacco in Sweden means many nicotine users are using smokeless tobacco instead of cigarettes [see Swedish tobacco use data].  The result is lower rates of tobacco related disease and death [see cancer data] – also reduced passive smoking and fire risk, and more ‘denormalisation’ of smoking.  All this has been consumer and market-led, with no public spending, health professional endorsement or regulatory coercion.  It’s also been clear for many years: research goes back a long way and colleagues made a statement on it in 2003 (European Union policy on smokeless tobacco: a statement in favour of evidence based regulation for public health) Last year I wrote a detailed account of the evidence and principles that show that a ban on oral tobacco simply cannot be justified on scientific, ethical or legal grounds: Death by regulation: the EU ban or low risk oral tobacco.

Call for political courage. So when all this is known, why would a proposed new EU directive continue to ban this product outside Sweden?  The problem is essentially political, and solution must therefore be political.  It seems almost everyone involved wants to look tough on smokeless tobacco, even if it actually would mean more sickness and death and help the dinosaurs of the cigarette industry. We need those countries where these products could have a significant positive impact on health to start making the case more assertively, but also to adopt a politically realistic approach.

Letter to Mrs Larsson, Sweden’s minister responsible for public health

So a group of European public health specialists has written to the Swedish Health Minister with responsibility for tobacco policy, Mrs Maria Larsson, to encourage her to take a positive approach to oral tobacco as the directive is considered by the European Council of Ministers. We identify three problems with directive and suggest three politically achievable solutions.  The full letter is here in PDF format and the text appended at the end of this post and some supporting graphical data is here.  In summary:

Problem 1: The ban on snus outside Sweden denies access to a greatly reduced risk nicotine product, but there is not enough political will to lift the ban across the whole EU.

Solution 1. Let each member state make the decision whether to ban or not, but where it is permitted by a member state impose a purity standard for all smokeless tobacco, like the one used in Germany. A new balance of subsidiarity (the decision to ban or allow) and EU competence (harmonising standards where it is allowed) is the pragmatic solution.

Problem 2. The ban on characterising flavours. Banning flavours would make oral tobacco relatively less attractive compared to cigarettes and so will cause harm.

Solution 2. Only ban characterising flavours for smoking products, and if necessary have a positive [or negative] list for the flavours allowed [or prohibited] for smokeless tobacco.

Problem 3. The warnings do not differentiate between risk of snus/oral tobacco and cigarettes, yet they are perhaps 95-99% less dangerous.

Solution 3. Use a warning that gives proportionate credible and useful information about relative risk.

Comments from signatories

The authors of the letter have commented on the situation (full affiliation details in the letter and links) as follows:

Professor Martin Jarvis of University College London, and a leading international authority on nicotine psycho-pharmacology, said:

“The evidence of a pronounced health benefit from oral tobacco is very strong and can no longer be ignored. The consumption of nicotine through snus in Sweden has greatly reduced smoking, and that in turn has caused a significant reduction in the cancer, cardiovascular disease and lung damage caused by smoking. It makes no sense scientifically or ethically to deny access to this much less dangerous alternative to cigarettes to smokers elsewhere in Europe.

Dr. Karl Erik Lund is an Oslo-based expert on tobacco and public health. He notes that similar effects are appearing in Norway:

“Northern Europeans have a greater tradition and culture of using smokeless products and oral snus, and compared to other countries health has benefited as a result.  In Norway we are having a similar experience to Sweden, with smoking rates now around 16 percent, mainly due to oral tobacco use.  There is no reason to ban snus in countries that want it in Northern Europe,  just because other countries in the European Union don’t realise or don’t want the benefits?

Professor Karl Fagerström is an internationally renowned Swedish expert in nicotine and one of the pioneers of nicotine replacement therapy (NRT). He points out:

“Snus has proved more successful at helping people to quit smoking than NRT in Sweden because it meets the smoker’s need for a strong nicotine ‘hit’ in a way that is a more effective substitute for smoking.  It is no good just hoping everyone will quit completely – just look at the rest of Europe, where average smoking rates are twice as high as Sweden. If we can meet the need for nicotine with products that create much lower risks, then we will see great improvements in health. This could be smokeless tobacco, or it could be new devices like e-cigarettes, but we have to have a harm-reduction approach to nicotine as well.

Professor Michael Kunze is an eminent physician at the Medical University of Vienna. Dr Kunze commented:

“I see many patients in their 30s and beyond whose lives are at grave risk from smoking, whose health is deteriorating, and who are miserable about their smoking. It is too easy just to tell them to quit, because many are simply unable or unwilling to give up the nicotine.  Doctors need to be able to discuss new approaches and put the health of the patient before everything else. That means talking honestly about smokeless tobacco or e-cigarettes as an option.  Banning much safer tobacco products helps no-one who is at risk from cigarettes.

Dr Jacques Le Houezec is managing editor of www.treatobacco.net an authoritative source on the treatment of tobacco dependence. He says it is unethical to ban a safer alternative to cigarettes.

“Everyone involved needs to think more carefully about the ethics of denying an addicted smoker access to a smokeless tobacco product that is far less harmful than cigarettes. We know there is strong evidence of substantial health benefits for individuals and at population level from the Sweden experience and also no signs of significant gateway effects – if it is a gateway, it is an exit from smoking, not an entrance.  There are no precedents for allowing a dangerous product like cigarettes on the market, whilst banning much safer alternatives, and as Europeans we should not just do this.   

Clive Bates, is former Director of Action on Smoking and Health (London-based) from 1997-2003:

“The main effect of banning snus is to prop up the cigarette market in Europe.  It’s easy and trivial for politicians and bureaucrats to look tough by banning something, but the effect of banning snus and heavy-handed regulation of e-cigarettes will be more cigarettes sales, more smoking, and more death and disease.  It need not be like this – there is now a real chance for the European Parliament and European Council to turn this directive into an instrument that works for health and harm reduction. They just need to pay attention to the evidence and find the political will. 

Other letters on harm reduction

This is not the first time there have been efforts to persuade the European institutions of a more rational approach to harm reduction.

In 2011 the Swedish Government wrote to the European Commission calling for a regulated market in all tobacco instead of an arbitrary ban on the safest form of tobacco.  A view that has been ignored, despite the careful argument that was made for it.

Within the framework of the upcoming revision of the Directive, the Swedish Government suggests that the Commission’s proposed new Directive should be based on the principle of uniform and responsible regulation of all tobacco products. The following are areas that could be covered by the regulation:
• Thresholds for hazardous substances in tobacco
• Development of standards for measuring the presence of hazardous substances
• Prohibitions on dangerous additives
• Prohibitions on certain other additives
• Development of standards for production, distribution and storage

Also, in 2011 a larger group of 15 experts wrote a technical letter to the European Commission calling for a more rational approach, that would facilitate harm reduction in tobacco control.

The WHO Framework Convention on Tobacco Control, FCTC, points out (in Article 1) that tobacco control means a range of supply, demand and harm reduction strategies. The “harm reduction strategies” deserve particular attention here, since there is evidence suggesting that such strategies can yield substantial health benefits in tobacco control, if smokers are encouraged to use less harmful nicotine products in appropriate ways (Royal College of Physicians, 2007; European Monitoring Centre for Drugs and Drug Addiction, 2010). The products with the greatest potential for use in tobacco harm reduction are non-tobacco nicotine products and low-toxicity combustion-free tobacco, such as Swedish Snus.

Appendix: full text of letter

Maria Larsson
Minister for Children and the Elderly
Ministry of Health and Social Affairs
Fredsgatan 8
SE-103 33 Stockholm
Sweden

15 February 2013

Dear Mrs Larsson

Re: Tobacco Products Directive and Sweden’s unique responsibility and opportunity
We are writing to you as independent public health specialists as the new Tobacco Products Directive begins its passage through the European Parliament and Council. We write to express our hope that you will take a positive approach to one of Sweden’s great health successes. That success is the widespread use of low-risk oral tobacco (snus) to quit smoking and as an alternative to high-risk cigarettes. Despite the unambiguous contribution to better public health in Sweden, the proposed directive continues with unjustified and counterproductive restrictions on this product. Recognising that many member states will not wish to lift the ban on oral tobacco, we would like to propose a politically pragmatic way forward in this letter.

Sweden’s unique health success. There has been a remarkable success for public health in Sweden that deserves more recognition by policy-makers. According to the most recent Eurobarometer survey, adult smoking prevalence in Sweden is just 13%. That is far lower than the EU average of 28% and the next closest member state at 23%. The reason for this is perfectly clear: it is that, in Sweden, snus has been widely used to quit smoking or as an alternative to cigarettes. Given that the risks associated with snus use are of the order of 95-99% lower than for smoking, this has resulted in substantially reduced burdens of tobacco-related disease (cancer, cardiovascular disease, emphysema) compared to other member states. Today’s low rates of smoking will translate to significant health benefits in future, relative to other member states.

Sweden’s proof of the tobacco harm reduction concept. Throughout Europe starting in the 1960s there have been steadily increasing efforts to reduce smoking through controls on marketing and branding, health warnings, taxation, restrictions on smoking in public places, information campaigns and support for smoking cessation. Smoking rates have reduced considerably, but today more than one in four adults in the European Union still smokes, and the WHO still predicts one billion premature deaths from tobacco in the present century. Sweden points the way to a new and additional strategy – tobacco harm reduction. This means helping the many people who are unable or unwilling to give up nicotine or tobacco to use it in ways that cause them dramatically reduced harm. Snus and the new nicotine products, such as e-cigarettes, meet this important need and there is no case to restrict them in the ways envisaged in the proposed directive. We wish to draw your attention to three particular weaknesses and our three proposed alternative approaches.

Problem 1. Outside Sweden snus would remain banned and smokers will be denied options to reduce their risk

• The ban on oral tobacco (outside Sweden) has no scientific basis: the evidence points to significant net health benefits from snus use due to reduced smoking with no evidence of significant ‘gateway effects’ or other unintended and undesirable consequences;
• It is deeply unethical: in our view it is an abuse of authority to deny any tobacco or nicotine user access to products that may greatly reduce their individual risk – there are many potential snus users in Northern Europe and amongst Swedish citizens moving freely in the European Union;
• There are no precedents: we cannot identify any other product where a much less hazardous alternative (snus) to the dominant high-risk product (cigarettes) is banned. While cigarettes are widely available in the EU, there can never be a case for banning a safer alternative;
• The ban is unlawful: both common sense and professional legal opinion suggest a ban on an arbitrarily defined sub-category of smokeless tobacco is discriminatory and disproportionate and certainly does not contribute to a ‘high level of health protection’ within the single market;
• There is no internal market logic: the ban protects the cigarette category from competition and penalises businesses and employees that make a significantly less damaging tobacco product;

Proposed approach to problem 1. We believe this is politically achievable and would create a more rational approach to oral tobacco / snus in Europe.

1. Replace the ban with a regulatory framework for all smokeless tobacco that would limit the toxic contaminants that potentially cause harm. That approach is already used voluntarily for snus in Sweden. This could remove from the market some of the more dangerous smokeless tobacco products that would otherwise remain on sale under the proposed directive. The German government has a standard that could be broadly applicable and adopted into the directive.
2. If a complete lifting of the ban is politically impossible, then the decision to ban oral tobacco should become a matter for each member state – reflecting the diverse cultural traditions in tobacco use and the different attitudes to harm reduction. However, it would use community competence to create harmonised rules in an effective single market in those member states that decide to permit sales of oral tobacco.

Problem 2. By banning characterising flavours, the directive will make smokeless tobacco less attractive relative to cigarettes
The ban on characterising flavours in tobacco products (Article 6.1) would apply to smokeless tobacco available throughout the EU as well as to smoking tobacco, such as menthol cigarettes. It is disputed whether it would apply to snus sold in Sweden, but if it did it could put at risk Sweden’s great health success.

• Characterising flavours are particularly important in smokeless tobacco, which does not have the strong flavours of tobacco smoke. The best selling snus in Sweden for example is flavoured with the herb bergamot, and many other flavours are in use in over 60% of products by volume.
• The danger of banning characterising flavours in smokeless tobacco is that these much safer products could become less appealing for some users. It therefore carries the risk they would revert to smoking, or never switch to smokeless tobacco in the first place.

Proposed approach to problem 2. We believe the right approach is to ban characterising flavours for smoking tobaccos only.  If greater safeguards were thought necessary for smokeless tobacco (we do not think they are), then a schedule of approved or prohibited flavours could be drawn up.

Problem 3. Misleading messages designed to alarm rather to inform better health choices. Smokers know they are at great risk, but many do not have a clear sense of how much less risky smokeless tobacco would be (95-99% less risky). The directive presents an opportunity to communicate risk much more effectively. Article 11.1 requires the following message is placed prominently on smokeless tobacco products: “This tobacco product can damage your health and is addictive”. Whilst this is technically correct, it is a incomplete and misleading communication with a smoker, who may benefit from switching to smokeless tobacco.

Proposed approach to problem 3. A more credible, health promoting message would be: “This product contains nicotine and may be addictive, but presents substantially lower risks to health than cigarettes”.

The draft directive as formulated will deny citizens in other member states access to a much lower risk alternative to smoking. Furthermore, it threatens to undermine significant health gains that have been made in Sweden. There is no scientific, ethical or legal basis to do this, and we hope that you will speak frankly and act decisively for public health as the directive completes its passage. We realise this is difficult, and that it can appear to be supporting a tobacco product. In reality, it is supporting better health and challenging the dominance of cigarette smoking, which is the most harmful and addictive form of tobacco and nicotine use.

If you would like to pursue these arguments, we would be pleased to provide you with more detailed information. If you would find it useful to meet, we would welcome the opportunity to discuss these issues with you in person at your convenience. Meanwhile, I hope you will be able to consider our suggestions, and confirm your support for our proposed approach.

Yours sincerely

Clive Bates
Former Director
Action on Smoking & Health UK (1997-2003)

Professor Martin Jarvis
Emeritus Professor of Health Psychology
Department of Epidemiology & Public Health
University College London, UK

Jacques Le Houezec, PhD
Consultant in Public Health, Tobacco dependence,
France

Professor Karl Olov Fagerström PhD
Emeritus Professor of Psychology
President Fagerström Consulting AB
Sweden

Professor Dr Michael Kunze
Head of the Institute for Social Medicine
Medical University of Vienna

Karl Erik Lund PhD
Research Director
Norwegian Institute for Alcohol and Drug Research
Oslo Norway