Death by Regulation: Analyzing Tobacco Harm Reduction in the European Union

While the outlook for FDA approval of “reduced risk”-labeled products is cloudy (as I discussed recently here), many safer smokeless tobacco products, minus the “reduced-risk” label, are being sold in the U.S.   In the European Union, the picture is bleaker: Snus is banned everywhere but Sweden. 

Clive Bates has written an insightful analysis of the absurd EU policy on vastly safer tobacco products.  He asks, “Is it right to ban certain types of smokeless tobacco from sale in the European Union?  The short and unequivocal answer is ‘no.’” 

Bates is well qualified to address EU policy.  He was director of Action on Smoking and Health in the UK from 1997 to 2003, and he has held high-level positions in the UK and Welsh governments.  In 2003, he was the principal author of a landmark analysis of the EU ban (available here).

Bates addresses three “major policy failings” related to the EU ban: public health science is ignored and abused; ethics and consumer rights are violated; and EU legal principles have been disregarded.  Following are selected passages from his essay that are relevant to U.S. regulation; the piece is worth reading in its entirety (here).

Public Health Science Is Ignored and Abused

Bates provides evidence that “The data is there for anyone who is prepared to look…Sweden provides a dramatic ‘proof of concept’ for smokeless tobacco as a population level harm-reduction product, based on the choices made by tobacco users unaided by the state.  Sweden has by far the lowest level of tobacco-related mortality in the developed world, the lowest rate of smoking and the highest use of tobacco in smokeless form.”

“In my view, the abundance of evidence suggesting a likely positive impact from wider introduction of smokeless tobacco shifts the burden of proof.  With evidence like this and clear proof of the harm reduction concept in Sweden, it should be up to those who want to ban these products to produce evidence of likely unintended and severe consequences that would outweigh the plausible benefits.  I don’t wish to overdramatise this, but when a government does something that stops people taking action to reduce their risk, they become culpable for the harm caused – up to and including death.”

Ethics and Consumer Rights Are Violated

“What is the ethical position of the legislator or campaigner seeking to ban a potential harm reduction product?  Impossible to defend in my view.  In doing so, they are denying an option to reduce harm, and so may be causing more harm and possibly premature death through their actions.  Pressing for a ban on these products is quite an abusive thing…to do to someone facing the risks from long-term smoking. Where is the legitimacy for that?”

EU Legal Principles Have Been Disregarded

Bates details how the EU ban violates four legal principles.  I’ll quote only his summary: “Is the EU ban on oral tobacco lawful?  No, basically. It is arbitrary, disproportionate, unjustified and violates the principles of the internal market – and therefore it is unlawful.”

What Now?

Bates issues a clear challenge to the European authorities: “The [EU] Commission, European governments and major health charities have largely been in denial about tobacco harm reduction – apparently seeing a ban on any tobacco product as progress, irrespective of the body of evidence that suggests otherwise.  They have been unwilling to face the idea that banning a low-risk tobacco product might actually be a bad idea and end up killing many more people than it saves by denying them an option to reduce risk. I do not know whether it is negligence, incompetence or cynicism that leads them to do this, but I hope they will look again at the evidence and reconsider their position.  Decisions like this do have lethal consequences, those advancing them are morally obliged to take a truly evidence-based approach, not the approach that is most comfortable from a [public relations] point of view.  There is an abundance of science and carefully argued reasoning for lifting the ban on smokeless oral tobacco in the EU. This is the most serious of all public health issues and most insidious driver of health inequalities – the lives of real European citizens are at stake.”

Bates closes with a prescription for progress in the EU:

“Here’s what I think should happen:

•    “The ban on smokeless oral tobacco is unjustified, illegal, harmful to health and represents a denial of consumer and human rights.  It should be lifted without delay.

•    “The [EU] Commission, member states and elements of the public health community should not misuse the science of smokeless tobacco and harm reduction or use the [Scientific Committee on Emerging and Newly Identified Health Risks] report to justify a ban on a sub-category of smokeless tobacco.  The science does not justify any ban on these products while cigarettes remain widely available and while more hazardous forms of smokeless tobacco is sold freely.

•    “Smokeless tobacco forms part of a ‘harm reduction’ market for lower risk alternatives to smoking – this could be an important market commercially in future, and if it does become sizeable, it will have considerable health benefits by reducing smoking.  The EU could facilitate development of this market by setting standards for toxins present in smokeless tobacco placed on the market in the EU.

•    “To balance the market in favour of reduced risk products, governments should consider favourable excise tax treatment, relative to smoked tobacco, for nicotine products with greatly reduced risk, and allow meaningful risk communication through product marketing.

•    “The public health community should be honest about the relative risks of smokeless tobacco and smoking, take an evidence-based approach to policy, and adjust its posture towards harm reduction strategies accordingly. It is lethally irresponsible to mislead smokers about less hazardous alternatives to smoking.”