I think the most important point to address in Tomar et al’s e-response [1] is their call for more evidence before any change to the status quo (the status quo is a ban on oral tobacco in the EU, and public health disinformation in the US). They say that “neither we nor the IOM Report are ready to accept extant data as sufficient for endorsing smokeless tobacco for harm reduction”. This stance does not reflect the real-world policy choices and inverts the natural burden of proof.

First, “endorsing smokeless tobacco for harm reduction” in Europe means unbanning and regulating the product as part of the tobacco market. In the US, it would involve health advocates no longer misleading the public about it – as regrettably the Surgeon General recently did. It does not involve doctors prescribing it, health advocates advocating it, or guest slots for UST at the Washington World Conference. What does ‘endorsing’ actually mean in Europe? In reality, there are some quite concrete decisions in Europe which we must take on the available evidence. These include: continue the oral tobacco ban or lift it? Tell the truth or mislead smokers about it? Whether to regulate oral tobacco, and if so, in what way? These are questions that cannot be ducked on the back of too little evidence – the ‘do nothing’ philosophy is simply a decision in favour of the status quo. This amounts to an active endorsement of the ”quit or die” approach, in which smokers are denied less hazardous alternatives to cigarettes, which themselves remain practically unregulated. There is no supporting evidence for leaving the market to the most dangerous products, and it seems illogical to me.

Second, let us be clear about the burden of proof. The 'intervention' in Europe is to ban oral tobacco while not banning cigarettes. It is that intervention that requires an evidence base – a point not considered by the IOM. The burden of proof naturally falls on those making and sustaining this intervention (the EU), but three reasons make the demand for supporting evidence more pressing:

• It is highly irregular to ban a less hazardous variant of a product, thereby deliberately denying users of the more hazardous product the choice of a switch and so preventing an individual risk reduction response. There are no precedents for this, and for that reason alone I would expect good evidence to support such an unorthodox approach to consumer safety.
• Common sense suggests that it is plausible that addicted smokers would use oral tobacco as an alternative to smoking and to quit, thus reducing harm. Given there is a reasonable hypothesis that smokeless tobacco will reduce harm, there is a commensurate need to show that hypothesis to be flawed if one is to support a ban on oral tobacco without banning smoking tobacco.
• The evidence from Sweden shows a compelling public health case against banning the product and no-one in their right mind would seek to extend the EU ban to Sweden. Sweden sends a powerful cautionary signal to the rest of the EU about perverse consequences of clumsy interventions. If it is not right to ban it in Sweden, how can we be so confident that it is right to ban it in the rest of the EU? Given the hypothetical opportunity, would American campaigners really ban smokeless tobacco in the US, while leaving cigarettes under the current weak regulatory regime?

If this was a controlled trial and the intervention (rest of EU, ban on oral tobacco) had consistently worse results than the control (Sweden, no intervention), we would stop the trial and abandon the intervention. To continue with the trial and intervention, the burden of proof would clearly fall on those supporting the intervention to prove that Sweden was not representative or that some other factors are at work in the rest of the EU. Tomar et al haven't any evidence and don't even seem to think they should supply it – perhaps relying on an a priori argument that any ban on any tobacco product represents some sort of progress. Sweden is not a controlled trial of course, but snus is not a medicine and long term changes in market structure do not lend themselves to such trials. Sweden shows us what is possible, and we forego that potential at our peril and at the expense of unfortunate people addicted to smoking and nicotine.

Sweden almost certainly is different to the rest of Europe – if only by virtue of history and the length of time this market has been established. But that is a reason to expect the benefits in the rest of Europe to be less and slower, not a reason to prevent that change in market structure ever occurring or a basis for believing that the effects would be the opposite in the rest of Europe. The EU justified its ban on the basis of a assumption that smokeless tobacco would unleash a plague of oral cancer and be a major gateway into smoking. Though this was muddled thinking from the outset, the evidence is clear from Sweden, and the opposite appears to be the case - there is no gateway and apparently little risk (and minimal compared to smoking). As the economist John Maynard Keynes famously said: “When the facts change, I change my mind. What do you do?”. In Europe, many of us are changing our minds.

So, let me restate the question – where is the evidence base that justifies this highly irregular intervention, especially in the face of evidence from Sweden that not banning the product contributes to a public health gain there? How do Tomar et al know their implicit backing for the highly irregular oral tobacco intervention in Europe isn’t simply killing more Europeans? Given what we know about how it works in Sweden, and given that the evidence shows relatively low risk of serious harm from using this product compared to smoking, don’t they think it would be wise to have some evidence to back the case for maintaining this intervention in the rest of the EU? I say they have implicit support for the EU ban because they raise difficult to impossible evidential hurdles to justify a move away from the ban, while offering no evidence to support it.

Tomar et al worry that people that would otherwise never use tobacco might use oral tobacco if it was unbanned in Europe. The question should be inverted – especially because of what we know in Sweden. How do they know that there are not people that would use snus instead of smoking or quit smoking using snus had it not been banned? Tomar et al pose this question as if it is a ‘red line’ and that it must be shown that no-one who would not otherwise use tobacco would use an oral tobacco product if it was unbanned. What if, more realistically, there was less smoking as smokers switched to snus or quit but some people that did use oral tobacco that would otherwise not have been tobacco users? The balance of risk and benefit (and civil liberties) is on the side of unbanning oral tobacco because oral tobacco is not especially harmful and there is little sign of a gateway to smoking. On the other hand, anyone displacing smoking or quitting with oral tobacco use experiences a considerable reduction in risk. Tomar et al offer no thoughts on this balance, though it is a central concern and has been discussed in Tobacco Control [2].

Tomar et al also resort to setting impossible evidential hurdles – "If smokeless tobacco has played any overall positive role in Swedish health, what is the relevance of the experience to other countries?" I have discussed above how the burden of proof is really with them, but how could anyone prove to their satisfaction how the tobacco market would respond to the unbanning of snus in Europe without unbanning it and conducting market surveillance? But they want the proof as a pre-condition for unbanning it. The most sensible way forward is to unban the product and conduct market surveillance, adjusting the regulatory regime if needed - and, yes, banning it again if it all goes wrong or the manufacturers behave badly. One could even envisage a 'sunset' clause on the lifting of the ban, requiring it to be reaffirmed in 10 years time.

Tomar et al use contradictory arguments at different times. For example they raise the (evidence-free) theory that smokeless tobacco may help smokers deflect the pressure to quit arising from smoke-free policies. In their e-response, they worry about "deadly delays in quitting smoking with the support of smokeless tobacco to manage smoking restrictions." But in their initial commentary [3] they attribute the low smoking prevalence in Sweden to the effectiveness of smoke-free policies specifically amongst men despite their high use of snus, suggesting that: "therefore, men would be more likely than women to be impacted by smoke-free workplace regulations". Hmmm… now which is it?

Let us also address the question of regulation. Yes it is true that a regulatory regime for smokeless tobacco and all tobacco products would be ideal. But the real issue is what should happen in what could be a long (or indefinite) interim period before such a regulatory regime is in place. Should the absence of a comprehensive regulatory regime justify the European ban or American disinformation? I believe not, because even without regulation these products are far less hazardous than cigarettes. The difference between smokeless tobacco products is small compared to the difference between smokeless products and cigarettes. Regulation is highly desirable, but not essential to justify a change from the status quo in the EU. If the EU simply moved to the same position as the US, that would represent progress in the EU because smokers would no longer be denied this option and would at least have the choice available in Sweden, if not the ‘endorsement’ of elements of the public health community.

However, there is a very good opportunity in unbanning snus to introduce world-leading regulation in the EU. There is a risk that the opportunity will be bungled, either because the public health community remains in denial and slumbers through the opportunity, or because there will be excessive zeal in applying regulation. In the latter case, the danger is that over-strong regulation would leave in place counter-productive asymmetries in regulation between smoking and smokeless tobacco. Regulation shouldn’t be so exacting and one-sided that it prevents the market functioning for public health in the way it has so far succeeded in Sweden. The same argument applies to pharmaceutical nicotine, where the excessive caution of regulators and manufacturers and over-zealous regulation is a barrier to clean nicotine maintenance products and competitors to tobacco and so, paradoxically, works against the wider public health interest [4].

The EU already has a regulatory regime for marketing – tobacco advertising, sponsorship and promotion is not regarded as legitimate free speech, and is banned. The more challenging regulatory question is whether smokeless companies should have some tightly defined partial exemption from that in order target smokers to switch.

Finally, please note that this response and my others are only from me, not ‘Bates et al’, and therefore do not include my fellow authors of the printed article.

[1] Tomar et al, A Reply to Bates et al. and Foulds et al. Tobacco Control e-response, 19 December 2003.

[2] Kozlowski L. et al. Applying the risk/use equilibrium: use medicinal nicotine now for harm reduction Tob Control 2001;10:201 -203

[3] Tomar SL, Connolly GN, Wilkenfeld J, Henningfield JE. Declining smoking in Sweden: Is Swedish Match getting the credit for Swedish tobacco control’s efforts? Tobacco Control2003; 12:368-59

[4] McNeill A, Foulds J, Bates C. Regulation of nicotine replacement therapies (NRT): a critique of current practice. Addiction 2001; 96: 1757-1768.

An important discussion of issues is being missed in a rash of name calling. Let’s back up, recognize our common goals and see if we can discuss issues and skip the personalities. We believe that the letters of Foulds et al and Bates et al badly mangled our comments and took statements out of context. Foulds et al. and Bates et al. obviously feel the same about our article. This issue has precipitated name calling, questioning of integrity, even rather defamatory slogans used to attack those with differing opinions ranging from “quit or die” to “flat earth believers”. Clearly, we disagree on several aspects of the issue, even while agreeing on others (such as the importance of efforts to reduce death and disease in those who continue to use nicotine without undermining prevention and cessation). This core point of agreement is shared by many of us engaged in this debate. It is unfortunate, and frankly very discouraging, that the differences seem to be resulting in more vitriol than are the common values resulting in constructive dialog. Many of the specific comments of Foulds et al. will be addressed in a subsequent response. Here we would like to briefly address some of the main issues. Our commentary takes issue with the position of Bates et al. and Foulds et al. which calls for a role for smokeless tobacco in tobacco control efforts to reduce smoking. We believe that Bates et al. and Foulds et al. overstate the benefits and generality of the Swedish snus experience and that they understate the risks and areas of uncertainty. Not surprisingly, they imply that we have overstated the risks and understated the benefits in our urge for caution and a regulated playing field. As we note in our commentary:

“If there is a role for oral tobacco in a comprehensive effort to reduce the death toll from tobacco use, then its manufacture and marketing must be overseen by an agency with comprehensive regulatory authority. A regulatory agency should be open to all strategies that are scientifically based and that will save lives. However, the decision about what role oral tobacco plays in that overall scheme is a decision that can only be made by an agency that has all of the relevant information.”

The fact that a population of persons using exclusively smokeless tobacco is at overall lower risk of most forms of smoking caused disease is not disputed by us. We do assert that smokeless tobacco has been repeatedly demonstrated to be a deadly addictive product that causes a variety of serious and life-threatening diseases as documented in the Institute of Medicine Report (IOM) (see pages 426-429 and 563-564 for a review of widely accepted oral diseases and attributable cancer). With regard to Swedish smokeless tobacco, at least as marketed in Sweden, we concur with the conclusion of that report on page 167 as follows: “It may be considered that such products could be used as PREPs [potentially reduced exposure products] for persons addicted to nicotine, but these product should undergo testing as PREPs using the guideline and research agenda contained herein.” Neither we nor the IOM Report are ready to accept extant data as sufficient for endorsing smokeless tobacco for harm reduction. Furthermore, we support the general strategies recommended by the IOM Report to develop the data that would enable such and endorsement. We apparently differ from Foulds et al. and Bates et al. in our call for such data. We stand by our position.

Perhaps the most important issue implicit in our concerns about our colleague’s characterizations of the Swedish experience is their explicit or implicit judgment that it is relevant outside of Sweden. Bates et al. do not recite their analysis of the Swedish experience solely for rhetorical purposes or to support its continuation in Sweden. They cite it in support of its application outside of Sweden to greater Europe and beyond. Similarly, because we were asked to provide a commentary for the Tobacco Control issue as Americans, we responded to this analysis with our concerns about the application of the Swedish experience to the United States and elsewhere. We noted that the U.S. Smokeless Tobacco Company (UST) did not cite the Swedish snus experience in its pleadings before the Federal Trade Commission in order to gratuitously commend Sweden: UST was making a pitch to expand its marketing of smokeless tobacco in the United States, armed with government endorsed harm reduction claims which it argued could then be made for all if its products, including those known to be gateways to tobacco use among youth and those that are among the highest in cancer-causing nitrosamines. In fact, neither the Foulds et al. nor Bates et al. reviews noted that outside of Sweden, even Swedish Match products are higher in cancer-causing nitrosamines than they sell in Sweden.

Thus, a fundamental question for all tobacco control experts is as follows: If smokeless tobacco has played any overall positive role in Swedish health, what is the relevance of the experience to other countries? Moreover, what questions should tobacco control leaders consider before endorsing smokeless tobacco as a component of comprehensive tobacco control strategies? We have many questions about the benefits attributable to snus in Sweden. Moreover, we are very concerned about the potential for expanded smokeless tobacco marketing in the absence of comprehensive tobacco and nicotine product regulation, particularly if endorsed by public health advocates, to cause more damage to public health than it will to improve public health. The potential risks are numerous and include: Deadly delays in quitting smoking with the support of smokeless tobacco to manage smoking restrictions. Uptake of smokeless tobacco by persons who would not have otherwise used any tobacco product. Substitution of the most popular high nitrosamine smokeless products in the U.S. and as available most everywhere but Sweden for cigarettes as an alternative to complete tobacco cessation. Graduation from smokeless tobacco use to cigarette smoking as has already been well documented in the United States.

Finally, it is not as if there are no alternatives to reducing smoking prevalence. As demonstrated in California, Florida, Mississippi, and Massachusetts, dramatic reductions in youth smoking initiation and adult smoking prevalence can occur, as compared to surrounding states, without advocating snuff use or trading cigarettes for snuff, but rather on the basis of comprehensive tobacco control efforts.

Other tobacco control experts will need to carefully examine the data, weigh their concerns, and come to their own conclusions. We remain concerned about the place of smokeless tobacco in tobacco control and will continue to insist that that comprehensive tobacco regulation should be the prerequisite for its further consideration.

Scott L. Tomar, University of Florida, Division of Public Health Services and Research, Gainesville, Florida, USA

Greg N. Connolly, Massachusetts Tobacco Control Program, Boston, Massachusetts, USA

Judith Wilkenfeld, Campaign for Tobacco-Free Kids, Washington, DC, USA

Jack E. Henningfield, Pinney Associates, Bethesda, Maryland; and Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

Like many others, John Polito [1] misses the point about smokeless tobacco. It is not a health strategy to be widely recommended by doctors, nor is it a medical smoking cessation treatment, nor should it be part of a community-based health programme. It is, or should be, part of a market for nicotine products in which the world will go on allowing the sale of cigarettes - the most hazardous form of nicotine. It should be a real- world assumption of all those working in public health that cigarettes will continue to be sold legally for the foreseeable future, and that their decline (which I believe is inevitable) will come as people, communities and wider society turn away by choice and through development of new norms. The availability of much less hazardous forms of the product makes sense in that context.

Polito's method may well work for some people some of the time - though I notice he cites only himself, self-published on his own web site as evidence for this. But even on the generous assumption that there is something in his approach, it cannot be the only possible route for reducing tobacco-related harm. What if people just don't want what he has to offer? What if people can’t or won’t quit using nicotine? What if they need to come off nicotine more gradually? Do you just deny them an alternative to reduce their risks because they are not doing or cannot do what you think they should? Frankly, that is an authoritarian “quit or die” mindset that belongs to an earlier century (not even the last one).

Tomar and his colleagues [2] clearly do not like to be referred to as advocates of “quit or die” - but that is exactly the choice they offer. However much they dislike it, the label will stick because it is accurate. Polito takes that prescription a step further into "quit my way or die".

On the subject of disclosure of competing interests, I believe Tobacco Control does require this (though Polito and Tomar et al make none). None of the authors of the discussion on smokeless tobacco (Bates et al [3]) is or was in any way supported by any part of the tobacco industry. We are not wounded by the charge of 'tobacco industry stooges' (as Tomar et al imply we might be) because it is an inaccurate and empty rejoinder to the accurate labelling of Tomar et al as advocates of 'quit or die'. As we explain in our discussion paper, our concern is about reducing cancer, lung and heart disease, and the rest of the consequences of tobacco use as effectively as possible. That's all. We worry that some prominent advocates have uncritically conflated these real goals with the common tactical aim of attacking the tobacco industry in every possible situation. In doing so, they have become confused about priorities and disorientated in the debate on harm reduction.

The "quit or die" philosophy would be easier to explain if it was straightforward influence-peddling and greed at work on behalf of Big Pharma, which has clear interests in this area. But I think that is the wrong (or only partial) explanation. I suggest the real explanation lies in the realm of ideology, personal views on the relation between the state and the citizen, vanity about anti-tobacco industry credentials, and on the pillars of orthodoxy on which tobacco control currently rests with inadequate critical scrutiny. Talk to people outside the public health field and the idea that governments ban, or advocates lie about, far less hazardous forms of the market-leading product and they find it as absurd as it is unacceptable.

[1] Polito J. "Another simple issue"?. Electronic response to Tobacco Control, 7 December 2003.

[2] Tomar SL, Connolly GN, Wilkenfeld J, et al. Declining smoking in Sweden: is Swedish Match getting the credit for Swedish tobacco control’s efforts? Tobacco Control 2003;12: 368-371

[3] Bates C, Fagerstrom K, Jarvis MJ, et al. European Union policy on smokeless tobacco: a statement in favour of evidence based regulation for public health. Tobacco Control 2003;12 360-367

Clive Bates [Former Director, ASH UK. Writing in a personal capacity]

Kawaldip Sehmi's letter seems to advocate ignorance and a kind of book-burning attitude to understanding this area. But in fact, better knowledge of the science might help his cause.

The paper by Enstrom and Kabat caused problems not because its findings conflicted with the established evidence base, but because it was flawed and the BMJ failed to put its contribution in context with the rest of the large evidence base. In contrast, Jonathan Foulds and his colleagues have done a good job at dispassionately examining and presenting the evidence on snus in Sweden, and the comparison with Enstrom and Kabat is unjustified.

Here are two examples where the developments that flow from this analysis may work to the advantage of the community Kawaldip Sehmi is concerned about (and where his ideas might cause more harm)...

If a regulatory framework was introduced in Europe for smokeless tobacco as part of unbanning snus (and this is what the harm reduction supporters are pressing for), it is likely many of the South Asian imported products would not meet the standard and have to come off the market. There may be a market response that reduced the hazardousness of the range of products available to the S. Asian community - either becase the S. Asian manufacturers would comply, or because other compliant products would enter the market to meet the gap. This would be an improvement on the status quo.

Science might also help re-think the evidence-free campaign to get these other smokeless tobacco products banned - in the UK or in S. Asia. How do the campaigners know that the former smokeless tobacco users would turn to the much higher risk smoking products? How do they know that those that would have started to use smokeless products would not just start to smoke instead? (and this would be a great opportunity for predatory cigarette companies). If they do, then they will be at much higher risk. In taking that gamble, what are the campaigners hoping to achieve through a prohibition and do they mind if some people are at greatly increased risk as a result of their idea? When Sweden joined the EU it was granted an exemption from the ban on oral tobacco - and it is a good thing too, because there would be more Swedish smokers now if the ban had been imposed. From reading Foulds et al's paper even the most extreme flat earth "quit or die" advocates cannot think that the EU's ban should be extended to Sweden - surely! But if not, why not? And if not in Sweden, should that give prohibitionist campaigners pause for thought about their campaigns to achieve this elsewhere? Sweden's experience issn't necessarily applicable everywhere - but it is a reason for caution about banning smokeless tobacco anywhere.

Please let's have less talk of editorial orifices and recognise that Tobacco Control journal and its editor are doing public health a service by shining light on this murky former no-go area and challenging some ill- considered orthodoxies.