Professor Boddewyn’s reply is interesting for what it admits and omits.

He admits that the International Advertising Association (IAA) reports published in 1983 and 1986 were based on his editing of “the draft paper written by Paul Bingham [of British American Tobacco].” To my knowledge, there has been no such public admission previously by Professor Boddewyn, BAT, or IAA in the 20+ years since publication of those reports.

However, Boddewyn omits an explanation as to why his name appeared prominently on the cover of the IAA reports (see the image of the 1983 cover in my paper in Tobacco Control) and as the author of the “Editor’s Introduction,” but Bingham’s name was nowhere to be seen in the entirety of both documents.

He explains that “I did reveal from the start that my 1983 and 1986 reports were ‘prepared by and from industry sources, using data from official and trade organizations.’” I acknowledged that disclosure in my paper, but I added the following:

“However, the report provides no further information on who conducted the analyses and wrote the text. Thus, the IAA publication links the 16–country study to the IAA itself, to Boddewyn and to ‘industry sources’, but it is unclear whether ‘industry’ refers to the advertising or tobacco industry.”

Boddewyn continues to obscure or ignore Bingham’s role in ghost–writing the reports when he refers to “MY 1983 and 1986 reports” (emphasis added).

Boddewyn claims that “MY reports on the impact of advertising bans on tobacco consumption ... provided much needed information about this issue at the time” (emphasis added). He omits any response to the comments in my paper about a key flaw in the analyses by IAA/Bingham—specifically, the failure to take into account other controls on tobacco demand (besides advertising) such as tobacco price or income. Because of that flaw, it would be correct to state that the reports provided misinformation or disinformation much needed by the tobacco industry.

Ronald M. Davis, MD

Director

Center for Health Promotion and Disease Prevention

Henry Ford Health System

Detroit, Michigan, USA

In response to our piece cautioning about the use of the ‘precautionary principle’ in debates about setting emissions limits, Nigel Gray writes that it has been around since the beginning of public health activity and offers as examples ‘[taking] the precaution of hunting for clean water on the grounds that doing nothing might allow epidemics of cholera, typhoid and hookworm to continue’ and the introduction of polio vaccine ‘as a precautionary manoeuvre because a small percentage of those infected developed clinical disease’. While these measures (and countless other public health measures) have been taken for ‘precautionary’ reasons, this does not mean that they were undertaken as an exercise of what is today known as the ‘precautionary principle’.

The point we were making in our piece was that the ‘precautionary principle’ has a commonly understood meaning – one that is being misapplied in the debate about emissions limits. Framing matters deeply to the resolution of policy debates. If the debate about setting emissions limits continues without assertions that the ‘precautionary principle’ favours the setting of limits and without assumptions that the TobReg proposal is a ‘precautionary’ one, we think the debate will be better for it.

BACKGROUND

The proposal by the World Health Organization Study Group on Tobacco Product Regulation (TobReg) for the setting of limits on emissions of certain toxicants in cigarette smoke (1) is certain to generate heated debate. Product regulation remains the most fraught policy area in tobacco control. In other areas, public health dictates are clear. Ongoing contests tend to be primarily either ones of competing values, political will or the details of implementation. Regulation of cigarette smoke emissions is fundamentally different. It is not clear how – or even if – regulation can advance public health, and there are substantial risks in getting things wrong.

In such circumstances, how does policy move forward? In its report, TobReg asserts that its approach is “based on the well-accepted precautionary approaches used in public health”, with known harmful constituents of products to be reduced “to the extent technically feasible” without need for “proof of a specific linkage between a lower level (amount) of any individual constituent and a lower level of human disease (response)”. Burns et al reiterate this point in their paper describing the proposal.(2) They argue that, while “[e]xisting science does not allow a definitive conclusion that reduction of nitrosamines, or any other individual toxicants in cigarette smoke, will reduce cancer incidence, or the rate of any other tobacco related disease, in smokers who use cigarettes with lower levels of these toxicants”, TobReg’s proposed strategy is “based on sound precautionary approaches of reducing toxicant levels wherever possible”. In papers that question the wisdom of setting emissions limits, Chapman and Hammond et al nevertheless accept that the approach enjoys the support of the “precautionary principle”.(3,4)

RISKS OF THE TOBREG PROPOSAL

Neither TobReg’s report nor the Burns et al paper elide the risks of the TobReg proposal. TobReg, acutely aware of the history of consumers being misled by the use of machine testing for tar and nicotine yields, recommends that regulation prohibit use of results from the proposed testing in marketing or other communications with consumers, including on labelling, and that manufacturers “be prohibited from making statements that a brand has met governmental regulatory standards, and from publicizing the relative ranking of brands by testing levels”. Regulators will need “to monitor the understanding of the consumer about the regulatory approaches undertaken” and “should pursue whatever corrective action is necessary to prevent consumers from being misled”. TobReg also acknowledges the risk that “changes in cigarette design and manufacturing implemented to lower the regulated toxicants may have the effect of increasing the levels of other non-regulated toxicants” and offers proposals for monitoring for such unintended consequences.

While TobReg does not elide the risks, it nonetheless argues for regulatory action. Others are less sanguine about the possibility of overcoming the risks. Chapman envisages tobacco industry PR machines going “into overdrive, spinning the changes in ways designed to comfort smokers and risking another major era of consumer disinformation”. He anticipates “a simple and misleading message by the media that the newly regulated products are now ‘safer’”.

Kozlowski is understandably sceptical of the capacity of regulators to monitor and correct consumer perceptions.(5) In the modern world of news reports, editorials and blogs, “[s]uch power would be the unrealizable dreams of the most powerful, paternalistic totalitarian state”. Both Chapman and Hammond et al refer also to the critical issue of resources required to introduce and monitor emissions limits.

THE PRECAUTIONARY PRINCIPLE

If TobReg is not sure that its proposed approach will have any public health benefit – it describes reduction in the incidence of cancer and other tobacco related disease in smokers who use cigarettes with lower levels of the regulated toxicants as a “hoped for outcome” – and if all acknowledge that it carries major risks and costs, an obvious question emerges. How could the regulatory precept known as the “precautionary principle” militate in favour of the proposed approach?

The precautionary principle emerged in the mid-1970s with the rise of environmentalism in Germany. It has since been widely invoked, including in a number of international environmental agreements,(6,7,8, 9,10,11)and defined in a range of different ways.(12,13) The most often referenced definition is that in the Rio Declaration on Environment and Development,(7) which states that: “Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation”. This understanding, mirrored in the United Nations Framework Convention on Climate Change(8) and the earlier Ministerial Declaration of the Second International Conference on the Protection of the North Sea,(14) is well accepted and unobjectionable. It suggests “that a lack of decisive evidence of harm should not be a ground for refusing to regulate”;(12) and “that regulatory policy should seek to prevent harm before it occurs, and that it should reject the insistence of regulatory targets that a never- ending quest for improved information should indefinitely postpone sensible regulatory measures”.(15)

However, attempts to take the precautionary principle further, and cast it as offering substantive prescriptive guidance on what steps regulators should take – as opposed to a reminder that, in certain circumstances, they should not refrain from taking steps solely because of scientific uncertainty – have been strongly critiqued. Sunstein argues persuasively that the fundamental problem with prescriptive invocations of the precautionary principle is that they are paralysing.12 Because risks exist on all sides of social situations, the precautionary principle offers no guidance – “it forbids all courses of action, including regulation. It bans the very steps that it requires”.

In contrast to the belief often held that the precautionary principle provides regulators with decision-making guidance, Sunstein argues that it “becomes operational if and only if those who apply it wear blinders – only, that is, if they focus on some aspects of the regulatory situation but downplay or disregard others”. Sunstein suggests that invocation of the precautionary principle can mask neglect of the systemic effect of regulatory interventions: people tend to fixate on isolated problems and fail to see the complex, system-wide effects of measures to address them. The guidance provided by the principle, interpreted as applying prescriptively, is illusory: “There are simply too many risks against which one might take precautions. Precautions cannot be taken against all risks … because efforts to redress any set of risks might produce risks of their own”.

Sunstein’s view that the prescriptive version of the precautionary principle is paralysing is echoed by Cross, who argues that if “environmental and public health regulations frequently produce health or other environmental harms, the basis for the precautionary principle collapses”, as the principle itself would counsel against adopting such regulations.(16) Cross notes that because “[f]ocusing great precaution upon the instant problem must reduce precaution upon other problems, which may prove greater and more serious”, the principle skews prioritisation of government efforts to reduce risk. He also suggests that there are significant risks from the societal economic costs of regulation, so that reliance on the precautionary principle in situations where there is little evidence of realisable health benefits from regulation “could cause more health harm than it prevents”.

A CAUTIOUS APPROACH

The TobReg proposal is universally acknowledged to carry substantial risks. TobReg itself acknowledges the risks and appears no more than hopeful that its proposal might yield public health benefits. Yet the proposal has somehow come to be accepted to embody a “precautionary” approach. An examination of the meaning and use of the “precautionary principle” sheds light on this confusion. The TobReg approach can only be described as “precautionary” if the principle is not used in its traditional sense (if it is used as offering prescriptive guidance rather than arguing against the postponement of action) and if a highly selective application of that contested version is invoked (one made through the wearing of Sunstein’s “blinders”). This is an area in which arguments have been, and will continue to be, made on both sides. Those who argue in favour of setting emissions limits are judging that the benefits of such an approach outweigh the risks and the costs. But it is hard to see how their approach can be regarded as more “precautionary” than that of those who argue against setting limits.

As we have argued, application of the precautionary principle as offering any prescriptive guidance in favour of the TobReg proposal is misguided. As the debate continues, we suggest that the precautionary principle not be invoked in support of the setting of emissions limits. Both Chapman and Hammond et al, after deferring to TobReg’s “precautionary” framing, bring the issues back to their correct regulatory framing – a weighing of benefits, risks and costs on the basis of the best available evidence. This is the context in which the debate about emissions limits should continue, without the precautionary principle being misapplied to ease the burden of those making the case for emissions limits.

REFERENCES

1. WHO Study Group on Tobacco Product Regulation (TobReg). The scientific basis of tobacco product regulation: report of a WHO study group. Geneva, Switzerland: World Health Organization, 2007. 2. Burns D, Dybing E, Gray N, et al. Mandated lowering of toxicants in cigarette smoke: a description of the WHO TobReg proposal. Tob Control 2008;17:132-41. 3. Chapman S. Benefits and risks in ending regulatory exceptionalism for tobacco. Tob Control 2008;17:73-4. 4. Hammond D, Wiebel F, Kozlowski L, et al. Revising the machine smoking regime for cigarette emissions: implications for tobacco control policy. Tob Control 2007;16:8-14. 5. Kozlowski L. The proposed tobacco regulation: the triumph of hope over experience?. Tob Control 2008;17:74-5. 6. Montreal Protocol on Substances that Deplete the Ozone Layer (opened for signature 16 September 1987, 1522 UNTS 3 (entered into force 1 January 1989) (Preamble)). 7. Rio Declaration on Environment and Development (UN Doc A/CONF.151/26 (vol I) (1992) (Principle 15)). 8. United Nations Framework Convention on Climate Change (opened for signature 4 June 1992, 1771 UNTS 107 (entered into force 21 March 1994) (Article 3(3))). 9. Treaty on European Union (Maastricht Treaty) (opened for signature 7 February 1992, [1992] OJ C 224, 1 (entered into force 1 November 1993) (Article 130r(2))). 10. Cartagena Protocol on Biosafety to the Convention on Biological Diversity (opened for signature 15 May 2000, 39 ILM 1027 (entered into force 11 September 2003) (Article 1)). 11. Stockholm Convention on Persistent Organic Pollutants (opened for signature 23 May 2001, 40 ILM 532 (entered into force 17 May 2004) (Article 1). 12. Sunstein C. Laws of fear: beyond the precautionary principle. Cambridge, UK: Cambridge University Press, 2005. 13. Morris J. Defining the precautionary principle. In Morris J, ed. Rethinking risk and the precautionary principle. Oxford, UK: Butterworth- Heinemann, 2000. 14. Ministerial Declaration for the Second International Conference on the Protection of the North Sea (London, 25 November 1987). 15. Percival R. Who’s afraid of the precautionary principle?. Pace Environmental Law Review 2005-2006:23;21-81. 16. Cross F. Paradoxical perils of the precautionary principle. Washington and Lee Law Review 1996:53;851-925.

In a recently published article in Tobacco Control, Vander Beken and colleagues [1] concluded that the Belgian cigarette black-market manifested myriad links with the legitimate business world and, as a result, effective tobacco control policies will need to address the role of legitimate businesses in this market. Our letter confirms this conclusion within a Canadian context.

Approximately 10-17% of cigarettes smoked in Canada in 2005-2006 were illicit, and 95% of all illicit cigarettes (i.e., contraband) in Canada were manufactured on First Nations reserves in the provinces of Ontario and Québec [2,3]. Even though two-thirds of contraband cigarette consumers report buying contraband cigarettes at off-reserve locations [4], little is known about the distribution network of contraband cigarettes in Canada.

Previously, we examined the contraband cigarette market at one of Canada's largest psychiatric hospitals, a 436-bed facility located in Toronto [5]. Approximately 60% of the cigarette butts sampled from patient ashtrays appeared to be contraband; and 80% of the cigarette packages found in a facility-wide garbage audit at the psychiatric hospital were from illicit brands manufactured on American Indian reservations in northern New York State. Anecdotal evidence suggested that independent convenience stores were serving as a prominent distribution source for native-manufactured contraband cigarettes, and the current letter examined this possibility.

We assessed the prevalence of legitimate independent convenience stores willing to sell illicit native-manufactured cigarettes in Toronto, Ontario. A list of all independent convenience store tobacco retailers in the study area was obtained from the City of Toronto. Our sample included all of the 115 independent convenience stores located within a 2 km distance from the psychiatric hospital: 30 within 1 km, and 85 within the 1-2 km span. Data collection occurred during July and August 2007. A male research assistant (aged 36 years) entered each of the 115 stores and asked the clerk, "Do you have any native cigarettes?" A store was coded as willing to sell illicit native cigarettes, if: (1) the clerk provided an affirmative answer; (2) the clerk engaged the research assistant in a selling transaction (e.g., the clerk asked the research assistant, "How much money do you have?"); or (3) the research assistant saw the clerk selling illicit native-manufactured cigarettes to another customer.

Legitimate independent convenience stores located closer to the psychiatric hospital were significantly more likely to be willing to sell illicit native-manufactured cigarettes. Approximately 57% (17/30) of the stores within 1 km of the hospital were willing to sell contraband cigarettes, while roughly 12% (10/85) of the stores located in the 1-2 km zone showed the same tendency (chi-square = 24.9, p < 0.001).

Similar to the findings of Vander Beken, et al. 2008, our results suggest that Ontario tobacco-control policies will need to recognize legitimate businesses—in our case, independent convenience stores—as important sources in the distribution network of black-market cigarettes.

References:

1. T Vander Beken, J Janssens, K Verpoest, A Balcaen, and F Vander Laenen. Crossing geographical, legal and moral boundaries: The Belgian cigarette black market. Tobacco Control 2008; 17:60-65.

2. Physicians for a Smoke-Free Canada. Warning signs about cigarette smuggling: And actions governments can take to address this growing problem. Ottawa: Physicians for a Smoke-Free Canada; 2006 December.

3. Imperial Tobacco. Collateral damage: Illicit tobacco trade takes on phenomenal proportions. 2006 [cited 2007 February 5th]; Available from: http://www.imperialtobacco.com/onewebca/sites/IMP_5TUJVZ.nsf/vwPagesWebLive/362441A11150B0B6C1257108005E76AC?opendocument&DTC=&SID=

4. GFK Research Dynamics. New Information on Illegal Tobacco Sales: National Study for the Canadian Tobacco Manufacturers' Council. Mississauga, ON: Imperial Tobacco; 2007 July.

5. RC Callaghan, J Tavares, and L Taylor. Illicit cigarette markets in marginalized, low-income populations: an example from psychiatric patients in Toronto, Ontario. American Journal of Public Health 2008; 98:4 -5.