‘This should change everything’ – A performance standard for cigarettes

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PerformanceUnlike many other consumer products, no safety standards have been set for cigarettes or other tobacco products. Now a performance standard proposal has been published in the British Medical Journal by Neil Collishaw of Physicians for a Smoke-Free Canada. Vigorous debate ensued, prompting commentaries for and against.

The article in the BMJ’s Tobacco Control states: “The performance standard proposed here is not a perfect solution to the tobacco epidemic but is a less bad alternative to the status quo.

“Some hazards would remain because e-cigarettes and HNB products are toxic products, but, overall, we would be less badly off. As more precise information becomes available on their emissions and hazards, revised performance standards could be set that would apply more specifically to these new products.

“Using these technologies as a springboard to better regulations would reduce the disease burden from smoking. It would also help protect public health from the new risks posed by these recent technologies, such as the risk of dual use or the vulnerability of new forms of nicotine becoming a gateway to conventional smoking. If tobacco companies want to add a new tobacco product to the marketplace, the price to be paid should be to subtract at least one existing one – the combustible cigarette.”

This should change everything: using the toxic profile of heat-not-burn products as a performance standard to phase out combustible cigarettes

In the Introduction to the Tobacco Controlarticle, Collishaw writes: “Cigarettes are inherently unsafe and no amount oftinkering and product modification over decadeshas made them safe or even less hazardous.Indeed, evidence suggests they have become morehazardous.But as there are now new substitutenicotine products available, it has been suggestedthat the viability of phasing out cigarettes shouldbe re-assessed.This paper proposes one way thiscould be done.

“Unlike many other consumer products, no safety standards have been set for cigarettes or other tobacco products. The Framework Convention on Tobacco Control (FCTC) acknowledges the role of regulating the toxicity of tobacco,and the World Health Organization (WHO) scientific committees on tobacco regulation (TobReg and SACTob) have repeatedly called for such regulations to be developed.

Despite this, no country or scientific authority has yet set out a path ‘to establish actual rather than theoretical control of product design’,and parties to the FCTC have yet to receive any guidance on how to do so.In the absence of such regulations, tobacco companies have continued to design their cigarettes without regulatory obligations to address their inherent harmfulness.

“Nonetheless, in the absence of any product standards, some of these companies have recently developed and are now marketing nicotine and tobacco products that they describe as reduced risk. These include tobacco products variously described as tobacco heating products (THPs) or heat-notburn (HNB) products, which use battery-powered heating elements rather than combustion to release nicotine and other compounds from a processed tobacco leaf.

“The design and marketing of these products is evidence that manufacturers have achieved the technical capacity to reduce the quantity of toxins inhaled through tobacco use. Manufacturers’ reports to investors claim that these new tobacco products are economically viable, and that smokers can be persuaded to use them.Whether they are meaningfully less harmful than conventional cigarettes is not established.”

Neil Collishaw’s “This should change everything” article in Tobacco Control

Commentary on ‘This could change everything’

Professor Mike Daube of Curtin University in Australia describes Collishaw’s proposal as creative and worthy of serious consideration, in his BMJ Tobacco Control commentary.

“Neil Collishaw is a doughty veteran of the tobacco wars. Like other campaigners, he is frustrated that while we have seen some encouraging developments, nearly 70 years after the first compelling evidence on the lethal nature of smoking, cigarettes are the cause of some 7 million deaths globally and tobacco companies still flourish.

“As a good public health advocate, he is constantly on the alert for new ideas and approaches to complement the strategies we know can be effective. This includes recognising that the current decade has seen more changes in tobacco company approaches than any since the 1950s—although always dedicated to the continuation of the industry and maximumpossible sales of its core product.

“Whether all those changes will, like earlier episodes such as their low tar promotions and tobacco substitutes, ultimately be viewed as frauds and distractions is still open to debate: it is, however, already clear that the tobacco companies’ claimed interest in harm reduction does not prevent them from opposing anything that might actually reduce smoking or from continuing promotion of traditional cigarettes, including to developing countries and the young people they need as replacement smokers.

“It is also clear that the industry is actively responding to a range of pressures, including proposals that even a decade ago might have seemed naïve, that public policy should seriously envisage completely phasing out traditional cigarettes.

“One approach, proposed by Collishaw,is that this be done by setting minimum performance standards using the industry’s own technology. The notion of using the industry’s data against it has attractions, but may also be fraught with complexities. For example tobacco companies have a horrendous record of gaming the evidence and finding ways around well-intentioned regulations; as yet we know very little about the harms of their novel products – but the more we learn, the more there is cause for concern about both

the products themselves and the ways in which the companies use them as part of their broader promotional strategies; and history has shown us that we should be exceptionally cautious about basing health policy on industry documents such as ‘manufacturers’ reports to investors’.

“Further, while sophisticated approaches based on carefully developed and monitored performance standards might seem possible in a few highly developed countries, the likelihood of this approach being workable in most of the world is remote and there is little doubt that debate over such policies would distract attention (as have the current debates over e-cigarettes) from the evidence-based policies recommended by WHO and other health authorities and outlined in the Framework Convention on Tobacco Control.

“But the history of tobacco control shows us that we need new ideas and approaches, not least to keep reminding governments and the public about the magnitude of the problem and that the need for action remains as urgent as ever. Collishaw’s creative proposal merits serious consideration, even if in the context of the concerns noted above, and as an incentive to others to come up with alternative approaches to phasing out all forms of harmful tobacco use.”

“Commentary on ‘This could change everything'”, in BMJ Tobacco Control

Why tobacco product regulation is no magic bullet

Deborah Arnott of Deborah Arnott of London-based Action on Smoking and Health argues in BMJ Tobacco Control that the proposal is interesting but has flaws:

“Alas, Collishaw’s interesting proposalhas fatal flaws. As he admits, it effectively bans combustible cigarettes, with ‘heat not burn’ the standard to meet. Any government implementing such a draconian measure could only justify it on the basis of risk reduction, which would have to be communicated. Yet his proposal doesn’t say anything about that issue, apart from saying that ‘whether they are meaningfully less harmful than conventional cigarettes is not established’.

“The assumption appears to be that, if cigarettes are banned, smokers would either quit or switch to non-combustible alternative nicotine products such as medicinally licensed nicotine, e-cigarettes or heated tobacco products like IQOS. Unsurprisingly as this assumption is not made explicit, no evidence is given to back up it up. And the lesson from alcohol prohibition is that while many smokers may quit or switch many others will not, leading to a rapid increase in demand for illegal combustible tobacco products, which are no longer subject to a regulatory framework.

“A substantial illicit market, by providing access to cheap untaxed products, reduces the effectiveness of tobacco taxation, widely acknowledged as the most effective tobacco control measure with the added benefit that it costs nothing, indeed it raises revenue.That is why tobacco taxes are recommended as a fundraising mechanism which could help achieve, as well as fund the achievement of, the Sustainable Development Goals.

“Rather than using product design to ban combustibles, a lower risk approach would be to use differential tax policies which have been shown to incentivise smokers, and could also be used to incentivise producers, to switch to less harmful products. Taxation could be calibrated and evolve as evidence of relative risk grows, whereas banning combustibles, even with a lead-in time, is an ‘all or nothing’ approach.

“Complete prohibition of combustible tobacco, along the lines envisaged by Collishaw, runs counter to the WHO Framework Convention on Tobacco Control (FCTC), both in principle and in practice. The Convention enshrines strict regulation as the appropriate approach for tobacco, and there is good evidence that best practice implementation is highly effective. However, nearly a decade after the Convention had come into force only one country had implemented all these policies at the highest level, and 40% had implemented none. Only one in five countries had tobacco taxes at the recommended levels.

“Do we really think that countries that haven’t managed to ban advertising, implement smoke-free laws, impose reasonable taxes on tobacco products etc, would be able to enforce a product standards-based ban on combustibles? Nor should they, their priority must remain implementing the key demand reduction measures of the FCTC (Articles 6, 8, 11, 13 and 14).

“It is no surprise that, despite what Collishaw refers to as repeated calls by WHO scientific committees for regulation of toxicity, no country has yet done so and ‘parties to the FCTC have yet to receive any guidance on how to do so’.It is not because such guidance has not been considered, indeed there have been at least nine meetings of the FCTC working group on Articles 9 and 10, and regulating toxicity has been considered and rejected. This is a complex policy area with limited experience of implementation, significant resource and financial implications, unclear benefit and serious risk of unintended consequences. Parties have, quite rightly, recognized that product standards are no magic bullet.

Why tobacco product regulation is no magic bullet

When will everything change?

Professor Ken Warner of the School of Public Health, University of Michigan, writes in the BMJ that if tobacco control has an iconic characterizationof cigarette smoking, it is surely Michael Russell’s1976 statement that ‘People smoke for nicotinebut they die from the tar’.

The statement suggestseither providing smokers with satisfying levels ofnicotine but with greatly reduced tar (Russell’sproposal) or, somewhat ironically (but no lesslogically), the opposite: ignoring the tar butreducing nicotine to non-addicting levels.

Four decades later, entrepreneurs are offeringsmokers a high-tech version of the first approachin the form of electronic cigarettes and heat-notburn(HnB) tobacco ‘sticks’. These novel productsdeliver satisfying levels of nicotine (at leastsatisfying for some smokers), while yielding manyfewer chemicals than does combusted tobacco.

The devices’ ultimate health effects are unknown and possibly unknowable, reflecting the decades required to accumulate sufficient evidence, constant product evolution and multiple patterns of use. But the new products’ dramatically reduced yields of toxins and biomarker evidence suggest that they represent much less risk than smoking.

For the first time in history, a significant subset of smokers now has an inhalable consumer-acceptable cigarette alternative to get nicotine while avoiding tar. To date, most countries’ tobacco products regulatory authorities have done little to mitigate the damage wrought by smoking. To the contrary, they have given the most harmful products – cigarettes and other combustible tobacco – a free ride, while many have created stringent barriers to the marketing of reduced-risk products.

Enter Neil Collishaw’s radically logical proposal: Let the new products (he proposes HnB) establish the limits for allowable toxins in nicotine-yielding products.Conventional cigarettes,

and other combustible products, would flunk the test and disappear from the (legal) market, spurring innovation in reduced-risk products.

Collishaw’s proposal confronts a myriad of problems, including:

  • How would regulators set product standards that would not rule out products that might fail one of the standards, while possibly besting HnB products in all others?
  • How could the new standards be designed to favour robust competition, the innovation driver, rather than cede the market to the major tobacco companies? Those companies control the HnB market. Currently, they play a minor role in the e-cigarette market. The major companies have the resources and marketing expertise to sell HnB products as a ubiquitous life-long behaviour, like cigarettes. Smokers transitioning from cigarettes to new products to nothing would be far more likely in an environment dominated by smaller competitive firms.
  • The elimination of legal cigarettes would increase the risk of an active black market, although with legal cigarettes gone, the black market would be reasonably visible. How could the impact be minimised?
  • How would the policy treat smokers not satisfied with the alternatives, currently presumably a sizeable majority of smokers?
  • And how would besieged regulatory agencies address the inevitable political and legal
  • challenges?

The US Food and Drug Administration (FDA) is considering a radical proposal of its own: reducing nicotine in legal cigarettes to levels incapable of sustaining addiction,the alternative approach to the Russell’s paradox. The Collishaw proposal would jettison the need for a nicotine reduction regulation, as it would remove cigarettes from the marketplace. But consider a hybrid: a nicotine reduction regulation for combusted tobacco products and HnB-based or e-cigarette-based product standards for all novel products. As Collishaw observes, the latter could evolve as the products themselves evolve.

FDA has acknowledged that a nicotine reduction regulation would need to be accompanied by the availability of consumer-acceptable low-risk nicotine-delivery products7 but has not yet reduced the agency’s formidable barriers to their approval. Product standards seem the obvious answer, with HnB and e-cigarettes a sensible basis for their establishment.

When will everything change?

Strategies for eliminating smoked tobacco

According to Dr Ron Borland of Cancer Council Victoria in Australia, writing in BMJ Tobacco Control, Collishawoutlines a proposal to set strict limits oncigarette emission at levels which will effectivelyprohibit all combusted cigarettes, leaving only heatnot burn (HnB) cigarettes in the market.

It wouldlimit toxicant levels of 38 chemicals set 2 SD abovethe higher mean of independent tests of two HnBproducts: British American Tobacco’s Glo and PhilipMorris International’s iQos. He provides a usefultable of observed values which shows the magnitudeand variability of the toxicant reductions this proposalwould achieve.

This proposal is a radical extensionof those to reduce toxicant levels, but in ways thatwould not eliminate cigarettes.It is an alternative toproposals, currently under consideration by the USFood and Drug Administration, to limit nicotine levelsin combusted cigarettes to non-addictive levels.

Alternative nicotine delivery systems are displacing large segments of the smoking market

in various places, such as smokeless in Scandinavia; HnB in Japan,and vaping appears to becontributing to smoking cessation in the USAandUK.These developments suggest that there arenow sufficiently consumer-acceptable substitutesfor smoking that the effective prohibition of hightoxin,addictive cigarettes is now feasible.

The underlying big question behind these proposals is that, if smoking is not going to disappear (quickly enough) with the current range of tobacco control strategies, which strategies (alone or in combination) are likely to complement the role of less harmful alternatives to most efficiently and rapidly eliminate smoking as a mass consumer activity?

In evaluating these proposals, we also need to consider the potential roles of other endgame strategies,such as legislatively gradually reducing the size of the cigarette market, prohibiting sales to all but existing smokers from some age or simply tilting the playing field to favour lower toxicant products, through such measures as differential tax and promotional channels.

We also need to consider strategies to restructure the market to minimise incentives and mechanisms for companies to undermine the public health goals.

Perhaps the greatest limitation of Collishaw’s proposal is that it neglects the potential for further toxicant reduction through the use of vaporized nicotine products which typically have much lower levels than HnB products.

I also think it is overly complex. Cigarette elimination could be achieved by requiring less stringent limits on a narrower range of emissions. Products of likely equivalent low harm, but with slightly higher levels for some toxicants than the reference two, but lower levels for others, would be prohibited.

Creating conditions that might unfairly favour products from two major tobacco companies is not good practice. I doubt Collishaw’sproposal will be part of the eventual solution, but hehas done us a service in linking the rapid eliminationof smoking to the acceptability of lower toxin alternatives,and showing us there are ways of ensuringthat alternatives cannot act as Trojan horses whichhelp sustain smoking.

The tobacco control movementneeds to accept that viable substitutes for smoking arenow available and work to develop the regulatoryframework to speed the elimination of smoking.

Strategies for eliminating smoked tobacco

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