Tobacco Documents Online

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Plugging oral tobacco's safety THE IDEAS RELAYED in our report on page 14 about the relative safety of oral tobacco produc~ are convincing, not least because they have come from, among others, a number of anti- tobacco activists and medical experts. They are convincing, too, simply because they have the ring of truth about them. The proposition that oral tobacco is not implicated in lung cancer is easy to swallow. And, given the evidence of Dr Brad Rodu, for instance, it is reasonable to accept that the health risks of mouth cancer etc have, for whatever reasons, been, at the very least, exaggerated. It is difficult, without a good deal of research, to evaluate properly the 'Swedish experience', where tobacco- related death rates among Swedish men have gone down against a background of decreasing smoking rates and increasing snus use amongst this group of people. Part of the difficulty is created because questions are inevitably raised about what are tobacco-related diseases and how many people suffer from them. But this is not the time to quibble. If it is true as stated that certain oral tobacco products are 90% safer than are other tobacco products, nobody could argue against consumers being informed about them without delay, nor against these products being made readily available at reasonable prices. Of course, this is not the end of the story. The big question is whether those people who should buy these products would do so. One country where they possibly would and where a vast study might be undertaken is India. The consumption of oral tobacco in India is traditional and Indian governments over the years have used taxation, in effect, to keep cigarette smoking (though not bidi smoking) at a low level. At the moment, most of the oral tobacco products consumed in India are not of the types that would be recommended by health activists; but it would surely be easier to convert an oral tobacco user to another type of oral tobacco than to convert a smoker to oral tobacco. So where does this leave cigarettes? Should BAT, PM and JTI start investigating whether their cigarette makers could be converted for use as fast food extruders? It is probably a little premature. At the moment, snus, the product that apparently has the lowest health risk of any tobacco product, is banned in the EU, and all oral tobacco in the US is labelled as deadly. These positions are not going to be changed overnight. Also, even in an open market, it would not be easy to convert cigarette smokers to what is, for them, an alien form of tobacco consumption. And for this reason it is important that research into less- hazardous cigarettes goes forward, quickly. As is reported on page II, it is feasible that a cigarette could be produced that would be only as hazardous as a cup of coffee, or a glass of wine. Those who are arguing that there is a moral obligation for authorities around the world to inform smokers who 'cannot or wiffnot' quit smoking about the choices available to them in respect of oral tobacco products, would surely not balk at smokers being informed about cigarettes that were as safe as coffee. George Gay. editor ! R. !. REYNOLDS was widely ! thought to have made a i remarkably astute deal when it sold its international business to Japan Tobacco a few years ago at what analysts regarded as an over-the-odds price. Yet now, RJR must be wondering whether it should have made the sale. RJR is becalmed in its US domestic market, its revenues are falling in the face of competition from deep discount brands and the compare/has been forced its international tobacco business in fiscal 2003 (to the end of March 2003), largely as a result of the continuing success of its 'global flagship brands' -- Winston, Camel, Salem and Mild Seven. JT, the world's third largest tobacco manufacturer [excluding the China National Tobacco Corp], made its forecast last month when announdng its 2003 fiscal year's third quarter (October to December 2002) ad~e~ ~ EBrrDA (~r~ and amortisation) growth of 17.4% or US$73m to US$492m for fiscal 2002, when compared with the previous year's figures. This growth was largely due, JT said, to the growth of its global flagship brands, the sales of which rose 4.3% or 4.6bn to I 12.4bn cigarettes. JT's international strategy has been to concentrate its focus on its higher-priced flagship brands since its total cigarette volumes have declined, largely because of reduced sales of value brands in Russia, the bulk of ~ are non- proprietary. Total international volum~s fell 7% to 207bn units in 2002. The biggest selling flagship brand is Winston, whose sales rose 10% during 2002 to 49bn. The company's major markets are the CIS, the Middle East and Africa, where volume sales are was ~ to ~e p~en¢ company and is now known as. the China Division. JT's domestic sales volume in the third quarter of the 2.003 financial year fell by 4.9% or 3. I bn cigarettes to 60bn, compared with its sales during the same quarter of 200 I. The fall was part of a trend that the company blames on Japan's ageing society, health concerns and tax increases. MOUNS' 2002 RESULTS show that the company has made a retmrka~ recover), from its dark days during the 1990s when ~ch dispiriting story of waning orders, staff reductions, closures and a share price moving inexorably dow~rards. Although turnover fell slightly ~=inst that of the previous year, c~er~ng profit ro~e 44% from £9.4m ~o £ 13.Sin, pro~ afar inca~e~ed ~m 29. I p m 4~.9p.

REDUCED RISK ~ FEATURE WO~.LD TOBACCO I~CH ?..~r.,~ Oral tobacco is talk of reduced-risk advocates A head of steam is being built up behind oral tobacco, especially snus, as anti-tobacco activists and medical researchers, disenchanted with the progress of abolitionist tobacco policies, turn their sights on the next best thing- tobacco products that present the lowest possible risk. m[ohe EU's near-ban on snus is coming under attack from two sides as rces from inside and outside the obacco industry challenge what is increasingly being seen as an unsustainable policy. Even some of those campaigners who nor- mally take an anti-tobacco stance have joined the battle against the ban on the grounds that, given certain regulatory conditions, a number of oral tobacco products, including snus, could be used as lower-risk substitutes for other tobacco products, especially smoking-tobacco products, or, in some cases, as a way of quit- ting tobacco altogether. The c~-npaigners believe that, given the results of recent research, there is a moral obligation on the EU to remove the ban on snus and to inform tobacco users of the rela- tive risks of the products available to them. The Royal College of Physicians (RCP) in the UK pointed up during December the anomaly in the EU's position when it said that while nicotine replacement therapies (NRTs) were strictly controlled under medicines regu- lation and oral tobacco was banned complete- ly under EU law, both represented much less hazardous ways of administering nicotine and both could be used for smoking cessation. Questions about whether significant num- bers of smokers could be persuaded to switch from dgarettes to snus are answered by point- ing to ~ Swedish example. And on the sur- face at leas~ the evidence from Sweden is While a number of activists -- both from the pro- and ant~-tobacco camps -- and sd- entists have been moving for some time in the direction of reduced risk, pol~cal momentum has been lagging behind. But a step was taken towards gathering political support in the UK in February w~h a low-key presentation of a report by a number of anti-tobacco campaign- ers and medical researchers: European Union policy on smokeless tobacco, A statement in favour of evidence-based regulation for public health. This initiative is being made at a crucial time because the EU is due to review by the end of next year its smokeless tobacco policy, in the light of developments in scientific and technical knowledge. The authors of the report are: Hr Clive Bates, director, Action on Smoking and Health, London; Dr Karl Fagerstr6m, consul- tant in tobacco and nicotine policy, and chair- man, Society for Research on Nicotine and Tobacco, Europe; Prof Martin Jarvis, professor of health psychology, Cancer Research UK Health Behaviour Unit, University College London; Prof Michael Kunze, professor of public health, and director of the Institute of Social Medicine, University of Vienna; Dr Ann McNeill, honorary senior lecturer, St George's • Hospital Medical School, London, and indepen- dent consultant in public health; and Dr Lars RamstrOm, director, Institute for Tobacco Studies, Stockholm, Sweden. The repcxt was presented by Mr Bates, Mr activists rather than, necessarily, anti-tobacco activists. This is an important distinction. Such a position makes room for a debate with tobacco interests that will undoubtedly be robust, but, unlike the abolitionist stance, will provide a basis for meaningful interaction. [Coincidentally, the oral tobacco issue seems to be coming to a head as the end is in sight of the abolitionist stance that was taken in the US during the early 1980s as a reaction to progress in redudng the risk of cigarette smoking. Once again, some people are talking about lower-risk dgarettes (see page I I).] Dr K. Michael Cummings, of the Department of Cancer Prevention, Epidemiology and Biostatistics, Rosewell Park Cancer Institute, US, is on record as saying that public health advocates should consider expanding their partnership list to include manufacturers of smokeless tobacco. And the RCP said that manufacturers that wanted to market smokeless tobacco as a harm reduc- tion option for nicotine users might find sup- port for that position in the public health community. As a way of using nicotine, the RCP said, the consumption of non-com- bustible tobacco was of the order of IO-I ,000 times less hazardous than was smoking, depending on the product. The consensus seems to be that wl~le all oral tobacco products are less hazardous than are smoking tobacco products, oral moist tobacco is the least hazardous of all. Among oral moist snuff products, Swedish Match's snus, which undergoes a 'sweating' process that is said to be akin to pasteurisation, is believed to be the safest, though this perception might have been engen- dered partly because a number of factors have meant that Sweden has lent itself to the study of tobacco use, especially a comparison of snus and cigarette consumption. Consequently, it should be no sur- prise that the EU's policy on snus ~s being challenged, too, by Swedish Match directly through a judidal review of the UK government's implementation of two directives that e~.apsulate the ban on saus and indirectly thro~ a German tobacco dis- to the European Ccx~ c~Justice. If~e Swedish expeder~e ofc~ to

Europe and agaJnst oral tobacco in gene.r~ in the US, where such products have been branded since the mid-1980s as highly dan- gerous, despite the availabilk'y for some time of evidence to the cont~ry. Snus was banned w~hin what was then the European Community in 1992, though Sweden, which had a tradition of snus use, was granted an exemption. Now, EU policy makers might have to face up to the fact that they have banned only the lowest-risk tobac- co product available. According to the report presented in February, Sweden has by far the lowest levels of tobacco-related mortal~ in the developed worid despite having comparable levels of tobacco usage. The country had the lowest male smoking prevalence in Europe, the report said, and low female prevalence, while half of the tobacco consumed in Sweden was consumed as snus. The Gothia (Swedish Match) website points out that while the risk of death from a tobacco-related disease among Swedish men is lower than in any other European country, the dsk for Swedish women, whose levels of snus use have remained fairly low and whose smoking pat- terns are similar to those of women in other European countries, is in line with the dsk in other European countries. Among Swedish men who had used a sin- gle aid to stop smoking arid had succeeded in doing so, about 70% had used snus and about 3096 had used an NRT. And there were far more ex-smokers among snus users than ex- snus users among smokers, the report added. If this is a true reflection of the situation in Sweden, it leaves the EU in an uncomfortable position, especially given that some apparent- ly 'high-risk' oral tobacco products have been entedng the EU legally from the Indian sub- continent. Even qat, which in the US is includ- ed in the same category as heroin and cocaine, is allowed into the EU. By continuing to ban snus, the argument goes, the EU i.s liming the health-related choices its citizens can make about the types of tobacco products to consume. The EU is comm~ng smokers to m~ng a choice between 'qu~ng and dying', when, by allow- ing snus into the equation, it could allow them to choose to use a relatively harmless product to either quit or substitute their current tobac- co habit. Given the histo~ of the tobacco 'debate' this is a radical message in itself, but it is g~ven an edge when it is learnt that it is being put for- Not ~ the report's authors have per- formed a ccx-nplete about-face. Given a free vote, they would come out in favour of a tobacco-~ee word. And the authors are not seeking simply the lifting of the ban on snus. They want the partial ban on snus to be replaced by a tobacco regulatory system based on the toxic'Cy of all oral tobacco prod- ucts. Significantly, they say that their proposal would be likely to remove more products from the market than it introduced. And the authors are not claiming that smokeless tobacco is harmless. Some of the smokeless tobacco used in India and the US caused oral cancer, they said. 'But the evi- dence shows that any link between smokeless tobacco in the form of Swedish snus and o4 cancer is not established,' they added. Later, in their report, the authors said that smokeless tobacco might be associated with cardiovascular disease, though the evidence was contradictory. 'However, for oral tobacco to play a role in harm reduction it is not necessary to show that it does not cause cancer -- it just needs to be substantially less hazardous than smok- ing,' the report argued. And of this the authors were convinced. It was reasonable to formulate that Scandinavian or US smokeless tobaccos were at least 90% less hazardous than were cigarettes, they speculated. In a spectrum of risk, snus was much closer to NRTs than to cigarettes, and the risk associated w~h smokeless tobacco products could be reduced further by regulat- ing levels of particular ingredients. Now EU policy makers might have to face up to the fact that they have banned only the lowest-risk tobacco product available. Further, Dr Rodu has given evidence to the Federal Trade Commission in the US that in comparing the risks of oral cancer from smokeless tobacco use w~ the divers risks from smoking, his department's peer- reviewed research had established that smokeless tobacco use was 98% safer than smoking. Nothing had been published that contradicted the results of this research, he said. The report's authors are not entirely happy could under cerl~ circumstances ~cl to reduced leve~s c~ ~bacco cessal~o~, an tobacco use, but they are c~, never- desirab~Trb, of applying the "preca~onary prin- ciple" -- the ~ which will undoubtedly be raised, that what is banned should not have that ban lifted unlJl aJ[ of its health effects have been evaluated. Smokeless tobacco, the report's authors said, was addictive, but its addictiveness was the result of a nicotine delivery system that most closely mimicked that of dgarettes. And the close match of the nicotine delivery pro- files, the authors speculated, might be one reason why tobacco users found smokeless tobacco more effective than NRTs, such as patches and chewing gum, as a replacement for smoking. The foray into the field of addiction where 'addicted' cigarette smokers are referred to as those who 'cannot or will not' give up is pos- sibly the least convincing part of the report- one that harks backto some of the less ratio- nal positions of the past. Overall, however, the report is to be welcomed for its honesty and for its radical stance, whose proposals are summed up in its six conclusions: 'a) It would create a legally defensible, fair and rational policy in which public health is given primacy consistent within the framework of the EU law. b) It could create public health benef~s through smoking cessation and smoking substitu~on. c) It gives smokers an extra strategy for controlling their risk and eliminating ETS risk, and thereby respects their con- sume~ and human rights. d) It would apply toxicity controls to the currently unregulated chewing pro~ducts such as gutkha and paan available in the European Union and currently unregu- lated. e) It could have benef'~ beyond Europe if a good regulatory model is developed for controlling toxicity of smokeless tobacco -- for example by establishing regulatory norms in the WHO Framework Convention on Tobacco Control. f) It opens the dominant dgarette makers to competition from tobacco products that do far less harm.' The question of competition is an interest- ing one. If the daimed health advantages of snus are accurate, and if the conversion of smokers to snus outstrips the conversion of smokers to NRTs. as seems to be the case, it would surely become the duty of the authori- ties to ensure that l~e publk:: was made a~are "We th~nk ~t ~s wrong to deny other Europeans the repc~ states. Ths pc~nt ~s ~ at ~

,n a paper by Dr Lynn T. Kozlows~ that was green out at the London event. Harm reduc- tion, pubhc healS, and human rights: Smokers ,have a ngh~ to be informed of significant harm reduc~on options. Dr Kozlowski said that avoiding or objecting to the fair presentation of ~nformation on effective harm reduction prod- ucts to smokers to allow them to make an informed choice to reduce health risks might represent a violation of a human right -- the right of information. Smokers had a right to information oo snus and medicinal nicotine as harm reduction options that would substantial- ly reduce the risk of death to individuals. The RCP. meanwhile, took the debate in another direction by asking at what level of reduced risk the author'r~ies would be negli- gent in not allowing consumers to be informed about products that do them less harm. But the point was made most forcibly by an oral tobacco industry insider who told World Tobacco that if the authorities did not act to ensure the public was fully informed, people would be justified in picketing government buildings with placards showing the daily, avoidable death toll from smoking, And the public, in the US at least, does seem ill-informed about these issues, though open to information. According to Dr Cummings, of the people asked in a survey whether chewing tobacco was just as likely to cause cancer as were cigarettes, 82% replied 'yes' and only 10% said 'no'. On the other hand, according to information provided by US Smokeless Tobacco, 71% of people believe that the federal government should provide guidance on how to communicate comparative health risks. If it were accepted that consumers should be informed of the benefCs of snus, a decision would have to be made about who would do the informing and who would regulate the information. And by the time that such a deci- sion is likely to be made, the sort of 'promo- tion' that would be necessary would probably require in the EU a change to the tobacco advertising ban that will then be in place. At an EU and at a member-state level, deci- sions would have to be made about tax levels, because all of the information in the world will not convince one smoker to switch if the price of a package of snus is too high. It is highly unlikely that any conversion of smokers would be rapid, if only because of the time needed between buying the necessary tobacco and ~ processing into snus. But if p~0motions were to be allowed and if the sorts of conver~ rmes seen in Sweden c~. gnnding, processing and packing, the machin- ery involved does not encapsulate the level of technology exhibited in cigarette making and packing. Part of this technology gap would have been created because the major tobacco machinery manufacturers would not have been drawn in the past to a snus industry whose sales volumes would have translated into only modest demand for machinery. But if snus sales increase, demand for machinery will increase, too, and the investment picture will change. Part of the technology gap, on the other hand, is simply down to the nature of the product, which is either presented in loose or portion formats, the latter comprising the moist tobacco contained in porous bags, simi- lar to, but smaller than, tea bags. But here again, increased volumes could conceivably lead to more sophisticated products or more sophisticated ways of packing existing prod- ucts. Away from machinery, a substantial conver- sion of smokers to snus would have an impact on the industries providing such items as filters; cigarette, tipping and plug-wrap papers; and adhesives for cigarettes and filters. It would affect, too, those companies involved in pack- aging materials, especially those currently pro- viding overwrap materials. Swedish snus is made from tobacco, water, salt and flavours. Some is contained in pouch- es similar to tea bags that are made of cellulose fibres, and this version is Some ant/tobacco campaigners have joined the battJe against the ban on mo~ snus, seen here in Swect/sh and US produc~ pad~ in polypropylene containers. Loose snus is generally packed in paraf~ coated cans produc~,n ~ed tr,~i~ too. Swedist'~ snus is sis put these days ~the elimination of tobac- co specific nitrosamines, these are no longer literally fire-cured), which are different to the flue-, air- and sun-cured tobaccos used in dg- arettes. The quantity of tobacco consumed is roughly similar, though, assuming that a dga- rette smoker consumes 140 cigarettes a week, each with 0.7 g of tobacco, while the snus consumer gets through about 2.5 cans a week, each containing either 50 g or 24 g of tobacco. Once tobacco consumers in Europe were given access to a full range of smokeless prod- ucts and once consumers around the world were made aware of the health advantages of these products, in practical terms, the big question would be whether or not consumers would change to the new products. Although the evidence in Sweden points to the fact that they would, at least in the case of men, it needs to be borne in mind that one of the rea- sons why anti-tobacco people have been drawn to snus is that they have come to the conclusion that even in those parts of the world where anti-smoking messages have been the shrillest, a substantial proportion of the population simply refuses all entreaties to give up smoking. Also, with snus, gone are some of the ritu- al and tactile elements of smoking that we have been told for years are all part of the smoking experience. And the general recom- mendation with snus is to keep it refrigerated, which might make it seem less convenient than .is a pack of cigarettes. On the other hand, snus offers a whole host of advantages. It is simple to use: take out a portion and put it in" your mouth. No one need know that you are using a tobacco product, you are not going to start a fire with it and you are not going to bother the person at the next table. Additionally, of course, snus can be used in all those places where cigarettes cannot be used', in trains, boats, planes and offices. This last advantage raises some concern among anti-tobacco people supporting snus. What they do not want to do is to encourage people who do not already use tobacco to start, or to provide a support system for peo- ple v/no might otherwise quit because of the long periods of the day that they have to spend without a dgare~e. In fa~-t, they say ~ the Swedish example ease ~ Europe. ~

AFTER NEARLY A QUARTER OF A CENTURY DURING WHICH WOULD-BE ABOLITIONISTS HAVE HELD SWAY OVER THE TOBACCO DEBATE, THE VOICES OF REASON ARE ONCE AGAIN BEING HEARD AS THEY MAKE THE CASE FOR LOWER-RISK TOBACCO PRODUCTS. HERE, AND ON PAGE 14, WE LOOK AT LESS- HAZARDOUS CIGARETTES AND LOWER-RISK TOBACCO PRODUCTS. Talldng again about less hazardous cigarettes Mr L~ers: "Nicotine is safe." by Bill Layers Nicotine is safe. This is self evident since, in many parts of the world, those attempting to quit the smoking habit are able to buy nicotine patches and gums across the counter without the need for a doctor's pre- scription or an accompanying public health warning. Nicotine is also pleasurable and therapeu- tic, especially within the narrow limits of dosage offered to cigarette smokers. This is self evident, too, since more than a billion people around the world are still smoking cig- arettes despite the ever more powerful anti- smoking campaigns in many countries. What cigarettes have to offer is a system of inhalation that provides subtle ways of modu- lating the delivery of the payload to suit indi- vidual mood. In other words, smokers inhale until a desired level of nicotine is attained, and then no more. Inhaled nicotine is in fact its own controller; it limits the level of smoke inhalation to the desired range of therapy pulses to the brain. According to some observers, the tobacco industry is about to tread the path from health warnings to health claims. But these are early days and it has to be remembered that the industry has been here before. which was now no less than a public duty, according to Dr Gio Batta Gori, of The Health Policy Center, Bethesda, Maryland, US, who spoke at the 2002 CORESTA Congress in New Orleans, US. Moreover, he said, it was a goal that was within reach. Dr Gori reminded the Congress delegates that the Institute of Medicine (IOIH) of the US National Academy of Sciences, the highest medical authority in the US, had issued a report in September 2001 asserting that tobacco products of reduced risk, and espe- cially LHCs, were within technical reach and, as such, should be officially endorsed, regulat- ed, and promoted and marketed with justifi- able health claims. Dr Gori said there had been a reluctance at both national (US) and international levels to discuss the ramifications of this report, most likely because of a misplaced sense of respon- sibility among government authorities. The report, which implied that official policies against tobacco and cigarettes had been unwise, ineffective and uncaring of smokers, had effectively 'scuttled' prohibitionist polities against smoking, he added. In fact, as Dr Gori pointed out, the IOM report essentially reiterated recommenda- tions advanced as long ago as 1980 by the Smoking and Health Program (SHP) of the US National Cancer Institute, but that were sup- pressed for more than 20 years by prohibi- tionist policies. SPECIAL APPEAL "The very transitory and changeable eFects of inhaled nicotine are essential to the appeal of dgarettes," Dr God told the Congress, before describing the minute to minute "titra- ed, "are what make cigarette smoking such a fungible rflexible] coping device for all seasons, quite unlike what happens with other sub- stances." The other substances Dr Gori had in mind were alcohol and, presumably, addic- tive drugs. He pointed out that nicotine was not psychotoxic and did not lead to deranged and asocial behaviour, nor to loss of person- ality control. Apart from a "brief upset" when starting to smoke, Dr God insisted, cigarette smoking was never unpleasant and only had positive behavioural consequences. This was why so many people found it pleasing, rewarding and ultimately helpful. It was, Dr Gori said, the "height of arro- gance" to contend that a billion people did not need cigarettes and were simply addicted or foolish. So, in the wake of the obvious failure of the prohibition route, Dr Gori reminded the" Congress, it was in 1999 that the US Food & " Drug Administration (FDA) had asked the IOM to make recommendations as to whether cigarettes could be made less haz- ardous, and, if so, how such products could be regulated. I.O.M. RECOMMENDATIONS The IOM recommendations, he said, had been nothing less than "revolutionary" given the political attitudes of the time. The 1OM report had found that "for many diseases attributable to tobacco use, reducing the risk of disease by redudng exposure to tobacco toxicants is feasible". And it justified this on the basis that ~current knowledge of the dose- response relationship is su~dent to support risk reduction through exposure reduction'. The epidem~ record shows that smol~, w~d-~ substa,q~ altering the tar clsease.

~;O~LD TOI~ACCO HARC~ 200~ example, at the apparently prefen-ed level of around 300 pE~Ipuif" -- while "redudng the inhalation of other smoke components, the ratio oftar to n~cotine (l'/N ratio)wll be low- ered. along with the expected dsk. Crucially, the IOM report also acknowl- edged that LHCs are meaningless unless they maintain their appeal to smokers. It also re- affirmed the notion that nicotine is safe at lev- els experienced by smokers, Dr God noted that the safety of nicotine -- at doses traditionally experienced by smokers -- had been recognised also in the first US Surgeon General's report on smoking, in 1964. The safety of nicotine had been re- affirmed by the FDA for heady two decades, and by regulators in other countries too. Any claim that smoking was, for example, as addictive as crack cocaine was dismissed by Dr Gori as simply not credible. He quoted the US Surgeon General's report of 1964 as say- ing that smoking was a personally controllable habit. Remarkably, according to Dr Gori, the conclusions of the IOPI report in 2001 were "virtually the same" as those reached by the SHP of the US National Cancer Institute, which were published in 1980, LOST OPPORTUNITY The SHP started about 35 years ago to look at the possibility of reducing the carcino- genic potential of cigarette smoke, Tests were carried out over several years, culminating in the detailed chemical characterisation of leaf, fillers, smoke and the tar generated, by more than I S0 varieties of cigarette. Certainly, the SHP established many of the key parameters and variables associated with smoking and cigarette manufacture, including su~estions for developing methods to adjust nicotine levels. "In fact," Gori pointed out, "by the late 1970s, the SHP and combined work from other laboratories around the wodd had arrived at an understanding of how to design and produce reduced-risk cigarettes." TECHNICAL CHALLENGE The key recommendation, that LHCs should deliver su~cient nicotine and less tar and ~aseous components, had already been made in 1980. But at that time, said Dr God, "US national policy was set on the ~ of a smoke-free Amedca by 2000, and was dear- ly opposed to the idea of LHCs', "Today. [~e] ~ report rnal~ a d~- ence ~ it was l:~epared by a committee The cc~e ~ for LHCs ~sto mair~,~ a level of nicotine sufficient to meet smoker satisfaction, while redudng undesirable com- ponents --to arrive at T/N ratios deddedly lower than those prevailing now. In the US today, Dr God pointed out, T/N ratios had already been reduced to a sales-weighted average of about 12, so that T/N ratios in the region of five to seven would be a realistic goal. ~idely acceptable cigarettes with T/N ratios between 5 and 7 should become tech- nically feasible in a few years," said Dr God. But there would be technical obstacles to overcome, not least in coping with "tastes that could depart radically from traditional ones". Since traditional cigarettes would continue to be marketed alongside LHCs, smokers would have the choice of accepting or rejecting these flavour changes. In the words of the IOM report, nicotine remains "crucial to the success of a tobacco product". And Dr God observed that the dose of the smoke inhaled was inversely pro- portional to the concentration of nicotine in the smoke; so the greater the nicotine con- centration, the greater was the reduction in the smoke inhaled and the greater was the reduction in the expected risk. However, the traditional flavour bouquet would weaken as the other smoke components declined, and harshness would increase as the buffering effect of the tobacco smoke constituents also declined. There are two possible approaches to the provision of an inhalable vehicle for the nico- tine. The first is to build a safe artificial smoke system with aerosols of small enough particle size for inhalation and with buffering proper- Nicotine remains "crucial to the success of a tobacco product". ties produced by safe ingredients. Up to now, moves along this path have achieved only modest market success. The second approach is to reduce the smoke yield and smoke composition of tradi- tional dEarettes, essentially an extension of some of the work that has been on-going in the tobacco industry for the past 25 years. While there are many ways of achieving the desired result, it is dear that, as the fraction of tobacco smoke is reduced, any successful for- rnula will have to compensate for flavour loss- within the pofCical climate of today, it is dear that voluntary regulation is unlikely to be an option. The IOH recommends legislation to "regulate tobacco-related products that pur- port to reduce one or more tobacco toxicants or to reduce the dsk of disease" to ensure that "claims are supported by adequate sdentific evidence and are not false or misleading". But to achieve this, current regulatoD' philosophy "would have to be turned on its head", said Dr God. QUANTIFYING 'REDUCED HARM' And the question arises as to how to quan- ti~ reduced harm. Well, there is the T/N ratio and the possible preferential removal of cer- tain smoke components, such as nitrosamines and polycydic aromatichyd rocarbons. Biological markers might have a role to play in measuring scientifically the nicotine delivered, and an index of relative (nicotine) dose expec- tations for different cigarette brands would be a likely requirement. Since it will be necessar~ to add non-toxic aerosol supplements (to carry the nicotine), a list of additives for this purpose will need to be generated; glycerol and propylene glycol are obvious prospects for this purpose, but no doubt there are many others. Whatever, a well-regulated future for LHCs will bring a massive benefit. "On moral grounds alone, authorities will be forced to abandon their anti-smoking intransigence," said Dr Gori. There would have to be "a pro- found shift from traditionally punitive policies towards a new era of benign tolerance". The IOM report stated, "smokers are entitled to respectful and cadng public consideration". OUTLOOK The long-term survival of the tobacco industry, said Dr God, hinged on the issue of LHCs, which provided the key to rehabilitat- ing the industry's social image. Further, LHCs should be seen as an opportunity for ulti- mately favourable legislation. Acceptance of LHCs would mean that "many premises of the WHO Framework Convention on Tobacco Control would become irrelevant and would have to change". A 5096 reduction in T/N ratios -- eminently feasible according to Dr God -- would mean an impressive risk reduction and public health 8~in, and anti-smokers "could not oppose their introduction". Eventually, the dsk of smokin~ could be reduced to thele~ OF enjoyir~ a cup of cof- fee or a ~-~ss of~ne. And then, ol cc~rse, there are ~ heath (or "r~k~cod harm')