House of Commons - Health

Select Committee on Health Second Report

II MEASURES AGAINST SMOKING

Measures to improve product safety:

124. When discussing measures to make cigarettes 'safer', it needs to be remembered that cigarettes are inherently unsafe products: as the Government's White Paper puts it - smoking kills. The Chief Medical Officer (CMO) told the Committee that "There is no such thing as a safe cigarette. It is a highly dangerous and lethal product".[220] Although this is the case, there have been since the 1970s, and there continue to be, efforts made to minimise the harm caused from smoking or, to put it another way, to slow down the rate at which smoking kills. This is what we mean in this report when we refer to "safer" cigarettes; we agree with the CMO that there is no such thing as a safe cigarette.

125. All the cigarette company representatives from whom we took evidence accepted that there was no such thing as a 'safe' cigarette,[221] with the exception of Mr Gareth Davis of Imperial Tobacco, who said "I do not think that we can say that it is safe or it is unsafe".[222] Tobacco companies should produce the least harmful product possible. We are totally unconvinced that Imperial Tobacco can be committed to producing such a product while its public stance is to refuse to accept that cigarettes are intrinsically unsafe.

126. Efforts made to produce a 'safer' cigarette over the last three decades have focused almost exclusively on reductions in tar and nicotine levels in cigarettes, first by voluntary agreements between Government and tobacco companies, and subsequently by European legislation. In 1971 the Government appointed the Standing Scientific Liaison Committee on the Scientific Aspects of Smoking and Health (known as the "Cohen Committee"). Following an influential report by the Royal College of Physicians, Smoking and Health Now,[223] the Committee recommended that the tar and nicotine yields of all important brands of cigarettes should be published twice yearly, and analyses should be undertaken by the Laboratory of the Government Chemist. They also recommended that the public should be educated about the effects of tar and nicotine and be encouraged to switch to brands with a lower tar yield. Subsequently, the Government appointed the Independent Scientific Committee on Smoking and Health (ISCSH) in 1973, (which was succeeded by the Scientific Committee on Tobacco and Health (SCOTH) in 1994). The ISCSH produced four reports between 1975 and 1988, as a result of which the industry entered into a number of voluntary agreements, which continued the policy of lowering of tar yields in cigarettes.[224]

127. Tar and nicotine yields in cigarettes have been reduced considerably in the last 30 years, with UK sales weighted average tar yields falling from 20.8mg in 1972 to 10.28 mg in 1997, and nicotine yields generally falling in a similar way from 1.33mg to 0.8mg.[225] Each of the tobacco companies stressed their contribution in achieving this reduction via the voluntary agreements: Imperial stated that it has "made enormous efforts to assist the Government in achieving its objectives of lowering tar yields in cigarettes";[226] BAT said that "a powerful scientific consensus in favour of reducing tar existed in the 1970s and 1980s, and was supported in the UK by the Government. Indeed, it became the central plank of the product modification programme.... given effect through a series of voluntary agreements.... BAT was responsive to this consensus";[227] Gallaher stated that it had had "a committed response to the smoking and health issue and lowered tar yields, long before tar reduction came within the ambit of voluntary agreements...";[228] Philip Morris told the Committee that "we believe that we have properly responded to calls to reduce "tar" and nicotine yields and would be pleased to work with Government on this issue";[229] RJR said that it had "worked closely with the Government to conclude voluntary agreements relating to....ingredients and additives...".[230] In accepting the tar reduction programme, however, the companies successfully argued that they needed to be able to introduce additives into their cigarettes in order to maintain a flavour that smokers could enjoy.[231] We look at the consequences of this action at paragraph 153 below.

128. In addition to the voluntary agreements referred to, tar yields are now governed by European legislation. EC Directive 90/239/EEC, enacted in 1992, limited tar yields to a maximum of 15mg until January 1998 and 12 mg after that date.[232] The Commission's proposed Directive[233] will limit tar yields to a maximum of 10mg from January 2004 (or three years from the date of adoption).[234]

129. Experts are divided on the impact that lowering nominal tar yields has had on health. Epidemiology suggests that cancer rates have fallen faster than can be explained by changes in smoking prevalence and overall consumption of tobacco, and that therefore it is likely that the harm caused by each cigarette has reduced. This has occurred at the same time that nominal tar yields have been reduced through voluntary agreement and regulation, and the conclusion drawn is that tar reduction is responsible for the health improvement.

130. Others argue that each smoker controls their own nicotine intake and that this is largely independent of the reduction in machine-measured tar and nicotine yields. The Health Education Authority's evidence stated that "smokers' behaviour is determined largely by their need to consume nicotine. People smoking low tar, low nicotine cigarettes engage in 'compensatory smoking'. They take more puffs, inhale more deeply and block the vent holes in the filter.... Just three or four extra puffs on a cigarette can transform a low tar cigarette into a regular strength cigarette....".[235]

131. Evidence received from ASH and the RCN stated that "the main problem with the so-called 'low-yield' cigarettes is the quality of the measurements gathered using US Federal Trade Commission (FTC) machines. Although the results of these machines have been accepted as a global standard, it has recently been recognised by the FTC itself that readings from the machine significantly under-estimate the nicotine and tar intake of a 'real' smoker". This is largely because of 'compensatory' smoking habits, which allow smokers "to get as much nicotine as their addiction required. Compensatory habits included blocking ventilation holes with lips, fingers or saliva and taking more and deeper puffs. This resulted in an almost unchanged nicotine and, by implication tar, intake. Currently the air drawn through ventilation holes in the filters of 'low-yield' brands can account for up to 70% of the total intake. This means that a testing machine not designed to recreate smoking compensation, gets only 30% of the potential nicotine and tar intake of a smoker with compensatory habits".[236] A recent study found that this figure is, if anything, likely to be an underestimate, and that smokers' nicotine intake is double that of the machine-measured yield for cigarettes with the highest nominal nicotine yield, but that nicotine intake for smokers of cigarettes with the lowest nominal yield can take in 15 times the machine-measured yield.[237]

132. Evidence suggests that some parts of the tobacco industry at least have been aware of the impact of compensation for many years. A BAT memo from 1984 states that "Consumers may have been obtaining 14-16 mg PMWNF[238] (and normal equivalent nicotine delivery) for a very long time, i.e. compensating down to 16 mg when cigarettes delivered 25 mg and compensating up if they are now smoking a 13 mg".[239]

133. Those who believe that smokers completely compensate for nominally reduced levels of nicotine and tar in cigarettes and that the machine measurement does not reflect the true exposure of smokers to tar point to other changes in cigarettes made over the relevant period, such as more favourable ratios of nicotine to tar in the smoke and the greater use of reconstituted tobacco sheet with lower specific toxicity. It is argued that those changes have led to the modern cigarette, whatever its nominal yield, being less carcinogenic than cigarettes of the 1960s and 1970s and that they are not acknowledged sufficiently in the epidemiological assessments made of the relationship between tar yield and health.

134. The Royal College of Physicians' recent report, Nicotine Addiction in Britain, stated that "there are.... reasonable grounds for concern that low tar cigarettes offer smokers an apparently healthier option while providing little if any true benefit". It also stated that "there is clear evidence that smokers misunderstand published machine-smoked yields and derive false health reassurance from them.... In so far as low yield cigarettes may discourage smokers who would otherwise have given up smoking completely from doing so, they may... be counterproductive in terms of public health".[240]

135. This view was supported by evidence presented by the Health Education Authority (HEA). In a recent survey of 3,448 adults (1,036 of them smokers), the HEA found that a third of all smokers smoked cigarettes described as 'light', 'mild' or 'ultra light'. It also found that most light smokers (over 77 per cent) switched from regular cigarettes largely because they see 'light' cigarettes as being less harmful, and that almost a third said that a main reason for switching was as a step towards quitting.[241] It recommended that the proposed EU Directive should curtail the use of the term 'light'.[242]

136. Evidence from ASH and the RCN was scathing about the tar reduction policy. It stated that "the development and branding of 'low-tar', light, mild cigarettes... offer the appearance but not the reality of reduced tar exposure. This has lent official endorsement to a confidence trick played on the consumers by the tobacco industry. The outcome has been to divert health concern about smoking into new brands offering false reassurance, rather than increasing the motivation to quit.... It has distracted from meaningful regulation that would have made a difference. While concentrating on 'tar', regulators have missed opportunities to force reductions in particular toxins, control the use of additives or subject cigarette engineering techniques to regulatory control".[243]

137. Three charges are made against the tar reduction strategy. The first - that, mainly because of compensatory smoking, it is simply ineffective in making cigarettes less harmful - is disputed amongst experts. Although the evidence about compensatory smoking is convincing, it is difficult to reconcile this with the fact that deaths from smoking have fallen faster than can otherwise be accounted for during the period in which the policy was enacted. This latter point leads us to support the further reduction in tar levels in the proposed EU Directive and the further provisions made in the Directive to review the effectiveness of the tar reduction programme based on the best evidence available. We further recommend that the Tobacco Regulatory Authority which we want to see established should, as a high priority, examine the factors responsible for the reductions in death rates from smoking, with a view to establishing a firmer basis for regulating cigarettes in the future.

138. The two further charges are that actual or implied claims about beneficial health effects of low-tar cigarettes have lessened the incentive of people to give up smoking entirely; and that it has distracted from the other, potentially much more effective, regulatory options available. We take these two charges very seriously. In order to tackle the first, we recommend that the terms 'light', 'mild' 'ultra', 'low tar' and 'low nicotine' be proscribed by law in cigarette branding and marketing (by EU Directive, or by primary legislation in the United Kingdom). To tackle the second charge we recommend that the Tobacco Regulatory Authority which we propose at paragraph 189 be able to examine, propose and enforce innovative and effective alternative regulatory regimes. It is clear that a regulatory approach based on reducing nominal tar yields alone is inadequate.

'Safer' cigarettes

139. As well as the tar reduction programme, other product modifications have been made to cigarettes in an attempt to make them 'safer' and some companies continue to try to produce and market such products. For example, Philip Morris told us about its Accord product which heats rather than burns tobacco, using a hand-held lighter.[244] They said that the product was "notable because it has significantly lower amounts of various constituents found in tobacco smoke. For example, in comparison with a standard reference cigarette, Accord provides significant reductions in carbon monoxide, aromatic amines, benzene and polyaromatic hydrocarbons".[245]

140. Unfortunately, the commercial precedents for such innovative cigarettes are not promising. For example, R J Reynolds launched Premier in the US, as a "new technology" cigarette, which heated rather than burned tobacco. However, their evidence stated that "consumers did not respond favourably to the product in trials in the US and Premier was consequently not put onto the UK market." Two other similarly innovative products failed market research tests. R J Reynolds stated that "a major contributory factor to the failure of the products described.... was [RJR's] inability to communicate the products' potential benefits to consumers".[246]

141. Gallaher told the Committee that "in July 1977, [it] launched four cigarette brands containing a substitute material named Cytrel. None of these brands....were commercially successful". It suggested that the reasons for this failure were:

247

142. Imperial's evidence stated that in the 1960s it started developing an unflavoured, nicotine-free smoking material known as NSM. In 1977 it launched six brands of cigarettes containing 25% NSM and 75% natural tobacco. However, it said that there was a lack of consumer demand and that the brands' failure could be attributed to: the Government's refusal to reduce levies on NSM products in relation to conventional cigarettes; adverse effects as a result of Government sponsored campaigns; and the fact that "cigarette smokers preferred conventional cigarettes".[248]

143. The reasons given by the tobacco companies for the failure of such "safer" products were in contrast to those suggested by ASH and the RCN. Their evidence stated that "the annual smoking death toll could be significantly reduced if cigarette manufacturers used their vast and detailed knowledge of the design and processes involved in the manufacture of their product to reduce its toxicity and carcinogenicity".[249] As evidence for this they referred to 57 patents taken out by tobacco companies which, they argued, could reduce the hazardous chemicals in cigarette smoke. They gave four reasons why they believed companies had not produced 'safer' products: legal (such a move would be an admission that other products were unsafe); marketing (a safe product might make the unsafe equivalent unappealing); economic (the costs of producing and marketing a new product); and regulatory (by showing that certain chemicals could be controlled, the companies might be inviting regulatory 'intrusion' which could force change).[250]

144. The contrasting reasons put forward for the failure - so far - of 'safer' cigarettes raises the issue of whether companies should be able to work in a 'looser' regulatory environment for such goods, for example, in terms of the claims used when marketing them. The RCP's report recognised the complexities of the situation: "Were these products to be marketed with promises, direct or implied, of substantially reduced risk to health, sales might be expected to rise substantially..... However, these novel nicotine delivery devices raise a number of regulatory concerns. One important question is whether the products have less toxicity than conventional products..... More difficult to answer, though, is the nature and extent of any long-term problems. Chronic toxicity may not be revealed in short-term tests, and products such as these could conceivably - as with 'light' cigarettes - make the problem worse".[251] The Secretary of State also recognised the problem of needing a long-term assessment of the impact of particular types of cigarettes.[252]

145. The RCP also stated that consideration would have to be given to the regulation of 'safer' cigarettes alongside that of medicinal forms of nicotine because of the interrelated issues. The report concluded that one approach "might be to grant preliminary approval for marketing of products such as these, based on a range of information and assurances from the manufacturers. Post-marketing studies by the manufacturer would be required so that adverse effects on public health could be detected and promptly corrected".[253]

146. Given that, because of their addiction, people will demand cigarettes for the foreseeable future, it is clearly preferable that they smoke 'safer' cigarettes. We therefore hope that such products will be developed. We note the argument put forward by some of the companies that the successful marketing of such products is stymied by the regulatory framework. We recommend that the new Tobacco Regulatory Authority which we want to see established should have powers to review and approve applications from companies to market such products in a way which conveys their potential benefits compared to normal cigarettes, as long as full information about the product is provided and assessed by an independent panel of experts (appointed by the Authority), a process which should be funded - via a charge by the Authority - by the company applying. There should then be regular and rigorous reviews of the product and its effects to ensure that it deserves to retain its preferential marketing status. We would expect that status to be very narrowly defined and its promulgation strictly enforced by the Authority.

Additives

147. Gallaher defined additives as "those substances other than water, which are added to tobacco products in the course of manufacture and which are intended to be burnt when products are smoked".[254] Until 1970 the use of additives was subject to long-standing restrictions imposed for "revenue reasons".[255] The Finance Act 1970 provided for tobacco duty to be charged on additives; however, it was not until 1978 that restrictions were finally lifted and statutory control of additives ceased.[256] The ISCSH was given the task of drawing up guidelines for the testing and marketing of additives which it produced in its First Report issued in 1975.[257] The then DHSS began maintaining an approved list of additives (the "permitted list") which specified the maximum usage for all additives.

148. The permitted list currently allows over 600 additives. Gallaher describes these additives as being "strictly regulated" but that is not an interpretation we believe the evidence can sustain.[258] More accurate, in our view, was the assessment of the Faculty of Public Health Medicine who described the regulatory frameworks as "wholly unsatisfactory".[259] They argued that although the additives were generally screened for their toxicity "by ingestion" no separate testing was carried out "under conditions of burning and inhalation". They went on to suggest that the sole function of some additives appeared to be to enhance the nicotine "hit".[260]

149. The DoH described other problems with the current regulatory framework. First, the UK is obliged to permit the use of any additive approved for use elsewhere in the EU "provided they have been assessed by a recognised scientific body". But EU countries vary widely in their protocols for determining which additives are permissible.[261] Second, there is "no compulsion" for the companies to reveal the purpose of the additive; this is merely "desirable".[262] The Department also cited a recent article in the journal Tobacco Control in which it is suggested that, before an additive is licensed for use, it should "meet a test of public health or public interest" and there should be an evaluation of the "overall public health impact of the use of an additive".[263]

150. In oral evidence the Department drew our attention to proposals in the draft EC Directive to ensure that by the end of 2003 all manufacturers and importers of tobacco products would have to notify member states of the quantities of each additive included together with a statement indicating the reason for inclusion of each ingredient and data on the impact of these additives in burnt and unburnt form to show they were safe.[264]

151. The Department also cited a document jointly produced by ASH and the Imperial Cancer Research Fund which claimed that the internal documents of the US tobacco companies indicated that their research had enabled them to use additives "to perfect the engineering of the cigarette" as a "very efficient drug (nicotine) delivery system".[265] The Chief Medical Officer expanded on some of the potential health problems additives might cause. He argued that additives might be hazardous to health "in their own right", might affect the smoke chemistry which would be particularly a matter of concern in respect of carbon monoxide and cadmium, might create free-based nicotine making the cigarette more addictive, and might, by increasing palatability make the cigarette more "desirable". He went on to suggest that sweeteners and chocolate, which were reportedly sometimes added, could make cigarettes "more palatable to children", cocoa might dilate the airways allowing larger amounts of tar to enter the lungs, additives might mask the smell of smoke to make it "more socially acceptable" and finally additives such as ammonia might predispose people to other illnesses.[266]

152. Mr Wilson of Gallaher pointed out to us that in the Virginia-tobacco based UK cigarette "hardly any additives are used", a point expanded upon in written evidence, where Gallaher pointed out it used only six additives in most of the cigarette brands it manufactures for sale in the UK.[267] Both BAT and Philip Morris strongly disputed claims that individual additives had the function of increasing the nicotine hit or encouraging underage smoking. For example, Philip Morris refuted the suggestion made by ASH that ammonia was used to increase the effect of nicotine. They added that they did not design cigarettes to increase the acetaldehyde levels in smoke and that no credible data existed to suggest that acetaldehyde in smoke was addictive or increased the effect of nicotine.[268] BAT offered a detailed rebuttal of ASH's allegations over the effect of particular additives. They dismissed out of hand claims made by ASH as to the purpose of additives, such as the suggestion that cocoa, containing theobromine, might have a bronchodilatory effect, or that ammonia boosted the nicotine delivery to smokers. They described the ASH evidence in this respect as "inflammatory and misleading".[269] At our meeting with BAT scientists in Southampton further detailed answers were given to counter the ASH allegations. BAT also assured us that it had engaged in discussions and presentations to the Department of Health and told us it would like its dialogue to continue so that it could meet the "Tobacco Policy Unit soon to find a sensible way forward".[270]

153. We strongly support the view of BAT that "objective scientific appraisal" should be the basis for regulation of additives but we do not believe that this currently applies. We believe that regulation of additives should take into account the overall public health impact of additives. For example, Dr Dawn Milner, the Senior Medical Officer in the Tobacco Research Unit of the DoH, told us that in the 1970s the Government had had to agree to requests from the tobacco companies to include more additives to make low tar cigarettes more palatable to consumers. But the inclusion of such additives - given the current debate over the actual health impact of 'lower' tar - should now, in our view, be subject to review. We are not the appropriate body to judge whether ASH or BAT is right in respect of their claims and counter-claims over the role of additives. Given the pitiful resources it dedicates to scientific research on tobacco control (see paragraph 198 below) we cannot believe that the DoH itself is well placed to make a judgement. In fact we believe that the idea of teams of BAT scientists offering presentations to poorly-resourced civil servants potentially represents a continuation of the highly unsatisfactory situation of the past 25 years, amounting almost to regulatory capture, in which the industry has been able to run rings round poorly-resourced civil servants.

154. We welcome the fact that the proposed EU directive requires manufacturers to submit evidence on the purpose of additives and their impact in both burnt and unburnt form, but we do not think that these measures go far enough. The Secretary of State told us that he thought there had to be "an independent scientific committee" at European level to assess the issues arising out of additives.[271] We believe responsibility for licensing additives permitted for use in tobacco products sold in the UK should be passed to the Tobacco Regulatory Authority we propose below. We further believe that this body should take account of the overall public health impact of the inclusion of an additive in determining whether or not it should be permitted for use in tobacco products. So if an additive is toxicologically harmless in itself, but in some way exacerbates the addictiveness of nicotine or makes cigarettes more palatable for children, we believe it should be banned.

155. The current regulation of additives is weak in another respect: neither the Department of Health nor the consumer has any idea which additives can be found in which products. After almost a year's delay the companies have, recently, submitted to the DoH a list of additives used in their brands. In the Secretary of State's view the limited information recently given was prompted by our current inquiry.[272] However, the brands in most cases were anonymised and given on a coded basis.[273] The Secretary of State told us that in his view the companies should be obliged to pass on information on the additives by brand to his Department, to us and to the consumer.

156. We felt it was completely unacceptable that information on additives by brand has been withheld for so long. So we required the companies to submit this information to us. The five companies from whom we requested oral evidence all duly submitted this material, though all considered it "commercially confidential". Imperial, however, told us it intended to make this material public shortly on its website.[274] We are not at all convinced by the argument for commercial confidentiality. As our Irish counterpart Committee pointed out, it would be perfectly possible for rival companies to establish what ingredients are included in cigarettes by a process of reverse engineering.[275] Even if this were not the case we believe that this is another area in which normal commercial rules should not apply.

157. Accordingly we have chosen to publish in full, brand by brand, the list of additives formerly submitted in anonymised form to the Department of Health. For the first time the UK consumer will be able to learn what exactly he or she is smoking. For example, someone smoking Lucky Strike King Size Filter Tip might be surprised to discover that, apart from tobacco, the product contained such things as sucrose and sucrose syrup, honey, licorice root, carob bean extract and diammonium hydrogen phosphate. Benson and Hedges Mellow Blend King Size has amongst its ingredients, sorbitol, caramel, dried fruit extracts, ethylene vinyl acetate copolymer and benzoic acid. Camel Lights offer such additives as glycerol, honey, maple syrup extract and concentrate and magnesium oxide. Marlboro King Size (Fliptop Box), amongst 20 or so ingredients, provides cocoa, cocoa shells and extract, cocoa distillate and butter, 4-Hydroxy benzoic acid propylene glycol and diammonium hydrogen phosphate.[276]

158. We think that the position of the tobacco companies in withholding information on the additives their cigarettes contain is completely untenable. Consumers have a right to know what they are smoking, including the percentage of the product such additives form, and we believe that this information should be available on every packet. We believe the companies should immediately take steps to ensure this is done and that the Secretary of State should introduce measures to make such labelling a mandatory requirement for cigarettes sold or manufactured in the UK.

220 Q68. Back

221 QQ393-400. Back

222 Q397. Back

223 Smoking and Health Now, 1971. Back

224 Ev., pp.6-8. Back

225 Ev., p.212. Back

226 Ev., p.214. Back

227 Ev., pp.142-43. Back

228 Ev., p.180. Back

229 Ev., p.230. Back

230 Ev., p.236. Back

231 Ev., p.66. Back