House of Commons - Health - Minutes of Evidence

Select Committee on Health Minutes of Evidence

Memorandum by the Department of Health

TOBACCO INDUSTRY AND THE HEALTH RISKS OF SMOKING (TB1)

EXECUTIVE SUMMARY

This memorandum describes how knowledge of the adverse health effects of smoking has developed. It is now clear that active smoking kills one in two of long-term, regular smokers. Passive smoking also increases the risk of serious disease for non-smokers exposed to it. The memorandum then outlines successive governments' response to the public health threat of tobacco in terms of regulation, voluntary and otherwise, and describes the drive to create lower tar cigarettes. The memorandum discusses current debates over the regulation of tobacco products. Finally, it sets out the Government's views on the way forward.

TOBACCO IN HISTORY

1. Smoking of tobacco was known to have taken place in Central America in the first century AD and was observed in the 15th century in the new world. In 1558 Sir Walter Raleigh introduced smoking to the court of Queen Elizabeth I who imposed a duty of 2 pence per pound on the imported leaf. In 1604 King James I wrote in "a Counterblaste to Tobacco" that smoking tobacco was "a custome loathsome to the eye, hateful to the nose, harmful to the brain, dangerous to the lungs and in the black and stinking fume thereof, nearest resembling the horrible Stigian smoke of the pit that is bottomless". By 1672 a pound of tobacco was consumed per head of population. In the 18th century snuff taking became popular and smoking tobacco declined. In the 19th century pipe smoking replaced snuff taking and accounted for 60 per cent of tobacco consumption by the mid 19th century.

2. In 1856 the first British cigarette factory opened and in 1884 mechanisation in America enabled mass production of cigarettes. 1908 saw the Children Act which made it illegal to sell cigarettes to children under 16 years. During the first world war tobacco was supplied to the troops and by the end of that war ready-made cigarettes accounted for 50 per cent of British tobacco sales. Emancipated women took to smoking and their consumption doubled between 1930 and 1939 from 5 to 10 per cent. By the end of the second world war 65 per cent of adult men and 41 per cent of women smoked cigarettes.

3. 1950 was the year when Sir Richard Doll and Professor Austin Bradford Hill published a study in the British Medical Journal linking cigarette smoking to lung cancer.1 In 1957 filter tip brands were introduced and in the 1960s lower tar and lower nicotine cigarette brands were introduced after the major reports on smoking and health by the Royal College of Physicians (RCP) and the US Surgeon General.

4. In 1965 cigarette advertising was banned from television particularly to protect children. In 1971 the first health warning was put on the side of the cigarette packets in the UK under a Voluntary Agreement between government and the industry. In 1972, following the second report of the RCP, routine measurement of tar and nicotine yields of cigarette brands was started and the Department of Health and Social Security (DHSS) published tables ranking brands by tar yields in 1973. In 1975 tar ratings (low, middle, high) were displayed on packets and in printed advertisements. By 1984 smoking levels had dropped to 36 per cent of men and 32 per cent of women and in 1986 London Transport banned smoking throughout the underground system.

5. The Committee for Monitoring Agreements on Tobacco Advertising and Sponsorship (COMATAS) was set up in 1986 comprising government and tobacco industry members. This Committee is still in existence, although it will eventually be disbanded, on the assumption that draft legislation to ban advertising and sponsorship is implemented successfully.

THE HEALTH EFFECTS OF ACTIVE SMOKING—SCIENTIFIC MILESTONES

6. Epidemiological evidence has contributed to our knowledge of the relationship between active smoking and a variety of human cancers. For example cancers clearly related to smoking such as cancers of the lung, upper respiratory and digestive tracts, lower urinary tract and pancreas occur at lower rates of incidence (and mortality) in religious groups that proscribe smoking such as the Seventh Day Adventists and the Mormons. Case control and cohort epidemiological studies first published in the early fifties agreed that there was an increased risk of several types of cancers amongst tobacco users, the predominant cancer being lung cancer. Two important papers published in 1950, one in the UK (Doll and Hill)1 and one in the USA (Wynder and Graham)2 first drew attention to the risk of lung cancer from case control studies. Cohort studies produced information on relative risks comparing never smokers, occasional smokers and smokers of cigarettes, cigars, pipes etc. Large cohort studies were begun in the 1950s and the following is a list of major studies of relevance on the relationship between smoking and cancer.

7. 1951 British Doctors Study. This was commenced by Richard Doll and Bradford Hill and a paper reviewing 40 years follow-up has now been published.3 A questionnaire on smoking habits was sent to all British doctors included in the medical register and survivors have been contacted at regular intervals since 1957. The 40 year study, reported by Doll and Peto in 19943 showed that 80 per cent of non smokers survived to age 70 and 33 per cent to age 85 whereas only 50 per cent of heavy smokers survived to age 70 and 8 per cent to age 85. The authors pointed out that the results from the first 20 years of the study, and other studies at that time, substantially underestimated the hazards of long term use of tobacco: "It now seems that about half of all regular cigarette smokers will eventually be killed by their habit."

8. The American Cancer Society Nine State Study4 began in 1952 and nearly 200,000 men were followed up for an average duration of 44 months. The Canadian Veterans Study5 1955 enrolled 78,000 men and 14,000 women and followed up the subjects over six years. The US Veterans Study6 began in 1954 and followed up nearly 3,000 men for 16 years. The American Cancer Society Twenty Five State Study7, commenced in 1959 to 1960 and followed up over a million subjects for five years. It showed that smokers of cigarettes had a death rate of 9.2 times the rate for those who had never smoked. These huge studies and others not listed, confirmed the link between smoking and lung cancer.

9. The Royal College of Physicians Report "Smoking and Health"8 was published in 1962 in order to alert doctors and others to the hazards of smoking. The report concluded that cigarette smoking is a cause of lung cancer and bronchitis and probably contributes to the development of coronary heart disease and various other less common diseases. It delays healing of gastric and duodenal ulcers.

10. In January 1964 the First Surgeon General's Report9 on smoking and health was published. This established that cigarette smoking is causally related to lung cancer in men; that cigarette smoking is directly related to illness and death from heart disease and other ailments; and that cigarette smoking is the leading contributory cause of death from chronic bronchitis and other lung disorders. The US Public Health Service published The Health Consequences of Smoking: A Public Health Service Review in 1967. A supplement was published in 1968 and in 1969. Further Surgeon General's reports on the Health Consequences of Smoking were published by the US Department of Health, Education and Welfare in 1971, 1972, 1973, 1974, 1975, 1977-1978 and 1979a. Another publication in the series was "The Changing Cigarette", published in 1981.

11. The US Department of Health and Human Services (DHHS) continued the series of reports of the Surgeon General on the Health effects of Smoking as follows: 1982, Cancer; 1983, Cardiovascular disease; 1984 Chronic Obstructive Lung Disease; Cancer and Chronic Lung Disease in the workplace, 1985. Further Surgeon General's reports considered The Health Consequences of Involuntary Smoking, 1986a; The Health Consequences of Using Smokeless Tobacco, 1986b; The Health Consequences of Smoking: Nicotine Addiction, 1988.

12. The second report of the Royal College of Physicians10 was entitled "Smoking and Health Now" and was published in 1971. A further report from the RCP entitled "Smoking or Health".11 was published in 1977 and a follow up report "Health or Smoking?" was published in 1983.12 In 1992 a new report "Smoking and the Young" from a Royal College of Physicians Working Party, was published.13

13. In 1986 the health risks of tobacco use were summarised by the International Agency for Research on Cancer.14,15

14. The link between smoking and coronary heart disease was discussed in the first Royal College of Physicians report "Smoking and Health".8 Whereas tobacco is the cause of a third of all cancer deaths it causes (numerically) even more deaths from coronary heart disease because coronary heart disease is the leading cause of death in most developed countries. The American Cancer Society Study 4 of both men and women showed that 22 per cent of ischaemic heart disease in men and 19 per cent in women was attributed to smoking. A United Kingdom Study16 of over 10,000 survivors from heart attacks showed that smokers in their thirties and forties have five times as many heart attacks as non-smokers.

15. The effect of smoking on lung function was reported in the US, DHHS Surgeon General report 1984. A report of the Surgeon General in 1989 was entitled "Reducing the Health Consequences of Smoking" "25 Years of Progress".17 This report compared the biomedical knowledge concerning tobacco and health that had accumulated since the first 1964 Surgeon General's report. It was stated that in the interim there had been 20 reports of the Surgeon General on tobacco and health substantiating and strengthening the original conclusions of the 1964 report.

16. In summary, evidence of the harmful effects of active smoking is, in the Department of Health's view, incontrovertible. Convincing evidence that smoking is extremely harmful emerged in the 1950s and has been widely available since the 1960s. Smoking is the single greatest cause of preventable illness and premature death in the UK and kills over 120,000 people in the UK a year.18 Smoking causes a third of all cancer deaths in the UK, amounting to 46,500 deaths a year. In the UK in 1995, 84 per cent of all (male and female) lung cancer deaths and 83 per cent of all deaths from chronic obstructive airways disease deaths were caused by smoking. One out of five male and one out of 10 female deaths from circulatory heart disease were caused by smoking. In 1995 this was estimated to be a total of 40,300 circulatory disease deaths. Cigarette smoking caused a third of all circulatory deaths under age 65.18

THE HEALTH EFFECTS OF PASSIVE SMOKING—SCIENTIFIC MILESTONES

17. In the UK the third report of the Independent Scientific Committee on Smoking and Health (ISCSH)19 discussed passive smoking and noted the publication of several reports investigating incidence of lung cancer in the non-smoking wives of smokers. It was noted that children exposed to tobacco smoke from their parents in the home had an increased incidence of respiratory illness, and that passive smoking exacerbated symptoms in adults already suffering from coronary and other arterial diseases and from chronic obstructive lung disease.

18. The fourth report of the ISCSH20 drew attention to the health effects of passive or involuntary smoking and the 1990s saw a number of important publications which confirmed the link between passive smoking and lung cancer, ischaemic heart disease and exacerbation of asthma, bronchitis and emphysema. The fourth report, known as the Froggatt Report after the Chairman Sir Peter Froggatt, recommended that further publicity should be given to the risk of lung cancer arising from exposure to other people's tobacco smoke; that continued attention should be given to the investigation of the role of the environmental tobacco smoke (ETS) in the occurrence of respiratory illness in children and to the longer term sequelae; that the tobacco industry should pursue research into ways of reducing the amount, irritancy and other deleterious properties of sidestream smoke from all tobacco products; and other consideration should be given to ways of ensuring that in work and leisure environments, in public transport and in other public enclosed spaces smokers could be segregated from non-smokers. The fourth report of the ISCSH concluded that there was an increase in the risk of lung cancer from exposure to ETS in the range of 10-30 per cent.

19. In 1992 the United States Environmental Protection Agency published a report entitled "Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders".21 This report confirmed the findings of the ISCSH fourth report on ETS and lung cancer and also identified links beween passive smoking and childhood diseases. Other important publications included: the National Research Council "Environmental Tobacco Smoke: Measuring Exposures and Assessing Health Effects 1986"22; the US DHHS "The Health Consequences of Involuntary Smoking": A report of the Surgeon General 1986;23 "Effects of Passive Smoking on Health" Report of the NHMRC (National Health and Medical Research Council) Working Party, Australia;24 Report of the California Environmental Protection Agency 1997;25 and "The Health Effects of Passive Smoking: A Scientific Information Paper". Australia National Health and Medical Research Council 1997.26

20. The Scientific Committee on Tobacco and Health (SCOTH) in their first report published March 199827 considered commissioned meta-analyses on ETS and lung cancer28, ETS and ischaemic heart disease29 and ETS and childhood diseases.30 The committee concluded that "exposure to environmental tobacco smoke is a cause of lung cancer, and in those with long term exposure, the increased risk is in the order of 20-30 per cent. Exposure to ETS is a cause of ischaemic heart diseases and if currently published estimates of magnitude of relative risk are validated, such exposure represents a substantial public health hazard. Smoking in the presence of infants and children is a cause of serious respiratory illness and asthmatic attacks. Sudden infant death syndrome, the main cause of post neonatal death in the first year of life, is associated with exposure to ETS. The association is judged to be one of cause and effect. Middle ear disease in children is linked with parental smoking and this association is likely to be causal." The committee recommended that "smoking in public places should be restricted on the grounds of public health. There is a need for public education about the risks of smoking in the home particularly in relation to respiratory diseases in children and that health education programmes should focus on the dangers of ETS in fetal development and post-natally in the sudden infant death syndrome".

21. The above report of SCOTH is currently subject to judicial review proceedings brought by UK tobacco companies. Leave to proceed to judicial review was granted on a very limited basis: namely that two passages in the report called into question the commercial morality of the tobacco companies, and it was arguable that their view of those passages should have been sought before the report was published. Therefore, the judicial review proceedings have no bearings on the scientific statements made in the report. The substantive hearing of the proceedings is scheduled to take place in November.

22. The World Health Organisation, under the auspices of its Tobacco Free Initiative, held an expert international consultation on ETS and child health and produced a report in 1999.31 The report noted that 700 million children, almost half of all children world-wide, live in the home of a smoker and that the large number of exposed children, coupled with the evidence that ETS causes illness in children, constitutes a substantial public health threat. Children whose mothers smoke have an estimated 70 per cent more respiratory problems, including croup, bronchitis and pneumonia as well as middle ear infections. The prevalence is 30 per cent higher if the father smokes. Infants of mothers who smoke have almost five times the risk of sudden infant death syndrome. There are also other well documented effects including reduced birthweight and reduced lung functioning.

23. Passive smoking incurs an increased risk of stroke. A population-based case control study in New Zealand found a significantly increased risk of acute stroke in men and women exposed to ETS compared to those who were not so exposed.32

RESPONSE OF GOVERNMENT TO PROTECT CONSUMERS LEGISLATION

24. During the twentieth century successive UK governments have acted to protect consumers, particularly children, against the effects of tobacco, through legislation and voluntary agreements.

(i) Action to Protect Children

25. There has been legislation in place for many years to outlaw sales of cigarettes to children. For example:

1908 The Children Act.

The Children and Young Persons Act 1933

The Protection of Children (Tobacco) Act 1986

Children and Young Persons Act 1933

Children and Young Persons (Scotland) Act 1937,

The Children and Young Persons (Protection from Tobacco) Act 1991

Children and Young Persons Act 1933.

26. The Government would agree with the view that in the past this legislation has not always been properly enforced. In "Smoking Kills" the Government set out its plans to work with local authorities to develop an enforcement protocol on enforcing the law on underage sales, and its intention to investigate the possibility of a new offence of repeated sales of tobacco to children.

27. It should be noted that in a number of EU countries, including Germany, Greece and Belgium there is no legal minimum age for the purchase of cigarettes.

(ii) Action to Protect Adults

28. Successive governments have operated voluntary agreements with the tobacco industry on issues such as labelling of tobacco products. This Memorandum discusses the development of these voluntary agreements in more detail below, in the context of scientific advice to the Department over many years.

29. As far as statute is concerned, a number of these voluntary agreements have subsequently been given legal force through action at the EU-level. Although the Consumer Protection Act 1987 excluded tobacco products from the definition of a "consumer good", under section 11 of that Act the Government has the power to make safety regulations with respect to tobacco products. The following list contains examples of secondary legislation introduced in recent years in this area:

The Oral Snuff (Safety) Regulations 1989

The Tobacco Products Labelling (Safety) Regulations 1991

89/622/EEC

92/41/EEC

The Cigarettes (Maximum Tar Yield) (Safety) Regulations 1992

The Protection from Tobacco (Display of Warning Statements) Regulations 1992

The Tobacco for Oral Use (Safety) Regulations 1992

The Tobacco Products Labelling (Safety) Amendment Regulations 1993

(iii) Action to Restrict Tobacco Advertising

30. Tobacco advertising has been subject to restrictions for many years. In 1965 the Government banned cigarette advertising on television under powers given to it by the Television Act 1964. This was extended to television advertising of any tobacco products under the Broadcasting Act 1990, which implemented Directive 89/552/EEC.

31. In 1986 the then government and the industry set up a Committee for Monitoring Agreements on Tobacco Advertising and Sponsorship (COMATAS). (See paragraph 5 above.) This was a watchdog committee set up to oversee the working of the Voluntary Agreements between the government and the UK tobacco industry. In May 1991 the European Commission adopted and forwarded to the Council an amended proposal for a Council Directive on Advertising for tobacco products. The United Kingdom with other member states, was part of a blocking minority which prevented the passage of this Council Directive.

32. The government commissioned the chief economist at the Department of Health to produce a paper on the effect of tobacco advertising on tobacco consumption, including the effect of advertising bans.33 This was published in 1992. The paper looked at bans in Norway, Finland, Canada and New Zealand and concluded that "the current evidence available on these four countries indicates a significant effect. In each case the banning of advertising was followed by a fall in smoking which cannot be attributed to other factors."

33. Following the change of administration in 1997 the UK Government reversed its previous opposition to action at an EU level to ban tobacco advertising. 98/43/EC, the Directive banning tobacco advertising and sponsorship was finally adopted in July 1998. Draft regulations implementing this Directive in the UK have been consulted upon and the Government's intention is to implement most aspects of the ban as soon as is practicable.

(iv) Action in the Workplace

34. The Health and Safety at Work etc Act 1974 requires employers to ensure, so far as is reasonably practicable, the health, safety and welfare of their employees. In 1988, the Health and Safety Executive published guidance for employers ("Passive smoking at work", IND(G)63L, last revised in 1992), explaining what they should do to comply with health, safety and welfare law as it applies to passive smoking.

35. On 29 July this year the Health and Safety Commission published a consultation document seeking views on further action to control passive smoking at work.34 Among the options proposed was an Approved Code of Practice under the 1974 Act. If introduced, an Approved Code would clarify what steps employers should be taking to protect their employees from the unpleasant effects of tobacco smoke, and to protect the health of those employees who suffer from a medical condition that could be made worse by exposure to tobacco smoke, such as asthma.

(v) Other Action

36. It is generally recognised on all sides that the single most effective policy for reducing tobacco consumption is price. Successive governments have therefore regularly raised excise duty on tobacco products as a means of discouraging consumption. The current Government has committed itself to raising tobacco duty by 5 per cent per annum in real terms.

37. Successive governments have also invested in education campaigns warning consumers of the dangers of tobacco products. The current Government is committed to a three year campaign costing almost £50m aimed at persuading smokers to quit and non-smokers, particularly children, not to start.

SCIENTIFIC ADVICE TO GOVERNMENT, VOLUNTARY AGREEMENTS AND THE LOW TAR POLICY

38. For many years successive governments have taken the advice of expert scientific committees set up to advise Ministers on the health aspects of smoking. The last 30 years have seen a policy of lowering tar levels in cigarettes through voluntary agreements with the industry (subsequently reinforced by European-level legislation). This section discusses how this policy was developed and modified in the light of the advice of successive independent scientific committees.

39. In 1971 the Royal College of Physicians' report Smoking and Health Now10 recommended that the tar and nicotine contents of the smoke of all brands should be published and packets of cigarettes labelled with this information. In response the government formed a Standing Liaison Committee (on the scientific aspects of Smoking and Health) of industry and government officials to consider the publication of tar and nicotine yields on packeted cigarettes. The advice of the committee was: "Stop smoking. If you cannot then smoke a lower tar cigarette, take fewer puffs, do not inhale, leave a longer stub and take the cigarette out of your mouth between puffs." The commitee recommended that the tar and nicotine yields of all important brands sold in the UK should be published twice a year and that analyses should be carried out by the Laboratory of the Government Chemist. In fact the decision to recommend lower tar cigarettes was made in 1972 in anticipation of the Committee's report and tables of the tar and nicotine yields by brands were first published by the Health Departments in April 1973. Subsequently the government appointed the Independent Scientific Committee on Smoking and Health (ISCSH) in 1973 to advise on the scientific aspects of matters concerning smoking and health (see Annex A). The first report of ISCSH was published in 1975.35 This report dealt with the testing and marketing requirements of tobacco substitutes and tobacco additives.

40. The tobacco industry has long argued that they could not produce lower tar cigarettes without the use of various additives to ensure that the product was palatable to smokers. The Finance Act 1970 and the resultant Tobacco Substitutes Regulations 1970 provided for tobacco duty to be charged on additives and substitutes used in the manufacture of smoking products. This opened the way for the Commissioners of Customs and Excise to relax long standing restrictions that had been applied for revenue reasons on the ingredients that could be used in tobacco manufacture. These restrictions however remained in force until January 1978 when statutory control over the materials used in the manufacture of tobacco products ceased.

41. A Voluntary Agreement between tobacco manufacturers and importers and health ministers was concluded in 1977. The industry agreed not to introduce new products containing additives other than those found acceptable to ISCSH and to notify the use of such products to the then DHSS. The understanding was that the government would amend the Medicines Act 1968 in order to control the use of tobacco substitutes and additives if the need arose at any time.

42. The second report of ISCSH published in 197936 revised the earlier guidelines for the testing and use of tobacco products containing additives to include the requirement of acute inhalation toxicity studies and data on transference to smoke for any new additive. Guidelines for the testing and marketing of tobacco substitutes were published in 1975 and amended in appendix 3 to the second report. The report discussed the use of flavouring additives to encourage smokers to switch from middle or high tar cigarettes to low tar brands, whilst acknowledging that adding flavouring might increase incentives to continue smoking. It contained a list of additives which the industry could use in the manufacture of tobacco products. The manufacturer was requested to produce evidence of acceptability of new additives not on the list. The availability of the permitted list of additives would be by means of a notice in the London Gazette. The second report also looked at the development of lower risk cigarettes and noted the progress that was made by the tobacco industry in the previous 10 years to reduce tar yields. These had fallen from an average of 31.4 mg per cigarette in 1965 to 17.4 mg in 1977. The report acknowledged that dependent smokers required nicotine and discussed the pharmacological effects of nicotine on the cardiovascular, nervous, gastrointestinal and endocrine systems. The committee also recommended that the Secretaries of States obtained manufacturers' co-operation in reducing carbon monoxide yields to the lowest possible level. Levels of nicotine were also discussed and it was noted that, in 1977, the Royal College of Physicians of London called for a ceiling of1 mg per cigarette.

43. In November 1980 a new Voluntary Agreement between the government and the tobacco industry was announced. The industry agreed to continue its longstanding policy of reducing the tar yield of cigarettes and a level of under 15 mg by the end of 1983 was recommended. The committee (ISCSH) recommended that nicotine levels should continue to fall although some brands should be available with low levels of tar and proportionately higher nicotine yield. This should not exceed 1 mg. Further reductions in carbon monoxide yields were proposed.

44. The third ISCSH report19 (see also para 17) made reference to passive smoking and also discussed "compensation" which occurs when smokers change to a lower tar/nicotine product. "Compensation" refers to smokers changing their smoking behaviour, eg by inhaling more deeply or taking more frequent and longer puffs, so as to receive the same dose of nicotine from a lower tar cigarette. In addition, more nicotine (and therefore tar) can be obtained by the smoker if the vents in the filter are blocked, consciously or unconsciously, with the fingers, lips or saliva. The industry was asked for evidence on the consumption and manner of smoking related to those who switched to lower tar cigarettes. A maximum nicotine level of 1 mg was recommended. Other noxa (harmful ingredients) were to be researched including acrolein, formaldehyde, hydrogen cyanide in relation to ciliatoxicity and pulmonary clearance; polycyclic aromatic hydrocarbons (PAHs) and nitrosamines in relation to carcinogenicity; nitric oxides in relation to respiratory diseases; hydrogen cyanide and carbon monoxide for effects on haemoglobin levels; and acetaldehyde for its effects on the heart. Other noxa mentioned were silica, cadmium, nickel, ammonia and polonium-210. The third report included discussions of machine yields and human uptake of smoke components, the compensation mechanisms and their importance . . . There was clear evidence that actual intakes of tar during smoking were not necessarily the same as machine measured yields. Whilst recommending that smokers should be encouraged to stop smoking, a policy of further reduction in tar levels was advocated. Further reductions to achieve a sales weighted average tar (SWAT) level of 13 mg per cigarette by the end of 1987 were advised. The evaluation of additives was extended to include all parts of the product which were intended to be burnt ie papers.

45. A new Voluntary Agreement with the industry became operative from 1 January 1984 with a proposed sales weighted average tar yield of about 13 mg. The 1984 Voluntary Agreement involved changes in tar banding according to the recommendations of the third ISCSH report.

46. The fourth report of ISCSH was published in 1988.20 (See also para 18). This report reiterated previous advice that smokers should be encouraged to stop smoking and also gave recommendations for the upper limit of SWAT yield to be achieved by the end of 1988 (13 mg per cigarette) and a target of 12 mg per cigarette by the end of 1991. The report reviewed the product modification programme and noted that routine measurements of tar and nicotine yields of marketed brands was started in 1972 following the second report of the RCP. The DHSS published tables biannually ranking brands by tar yields. It was noted that the SWAT target for cigarettes which had been set in the 1980 Voluntary Agreement (15 mg by the end of 1983) had been achieved.

47. The fourth report of the ISCSH discussed the health effects related to lower tar cigarettes and concluded that smoking lower tar cigarettes conferred a reduced risk of lung cancer compared to smoking cigarettes with the relatively high yields that were customary 25 or more years before. There was less evidence of a lower risk of chronic obstructive lung disease from smoking lower tar cigarettes. The risk of ischaemic heart disease was not much effected by the tar yield. This was thought to be because the nicotine and carbon monoxide yields had been reduced less than tar yields, and that compensatory smoking resulted in the intake of carbon monoxide and nicotine that was not much less than that associated with the higher tar cigarettes.

48. The fourth report acknowledged the tobacco industry's contribution to research: £3 million over the three years 1981-83 was provided to ISCSH, by way of the Tobacco Products Research Trust, by the Tobacco Advisory Council under the 1980 Voluntary Agreement. Further monies (£1.5 million) were lodged into this Trust under the more restrictive 1984 Voluntary Agreement, making a total fund, with interest, of £8 million. The Trust and its sponsored research are described in the fourth report of ISCSH and in 1996 a report of the Tobacco Products Research Trust, which ran from 1982-1996, was published.37

49. The approved additives list was included in this report which also addressed the issue of environmental tobacco smoke and the growing public concern about its possible effects on health. It commented on the evidence for low birthweight and perinatal mortality associated with smoking and pregnancy. The ISCSH continued until the end of 1991. At the same time there was a Department of Health Committee for Research Into Behavioural Aspects of Smoking and Health (CRIBASH). This Committee's terms of reference complemented and did not overlap those of ISCSH and its major remit was to assess surveys of the prevalence, distribution and attitudes to smoking carried out by the Office of Population, Censuses and Surveys (OPCS) and other organisations. It was decided that both ISCSH and CRIBASH could be subsumed into a restructured committee.

50. The Scientific Committee on Tobacco and Health (SCOTH) was therefore established in 1994 under the Chairmanship of Professor David Poswillo. This Committee comprises experts from a range of medical, scientific and behavioural disciplines concerned with the health effects of smoking and the Committee provides advice to Ministers through the Chief Medical Officer. The terms of reference of this committee and its Technical Advisory Group are set out at Annex A.

51. The current Voluntary Agreement on the Approval of New Additives in Tobacco Products in the UK was agreed with the industry in March 1997. This replaced the 1984 agreement and set out the arrangements for obtaining approval for new additives and usage limits. A copy of the Voluntary Agreement (VA) can be found in the Report of the Scientific Committee on Tobacco and Health27. Additives approved in EU Member States are also approved provided they have been assessed by a recognised scientific body. The Voluntary Agreement makes no mention of recommended tar levels since this is dealt with by European legislation and UK regulations.

52. The list of approved additives is regularly reviewed with the aim of protecting the public health and achieving standardisation between additives used in tobacco, food and cosmetics. The number of additives available for use in tobacco products approaches 600. Manufacturers and importers are required to provide toxicological information to demonstrate the additive would not increase the hazard of the product. Additives may be used for any reasonable purpose provided they are shown to be safe. It is desirable (but not compulsory) for the manufacturer to detail the purpose of use. The Department will set a maximum safe level of use based on toxicological evidence. Chemical analytical details of the transference to smoke of the original substance is required. Biological studies such as inhalational studies are described in the VA although it is acknowledged that permission for animal testing (from the Home Office) is unlikely to be granted. Mutagenicity studies are carried out in accordance with the Committee on Mutagenicity's guidelines.

53. The provisions of the VA cover additives to cigarettes, hand-rolling tobacco, cigars and pipe tobacco. Imprinting inks and additives to filters and overwrappers are excluded from the agreement. The agreement will stand for 10 years with provision for amendment in the light of UK legislation needed to enact European Community legislation, and was notified to the European Commission. All information supplied to the Department of Health is treated in strictest confidence. The scrutiny of technical data rests with Departmental scientists assisted as necessary by SCOTH and the Technical Advisory Group.

54. Manufacturers and importers are required to produce a signed annual certificate of compliance confirming that their products comply with the provisions of the VA. The Department of Health keeps a register of UK tobacco manufacturers and importers of tobacco products marketed for consumption in the UK. Six monthly meetings take place between the TMA and the Department to review the workings of the VA.

55. Since March 1997 thirty new additives have been approved, of which 23 were already approved by member states, and twelve have been removed from the permitted list because of new evidence of toxicity or because they are no longer used by the industry.



© Parliamentary copyright 2000	Prepared 14 January 2000