Tobacco Documents Online

ASH UK - The safer cigarette Page 1 of 40 The safer cigarette: what the tobacco industry could do ...and why it hasn't done it A survey of 25 years of patents for innovations to reduce toxic and carcinogenic chemicals in tobacco smoke 3rd March 1999 ASH Action on Smoking and He/ilth 16 Fitzhardinge Street London W1H 9PL Tel: 0171 224 0743 Fax: 0171 224 0471 ..~C Imperial Cancer Research Fund 61 Lincoln's Inn Fields London WC2A 3PX Tel: 0171 242 0200 Fax: 0171 269 3101 Web: http://www.as h.org, u k Web: http://www.icnet.uk 1. Summary and introduction 'This invention, in general, is directly concerned with the reduction of the biologically undesirable constituents of cigarette smoke without substituting any similar noxious substances therefore, thereby in effect, leading to the production of a safer cigarette. By reducing the quantity of benzo(a)pyrene in the smoke condensates, the presence of one of the two most potent of the seven carcinogens known in tobacco smoke will be diminished.' http://www.ash.org.uk/papers/patent.html 04/03/99 321875546

ASH UK~ - The safer cigarette Page 2 of 40 See patent 26, patent no. 3577997, publication date: 11 May 1971 'In attempting to develop a 'safe' cigarette you are, by implication, in danger of being interpreted as accepting that the current product is 'unsafe' and this is not a position I think we should take.' Patrick Sheehy, Chief Executive, British American Tobacco. Confidential Internal Memo, 1986, 18 December {Minn.Trial Exhibit 11,296} Over 500,000 EU citizens die prematurely each year as a result of smoking tobacco. This research suggests that modifications to cigarette design and manufacturing technology could reduce the toxicity and carcinogenicity of tobacco smoke, and therefore reduce the toll of illness and disease caused by smoking. Tobacco smoke contains over 4,000 chemicals and some of these are responsible for cancer, heart disease and respiratory illnesses in smokers (see Appendix one). These chemicals include carbon monoxide, nitrosamines, polycyclic aromatic hydrocarbons such as benzo(a)pyrene, oxides of nitrogen, hydrogen cyanide and heavy metals. Research in the patent libraries shows that tobacco companies and others have filed numerous patents for technologies and processes that would reduce the concentration of particular known harmful chemicals in tobacco smoke. For example, these patents include: The addition of catalysts to cigarettes to reduce carbon monoxide and nitrous oxides. This is a similar chemical approach to catalytic converters used to clean motor vehicle exhausts. If used, this approach would reduce the burden of heart disease. Manufacturing processes that would inhibit or block the Iocalisation of at least one nitrosamine in smokers' lung tissue. This would reduce the burden of cancer. Chemical filters that would remove large quantities of hydrogen cyanide and hydrogen sulphide while also removing acetaldehyde. This would help to reduce the burden of respiratory illness. We identify 57 patents in the body of this report. These may be summarised as follows. Patent Claim and compound Reduce tar Remove/reduce carbon monoxide (CO) Remove/reduce polycyclic aromatic hydrocarbons i.e. benzo(a)pyrene Removel reduce hydrogen cyanide (HCN) Remove/reduce nitrosamines Remove/reduce nitrogen dioxide/nitrate/nitrite/nitric oxide Number of Patents (reference in document) Publication year range 11 (1-11) 1974 to 1998 14 (2,4,12-23) 1972 to 1997 8 (1,16,24-29) 1971 to 1988 11 (2,14,30-38) 1971 to 1988 6 (3,39-43) 1979 to 1998 1980 to 1998 14 14,15,34-36,40,44-51) http://www.ash.org.uk/papers/patent.html 04/03/99 321875547

ASH UK - The safer cigarette Page 3 of 40 Remove potassium nitrate 2(52,53) 1978 and 1986 Remove radioactive compounds 2 (54,55) 1971 and 1980 i.e. polonium Remove metals carbony]s 1 (56) 1972 Reduce aldehyde 1 (57) 1988 Remove/reduce other misc. 7 (2,16,30,39,40,50,54) 1976 to 1998 compounds The report also highlights recent developments in Canada. The Government of British Columbia now requires extensive measurements and disclosure of tobacco smoke constituents. Appendix two shows measurements of 40 ingredients of tobacco smoke for one particular brand. For many of these chemicals there are patents for technologies or processes to reduce their presence in tobacco smoke. We believe that disclosure of these chemicals, as now practised in British Columbia, is a vital first step and should be introduced in the European Union. This could eventually lead to regulations aimed at reducing critical target chemicals - either by using inventions listed in existing patents, or by stimulating R&D to produce new innovations. Measurement and disclosure are important pre-requisites to regulation. Before introducing maximum legal limits, policy-makers must first become familiar with more complex and disaggregated characterisation of tobacco smoke constituents. We do not believe a safe cigarette will ever be made - at least cigarettes based on burning of tobacco. However, the current products cause premature death for one in two of long-term smokers. Even a small improvement in this grim statistic would spare thousands of lives. Few of the inventions, if any, have been used by the tobacco companies. The likely reasons include: marketing and legal difficulties in admitting that existing products are dangerous; extra cost; failure of regulators to require reductions in toxicity; and, the focus on lowering machine-measured tar yields as an alternative. Section 2 "Why have these innovations not been used' on page 4 examines these reasons further. The failure and misleading strategy of reducing machine tar yields is discussed in section 3 on page 6. Consumers have a basic right to expect that producers make their products as safe as they reasonably can. Even in the unique case of tobacco, where it is assumed and accepted that the product will cause great harm to its users, the smoker should still expect the manufacturer to reduce harmfulness of the product if this is possible. Case law dating back to 1932 shows that there is a general duty of care by manufacturers of goods towards the user whereby the product should be "free from defect likely to cause injury to health". Furthermore, there is a continuing duty on the manufacturer to safeguard the user from his product and to take into account new knowledge. Although tobacco products are exempted from most consumer protection legislation this does not absolve the tobacco industry of all legal and moral responsibility. Recommendations Tobacco companies should measure and disclose key constituents in tobacco products. Disclosure should be two-fold: to satisfy authorities and as a source of comprehensive and accurat~ information for consumers. http://www.ash.org.uk/papers/patent.html 04/03/99 321875548

ASH UK - The safer cigarette Page 4 of 40 Abandon the ISO/FTC test for tar, nicotine and carbon monoxide yield. The test should be kept only for archival continuity and replaced with other approaches for measuring toxicity. Develop regulatory capacity. Plans should be set in place to establish an EU tobacco product modification expert committee to regulate tobacco constituents and develop the means to reduce constituent hazards over time. This should be part of the forthcoming EU Directive on cigarette tar and nicotine yield, additives and labelling. 2 Why have these innovations not been used? It might reasonably be asked why these innovations have not been used. We suggest four possible explanations for the failure to incorporate potentially life-saving innovations in cigarettes. 1. Legal and marketing difficulties. Innovations in cigarette safety cause legal and marketing difficulties for tobacco companies. If the new product is safer, then the company has to acknowledge danger in its existing products. As part of legal defences, tobacco companies continue to insist that the links between smoking and harm be shrouded in controversy. Sir Patrick Sheehy, former Chief Executive of British American Tobacco made the following revealing statement in 1986 in a confidential internal document, recently released through litigation in the United States: I cannot support your contention that we should give a higher priority to projects aimed at developing a 'safe' cigarette (as perceived by those who claim our current product is 'unsafe'), either by eliminating, or at least reducing to an acceptable level, all components cla~medby our critics to be carcinogenic. In attempting to develop a 'safe' cigarette you are, by implication, in danger of being interpreted as accepting that the current product is 'unsafe' and this is not a position I think we should take. Patrick Sheehy, Chief Executive, British American Tobacco. Confidential Internal Memo, 1986, 18 December {Minn.Trial Exhibit 11,296} 2. Cost to tobacco companies The innovations would undoubtedly cost money in new process plant investment, manufacturing costs and advanced cigarette design, Unless it was possible to recover http://www.ash.org.uk/papers/patent.html 04/03/99 321875549

ASH UK - The safer cigarette Page 5 of 40 these costs by marketing the product as a premium cigarette, there is no commercial incentive to do it. To recover the costs, the manufacturers would need to market the benefits of reduced harm. However, if companies started to compete.on 'safety' of their products, a highly dangerous (for them) dynamic could be established. The last thing the manufacturers would want is smokers becoming sensitised to health risks through the companies' own competitive marketing. Confidence in the product in new markets where the health impacts are not yet widely known could evaporate. 3. Failure of regulators to set standards Regulators such as the US Federal Trade Commission and European Union have never required the tobacco companies use the best available technologies to reduce the harm caused by the product. Regulation worldwide continues to be based on the US Federal Trade Commission. 4. Development of misleading low-tar cigarettes as an alternative An alternative methodology that appears to offer safer cigarettes has been adopted and widely used instead. This is the approach of reduced 'tar' cigarettes and the use of smoking machine measurements of tar yield. As explained in section 3, this has created a distracting illusion of reduced harm. It is a low cost approach, which offers smokers deliberately false reassurance. With this broad but misleading approach, tobacco companies have been able to avoid expensive and troublesome product modifications that would actually reduce the toxicity of tobacco smoke and therefore the harm caused and lives lost. 3 Existing regulation of cigarette smoke toxins Most of the world's minimal tobacco regulation is based on the approach developed by the Federal Trade Commission of the United States in the mid-1960s. Existing regulation deals in, at most, just three quantities - these are the 'tar', nicotine and carbon monoxide yields as measured with a mechanical smoking machine. 'Tar' is a collective name for the thousands of chemicals that make up the sticky residue deposited in smoker's lungs. Most jurisdictions regulate tar only. The use of a mechanical smoking machine to measure even these three quantities has been shown to be deeply misleading as a way of characterising harmfulness of tobacco smoke. To our knowledge .there are no regulations anywhere in the world that require tobacco companies to reduce or control the concentration of specific harmful chemicals in tobacco smoke. In the EU there is only a single regulation governing the hazardous properties of tobacco smoke. Directive 90/239/EEC sets a limit of 12 mg tar yield per cigarette - as measured by a mechanical smoking machine. Reductions in machine-measured tar yield are achieved by two main design techniques: filters and ventilation. Filters: Conventional filters remove some of the sticky particulates in smoke. If a filter also reduces the nicotine content of the smoke, then smokers will adjust their smoking to achieve a satisfactory nicotine dose. A smoker can do this by taking more puffs, deeper puffs, smoking more of each cigarette or smoking more cigarettes - a process known as 'compensation'. The value of a filter therefore depends on the extent that it can selectively remove 'tar' constituents http://www.ash.org.uk/papers/patent.html 04/03/99 321875550

ASH UK - The safer cigarette Page 6 of 40 without removing nicotine. For many years tar and nicotine yields have been in an approximately constant ratio of 10 to 1 though there has been some modest improvement. However, machine measured tar yields have reduced by at least a 70% Ventilation: By making tiny holes in the filter, air is introduced into the smoke to dilute it. Of course, this also dilutes the nicotine in the smoke, and smokers compensate by taking in more smoke. As well as drawing harder on the cigarette, smokers can also block the holes in filters to keep the air out and ensure that they take in enough smoke to receive an adequate dose of nicotine. Neither method necessarily delivers less harmful tar to the smoker - and certainly neither reduces the tar inhaled by a smoker by anything close to the levels suggested by the tar yield numbers measured by the machine. A person smoking a 6 mg tar cigarette is likely to be ingesting almost as much tar as a person smoking a 12 mg tar cigarette is. The US Federal Trade Commission (FTC) itself no longer supports the approach that it created for characterising the harm caused by cigarettes. The FTC wrote to the US Health Secretary Donna Shalala on 19th November 1998 acknowledging that the machine method of testing tar, nicotine and carbon monoxide yields is open to serious criticism and needs a substantial rethink lasting 18 months. In this period, the FTC plans to launch adverts "designed to alert consumers to the significant limitations in existing tar and nicotine numbers." The ads include such statements as "don't count on the numbers", "counting on low numbers? Get rear' and "Think smoking a low tar and nicotine cigarette is 'healthier'? - Give it up". The FTC's press release of 24 November acknowledges that it received critical comments in response to its initial proposals for a new methodology (which it has now withdrawn). The press release states: The National Cancer Institute and US Food and Drug Administration stated in comments that new data suggests that the limited health benefits, previously believed to be associated, with lower tar and nicotine cigarettes, may not exist. Federal Trade Commission (1998). FTC statement in response to Senator Frank Lautenberg letter. Press release dated November 24, 1998. 'Tar' is a poor concept as a basis for regulating tobacco. It has been shown that different cigarettes produce tars with greatly varying concentrations of key toxins (see Appendix three). As new tobacco or nicotine products are developed in the future, 'tar' may change beyond recognition. There are already cigarettes under test that have very different tars - for example the 'Eclipse' product made by RJ Reynolds heats tobacco rather than burning it. The tar contains a high proportion of glycerol. Milligram for milligram the tar from Eclipse is significantly less toxic than tar from other R JR brands. We believe that such product innovation should be required by regulation, not left to the whims of the manufacturers. There is extensive documentation showing that the tobacco companies have known for many years that reducing 'tar' does not offer significant health benefits. This evidence is documented in an ASH and Imperial Cancer Research Fund report titled: April One: http://www.ash.org.uk/papers/patent.html 04/03/99 321875551

ASH UK - The safer cigarette Page 7 of 40 why low tar cigarettes don't work and how the tobacco industry fooled the smoking public. An updated version of this report is available at http:llww~.ash.org.uk/paperslbig-one.html. Previously confidential tobacco industry documents, now available as a result of litigation in the USA, form the basis of a further ASH report titled: Tobacco Explained -- the truth about the tobacco industry in its own words. This report is available at http://www.ash.org.uk/papers/tobexpld0.html. Chapter 5 focuses on cigarette design: additives, low-tar and safe cigarettes, and is available at http://www.ash.org.uk/papers/tobexpld5.html. In summary, current tobacco regulation and the approach to reducing harm does not work. Any reductions in harm that have occurred have been incidental side effects, rather than the direct result Of enlightened health-orientated regulation. The tobacco industry has continued to promote the existing approach, knowing that it is thoroughly flawed and misleading to smokers. 4 Patents database search and cigarette modifications The remainder of this report is made up from extracts taken directly from the United States patents database, available at: http://www.patents.ibm.com/ibm.html A search can be performed by 'patent number' or by searching for tobacco 'and' another compound, for example, 'tobacco and tar'. Whilst researching for this document a second patents Internet database was found. The UK Patent Office site is called 'Esp@cenet'. It is a part of the British Library, and is available at: http:Udips.patent.gov.uk Searches can be performed by country of origin, e.g. UK, Japan, and also using a worldwide parameter. If a similar search were to be undertaken using a worldwide search the list of patented cigarette modifications would be much larger. I Reduce ~r 'Tobacco filter using a smoke filter and remove comprising a processed product of fruiting benzopyrene body of Bacidiomycetes of bracket fungus or its analogue or mycelium or processed product of the Bacidiomycetes. This filter is remarkably effective in absorbing tar and nicotine, harmful materials of the particulate phase component of tobacco smoke and can remove harmful materials of gas phase, making the smoke taste light and mild, and also remove carcinogens such as 3,4-benzopyrene. ' 4735218: Tobacco filter. Pub. date: 5 April 1988. Assignees: none IU.S. Patent Apr. 5, 1988 Sheet I of 5 4,735,2181 http://www.ash.org.uk/papers/pat~nt.htmi 04/03/99 321875552

ASH UK - The safer cigarette Page 8 of 40 FIG. 1 (A) and (B) are general views showing the sectional structures of a pipe used in the experiments for the tobacco filter of this invention and a pipe used as the control. AS seen in FIG. 1 (A), the test was made with a different type of the Bacidiomycetes filtering material filled in each plastic pipe (10). In FIG. 1 (A), the fibrous acetate filters (1) and (2) are arranged and the crushed product of the fruiting body or mycelium of Bacidiomycetes (3) is inserted between them in the plastic pipe (10) with a cigarette {11) inserted in it. On the other hand, the pipe of the same structure as FIG. 1 (A) ~xcept that the filtering portion consists of the fibrous acetate layer ~4) only is used as the control, as shown in FIG. 1 (B). The smoke :omponents that passed through each pipe of this invention and the control were collected with a submicron paper filter in the suction filter, and the quantity collected was measured. 2 Reduce tar, phenols, CO, HCN 3 Reduce tar and nitrosamines 'The amounts of tars, nicotine, phenols, CO, hydrogen cyanide, and other toxic materials generated during the smoking of tobacco and its substitutes is reduced by incorporating.in the smoking composition a small amount of a transition metal compound e.g. chromium n-heptanoate.' 4125118: Smoking compositions. Pub. date: 14 November 1978. Assignees: Tenneco Chemicals Inc., NJ 'Tobacco products improved by the use of uncured, yellow tobacco low in tar and carcinogenic nitrosamines for use in smoking tobacco, chewing tobacco, tobacco chewing gum. In one preferred embodiment tobacco, uncured or cured, is microwaved to reduce further tar and carcinogenic nitrosamines.' 5803081: Tobacco and related products. Pub. date: 8 September 1998. Assignees: Regent Court Technologies, MO http:/lwww.ash.org.uk/papers/patent.html 04/03/99 321875553

ASH UK - The safer cigarette Page 9 of 40 4 Reduce tar and CO 'Invention provides tobacco and non-tobacco smoking compositions which deliver smoke of reduced tar and nicotine content, and with a substantially reduced CO content. In one of its embodiments this invention provides smoking preparations which contain a combustible filler, and uniformly dispersed therein a catalyst composition consisting of (a) fine ash, and (b) a transition metal compound.' 5 Reduce tar 4397321: Smoking p~par~ions. Pub. date: 9 August 1983. Assignees: Celanese Corporation, NY 'An improved cigarette envelope comprising a mixture of highly methylated methyl cellulose, acetyl cellulose, a filler agent, and a softener agent. According to the preferred process described in the disclosure, the mixture is prepared by using the above mentioned materials in a suspension wherein the solvent is a mixture of methylene chloride and methanol and in which acetyl to methyl cellulose is in the ratio of 4:1 to 20:1" and the suspension is dried by gradually increasing the temperature in at least three zones said envelope having the properties of restricted shrinkage and reduction of tar and nicotine content of tobacco products s4~oke.' 6 Reduce tar 3826268: Envelope ~r tobacco pmdu~s. Pub. date: 30 July 1974. Assignees: Eduard Gerlach, GmbH Chemische Fabrik, Fed. Rep of Germany 'A high level of flavour can be provided in cigarette smoke at a low tar level while providing a more uniform delivery of flavour and tar as the cigarette is smoked, in comparison to a conventional cigarette. A tobacco blend is employed using higher-than-normal quantities of tobacco from the upper levels of the tobacco plant, to provide an initial high flavour-to-tar ratio. A flavour reset technique is employed to attenuate the flavour strength of the smoke to the smoker, so that such attenuated but acceptable flavour level is provided at a much lower tar level. In addition, latter puff manipulation of the tobacco smoke is http://www.ash.org.uk/papers/patent.html 04/03/99 321875554

ASH UK - The safer cigarette Page I0 of 40 effected to decrease the flavour level and tar produced in the latter puffs of smoking to provide a more uniform flavour delivery. Filter element structures and other specific elements to achieve these results are described.' 5524647: Control of cigarette smoke chemistry. Pub date: 11 June 1996. Assignees: Rothmans, Benson & Hedges Inc., Canada IU.S. Patent Jun. 11, 1996 Sheet 1 of 4 5,524,6471 FIGS. 1A, 1B, 1C and 1D are bar graph presentations of smoking test results. Smoking tests were carried out on the cigarette samples, determinations were carried out for total tar, nicotine and CO at the same flavour strength. The results are shown in bar graph form in FIG. 1, the Benson & Hedges cigarette being labelled "B&H" and the inventive cigarette being labelled "H-S". As can be seen, at the same flavour strength level, for the cigarette of the present invention, tar was decreased to 48% of the level of the standard cigarette from 14.0 mg to 6.7 mg, nicotine was decreased to 57% from 1.2 mg to 0.68 mg and CO was decreased to 71% from 14.0 mg to 10.0 mg. 7 Reduce t~r 'A low tar cigarette product and method of use which enhances the sensory impact of low tar and nicotine cigarettes in order to increase their acceptability and reduce the liklihood that smokers will exhibit compensatory smoking during thereof. The novel cigarette utlilizes an irritant selected from the group consisting of one http://www.ash.org.uldpapers/patent.html 04/03/99 321875555