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Tobacco Additives / Cigarette Engineering and Nicotine Addiction

Date: 14 Jul 1999
Length: 23 pages

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Abstract

Discusses use of additives in cigarette manufacture, notes the additives approved for use in European Union may be benign but lead to greater smoking incidence or consumption by making cigarettes more palatable or less irritating without reducing health risks. Discusses use of ammonia to raise levels of free nicotine and calls for greater regulation of additives. Urges disclosure of additives, listing ingredients on packaging, stating the purpose of each ingredient, and toxicological/pharmacological testing of all additives. Recommends regulators have authority to challenge any additives, ban any that are found to be harmful as well as those that cannot be proven to be safe due to European restrictions on animal testing. Includes introduction to tobacco products and additives, discussions of scientific advisory committee reports on tobacco additives, the enhancing impact of additives with a pharmacological effect, masking the taste and immediate effects of tobacco, additive toxicity and changing the perception of sidestream smoke.

User-Contributed Notes

  1. Aditivos aprobados por la UE que no son directamente nocivos pero inciden en el sabor y la liberación de nicotina y, en consecuencia, son más adictivos

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Document code 5457, e-mail.

"Using additive technology they were able to build cigarettes which registered low tar reading on the machine but delivered high levels of nicotine to the smoker." p 11

Author
Bates, C.
Connolly, Gregory N., D.M.D., M.P.H. (MA Dental Public Health Dir., Anti-Tobacco Expert)
Plaintiff, Tobacco Control Program Dir.
Jarvis, M.
Recipient
Cummings, Kenneth Michael, Ph.D., M.P.H. (Epidemiologist, Roswell Park, Plaintiff's Expert)
Senior research scientist in the Department of Cancer Control and Epidemiology at the Roswell Park Cancer Institute in Buffalo, NY
Leavell, Nadine-Rae, M.L.S. (Proprietor/Information Specialist, Summerland Communications)
Hypothesis
Design changes over time
Changes in cigarette design over the past half century.
Health effects
Design changes which have measurably altered health effects of cigarette smoke, both for smokers and nonsmokers.
Mainstream constituent yields
Modification of selected mainstream smoke constituents in response to health concerns.
Nicotine transport, transfer, and uptake
Design changes which alter nicotine delivery or effect how the product causes and maintains dependence, including transfer of nicotine from tobacco to smoke, and uptake into the body.
Perceptions of ETS
Design changes to reduce perception of environmental tobacco smoke among smokers and nonsmokers in response to public concerns about the dangers of ETS.
Smoke constituent testing
Development of methods for measurement of gas and particulate yields in mainstream and sidestream smoke.
Use of additives
Modification of tobacco products through use of additives and measuring effects on dependence, behavior, and toxicity.
Keyword
Addiction (Dependence)
Attribute perception ratings
Behavioral effects (Behavioral pharmacology)
Addiction behavior, withdrawal, and measured nicotine effects
Carcinogenic (Cancer-causing)
Consumer acceptability (Consumer preference)
Delivery modification
Flavor/ Taste (Attribute measure)
Impact (Throat grab)
Low delivery (Reduced delivery)
Nicotine delivery (Smoke nicotine or nicotine yield)
Nicotine manipulation
Puff frequency
Toxicity
Additive
Acetaldehyde (RCHO)
Ammonia
see also: Ammonium bicarbonate, Ammonium carbonate, Ammonium chloride, Ammonium hydroxide, Ammonium sulfide, Diammonium phosphate, and Urea
Cocoa (Chocolate) (Cocoa Shells, Extract, Distillate and Powder)
Composed of nearly 400 identified chemical substances as of 1967
Eugenol
Furfural
Levulinic acid
Licorice (Licorice Fluid Extract, Powder, and Root)
Menthol
Pyridine
Smoke Constituent
acetaldehyde
ammonia
Furfural
Nicotine
Nicotine salts
Design Component
Ammoniated blend
Filter ventilation (Filter vents, air vents)
Nicotine content (Tobacco nicotine content)
Total nicotine in the unburnt tobacco rod
Nicotine transfer efficiency (NTE)
Named Organization
Action on Smoking and Health, US
Plaintiff
*British American Tobacco Company Limited BAT (See British-American Tobacco Co.)
Defense
Brown & Williamson Tobacco Corporation (B&W)
Subsidiary of BAT U.S., located in Louisville, KY.
Commissioners of Customs and Excise
Department of Health
European Commission
European Union
Federal Trade Commission (Enforcement agency for laws against deceptive advertising)
Enforces laws against false and deceptive advertising, including ads for tobacco products. Ensures proper display of health warnings in ads and on tobacco products;collects and reports to Congress information concerning cigarette and smokeless tobacco advertising, sales expenditures, and the tar, nicotine, and carbon monoxide content of cigarettes.
Imperial Cancer Research Fund
Independent Committee on Smoking and Health (The Independent Committee on Smoking and Health - U.K.)
The Independent Committee on Smoking and Health is in the United Kingdom
Johns Hopkins University
Massachussetts Tobacco Control Program
Philip Morris Companies Inc. (Parent company of Philip Morris USA, Kraft, Miller)
America's seventh-largest industrial enterprise in 1993, owns Kraft, Miller Brewing, General Foods, and more.
R.J. Reynolds Tobacco Co. (Cigarette manufacturer (Camel, Winston, Doral))
Cigarette manufacturer (Camel, Winston, Doral)
Santa Fe Natural Tobacco Company
SCOTH (Scientific Committee on Tobacco and Health)
Scientific Committee on Tobacco and Health was convened by the UK Dept. of Health in early 1994, replacing the Independent Scientific Committee on Smoking and Health. Advises the UK Labour government's Dept. of Health on tobacco issues. BAT, Gallaher Group Plc, Imperial Tobacco Group Plc and Rothmans (UK) sought legal challenges against SCOTH for releasing a report relating to smoking without consulting the tobacco industry.
Technology/Method
Free basing nicotine
Brand
Kent (Lorillard)
Kool (BW (1933-2003)/RJR (2003-present))
First Menthol cigarette line, released in 1933. Premium priced brand.
Marlboro (PM)
Merit (PM)
Now (RJR)
Winston (RJR)
Subject
additives
Ammonia (Additives)
Ammoniation (Technology)
Blends (Design)
Irritation (Effects)
pH Manipulation (Technology)
Pharmacology (Effects)
Smoke Nicotine (Measures)
Smoke pH (Measures)
Smoothness/Harshness (Effects)
Levulinic Acid (Additives)
reduces the harshness of cigarettes

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Page 1: 5457
545-/ Mike Cummings PhD, 03:18 PM 7/14/99 , FW: 99/07/14 Tobacco Additives Reply-To: <MCummings@sc3102.med.buffalo.edu> From: "Mike Cummings PhD" <MCummings@sc3102.med.buffalo.edu> To: "'Nadine-Rae Leavell'" <nleavell@sc3103.med.buffalo~edu> Subject: FW: 99/07/14 Tobacco Additives Report Date: Wed, 14 Jul 1999 15:18:39 -0400 X-MSMail-Priority: Normal X-Maile~: Microsoft Outlook 8.5, Build 4.71.2173.0 Importance: Normal X-MimeOLE: Produced By Microsoft MimeOLE V4.72.3110.3 Please download this new report. Mike ..... Original Message .... From: Gene Borio [mailto:geneb@tobacco.org] Sent: Wednesday, July 14, 1999 2:57 PM TO: tob~cco-enews@smokescreen.org Subject: 99/07/14 Tobacco Additives Report Tobacco Additives / Cigarette engineering and nicotine addiction ASH London Date: Jul 14, 1999 Clive Bates Action on Smoking and Health London Dr. Martin Jarvis Imperial Cancer Research Fund London Dr. Gregory Connolly Massachusetts Tobacco Control Program Boston 14 July 1999 Summary Introduction. In the European union over 600 additives may be used in the manufacture of tobacco products under an extremely loose and de-centralised regulatory framework. Although tobacco additives are generally screened for their direct toxicity, there is virtually no assessment of the impact additives have on smoking behaviour or other undesirable external consequences. If a small quantity of a relatively benign substance added to a tobacco product can make the product more addictive~ make it easier to start smoking or facilitate continued smoking then it may be causing great harm by 'leveraging' additional smoking. The additional smoking brings increased exposure to over 4,000 chemicals, including many that are highly toxic and carcinogenic. Given that over 500,000 people die prematurely in the European Union each year as a result of smoking-related disease, even a one per cent change in smoking attributable to the use of additives would have large absolute health consequences - tens of thousands of lives annually. For this reason, tobacco additives should be seen as major public health issue in their own right. Evidence. This report draws on evidence from tobacco industry Printed for Nadine-Rae Leavell <nleavell@sc3103.med.buffalo .... 1
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Mike Cummings PhD, 03:18 PM 7/14/99 , FW: 99/07/14 Tobacco Additives internal documents released during recent litigation in the United States and held on the Internet or in British American Tobacco's document depository in Guildford, UK. The views of the UK Government's scientific advisory committees since 1971 are also discussed - showing that the issue has been recognised and debated for more than twenty years. Which brands use which additives? Though 600 additives are authorised for use in tobacco products, only the tobacco manufacturers can say which additives are used and in which brands. Not even the Government or the European Commission, which are responsible for the regulation of tobacco products have this information or the power to demand it. Findings. Most additives are not necessary and few were used before 1970. The purpose of this report is to raise concerns about the impact of additives on smoking behaviour. The finding~ suggest that there is a case to answer and that there is need for increased regulatory scrutiny. There is cause for concern in the following areas. * Additives are used to make cigarettes that provide high levels of 'free' nicotine which increases the addictive 'kick' of the nicotine. Ammonium compounds can fulfil this role by raising the alkalinity of smoke * Additives are used to enhance the taste of tobacco smoke, to make the product more desirable to consumers. Although seemingly innocuous the addition of flavourings making the cigarette 'attractive' and 'palatable' is in itself cause for concern. * Sweeteners and chocolate may help to make cigarettes more palatable to children and first time users; eugenol and menthol numb the throat so the smoker cannot feel the smoke's aggravating effects. * Additives such as cocoa may be used to dilate the airways allowing the smoke an easier and deeper passage into the lungs exposing the body to more nicotine and higher levels of tar. * Some additives are toxic or addictive in their own right or in combination. When additives are burned, new products of combustion are formed and these may be toxic or pharmacologically active. * Additives are used to mask the smell and visibility of side-stream smoke, making it harder for people to protect themselves and undermining claims that smoking is anti-social without at the same time reducing the health risks of passive smoking, Regulation. The existing regulatory framework is based on the assumption that additives are useful to facilitate consumer acceptance of lower tar yield cigarettes. By facilitating the switch to lower tar products, it was hoped that tobacco additives would lead to 'health gains'. No data is available to show that additives are in fact used only or predominantly in lower yielding brands. However, there is now good evidence that questions the value of low tar cigarettes. Low tar cigarettes have generally used perforated filters to dilute the smoke with air. Smokers learn to block the holes, often subconsciously, thus adjusting the dilution of nicotine in the smoke. The smoker may also compensate by smoking more intensely. With the primary rationale for a relaxed regime discredited, it is necessary to adopt a new approach. New regulatory framework needed. A new regulatory framework is required in which the manufacturer is obliged to demonstrate that no Printed for Nadine-Rae Leavell <nleavell@sc3103.med.buffalo .... 2
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Mike Cummings PhD, 03:18 PM 7/14/99 , FW: 99/07/14 Tobacco Additives additional harm arises from tobacco product design decisions such as the use of an additive. This should include the impact of additives on smoking behaviour, passive smoking and fire risks~ While it is impossible to make safe cigarettes, it is perfectly reasonable to prevent the manufacturers doing things that lead to an increase in the harm caused by tobacco. Such a framework may have the following elements: * Disclosure. As a first step, manufacturers should be required to disclose all additives used in tobacco products, by brand, to a regulator - in the UK this is the Department of Health. This approach has already been adopted in Massachusetts and British Colu~oia. * Public information. Such information should not be confidential, but made available to the public through publications, the Internet or on request from the regulator. * Packaging. There may be some additives that should be listed as ingredients on tobacco product packaging. This is a separate decision to a requirement for disclosure and making the information public in other ways -- the right approach will depend on assessment of the direct value of such information to consumers. * Disclosure of purpose. Tobacco companies should be required to disclose the purpose of an additive and any secondary consequences -- whether intentional or unintended. * Conduct and disclosure of research. Tobacco companies should be required to undertake extensive toxicology and pharmacological testing of all additives * Regulatory challenges. Regulators should have the power to challenge any of the existing 600 additives currently allowed and to have them removed until the manufacturer is able show that no extra har~ to the public arises as a direct or indirect result of the additive. If it is impossible to supply evidence, for example because of restrictions on animal testing, then under a precautionary approach the additive should be banned. * Focus on pharmacologically active additives. There should be an automatic challenge to any additive thought to have a direct or indirect pharmacological influence~ New additives should be permitted only if the manufacturer can show that no extra harm or other net negative consequences arise from use of the additive. * Permit essential additives. A~y regulatory framework should permit additives necessary for the manufacture and storage of tobacco products providing these are safe, but should challenge all additives that may influence smoking behaviour. Contents iIntroduction: tobacco products and additives 2Scientific advisory con~mittee reports on tobacco additives 2.1First Report of the ISCSH (1975) 2.2Second Report of the ISCSH (1979) 2.3Third (1983) and Fourth (1988) Report of ISCSH 2.4SCOTH (1998) 2.5The 1997 UK Voluntary Agreement Printed for Nadine-Rae Leavell <nleavell@sc3103.med.buffalo .... 3
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Mike Cummings PhD, 03:18 PM 7/14/99 , FW: 99/07/14 Tobacco Additives 3Enhancing impact -- additives with a pharmacological effect 3.1Free basing nicotine 3~2Ammonia Technology and The Marlboro Story 3.3Concealing the nicotine by increasing the vapour phase 3.4Other additives that may enhance the effect of nicotine 3.4.1Acetaldehyde 3~4.2Levulinic acid 3~4.3Cocoa and theobromine 3.4.4Glycyrrhizin 3.4.5Pyridine 4Masking the taste and immediate effects of tobacco 4.1Additives and 'low tar' cigarettes. 4.2Front end ~lift~ 5Additive Toxicity 6Changing the Perception of side-stream smoke 7Notes i. Introduction: tobacco products and additives Cigarettes as nicotine delivery systems To understand the role of additives, it is important first to have a grasp of how cigarettes work. The long-term success of the tobacco industry is the direct result of the addictive nature of nicotine and tobacco use. AS those in the industry were first to recognise, the cigarette - marketed as a lifestyle accessory - is in fact a delivery device for an addictive drug. There are many tobacco industry documents that show tobacco products acting in this role, essentially as sophisticated, highly engineered nicotine delivery systems. For a more detailed survey see ASH's report Tobacco Explained (Chapter Two).l Two examples are given below: Philip Morris explains.,. "The cigarette should be conceived not as a product but as a package. The product is nicotine. Think of the cigarette pack as a storage container for a day's supply of nicotine .... Think of the cigarette as the dispenser for a dose unit of nicotine ..... Smoke is beyond question the most optimised vehicle of nicotine and the cigarette the most optimised dispenser of smoke."2 (Philip Morris 1972) RJR recognises it is in the drug business "In a sense, the tobacco industry may be thought of as being a specialised, highly rituallsed, and stylised segment of the pharmaceutical industry."3 (RJR 1972) Impact of additives on smoking behaviour Additive technology is a major tool used by the tobacco industry in the production of this nicotine ,p~ckage' . While some cigarettes have been Marketed as additive free, according to the verbal testimony of JL Pauly of the Santa Fe Natural Tobacco Co., the modern U.S cigarette contains about i0 percent additives by weight, mostly in the form of sugars, flavourings, and humectants4. But there are others - present in smaller quantities -- which may have a more profound influence on the product. Evidence suggests that additives are actually used by manufacturers to influence the pharmacological effects of nicotine, make individual brands taste more appealing to young and 'aspirational' smokers and mask the taste and immediate discomfort of smoke. How nicotine addiction works -- additives play a subtle role At the simplest level, a cigarette delivers a dose of the main active Printed for Nadine-Rae Leavell <nleavell@sc3103.med.buffalo .... 4
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Mike Ctu~nings PhD, 03:18 PM 7/14/99 , FWz 99/07/14 Tobacco Additives ingredient, nicotine, into the smokers' lungs in a mixture of smoke particles and gases. The nicotine is rapidly absorbed into the blood through the large surface of the lungs (and mouth and throat) and reaches the brain within ten seconds. Rsceptors in the brain respond to nicotine stimulation by producing chemicals (dopamines and other neurotransmitters) that give the user what is variously described as a 'hit', 'kick' or 'impact' - the drug effect of nicotine. Over time the receptors become conditioned to expect nicotine (tolerance), and when deprived, the smoker experiences nicotine withdrawal - a very unpleasant sensation for many. This pharmacological impact and withdrawal, enhanced by psychological and social factors related to smoking, create dependency on tobacco products. Nicotine is the main reason why tobacco products are addictive. AS this report shows there are a number of subtle ways in which the delivery of nicotine to the brain,s receptors can be influenced by additives. Harm caused by smoking The smoke particles and gases in which the nicotine is transported contain thousand of chemicals, many of which are toxic or carcinogenic. Though nicotine itself is the reason people smoke, the other chemicals do the bulk of the damage to health. The other chemicals are often collectively referred to as 'tar' and provide flavour and other taste sensations. This tar and the gases produced by combustion such as carbon monoxide, cause cancer, heart disease and respiratory illnesses as well as many other conditions. Regulators aimed to reduce tar exposure by insisting that tar yields should be decreased. Low tar cigarettes in theory The rise of additives in tobacco products is intimately linked with the strategy to reduce tar yields. The amount of tar and nicotine in smoke is measured by a standard smoking machine in which the cigarette is smoked with a fixed puff volume and frequency with tar and nicotine residues collected on a filter and weighed. Governments have insisted on reducing tar 16vels as measured by this approach, hoping that this would reduce tar exposure to smokers -- and therefore lead to reduced harm. Low tar cigarettes in practice In practice, low tar cigarettes have been produced by the addition of filters and most importantly, by the use of filter ventilation (Kozlowski et al, 1998).5 Holes in the filter allow air to be drawn in to dilute the smoke and this reduces the amount of tar and nicotine residues collected by the machine. ~n the lowest tar cigarettes 80% of the 'smoke' is air drawn in through ventilation holes. Ventilation also means that the smoke might taste 'weaker' because the agents that give rise to flavour are diluted with air. However, smokers do not smoke like machines. Faced with diluted smoke, smokers will tend to 'compensate' by smoking the lower-tar cigarette more intensively, in order to obtain a satisfactory dose of nicotine. Compensation may take the form of deeper or more frequent puffs, or blocking of ventilation holes -- often sub-consciously. The result is that smokers of low-tar cigarettes do not consume less nicotine (Benowitz et al, 1983,6 Bates and Jarvis, 19997). A survey of tobacco company documents by ASH and Imperial Cancer Research Fund (Low Tar: why low tar cigarettes don't work and how the tobacco industry fools the smoking publicS) gives greater detail on why low tar cigarettes do not work and what the tobacco companies knew privately and said publicly. Low tar cigarettes and additives One of the prime justifications for the addition o£ artificial flavourings is to replace the 10st flavour of the diluted smoke. This has in theory been done to facilitate the switch to low-tar. However, any hoped-for health benefits from low-tar cigarettes have largely failed to materialise. At the same time an extremely lax regulatory regime for additives has emerged. Printed for Nadine-Rae Leavell <nleavell@sc3103.med.buffalo .... 5
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Mike Cummings PhD, 03:18 PM 7/14/99 , FW: 99/07/14 Tobacco Additives Although smokers of lower tar cigarettes may be consuming as much tar and nicotine in total, they will be consuming greater volumes of diluted smoke to do it. This is perhaps analogous to drinking watered down wine - it is possible to become intoxicated, but drinkers will have to consume more and the flavour will be weaker. 2. Scientific advisory committee reports on tobacco additives Scientific advice to government The Government takes advice on smoking and health from a long-running scientific standing committee. Guidelines for the monitoring of tobacco additives were initially published in the First Report of the Independent Scientific Committee on Smoking and Health (ISCSH) in 1975.9 The ISCSH was established in 1973, primarily to prepare guidelines for the testing of tobacco substitutes which were being developed at the time. This section gives an overview of the conclusions regarding tobacco additives. Arrangements before 1970 Prior to 1970, the use of additives in tobacco products was prohibited without special permission from the Commissioners of Customs and Excise, under Section 176 of the Customs and Excise Act, 1952. This permission was given only within very strict limits and mainly in respect of flavourings in tobacco products other than cigarettes. The prohibition extended to the importation of tobacco products containing additives as well as a ban on the production of cigarettes with additives for export. 2.1 First Report of the ISCSH (1975) The Finance Act of 1970 changed the rules and allowed for tobacco duty to be charged on additives and tobacco substitutes, thus paving the way for the restrictions on additives to be removed. Statutory control over the materials used in the manufacture of cigarettes finally ceased with a revision of the tax system in 1978, The First Report of the ISCSR stated that the Committee was concerned that these changes in the law should not increase the health hazards of smoking and concluded that: "Other means have to be found to guard against the possible risk to health." The *'other means" resulted in a voluntary agreement between the tobacco manufacturers and the Government whereby the companies would supply details of proposed additives. Only those approved by the ISCSR would be permitted. Guidelines for the testing and use of tobacco products containing additives were included an appendix to the First Report of the ISCSH, published in 1975. In the Second Report, the guidelines were amended to include the general requirement for an acute inhalation toxicity study and data on transference to smoke for any new additive. 2.2 Second Report of the ISCSH (1979) The Second Report of the ISCSR expresses concern that no additional "dependence-inducing" compounds should be incorporated into tobacco. Paragraph 13 states: ,'The concept of adding flavouring ingredients to cigarettes might not lessen the incentives to smoke and could indeed have the opposite effect."10 The tobacco industry argues that one of the key purposes of additives is to make lower tar cigarettes more palatable. The ISCSH accepts this and notes~ Printed for Nadine-Rae Leavell <nleavell@sc3103.med.buffalo .... 6
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Mike Cummings PhD, 03:18 PM 7/14/99 , FW: 99/07/14 Tobacco Additives ,'Some smokers find existing low and low to middle tar brands unsatisfying, but if those who smoked middle or middle to high tar cigarettes could switch to low tar brands whose acceptability was improved by additives, the dangers of smoking could be reduced. The Committee recognises the potential value of using flavouring additives in this way."ll The Second Report of the ISCSH expresses satisfaction with the use of other additives not covered by the guidelines. These include additives in filters, cigarette papers, filter wrappers, tips and overwrappers. Thus, such additives could be used without reference to the Committee. Between 1979 and 1983, the Committee revised the guidelines to include an assessment of ',all substances added to those parts of tobacco products intended to be bur~t". Thus any substances added to cigarette papers were included in the revised guidelines as ~ppended to the Third Report. 2.3 Third (1983) and Fourth (1988) Report of ISCSH The Third Report of the ISCSH concluded that the system of providing information on additives had been working well and recommended that the system should continue.12 The Fourth Report, published in 1988, made a similar recommendation for the continuation of the voluntary system.13 2.4 SCOTH (1998) official acceptance of the tobacco industry's arguments regarding the need for additives appears to have continued until the publication of the report of the Scientific Committee on Tobacco and Health (SCOTH) in 1998. SCOTH states: "One of the effects [of additives] has been the maintenance of "taste" as tar yields have fallen with an ensuing reduction in natural flavour. The negative side of this has been the maintenance of the appeal of a product, which might otherwise have been rendered unacceptable through the adulteration of intrinsic flavour."14 SCOTH, which replaced the ISCSH, reviewed the tobacco additive guidelines and made recommendations for their revision in the light of scientific and technical advances. While the Committee expressed the clear reservation about the possibility that additives may prolong use of cigarettes by making them more palatable, SCOTH only recommends that the use of additives in tobacco products be closely monitored. Specifically, it recommends that the Technical Advisory Group, which reports to SCOTH, should regularly review the changing patterns and types of additives used. At no stage in the 25 year period has the Department of Health or its advisory committees been provided with information regarding which additives have been used in which tobacco product brands. There has therefore, never been evidence of whether the approved additives have actually been used in low-yield brands, or more widely. There has also been no validation of the anticipated health benefits that the liberal regulatory regime for additives was supposed to offer. 2.5 The 1997 UK Voluntary Agreement Existing additives escape detailed scrutiny The 1997 Voluntary Agreement requires tobacco manufacturers to provide toxicological and other data for any new additives manufacturers wish to add to the approved list, but such information is not required for the 600 existing approved additives. Printed for Nadine-Rae Leavell <nleavell@sc3103.med.buffalo .... 7
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Mike Cummings PhD, 03:18 PM 7/14/99 , FW: 99/07/14 Tobacco Additives Limited scope of evaluation Furthermore, even for new additives there is no requirement for companies to state the purpose of the additives, merely that it is "desirable that the purpose of use should be detailed". While it is possible that some additives may be harmless or even beneficial, under the present voluntary agreement system there is no way of ascertaining the relative advantages and disadvantages of these substances. No broad criteria for acceptance or rejection are stated in the agreement. The criteria applied are only ',the results of toxicity testing are unsatisfactory; or acceptability cannot be judged on the basis of the information provided." The impact on smoking behaviour is not assessed. European loophole The final and fatal weakness of the Voluntary Agreement is that it can be side-stepped in its entirety. Directive S3/189/EEC requires the Department of Health to 'raise no objection' to the use of an additive permitted in any other EU me~Iber state provided that certain specified information is provided. Conclusion The regime established in the 1997 UK Voluntary Agreement is not retrospective, too narrowly focussed, can be avoided entirely. It therefore offers minimal safeguards and may be lending spurious legitimacy to practices that cause harm to health. 3. Enhancing impact -- additives with a pharmacological effect "The main technical challenge was to decrease the yield of tar in a cigarette while maintaining a level of nicotine acceptable to the smoker."15 (Farone, W.A. 1996 former Philip Morris scientist.) 3.1 Free basing nicotine Free-basing nicotine At least as far as its rivals are concerned, the success of Philip Morris's Marlboro brand stems from greater 'free' nicotine resulting from higher alkalinity (pH) induced by the addition of ammonia technology (see section 3.2). Ammonia can speed the delivery of 'free' or unbound nicotine to smokers by raising the pH (alkalinity) of tobacco smoke using additives. This causes the smoker to ~freebase' the drug -- much as a crack-user takes cocaine. Dr. Jack E Henningfield of the John Hopkins University School of Medicine explains the action of ammonia thus: "A third thing that ammonia-like compounds can do is increase the pH, increase the amount of free base nicotine, or what Dr Rickert earlier referred to as unprotonated nicotine .... The free-based form of cocaine or the free based form of nicotine is more rapidly absorbed, has a more explosive effect on the nervous system. Ammonia is one of the ways that you can provide free-based cocaine or free-based nicotine." (1997)16 Nicotine in different forms Many documents explain the tobacco companies' recognition that nicotine is available in different forms. "Nicotine may be presented to the smoker in at least three forms: (I) salt form in the particulate phase, (ii) free base form in the particulate phase, (iii) free base form in the vapour phase. It has long been believed that nicotine presented as in {ii)/(iii) is considerably more 'active'."(BAT 1984)17 "Nicotine is in the smoke in two forms as free nicotine base (think of ammonia) and as a nicotine salt (think of ammonium chloride) and Printed for Nadine-Rae Leavell <nleavell@sc3103.med.buffalo .... 8
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Mike Cummings PhD, 03~18 PM 7/14/99 , FW: 99/07/14 Tobacco Additives it is almost certain that the free nicotine base is absorbed faster into the blood-stream."(BAT 1964)18 More free nicotine means higher 'impact' Once the relationship between pH, free nicotine and nicotine ~impact~ was established, it became a research objective. ,'The purpose of this project is to develop a method for increasing the smoke pH of a cigarette. A low smoke solids, low nicotine cigarette with an increased smoke pH would then have relatively more free nicotine in its smoke, and consequently, a higher nicotine impact." (Liggett 1974)19 Changing the chemical form of nicotine increases the 'kick' In a paper entitled, 'Cigarette concept to assure RJR a larger segment of the youth market' RJR talk about the 'kick' of nicotine: "Still with an old style filter, any desired additional nicotine 'kick' could be easily obtained through pH regulatlon."20 (RJR 1973) The pH also relates to the immediacy of the nicotine impact. As the pH increases, the nicotine changes its chemical form so that it is more rapidly absorbed by the body and more quickly gives a 'kick' to the smoker."21 (RJR 1976) "When a cigarette is smoked, nicotine is released momentarily in the free-form. In this form, nicotine is more readily absorbed through the body tissue. Hence it is the free nicotine which is associated with IMPACT, i.e. The higher the free nicotine, the higher the IMPACT," (BAT 1988)22 Making nicotine more potent "Increasing the pH of a medium in which nicotine is delivered increases the physiological effect of the nicotine by increasing the ratio of free base to acid salt form, the free base form being more readily transported across physiological membranes. We are pursuing this project with the eventual goal of lowering the total nicotine present in smoke while increasing the physiological effect of the nicotine which is present, so that no physiological effect is lost on nicotine reduction."23(Liggett 1971) Free nicotine fraction increases 'physiological strength' "Since the unbound nicotine is very much more active physiologically and much faster acting than the bound nicotine, the smoke at a high pH seems to be strong nicotine. Therefore~ the amount of free nicotine in the smoke may be used for at least a partial measure of the physiological strength of the cigarette."24(RJR 1973) Nicotine transfer increased as a result of ammonia treatment According to BAT, the addition of ammonia was a technical option to enhance nicotine transfer: "The results show that ammonia treatment caused a general increase in the delivery of bases including a 29% increase in nicotine. This result, despite the decrease in nicotine content and a 10% drop in the weight of tobacco burnt in puffing, is only partly due to a small decrease in nicotine filtration. In other words, the nicotine transfer has increased as a result of ammonia treatment..."25 (BAT 1965) 'Judicious' use of additives to increase the free base nicotine The US tobacco company Lorillard accepts that additives can change the qualitative delivery of nicotine: Printed for Nadine-Rae Leavell <nleavell@sc3103.med.buffalo .... 9
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Mike Cuaunings PhD, 03:18 PM 7/14/99 , FW: 99/07/14 Tobacco Additives "It should be obvious that if the preceding goals of high physiological impact are to be realised, flavour profiles and their effect on physiological impact must be understood, even though measures of such perceived quantities are highly subjective... Hence judicious use of additives may increase the pH of the delivered smoke, thereby the apparent free base nicotine.,, (Lorillard, 1976)26 Additives to increase nicotine 'kick' Ammonia can be used to increase the alkalinity of smoke and increase the amount of nicotine in the 'free' form rather than in the 'bound' form of nicotine salts. R J R explains: "In essence, a cigarette is a system for delivery of nicotine to the smoker in attractive, useful form. At ',normal' smoke pH, at or below about 6.0, essentially all of the smoke nicotine is chemically combined with acidic substance hence is non-volatile and relatively slowly absorbed by the smoker. As the smoke pH increases above about 6.0, an increasing proportion of the total smoke nicotine occurs in 'free' form, which is volatile, rapidly absorbed by the smoker, and believed to be instantly perceived as nicotine 'kick'."27 (RJR 1973) 3.2 Ammonia Technology and The Marlboro Story The Rise of Marlboro - the world's best selling cigarette The myth is that Marlboro man ~nade the Marlboro cigarette: The square jawed icon of American individualism lassoed a gullible public and herded them into the Marlboro corral. On the face of it Marlboro's success appears to be a tribute to the power of advertising and iconography, However, the chemical history of the brand sheds interesting light on the subject. In the early sixties Philip Morris was the smallest of America's six leading cigarette companies and RJR's brand Winston had annual sales nearly three times the size of Marlboro's. By 1978 there had been a seismic shift, Marlboro was the world's best selling cigarette accounting for one in five of all cigarettes sold and over fifty percent of smokers aged 17 and below.28 The search begins for the 'soul of Marlboro' Not surprisingly this dramatic growth in Marlboro cigarettes instigated frenzied research by other tobacco manufacturers. Through analysis and reverse engineering of Marlboro cigarettes, industry competitors came to the conclusion that 'ammonia technology' was essentially the ,soul, of Marlboro. "Philip Morris began using an ammoniated sheet material in 1965 and increased use of the sheet periodically from 1965 to 1974. This time period corresponds to the dramatic sales increase Philip Morris made from 1965 to 1974."29(RJR) Ammonia technology is the key to Marlboro "What product technology, then, makes Marlboro a Marlboro? Looking at all of the technology employed in Marlboro on a world-wide basis, ammonia technology remains the key factor."30 (B&W 1992) Brands that are selling well have high levels of free nicotine The higher pH of Marlboro cigarettes helped to maintain the same level of free nicotine as high-tar cigarettes despite a two third reduction in overall tar and nicotine - and helped develop a 'US standard taste', enhancing the iconography associated with the quintessentially American 'Marlboro Man'. Printed for Nadine-Rae Leavell <nleavell@sc3103.med.buffalo .... I0

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