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Commitments Fulfilment
Harm Reduction
- Following stakeholders’ feedback we may consider also liaison with the Plain English Campaign and will seek their advice on how to make the communication of our position on harm reduction more accessible and simple.
- Our "glossary of terms" on harm and harm reduction will be included on the EU social reporting website - www.batresponsibility.eu. We will report substantive comments made by stakeholders.
- Through the feedback form, we will seek stakeholders’ feedback on our social report – whether our responses and positions are clearly articulated and our commitments are formulated in a simple and understandable manner.
- We will report our key scientific publications on our EU social reporting website including a commentary on findings and the rationale for the work. We have a long history of scientific publications but for reasons of clarity moving forward we will list our recent publications as a starting point for scientific dialogue with stakeholders. As a matter of course we will list all of our future scientific publications.
- In Q1 2008 we will invite EU stakeholders involved in public health issues to visit our scientific facilities and will organise a panel discussion on the key scientific and regulatory challenges for harm and harm reduction. Despite the difficulties in gaining the confidence of the public health community we will not be deterred from pursuing engagement with all working in the tobacco area.
- Before the end of 2007 we will develop and share, initially with the European Commission, our views on a research agenda for Europe designed to underpin public health policy developments on tobacco regulation and comprising our proposed contribution to this process.
- By the end of Q1 2008 we will ensure that our European Operating Companies have clear links from their websites to local sources of information on smoking cessation and quitting advice.
- By the end of 2007 we will put on the EU social reporting website all the national telephone numbers (quit lines) printed on cigarette packs as part of EU health warnings.
- We will continue to communicate to competent bodies and the scientific community the reduced health risks of snus when compared with smoking.
- We will work with others to organise a European seminar on snus and harm reduction by the end of 2007 to include a review of the findings and recommendations of the SCENIHR Committee.
- By the end of 2007 we will provide, through our EU social reporting website, access to those internet sources of information and fora which follow the scientific debate on snus.
- Within the next 12 months we will initiate a pilot test of Swedish snus in Canada. All new introductions of snus will be carefully monitored and we seek to develop these potential opportunities through engagement and co-operation with regulators and public health stakeholders.
- We will continue to share relevant consumer insights and information - generated from such initiatives as launching snus in Canada and potentially other markets - with authorities and competent scientific bodies in an open and transparent manner.
- Depending on our evolving learning, we will consider the potential to expand our snus portfolio not only geographically but also using additional brands and product variants.
- We would be pleased to share with interested parties the design of our consumer research. We will publish an outline of the consumer research design on our EU social reporting website by the end of 2007.
- We will share our research findings with the Commission and its advisors no later than one year after publication of this social report. Subsequently we will share the findings of our research with other interested parties as may be appropriate.
- We will continue to track the scientific literature and the public health concerns on TSNA and nicotine content in snus and will respond accordingly. If our position changes on this matter we will report our change of view.
- We will include the issue of independent research and future funding of research and any proposals on this matter into the agenda of the "panel discussion" planned under commitment No. 5.
- We will investigate possibilities for our involvement in the EU Community framework programmes for research and technological development in Europe and in the Sinapse research network*, where, if appropriate, we will contribute research know-how and scientific expertise. Information on the progress in this area will be posted on the EU social reporting website within a year after the social report publication.
- We believe that we have scientific knowledge and expertise in this area and will seek to publish our findings as appropriate and share these findings with the public health community and their scientific advisors.
- We will seek to drive and contribute to the design of a specific research method, to study consumer perception and potential behaviour in respect of reduced risk products, and to establish their likely acceptability and use. We would intend to discuss our approach with the scientific community and to seek recognition for the method as part of a public health impact assessment. Once such a method is available we are committed to use it and report our research findings appropriately. This approach would become an element of our proposal for an EU research agenda (see commitment No 6).
- We will provide periodic updates on the progress or otherwise we achieve in communicating with stakeholders on these issues on the EU social reporting website and specific commitments that may arise through continued dialogue.
- We shall seek to develop a protocol which can demonstrate whether modified products result in reduced exposure to specific smoke constituents when used by consumers. As part of this commitment we shall:
- seek independent recognition of this protocol by the scientific and public health community,
- share the protocol as appropriate with external stakeholders and seek their feedback,
- apply the protocol in the development, assessment and validation of future modified products presuming acceptance by the scientific and public health community,
- provide information on progress in this area on the EU social reporting website no later than one year from publication of this social report.
- We will seek engagement with regulators, scientific and health community in order to identify the ways of providing consumers with meaningful information about the risks associated with tobacco consumption and potential ways to reduce them. The results of this engagement, being one of the elements of EU research agenda proposal (see commitment No. 6), will be reported on EU social reporting website on annual basis.
Commitment:
- Following stakeholders’ feedback we may consider also liaison with the Plain English Campaign and will seek their advice on how to make the communication of our position on harm reduction more accessible and simple.
- Through the feedback form, we will seek stakeholders’ feedback on our social report – whether our responses and positions are clearly articulated and our commitments are formulated in a simple and understandable manner.
Action resulting from the Commitments
To date, we have received no comment or request regarding the communication of our position on harm reduction or the formulation of positions and commitments in our social report. Our aim is to express ourselves in clear and simple terms and we remain open to any suggestions to improve the language. Our corporate website www.bat.com has been approved by the Plain English Campaign.
Commitment:
- Our "glossary of terms" on harm and harm reduction will be included on the EU social reporting website - www.batresponsibility.eu. We will report substantive comments made by stakeholders.
Action resulting from the Commitment
Definitions of Tobacco Harm Reduction
"Tobacco harm reduction is the general term used to describe the scientific, policy, legal and communications issues raised by products designed to continue tobacco use, albeit with products holding out the promise to reduce risk of tobacco-related disease."
D Hatsukami & M Zeller - American Psychological Association - Psychological Science Agenda, Vol 18, No 4, April 2004
"Tobacco harm reduction refers to decreasing the burden of death and disease, without completely eliminating nicotine and tobacco use..."
R Wallace - Institute of Medicine
Testimony to the US House of Representatives, June 2003
"In tobacco control, harm reduction can be reasonably defined as any process or programme that reduces harm in continuing users of tobacco. Thus the term can be applied to methods for reducing toxins in tobacco smoke
by setting upper limits on them, to programmes promoting the conversion of continuing smokers to smokeless tobacco, or to the long-term complete substitution of nicotine as replacement therapy for tobacco."
N Gray & J Henningfield - The Lancet, Vol 368, September 2006
Related document : Glossary of terms
Commitment:
- We will report our key scientific publications on our EU social reporting website including a commentary on findings and the rationale for the work. We have a long history of scientific publications but for reasons of clarity moving forward we will list our recent publications as a starting point for scientific dialogue with stakeholders. As a matter of course we will list all of our future scientific publications.
Action resulting from the Commitment
Five key publications from peer-reviewed journals are listed below:
1. An overview of the effects of tobacco ingredients on smoke chemistry and toxicity.
Baker, R. R., Massey, E. D., Smith, G. (2004)
Food and Chemical Toxicology. 42: S53-S83
This paper presents an overview of a series of studies designed to assess the influence of 482 tobacco ingredients on cigarette smoke chemistry and toxicity. The study indicates that commonly used tobacco ingredients do not change the toxicity of smoke as measured in specified tests. Also the ingredients had no effect on the levels of most smoke constituents that may be relevant to smoking-related diseases. The few smoke constituents where increases have been observed in the presence of some tobacco ingredients, in particular formaldehyde, are highlighted in this paper.
2. Exposure of Bronchial Epithelial Cells to Whole Cigarette Smoke: Assessment of Cellular Responses.
Phillips, J., Kluss, B., Richter, A., Massey, E. D. (2005)
ATLA. 33 (3): 239-248
This study describes a new system for exposing cells at an air-liquid interface to whole cigarette smoke. The system will facilitate further investigations into the toxicological mechanisms of cigarette smoke and its components and may be useful for studying other gaseous mixtures or aerosols.
3. An approach to the validation of biomarkers of harm for use in a tobacco context.
Gregg, E. O., Fisher, A.- L., Lowe, F., McEwan, M., Massey, E. D. (2006)
Regulatory Toxicology and Pharmacology. 44 (3): 262-267
There is both a call and a need for biomarkers of harm that are validated for use in a tobacco context. The paper provides a definition of biomarkers of harm and a shortlist of candidate biomarkers. It also outlines a framework for the validation of biomarkers of harm using a series of epidemiological studies culminating in a targeted prospective study.
4. A comparison of nicotine dose estimates in smokers between filter analysis, salivary cotinine, and urinary excretion of nicotine metabolites.
St Charles, F. K., Krautter, G. R., Dixon, M., Mariner, D. C. (2006)
Psychopharmacology. 189 (3): 345-354.
This study correlates nicotine uptake estimates between filter analysis, salivary cotinine and urinary excretion of selected nicotine metabolites to determine the suitability of these methods in estimating nicotine absorption in smokers of filtered cigarettes. The filter analysis method was shown to correlate with more traditional methods of estimating nicotine uptake. However, because filter analysis is less complicated and intrusive, subjects can collect samples easily and unsupervised. This should enable improvements in study compliance and future study design.
5. Human bronchial epithelial cell transcriptome: Gene expression changes following acute exposure to whole cigarette smoke in vitro
Maunders, H., Patwardhan, S., Phillips, J., Clack, A., Richter, A. (2007)
American Journal of Physiology - Lung Cellular and Molecular Physiology. 292 (5): L1248-L1256
This paper describes the effect of whole smoke exposure on the expression of genes in 3-dimensional cultures of human lung epithelial cells. It summarises changes in cell signalling and function. Effects were observed on many cellular processes including xenobiotic metabolism, oxidant/antioxidant balance and DNA damage and repair. The original data has been made publicly available to provide a resource for independent external scientists with an interest in cigarette smoke toxicity.
Access to all of these publications and new publications is also available on the bat-science.com website.
Commitment:
- By the end of Q1 2008 we will ensure that our European operating companies have clear links from their websites to local sources of information on smoking cessation and quitting advice.
Action resulting from the Commitment
Please find below links to relevant pages on our European operating companies’ websites which refer to local sources of information on smoking cessation and quitting advice.
Commitment:
- By the end of 2007 we will put on the EU social reporting website all the national telephone numbers (quit lines) printed on cigarette packs as part of the EU health warnings.
Action resulting from the Commitment
Please refer to the table below
Country |
Health Warnings and Quit Lines |
|
| Local Language | English Translation | |
| Austria | Hier finden Sie Hilfe, wenn Sie das Rauchen aufgeben möchten: Kontaktieren Sie das Rauchertelefon (0810 810 013 oder www.rauchertelefon.at). Befragen Sie Ihren Arzt oder Apotheker. | If you want to stop smoking, this is where you can get help: contact the quitline (0810 810 013 or www.rauchertelefon.at). Consult your doctor or pharmacist. |
| Belgium | Zoek hulp om te stoppen met roken: 0800 111 00. Faites-vous aider pour arrêter de fumer: 0800 111 00. Hier finden Sie Hilfe, wenn Sie das Rauchen | Get help to stop smoking: 0800 111 00 |
| Bulgaria | Потърсете помощ, за да спрете да пушите: телефон 02/954 98 54. | Get help to stop smoking: tel. 02/954 98 54. |
| Cyprus | Ζητείστε βοήθεια για να σταματήσετε το κάπνισμα : Συμβουλευτείτε το γιατρό/ φαρμακοποιό σας. | Get help to stop smoking: consult your Doctor/pharmacist. |
| Czech Rep. | Váš lékař nebo lékárník Vám může pomoci přestat kouřením. | Your doctor or pharmacist may help you to quit smoking. |
| Denmark | Få hjælp til at holde op med at ryge: Tlf.nr. 80313131. | Get help to stop smoking. Tel. 80313131. |
| Estonia | Otsi abi suitsetamisest loobumiseks: küsi nõu oma perearstilt või apteekrilt. | Seek advice to stop smoking: consult your a family doctor or pharmacist. |
| Finland | Pyydä apua tupakoinnin lopettamiseen: puh. 0800 148 484 / Sök hjälp för att sluta röka: tel. 0800 148 484. | Get help to stop smoking: tel. 0800 148 484. |
| France | Faites vous aider pour arrêter de fumer, téléphonez au 0825 309 310 (0,15 EUR/min). | Get help to stop smoking: call 0825 309 310 (0,15 EUR/min). |
| Germany | Hier finden Sie Hilfe, wenn Sie das Rauchen aufgeben möchten: Bundeszentrale für gesundheitliche Aufklärung (BZgA) Tel. 01805-313131, www.rauchfrei-info.de. | If you want to quit smoking, this is where you can get help: Bundeszentrale für gesundheitliche Aufklärung (BZgA) Tel. 01805-313131, www.rauchfrei-info.de. |
| Greece | 1. Ζητείστε βοήθεια για να σταματήσετε
το κάπνισμα: συμβουλευτείτε το
γιατρό σας. 2. Ο γιατρός σας ή ο φαρμακοποιός σας μπορούν να σας βοηθήσουν να κόψετε το κάπνισμα. |
1. Get help to stop smoking: consult your Doctor. Pharmacist 2. Your doctor or pharmacist may help you to quit smoking |
| Hungary | Kérjen segítséget a leszokáshoz (06-40/200-493; Budapest 1096, Nagyvárad tér 2.; www.oefi.hu), kérdezze meg háziorvosát/gyógyszerészét. | Ask for help to stop smoking: (06-40/200-493; Budapest 1096, Nagyvárad square 2.; www.oefi.hu) consult your doctor/pharmacist. |
| Ireland | Get help to stop smoking: Callsave Quitline 1850 201 203. | Get help to stop smoking: Callsave Quitline 1850 201 203. |
| Italy | Il tuo medico o il tuo farmacista possono aiutarti a smettere di fumare. | Your doctor or pharmacist can help you to quit smoking. |
| Latvia | Lūdz palīdzību, lai atmestu smēkēšanu! (tālr. 7037333). | Ask for help to quit smoking: phone: 7037333. |
| Lithuania | Jūsu gydytojas ar vaistininkas padės jums mesti rūkyti. | Your doctor or pharmacist will help you quit smoking. |
| Luxembourg | Faites-vous aider pour arrêter de fumer: consultez votre médecin / Wenn Sie das Rauchen aufgeben möchten: Befragen Sie Ihren Arzt. | Get help to stop smoking: consult your Doctor/pharmacist. |
| Malta | Itlob l-ghajnuna biex tieqaf tpejjep - 23266116. | Get help to stop smoking - 21231247. |
| The Netherlands | Zoek hulp om te stoppen met roken: DEFACTO 0900 - 9390 (0,10/min) of www.stoppen-met-roken.nl of raadpleeg uw arts of apotheker. | Get help to stop smoking: DEFACTO 0900 - 9390 (0,10/min) or www.stoppen-met-roken.nl or consult your Doctor/pharmacist. |
| Poland | Dzwoniąc pod nr telefonu 0801108108, uzyskasz pomoc w rzuceniu palenia. | Calling 0801108108, you will get help in quitting smoking. |
| Portugal | Para o ajudar a deixar de fumar, consulte o seu médico ou contacte o seu farmacêutico. | Get help to stop smoking:consult your Doctor/ pharmacist. |
| Romania | 0800 87 86 73 Alege libertatea, noi te vom ajuta. Pentru a renunţa la fumat, consultaţi doctorul / farmacistul dumneavoastră. | 0800 87 86 73 Choose freedom, we help you. To stop smoking, consult your doctor/ pharmacist. |
| Slovakia | Váš lekár alebo lekárnik Vám može pomocť prestať s fajčením. | Your doctor or pharmacist may help you to quit smoking. |
| Slovenia | Kajenje ubija. Opustite kajenje: tel. št. 080 2777. | Smoking kills. Quit smoking: tel. no. 080 2777. |
| Spain | Ayuda para dejar de fumar: consulte a su médico o farmacéutico. | Get help to stop smoking:consult your Doctor/ pharmacist. |
| Sweden | Sök hjälp för att sluta röka: fråga din läkare, på apotek eller Sluta röka-linjen 020-84 00 00. | Get help to stop smoking: consult your doctor, your pharmacist or the Stop Smoking telephone line 020-840000. |
| UK | 0800 169 0 169 Choose freedom, we'll help you. Get help to stop smoking. | 0800 169 0 169 Choose freedom, we'll help you. Get help to stop smoking. |
Commitment:
- By the end of 2007 we will provide, through our EU social reporting website, access to those internet sources of information and fora which follow the scientific debate on snus.
Action resulting from the Commitment
www.tobaccoharmreduction.org
A project of the Alberta Smokeless Tobacco Education & Research Group at the University of Alberta which aims at providing a forum in which to discuss the essence and thinking behind Tobacco Harm Reduction.
www.harmreductionjournal.com
Harm Reduction Journal is an open access, peer-reviewed, online journal whose focus is prevalent patterns of psychoactive drug use, public policies meant to control them, and the search for effective methods of reducing the adverse medical, public health, and social consequences associated with both drugs and drug policies.
www.gothiatek.com
The purpose of this site is to explain GothiaTek®, a quality standard for Swedish Snus, and also to summarise existing scientific documentation about Swedish Snus.
Organisations active in the field of tobacco control:
Commitment:
- In Q1 2008 we will invite EU stakeholders involved in public health issues to visit our scientific facilities and will organise a panel discussion on the key scientific and regulatory challenges for harm and harm reduction. Despite the difficulties in gaining the confidence of the public health community we will not be deterred from pursuing engagement with all working in the tobacco area.
- Before the end of 2007 we will develop and share, initially with the European Commission, our views on a research agenda for Europe designed to underpin public health policy developments on tobacco regulation and comprising our proposed contribution to this process.
- We will include the issue of independent research and future funding of research and any proposals on this matter into the agenda of the "panel discussion" planned under commitment 5.
- We will investigate possibilities for our involvement in the EU Community framework programmes for research and technological development in Europe and in the Sinapse research network, where, if appropriate, we will contribute research know-how and scientific expertise. Information on the progress in this area will be posted on the EU social reporting website within a year after the social report publication.
- We believe that we have scientific knowledge and expertise in this area and will seek to publish our findings as appropriate and share these findings with the public health community and their scientific advisors.
- We will seek to drive and contribute to the design of a specific research method, to study consumer perception and potential behaviour in respect of reduced risk products, and to establish their likely acceptability and use. We would intend to discuss our approach with the scientific community and to seek recognition for the method as part of a public health impact assessment. Once such a method is available we are committed to use it and report our research findings appropriately. This approach would become an element of our proposal for an EU research agenda.
- We will provide periodic updates on the progress or otherwise we achieve in communicating with stakeholders on these issues on the EU social reporting website and specific commitments that may arise through continued dialogue.
- We shall seek to develop a protocol which can demonstrate whether modified products result in reduced exposure to specific smoke constituents when used by consumers. As part of this commitment we shall:
- seek independent recognition of this protocol by the scientific and public health community,
- share the protocol as appropriate with external stakeholders and seek their feedback,
- apply the protocol in the development, assessment and validation of future modified products presuming acceptance by the scientific and public health community,
- provide information on progress in this area on the EU social reporting website no later than one year from publication of this social report.
- We will seek engagement with regulators, scientific and health community in order to identify the ways of providing consumers with meaningful information about the risks associated with tobacco consumption and potential ways to reduce them. The results of this engagement, being one of the elements of EU research agenda proposal (commitment 6), will be reported on EU social reporting website on annual basis.
Action resulting from the Commitments
In our Social Report 2006/2007, we set out a number of commitments in respect of areas of our scientific research-related activities, some of which we have reported on with others remaining open or on-going. One key component of our stated commitments was commitment 5. This was intended to involve inviting a significant number of public health stakeholders to our Group Research and Development facility in Southampton, UK, to present to them our approach to European tobacco product regulation and to the issue of tobacco harm reduction. Invitees were to have an opportunity to tour our Group Research and Development facility and to generate a series of questions and topics to be discussed in an open, independently facilitated, panel discussion. It was anticipated that the subjects which would be raised and discussed would have relevance to a number of our outstanding commitments in our Social Report.
In early 2008 over 50 EU-based stakeholders were contacted and invited to visit our Group Research and Development facility to discuss and exchange views on tobacco product regulation and key scientific and regulatory challenges in the area of tobacco harm reduction. Whilst a small number of stakeholders did accept our invitation, the number of acceptances was deemed too low to be able to develop a substantive and broad-based panel discussion on these areas and, regrettably, the event was cancelled.
In the interests of openness and transparency, we are including on this website the outline agenda we had proposed for this event and we will provide some context for our positions and views on issues relating to tobacco product regulation and our approach to tobacco harm reduction. We would like to invite any interested stakeholder to comment on our views and we will provide detailed responses, as appropriate.
Related document : Developing a Scientific Basis for Product Regulation & Harm Reduction
Through our membership of the European industry association CECCM (Confederation of European Community Cigarette Manufacturers), we have provided our views on the European Commission’s review process on the Tobacco Products Directive (TPD) and on Articles 9 and 10 of the WHO’s Framework Convention on Tobacco Control (FCTC) relating to regulation of the contents of tobacco products and disclosures. In the case of FCTC Articles 9 and 10, CECCM members have provided their views on the FCTC Working Group’s progress report of 26 April 2007 on measurement and reporting of product contents and emissions including consideration of product characteristics (see commitment No 6).
The CECCM communications referred to above set out where it saw clear alignment between developments under the TPD and the emerging FCTC Articles 9 and 10 guideline process, and proposed an outline on how further progress could be made in addressing the public health regulatory agenda on tobacco product regulation issues. CECCM also highlighted the initiatives undertaken by the European Commission on the format for ingredients reporting and the emerging electronic database system for collecting and holding industry data in a secure form that could become the basis of international best practice.
A. In the absence of a specific stakeholder dialogue meeting and a panel debate on tobacco product regulation and harm reduction in 2008 (see above), we wish to present our initial thoughts on British American Tobacco’s approach to tobacco product regulation in Europe, which can be broadly summarised as follows:
- We believe there should be clear definitions for what is meant by "contents" and "emissions" of tobacco products. We support the FCTC Working Group’s provisional definitions (contained in its progress report of 26 April 2007) for: (1) "contents" to include “all tobacco product components, materials used to manufacture those components, residual substances in tobacco from agricultural practices and from storage and processing and substances that migrate from packaging material into the product, as well as all additives and processing aids…[and] substances that occur naturally in the tobacco”; and (2) "emissions" to include "all substances that are produced and released when the product is used…in the case of cigarettes and other combusted or heated products, emissions refers to the substances found in smoke. In the case of smokeless tobacco products for oral use, emissions refer to substances released during the process of chewing or sucking, and in the case of nasal use, to substances released during the process of sniffing." In the case of "emissions" we understand this to mean those compounds that are extracted from tobacco during use (as in the case of oral tobacco products) and compounds generated during combustion of smokable products and contained in the smoke.
- We support the principle of two reporting templates. One template should be for the reporting by manufacturers of ingredients used in product manufacture for use by national regulatory authorities. This template would contain full ingredients’ disclosure by brand and be accompanied by a table summarising the available toxicological data provided in part to support use of such ingredients. The second template should be provided for the benefit of consumers and should contain relevant and understandable non-trade secret information.
- We support the principle of an electronic secure database system of the type under development by EMTOC that could be used for collecting and holding ingredients, and potentially other brand specific, information.
- We believe that these basic approaches described in paragraphs (2) and (3) above, and which are under development for application within the EU, could form the basis of international best practice for product information reporting to regulators worldwide.
- We support the principle of seeking independent expert opinion and research being undertaken to establish the criteria and process whereby ingredients could be assessed to determine their acceptability for use. In addition, we acknowledge the public health interest in determining the extent to which an ingredient could possibly enhance dependence liability (addictiveness). Although we do not believe that any ingredients as currently used have this potential property, we would support any research to resolve this issue.
- In the case of emissions, we accept the principle of measuring certain analytes and we are ready and willing to share our knowledge and experience with the European Commission on this subject, as well as with the GoToLab as part of the WHO Tobacco Laboratory Network which has proposed that it validates methods for testing and measuring the nine cigarette smoke analytes as referred to in the FCTC Working Group’s progress report of 21 August 2008 on FCTC Articles 9 and 10. It is our view that measurement should be for the purpose of informing public health policy development and we believe that these nine and any other cigarette smoke analytes to be measured should have public health relevance in order to set priorities and targets for reduction. We believe that appropriate research should be undertaken to:
- (a) Agree which analytes to focus on and to what extent each has public health relevance in order to set priorities for potential reduction; and
- (b) Ensure that any product designs or analyte level setting has meaningful reduction and relevance for actual human exposure.
In agreeing and setting the principles proposed in paragraph A (6) above, it is implicit that products must be measured to determine analyte yields using some form of standardised smoking regime as a basis of assessing product performance under such conditions. For this purpose the standardised regimes of the International Organisation for Standardisation (ISO), and the “Massachusettes” (MA) and Canadian intense machine smoking regimes are currently available. However, the selected smoking regime will affect the complex combustion process taking place and will potentially change the relative amounts of each analyte generated. Each selected regime will have some effect on the individual yields of each analyte. The Canadian intense method will have the most significant effects in this regard due to the extreme modifications made to the product as part of the smoking regime. Consequently, if such smoking regimes are used for the purpose of measuring analytes, if comparing these yields relative to e.g. nicotine and/or setting levels for regulatory purposes, it is critically important for regulators to understand how any chosen regime may differ from the wide range of human smoking behaviours and hence how any measurements taken may differ from actual human exposure. - The issue of estimating how populations of consumers use their products was considered as part of the ASPECT report on Tobacco or Health in the European Union (The ASPECT Consortium 2004; Office for Official Publications of the European Committees) prepared for the European Commission, and one suggested approach was the use of filter analysis. We have studied extensively the method of filter analysis and believe this technique is a valid and appropriate public health approach to estimate how individuals and populations of smokers use their cigarette products. Details of our filter analysis methodology can be found on (www.bat-science.com; Yield in use).
- We would also support the recommendations of the ASPECT report that research should be undertaken to determine a series of biomarkers of exposure in respect of analytes identified by the FCTC Working Group for emissions’ testing and measuring. We believe that this would allow the relationship between levels in smoke determined from machine measures and those found in smokers to be established, and thereby determine the consequences of changing product yields. This would identify whether such changes have significance for public health policy. We have undertaken some research in these areas which show, in general, strong correlation between yields of specific analytes estimated using filter analysis and a series of their bio-makers of exposure (www.bat-science.com; Exposure assessment).
- We are continuing to review and explore research funding options within the EU for independent research to further the interests of public health e.g. on the toxicological assessment of ingredients (commitments 18 and 19).
- In the absence of opportunities in 2008 to share our scientific knowledge and expertise directly with members of the European public health community, we will continue to report our scientific research articles and publications on www.bat-science.com (commitment 20). We will continue to seek engagement opportunities with regulators and the scientific and public health communities in order to identify ways of providing consumers with meaningful information about the risks associated with tobacco consumption and potential ways to reduce them (commitments 22 and 24). We envisage governments and public health authorities taking the lead in providing this type of information.
B. In the absence of a specific stakeholder dialogue meeting and a panel debate on tobacco product regulation and harm reduction in 2008, we wish to outline below our Group’s approach to tobacco harm reduction:
- Our Group approach is to pursue the research, development and test marketing of innovative tobacco products that will have consumer acceptability and will be recognised by scientific and public health communities and regulators as posing reduced risks to health.
- We believe that a pragmatic, public health approach to tobacco control should recognise a risk continuum of products. Conventional cigarettes would sit at the higher risk end, while certain types of smokeless tobacco products would sit at the lower risk end. We also believe that tobacco consumers should be provided with practical advice on different product choices and behaviours that might reduce their risks, in addition to quitting advice. We think that the most important contribution we can make to tobacco harm reduction is to develop and make available a range of products that are potentially reduced-risk compared to conventional cigarettes.
- A large number of epidemiological studies have been conducted over many years covering the use of products such as cigarettes. For each category of product there is invariably a clear relationship between the average number of cigarettes smoked on a daily basis, the number of years of smoking history and the observed relative risk of a smoking-related disease. This finding is consistent with the general toxicological observation that time (the period of use) and the dose (the daily exposure to toxicants absorbed into the body), are the primary determinants of the observed risk. It follows from this observation that, whilst consumers determine their duration of product use, it may be possible to develop modified combustible products that could potentially result in a reduction in exposure to smoke and certain toxicants. Smoke exposure can be represented by tar or some specific analytes (including their combination) present in smoke emissions, which when reduced, may result in both their reduction in exposure and lower risk.
- There are three categories of product and their use that might be considered in respect of duration of product use and dose and hence their potential risk. The first product category is that of currently available conventional cigarette products. The second category is that of modified conventional cigarette products with reduced levels of specific toxicants and, thirdly, there is a category of non-combustible tobacco products such as the low toxicant smokeless tobacco product known as Swedish-style snus.
- Setting aside the controversial issue of whether groups of smokers smoking products of lower tar and nicotine yields determined on smoking machine values (ISO numbers) obtain the same level of smoke as those smoking products with higher machine values, all scientists would agree that there is significant merit in being able to determine the dose when assessing risk (which may or may not be different across populations of smokers). It is our view, which accords with that stated in the ASPECT report, that such an objective is highly desirable. We believe that filter analysis (see section A above) would enable estimates of cigarette tar and nicotine yields to be made for both individuals and populations of smokers, and that such information would provide a critical foundation for informing public health policy and the development of future regulation in this area. Our data to date would clearly indicate that populations of low and ultra low products smokers (based on ISO yields) receive, on average, lower amounts of smoke (at least at the mouth level) than those smoking the highest yielding ISO products. Whilst the reduction in mouth level yields is not directly proportional to the ISO yield values, there is a clear correlation between the two (www.bat-science.com; Exposure assessment). We think this observation should be investigated further. In addition a tool such as filter analysis should be considered as a means of researching the factors that might influence smokers’ behaviour; examples being nicotine levels in products, tar and nicotine ratios and the role of tar in influencing smokers’ behaviour.
- In section A above, we outlined the potential public health interest in measuring and setting levels for certain smoke (product) emissions. We stated that such an objective should be for a purpose which we see as being the identification of, and agreement on, priority emissions (toxicants) to determine whether setting product performance criteria will result in quantifiable reductions in exposure of consumers to such toxicants. We would advocate that this objective lays the foundations for a programme of product modification that could result in substantial reduction of priority toxicants (emissions) with the potential to reduce the health risks of smoking (commitments 21 and 23). It is our view that this approach requires a multi-step research process that can be outlined as follows:
- (a) Quantification of how consumers smoke their products and their mouth level intake of smoke. We believe that filter analysis is a critical tool for this purpose (www.bat-science.com; Yield in use).
- (b) The identification of criteria to determine priority toxicants (emissions) that have significance for public health.
- (c) The evaluation and development of biomarkers of exposure to determine smoker uptake of toxicants and assess the correlation between filter analysis and toxicant exposure (www.bat-science.com; Exposure assessment).
- (d) Develop and assess product designs and technologies that can substantially reduce levels of toxicants in smoke.
- (e) Undertaking of clinical studies to quantify the extent to which reduced smoke toxicant levels result in actual reductions in exposure.
- (f) Over time the development of assessment procedures to determine whether such changes can reasonably be expected to reduce the risk of one or more specific diseases.
- (g) Our general approach to the development and assessment of reduced toxicant products can be found on www.bat-science.com. As we publish our scientific research and findings we will continue to post them on this website.
- (a) Quantification of how consumers smoke their products and their mouth level intake of smoke. We believe that filter analysis is a critical tool for this purpose (www.bat-science.com; Yield in use).
Commitment:
- We will continue to communicate to competent bodies and the scientific community the reduced health risks of snus when compared with smoking.
- We will work with others to organise a European seminar on snus and harm reduction by the end of 2007 to include a review of the findings and recommendations of the SCENIHR Committee.
- Within the next 12 months we will initiate a pilot test of Swedish snus in Canada. All new introductions of snus will be carefully monitored and we seek to develop these potential opportunities through engagement and co-operation with regulators and public health stakeholders.
- We will continue to share relevant consumer insights and information - generated from such initiatives as launching snus in Canada and potentially other markets - with authorities and competent scientific bodies in an open and transparent manner.
- Depending on our evolving learning, we will consider the potential to expand our snus portfolio not only geographically but also using additional brands and product variants.
- We would be pleased to share with interested parties the design of our consumer research. We will publish an outline of the consumer research design on our EU social reporting website by the end of 2007.
- We will share our research findings with the Commission and its advisors no later than one year after publication of this social report. Subsequently we will share the findings of our research with other interested parties as may be appropriate.
- We will continue to track the scientific literature and the public health concerns on TSNA and nicotine content in snus and will respond accordingly. If our position changes on this matter we will report our change of view.
Action resulting from the Commitments
We believe adult tobacco consumers should have the option of a choice of tobacco products in Europe including snus, a form of smokeless tobacco traditionally used in Sweden. There is increasing consensus that snus presents substantially lower overall health risks than cigarettes, such as lower risks of lung cancer and chronic obstructive pulmonary disease. Research on snus and heart disease is less clear and some public health bodies have concluded that snus is a cause of pancreatic cancer and other diseases. Sales of snus products are currently banned within the EU, except in Sweden which obtained an exemption to this ban when it acceded to the EU. In 2008, the Scientific Committee on Emerging and Newly Identified Health Risks, which provides scientific advice to the European Commission, published its opinion on the “Health Effects of Smokeless Tobacco Products”. The conclusions in this publication included that “for those who substitute smoking by smokeless tobacco products, the benefits outweigh the risks.” We believe that potentially reduced-risk products such as snus might have a role to play in a broader public health approach to tobacco harm reduction, in addition to prevention and cessation efforts, and that these types of products should be allowed to be sold within the EU.
This is a recent and new tobacco product category for British American Tobacco, and we are currently test marketing snus products in Canada and South Africa to develop our understanding of consumer preferences and appeal. We will share relevant information when available.
The European Smokeless Tobacco Council (ESTOC) has in June 2008 organised a seminar to discuss and review science in relation to snus.
We have made scientific findings on smokeless tobacco products and a summary of our snus research programme available on www.bat-science.com.