Further development of the partial guidelines for implementation of articles 9 and 10 of the WHO Framework Convention on Tobacco Control: report by the working group

Conference of the Parties to the WHO Framework Convention on Tobacco Control Seventh session Delhi, India, 7 - 12 November 2016 Provisional agenda item 5.4 FCTC/COP/7/8 15 August 2016 66 Further development of the partial guidelines for implementation of Articles 9 and 10 of the WHO Framework Convention on Tobacco Control Report by the Working Group BACKGROUND 1. This document was prepared in response to the request made by the Conference of the Parties (COP) 1 at its sixth session (Moscow, Russian Federation, 13–18 October 2014), asking the working group on Articles 9 and 10 to: (a) continue its work in elaborating guidelines in a step-by-step process, and to submit draft partial guidelines or a progress report on the disclosure, testing and measuring of contents and emissions to the next session of the COP, taking into account: (i) the analytical chemical methods for testing and measuring cigarette contents and emissions validated by WHO; and (ii) the draft text prepared by the Key Facilitators followed by discussions of the working group at its eighth meeting 2 ; (b) explore possibilities for defining “constituents” in a way that is meaningful and acceptable to the COP, taking into account the alternative possible definitions discussed by the working group at its eighth meeting 3 and continue work on other definitions in the area of product regulation; (c) continue to monitor areas such as dependence liability and toxicology, including for smokeless tobacco products and waterpipe tobacco products, and in particular take stock of information obtained from WHO in relation to these areas, examine relevant issues, and report back to the next session of the COP; (d) consider specific cigarette characteristics of interest, including slim/super slim designs, filter ventilation, and innovative filter design features including flavour-delivering mechanisms such as capsules, to the extent that those characteristics affect the objectives of the WHO 1 Decision FCTC/COP6(12) http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6(12)-en.pdf 2 See Annexes 1 and 2 of document FCTC/COP/6/13 http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_13-en.pdf 3 See Annex 3 of document FCTC/COP/6/13http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_13-en.pdf FCTC/COP/7/8 2 FCTC, and submit further draft partial guidelines or a progress report in relation to these issues to the next session of the COP. 2. This document also addresses, in part, the ongoing mandate assigned to the working group by the COP at its fourth session (Punta del Este, Uruguay, 15–20 November 2010)4 to “continue its work in elaborating guidelines in a step-by-step process, and to submit draft guidelines on addictiveness and toxicity to future sessions of the Conference of the Parties for consideration”. 3. The ninth meeting of the working group (Antalya, Turkey, 2–4 February 2016), organized by the Convention Secretariat, was attended by 25 Parties 5 and three Key Facilitators 6 . Representatives from WHO, the WHO Study Group on Tobacco Product Regulation and the WHO Tobacco Laboratory Network also attended at the invitation of the Convention Secretariat, while representatives of civil society participated as observers. 4. During the meeting, the working group discussed all matters falling within its mandate. In particular, it examined a text drafted by the Key Facilitators for inclusion in the partial guidelines in relation to tobacco product addictiveness, disclosure of information on the contents of tobacco products to governmental authorities, disclosure of information on product characteristics and their regulation, as well as well as considered updates from WHO in the area of analytical chemical method validation. 5. The working group did not explore definitions for “constituents” given its heavy agenda, but discussed smokeless tobacco products and waterpipe tobacco products as requested by the COP 7 . 6. The Key Facilitators prepared the present report based on deliberations at the ninth meeting of the working group. A draft was made available to the Parties on 18 May 2016. Comments from 18 Parties were received and considered by the Key Facilitators. Addictiveness of tobacco products 7. The mandate of the working group assigned by COP4 included submitting draft guidelines on addictiveness and monitoring progress in this area. The working group agreed at the time that drafting guidelines on addictiveness reduction would be premature and opted instead to provide the COP with a background paper 8 containing information on the level of knowledge, as well as guidance on additional research that could be undertaken in this area. 8. Further to the mandate it received at COP6, the working group considered at its ninth meeting the latest research on the reduction of tobacco product addictiveness, as well as the recent WHO Advisory Note on nicotine reduction 9 . 9. Bearing in mind the step-by-step development of the guidelines for implementation of Articles 9 and 10, the working group presents a draft text relating to the addictiveness of tobacco products, attached to the present document as Annex 1. The draft text is for insertion in sections labelled “Use of 4 Decision FCTC/COP4(10) http://www.who.int/fctc/guidelines/Decisions9and10.pdf 5 Australia, Belgium, Benin, Bhutan, Burkina Faso, Colombia, Cameroon, Democratic Republic of the Congo, Germany, Hungary, India, Japan, Kenya, Madagascar, Maldives, Mauritania, Nicaragua, Nigeria, Norway, Philippines, Senegal, Singapore, Thailand, Ukraine, Viet Nam 6 Brazil, Canada and Turkey (regrets from European Union) 7 Decisions FCTC/COP6(8) and FCTC/COP6(10) http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6(8)-en.pdf and http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6(10)-en.pdf 8 See document FCTC/COP/5/9, Annex 3 http://apps.who.int/gb/fctc/PDF/cop5/FCTC_COP5_9-en.pdf 9 See Advisory Note : Global Nicotine Reduction Strategy, WHO Study Group on Tobacco Product Regulation (http://www.who.int/tobacco/publications/prod_regulation/nicotine-reduction/en/) FCTC/COP/7/8 3 terms” and “Objectives” of the Partial Guidelines for implementation of Articles 9 and 10, as adopted at COP4 and 5. 10. The working group also discussed a draft text on the regulation of contents to reduce the addictiveness of tobacco products, but did not reach consensus. Some participants felt that it was premature to develop guidelines, while others supported advances in addictiveness reduction policies. Annex 4 shows, for information purposes, the draft text prepared by the Key Facilitators following the deliberations of the working group. Disclosure of information on the contents of tobacco products 11. The working group presents a draft text, attached to the present document as Annex 3, on the disclosure to governmental authorities of information on the contents of tobacco products. This draft text is for insertion in the indicated sections of the Partial Guidelines for implementation of Articles 9 and 10. 12. The working group noted the progress made by WHO in validating the analytical chemical methods for testing and measuring the contents and emissions of tobacco products. Work on validating the methods for the chemicals identified as priorities at COP3 is now completed (a current description of the work performed can be found in the report of WHO to the COP 10 ). Product characteristics – disclosure and regulation 13. Subsequent to discussion at the eighth meeting of the working group, as well as at COP6, and following an expert presentation on how specific product characteristics can affect the perception and consumption of tobacco products and, thereby, public health, the working group is offering a draft text on the disclosure to governmental authorities of information relating to product characteristics and on the regulation of product characteristics, attached to the present document as Annex 2. This draft text is for insertion in the indicated sections of the Partial Guidelines for implementation of Articles 9 and 10. 14. The working group is concerned about constant modifications to tobacco products to make them more attractive to tobacco users. Studies have shown that product characteristics or product design features have the potential to mislead smokers and potential consumers, and to affect their perception, knowledge and attitude towards tobacco use. 15. For instance, slim cigarettes have been used by the industry to target women and have been marketed to strengthen the perceived association between smoking and a slender appearance. Slim cigarettes, and the more recent versions known as superslim and ultraslim, are especially appealing to young women and seek association with femininity, elegance, slimness and reduced harm. 16. Flavour capsules have been placed in the filter of cigarettes by tobacco manufacturers to provide highly concentrated flavour (generally menthol and related flavours) when the capsule is crushed by the smoker thus making the product more palatable by giving a cooling and moistening effect to tobacco smoke and masking its harsh and irritating character. This can encourage consumption and help sustain smoking and continued exposure to the toxic substances found in the smoke. 17. The issue of filter ventilation was briefly considered, but the regulation of this design feature warrants further discussion. 10 See document FCTC/COP/7/9 FCTC/COP/7/8 4 Smokeless tobacco products 18. The working group was presented with information regarding the toxicity, addictiveness and public health impact of smokeless tobacco products (SLT), as well as one Party’s experience in regulating these products. 19. The working group agrees that smokeless tobacco products are to be considered tobacco products, as per the definition set out in the WHO FCTC. The working group recognizes that the provisions in the FCTC, its guidelines and the Protocol apply. 20. The working group further agrees that existing partial guidelines for implementing Articles 9 and 10 already include recommendations about the regulation of ingredients and the disclosure of information that are applicable to smokeless tobacco products. 21. The working group took note of the establishment of a Knowledge Hub on smokeless tobacco products and of its plan to help Parties access related information. 22. In view of the fact that there is no single compendium that brings together information on the toxicants found in smokeless tobacco products and the available methods to analyze them, the working group would like to suggest that the COP invite WHO to address this gap, by working with the Knowledge Hub on SLT to: (a) Collect scientific information on the toxicants in SLT and analytical methods used to measure them, and the levels found in products on the market; (b) Advise on the availability of validated analytical methods and need for further development and validation of analytical methods; (c) Identify available processes to reduce toxicants; and (d) Determine the feasibility of achieving a reduction in toxicant levels resulting in meaningful reductions in health risk and identify, where possible, the nature and magnitude of the expected reduction in health risks. Waterpipe tobacco products 23. The working group was presented with information regarding the contents and emissions of waterpipe tobacco products, their toxicity and public health impact, as well as the experience of two Parties in regulating these products. 24. The working group took note of the establishment of a Knowledge Hub on waterpipe products and of its plan to help Parties access related information. 25. The working group agrees that waterpipe tobacco products are to be considered tobacco products, as per the definition set out in the WHO FCTC. The working group recognizes that the provisions in the FCTC, its guidelines and the Protocol apply. 26. The working group further agrees that the existing partial guidelines for implementing Articles 9 and 10 already include recommendations about the regulation of ingredients and the disclosure of information that are applicable to waterpipe tobacco products. 27. The working group heard about the negative impact of tobacco-free waterpipe products on waterpipe tobacco smoking prevention and control. The working group wishes to obtain direction from the COP as to whether or not these products should be considered as waterpipe tobacco products for the purposes of Articles 9 and 10. 28. In view of the preceding information, does the Conference of the Parties agree that within the context of Articles 9 and 10 the definition of waterpipe tobacco products includes tobacco-free waterpipe products? FCTC/COP/7/8 5 29. The working group heard about the negative health impact stemming from the use of charcoal in waterpipe smoking and from the re-use of water and other fluids. The working group wishes to obtain direction from the Conference of the Parties as to whether or not such design features should be considered as part of the “contents and emissions” for the purposes of Articles 9 and 10. 30. In consideration of the preceding information, does the Conference of the Parties agree that within the context of Articles 9 and 10 “contents and emissions” is understood to comprise the characteristics, including the design features, of the waterpipe apparatus and its various components, such as its heating/burning parts and water/fluids? Research infrastructure and capacity issues 31. The working group wishes, as it has before, to invite all Parties, the Knowledge Hubs and WHO to continue building capacity to require the tobacco industry to test and disclose the contents and emissions of tobacco products to regulatory authorities, as well as to share their newly acquired knowledge and technical expertise with other Parties. PROPOSED FUTURE WORK 32. The following are tasks that COP may wish to assign to this working group, an expert group, or to invite WHO to undertake: (a) Engagement in discussion on the regulation of addictiveness reduction (as per Annex 4) to identify barriers to implementation and to increase knowledge and bridge the gap between science and policy development; (b) Weighing the positive and negative consequences of implementing addictiveness reduction policies; (c) Identification of strategies to build capacity for Parties wishing to monitor markets through registration, licensing or notification of tobacco products in order to inform policy making; (d) Examination of market developments and usage related to “heat-not-burn” tobacco products and other novel tobacco products. 33. Should the Conference of the Parties decide that within the context of Articles 9 and 10 the definition of waterpipe tobacco products does not include tobacco-free waterpipe products, the working group could nevertheless be asked to examine these products as part of its deliberations. Action by the Conference of the Parties 34. The COP is invited to note this report, to review and consider adopting Annexes 1, 2 and 3 proposed for insertion into the existing partial guidelines on Articles 9 and 10, and to provide further guidance respecting the questions set out in paragraphs 28 and 30 of this report. Corrigenda 35. The working group wishes to correct two errors in Section 8 of Annex 3 of its report to COP 5 (FCTC/COP/5/9), at page 14. 36. The last sentence of the second paragraph should read: “These cigarettes each reportedly contained 0.3 mg nicotine per gram of dry tobacco.” 37. The last sentence of the fourth paragraph should read: “Researchers used molecular biological technologies in the late 1990s at North Carolina State University in the USA to develop a tobacco line with nicotine yields of about 0.05 mg nicotine per cigarette (measurements made from cigarettes produced in the USA that used leaves from this line)”. FCTC/COP/7/8 6 ANNEX 1 (Partial Guidelines for Implementation of Articles 9 and 10 of the WHO FCTC) OBJECTIVES – ADDICTIVENESS REPLACE 1.2.1.2 Addictiveness (dependence liability) with the following 1.2.1.2 Addictiveness The addictive nature of tobacco products is well established. This is recognized in the WHO FCTC which, in its preamble, clearly states that tobacco products create and maintain dependence. Further, Article 5.2 of the WHO FCTC stipulates that Parties shall “adopt and implement effective legislative, executive, administrative and/or other measures and cooperate, as appropriate, with other Parties in developing appropriate policies for preventing and reducing tobacco consumption, nicotine addiction and exposure to tobacco smoke. Modifying tobacco products by regulating their contents alone, or both their contents and emissions, may help prevent nicotine addiction/tobacco dependence. Such modificatıons may also help addicted tobacco users in their cessation efforts. Any reduction of the addictiveness of tobacco products resulting from the regulation of their contents, or both their contents and emissions, in no way suggests that those tobacco products are less dangerous for human health. USE OF TERMS – ADDICTIVENESS INSERT at “1.3 Use of Terms” “Addictiveness”, sometimes referred to as dependence liability or addiction potential, means the pharmacological potential of a substance or product to cause dependence. Addictiveness is a complex process that varies wıth the chemical characteristics of the tobacco product’s emissıons, with key elements including the dose, speed of absorption, metabolism, and physical and chemical features of the product. Although the concepts of “addictiveness” and “nicotine addiction/tobacco dependence” are linked, they have different meanings 11.” 11 “Nicotine addiction” is used in Articles 5 and 22 of the FCTC, whereas “tobacco dependence” is used in Article 14. The Guidelines for implementation of Article 14 of the WHO Framework Convention on Tobacco Control offer a definition of “tobacco addiction/dependence” which is found in the section entitled “Use of terms.” FCTC/COP/7/8 7 ANNEX 2 (Partial Guidelines for Implementation of Articles 9 and 10 of the WHO FCTC) PRODUCT CHARACTERISTICS – DISCLOSURE ADD at 3.3.1.1 “Background” after first paragraph Furthermore, when combined with sales figures, such data will help Parties analyze market trends. ADD at “APPENDIX 2 Design features of cigarettes” (n) Description and explanation of function of all innovative components added to the cigarette, such as capsules. PRODUCT CHARACTERISTICS - REGULATION INSERT 3.3.2.2 Tobacco Products – Regulation in relation to attractiveness (i) Background The tobacco industry is continuously aiming at making tobacco products more attractive by modifying existing product design features or introducing new ones. An example is the industry’s manufacture of cigarettes with an ever-smaller circumference (slim, superslim, ultraslim). Another example is the placement of capsules in cigarette filters that release flavour when crushed. Product design features are used by the tobacco industry to develop strategies making products more attractive to different segments of society, an approach known as market segmentation. These segments can be based for example on age, gender, ethnic or cultural background, socioeconomic status and health concerns. The tobacco industry then targets these segments by developing product design features that meet their expectations and interests with regard to health, glamour, novelty, self- image, weight loss, convenience/ease of use, sensory experience and others. Regulating product design characteristics to decrease tobacco product attractiveness can contribute to reducing the prevalence of tobacco use. (ii) Recommendations Parties should consider regulating tobacco products by prohibiting or restricting product design features that increase their attractiveness. These may include cigarettes with a reduced circumference, the placement of capsules in filters and innovative product design features. FCTC/COP/7/8 8 ANNEX 3 (Partial Guidelines for Implementation of Articles 9 and 10 of the WHO FCTC) CONTENTS – DISCLOSURE REPLACE 3.1.3 Constituents (Disclosure) WITH the following 3.1.3 Contents (Disclosure to governmental authorities) This section outlines requirements which Parties could introduce for the disclosure by manufacturers and importers of tobacco products of information on the contents of these products to governmental authorities 3.1.3.1. Background Given the numerous toxic and addictive substances contained in tobacco products, governmental authorities with access to information on tobacco contents are in a better position to understand the nature of their tobacco product market. Such information can then be used by governmental authorities to inform the development of policies and regulations respecting the attractiveness, addictiveness or toxicity of tobacco products. For example, given that nicotine is the main substance in tobacco involved in the addictive process, Parties may wish to obtain information on the amount of nicotine present in the various tobacco products available in their domestic market. To help collect such information, governmental authorities can mandate the use of analytical laboratory methods for the testing and measuring of contents of tobacco products developed under the auspices of WHO. 12 The WHO Study Group on Tobacco Product Regulation identified a non- exhaustive list of priority toxic contents and emissions of tobacco products for regulation under Articles 9 and 10 of the WHO FCTC. 13 These methods can be easily performed by a wide spectrum of laboratories. Methods have also been developed by various governmental authorities and international organizations. 3.1.3.2 Recommendations (i) Parties should consider requiring manufacturers and importers of tobacco products to disclose to governmental authorities at specified intervals, information about the contents of their tobacco products by product type, and for each brand within a brand family. (ii) When requiring the testing and measuring of nicotine, Parties should consider specifying that the Tobacco Laboratory Network Official Method SOP 04, entitled Standard operating procedure for determination of nicotine in cigarette tobacco filler, World Health Organization 14 , be used by the laboratories performing the test on behalf of the manufacturers and importers of tobacco products. (iii) Parties should consider requiring that every manufacturer and importer provides to governmental authorities a copy of the laboratory report that shows the product tested and the results of the testing and measuring conducted on that product. In accordance with paragraph 2.4, Parties should also consider asking for proof of accreditation of the laboratory that performed the testing and measuring. 12 See the list of available WHO methods at http://who.int/tobacco/publications/prod_regulation/en/ 13 For the full list, see WHO Technical Report Series, n. 989, WHO Study Group on Tobacco Product Regulation: report on the scientific basis of tobacco product regulation, available at: http://apps.who.int/iris/bitstream/10665/161512/1/9789241209892.pdf?ua=1&ua=1 14 See http://apps.who.int/fctc/implementation/database/article/article-10/resources FCTC/COP/7/8 9 ANNEX 4 FOR INFORMATION PURPOSES ONLY (Partial guidelines for Implementation of Articles 9 and 10 of the WHO FCTC) CONTENTS – REGULATION REPLACE “3.1.4 Constituents (Regulation)” WITH the following 3.1.4 Contents (Regulation) This section outlines measures that Parties could introduce to regulate contents. Parties should introduce the measures recommended in this section, in accordance with their national laws, taking into account their national circumstances and priorities. 3.1.4.1. Regulating the addictiveness of tobacco products The preamble to the WHO FCTC states that Parties recognize that cigarettes and some other products containing tobacco create and maintain dependence. Tobacco-related diseases and death caused by the toxic substances present in tobacco products and tobacco smoke, often occur because of long-term tobacco use triggered by nicotine, the substance that is primarily responsible for the addictive nature of tobacco products. Other substances in tobacco products could also be involved in nicotine addiction/tobacco dependence. Regulating the contents and emissions of tobacco products aimed at reducing tobacco product addictiveness can contribute to reducing the prevalence of tobacco use. Recommendations (i) Parties should consider regulating the contents of tobacco products in order to minimize their addictiveness. (ii) Prior to implementing measures to regulate the contents of tobacco products, in order to minimize their addictiveness, Parties should have adequate capacity for market surveillance and product testing. (iii) In implementing measures to regulate the contents of tobacco products in order to minimize their addictiveness, Parties should be prepared to scale up capacity to address increased demands for adequate treatment for tobacco dependence in accordance with Article 14 of the WHO FCTC and the guidelines for its implementation. (iv) Parties adopting measures to regulate the contents of tobacco products in order to minimize their addictiveness should consider prohibiting claims that suggest that such products are less harmful to human health. (v) Parties considering the adoption of measures to regulate the contents of tobacco products in order to minimize their addictiveness, should weigh the impact of such measures on potential increased use of alternative nicotine products against the benefits of a potential reduction in the prevalence of tobacco use. (vi) Parties should consider preventing the addition to tobacco products of nicotine analogues or other substances that may foster the development or maintenance of nicotine addiction/tobacco dependence. = = =