|Year : 2017 | Volume
| Issue : 5 | Page : 3-6
Regulating smokeless tobacco and processed areca nut in South-East Asia region: The journey so far and the road ahead
Jagdish Kaur1, Thaksaphon Thamarangsi2, Arvind Vashishta Rinkoo3
1 Regional Advisor, Tobacco-Free Initiative, Regional Office for South-East Asia, World Health Organization, Faridabad, Haryana, India
2 Director, Department of Noncommunicable Diseases and Environmental Health, Regional Office for South-East Asia, World Health Organization, Faridabad, Haryana, India
3 Freelance Public Health Consultant, Faridabad, Haryana, India
|Date of Web Publication||15-Sep-2017|
Arvind Vashishta Rinkoo
Freelance Public Health Consultant, 15/8, Faridabad, Haryana
Source of Support: None, Conflict of Interest: None
| Abstract|| |
South-East Asia Region (SEAR) has more smokeless tobacco users as compared to smokers. The growing prevalence and cultural acceptance of consumption of flavored areca nut and related products, for example, supari and pan masala in many countries are confounding the scenario. The prevalence of a variety of tobacco products makes regulation a challenge which gets more complicated in view of weak enforcement of regulatory policies aggressive marketing of such products by the tobacco industry. Some countries have attempted to regulate smokeless tobacco and related products by enforcing bans. However, limited evidence base along with lack of technical and regulatory capacities have restricted the SEAR countries to effectively implement product regulation in respect of smokeless tobacco and related products. This paper lays out specific priorities for research and need to enhance regulatory capacity for smokeless tobacco and processed areca nut in the SEAR countries. A systematic and comprehensive search was conducted to identify all original published literature related to regulating smokeless tobacco and processed areca nut. Studies reporting on the same were obtained through searches in relevant academic databases. Relevant World Health Organization (WHO) documents and reports on tobacco products regulation were consulted. Generating the right evidence along with the need to build the capacity of the countries to test the smokeless tobacco and processed areca nut products by establishing testing facilities and providing practical guidelines is of paramount importance. The countries of the SEAR need to prioritize the implementation of Articles 9 and 10 of the WHO Framework Convention on Tobacco Control to strengthen the regulation of smokeless tobacco and processed areca nut products.
Keywords: Areca nut, product regulation, smokeless tobacco, South-East Asia Region
|How to cite this article:|
Kaur J, Thamarangsi T, Rinkoo AV. Regulating smokeless tobacco and processed areca nut in South-East Asia region: The journey so far and the road ahead. Indian J Public Health 2017;61, Suppl S1:3-6
|How to cite this URL:|
Kaur J, Thamarangsi T, Rinkoo AV. Regulating smokeless tobacco and processed areca nut in South-East Asia region: The journey so far and the road ahead. Indian J Public Health [serial online] 2017 [cited 2021 Mar 4];61, Suppl S1:3-6. Available from: https://www.ijph.in/text.asp?2017/61/5/3/214908
| Introduction|| |
Smokeless tobacco users outnumber the estimated number of smokers in the South-East Asia Region (SEAR). In many countries of the region, while the prevalence of smoking is decreasing, the use of smokeless tobacco is on the rise. The growing prevalence and cultural acceptance of consumption of areca nut, a Group 1 human carcinogen, including products such as supari (dried fragmented areca nut blended with flavoring agents) and pan masala (a preparation of areca nut, catechu, cardamom, lime, and a number of natural and artificial perfuming and flavoring materials) are confounding the scenario. Flavoring agents and sweeteners are added to reduce harshness and improve taste and palatability of these harmful products.
Regulation of smokeless tobacco and related products is a sizeable gap in overall tobacco control in SEAR. This is all the more significant in light of a large variety of smokeless tobacco and related products consumed across the region and weak enforcement of existing smokeless tobacco regulatory laws. The recent aggressive marketing of smokeless tobacco and areca nut products such as supari and pan masala by the industry, especially in countries attempting to enforce some sort of ban on these products have further challenged the regulation of these products. Limited evidence base along with lack of technical and regulatory capacities has restricted the SEAR countries to effectively implement product regulation in respect of smokeless tobacco and related products. To take this agenda forward, this paper lays out specific priorities for research and need to enhance regulatory capacity for smokeless tobacco and processed areca nut in SEAR countries.
| Setting the Context for the South-East Asia Region|| |
The eleven countries in the SEAR have over 290 million smokeless tobacco users, nearly 90% of the global number., Smokeless tobacco users outnumber the estimated number of smokers in the SEAR. In many countries of the region, while the prevalence of smoking is decreasing, the use of smokeless tobacco is on the rise. The situation calls for urgent, focused attention to counter the ongoing epidemic. Notably, the region has myriad varieties of smokeless tobacco and areca nut products prevalent in many countries. These products range in complexity from tobacco only products to products containing numerous chemical ingredients, flavoring agents, and additives. Smokeless tobacco products can be grouped into those used for chewing, sucking, gargling, sniffing, and as dentifrice. Some products are commercially available; in other cases, users can prepare the desired product for consumption from ingredients freely available in the market. The growing prevalence and cultural acceptance of areca nut consumption which has been classified as Group 1 human carcinogen-including products such as supari (dried fragmented areca nut blended with flavoring agents) and pan masala (a preparation of areca nut, catechu, cardamom, lime, and a number of natural and artificial perfuming and flavoring materials) are further confounding the scenario. Flavoring agents and sweeteners are added to improve taste and thus palatability of these harmful products. Masking harshness of these products with flavors contributes to promoting and sustaining tobacco use by the current users and attract new users into tobacco use. Certain additives accelerate the absorption of these products from the oral mucosa and their delivery into the circulatory system contributing to increased addictiveness to the modified products.
| The Regional Scenario|| |
Many countries in SEAR have initiated steps to regulate smokeless tobacco. Bhutan has banned manufacture and sale of tobacco products, including smokeless tobacco products. Thailand has ban on import of smokeless tobacco products. A comprehensive legislation in individual states in India invoked food safety laws (regulation 2.3.4 of the Food Safety and Standards regulations, 2011 mandating tobacco and nicotine not to be used as ingredients in any food product) to ban “gutka” and “pan masala containing tobacco”, which are one of the most commonly used smokeless tobacco products. India also has examples of sub national ban on production and sale of flavored and packaged smokeless tobacco products with some state governments imposing such bans for regulating smokeless tobacco. Nepal has banned the use of smokeless tobacco products in public places. Myanmar has banned the use of betel quid chewing in government premises. Democratic People's Republic of Korea (DPRK) has banned smokeless tobacco products through a recent legislation. However, in particular, the region lacks effective policies and strategies to regulate smokeless tobacco and related products. This is all the more significant in light of a large variety of smokeless tobacco and related products prevalent across the region, weak enforcement of existing smokeless tobacco regulatory laws, and recent aggressive marketing of areca nut products such as supari and pan masala by the industry, especially in countries attempting to enforce some sort of ban on smokeless tobacco products.,
The international tobacco control fraternity has recognized the need to regulate smokeless tobacco for effective tobacco control. The SEAR countries favored effective implementation of Articles 9 and 10 of the World Health Organization (WHO)-Framework Convention on Tobacco Control (FCTC) with special emphasis on smokeless tobacco productsin the discussions held during the recently concluded seventh session of the Conference of the Parties (COP 7) to the WHO-FCTC. The Region has strongly called for prioritizing issues concerning smokeless tobacco products by the working group involved in the development of partial guidelines for the implementation of Articles 9 and 10 of the WHO FCTC and specifically for improvements needed in standard testing methods, specific product standards, and testing regimens concerning these products. These efforts should ideally be coordinated by the region through the existing platforms of the WHO Tobacco Laboratory Network (TobLabNet) and the WHO Study Group on Tobacco Product Regulation (TobReg). WHO TobLabNet is a global tobacco testing laboratory network for advancing tobacco control by combining testing and research at the global level, created to match the tobacco industry's expert product testing capabilities. WHO TobReg includes leading scientists in the field, carries out research, and drafts recommendations for the WHO's Member States on the issue of establishing regulatory frameworks for the design and manufacture of tobacco products basically to address the regulation of products. Still, insufficient research base, absence of standard guidelines, and inadequate technical and regulatory capacities have restricted the countries of the region to effectively implement the provisions of Articles 9 and 10 of the Convention, more so in respect of smokeless tobacco products.
The first meeting of the Global Tobacco Regulators' Forum, coordinated by the WHO in April 2017, also brought up these gaps in regulating flavored smokeless tobacco and related products globally and especially prevalent in SEAR. The Global Tobacco Regulators' Forum is a network of tobacco regulatory agencies from various jurisdictions across the world which is envisioned as a platform for knowledge exchange and learning between tobacco regulatory agencies of different countries and provides an opportunity for regulators to identify avenues for collaboration.
At present, there is no testing facility for tobacco products in the region. India has been making efforts to establish tobacco testing laboratories for more than a decade. Once established the laboratories can serve as regional reference as well as testing laboratories for all sorts of tobacco products. Thailand and DPR Korea have put the onus of testing the tobacco products on the industry for regulation purpose.
The Global Knowledge Hub on Smokeless Tobacco Products in accordance with the decision FCTC/COP6 adopted by the COP at its sixth session has been setup in India with support from the WHO FCTC Secretariat and Indian Ministry of Health. This hub strives to address the existing research gaps in respect of smokeless tobacco products, including identifying the ingredients of a wide range of these products available in the market, fixing standards and validation methods to test the contents of different smokeless tobacco products, characterizing the properties of different constituents of these products, and the methods of manufacturing the same, and estimating the health impact and characterizing the properties of different constituents of carcinogenic, culturally-acceptable, nontobacco smokeless products that are frequently used in conjunction with tobacco products, such as areca nut (betel nut) and related products such as supari and pan masala.
| Priorities for Research|| |
Generating the right evidence is of paramount importance to take the agenda of regulation of smokeless tobacco and processed areca nut forward in the SEAR.
A growing body of evidence suggests feasibility of implementation of standards for the levels of toxic and carcinogenic constituents in smokeless tobacco products and supports the likelihood of public health benefits from the establishment of such standards. Thus, excluding or monitoring the potential sources of contamination with these constituents can control their levels in these products. For this to happen, factors influencing the levels of major toxicants and carcinogens in smokeless tobacco products ought to be studied in detail, especially in the context of prevailing socioeconomic and cultural determinants in the SEAR. However, in the absence of well-established standards, robust legislative provisions, regulatory mechanisms, and technical knowhow, the levels of these carcinogens continue to vary significantly in different smokeless tobacco products across the region.
In particular, biomarkers of exposure account for a variety of factors that affect constituent intake by smokeless tobacco users, including patterns of use and the extent of constituent extraction from the product; therefore, they can provide valuable information on constituent uptake from products that differ in content of harmful and potentially harmful constituents (HPHC). Moreover, tobacco constituent biomarkers can serve as an important tool to support TobReg. Unfortunately, to date, human exposure studies investigating the effects of variations in the levels of specific HPHCs in smokeless tobacco products are limited, and most of the studies have been focused on tobacco-specific nitrosamines (TSNA), and specifically, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK). Still, the available evidence strongly suggests that reducing HPHCs in smokeless tobacco products will result in reduction of human exposures to these constituents.
To date, neither clinical nor epidemiological or longitudinal studies have been conducted to investigate the effects of smokeless tobacco products with differing levels of HPHCs on risk for disease. However, several studies showed a significant dose response relationship between the biomarker-assessed systemic doses of some HPHCs and cancer risks in cigarette smokers, and it is not unreasonable to extrapolate these results to smokeless tobacco users. Another way to determine if exposure to HPHCs are associated with disease risk in smokeless tobacco users is to examine the incidence of smokeless tobacco-related disease across countries that market products that differ in levels of these harmful constituents. The countries of the SEAR, given the wide varieties of smokeless tobacco and processed areca nut products available across the region, ought to be prioritized for such an approach.
Currently, for the smokeless tobacco products, the WHO Study Group on TobReg recommends that the concentrations of NNN plus NNK should be limited to 2 μg/g of dry weight and benzo[a]pyrene should be limited to 5 ng/g of dry weight. As an initial step, this group focused on TSNA and polycyclic aromatic hydrocarbon because these constituents might explain the diversity in cancer risks observed across different regions of the world as a result of smokeless tobacco use, and the limits were considered to be achievable. However, strictly speaking, there is a lack of single compendium that brings together all the information on different toxicants found in smokeless tobacco products and the available standardized methods to analyze them. In this background, it is imperative that the countries of the region work in close collaboration with the Global Knowledge Hub on Smokeless Tobacco Products and the recently formed Global Tobacco Regulators' Forum. In particular, the future research should be directed toward the collection of scientific information on the chemicals in contents and emissions of smokeless tobacco products that contribute to their toxicity, addictiveness, and attractiveness, the analytical methods used to measure them, and the levels found in these products in the markets across the SEAR; finalization of the standard operating procedures for measuring nicotine and TSNAs; applicability of the WHO TobLabNet standard operating procedures to measure humectants and ammonia in smokeless tobacco products; and identification of any available technical approaches to reduce toxicants in smokeless tobacco. In addition, given the regional context, efforts should be made to estimate the health impact and characterize the properties of different constituents of carcinogenic, culturally-acceptable, nontobacco smokeless products that are frequently used in conjunction with tobacco products, such as areca nut (betel nut) and related products such as supari and pan masala.,,
| Priorities for Regulatory Action|| |
During COP7, most of the countries of the SEAR were of the view that their current levels of technical capacity and scientific knowledge do not allow them to meaningfully engage in discussions centered on the regulation of addictiveness reduction in smokeless tobacco products.
To address this situation, apart from undertaking new research on priority agendas as underscored in the previous section, two clear action points stand out. First, there is a need to establish tobacco testing laboratories in the region wherein the declarations made by the tobacco industry regarding the contents and emissions of various smokeless tobacco products and claimed nontobacco products such as supari and pan masala could be verified and the actual chemical constituents of these products could be reliably tested. Second, till full-fledged guidelines and “state-of-the-art” tobacco testing laboratories are available, it is important to develop practical and scalable guidelines for testing and measuring the “main” contents of popular and commonly prevalent smokeless tobacco products in the SEAR and for setting up a “basic” tobacco testing laboratory within the resources available at the country level to test and measure these contents.
Any suggested reduction of toxicant levels in smokeless tobacco products, i.e., a toxicity regulatory approach, is fraught with possibilities of potential misuse in the SEAR, even in the presence of likely safeguards, unless there is strong regulatory capacity available with the countries to monitor and regulate such levels and guard against their possible misuse by the Industry.
In this context, the recommendations in the partial guidelines for implementation of Articles 9 and 10 of the WHO FCTC hold tremendous significance. The countries of the SEAR should explore legislative measures to regulate, by prohibiting or restricting, ingredients that may be used to increase palatability, addictiveness, or attractiveness of smokeless tobacco and related products such as supari and pan masala. Ingredients indispensable for the manufacturing of these products and not linked to attractiveness should be subject to regulation according to strong, clear, and comprehensive national laws. In the present scenario, recommendation to reduce the appeal of smokeless tobacco and several nontobacco smokeless products such as supari and pan masala by banning or regulating sweeteners and flavoring substances (including herbs, spices, and flowers) does hold a lot of ground for SEAR countries.
To conclude, the countries of the SEAR need to prioritize the implementation of Articles 9 and 10 of the WHO FCTC which is currently lacking due to paucity of rigorous research, regulatory capacities, and technical tools and guidance. The time may not be more opportune to take this important tobacco control agenda forward with special focus on the priorities for research and regulatory approaches identified in this paper.
The opinions or views expressed in this article are solely those of the authors and do not express the views or opinions of the organization to which the authors are affiliated.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
International Agency for Research on Cancer (IARC). Smokeless Tobacco and Some Tobacco-Specific N-Nitrosamines: IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol. 89. Lyon, France: World Health Organization International Agency for Research on Cancer; 2007. p. 626.
Khan Z, Khan S, Christianson L, Rehman S, Ekwunife O, Samkange-Zeeb F, et al
. Smokeless tobacco and oral potentially malignant disorders in south Asia: A systematic review and meta-analysis. Nicotine Tob Res 2016;ntw310. doi: 10.1093/ntr/ntw310. [Epub ahead of print].
Gupta PC, Ray CS. Smokeless tobacco and health in India and South Asia. Respirology 2003;8:419-31.
U.S. Department of Health and Human Services. The Health Consequences of Using Smokeless Tobacco: A Report of the Advisory Committee to the Surgeon General. NIH Publication No. 86-2874. U.S. Department of Health and Human Services, Public Health Services, National Institutes of Health; 1986.
International Agency for Research on Cancer (IARC). Tobacco Habits Other than Smoking; Betel Quid and Areca Nut Chewing; and some Related Nitrosamines: IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Vol. 37. Lyon, France: World Health Organization International Agency for Research on Cancer; 1985. p. 291.
Sinha DN, Gupta PC, Ray C, Singh PK. Prevalence of smokeless tobacco use among adults in WHO South-East Asia. Indian J Cancer 2012;49:342-6.
] [Full text]
World Health Organization. Report of the Expert Group Consultation on Smokeless Tobacco and Public Health in WHO-SEAR Countries. Mumbai, India: World Health Organization; 2015.
Sein T1, Swe T, Toe MM, Zaw KK, Sein TO. Challenges of smokeless tobacco use in Myanmar. Indian J Cancer 2014;51 Suppl 1:S3-7.
Kaur J, Prasad V. Smokeless tobacco–Countering the global epidemic. J Commun Med Health Educ 2013;3:198.
Mukherjea A, Modayil MV, Tong EK. Paan (pan) and paan (pan) masala should be considered tobacco products. Tob Control 2015;24:e280-4.
Khan A, Huque R, Shah SK, Kaur J, Baral S, Gupta PC, et al.
Smokeless tobacco control policies in South Asia: A gap analysis and recommendations. Nicotine Tob Res 2014;16:890-4.
Hatsukami DK, Stepanov I, Severson H, Jensen JA, Lindgren BR, Horn K, et al.
Evidence supporting product standards for carcinogens in smokeless tobacco products. Cancer Prev Res (Phila) 2015;8:20-6.
Stepanov I, Hatsukami DK. Call to establish constituent standards for smokeless tobacco products. Tob Regul Sci 2016;2:9-30.
WHO Study Group on Tobacco Product Regulation. Report on the scientific basis of tobacco product regulation: Fifth Report of a WHO Study Group. World Health Organ Tech Rep Ser 2015;989:238.
Mathew P, Austin RD, Varghese SS, Manojkumar AD. Role of areca nut and its commercial products in oral submucous fibrosis – A review. J Adv Med Dent Sci Res 2014;2:192-200.
Patidar KA, Parwani R, Wanjari SP, Patidar AP. Various terminologies associated with areca nut and tobacco chewing: A review. J Oral Maxillofac Pathol 2015;19:69-76.
] [Full text]
Bhisey RA. Chemistry and toxicology of smokeless tobacco. Indian J Cancer 2012;49:364-72.
] [Full text]
World Health Organization Framework Convention on Tobacco Control. 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; November, 2016. Available from: http://www.who.int/fctc/cop/cop7/FCTC_COP_7_8_EN.pdf?ua=1
. [Last accessed on 2017 Feb 28].
World Health Organization Framework Convention on Tobacco Control. Decision FCTC/COP7 (14) on Further Development of the Partial Guidelines for Implementation of Articles 9 and 10 of the WHO FCTC (Regulation of the Contents of Tobacco Products); November, 2016. Available from: http://www.who.int/fctc/cop/cop7/FCTC_COP7(14)_EN.pdf?ua=1
[Last accessed on 2017 Feb 28].