Health Warning Label Compliance for Smokeless Tobacco Products and Bidis in Five Indian States.

BACKGROUND: The burden of tobacco use In India is very high. To inform users of harm, India has a strong health warning label law that applies to all tobacco products. This study examines the extent of compliance of health warning labels on smokeless tobacco (SLT) and bidi products with the Indian law. METHODS: In 2017, a systematic protocol was used to collect unique SLT and bidi packages from five Indian states. To assess compliance, we used three indicators: location, label elements, and warning size. RESULTS: Only 1% of the 133 SLT products and none of the 32 bidi packs were compliant with all three compliance indicators. Other compliance-related issues included non-standardized packaging, incomplete health warning labels, poor printing quality, and old warning labels. CONCLUSION: There is very poor compliance with the health warning label law on bidi and SLT products. India needs to regularly monitor and address implementation to ensure that warning labels are effective.

Compliance of smokeless tobacco supply chain actors and products with tobacco control laws in Bangladesh, India and Pakistan: protocol for a multicentre sequential mixed-methods study.

INTRODUCTION: South Asia is home to more than 300 million smokeless tobacco (ST) users. Bangladesh, India and Pakistan as signatories to the Framework Convention for Tobacco Control (FCTC) have developed policies aimed at curbing the use of tobacco. The objective of this study is to assess the compliance of ST point-of-sale (POS) vendors and the supply chain with the articles of the FCTC and specifically with national tobacco control laws. We also aim to assess disparities in compliance with tobacco control laws between ST and smoked tobacco products. METHODS AND ANALYSIS: The study will be carried out at two sites each in Bangladesh, India and Pakistan. We will conduct a sequential mixed-methods study with five components: (1) mapping of ST POS, (2) analyses of ST samples packaging, (3) observation, (4) survey interviews of POS and (5) in-depth interviews with wholesale dealers/suppliers/manufacturers of ST. We aim to conduct at least 300 POS survey interviews and observations, and 6-10 in-depth interviews in each of the three countries. Data collection will be done by trained data collectors. The main statistical analysis will report the frequencies and proportions of shops that comply with the FCTC and local tobacco control policies, and provide a 95% CI of these estimates. The qualitative in-depth interview data will be analysed using the framework approach. The findings will be connected, each component informing the focus and/or design of the next component. ETHICS AND DISSEMINATION: Ethical approvals for the study have been received from the Health Sciences Research Governance Committee at the University of York, UK. In-country approvals were taken from the National Bioethics Committee in Pakistan, the Bangladesh Medical Research Council and the Indian Medical Research Council. Our results will be disseminated via scientific conferences, peer-reviewed research publications and press releases.

Inadequate checks on smokeless tobacco usage in Pakistan: cultural heritage or policy neglect?

The Asian-Eastern Mediterranean block has increased inhabitation of the smokeless tobacco users. Due to geopolitical reasons, Pakistan is one of the countries which is in danger of suffering from future smokeless tobaccorelated morbidity and mortality due to weak policy measures. This paper is an overview of smokeless tobacco control measures practised in Pakistan, in comparison to its neighbouring countries sharing similar socio-cultural parameters. Tobacco control reports confined only to smokeless tobacco control were extracted for the region of Southeast Asia and Eastern Mediterranean regions published under World Health Organisation. The selection of countries from each region was based upon the fulfilment of the criterion of sharing common borders with Pakistan and holding a signatory status under framework convention on tobacco control. There is a need to revise existing tobacco control strategy to include smokeless tobacco reforms over pricing, packaging and media communication in Pakistan.

Identification of Policy Priorities to Address the Burden of Smokeless Tobacco in Pakistan: A Multimethod Analysis.

INTRODUCTION: We assessed the magnitude of smokeless tobacco (ST) use in Pakistan and identified policy gaps to help ascertain short-, medium-, and long-term priorities. We then elicited stakeholders' views as to which of these identified priorities are most important. METHODS: In a multimethod study, we: analyzed Global Tobacco Surveillance System data sets to estimate ST consumption and disease burden; conducted a documentary review to identify gaps in policies to control ST in comparison with smoking; elicited stakeholders' views in an interactive workshop to identify a set of policy options available to address ST burden in Pakistan; and ranked policy priorities using a postevent survey. RESULTS: Among all tobacco users in Pakistan (n = 24 million), one-third of men and two-thirds of women consume ST. In 2017, its use led to an estimated 18 711 deaths due to cancer and ischemic heart disease. Compared to smoking, policies to control ST lag behind significantly. Priority areas for ST policies included: banning ST sale to and by minors, advocacy campaigns, introduction of licensing, levying taxes on ST, and standardizing ST packaging. A clear commitment to close cooperation between state actors and stakeholder groups is needed to create a climate of support and information for effective policy making. CONCLUSIONS: Smokeless tobacco control in Pakistan should focus on four key policy instruments: legislation, education, fiscal policies, and quit support. More research into the effectiveness of such policies is also needed. IMPLICATIONS: A number of opportunities to improve ST regulation in Pakistan were identified. Among these, immediate priorities include banning ST sale to and by minors, mobilizing advocacy campaign, introduction of licensing through the 1958 Tobacco Vendors Act, levying taxes on ST, and standardizing ST packaging.

Smokeless tobacco control in 180 countries across the globe: call to action for full implementation of WHO FCTC measures.

Smokeless tobacco is consumed by 356 million people globally and is a leading cause of head and neck cancers. However, global efforts to control smokeless tobacco use trail behind the progress made in curbing cigarette consumption. In this Policy Review, we describe the extent of the policy implementation gap in smokeless tobacco control, discuss key reasons on why it exists, and make recommendations on how to bridge this gap. Although 180 countries have agreed that the WHO Framework Convention on Tobacco Control is the best approach to control the demand and supply of smokeless tobacco, only 138 (77%) Parties define smokeless tobacco in their statutes. Only 34 (19%) Parties tax or report taxing smokeless tobacco products, six (3%) measure content and emissions of smokeless tobacco products, and 41 (23%) mandate pictorial health warnings on these products. Although awareness of the harms related to smokeless tobacco is growing in many parts of the world, few Parties collect or present data on smokeless tobacco use under global or national surveillance mechanisms (eg, Global Tobacco Surveillance System and WHO STEPwise). Only 16 (9%) Parties have implemented a comprehensive ban on smokeless tobacco advertisement, promotion, and sponsorships. Globally, a smaller proportion of smokeless tobacco users are advised to quit the use of smokeless tobacco products compared to tobacco users. Use of smokeless tobacco is becoming a global cause of concern, requiring a greater commitment on the full implementation of the WHO Framework Convention on Tobacco Control measures.

Smokeless tobacco control: Litigation & judicial measures from Southeast Asia.

Recourse to litigation and positive judicial interventions is one of the most effective tools to meet public health objectives. The present review envisions compiling litigation and judicial measures in Southeast Asia Region (SEAR) while assessing their role in advancing smokeless tobacco (SLT) control, and equally highlighting, how tobacco industry has used litigation to undermine tobacco control efforts in the Region. The litigation, especially from the SEAR, up to 2017, that have facilitated SLT control or have been used by the tobacco industry to challenge an SLT control policy decision were reviewed. Most of the litigation related to SLT control from the Region are on pictorial health warnings. Bhutan has imposed a complete prohibition on sale, manufacture and import of all kinds of tobacco products and the litigation there relates to the prosecution of offenders for violating the ban. Judiciary in the Region is well informed about the ill-effects of tobacco use and remains positive to tobacco control initiatives in the interest of public health. In India, several SLT-specific litigation helped in better regulation of SLT products in the country. Litigation has compelled governments for effective enforcement of the domestic tobacco control laws and the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC). Parties to the WHO FCTC must now use Treaty Article 19 to strengthen their legal procedures and make the tobacco industry liable, for both criminal and civil wrongs.

A review of trade practices of smokeless tobacco products in terms of prohibition on sale, manufacturing & importation in Framework Convention on Tobacco Control ratified Parties.

BACKGROUND & OBJECTIVES: Over the past decade, the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) has served as a powerful tool to initiate and advance global tobacco control efforts. However, the control strategies have mainly targeted demand-side measures. The goal of a tobacco-free world by 2040 cannot be achieved if the supply-side measures are not addressed. This analysis was undertaken to examine the tobacco control legislations of various Parties ratifying WHO FCTC with an objective to ascertain the status of prohibition of importation, sale and manufacturing of smokeless tobacco products. METHODS: All 180 Parties to WHO FCTC were included for the study. A comprehensive database of all the parties to FCTC was created and tobacco control legislations and regulations of all parties were studied in detail. RESULTS: Overall, the sale of smokeless tobacco (SLT) products was prohibited in 45 Parties. Eleven Parties prohibited manufacturing of SLT products and six Parties imposed a ban on importation of SLT products. Australia, Bhutan, Singapore and Sri Lanka banned all three. INTERPRETATION & CONCLUSIONS: Comprehensive tobacco control strategy with effective tobacco cessation programme should complement strong legal actions such as prohibition on trade in SLT products to meet the public health objective of such laws and regulations. In addition, multisectoral efforts are needed for effective implementation of such restrictions imposed by the governments.

Origins in the USA in the 1980s of the warning that smokeless tobacco is not a safe alternative to cigarettes: a historical, documents-based assessment with implications for comparative warnings on less harmful tobacco/nicotine products.

BACKGROUND: Before the 1980s in the USA, smokeless tobacco carried no health warnings, was not judged to cause disease, and was a declining practice. In 1986, the federal government passed legislation requiring rotating warnings on "mouth cancer," "gum disease and tooth loss," and "This product is not a safe alternative to cigarettes." This paper explores the history of the establishment of these warnings with emphasis on the 'not a safe alternative' warning and the bases for claiming that smokeless was 'not safe' (absolute harm) versus 'not safer than cigarettes' (relative harm). METHODS: Results of searches of Truth Tobacco Industry Document archives and transcripts of legislative hearings were analyzed. Critical assessments were made of the evidence-base. RESULTS: New evidence of oral cancer causation emerged along with a much-publicized case of a teenager dying of oral cancer. Public health concerns also arose over a widespread, successful marketing campaign implying smokeless was a safe alternative to cigarettes. Industry wanted pre-emptive federal warnings, to prevent a diversity of pending state warnings. To avoid an addiction warning, the industry accepted a compromise 'not a safe alternative' warning, which had not been initially proposed and which the cigarette industry may have sought in order to constrain the smokeless tobacco industry. The evidence presented supported smokeless only as 'not safe' and not 'as harmful as cigarette smoking.' CONCLUSIONS: The comparative warning was a compromise to prevent an addiction warning and consistent with the preferences of cigarette companies. Prior surveys indicated that the public generally did not view smokeless tobacco as harmless, but they did generally report smokeless as less harmful than cigarettes despite expert interpretations to the contrary. As would not have been appreciated by public health supporters at the outset, subsequent research has shown that the 'not a safe alternative' message is misinterpreted by consumers to indicate that smokeless is 'not safer' than cigarettes-which was not established and has been disconfirmed by subsequent assessments of that question. Though many countries have banned smokeless tobacco (but not cigarettes), where smokeless is legally available accurate information on the nature of harms and differential harms needs to be developed.

Policy Implications and Research Recommendations: A Review of Hookah Use Among US College Students.

The rate of Hookah use among college students during the last decade is about 30%. Although college students perceive hookah use as a safer alternative to conventional cigarettes, hookah use increases the risk of disease and nicotine dependence, and therefore remains an area of concern. Presently, the US Food and Drug Administration (FDA) has little regulation for the manufacture, distribution, or sale of hookah. This review attempts to assess empirical literature relating to hookah use while focusing on the consequences for regulatory policy. PubMed (including MEDLINE 2010-2017), PsycINFO, EBSCO, Scopus (Elsevier) databases were examined to pinpoint articles published in English. The following terms were used in the searches: Hookah or Waterpipe or nargile or "arghile" or "shisha" or "hubble bubble" or "alternative tobacco product" or "flavored tobacco". Hookah use may initiate smoking among tobacconaïve college students. College students who use hookah are generally not aware of the increased risks for tobacco related diseases as it relates to their behavior. In addition, few public health messages target college-age adults with anti-hookah messages. A lack of information regarding the dangers and potential harms of hookah use may be misinterpreted as a sign of "safety" which inadvertently may imply a suggestion of no need for safety measures. Hence, a research agenda that would inform about health policy actions has been proposed.

Reducing tobacco-related harm: FDA's proposed product standard for smokeless tobacco.

This Special Communication discusses the Food and Drug Administration's (FDA's) proposed rule that would limit N-nitrosonornicotine (NNN) levels in smokeless tobacco products. It argues that finalising and implementing this first 'product standard' would mark a significant step forward in the FDA's efforts to reduce tobacco-related harms.

Burden of Tobacco in Pakistan: Findings From Global Adult Tobacco Survey 2014.

Introduction: The Global Adult Tobacco Survey (GATS) is the global standard for systematically monitoring adult tobacco use and tracking key tobacco control indicators. Methods: Using a multistage stratified cluster design, 9856 households were sampled, and one individual was randomly selected from each household. Standard GATS questionnaire was used to collect information on tobacco use, cessation, second-hand smoke, knowledge, attitudes, and perceptions. Data were analyzed per standard GATS protocol. Results: Of 9856 individuals, 7831 individuals completed the interview. The response rate was 81%. Overall, 19.1% adults were currently using tobacco products and among them, 12.4% smoked tobacco, and 7.7% smokeless tobacco. Exposure to second-hand smoke was seen in 86% in a restaurant while it was 76% on public transportation. A total of 24.7% smokers made a quit attempt in the past 12 months. Anticigarette smoking information was observed by 37.7% adults, while 29.7% current smokers thought about quitting after reading health warning labels on cigarette packages. Most (85%) adults favored no smoking in public places, and 74.8% favored increasing taxes on tobacco products. Current cigarette smokers spent Pakistani Rupees 767.3 per month (7.78 USD) on manufactured cigarettes and consumed 4500 cigarette sticks (225 packs) annually. Conclusions: Besides 19.1% tobacco users, the majority (86%) were exposed to second-hand smoke at public places indicating that ban on tobacco use in public places is not being followed. A quarter of current smokers wants to quit smoking who may be provided assistance to reduce tobacco burden. Implications: This study provides national-level data about tobacco use and its burden and also indicates weak implantation of tobacco control laws. There is need to devise a strategy for proper implementation of these laws to reduce the tobacco burden in the country.

Consortium on Methods Evaluating Tobacco: Research Tools to Inform US Food and Drug Administration Regulation of Snus.

Introduction: The US Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this article is to describe these assessment methods using a US manufactured "snus" as the test product. Methods: In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This article integrates COMET's findings over the last 4 years. Results: Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Conclusions: Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. Implications: This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm.

Regulating smokeless tobacco and processed areca nut in South-East Asia region: The journey so far and the road ahead.

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.

Smokeless tobacco and public health in Bangladesh.

Despite the high prevalence of smokeless tobacco (SLT) use among adults in Bangladesh, SLT was not included in the Tobacco Control Law till 2013. Information on SLT use among Bangladeshi people is inadequate for policymaking and implementing effective control measures. With the aim to identify the prevalence and trends of different SLT products, health and economic impacts, manufacture, and sale of and policies related to SLT in Bangladesh, we carried out a literature review, which involved literature search, data extraction, and synthesis. Evidence suggests that in Bangladesh, SLTs range from unprocessed to processed or manufactured products including Sada Pata, Zarda, Gul, and Khoinee. Over 27% of Bangladeshi adults aged 15 years and older use SLT in one form or other. SLT use is associated with age, sex, education, and socioeconomic status. SLT consumption has reportedly been associated with increased prevalence of heart diseases, stroke, and oral cancer and led to around 320,000 disability adjusted life years lost in Bangladesh in 2010. No cessation service is available for SLT users in public facilities. Compared to cigarettes, taxation on SLT remains low in Bangladesh. The amendment made in Tobacco Control Law in 2013 requires graphic health warnings to cover 50% of SLT packaging, ban on advertisement of SLT products, and restriction to sale to minors. However, implementation of the law is weak. As the use of SLT is culturally accepted in Bangladesh, culturally appropriate public awareness program is required to curb SLT use along with increased tax and cessation services.

Use of rodent data for cancer risk assessment of smokeless tobacco in the regulatory context.

To support risk management decisions, information from different fields has been integrated in this presentation to provide a realistic quantitative cancer risk assessment of smokeless tobacco. Smoking among Swedish men is currently below 10%, while about 20% use a special smokeless tobacco (snus) as a substitute for cigarettes. Epidemiological data and molecular biomarkers demonstrate that rodent bioassays with tobacco specific nitrosamines (TSNA) overestimate cancer risk from snus by more than one order of magnitude. The underlying reasons are discussed. DNA damage constitutes a necessary, although not sufficient prerequisite for cancer initiation. Individuals who have not used tobacco exhibit DNA lesions identical with those induced by TSNA. No increase above this adduct background can be shown from snus, and extensive epidemiological studies in Sweden have failed to demonstrate elevated cancer risks even in long term users. A "bench mark" for acceptable risk of 1/10(6) derived from rodent data has been suggested when regulating snus. By relating similarly derived estimates for some food contaminants, the implementation even of a limit of 1/10(4) may be unrealistic. The management of smokeless tobacco products has rarely been based on a scientifically sound risk assessment, where attention is given to the outstandingly higher hazards associated with smoking.

Influence of the Flavored Cigarette Ban on Adolescent Tobacco Use.

INTRODUCTION: This paper estimated the association between the U.S. Food and Drug Administration's 2009 ban on flavored cigarettes (which did not apply to menthol cigarettes or tobacco products besides cigarettes) and adolescents' tobacco use. METHODS: Regression modeling was used to evaluate tobacco use before and after the ban. The analyses controlled for a quadratic time trend, demographic variables, prices of cigarettes and other tobacco products, and teenage unemployment rate. Data from the 1999-2013 National Youth Tobacco Surveys were collected and analyzed in 2016. The sample included 197,834 middle and high schoolers. Outcomes were past 30-day cigarette use; cigarettes smoked in the past 30 days among smokers; rate of menthol cigarette use among smokers; and past 30-day use of cigars, smokeless tobacco, pipes, any tobacco products besides cigarettes, and any tobacco products including cigarettes. RESULTS: Banning flavored cigarettes was associated with reductions in the probability of being a cigarette smoker (17%, p<0.001) and cigarettes smoked by smokers (58%, p=0.005). However, the ban was positively associated with the use by smokers of menthol cigarettes (45%, p<0.001), cigars (34%, p<0.001), and pipes (55%, p<0.001), implying substitution toward the remaining legal flavored tobacco products. Despite increases in some forms of tobacco, overall there was a 6% (p<0.001) reduction in the probability of using any tobacco. CONCLUSIONS: The results suggest the 2009 flavored cigarette ban did achieve its objective of reducing adolescent tobacco use, but effects were likely diminished by the continued availability of menthol cigarettes and other flavored tobacco products.