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Background: Reducing nicotine content in cigarettes and other combustible products to levels that are not reinforcing or addictive has the potential to substantially reduce tobacco-related morbidity and mortality. The authority to reduce nicotine levels as a regulatory measure is provided in the U.S. Family Smoking Prevention and Tobacco Control Act and is consistent with the general regulatory powers envisioned under the relevant articles of the World Health Organization's Framework Convention on Tobacco Control. Many experts have considered reducing nicotine in cigarettes to be a feasible national policy approach, but more research is necessary. Purpose: This article describes proceedings from a conference that had the goals of identifying specific research gaps, describing methods and measures to consider for addressing these gaps, and considering ways to foster collaboration. Results and Conclusion: Identified research gaps included determining the dose of nicotine that would be optimal for reducing and extinguishing cigarette use, examining approaches for reducing nicotine levels in the general and special populations of smokers, understanding how constituents other than nicotine may contribute to the reinforcing effects of tobacco, and identifying unintended consequences to determine ways to mitigate them. Methods that can be used ranged from brain imaging to large human clinical trials. The development and availability of valid biomarkers of exposure and effect are important. Infrastructures to facilitate collaboration need to be established. © The Author 2012. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved.

Objective Secondhand smoke exposure (SHSe) harms adults and children. Though most governments are obliged by international health treaty to protect nonsmokers from SHSe, few adequately do so. Public opinion can provide a powerful mandate for smoke-free policies, but a representative public voice is often absent from the political discussion. For example, following Cabinet approval of a national tobacco control plan, Israel remains embroiled in stormy debate about smoke-free legislation. This debate has unfolded without benefit of current empirical evidence on nationwide public support. The present study reports and assesses public opinion regarding smoke-free places. Methods A nationally representative survey ( n = 505) was conducted in December, 2010. The response rate was 61%. Results Public opinion supports smoke-free air in many places. There was broad consensus among current, former, and never-smokers for smoke-free cars carrying children (94.4%), and smoke-free healthcare facility entrances (92.6%). A clear majority (67.0%) supportedcompletely smoke-free bars and pubs. Nearly half (47.3%) supported eliminating school staff smoking rooms. Conclusions These data strengthen the case for the recent government-approved tobacco control plan. Valid data regarding public opinion on tobacco control can facilitate passage and implementation of smoke-free legislation, thus speeding transition to smoke-free societies.

Tobacco product testing is a critical component of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which grants the Food and Drug Administration the authority to regulate tobacco products. The availability of methods and measures that can provide accurate data on the relative health risks across types of tobacco products, brands, and subbrands of tobacco products on the validity of any health claims associated with a product, and on how consumers perceive information on products toxicity or risks is crucial for making decisions on the product's potential impact on public health. These tools are also necessary for making assessments of the impact of new indications for medicinal products (other than cessation) but more importantly of tobacco products that may in the future be marketed as cessation tools.To identify research opportunities to develop empirically based and comprehensive methods and measures for testing tobacco and other nicotine-containing products so that the best science is available when decisions are made about products or policies.Literature was reviewed to address sections of the FSPTCA relevant to tobacco product evaluation; research questions were generated and then reviewed by a committee of research experts.A research agenda was developed for tobacco product evaluation in the general areas of toxicity and health risks, abuse liability, consumer perception, and population effects.A cohesive, systematic, and comprehensive assessment of tobacco products is important and will require building consensus and addressing some crucial research questions.

Much has been discussed and written about the purposes, outcomes and ethics related to tobacco industry funding of research.1–9 The issue is controversial because of tobacco industry funding mechanisms that have been used by the tobacco industry to gain credibility and to advance the industry’s interests, which may come at the expense of public health;6 at the same time others have argued that, given the scarcity of funding from other sources, tobacco industry support may be defensible, at least under some circumstances.10 These concerns raise the question of whether there could be a model of tobacco company funding that would be acceptable to the tobacco control research community. This paper presents a set of criteria for evaluating funding models and applies them to four diverse models. While tobacco consumption and prevalence rates have declined in many developed countries over the past 40 years, the projections are that worldwide tobacco-related deaths will increase in the 21st century.11 Despite the disproportionate toll tobacco use takes, there remains only a modest investment in research to better understand tobacco products, tobacco product marketing, addiction, treatment and consumer behaviour. For example, in the USA, where tobacco causes almost 30% of all cancer deaths, only 2.3% of the National Cancer Institute’s 2003 budget was spent on tobacco-related research funding.12 This level of research investment is inadequate relative to the magnitude of the damage caused by tobacco use.13 14 At the same time, the tobacco industry has funded tobacco and health related research at universities. In the current context of limited funding, individuals and institutions may welcome additional sources of support. However the evidence is now clear that the tobacco industry participated in a long-standing conspiracy to defraud the public regarding the health risks of smoking. In 2006, the …

This paper reviews the tobacco industry's litigation strategy for addressing the addiction issue through trial testimony by its experts, and opening and closing statements by its lawyers. Despite the fact that several companies now claim to accept, in varying degrees, the conclusions of the Surgeon General concerning tobacco addiction, the tobacco industry litigation strategy pertaining to addiction is essentially unchanged since that of the early 1980s when the issue emerged as crucial. The industry uses its experts and the process of cross‐examination of plaintiff's experts to imply that the addictiveness of tobacco and nicotine are more comparable to substances such as caffeine, chocolate, and even milk, than to heroin, cocaine and alcohol. Furthermore, the tobacco industry contends that the definition of addiction has now become so broadened as to include carrots and caffeine and hence that any concurrence that smoking is addictive, does not imply that cigarettes are addictive to the standards that drugs such as heroin and cocaine are addictive. Finally, the industry has continuously asserted that tobacco users assumed the risks of tobacco since they understood that quitting could be difficult when they began to use, and moreover, that the main barrier to cessation is lack of desire or motivation to quit and not physical addiction. These positions have been maintained through the 2004–2005 US Government litigation that was ongoing as the time of this writing.

Nicotine has a long and storied history in physiology and pharmacology. Historically, it has been used as a tool to explore the nervous system, studied for its role in tobacco use, and more recently examined for its diverse potential medicinal uses. Psychopharmacology research has been pivotal in the science foundation for nicotine and tobacco product regulation.

Introduction A new law in the United States gives the Food and Drug Administration (FDA) wide latitude to regulate tobacco products for the first time. Given the need for science to serve as a foundation for FDA actions, it is critical that a scientific review of the literature relevant to the proposed legislation be undertaken by experts in the field of nicotine and tobacco research in order to develop research priorities. Methods This paper describes an initiative that was implemented to identify research opportunities under "The Family Smoking Prevention and Tobacco Control Act" and summarizes the conclusions and future directions derived from that initiative. Results Multiple research and surveillance needs were identified, such as characterization of biomarkers and increased analysis of risk perception. It was also recognized that science will play a critical role in policy determinations such as what constitutes "substantial equivalence" and that there will be considerable infrastructure needs (e.g., laboratories for product testing). Conclusions Science must drive FDA's decision making regarding tobacco regulation. This article provides a summary of research opportunities identified through literature reviews related to various provisions of the new law. However, the science required by the law requires a transdisciplinary approach because of its complexity, so one of the challenges facing the FDA will be to connect the silos of research in recognition that the "system" of tobacco regulation is greater than the sum of its parts.

The rate of initiation and progression to dependence and premature mortality are higher for tobacco products than for any other dependence producing substance. This is not explained simply by the addictiveness (“abuse liability”) or by enticing product designs (“product appeal”) alone, but rather by both of these factors in combination with marketing and social influences that also influence “product appeal”. A working meeting of leading experts in abuse liability (AL) and product appeal was convened to examine how these disciplines could be more effectively applied to the evaluation of tobacco products for the purposes of regulation that would include setting standards for designs and contents intended to reduce the risk of initiation and dependence. It was concluded that abuse liability assessment (ALA) is a validated approach to testing pharmaceutical products but has not been extensively applied to tobacco products: such application has demonstrated feasibility, but special challenges include the diverse range of products, product complexity, and the absence of satisfactory placebo products. Consumer testing for product appeal is widely used by consumer product marketers as well as by researchers in their efforts to understand consumer product preferences and use but has not been extensively applied to tobacco products except by the tobacco industry. Recommendations for testing, methods development, and research were developed. A major recommendation was that tobacco products should be tested for AL and product appeal, and the results integrated and evaluated so as to more accurately predict risk of initiation, dependence, and persistence of use.

Powerful nerve agent, poison, addictive drug, or wonder medicine of the future? Nicotine has had a long and storied history in pharmacology, physiology, public health and, more recently, in regulatory policy initiatives in the United States and internationally. Psychopharmacology research on nicotine and tobacco came to particular prominence in the latter third of the twentieth century with exploration addressing the role of nicotine in tobacco use, the potential categorization of nicotine as an addictive drug, the pharmacological basis for treatment of tobacco addiction, and the perspective of policy developers seeking to reduce the toll of tobacco use. In fact, the 2005 ratification of the World Health Organization's first global health treaty, the Framework Convention on Tobacco Control, provides further impetus for extending the science foundation for tobacco disease control and policy efforts. Implementation of the treaty's provisions will control tobacco use and reduce the 500 million premature deaths projected to occur in the first half of the twenty-first century from tobacco use. Psychopharmacological research on nicotine and tobacco was important in the rationale and development of the treaty. The public health relevance of psychopharmacology research continues to grow with the realization of the potential of nicotine and related drugs to treat or prevent a diverse range of disorders (e.g., Alzheimer's disease, attention deficit hyperactivity disorder, and pain). Although comprehensive review of the research and implications is beyond the scope of this article, the more modest goal of providing insight into the theoretical, clinical, and policy importance of key psychopharmacology research laboratories over the past few decades is attempted.

Powerful nerve agent, poison, addictive drug, or wonder medicine of the future? Nicotine has had a long and storied history in pharmacology, physiology, public health and, more recently, in regulatory policy initiatives in the United States and internationally. Psychopharmacology research on nicotine and tobacco came to particular prominence in the latter third of the twentieth century with exploration addressing the role of nicotine in tobacco use, the potential categorization of nicotine as an addictive drug, the pharmacological basis for treatment of tobacco addiction, and the perspective of policy developers seeking to reduce the toll of tobacco use. In fact, the 2005 ratification of the World Health Organization's first global health treaty, the Framework Convention on Tobacco Control, provides further impetus for extending the science foundation for tobacco disease control and policy efforts. Implementation of the treaty's provisions will control tobacco use and reduce the 500 million premature deaths projected to occur in the first half of the twenty-first century from tobacco use. Psychopharmacological research on nicotine and tobacco was important in the rationale and development of the treaty. The public health relevance of psychopharmacology research continues to grow with the realization of the potential of nicotine and related drugs to treat or prevent a diverse range of disorders (e.g., Alzheimer's disease, attention deficit hyperactivity disorder, and pain). Although comprehensive review of the research and implications is beyond the scope of this article, the more modest goal of providing insight into the theoretical, clinical, and policy importance of key psychopharmacology research laboratories over the past few decades is attempted.

The concept of an ‘endgame’ for tobacco control efforts is receiving increasing attention in advocacy, policy and academic circles. This may strike some as entirely premature in countries such as Bangladesh, where 63% of adults are exposed to secondhand smoke in the workplace,1 or the Russian Federation, where 60% of adult men still smoke.2 Nonetheless, experts in countries like Australia and New Zealand, with a decades-long commitment to comprehensive tobacco control, have grown increasingly serious about the so-called ‘endgame’. Numerous potential endgame strategies are being explored, the most prominent of which are chronicled elsewhere in this supplement. We have yet to reach a consensus on which one or two strategies should be pursued. But when a group of global thought leaders gathered in 2012 to consider the endgame, there was convergence around the notion that we need new approaches to dramatically reduce consumption of conventional combusting cigarettes, if not other tobacco products that burn. If such an approach is to succeed, it will be because policy makers and tobacco control advocates have overcome their reluctance and finally embraced a concept known as the ‘continuum of risk’. Over time, many policy thinkers—this author included—have seen their views on these issues evolve in just such a manner. There is a spectrum or continuum of tobacco and medicinal products that aim to do the same thing—deliver nicotine …

Tobacco product regulation has the potential to help reduce tobacco attributable disease by reducing the toxicity of these products and by reducing the prevalence of tobacco use and addiction.

I had the privilege of serving at the US Food and Drug Administration (FDA) for 7 years and helping oversee the agency's 1994–1996 investigation of the tobacco industry. That effort enabled FDA to assert jurisdiction over cigarettes and smokeless tobacco products. From 1997 to 2000, FDA began to regulate these products and enforce certain youth access restrictions. In March 2000, after a lawsuit brought by the tobacco industry, the US Supreme Court overturned the FDA assertion of jurisdiction. It was nearly a decade before FDA returned to the business of regulating tobacco products. On 22 June 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA)1 into law. The FSPTCA passed with overwhelming bipartisan support in both houses of the US Congress. It gives FDA broad regulatory powers to control the manufacture, sale and distribution of tobacco products. The law itself, and FDA's approach to implementation, have important implications for global tobacco product regulatory initiatives under the relevant provisions of the Framework Convention on Tobacco Control. Now that just over 3 years have passed, it is time for an overall assessment of the implementation of the FSPTCA. The law is built around a public health standard that represents a departure from the traditional ‘safety and efficacy’ standard in the Food, Drug and Cosmetic Act. This standard obligates FDA to regulate tobacco products in a manner that ‘is appropriate for the protection of the public health.2 Equally important, the public health decisions FDA makes must take into account key population-level behavioural considerations, including the impact of regulation on initiation, cessation and re-initiation of tobacco use.3 FDA faced the daunting task of building an entire regulatory program while simultaneously meeting various mandatory deadlines in the FSPTCA. The agency has done an admirable job of creating a new …

Regulation of nicotine levels in cigarettes and other tobacco products is now possible with the passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009 giving the U.S. Food and Drug Administration authority to regulate tobacco products, and with Articles 9-11 of the World Health Organization Framework Convention on Tobacco Control.[1-2] Both regulatory approaches allow establishing product standards for tobacco constituents, including nicotine. The FSPTCA does not allow nicotine levels to be decreased to zero, although FDA has the authority to reduce nicotine yields to very low, presumably non-addicting levels. The proposal to reduce levels of nicotine to a level that is non-addicting was originally suggested in 1994.[3] Reduction of nicotine in tobacco products could potentially have a profound impact on reducing tobacco-related morbidity and mortality. To examine this issue, two meetings were convened in the United States with non-tobacco-industry scientists of varied disciplines, tobacco control policy-makers and representatives of government agencies. This article provides an overview of the current science in the area of reduced nicotine content cigarettes and key conclusions and recommendations for research and policy that emerged from the deliberations of the meeting members.