PMI-funded foundation for a smoke-free world: application of criteria to assess funding models that include financial support from the tobacco industry.

Recent changes to the leadership and the terms of tobacco industry financing of the Foundation for a Smoke-Free World (FSFW) have called for a revisiting of a paper published in 2009 where we proposed criteria and other considerations to assess possible funding models for research that include financial support from the tobacco industry. This paper reviews and attempts to apply the elements laid out in 2009 to the current state of FSFW. After discussing each criterion and consideration we conclude that, at this point in time, conducting a thorough assessment using our 2009 paper is not possible because critical details related to FSFW governance, decision-making and process have not been announced. Nonetheless, we hope this paper will remind the tobacco control community that the 2009 criteria exist and highlight the information needed and questions that might be asked of FSFW to help form judgements about this new iteration of the foundation. We further hope this will put the FSFW on notice that they need to address each of these criteria and speak publicly about their plans regarding the specific issues raised in the 2009 paper.

Nicotine reduction: strategic research plan.

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.

Research priorities and infrastructure needs of the Family Smoking Prevention and Tobacco Control Act: science to inform FDA policy.

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.

Tobacco and nicotine product testing.

INTRODUCTION: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: A cohesive, systematic, and comprehensive assessment of tobacco products is important and will require building consensus and addressing some crucial research questions.

Nicotine reduction revisited: science and future directions.

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 US Food and Drug Administration (FDA) authority to regulate tobacco products, and with Articles 9-11 of the WHO Framework Convention on Tobacco Control. 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 the 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. 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 US with non-tobacco-industry scientists of varied disciplines, tobacco control policymakers 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.

Nicotine psychopharmacology: policy and regulatory.

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.

Nicotine psychopharmacology research contributions to United States and global tobacco regulation: a look back and a look forward.

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.

Tobacco industry litigation position on addiction: continued dependence on past views.

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.

Public support for smoke-free areas in Israel: a case for action.

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%) supported completely 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.

Conference on abuse liability and appeal of tobacco products: conclusions and recommendations.

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.