Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.

Tobacco use has declined because of measures such as high taxes on tobacco products and bans on advertising, but worldwide there are still more than one billion people who regularly use tobacco, including many who purchase products illicitly. By contrast to many other commodities, taxes comprise a substantial portion of the retail price of cigarettes in the United States and most other nations. Large tax differentials between jurisdictions increase incentives for participation in existing illicit tobacco markets. In the United States, the illicit tobacco market consists mostly of bootlegging from low-tax states to high-tax states and is less affected by large-scale smuggling or illegal production as in other countries. In the future, nonprice regulation of cigarettes - such as product design, formulation, and packaging - could in principle, contribute to the development of new types of illicit tobacco markets. Understanding the U.S. Illicit Tobacco Market reviews the nature of illicit tobacco markets, evidence for policy effects, and variations among different countries with a focus on implications for the United States. This report estimates the portion of the total U.S. tobacco market represented by illicit sales has grown in recent years and is now between 8.5 percent and 21 percent. This represents between 1.24 to 2.91 billion packs of cigarettes annually and between $2.95 billion and $6.92 billion in lost gross state and local tax revenues. Understanding the U.S. Illicit Tobacco Market describes the complex system associated with illicit tobacco use by exploring some of the key features of that market - the cigarette supply chain, illicit procurement schemes, the major actors in the illicit trade, and the characteristics of users of illicit tobacco. This report draws on domestic and international experiences with the illicit tobacco trade to identify a range of possible policy and enforcement interventions by the U.S. federal government and/or states and localities.

Untoward reactions to environmental chemicals, particularly when a subject reports difficulties with exposures to chemicals of diverse classes involving more than one organ system, have been poorly understood and an area of great controversy. Studies of airway inflammation induced by respiratory irritants have established neurogenic inflammation as the mechanism for irritant asthma and rhinitis. Remodeling of the airway after an acute irritant exposure can lead to a heightened sensitivity to irritants that persists. Recognition that rhinitis, while sometimes regarded as a trivial disease, is associated with extra-airway manifestations such as fatigue and disturbances of sleep, mood, and cognition, further elucidates how chemical exposures can be serious for susceptible individuals. This book reviews current scientific understanding of irritant airway inflammation and related conditions, including cardiovascular effects of particulate exposures, airborne contact dermatitis and irritant dermatitis, and the brain as a target organ for both allergic and irritant reactions. It is essential reading for physicians and other healthcare workers caring for patients with environmental intolerances. Allergists, toxicologists, occupational and environmental physicians, and pulmonologists will find the materials particularly valuable. Patients and advocates for those with chemical intolerances will also find the book of interest.

This book comprehensively covers the science and policy issues relevant to one of the major public health issues in China. It pulls together the prevalence pattern of tobacco use in different population and burden of the myriad of tobacco-related diseases. The book pays more attention to review the successes and failures of tobacco control policies in China, including the protect peoples from second-hand smoke, comprehensive banning tobacco advertisement promotion and sponsor, regulation of the contents of tobacco products and low tar cigarettes, warn about the dangers of tobacco, support for smokers to quit, and increasing tobacco taxation and price, as well as monitor and assessment on tobacco use and implement of prevention policy under the international background of tobacco control. The book analyse and explain the influence factors, especially interference from tobacco industry with public management theory frame for promoting tobacco control policies and looks at lessons learnt to help set health policy for reducing the burden of tobacco-related diseases. It is a helpful reference for experts in public health and epidemiologists in tobacco control, advocators and policy maker.

Toxicological Evaluation of Electronic Nicotine Delivery Products (ENDP) discusses the scientific basis for the toxicological assessment and evaluation of ENDPs. The book covers aerosol chemistry, in vitro and in vivo studies as well as clinical studies. It provides the basis for the evaluation of short and long term-effects, along with relative risks. It also examines the potential role of ENDPs in tobacco harm reduction and how they may reduce the risk of disease in smokers who switch to them. This book is a comprehensive resource for toxicologists, health practitioners and public health professionals who want the scientific information necessary to assess the relative risk of ENDPs when compared with cigarette smoking and cessation. - Delivers a comprehensive overview of current state of science - Offers an integrated analysis of e-cigarettes and heated tobacco products - Provides guidance for methodologies

The field of behavioural economics can tell us a great deal about cognitive bias and unconscious decision-making, challenging the orthodox economic model whereby consumers make rational and informed choices. But it is in the arena of health that it perhaps offers individuals and governments the most value. In this important new book, the most pernicious health issues we face today are examined through a behavioral economic lens. It provides an essential and timely overview of how this growing field of study can reframe and offer solutions to some of the biggest health issues of our age. The book opens with an overview of the core theoretical concepts, after which each chapter assesses how behavioral economic research and practice can inform public policy across a range of health issues. Including chapters on tobacco, alcohol and drug use, physical activity, dietary intake, cancer screening and sexual health, the book integrates the key insights from the field to both developed and developing nations. Also asking important ethical questions around paternalism and informed choice, this book will be essential reading for students and researchers across psychology, economics and business and management, as well as public health professionals wishing for a concise overview of the role behavioral economics can potentially play in allowing people to live healthier lives.

This book reflects the current thinking and research on how consumers’ perception of product risks and benefits affects their behavior. It provides the scientific, regulatory and industrial research community with a conceptual and methodological reference point for studies on consumer behavior and marketing. The contributions address various aspects of consumer psychology and behavior, risk perception and communication, marketing research strategies, as well as consumer product regulation. The book is divided into 4 parts: Product risks; Perception of product risks and benefits; Consumer behavior; Regulation and responsibility.

The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility.