Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309223989
Category : Medical
Languages : en
Pages : 370
Book Description
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.
Scientific Standards for Studies on Modified Risk Tobacco Products
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309223989
Category : Medical
Languages : en
Pages : 370
Book Description
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.
Publisher: National Academies Press
ISBN: 0309223989
Category : Medical
Languages : en
Pages : 370
Book Description
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.
Clearing the Smoke
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309072824
Category : Medical
Languages : en
Pages : 657
Book Description
Despite overwhelming evidence of tobacco's harmful effects and pressure from anti-smoking advocates, current surveys show that about one-quarter of all adults in the United States are smokers. This audience is the target for a wave of tobacco products and pharmaceuticals that claim to preserve tobacco pleasure while reducing its toxic effects. Clearing the Smoke addresses the problems in evaluating whether such products actually do reduce the health risks of tobacco use. Within the context of regulating such products, the committee explores key questions: Does the use of such products decrease exposure to harmful substances in tobacco? Is decreased exposure associated with decreased harm to health? Are there surrogate indicators of harm that could be measured quickly enough for regulation of these products? What are the public health implications? This book looks at the types of products that could reduce harm and reviews the available evidence for their impact on various forms of cancer and other major ailments. It also recommends approaches to governing these products and tracking their public health effects. With an attitude of healthy skepticism, Clearing the Smoke will be important to health policy makers, public health officials, medical practitioners, manufacturers and marketers of "reduced-harm" tobacco products, and anyone trying to sort through product claims.
Publisher: National Academies Press
ISBN: 0309072824
Category : Medical
Languages : en
Pages : 657
Book Description
Despite overwhelming evidence of tobacco's harmful effects and pressure from anti-smoking advocates, current surveys show that about one-quarter of all adults in the United States are smokers. This audience is the target for a wave of tobacco products and pharmaceuticals that claim to preserve tobacco pleasure while reducing its toxic effects. Clearing the Smoke addresses the problems in evaluating whether such products actually do reduce the health risks of tobacco use. Within the context of regulating such products, the committee explores key questions: Does the use of such products decrease exposure to harmful substances in tobacco? Is decreased exposure associated with decreased harm to health? Are there surrogate indicators of harm that could be measured quickly enough for regulation of these products? What are the public health implications? This book looks at the types of products that could reduce harm and reviews the available evidence for their impact on various forms of cancer and other major ailments. It also recommends approaches to governing these products and tracking their public health effects. With an attitude of healthy skepticism, Clearing the Smoke will be important to health policy makers, public health officials, medical practitioners, manufacturers and marketers of "reduced-harm" tobacco products, and anyone trying to sort through product claims.
Federal Register
Author:
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 412
Book Description
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 412
Book Description
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2011
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 804
Book Description
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 804
Book Description
How Tobacco Smoke Causes Disease
Author: United States. Public Health Service. Office of the Surgeon General
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 728
Book Description
This report considers the biological and behavioral mechanisms that may underlie the pathogenicity of tobacco smoke. Many Surgeon General's reports have considered research findings on mechanisms in assessing the biological plausibility of associations observed in epidemiologic studies. Mechanisms of disease are important because they may provide plausibility, which is one of the guideline criteria for assessing evidence on causation. This report specifically reviews the evidence on the potential mechanisms by which smoking causes diseases and considers whether a mechanism is likely to be operative in the production of human disease by tobacco smoke. This evidence is relevant to understanding how smoking causes disease, to identifying those who may be particularly susceptible, and to assessing the potential risks of tobacco products.
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 728
Book Description
This report considers the biological and behavioral mechanisms that may underlie the pathogenicity of tobacco smoke. Many Surgeon General's reports have considered research findings on mechanisms in assessing the biological plausibility of associations observed in epidemiologic studies. Mechanisms of disease are important because they may provide plausibility, which is one of the guideline criteria for assessing evidence on causation. This report specifically reviews the evidence on the potential mechanisms by which smoking causes diseases and considers whether a mechanism is likely to be operative in the production of human disease by tobacco smoke. This evidence is relevant to understanding how smoking causes disease, to identifying those who may be particularly susceptible, and to assessing the potential risks of tobacco products.
The Toxicant Induction of Irritant Asthma, Rhinitis, and Related Conditions
Author: William J. Meggs
Publisher: Springer Science & Business Media
ISBN: 1461490448
Category : Medical
Languages : en
Pages : 297
Book Description
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.
Publisher: Springer Science & Business Media
ISBN: 1461490448
Category : Medical
Languages : en
Pages : 297
Book Description
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.
Consumer Perception of Product Risks and Benefits
Author: Gerard Emilien
Publisher: Springer
ISBN: 3319505300
Category : Business & Economics
Languages : en
Pages : 600
Book Description
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.
Publisher: Springer
ISBN: 3319505300
Category : Business & Economics
Languages : en
Pages : 600
Book Description
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.
Understanding the U.S. Illicit Tobacco Market
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309317150
Category : Law
Languages : en
Pages : 316
Book Description
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.
Publisher: National Academies Press
ISBN: 0309317150
Category : Law
Languages : en
Pages : 316
Book Description
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.
Toxicological Evaluation of Electronic Nicotine Delivery Products
Author: Manuel C. Peitsch
Publisher: Academic Press
ISBN: 0128209356
Category : Medical
Languages : en
Pages : 622
Book Description
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
Publisher: Academic Press
ISBN: 0128209356
Category : Medical
Languages : en
Pages : 622
Book Description
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
Advances in Clinical Chemistry
Author:
Publisher: Academic Press
ISBN: 0128024666
Category : Science
Languages : en
Pages : 285
Book Description
Volume 67 in the internationally acclaimed Advances in Clinical Chemistry contains chapters authored by world renowned clinical laboratory scientists, physicians and research scientists. The serial provides the latest and most up-to-date technologies related to the field of Clinical Chemistry and is the benchmark for novel analytical approaches in the clinical laboratory. - Expertise of international contributors - Latest cutting-edge technologies - Comprehensive in scope
Publisher: Academic Press
ISBN: 0128024666
Category : Science
Languages : en
Pages : 285
Book Description
Volume 67 in the internationally acclaimed Advances in Clinical Chemistry contains chapters authored by world renowned clinical laboratory scientists, physicians and research scientists. The serial provides the latest and most up-to-date technologies related to the field of Clinical Chemistry and is the benchmark for novel analytical approaches in the clinical laboratory. - Expertise of international contributors - Latest cutting-edge technologies - Comprehensive in scope