Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)

Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)

Author: The Law The Law Library

Publisher: Createspace Independent Publishing Platform

Published: 2018-09-22

Total Pages: 30

ISBN-13: 9781727546606

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Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA or we) is issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA recently expanded its authority by issuing a final rule, "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products" (Deeming rule), deeming all products that meet the statutory definition of "tobacco product," except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjected domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act's user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, this final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA. This book contains: - The complete text of the Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section


Book Synopsis Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) by : The Law The Law Library

Download or read book Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) written by The Law The Law Library and published by Createspace Independent Publishing Platform. This book was released on 2018-09-22 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt: Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA or we) is issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA recently expanded its authority by issuing a final rule, "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products" (Deeming rule), deeming all products that meet the statutory definition of "tobacco product," except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjected domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act's user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, this final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA. This book contains: - The complete text of the Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section


Importing Into the United States

Importing Into the United States

Author: U. S. Customs and Border Protection

Publisher:

Published: 2015-10-12

Total Pages: 0

ISBN-13: 9781304100061

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Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.


Book Synopsis Importing Into the United States by : U. S. Customs and Border Protection

Download or read book Importing Into the United States written by U. S. Customs and Border Protection and published by . This book was released on 2015-10-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.


Understanding the U.S. Illicit Tobacco Market

Understanding the U.S. Illicit Tobacco Market

Author: National Research Council

Publisher: National Academies Press

Published: 2015-04-30

Total Pages: 240

ISBN-13: 0309317150

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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.


Book Synopsis Understanding the U.S. Illicit Tobacco Market by : National Research Council

Download or read book Understanding the U.S. Illicit Tobacco Market written by National Research Council and published by National Academies Press. This book was released on 2015-04-30 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


The Tobacco Atlas

The Tobacco Atlas

Author: Judith Mackay

Publisher: World Health Organization

Published: 2002

Total Pages: 140

ISBN-13: 9789241562096

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Research in the past five years suggests a bleak picture of the health dangers of smoking, with tobacco the biggest single killer of all forms of pollution. It is estimated that one person dies every ten seconds due to smoking-related diseases. This publication considers the history and current position regarding tobacco use, as well as providing some predictions for the future of the tobacco epidemic upto the year 2050. It contains a number of full-colour world maps and graphics to illustrate the variations between countries and regions. Issues discussed include: tobacco prevalence and consumption; youth smoking; the economics of tobacco farming and manufacturing; smuggling; the tobacco industry, promotion, profits and trade; smokers' rights; legislative action such as smoke-free areas, tobacco advertising bans and health warnings.


Book Synopsis The Tobacco Atlas by : Judith Mackay

Download or read book The Tobacco Atlas written by Judith Mackay and published by World Health Organization. This book was released on 2002 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research in the past five years suggests a bleak picture of the health dangers of smoking, with tobacco the biggest single killer of all forms of pollution. It is estimated that one person dies every ten seconds due to smoking-related diseases. This publication considers the history and current position regarding tobacco use, as well as providing some predictions for the future of the tobacco epidemic upto the year 2050. It contains a number of full-colour world maps and graphics to illustrate the variations between countries and regions. Issues discussed include: tobacco prevalence and consumption; youth smoking; the economics of tobacco farming and manufacturing; smuggling; the tobacco industry, promotion, profits and trade; smokers' rights; legislative action such as smoke-free areas, tobacco advertising bans and health warnings.


The Role of the Media in Promoting and Reducing Tobacco Use

The Role of the Media in Promoting and Reducing Tobacco Use

Author: National Cancer Institute

Publisher: Createspace Independent Pub

Published: 2012-06-23

Total Pages: 684

ISBN-13: 9781478117902

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The National Institutes of Health Publication 07-6242, The Role of the Media in Promoting and Reducing Tobacco Use, NCI Tobacco Control Monograph 19, (the 19th of the Tobacco Control Monograph series of the National Cancer Institute (NCI) provides a critical, scientific review and synthesis of current evidence regarding the power of the media both to encourage and discourage tobacco use. The work presented is the most current and comprehensive distillation of the scientific literature on media communications in tobacco promotion and tobacco control. The six main parts of this monograph deal with aspects of media communications relevant to tobacco promotion and tobacco control. Part 1, an overview, frames the rationale for the monograph's organization and presents the key issues and conclusions of the research as a whole and of the individual chapters. This section describes media research theories that guided this assessment of the relationship between media and tobacco use, which can be viewed as a multilevel issue ranging from consumer-level advertising and promotion to stakeholder-level marketing aimed toward retailers, policymakers, and others. Part 2 further explores tobacco marketing—the range of media interventions used by the tobacco industry to promote its products, such as brand advertising and promotion, as well as corporate sponsorship and advertising. This section also evaluates the evidence for the influence of tobacco marketing on smoking behavior and discusses regulatory and constitutional issues related to marketing restrictions. Part 3 explores how both the tobacco control community and the tobacco industry have used news and entertainment media to advocate their positions and how such coverage relates to tobacco use and tobacco policy change. The section also appraises evidence of the influence of tobacco use in movies on youth smoking initiation. Part 4 focuses on tobacco control media interventions and the strategies, themes, and communication designs intended to prevent tobacco use or encourage cessation, including opportunities for new media interventions. This section also synthesizes evidence on the effectiveness of mass media campaigns in reducing smoking. Part 5 discusses tobacco industry efforts to diminish media interventions by the tobacco control community and to use the media to oppose state tobacco control ballot initiatives and referenda. Finally, Part 6 examines possible future directions in the use of media to promote or to control tobacco use and summarizes research needs and opportunities. Key lessons from this volume can inform policymakers as well as scientists and practitioners. Most critical from a policy standpoint is the conclusion, supported by strong evidence, that both exposure to tobacco marketing and depictions of tobacco in movies promote smoking initiation. In the United States in 2005—the same year in which 2.7 million American adolescents aged 12 to 17 used cigarettes in the past month1 and 438,000 Americans died prematurely from diseases caused by tobacco use or secondhand smoke exposure2—the tobacco industry spent $13.5 billion (in 2006 dollars) on cigarette advertising and promotion,3 an average of $37 million per day. The tobacco industry continues to succeed in overcoming partial restrictions on tobacco marketing in the United States, and tobacco marketing remains pervasive and effective in promoting tobacco use. Efforts to curb the depiction of tobacco use in movies have increased in recent years, and the evidence reviewed here indicates that progress in this area could be expected to translate into lower rates of youth smoking initiation in the future. Strong evidence indicates that media campaigns can reduce tobacco use. This volume highlights the complexities of assessing the media's influence on tobacco-related attitudes and behavior. A vast range of research is reviewed.~


Book Synopsis The Role of the Media in Promoting and Reducing Tobacco Use by : National Cancer Institute

Download or read book The Role of the Media in Promoting and Reducing Tobacco Use written by National Cancer Institute and published by Createspace Independent Pub. This book was released on 2012-06-23 with total page 684 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Institutes of Health Publication 07-6242, The Role of the Media in Promoting and Reducing Tobacco Use, NCI Tobacco Control Monograph 19, (the 19th of the Tobacco Control Monograph series of the National Cancer Institute (NCI) provides a critical, scientific review and synthesis of current evidence regarding the power of the media both to encourage and discourage tobacco use. The work presented is the most current and comprehensive distillation of the scientific literature on media communications in tobacco promotion and tobacco control. The six main parts of this monograph deal with aspects of media communications relevant to tobacco promotion and tobacco control. Part 1, an overview, frames the rationale for the monograph's organization and presents the key issues and conclusions of the research as a whole and of the individual chapters. This section describes media research theories that guided this assessment of the relationship between media and tobacco use, which can be viewed as a multilevel issue ranging from consumer-level advertising and promotion to stakeholder-level marketing aimed toward retailers, policymakers, and others. Part 2 further explores tobacco marketing—the range of media interventions used by the tobacco industry to promote its products, such as brand advertising and promotion, as well as corporate sponsorship and advertising. This section also evaluates the evidence for the influence of tobacco marketing on smoking behavior and discusses regulatory and constitutional issues related to marketing restrictions. Part 3 explores how both the tobacco control community and the tobacco industry have used news and entertainment media to advocate their positions and how such coverage relates to tobacco use and tobacco policy change. The section also appraises evidence of the influence of tobacco use in movies on youth smoking initiation. Part 4 focuses on tobacco control media interventions and the strategies, themes, and communication designs intended to prevent tobacco use or encourage cessation, including opportunities for new media interventions. This section also synthesizes evidence on the effectiveness of mass media campaigns in reducing smoking. Part 5 discusses tobacco industry efforts to diminish media interventions by the tobacco control community and to use the media to oppose state tobacco control ballot initiatives and referenda. Finally, Part 6 examines possible future directions in the use of media to promote or to control tobacco use and summarizes research needs and opportunities. Key lessons from this volume can inform policymakers as well as scientists and practitioners. Most critical from a policy standpoint is the conclusion, supported by strong evidence, that both exposure to tobacco marketing and depictions of tobacco in movies promote smoking initiation. In the United States in 2005—the same year in which 2.7 million American adolescents aged 12 to 17 used cigarettes in the past month1 and 438,000 Americans died prematurely from diseases caused by tobacco use or secondhand smoke exposure2—the tobacco industry spent $13.5 billion (in 2006 dollars) on cigarette advertising and promotion,3 an average of $37 million per day. The tobacco industry continues to succeed in overcoming partial restrictions on tobacco marketing in the United States, and tobacco marketing remains pervasive and effective in promoting tobacco use. Efforts to curb the depiction of tobacco use in movies have increased in recent years, and the evidence reviewed here indicates that progress in this area could be expected to translate into lower rates of youth smoking initiation in the future. Strong evidence indicates that media campaigns can reduce tobacco use. This volume highlights the complexities of assessing the media's influence on tobacco-related attitudes and behavior. A vast range of research is reviewed.~


WHO report on the global tobacco epidemic, 2017

WHO report on the global tobacco epidemic, 2017

Author: World Health Organization

Publisher: World Health Organization

Published: 2017-08-28

Total Pages: 0

ISBN-13: 9789241512824

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The report "Monitoring tobacco use and prevention policies" tracks the status of the tobacco epidemic and interventions to combat it. The report finds that more countries have implemented tobacco control policies, ranging from graphic pack warnings and advertising bans to no smoking areas. About 4.7 billion people - 63% of the world's population - are covered by at least one comprehensive tobacco control measure, which has quadrupled since 2007 when only 1 billion people and 15% of the world's population were covered.


Book Synopsis WHO report on the global tobacco epidemic, 2017 by : World Health Organization

Download or read book WHO report on the global tobacco epidemic, 2017 written by World Health Organization and published by World Health Organization. This book was released on 2017-08-28 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The report "Monitoring tobacco use and prevention policies" tracks the status of the tobacco epidemic and interventions to combat it. The report finds that more countries have implemented tobacco control policies, ranging from graphic pack warnings and advertising bans to no smoking areas. About 4.7 billion people - 63% of the world's population - are covered by at least one comprehensive tobacco control measure, which has quadrupled since 2007 when only 1 billion people and 15% of the world's population were covered.


Curbing the Epidemic

Curbing the Epidemic

Author: Prabhat Jha

Publisher: World Bank Publications

Published: 1999-01-01

Total Pages: 140

ISBN-13: 9780821345191

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Annotation. Addresses important economic and social issues confronting policymakers when dealing with the issue of tobacco control and its impact on the social and economic resources of both developed and developing countries.


Book Synopsis Curbing the Epidemic by : Prabhat Jha

Download or read book Curbing the Epidemic written by Prabhat Jha and published by World Bank Publications. This book was released on 1999-01-01 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: Annotation. Addresses important economic and social issues confronting policymakers when dealing with the issue of tobacco control and its impact on the social and economic resources of both developed and developing countries.


Health Systems in Transition

Health Systems in Transition

Author: Thomas Rice

Publisher: University of Toronto Press

Published: 2021-10-20

Total Pages: 505

ISBN-13: 1487526458

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The book provides a thorough review of the U.S. health care system, including its organization and financing, care delivery, recent reforms, and an evaluation of the system's performance.


Book Synopsis Health Systems in Transition by : Thomas Rice

Download or read book Health Systems in Transition written by Thomas Rice and published by University of Toronto Press. This book was released on 2021-10-20 with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book provides a thorough review of the U.S. health care system, including its organization and financing, care delivery, recent reforms, and an evaluation of the system's performance.


Building an Import/Export Business

Building an Import/Export Business

Author: Kenneth D. Weiss

Publisher:

Published: 1997-08-19

Total Pages: 308

ISBN-13:

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Do you dream of traveling to exotic places to buy or sell your lines of merchandise? Building an Import/Export Business shows you how to start your own business, from researching a raw idea to a successful launch to ongoing, profitable business operations. Author Kenneth Weiss objectively and accurately describes the difficulties and rewards of this kind of business.


Book Synopsis Building an Import/Export Business by : Kenneth D. Weiss

Download or read book Building an Import/Export Business written by Kenneth D. Weiss and published by . This book was released on 1997-08-19 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: Do you dream of traveling to exotic places to buy or sell your lines of merchandise? Building an Import/Export Business shows you how to start your own business, from researching a raw idea to a successful launch to ongoing, profitable business operations. Author Kenneth Weiss objectively and accurately describes the difficulties and rewards of this kind of business.


Cigarette Wars

Cigarette Wars

Author: Cassandra Tate

Publisher: Oxford University Press, USA

Published: 2000-06-15

Total Pages: 224

ISBN-13: 9780195140613

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We live in an age when the cigarette industry is under almost constant attack. Few weeks pass without yet another report on the hazards of smoking, or news of another anti-cigarette lawsuit, or more restrictions on cigarette sales, advertising, or use. It's somewhat surprising, then, that very little attention has been given to the fact that America has traveled down this road before. Until now, that is. As Cassandra Tate reports in this fascinating work of historical scholarship, between 1890 and 1930, fifteen states enacted laws to ban the sale, manufacture, possession, and/or use of cigarettes--and no fewer than twenty-two other states considered such legislation. In presenting the history of America's first conflicts with Big Tobacco, Tate draws on a wide range of newspapers, magazines, trade publications, rare pamphlets, and many other manuscripts culled from archives across the country. Her thorough and meticulously researched volume is also attractively illustrated with numerous photographs, posters, and cartoons from this bygone era. Readers will find in Cigarette Wars an engagingly written and well-told tale of the first anti-cigarette movement, dating from the Victorian Age to the Great Depression, when cigarettes were both legally restricted and socially stigmatized in America. Progressive reformers and religious fundamentalists came together to curb smoking, but their efforts collapsed during World War I, when millions of soldiers took up the habit and cigarettes began to be associated with freedom, modernity, and sophistication. Importantly, Tate also illustrates how supporters of the early anti-cigarette movement articulated virtually every issue that is still being debated about smoking today; theirs was not a failure of determination, she argues in these pages, but of timing. A compelling narrative about several clashing American traditions--old vs. young, rural vs. urban, and the late nineteenth vs. early twentieth centuries--this work will appeal to all who are interested in America's love-hate relationship with what Henry Ford once called "the little white slaver."


Book Synopsis Cigarette Wars by : Cassandra Tate

Download or read book Cigarette Wars written by Cassandra Tate and published by Oxford University Press, USA. This book was released on 2000-06-15 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: We live in an age when the cigarette industry is under almost constant attack. Few weeks pass without yet another report on the hazards of smoking, or news of another anti-cigarette lawsuit, or more restrictions on cigarette sales, advertising, or use. It's somewhat surprising, then, that very little attention has been given to the fact that America has traveled down this road before. Until now, that is. As Cassandra Tate reports in this fascinating work of historical scholarship, between 1890 and 1930, fifteen states enacted laws to ban the sale, manufacture, possession, and/or use of cigarettes--and no fewer than twenty-two other states considered such legislation. In presenting the history of America's first conflicts with Big Tobacco, Tate draws on a wide range of newspapers, magazines, trade publications, rare pamphlets, and many other manuscripts culled from archives across the country. Her thorough and meticulously researched volume is also attractively illustrated with numerous photographs, posters, and cartoons from this bygone era. Readers will find in Cigarette Wars an engagingly written and well-told tale of the first anti-cigarette movement, dating from the Victorian Age to the Great Depression, when cigarettes were both legally restricted and socially stigmatized in America. Progressive reformers and religious fundamentalists came together to curb smoking, but their efforts collapsed during World War I, when millions of soldiers took up the habit and cigarettes began to be associated with freedom, modernity, and sophistication. Importantly, Tate also illustrates how supporters of the early anti-cigarette movement articulated virtually every issue that is still being debated about smoking today; theirs was not a failure of determination, she argues in these pages, but of timing. A compelling narrative about several clashing American traditions--old vs. young, rural vs. urban, and the late nineteenth vs. early twentieth centuries--this work will appeal to all who are interested in America's love-hate relationship with what Henry Ford once called "the little white slaver."