Download or read book FDA Tobacco Regulation written by C. Stephen Redhead and published by DIANE Publishing. This book was released on 2009-11 with total page 33 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 111th Congress is considering legislation that would give the FDA broad new statutory authority to regulate the manufacture and marketing of cigarettes and smokeless tobacco products. This report provides a detailed summary of the proposed legislation and discusses the public health and legal issues it raises. Contents: (1) Views on FDA Tobacco Regulation: Public Health Viewpoint; Industry Viewpoint; (2) Proposed Tobacco Product Regulation: Reduced-Risk Tobacco Products; Tobacco Product Design and Characteristics; Menthol Cigarettes; (3) Legal Issues: Restrictions on Ads and Promotion; First Amend. Issues; Preemption of State and Local Regulation Re: Labeling, Ads, and Promotion; (4) Tobacco Master Settlement Agreement.
Download or read book Food and Drug Administration written by United States. General Accounting Office and published by . This book was released on 1997 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
Download or read book FDA Regulation of Tobacco Products written by Victoria C. Lockwood and published by Nova Science Publishers. This book was released on 2009 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: Last year, lawmakers reintroduced bipartisan, bicameral legislation (H.R. 1108, S. 625) to give the Food and Drug Administration (FDA) broad new authority to regulate the manufacture, distribution, advertising, promotion, sale, and use of cigarettes and smokeless tobacco products. Amended versions of both bills have been reported out of committee and await floor action in their respective chambers. The Secretary of Health and Human Services has stated in a July 21, 2008, letter that the Bush Administration "would strongly oppose this legislation." The Family Smoking Prevention and Tobacco Control Act was first introduced in the 108th Congress, the product of lengthy negotiations in which lawmakers sought to balance the competing interests of public health groups and Philip Morris, the nation's leading cigarette company. While these organisations support the legislation, the FDA Commissioner, other tobacco manufacturers, and tobacco industry and convenience store associations have expressed concerns about the bills, which would create a new Chapter IX in the Federal Food, Drug, and Cosmetic Act (FFDCA) solely for the regulation of tobacco products. Among their many provisions, the measures would authorise FDA to: restrict tobacco advertising and promotions, especially to children; develop standards that require changes in tobacco product composition and design, such as the reduction or elimination of toxic chemicals; and require manufacturers to obtain agency approval in order to make reduced-risk and reduced-exposure claims for their products. In the mid-1990s, FDA claimed authority under the FFDCA to regulate cigarettes and smokeless tobacco products as delivery devices for nicotine, an addictive drug. The agency's 1996 tobacco regulation was invalidated by the U.S. Supreme Court in March 2000. The Court concluded that Congress had clearly intended to preclude FDA from regulating tobacco products. It found that because the FFDCA prohibits the marketing of products that have not been found to be safe and effective, the statute would have required FDA to ban such manifestly harmful products as cigarettes and smokeless tobacco if the agency had jurisdiction over them. Such a ban, argued the Court, would plainly contradict congressional intent. The Supreme Court's decision made it clear the Congress would have to enact legislation giving FDA statutory authority over tobacco products in order for the agency to assert jurisdiction. Lawmakers first drafted such language in the 105th Congress as part of legislation to implement the 1997 proposed national tobacco settlement.
Download or read book Tobacco Products written by Jared Hart and published by Nova Science Publishers. This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tobacco use is the leading cause of preventable death and disease in the United States. In 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) granted FDA, an agency within the Department of Health and Human Services (HHS), authority to regulate tobacco products, including marketing and distribution to youth. The act established CTP, which implements the act by educating the public on the dangers of tobacco use; developing the science needed for tobacco regulation; and developing and enforcing regulations on the manufacture, marketing, and distribution of tobacco products. The act authorized FDA to assess and collect user fees from tobacco manufacturers and importers. This book examines how FDA spent tobacco user fees for key activities using its authorities granted in the act, and any challenges FDA encountered in using its authorities.
Download or read book The Need for FDA Regulation of Tobacco written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2007 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Tobacco Products written by Jared Hart and published by Gazelle Book Services, Limited. This book was released on 2014-01-01 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tobacco use is the leading cause of preventable death and disease in the United States. In 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) granted FDA, an agency within the Department of Health and Human Services (HHS), a
Download or read book Assessing the Use of Agent Based Models for Tobacco Regulation written by Institute of Medicine and published by National Academies Press. This book was released on 2015-07-17 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tobacco consumption continues to be the leading cause of preventable disease and death in the United States. The Food and Drug Administration (FDA) regulates the manufacture, distribution, and marketing of tobacco products - specifically cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco - to protect public health and reduce tobacco use in the United States. Given the strong social component inherent to tobacco use onset, cessation, and relapse, and given the heterogeneity of those social interactions, agent-based models have the potential to be an essential tool in assessing the effects of policies to control tobacco. Assessing the Use of Agent-Based Models for Tobacco Regulation describes the complex tobacco environment; discusses the usefulness of agent-based models to inform tobacco policy and regulation; presents an evaluation framework for policy-relevant agent-based models; examines the role and type of data needed to develop agent-based models for tobacco regulation; provides an assessment of the agent-based model developed for FDA; and offers strategies for using agent-based models to inform decision making in the future.
Download or read book Reducing Tobacco Related Cancer Incidence and Mortality written by Institute of Medicine and published by National Academies Press. This book was released on 2013-04-16 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tobacco use is the leading cause of preventable death in United States, causing more than 440,000 deaths annually and resulting in $193 billion in health-related economic losses each year-$96 billion in direct medical costs and $97 billion in lost productivity. Since the first U.S. Surgeon General's report on smoking in 1964, more than 29 Surgeon General's reports, drawing on data from thousands of studies, have documented the overwhelming and conclusive biologic, epidemiologic, behavioral, and pharmacologic evidence that tobacco use is deadly. This evidence base links tobacco use to the development of multiple types of cancer and other life-threatening conditions, including cardiovascular and respiratory diseases. Smoking accounts for at least 30 percent of all cancer deaths, and 80 percent of lung cancer deaths. Despite the widespread agreement on the dangers of tobacco use and considerable success in reducing tobacco use prevalence from over 40 percent at the time of the 1964 Surgeon General's report to less than 20 percent today, recent progress in reducing tobacco use has slowed. An estimated 18.9 percent of U.S. adults smoke cigarettes, nearly one in four high school seniors smoke, and 13 percent of high school males use smokeless tobacco products. In recognition that progress in combating cancer will not be fully achieved without addressing the tobacco problem, the National Cancer Policy Forum of the Institute of Medicine (IOM) convened a public workshop, Reducing Tobacco-Related Cancer Incidence and Mortality, June 11-12, 2012 in Washington, DC. In opening remarks to the workshop participants, planning committee chair Roy Herbst, professor of medicine and of pharmacology and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital, described the goals of the workshop, which were to examine the current obstacles to tobacco control and to discuss potential policy, outreach, and treatment strategies that could overcome these obstacles and reduce tobacco-related cancer incidence and mortality. Experts explored a number of topics, including: the changing demographics of tobacco users and the changing patterns of tobacco product use; the influence of tobacco use on cancer incidence and cancer treatment outcomes; tobacco dependence and cessation programs; federal and state level laws and regulations to curtail tobacco use; tobacco control education, messaging, and advocacy; financial and legal challenges to tobacco control efforts; and research and infrastructure needs to support tobacco control strategies, reduce tobacco related cancer incidence, and improve cancer patient outcomes. Reducing Tobacco-Related Cancer Incidence and Mortality summarizes the workshop.
Download or read book Scientific Standards for Studies on Modified Risk Tobacco Products written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-19 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book A Practical Guide to FDA s Food and Drug Law and Regulation Seventh Edition written by Stephen M. Kanovsky and published by . This book was released on 2020-09 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
Download or read book The Tobacco Control Act and FDA Review of New Tobacco Products written by Gia A. Chance and published by Nova Science Publishers. This book was released on 2014-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) became a law on June 22, 2009. It gives the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. This book highlights some of the provisions of the Tobacco Control Act and provides an assessment of FDA efforts to implement the Tobacco Control Act since it was signed into law.
Download or read book FDA Regulation of Tobacco Products written by and published by . This book was released on 2007 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Question Of Intent written by David Kessler and published by Public Affairs. This book was released on 2001 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: Former FDA commissioner David Kessler guides the reader through a legal thriller, telling the story of the FDA's fight with big tobacco.
Download or read book Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products written by Institute of Medicine and published by National Academies Press. This book was released on 2015-07-23 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tobacco use by adolescents and young adults poses serious concerns. Nearly all adults who have ever smoked daily first tried a cigarette before 26 years of age. Current cigarette use among adults is highest among persons aged 21 to 25 years. The parts of the brain most responsible for cognitive and psychosocial maturity continue to develop and change through young adulthood, and adolescent brains are uniquely vulnerable to the effects of nicotine. At the request of the U.S. Food and Drug Administration, Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products considers the likely public health impact of raising the minimum age for purchasing tobacco products. The report reviews the existing literature on tobacco use patterns, developmental biology and psychology, health effects of tobacco use, and the current landscape regarding youth access laws, including minimum age laws and their enforcement. Based on this literature, the report makes conclusions about the likely effect of raising the minimum age to 19, 21, and 25 years on tobacco use initiation. The report also quantifies the accompanying public health outcomes based on findings from two tobacco use simulation models. According to the report, raising the minimum age of legal access to tobacco products, particularly to ages 21 and 25, will lead to substantial reductions in tobacco use, improve the health of Americans across the lifespan, and save lives. Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products will be a valuable reference for federal policy makers and state and local health departments and legislators.
Download or read book Tobacco product regulation most FDA spending funded public education regulatory science and compliance and enforcement activities written by and published by . This book was released on 2014 with total page 53 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Growing Up Tobacco Free written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tobacco use kills more people than any other addiction and we know that addiction starts in childhood and youth. We all agree that youths should not smoke, but how can this be accomplished? What prevention messages will they find compelling? What effect does tobacco advertisingâ€"more than $10 million worth every dayâ€"have on youths? Can we responsibly and effectively restrict their access to tobacco products? These questions and more are addressed in Growing Up Tobacco Free, prepared by the Institute of Medicine to help everyone understand the troubling issues surrounding youths and tobacco use. Growing Up Tobacco Free provides a readable explanation of nicotine's effects and the process of addiction, and documents the search for an effective approach to preventing the use of cigarettes, chewing and spitting tobacco, and snuff by children and youths. It covers the results of recent initiatives to limit young people's access to tobacco and discusses approaches to controls or bans on tobacco sales, price sensitivity among adolescents, and arguments for and against taxation as a prevention strategy for tobacco use. The controversial area of tobacco advertising is thoroughly examined. With clear guidelines for public action, everyone can benefit by reading and acting on the messages in this comprehensive and compelling book.
