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 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 The FDA s Misplaced Priorities written by Micah L. Berman and published by . This book was released on 2016 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt: Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the U.S. Food and Drug Administration (FDA) before they can be sold. To assess the FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that the FDA has not implemented the premarket review process in a manner that prioritizes the protection of public health. In particular, the FDA has: (1) prioritized the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially noncompliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications; and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process.

Download or read book New Tobacco Products written by U.s. Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2017-08-03 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt: " In 2009, the Family Smoking Prevention and Tobacco Control Act granted FDA, an agency within the Department of Health and Human Services (HHS), authority to regulate tobacco products such as cigarettes. The act requires that tobacco manufacturers submit information to be reviewed by FDA in order to market new tobacco products and established tobacco user fees to fund FDA's tobacco-related activities. The act represents the first time that FDA has had the authority to regulate tobacco products. Manufacturers have raised concerns about the progress of CTP, the FDA center established by the act to implement its provisions. GAO was asked to examine CTP's review of new tobacco product submissions, responses to meeting requests, and use of funds. This report examines (1) the status of CTP's reviews of new tobacco product submissions; (2) how CTP responded to manufacturers' and other entities' meeting requests, and the length of time CTP took to hold the meetings; and (3) the extent to which FDA has spent its tobacco user fee funds. GAO analyzed data regarding submissions received by FDA as of January 7, 2013; reviewed data on meeting requests, spending plans, and amounts obligated; and interviewed CTP and tobacco industry officials. "

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 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 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 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 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 Deeming Tobacco Products to Be Subject to the Federal Food Drug and Cosmetic Act as Amended by the Family Smoking Prevention and Tobacco Control 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 2018-09-12 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is issuing this final rule to deem products meeting the statutory definition of "tobacco product," except accessories of the newly deemed tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. With this final rule, FDA is extending the Agency's "tobacco product" authorities in the FD&C Act to all other categories of products that meet the statutory definition of "tobacco product" in the FD&C Act, except accessories of such newly deemed tobacco products. This final rule also prohibits the sale of "covered tobacco products" to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to reduce the death and disease from tobacco products. In accordance with the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable. This book contains: - The complete text of the Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section

Download or read book Examining the Implementation of the Tobacco Control Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2014 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Tobacco Products Exemptions from Substantial Equivalence Requirements 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 2018-10 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tobacco Products - Exemptions From Substantial Equivalence Requirements (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Tobacco Products - Exemptions From Substantial Equivalence Requirements (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is issuing this final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions. This regulation satisfies the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision. This book contains: - The complete text of the Tobacco Products - Exemptions From Substantial Equivalence Requirements (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section

Download or read book Secondhand Smoke Exposure and Cardiovascular Effects written by Institute of Medicine and published by National Academies Press. This book was released on 2010-02-21 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data suggest that exposure to secondhand smoke can result in heart disease in nonsmoking adults. Recently, progress has been made in reducing involuntary exposure to secondhand smoke through legislation banning smoking in workplaces, restaurants, and other public places. The effect of legislation to ban smoking and its effects on the cardiovascular health of nonsmoking adults, however, remains a question. Secondhand Smoke Exposure and Cardiovascular Effects reviews available scientific literature to assess the relationship between secondhand smoke exposure and acute coronary events. The authors, experts in secondhand smoke exposure and toxicology, clinical cardiology, epidemiology, and statistics, find that there is about a 25 to 30 percent increase in the risk of coronary heart disease from exposure to secondhand smoke. Their findings agree with the 2006 Surgeon General's Report conclusion that there are increased risks of coronary heart disease morbidity and mortality among men and women exposed to secondhand smoke. However, the authors note that the evidence for determining the magnitude of the relationship between chronic secondhand smoke exposure and coronary heart disease is not very strong. Public health professionals will rely upon Secondhand Smoke Exposure and Cardiovascular Effects for its survey of critical epidemiological studies on the effects of smoking bans and evidence of links between secondhand smoke exposure and cardiovascular events, as well as its findings and recommendations.

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.

Download or read book Countervailing Effects written by Mark Kleiman and published by . This book was released on 2015 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Family Smoking Prevention and Tobacco Control Act [P.L. 111-31] gives the US Food and Drug Administration (FDA) the authority to regulate tobacco products, including placing restrictions on product composition, sale, and distribution. A complete accounting of the costs and benefits of any tobacco regulation includes harms from possible illicit trade in tobacco products (ITTP): costs of enforcement, violence, incarceration, etc. Indeed, the law instructs the FDA to take into account the “countervailing effects” of regulation on public health, “such as the creation of a significant demand for contraband or other tobacco products that do not meet the requirements.” While the law's narrow focus on public health may limit the scope of an inquiry by the FDA compared to a full benefit-cost analysis, aspects of ITTP such as violence and incarceration have substantial health impacts. Illicit markets in drugs such as cocaine, heroin, and methamphetamine, not to mention the grand experiment of alcohol Prohibition in the early 20th century, illustrate the substantial risks of unwanted side effects of drug prohibition. But taxes, product limitations, access restrictions, and narrowly defined product bans constitute “lesser prohibitions,” and are subject to the same kind (if not degree) of risks. All tobacco policy-making should therefore consider ITTP. This article sets forth a research agenda for the FDA to consider in order to estimate the effects of contemplated tobacco-product regulation and ITTP. We argue that, to carry out fully its legislative mandate, the FDA would have to determine the current size and impact of ITTP, analyze how these may be expected to change under new regulations, and look for interdependencies among tobacco-product markets that may complicate single-product regulation. A more challenging element of the research agenda would be to develop a better theoretical groundwork for the prediction of the emergence, size, and side effects of illicit markets.

Download or read book Ending the Tobacco Problem written by Institute of Medicine and published by National Academies Press. This book was released on 2007-10-27 with total page 643 pages. Available in PDF, EPUB and Kindle. Book excerpt: The nation has made tremendous progress in reducing tobacco use during the past 40 years. Despite extensive knowledge about successful interventions, however, approximately one-quarter of American adults still smoke. Tobacco-related illnesses and death place a huge burden on our society. Ending the Tobacco Problem generates a blueprint for the nation in the struggle to reduce tobacco use. The report reviews effective prevention and treatment interventions and considers a set of new tobacco control policies for adoption by federal and state governments. Carefully constructed with two distinct parts, the book first provides background information on the history and nature of tobacco use, developing the context for the policy blueprint proposed in the second half of the report. The report documents the extraordinary growth of tobacco use during the first half of the 20th century as well as its subsequent reversal in the mid-1960s (in the wake of findings from the Surgeon General). It also reviews the addictive properties of nicotine, delving into the factors that make it so difficult for people to quit and examines recent trends in tobacco use. In addition, an overview of the development of governmental and nongovernmental tobacco control efforts is provided. After reviewing the ethical grounding of tobacco control, the second half of the book sets forth to present a blueprint for ending the tobacco problem. The book offers broad-reaching recommendations targeting federal, state, local, nonprofit and for-profit entities. This book also identifies the benefits to society when fully implementing effective tobacco control interventions and policies.