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FDA Tobacco Regulation

FDA Tobacco Regulation
Author: C. Stephen Redhead
Publisher: DIANE Publishing
Total Pages: 33
Release: 2009-11
Genre: Law
ISBN: 1437918042

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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.


Food and Drug Administration

Food and Drug Administration
Author: United States. General Accounting Office
Publisher:
Total Pages: 28
Release: 1997
Genre: Advertising
ISBN:

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FDA Regulation of Tobacco Products

FDA Regulation of Tobacco Products
Author: Victoria C. Lockwood
Publisher: Nova Science Publishers
Total Pages: 103
Release: 2009
Genre: Cigarette industry
ISBN: 9781606925508

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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.


Tobacco Products

Tobacco Products
Author: Jared Hart
Publisher: Nova Science Publishers
Total Pages: 0
Release: 2014
Genre: Tobacco industry
ISBN: 9781634631839

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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.


The Need for FDA Regulation of Tobacco

The Need for FDA Regulation of Tobacco
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
Total Pages: 232
Release: 2007
Genre: Cigarette industry
ISBN:

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An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
Author: Eunjoo Pacifici
Publisher: Academic Press
Total Pages: 292
Release: 2018-06-13
Genre: Medical
ISBN: 0128111569

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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


Tobacco Products

Tobacco Products
Author: Jared Hart
Publisher: Gazelle Book Services, Limited
Total Pages: 88
Release: 2014-01-01
Genre: Electronic books
ISBN: 9781634632065

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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


The Tobacco Control Act and FDA Review of New Tobacco Products

The Tobacco Control Act and FDA Review of New Tobacco Products
Author: Gia A. Chance
Publisher: Nova Science Publishers
Total Pages: 0
Release: 2014-09
Genre: Smoking
ISBN: 9781633214682

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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.


Reducing Tobacco-Related Cancer Incidence and Mortality

Reducing Tobacco-Related Cancer Incidence and Mortality
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 131
Release: 2013-04-16
Genre: Medical
ISBN: 0309264049

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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.