The Need for FDA Regulation of Tobacco

The Need for FDA Regulation of Tobacco PDF Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Cigarette industry
Languages : en
Pages : 232

Get Book Here

Book Description

The Need for FDA Regulation of Tobacco

The Need for FDA Regulation of Tobacco PDF Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Cigarette industry
Languages : en
Pages : 232

Get Book Here

Book Description


FDA Regulation of Tobacco Products

FDA Regulation of Tobacco Products PDF Author: Victoria C. Lockwood
Publisher: Nova Science Publishers
ISBN: 9781606925508
Category : Cigarette industry
Languages : en
Pages : 103

Get Book Here

Book Description
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.

FDA Tobacco Regulation

FDA Tobacco Regulation PDF Author: C. Stephen Redhead
Publisher: DIANE Publishing
ISBN: 1437918042
Category : Law
Languages : en
Pages : 33

Get Book Here

Book Description
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.

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products PDF Author: Eunjoo Pacifici
Publisher: Academic Press
ISBN: 0128111569
Category : Medical
Languages : en
Pages : 280

Get Book Here

Book Description
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

Food and Drug Administration

Food and Drug Administration PDF Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 28

Get Book Here

Book Description


FDA Regulation of Tobacco Products

FDA Regulation of Tobacco Products PDF Author:
Publisher:
ISBN:
Category :
Languages : en
Pages :

Get Book Here

Book Description


The Need for FDA Regulation of Tobacco

The Need for FDA Regulation of Tobacco PDF Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Cigarette industry
Languages : en
Pages : 224

Get Book Here

Book Description


S. Hrg. 110-100

S. Hrg. 110-100 PDF Author: U.S. Government Printing Office (Gpo)
Publisher: BiblioGov
ISBN: 9781293028346
Category :
Languages : en
Pages : 234

Get Book Here

Book Description
The United States Government Printing Office (GPO) was created in June 1860, and is an agency of the U.S. federal government based in Washington D.C. The office prints documents produced by and for the federal government, including Congress, the Supreme Court, the Executive Office of the President and other executive departments, and independent agencies. A hearing is a meeting of the Senate, House, joint or certain Government committee that is open to the public so that they can listen in on the opinions of the legislation. Hearings can also be held to explore certain topics or a current issue. It typically takes between two months up to two years to be published. This is one of those hearings.

The Need for FDA Regulation of Tobacco Products - Scholar's Choice Edition

The Need for FDA Regulation of Tobacco Products - Scholar's Choice Edition PDF Author: United States Congress Senate Committee
Publisher:
ISBN: 9781298013170
Category :
Languages : en
Pages : 234

Get Book Here

Book Description
This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work was reproduced from the original artifact, and remains as true to the original work as possible. Therefore, you will see the original copyright references, library stamps (as most of these works have been housed in our most important libraries around the world), and other notations in the work. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work.As a reproduction of a historical artifact, this work may contain missing or blurred pages, poor pictures, errant marks, etc. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.

Tobacco Products

Tobacco Products PDF Author: Jared Hart
Publisher: Nova Science Publishers
ISBN: 9781634631839
Category : Tobacco industry
Languages : en
Pages : 0

Get Book Here

Book Description
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.