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.
Chapter 1 - The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) became 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 overview highlights some of the provisions of the Tobacco Control Act
Chapter 2 - The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products and protect the public from the harmful effects of tobacco product use. This report, which satisfies the requirements of section 106(a) of the Tobacco Control Act, provides an assessment of FDA efforts to implement the Tobacco Control Act since it was signed into law on June 22, 2009.
Among the major accomplishments achieved in these early years is the creation of the FDA Center for Tobacco Products. This report describes the establishment of the new Center with dedicated tobacco program funding, as authorized by the Tobacco Control Act.
Chapter 3 - 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.
Chapter 4 - This is the Statement of Marcia Crosse, Director, Health Care, Government Accountability Office. Hearing on "Examining the Implementation of the Tobacco Control Act."

Preface vii

Chapter 1 Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet 1 Center for Tobacco Products, U.S. Food and Drug Administration

Chapter 2 Progress and Effectiveness of the Implementation of the Family Smoking Prevention and Tobacco Control Act 7 U.S. Food and Drug Administration

Chapter 3 New Tobacco Products: FDA Needs to Set Time Frames for Its Review Process 61 United States Government Accountability Office

Chapter 4 Tobacco Products: FDA Spending and New Product Review Time Frames. Statement of Marcia Crosse, Director, Health Care, Government Accountability Office. Hearing on "Examining the Implementation of the Tobacco Control Act" 103

Index 119

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