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The Tobacco Control Act and FDA Review of New Tobacco Products : Selected Assessments /
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...
| Clasificación: | Libro Electrónico |
|---|---|
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
New York [New York] :
Nova Publishers,
[2014]
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| Colección: | Public health in the 21st century series.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- THE TOBACCO CONTROL ACT AND FDA REVIEW OF NEW TOBACCO PRODUCTS: SELECTED ASSESSMENTS; THE TOBACCO CONTROL ACT AND FDA REVIEW OF NEW TOBACCO PRODUCTS: SELECTED ASSESSMENTS; Library of Congress Cataloging-in-Publication Data; Contents; Preface; Chapter 1: Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet; The Tobacco Control Act; What the Tobacco; Control Act Does; The Tobacco Control Act Also Requires; How FDA Oversees the Implementation; of the Tobacco Control Act.
- Chapter 2: Progress and Effectiveness of the Implementation of the Family Smoking Prevention and Tobacco Control Act(Executive Summary; I. Overview; II. Progress of the FDA in Implementing; the Family Smoking Prevention and; Tobacco Control Act; Establishing the Center for Tobacco Products; Hiring CTP's Director and Deputy Director; Staffing the Center; Objective Measures of Progress; III. The Regulatory Framework for; Tobacco Products; 1. Understand the Regulated Products; 2. Review New Products and Product Changes to Protect Public Health; Premarket Tobacco Product Applications.
- Demonstrating Substantial Equivalence to Certain Commercially Marketed ProductsExemption from Demonstrating Substantial Equivalence; Status of New Product Applications under Section 910; Process for Review of Substantial Equivalence Reports; 3. Prohibit False/Misleading/Unsubstantiated Product Claims That State or Imply Modified Risk; 4. Decrease the Harms of Tobacco Products; 5. Expand the Science Base for Regulatory Action; Tobacco Products Scientific Advisory Committee; NIH Research Collaborations; NIH Grants and Supplements; Population Assessment of Tobacco and Health Study.
- Tobacco Research Center InitiativesOther Collaborative Research Activities; Scientific publications and communications; FDA Tobacco Regulatory Science Fellowships; 6. Restrict Marketing and Distribution to Protect Public Health; Final Rule on Cigarettes and Smokeless Tobacco; Remote sales; Enforcement Action Plan on Advertising to Youth and Regulation of Free Tobacco Samples; 7. Ensure Industry's Compliance with FDA Regulations; Compliance Training and Assistance; Retailer Compliance; Advisory and Enforcement Authorities; Promotion, Advertising and Labeling Compliance.
- Manufacturer Compliance and Enforcement ActivitiesComplaint Submissions; 8. Educate the Public; Public Education Campaigns; Regulatory Actions for Prescribed Health Warnings; Graphic Health Warnings; Smokeless Tobacco Health Warnings; Public Outreach; International Engagement; Ombudsman; IV. Challenges and Opportunities; V. Conclusion; Appendix A. Regulations, Guidance Documents, and Other Regulatory Documents Issued by FDA Related to the Family Smoking Prevention and Tobacco Control Act.