Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Staff, Institute of Medicine
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington : National Academies Press, 1999.
Temas:
Food additives > United States > Congresses.
Food additives > Safety regulations > United States > Congresses.
Food.
Social control.
Medical care.
Food additives.
Food law and legislation.
Legislation as Topic
Specialty Uses of Chemicals
Food
Social Control, Formal
Chemical Actions and Uses
Food and Beverages
Health Care Economics and Organizations
Technology, Industry, Agriculture
Chemicals and Drugs
Delivery of Health Care
Food Additives
Legislation, Food
Patient Care
Aliments > Additifs > États-Unis > Congrès.
Aliments > Additifs > Sécurité > Règlements > États-Unis > Congrès.
Aliments.
Contrôle social.
Prestation de soins.
Aliments > Additifs.
Aliments > Droit > Législation.
Soins médicaux.
food.
Social control
Medical care
Food law and legislation
Food additives
Food additives > Safety regulations
United States
Conference papers and proceedings
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies
  • Copyright
  • PREFACE
  • Contents
  • WORKSHOP SUMMARY
  • INTRODUCTION AND BACKGROUND
  • OVERVIEW OF THE APPROVAL PROCESS FOR FOOD USE SUBSTANCES
  • Food Additives
  • GRAS SUBSTANCES
  • Interim Additives
  • LEGAL FRAMEWORK OF THE INGREDIENT APPROVAL PROCESS
  • Flaws of the Current Review Process
  • Proposed Changes in the Approval Process
  • Change or Enforce Deadlines for Petition Reviews
  • Implement User Fees
  • Grant a Period of Market Exclusivity
  • Re-evaluate GRAS Affirmation ProcessEliminate Notice-and-Comment Procedures
  • Abbreviate Review for Supplemental Uses
  • Evaluate Use of Extramural Petition Review
  • Prioritize Reviews
  • Implement Safeguards to Prevent Sham Petitioning
  • Establish a Sunset Period for Interim Additives
  • Foster Improved Communication between Industry and FDA
  • Improve Quality of Petitions Submitted to FDA
  • SCIENTIFIC INTERPRETATION AND THE APPROVAL PROCESS
  • CRITERIA TO EVALUATE FOOD ADDITIVE SAFETY
  • CURRENT EFFORTS
  • International Efforts
  • IMPROVING THE REGULATORY REVIEW PROCESSGovernment Perspective
  • Industry Perspective
  • Consumer Perspective
  • SUMMARY
  • APPENDIX A Legal Aspects of the Food Additive Approval Process
  • HISTORY
  • The Food, Drug, and Cosmetic Act of 1938
  • The Food Additives Amendment of 1958
  • DEFINITION OF FOOD ADDITIVE
  • Components of Food
  • Indirect Additives
  • Dietary Supplements
  • Generally Recognized as Safe
  • APPROVAL PROCEDURES
  • Food Additive Petitions
  • GRAS Affirmation Petitions
  • Interim Food Additives
  • SAFETY STANDARDS
  • General Safety StandardCarcinogenicity and the Delaney Clause
  • Special Restrictions: Labeling
  • CASE STUDIES
  • Artificial Sweeteners: Aspartame
  • Biotechnology: Calgene's Tomato
  • Novel Macroingredients: Olestra
  • THE COMPOSITE PICTURE
  • Track Records Compared
  • A Catalogue of Proposed Solutions
  • Internal Management Initiatives
  • Statutory Hammers
  • Prioritizing Reviews
  • Imposing User Fees
  • Extramural Reviews
  • Combatting Sham Petitioning
  • CONCLUSION
  • APPENDIX: INTERNATIONAL COMPARISONS
  • Canada
  • The United Kingdom
  • The European UnionJapan
  • REFERENCES
  • APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug, â€?
  • TECHNOLOGICAL AND SOCIAL FACTORS THAT HAVE AFFECTED INTRODUCTION OF NEW DIRECT FOOD INGREDIENTS AND PROCESSES
  • Introduction
  • Developments in Analytical Chemistry
  • Developments in Toxicology
  • The Emerging Understanding of Mechanisms
  • Changes in Risk and Safety Assessment
  • Changes in Agriculture
  • Environmental Concerns
  • Consumer Activity

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