Description |
1 online resource (158 pages) |
Contents |
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 |
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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 |
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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 |
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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 |
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The European UnionJapan -- REFERENCES -- APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug, � -- 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 |
Notes |
""Changes in Food Marketing and Consumption Trends"" |
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English |
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Print version record |
Subject |
Food additives -- United States -- Congresses
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Food additives -- Safety regulations -- United States -- Congresses
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Food.
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Social control.
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Medical care.
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Food additives.
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Food law and legislation.
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Legislation as Topic
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Specialty Uses of Chemicals
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Food
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Social Control, Formal
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Chemical Actions and Uses
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Food and Beverages
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Health Care Economics and Organizations
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Technology, Industry, Agriculture
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Chemicals and Drugs
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Delivery of Health Care
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Food Additives
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Legislation, Food
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Patient Care
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food.
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Social control
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Medical care
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Food law and legislation
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Food
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Food additives
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Food additives -- Safety regulations
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United States
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Genre/Form |
Conference papers and proceedings
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Form |
Electronic book
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ISBN |
9780309597043 |
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0309597048 |
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0309064864 |
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9780309064866 |
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