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The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers.
On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Contents
- Food Forum
- Food And Nutrition Board
- PREFACE
- WORKSHOP SUMMARY
- Introduction and Background
- Overview of the Approval Process for Food Use Substances
- GRAS Substances
- Legal Framework of the Ingredient Approval Process
- Scientific Interpretation and the Approval Process
- Criteria to Evaluate Food Additive Safety
- Current Efforts
- Improving the Regulatory Review Process
- Summary
- APPENDIX A Legal Aspects of the Food Additive Approval Process
- APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug, and Cosmetic Act of 1938
- APPENDIX C Workshop Agenda
- APPENDIX D Participants List
- ACRONYMS
This project was funded by the U.S. Department of Health and Human Services Food and Drug Administration, U.S Department of Agriculture Food Safety and Inspection Service, U.S. Department of Commerce National Marine Fisheries Service, U.S. Environmental Protection Agency, Frito-Lay, Inc.; Hershey Foods; Kellogg Company; Kraft Foods, Inc.; McDonald's Corporation, Monsanto Company; Nabisco, Inc.; Nestlé USA; Proctor & Gamble; and Ross Products. The opinions expressed herein are those of the workshop participants and do not necessarily reflect those of the funders.
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and on its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.
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