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

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. Table of Contents Front Matter Workshop 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 Cosmetics Act of 1938 Appendix C: Workshop Agenda Appendix D: Participant List Acronyms