Discusses the "Delaney clause" of the Food, drug, and cosmetic act.

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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.

Regulatory Aspects of Carcinogenesis and Food Additives: The Delaney Clause is composed of papers and discussions presented in the seventh meeting of the International Academy of Environmental Safety regarding the philosophy of the Delaney Clause. The Delaney Clause became a part of the Food and Drug Law in 1958. It states in part "that no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found after tests which are appropriate for evaluation of safety of food additives to induce cancer in man or animal. This book covers the different views of the meeting's participants on the interpretation of the Delaney Clause. It presents list of points that should be considered in making decisions with respect to safety. Many other factors that should be taken into consideration are also discussed in this reference.