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

Regulation of Cancer-Causing Food Additives--Time for a Change

The 1958 Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which requires the Food and Drug Administration to ban the use of cancer-causing food additives, continues to be a source of controversy, an emotional issue, and a target for change. While food safety experts agree that the Delaney Clause should be changed because of its inflexibility, they disagree on the regulatory alternatives that should replace it. This report discusses the views of experts on this matter, the scientific tests used as a basis for decisionmaking, and the manner in which different agencies regulate cancer-causing substances. It also presents several alternative decisionmaking frame-works for the Congress to consider.

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.

Despite increasing knowledge of human nutrition, the dietary contribution to cancer remains a troubling question. Carcinogens and Anticarcinogens assembles the best available information on the magnitude of potential cancer riskâ€"and potential anticarcinogenic effectâ€"from naturally occurring chemicals compared with risk from synthetic chemical constituents. The committee draws important conclusions about diet and cancer, including the carcinogenic role of excess calories and fat, the anticarcinogenic benefit of fiber and other substances, and the impact of food additive regulation. The book offers recommendations for epidemiological and diet research. Carcinogens and Anticarcinogens provides a readable overview of issues and addresses critical questions: Does diet contribute to an appreciable proportion of human cancer? Are there significant interactions between carcinogens and anticarcinogens in the diet? The volume discusses the mechanisms of carcinogenic and anticarcinogenic properties and considers whether techniques used to evaluate the carcinogenic potential of synthetics can be used with naturally occurring chemicals. The committee provides criteria for prioritizing the vast number of substances that need to be tested. Carcinogens and Anticarcinogens clarifies the issues and sets the direction for further investigations into diet and cancer. This volume will be of interest to anyone involved in food and health issues: policymakers, regulators, researchers, nutrition professionals, and health advocates.

Reference to U.S. General Accounting Office (GAO) documents related to food, nutrition, or agriculture, and released in various years as stated. Intended for in-depth research or general browsing. Arranged according to accession numbers. Each entry gives such information as title, author, agencies concerned, GAO contact, Congressional relevance, and lengthy abstract. Subject, agency/organization, and Congressional indexes.