![]() The federal government first asserted authority over the quality and safety of food products early this century. Studies of other federal agencies have uncovered valuable lessons about effective regulation that transcend the particular program under consideration. Moreover, the history of the food additive approval process illuminates significant and recurring challenges faced in the design of properly functioning regulatory programs. ![]() Debates about proposals to modify existing procedures must start with a proper appreciation of the difficulties encountered in the past. This paper focuses primarily on a description of the FDA's regulation of substances intentionally added to food as it has evolved over the last several decades, and it concludes with a discussion of several possible avenues for reform. The problems are multifaceted, and policymakers will require input from both legal and scientific perspectives to address them. These latest controversies pose significant and timely questions about how best to regulate substances added to food. 1 At the same time, others have argued that the agency does not adequately ensure the safety of such substances. Food and Drug Administration (FDA) for its lengthy delays in reviewing these and other substances added to food. In the past few years, novel food substances have attracted significant public attention, most notably Procter & Gamble's fat substitute olestra and Calgene's bioengineered tomato. What is food to one, is to others bitter poison.
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