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The Archer Daniels Midland Company (ADM) has provided the Food and Drug Administration (FDA) with notice that it has determined that the substance soy isoflavone is generally recognized as safe (GRAS). This notice was made in accordance with the FDA proposed rule "Substances Generally Recognized as Safe" 21 CFR Parts 170,184,186 and 570. In support of this notice, ADM has provided a document entitled "An information document reviewing the safety of soy isoflavones used in specific dietary applications." In my opinion, soy isoflavone (or more correctly, the soy isoflavones) should not be granted GRAS status. In fact, given the current state of knowledge in the body of scientific literature it would make more sense, in terms of risk assessment, to prohibit the addition of soy isoflavones to foods. Further, manufacturers should act to minimize exposure of human and animal population to these compounds that appear to occur in all foods that contain soy protein. This opinion is based on my understanding of the scientific literature on soy isoflavones arid some experience as a researcher in the field.