Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease

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The Food and Drug Administration (FDA) is issuing this document as a reproposal of one provision of its proposed rule of November 10, 1998, entitled ``Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease.'' In that proposal, FDA tentatively indicated its intention to use a specific analytical method to measure soy protein for assessing compliance. Comments on that proposal argued that that method is inadequate for many products. FDA is therefore proposing an alternative procedure that will rely on measurement of total protein and require manufacturers, in certain circumstances, to maintain records that document the amount of soy protein in products and to make those records available to appropriate regulatory officials for inspection and copying upon request.