Food Labeling: Health Claims; Oats and Coronary Heart Disease

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The Food and Drug Administration (FDA) is announcing its decision to authorize the use, on food labels and in food labeling, of health claims on the association between soluble fiber from whole oats and a reduced risk of coronary heart disease (CHD). Based on its review of evidence submitted with comments to the proposal, as well as of the evidence described in the proposal, the agency has concluded that the type of soluble fiber found in whole oats, i.e., beta ( )- glucan soluble fiber, is primarily responsible for the association between consumption of whole oats, including oat bran, rolled oats, and whole oat flour, and an observed lowering of blood cholesterol levels. The agency has concluded that, based on the totality of the scientific evidence, there is significant scientific agreement among qualified experts to support the relationship between soluble fiber in whole oats and CHD. Therefore, FDA has decided to make the subject of the health claim ``soluble fiber from whole oats'' and has concluded that claims on foods relating the onsumption of soluble fiber from whole oats to reduced risk of heart disease are justified. FDA is announcing this action in response to a petitio