Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease

The Food and Drug Administration (FDA) is amending the regulation authorizing a health claim on the relationship between beta- glucan soluble fiber from whole oat sources and reduced risk of coronary heart disease (CHD). The amendment adds as an additional eligible source of whole oat beta-glucan soluble fiber, the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan soluble fiber content of up to 10 percent on a dry weight basis (dwb) and not less than that of the starting material (dwb). We (FDA) are taking this action in response to a petition jointly filed by the Quaker Oats Co. and Rhodia, Inc. (the petitioners). We concluded previously that there was significant scientific agreement that a relationship exists between the beta-glucan soluble fiber of certain whole oat sources and the reduction of risk of CHD by lowering blood cholesterol levels. We now have concluded, based on the publicly available scientific evidence that, in addition to rolled oats, oat bran, and whole oat flour, the soluble fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with a beta-glucan content up to 10 percent (dwb) and not less than that of the starting material (dwb) is an appropriate source of beta-glucan soluble fiber for the health claim. Therefore, we are amending the regulation that authorizes a health claim on the relationship between soluble fiber from whole oats and reduced risk of CHD to include this additional source of beta- glucan soluble fiber.