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

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The Food and Drug Administration (FDA) is amending the health claim regulation entitled "Soluble fiber from certain foods and risk of coronary heart disease (CHD)" to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley flour. FDA is taking this action in response to a health claim petition submitted by Cargill, Inc. FDA previously concluded that there was significant scientific agreement that a claim characterizing the relationship between beta- glucan soluble fiber of certain whole oat and whole grain barley products and CHD risk is supported by the totality of publicly available scientific evidence. Based on the totality of publicly available scientific evidence, FDA now has concluded that in addition to certain whole oat and whole grain barley products, barley betafiber is also an appropriate source of beta-glucan soluble fiber. Therefore, FDA is amending the health claim regulation entitled "Soluble fiber from certain foods and risk of CHD" to include barley betafiber as another eligible source of beta-glucan soluble fiber.