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

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 psyllium seed husk and reduced risk of coronary heart disease (CHD). Based on its review of evidence submitted with comments to the proposal, as well as evidence described in the proposal, the agency has concluded that soluble fiber from psyllium seed husk, similar to beta (<greek-b>)- glucan soluble fiber from whole oats, when included as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD by lowering blood cholesterol levels. The agency has concluded, based on the totality of publicly available scientific evidence, that there is significant scientific agreement among qualified experts to support the relationship between soluble fiber in psyllium seed husk and CHD. Therefore, the agency has decided to amend the regulation that authorized a health claim on soluble fiber from whole oats and the risk of CHD to include soluble fiber from psyllium seed husk. FDA has determined that label statements alerting consumers to the need to consume adequate amounts of liquids with products containing dry or incompletely hydrated psyllium will be required on products bearing the health claim. FDA is announcing this action in response to a petition filed by the Kellogg Co. (the petitioner).