FDA Amends Soluble Fiber/Coronary Heart Disease Health ClaimMay 7, 2008
In response to a February 2006 citizen petition by Quaker Oats Co. (“Quaker”), FDA amended 21 C.F.R. § 101.81 concerning health claims on the relationship between soluble fiber from certain foods and a reduced risk of coronary heart disease. Before the amendment, food eligible for the health claim had to meet the nutrient content requirements for low saturated fat, low cholesterol and low fat. Quaker’s “flavored reduced sugar instant oatmeal products were ineligible” for the health claim because the substitution of sugar with more whole oats caused the products to exceed the low fat criterion. Effective May 1, 2008, the final rule allows qualifying foods bearing the health claim to exceed the nutrient content requirement for low fat, provided that the fats in the foods are from whole oat sources.
In response to a comment stating that the new exemption “would be the same as saying that full fat whole oatmeal cookies could reduce the risk of heart disease,” FDA emphasized that “[u]nder the new exemption, a food must meet the low fat requirement unless the food exceeds this requirement due to fat content derived from whole oat sources . . . . The products eligible to bear the claim would not contain any fat from sources other than the fat inherent in the whole oat sources. Food products that are typically made with other fat sources, such as cookies, would likely be ineligible for the claim.”