Health claims approved for whole-oat products

FDA Consumer, April, 1997

The claims that foods with soluble fiber from whole oats may reduce heart disease risk when eaten as part of a diet low in saturated fat and cholesterol is now allowed under an FDA final rule. Foods covered by the action include rolled oats, oat bran, and whole-oat flour.

FDA concluded that the beta-glucan soluble fiber of whole oats is the primary component responsible for lowering total and LDL (low-density lipoprotein), or "bad," blood cholesterol in diets including these foods at appropriate levels. This conclusion is based on a scientific review showing a link between the soluble fiber in whole-oat foods and a reduction in coronary heart disease risk.

To qualify for the claim, whole-oat foods must provide at least 0.75 grams of soluble fiber per serving. About 3 grams of soluble fiber is needed daily for an effect on cholesterol levels.

The whole-oat claims must include the words "diets low in saturated fat and cholesterol" because consumers might otherwise think that eating a diet high in oats is all that is needed to reduce heart disease risk.

FDA acknowledges that other sources of beta-glucan soluble fiber and other types of soluble fiber may have similar effects on cholesterol levels. But the agency is awaiting evidence before judging these effects.

FDA regulates health claims on food labels to ensure that claims are accurate and don't mislead consumers. The agency requires a "significant scientific agreement" on claims before allowing them. (See "Starting This Month: Look for `Legit' Health Claims on Foods" in the May 1993 FDA Consumer.)

More details on the final rule are in the Jan. 23, 1997, Federal Register.