The FDA will display at the Federal Register a final rule allowing health claims on the labels of foods containing soluble fiber from whole oats (rolled oats, oat bran and oat flour) noting that these foods, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.  The following may be used to answer questions.

The FDA regulates health claims on food labels under provisions of the Nutrition Labeling and Education Act of 1990 to ensure that claims are accurate and not misleading to consumers.  The law allows the agency to authorize a health claim only if there is significant scientific agreement that the claim is true.

In allowing this health claim, the FDA concluded that the beta-glucan soluble fiber of whole oats is the primary component responsible for the total and LDL blood cholesterol-lowering effects of diets that contain these whole oat-containing foods at appropriate levels.  This conclusion is based on review of scientific evidence indicating a relationship between the soluble fiber in these whole oat-containing foods and a reduction in the risk of coronary heart disease.

Food products eligible to bear the health claim include oat bran and rolled oats, such as oatmeal, and whole oat flour.  Oat bran and rolled oats were the two food products named in a petition submitted by the Quaker Oats Company in March 1995.  The FDA added whole oat flour to this final rule in response to data provided in comments following the agency’s publication of the proposed rule on January 4, 1996.  The data submitted showed that whole oat flour is nutritionally equivalent to rolled oats and, more importantly, has similar effects on serum lipids.

In the final rule, the FDA acknowledges that sources of beta-glucan soluble fiber other than from whole oats, and certain soluble fibers other than beta-glucan, are also likely to affect blood lipid levels.  However, the FDA must await evidence on these other sources before making a judgment on their effects.

To qualify for the health claim, the whole oat-containing food must provide at least 0.75 grams of soluble fiber per serving.  The amount of soluble fiber needed for an effect on cholesterol levels is about 3 grams per day.  Adding whole oat flour to the list of substances eligible to be the subject of a claim means that many products will qualify for the claim, thus making it possible that oat-containing products could be consumed as many as 4 times a day.

Examples of how the newly allowed health claim may be used are:

• “Soluble fiber from food such as oat bran, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.”
• “Diets low in saturated fat and cholesterol that include soluble fiber from oatmeal may reduce the risk of heart disease.”

The words “Diets low in saturated fat and cholesterol” must be included in any such health claim because the FDA concluded, after reviewing comments, that consumers might otherwise be misled into thinking that eating a diet high in oats is all that is necessary to reduce the risk of heart disease.