T96-3 Brad Stone Jan. 11, 1996 (202) 205-4144 FDA PROPOSES HEALTH CLAIMS FOR OATMEAL AND OAT BRAN A new FDA proposal would allow manufacturers of foods containing oatmeal or oat bran to claim on the labels that diets high in these grain products and low in saturated fat and cholesterol may reduce the risk of coronary heart disease. This proposal was published today in the Federal Register. The following may be useful for answering questions. 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 March 1995 Quaker Oats Co. petitioned FDA to allow claims of health benefits on products containing oatmeal or oat bran. In response, the agency reviewed more than 37 clinical studies on the effects of oatmeal and oat bran in reducing serum cholesterol levels in the body and lowering risk of coronary heart disease. FDA also reviewed an evaluation of studies on the health effects of oatmeal and oat bran conducted by the Federation of American Societies for Experimental Biology (FASEB). The FASEB - more - Page 2, T96-3, Bran review was published in a 1987 FASEB report entitled, "Physiological Effects & Health Consequences of Dietary Fiber." FDA found that the studies demonstrated significant scientific agreement on the beneficial effects of oatmeal and oat bran. FDA is in agreement with most dietary experts in its conclusion that eating oatmeal or oat bran can reduce the risk of coronary heart disease when part of an overall diet that is low in saturated fat and cholesterol. However, based on the scientific evidence, FDA cannot conclude that eating oatmeal or oat bran in and of itself reduces risk of heart disease. FDA's model health claim reads as follows: "Diets high in oatmeal or oat bran and low in saturated fat and cholesterol may reduce the risk of heart disease." Manufacturers of food products containing oatmeal and oat bran may develop their own language for the health claim, subject to FDA review and provided that the wording is in accord with the evidence indicating that a reduction of heart disease risk is associated with consumption of oatmeal and oat bran only when incorporated with other healthy dietary and lifestyle practices. In the United States, coronary heart disease is the underlying cause of more than 500,000 deaths each year, and is a contributing factor in about 250,000 others. About 20 percent of adults from 20 to 74 years old are estimated to have serum cholesterol levels high enough to put them at high risk for coronary heart disease. This proposal was published Jan. 4 in the Federal Register. Written comments on the proposal may be submitted within 90 days of that date to the FDA Dockets Management Branch, HFA-305, 12420 Parklawn Drive, Rockville, MD 20857-0001. ####
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