FDA ASKS COMMENT ON SOY

BARBARA McDONALD

ROCKVILLE, Md. -- The U.S. Food and Drug Administration here is seeking comment on a proposed regulation allowing food labels to carry health claims for soy protein.

This proposal is based on the agency's determination that soy protein, as part of a diet low in saturated fat and cholesterol, may reduce the risk of coronary heart disease. The FDA is proposing this action in response to a petition filed in May, 1998, by Protein Technologies International, St. Louis, a manufacturer of soy products used as food ingredients. The company is now owned by DuPont, Wilmington, Del.

CHD is the most common, most frequently reported, and most serious form of cardiovascular disease, and is the No. 1 cause of death in the United States, the FDA said Nov. 10, when the comment period started. Written comments can be sent until Jan. 25 to the FDA at: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852.

In proposing this health claim, the FDA concluded that foods containing protein from the soybean as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease by lowering blood total cholesterol and LDL-cholesterol. To qualify for the health claim, each serving must contain at least 6.25 grams of soy protein.

The FDA provided this example of a claim using this food-disease relationship: "Diets low in saturated fat and cholesterol that include 25 grams of soy protein per day may reduce the risk of heart disease."