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FDA Soy Protein Claim

Heart CheckResearch undertaken by the Food and Drug Administration (FDA) concludes that:

"25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease."

FDA TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857


FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.


T99-48
October 20, 1999
Print Media: 202-205-4144
Broadcast Media: 301-827-3434
Consumer Inquiries: 888-INFO-FDA

FDA APPROVES NEW HEALTH CLAIM FOR SOY PROTEIN AND CORONARY HEART DISEASE

On October 26, 1999, the FDA will authorize use of health claims about the role of soy protein in reducing the risk of coronary heart disease (CHD) on labeling of foods containing soy protein. This final rule is based on the FDA's conclusion that foods containing soy protein included in a diet low in saturated fat and cholesterol may reduce the risk of CHD by lowering blood cholesterol levels.

Coronary heart disease, one of the most common and serious forms of cardiovascular disease, is a major public health concern because it causes more deaths in the U.S. than any other disease. Risk factors for CHD include high total cholesterol levels and high levels of low density lipoprotein (LDL) cholesterol.

This new health claim is based on evidence that including soy protein in a diet low in saturated fat and cholesterol may also help to reduce the risk of CHD. Recent clinical trials have shown that consumption of soy protein compared to other proteins such as those from milk or meat, can lower total and LDL-cholesterol levels.

Foods that may be eligible for the health claim include soy beverages, tofu, tempeh, soy-based meat alternatives, and possibly some baked goods. Foods that carry the claim must also meet the requirements for low fat, low saturated fat, and low cholesterol content except the foods made with the whole soybean may also qualify for the health claim if they contain no fat in addition to that present in the whole soybean.

Scientific studies show that 25 grams of soy protein daily in the diet is needed to show a significant cholesterol lowering effect. In order to qualify for this health claim, a food must contain at least 6.25 grams of soy protein per serving, the amount that is one-fourth of the effective level of 25 grams per day. Because soy protein can be added to a variety of foods, it is possible for consumers to eat foods containing soy protein at all three meals and for snacks...

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