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FDA Proposes Health Claim for Soy Protein*

By Soyfoods USA, Vol. 2, No. 11

The Food and Drug Administration (FDA) has proposed allowing health claims about the role soy protein may have in reducing the risk of coronary heart disease (CHD) on the labels and labeling of foods containing 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 CHD.

CHD is the most common, most frequently reported, and most serious form of cardiovascular disease, and is the number one cause of death in the United States. Despite the decline in deaths from CHD over the past 30 years, this disease still causes more than 500,000 deaths annually and contributes to another 250,000 deaths. High blood total cholesterol and high low-density lipoprotein (LDL) cholesterol levels are proven risk factors for CHD.

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. The amino acid content in soy protein is different from animal and most other vegetable proteins and appears to alter the synthesis and metabolism of cholesterol in the liver.

Foods containing soy protein include soy milk, tofu, meat substitutes (such as vegetable burgers) and baked goods made with soy flour. Because soy protein occurs in or can be added to a wide variety of foods and beverages, it is possible to eat soy protein-containing products as many as 4 times a day (3 meals and a snack), according to the FDA.

Studies show 25 grams of soy protein per day have a cholesterol-lowering effect. Therefore, for a food to qualify for the health claim, each serving of the food must contain at least 6.25 grams of soy protein, or one-fourth of the 25-gram amount shown to have a cholesterol-lowering effect.

Note: Vitamark SuperSOY™ products contain an average of 25 grams of protein per serving.

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AHA Endorsement

A Statement for Healthcare Professionals From the Nutrition Committee of the American Heart Association (AHA)by John W. Erdman, Jr, PhD, for the AHA Nutrition Committee:

"…it is prudent to recommend soy protein foods to promote heart health."

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