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FDA Approves Soy Health Claims for Heart Disease

Dateline: 10/22/99

Can soy in your diet reduce your risk of heart disease? According to the Food and Drug Administration's (FDA) decision to authorize, on October 26, 1999, the use of health claims about the role of soy protein in reducing the risk of coronary heart disease (CHD) the answer may be yes.

This ruling is based on the FDA's decision 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.

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Coronary heart disease is the number one cause of death in the United States. 5,800,000 men and 6,100,000 women alive today in the US have a history of heart attack, chest pain, or both. Heart disease is the most serious health issue facing Americans today with over one million having new or recurrent heart attacks each year and one-third of them will die.

Recent clinical trials have shown that consumption of soy protein in a diet low in saturated fat and cholesterol may help to reduce the risk of CHD. Researchers compared soy protein with other proteins such as milk and meat, and found that soy protein can lower total and LDL-cholesterol levels.

The FDA's authorization may cover some soy beverages, tofu, soy-based meat alternatives, and perhaps some baked goods. Foods that carry the claim must meet the requirements for low fat, low saturated fat, and low cholesterol content. An exception is for foods made with the whole soybean which may also qualify for the health claim if they contain no fat in addition to that present in the whole soybean.

Scientific studies concluded that 25 grams of soy protein daily is necessary to show a significant cholesterol lowering effect. Foods that qualify must contain at least 6.25 grams of soy protein per serving--this is equal to one-fourth of the daily recommendation and is based on the possibility that consumers may eat soy protein during each of 3 meals plus a snack. 

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