FDA Approves New Health Claim for Soy Protein and Coronary Heart Disease

On October 26, 1999, the FDA authorized 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.

This new health claim rule responds to a petition submitted to the FDA by Protein Technologies International. This rule is based on the proposed rule that was published in the Federal Register on November 10, 1998, and comments received by the FDA. Use of the claim in food labeling is authorized immediately.

Source: FDA Press Release, October 20, 1999.

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