FDA soy cholesterol claim

Since October 26, 1999, the FDA authorises use of health claims about the role of soy protein in reducing the risk of coronary heart disease (CHD) on labelling 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.

This 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.