In October 1999, FDA approved a health claim that can be used on labels of soy-based foods to tout their heart-healthy benefits. The agency reviewed research from 27 studies that showed soy protein's value in lowering levels of total cholesterol and low-density lipoprotein (LDL, or "bad" cholesterol).
Food marketers can now use the following claim, or a reasonable variation, on their products: "Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides __ grams of soy protein." To qualify for the claim foods must contain per serving:
6.25 grams of soy protein
low fat (less than 3 grams)
low saturated fat (less than 1 gram)
low cholesterol (less than 20 milligrams)
sodium value of less than 480 milligrams for individual foods, less than 720 milligrams if considered a main dish, and less than 960 milligrams if considered a meal.
Foods made with the whole soybean, such as tofu, may qualify for the claim if they have no fat other than that naturally present in the whole bean.