The Soy Health Claim

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.

U.S. Food and Drug Administration (FDA)