In the late 1990s, the U.S. Food and Drug Administration (FDA) reviewed the findings of 50 clinical trials related to the effects of soy protein on the levels of total cholesterol and LDL cholesterol in the blood. As a result of that review, in the fall of 1999 the FDA approved a health claim on soy protein’s ability to reduce the risk of heart disease within the context of a low-saturated fat and low-cholesterol diet. The approval means that manufacturers may use the following statements (or one reasonably similar) to market certain soy 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.”

OR

“25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies ____ grams of soy protein.”

To qualify to use this health claim, the food in question must meet the following FDA criteria. Per serving, the product must have:

• At least 6.25 grams of soy protein
• Less than 3 grams of fat (low fat)
• Less than 1 gram of saturated fat (low saturated fat)
• Less than 20 milligrams of cholesterol (low cholesterol)
• Less than 480 milligrams of sodium in an individual food, less than 720 milligrams of sodium if considered a main dish and less than 960 milligrams of sodium if considered a meal.

Foods made from the whole soybean (instead of soy protein) such as tofu can qualify for the health claim if the product has no added fat. These would include soy foods such as tofu, soy milk, soy-based burgers, tempeh, and soy nuts.

According to FDA research, diets with four daily servings of soy can reduce levels of low-density lipoproteins (LDLs, the so-called “bad proteins”) by as much as 10 percent. Heart experts agree that a 1 percent drop in total cholesterol can equal a 2 percent drop in heart disease risk.