FDA Authorizes Soy Protein Health Claim

October 21, 1999

The United States Food and Drug Administration (FDA) yesterday authorized the use to a health claim linking the consumption of soy protein with a reduced risk of coronary heart disease. The FDA based its approval on numerous studies cited in the health claim petition submitted by Protein Technologies International, Inc. (PTI) on May 4, 1998.

The approved soy health claim will be used on food labels and in food labeling of many soyfoods including tofu, soy-based beverages, soy meat and soy protein bars and powders. Those food products that contain a minimum of 6.25 grams of soy protein per serving will be allowed to feature one of two claim wordings.

•	"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."
•	"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."

The health claim was approved after careful evaluation of more than 20 years work of accumulated scientific evidence and over 50 human trials addressing this issue. According to the compiled research 25 grams of soy protein a day - which may be obtained through four servings of foods each containing 6.25 grams of soy protein - are effective in reducing both total cholesterol and LDL-cholesterol levels.

The FDA approved soy protein health claim has been authorized for immediate use on food and food labels. The claim has important implications for Americans, 750,000 of whom die from coronary heart disease each year. Elevated cholesterol levels are frequently a contributing cause.