FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T98-80                         Judith Foulke:     202 205-4144
November 10, 1998              
                               Consumer Hotline:  888 INFO-FDA

NEW HEALTH CLAIM PROPOSED FOR RELATIONSHIP OF
SOY PROTEIN AND CORONARY HEART DISEASE

FDA has proposed allowing health claims about the role soy protein may have in reducing the risk of coronary heart disease (CHD) on the labels and labeling of foods containing soy protein. This proposal is based on the agency's determination that soy protein, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD.

CHD is the most common, most frequently reported, and most serious form of cardiovascular disease, and is the number one cause of death in the United States. Despite the decline in deaths from CHD over the past 30 years, this disease still causes more than 500,000 deaths annually, and contributes to another 250,000 deaths. High blood total cholesterol and high low-density lipoprotein (LDL) cholesterol levels are proven risk factors for CHD.

In proposing this health claim, FDA concluded that foods containing protein from the soybean as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease by lowering blood total cholesterol and LDL-cholesterol. The amino acid content in soy protein is different from animal and most other vegetable proteins, and appears to alter the synthesis and metabolism of cholesterol in the liver.

Foods containing soy protein include soy milk, tofu, meat substitutes (such as vegetable burgers) and baked goods made with soy flour. Because soy protein occurs in or can be added to a wide variety of foods and beverages, it is possible to eat soy protein-containing products as many as 4 times a day (3 meals and a snack).

Studies show 25 grams of soy protein per day have a cholesterol-lowering effect. Therefore, for a food to qualify for the health claim, each serving of the food must contain at least 6.25 grams of soy protein, or one-fourth of the 25-gram amount shown to have a cholesterol-lowering effect.

An example of a claim using this food-disease relationship is:

"Diets low in saturated fat and cholesterol that include 25 grams of soy protein per day may reduce the risk of heart disease. One serving of (name of food) supplies ____grams of soy protein."

FDA is soliciting comments on this proposed regulation. Written comments will be received until January 25, 1999, and may be addressed to:

Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852
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