FDA Proposes Allowing Claims That Soy Protein Reduces Risk of Coronary Heart Disease

A RiskWorld news brief by Mary Bryant
E-mail to bryant@tec-com.com


The U.S. Food and Drug Administration is seeking comments on its proposed regulation to allow health claims on labels about the role soy protein may have in reducing the risk of coronary heart disease. The 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 coronary heart disease, the number one cause of death in the United States (resulting in more than 500,000 deaths and contributing to another 250,000 deaths annually).

FDA has concluded that foods containing soy protein--including soy milk, tofu, meat substitutes (such as vegetable burgers), and baked goods made with soy flour--as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease by lowering the blood's total cholesterol level and high low-density lipoprotein (LDL) cholesterol level, both of which are proven risk factors for coronary heart disease. Studies show that consuming 25 grams of soy protein per day has a cholesterol-lowering effect.

An example of a health claim the new FDA regulation might allow 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."

In general, any citizen can submit comments on rules that FDA proposes. The agency will accept written comments on this proposed rule until January 25, 1999. Send comments to Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852. For more information about submitting comments, call FDA Dockets Management Branch at (301) 443-7542.

More information on the proposed regulation is available in an FDA Talk Paper or the Federal Register.


Posted November 13, 1998.


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