ROCKVILLE, Md., Nov. 10 /PRNewswire/ -- 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
Consumer Hotline: 888 INFO-FDA
SOURCE Food and Drug Administration
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Related links:
http://www.fda.gov
CONTACT:
Judith Foulke of the FDA, 202-205-4144; or
Broadcast media: 301-827-3434
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