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Soy Health Claim
FDA
Approves New Health Claim for Soy Protein and Coronary Heart Disease
On
October 26, 1999, the FDA authorized use of health claims about the role
of soy protein in reducing the risk of coronary heart disease (CHD) on
labeling of foods containing soy protein. This final rule is based on
the FDA's conclusion that foods containing soy protein included in a
diet low in saturated fat and cholesterol may reduce the risk of CHD by
lowering blood cholesterol levels.
Coronary
heart disease, one of the most common and serious forms of
cardiovascular disease, is a major public health concern because it
causes more deaths in the U.S. than any other disease. Risk factors for
CHD include high total cholesterol levels and high levels of low density
lipoprotein (LDL) cholesterol.
This new
health claim is based on evidence that including soy protein in a diet
low in saturated fat and cholesterol may also help to reduce the risk of
CHD. Recent clinical trials have shown that consumption of soy protein
compared to other proteins such as those from milk or meat, can lower
total and LDL-cholesterol levels.
Foods
that may be eligible for the health claim include soy beverages, tofu,
tempeh, soy-based meat alternatives, and possibly some baked goods.
Foods that carry the claim must also meet the requirements for low fat,
low saturated fat, and low cholesterol content except the foods made
with the whole soybean may also qualify for the health claim if they
contain no fat in addition to that present in the whole soybean.
Scientific studies show that 25 grams of soy protein daily in the diet
is needed to show a significant cholesterol lowering effect. In order to
qualify for this health claim, a food must contain at least 6.25 grams
of soy protein per serving, the amount that is one-fourth of the
effective level of 25 grams per day. Because soy protein can be added to
a variety of foods, it is possible for consumers to eat foods containing
soy protein at all three meals and for snacks.
An
example of a health claim about the relationship between diet and the
reduce risk of heart disease is:
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.
This new
health claim rule responds to a petition submitted to the FDA by Protein
Technologies International. This rule is based on the proposed rule that
was published in the Federal Register on November 10, 1998, and comments
received by the FDA. Use of the claim in food labeling is authorized
immediately.
- October 20, 1999
- Consumer Inquiries:
888-INFO-FDA
Food and Drug
Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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