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Research
undertaken by the Food and Drug Administration (FDA)
concludes that:
"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."
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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.
T99-48
October 20, 1999
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Print Media: 202-205-4144
Broadcast Media: 301-827-3434
Consumer Inquiries: 888-INFO-FDA |
FDA
APPROVES NEW HEALTH CLAIM FOR SOY PROTEIN AND CORONARY
HEART DISEASE
On October 26, 1999, the FDA will
authorize 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...
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