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12125 WOODCREST EXECUTIVE DRIVE, SUITE 100, ST. LOUIS, MO 63141-5009,
PHONE: (314) 576-1770, FAX: (314) 576-2786

June 14, 2004

Division of Dockets Management

Food and Drug Administration

5630 Fishers Lane, Room 1061 (HFA-305)

Rockville, MD 20852

Re: Docket \# 2004Q-0151 Qualified Health Claim (QHC): Soy Protein and
Cancer

To Whom It May Concern:

The American Soybean Association (ASA) is pleased to provide this letter
in support of the health claim petition submitted by The Solae Company
on the association between consumption of soy protein containing foods
and the reduced risk of certain cancers.

The American Cancer Society (ACS) estimates that in 2004, 1.3 million
new cases of cancer will be diagnosed and greater than 500,000 people
will die from cancer-related disease. ACS further states, "There is
strong scientific evidence that healthful dietary patterns, in
combination with regular physical activity, can reduce cancer risk.
Approximately 35 per cent of cancer deaths in the United States may be
avoidable through dietary modification."

Today most consumers are aware that food choice has an impact on their
daily well-being as well as their long-term health and risk of diseases.
However, many do not understand how to construct a healthy diet given
the array of choices currently available. Health claims on packages
provide consumers with validated evidence of a specific health benefit
associated with consumption of a specific food or ingredient.

We believe that The Solae Company's petition is a comprehensive
evaluation of the existing scientific research investigating consumption
of soy-based foods and the reduced risk of certain types of cancer. The
petition extensively reviews 58 epidemiological studies, which include
22 studies assessing the role of soyfood consumption on the risk of
breast cancer, 10 studies on prostate cancer risk and 30 studies on the
risk of cancers of gastrointestinal tract. (Some studies reviewed more
than one type of cancer.) This assessment is not unlike other health
claims for cancer risk reduction based on epidemiological evidence such
as those for limiting dietary fat and increasing intake of
fiber-containing grain products, fruits and vegetables.

The Solae Company further conducted meta-analyses on each specific
cancer type that allow for a comprehensive view of the data taken
together. These meta-analyses resulted in the following pooled risk
estimates for consumption of soy protein-containing foods and:

# Cancer Population Pooled Risk Estimate (p-value)

Breast Cancer Women (all ages) 0.78 (p\<0.001)

Post-menopausal Women 0.64 (p\<0.005)

Prostate Cancer Men 0.66 (p\<0.001)

Gastro-intestinal Cancer Men/Women 0.70 (p\<0.001)

June 14, 2004

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These pooled estimates indicate significant reductions in the risk of
developing these cancers among those who consumed foods containing soy
protein.

The level of intake in the petition suggests inclusion of 5.0g of soy
protein would qualify food or beverage to carry the claim. This is based
on the estimated soy protein consumption of these epidemiological
studies and a value found to be associated with reduction in the risk of
the stated cancers. The data further support that those consuming the
greatest amount of soy protein had the lowest risk of these cancers.

The Solae Company's petition provides a fair and accurate assessment of
numerous studies on other types of cancers to underscore that there is
no increased risk of the development of these cancers associated with
consuming soy protein containing foods. In addition, it reviews animal
models of cancer and tumor growth. This section provides a balanced
review of animal models, some controversial, used to assess tumor growth
of certain cancers.

It is our understanding that The Solae Company gathered the best-known
experts in the area of soy consumption and cancer development to provide
additional review of the data presented in the petition. The Solae
Company's decision to submit the petition was predicated on the
unanimous agreement of this expert panel.

Health claims provide important and validated information on specific
health benefits associated with specific foods and/or ingredients. Thus,
we believe that this health claim will be of great value to consumers in
their efforts to select foods for a healthy diet and ask that the FDA
authorize the qualified health claim for soy protein containing foods
and reduced risk of cancer.

Thank you for your consideration

Sincerely,

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Ron Heck

President