To Whom It May Concern:
The below and attached comments are submitted by Ron Heck, American Soybean Association President. Should you have questions regarding this matter please contact me directly at (314) 754-1336.
Thank you for your consideration.
Sincerely,
Neil E. Caskey
Special Assistant to the CEO
<<Cancer Claim Letter Template1.doc>>
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)
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,
Ron Heck
President