FDA Reviews Health Claim Petition Regarding Reduction in Cancer Risk

ST. LOUIS, Apr 16, 2004 /PRNewswire via COMTEX/ -- The Food and Drug Administration (FDA) yesterday confirmed it is in the process of reviewing a petition for a health claim that suggests the consumption of soy protein-based foods may reduce the risk of certain types of cancer including breast, prostate and colon cancer. A leader in the research of soy protein, The Solae Company submitted the petition with the government agency in order to seek approval for the health claim, which focuses on 58 studies supporting the relationship between the consumption of soy protein-based foods and the reduced risk of developing these types of cancer.

"We have worked diligently for the past three years to compile existing research and review emerging data regarding the role soy protein-based foods play in reducing the risk of certain types of cancer," stated Dr. Lin Yan, director of cancer research for The Solae Company. "We are pleased that the FDA has decided to accept our petition for review. And we are looking forward to the agency's evaluation."

The process for compiling the health claim petition included a comprehensive evaluation by The Solae Company of scientific research that investigated soy protein-based foods and the reduced risk of developing certain types of cancer. Subsequently, the company worked with external experts in the field and meta-analyses (statistical procedures designed to analyze associated results across independent studies) were conducted. This careful process and the weight of the scientific evidence led to the decision to file the petition with the FDA.

Expert researchers from The Solae Company's Health & Nutrition and Nutraceuticals team were responsible for spearheading the research results on which the petition is based. Several other leading researchers were involved in the scientific review of the data and supported the decision of The Solae Company to file the petition with the FDA. External reviewers of the petition included researchers from Harvard University, the University of California Los Angeles Center for Human Nutrition, the University of Illinois at Urbana- Champaign, the University of Arkansas, and Wake Forest University.

Approved health claims, which can be used in product labeling and packaging, can provide important information to consumers as it relates to dietary choice and disease prevention. According to the American Cancer Society, approximately 35 percent of cancer deaths in the United States can be avoided through dietary modification.

"Most consumers today know that food choice has an impact on their daily well-being as well as their long-term health and risk of certain diseases. However, there are many -- sometimes conflicting -- messages about which foods provide health benefits," explained Dr. Debra Miller, director of nutrition science communications for The Solae Company. "The health claim process involves extensive review by the FDA of scientific evidence regarding the health benefits associated with specific foods. Therefore, health claims can be important for consumers in making informed decisions about which foods to choose to achieve a healthy diet."

The scientific association between soy protein consumption and a reduced risk of certain types of cancer builds on growing evidence -- and increasing public awareness -- that a diet rich in soy protein may provide several health benefits. For instance, numerous studies indicate that eating a diet rich in soy protein has several heart health benefits. The evidence was compelling enough for the FDA to approve a health claim in 1999 stating, "25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of coronary heart disease." This health claim also was spearheaded by researchers at The Solae Company.

About The Solae Company

For more than 30 years, The Solae Company (an innovative venture between DuPont and Bunge Limited) has invested in fundamental research to further understand the real health benefits of soy protein. The Solae Company researchers also have studied the effects of soy protein on heart health for more than a quarter century. Other areas of study related to soy protein include sports nutrition and women's health (e.g., menopausal issues and bone health).

For many years, researchers at more than 180 leading universities and research institutions have used soy protein products produced by The Solae Company in hundreds of completed or ongoing soy studies.

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