Solae Withdraws Health Claim Petition

04/10/05 The Solae Company has announced that it is temporarily withdrawing its request for a qualified health claim related to soy protein consumption and cancer prevention. The Solae Company made its decision after an analysis of recent FDA health claim decisions.

The company believes the relationship between consumption of soy protein and the prevention of cancer is strong but withdrew the claim because it felt the FDA’s process is new and its evaluation process is evolving. By making sure the petition meets the current criteria required for the restructured evaluation process, The Solae Company will be putting forward the strongest possible case based on the science for the FDA. The company’s objective in filing this petition was to enable research-based health information to be made more readily available to consumers.

“Our decision has nothing to do with our confidence in the science,” said Dr. Greg Paul, director of health and nutrition for The Solae Company. “We have an improved understanding of the process and have decided to withdraw the petition and re-structure it so it will be in-line with the FDA’s current qualified health claim process.”

Nearly 60 different independent research studies support the relationship between the consumption of soy protein-based foods and reduced risk of developing several types of cancer, and new studies continue to investigate such a link. For example, a study in this week’s Journal of the American Medical Association found that higher consumption of some soy products is associated with a reduced risk of lung cancer.

Solae said it will continue to spearhead research exploring the health benefits of soy protein and will continue to seek ways to communicate those benefits to consumers. The company plans to re-submit the petition to the FDA at a later date but no specific timelines have been set.