Solae withdraws soy/cancer health claim petition

10/3/2005 - FDA’s record on qualified health claims approvals is causing companies to re-think their petitions. In the light of recent decisions the FDA has handed down, The Solae Company has decided to temporarily withdraw its soy/cancer prevention claim.

A spokesperson for Solae told NutraIngredients-USA.com that the company first submitted its petition for a claim on the link between soy and cancer prevention in April 2004. As is the case with a number of other submissions, a decision has been delayed on a number of occasions.
But despite the industry's frustration over such delays, Solae's withdrawal is not a sign of total disillusionment with the process. Rather, it has signaled that it will be making some improvements to its submission, after having studied the nature of other recent petitions and approvals. This, it believes, will give it a better chance of success.

"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."

No specific time-line has been set for the resubmission, but Solae has said that the 60-study strong body of evidence supporting the link between soy consumption and a reduced risk of developing several types of cancer continues to grow.

Most recently, the current issue of the Journal of the American Medical Association contains a University of Texas study indicating that eating foods containing phytoestrogens, including soya products, reduces the risk of developing lung cancer even in smokers.

“The company's objective in filing this petition was to enable research-based health information to be made more readily available to consumers,” said the company in a statement.

In an interview with NutraIngredients-USA.com in June, Kathy Ellwood, director of nutrition programs and labeling at the FDA's Center for Food Safety and Applied Nutrition, said that the approval delays are the result of “very limited resources”.

http://www.fda.gov/ohrms/dockets/dockets/04q0151/04Q-0151-emc0002-vol4.doc

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