The Food and Drug Administration is expected to approve a second qualified health claim for soy, addressing its relationship to decreased incidence of certain cancers, such as those affecting the prostate, breasts and gastrointestinal system.
The Solae Co., a manufacturer of soy products, petitioned the government last April for the qualified health claim for foods with at least 5 grams of soy protein per serving.
In 1999, the FDA approved a heart-health claim for soyfoods containing at least 6.25 grams of soy and low in saturated fat and cholesterol.
Initially, the new claim was expected to meet approval by the end of April, said Mindy Kurzer, Ph.D., of the University of Minnesota. Now, Kurzer said, ?It?s going to be another couple of months.?
For some, that?s welcome news. A Washington, D.C.-based nutrition education organization, the Weston A. Price Foundation, warned supporters March 28 that ?sales of soy protein would double in America ? putting millions of Americans at risk of allergic reaction, thyroid damage, and other health problems including the increased risk of various cancers.?
Kurzer said the foundation?s concerns stem from studies done in the past five years. ?Soy, in certain animal models, stimulates cancer cell growth,? she said. ?The reason the claim application is not in conflict with those is that those studies were done in animals that had a human cancer implanted before they were exposed to soy.? Kurzer added that the claim addresses a preventive approach for healthy people.
Nancy Chapman, executive director of the Soyfoods Association of North America, attributed the delay primarily to ?an enormous backlog? at FDA, which has nine or 10 health claims pending review by a very small staff. Chapman said she expects a decision from FDA by June.
Natural Foods Merchandiser volume XXVI/number 5/p. 7