Solae withdraws soy/cancer health claim petition

The FDA confirmed on October 4 that the Solae Company has withdrawn its petition for a soy protein and cancer health claim. Had this health claim been approved, it would have doubled the sales of soy protein in this country, bringing huge profits to the soy industry while putting American men, women and children at risk.

"This represents a major blow to the soy industry," says Kaayla T. Daniel, PhD, author of The Whole Soy Story: The Dark Side of America's Favorite Health Food. "The FDA advised Solae on at least one occasion that it had not convincingly established that soy can prevent cancer and that it had failed to counter massive evidence that soy can cause, contribute to or accelerate cancer growth."

Dr. Daniel joined the Weston Price Foundation to present much of the scientific evidence against soy that led to the FDA's questions and to Solae's withdrawal. The Weston A. Price Foundation has been a leader in alerting the public to the fact that soy protein and soy oil in the food supply have been linked to digestive distress, thyroid damage, reproductive problems, infertility, ADD/ADHD, dementia, heart disease and cancer.

Solae first petitioned the FDA for a health claim in February 2004. Food manufacturers put health claims approved by the FDA on labels and packages to increase sales because they encourage consumers to make "healthier"
purchases. The FDA had hoped to announce its final decision on October 23, 2005.

Between June 2004 and April 2005, the Weston A. Price Foundation submitted three detailed and heavily referenced documents to the FDA that refuted the claims for soy and cancer made by the Solae Company, a joint venture of Dupont and Bunge. This summer the Foundation drew the FDA's attention to a July 2005 health advisory issued by the Israeli Health Ministry that warned that soy infant formula should not be given to infants, that children should be fed soy foods no more than once per day to a maximum of three times per week and that adults should exercise caution because of increased risk of breast cancer and adverse effects on fertility.

In addition, the Foundation spearheaded a write-in campaign to the FDA earlier this year that brought in over 1,000 comments by our members requesting the FDA to not approve Solae's petition. You are all to congratulated for this fine effort.

In its petition to the FDA, Solae contended that a qualified health claim was warranted because of "substantial scientific agreement" among experts that soy protein reduces the risk of breast, prostate and colon cancers. "No such consensus exists," says Dr. Daniel. "Scientists at the FDA's own Center for Toxicological Research have warned of soy protein's carcinogenic potential and of the health dangers of excess soy-food consumption. We showed the FDA that Solae was highly selective in its choice of evidence and biased in its interpretations. We reported on the fact that they had omitted many studies proving soy to be ineffective in preventing cancer, emphasized favorable outcomes in studies with mixed results and excused the results of the few unfavorable studies that they included to give the illusion of balance. Most importantly, we drew the FDA's attention to the fact that Solae excluded many studies showing that soy protein can cause and accelerate the growth of cancer, particularly breast cancer."

In addition to the recent soy warning issued by the Israeli Health Ministry, expert scientists with the British Committee on Toxicity, Swiss Federal Health Service and other government agencies have all expressed concern about soy's potential to disrupt the digestive, immune and neuroendocrine systems of the human body and its role in rising rates of infertility, hypothyroidism and some types of cancer including thyroid and pancreatic cancers.

Soy is also highly allergenic. Most experts now place soy protein among the top eight allergens, and some rate it in the top six or even top four. The Swedish Health Ministry has warned that allergic reactions to soy are increasingly common, ranging from mild to life threatening, and that fatalities have been reported.

"People are finally starting to hear that soy is not a 'miracle food,'" says Dr. Daniel. "More and more expert scientists are issuing warnings about soy.

The FDA made a big mistake in 1999 when it kowtowed to the soy industry and allowed a soy-and-heart-disease health claim. Today's FDA is under intense scrutiny because of the Vioxx debacle and could not afford to approve an unfounded soy-prevents-cancer health claim. Solae withdrew its petition because it knew that its science was unconvincing and that the FDA had no choice but to turn them down. The bottom line is that soy does not prevent cancer."

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