Bad News for the Soy Industry

By Kaayla T. Daniel, PhD, CCN

Soy food sales are finally slowing down. According to the recent market study Soyfoods: The U.S. Market 2005, soy food sales hit $4 billion in 2004 but climbed only 2.1 percent that year, the slowest growth for the industry since the early 1980s.

Industry spokesman Peter Golbitz of Soya-tech blamed consumer “boredom” with the products currently in the marketplace and consumer concerns about news reports and articles that have “questioned the health benefits of consuming soy-based food products.”

In fact, the media have not only questioned the health benefits of soy but begun reporting on the risks. In July, the Israeli Health Ministry warned that babies should not receive soy formula, that children should eat soy 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. The Ministry based its advice upon the conclusions reached by a 13-member committee of nutritionists, oncologists, pediatricians and other specialists who spent more than year examining the evidence. They concluded that the estrogen-like plant hormones in soy can cause adverse effects on the human body and strongly urged consumers to minimize their consumption of soy foods until absolute safety has been proven.

That same month Cornell University’s Program of Breast Cancer and Environmental Risk Factors issued a “Fact Sheet” warning that women at risk for breast cancer should take it easy on their soy consumption. Cornell explained that researchers once thought that soy phytoestrogens would block the effects of endogenous estrogens in the body to reduce breast cancer risk but are now seriously concerned about the mounting evidence that high-soy diets cause greater cell multiplication in the breast. Increased cell multiplication is a widely acknowledged risk factor for the development of breast cancer. Then, just in time for Breast Cancer Awareness Month in October, the Journal of the American Dietetic Association reported that high intake of soy may increase breast cancer risk and that “health professionals should take an active role in communicating
and clarifying such information.”

In a strategy to counteract a slowdown in sales, the soy industry had put its soybeans mostly in one basket—winning approval of an FDA-approved health claim that soy prevents cancer. This hope was dashed early in October of this year when the Solae Company withdrew its petition to the FDA in the face of growing evidence that soy can cause, contribute to or accelerate the growth of cancer. Solae petitioned the FDA for the health claim in February 2004 with the stated intent of doubling the sales of its soy protein products. The FDA’s current extension ended on October 23.

According to Solae officials, the withdrawing of their petition had “nothing to do” with the science but was a strategy designed to allow the company to “re-structure” their petition. However, between June 2004 and April 2005, the Weston A. Price Foundation submitted three detailed and heavily referenced documents to the FDA that refuted Solae’s claims that soy prevents cancer. In response to a request by the Weston A. Price Foundation, over 1000 people wrote letters of protest. (The FDA has posted these comments at http://www.fda.gov/ohrms/dockets/04Q0151/04Q0151.htm.)

This summer the Foundation also drew the FDA’s attention to the warning issued by the Israeli Health Ministry.

Solae still contends that a qualified health claim is warranted because of “substantial scientific agreement” among experts that soy protein reduces the risk of breast, prostate and colon cancers. In fact, no such consensus exists. 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. 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. The Swedish National Food Administration has warned that allergic reactions to soy are increasingly common, ranging from mild to life-threatening, and that fatalities have been reported.

Clearly, Solae knew that the FDA could not approve its proposed soy protein and cancer health claim. The FDA advised Solae on at least one occasion that it had not convincingly established
the claim that soy can prevent cancer and that it had failed to counter massive evidence that soy can cause, contribute to or accelerate cancer growth. Back in 1999, the FDA sided with the soy industry and allowed a soy-and-heart-disease health claim, but 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.

Earlier this summer the Freedonia Group, a market research organization, predicted that new research and health claims would “hot up” the demand for soy and drive sales upward from $4 billion in 2004 to a $8.5 billion in 2007. Instead, researchers are saying “better safe than sorry” and there won’t be another soy health claim in the near future. What’s more, the Weston A Price Foundation will soon petition the FDA for warning
labels on soy products.
Possible Legal Action on Medical Problems
Caused by Soy

The Weston A. Price Foundation is undertaking an initiative to investigate instances and arrange possible legal assistance
for individuals who believe that they or their child may have suffered serious physical or medical consequences as a result of ingesting one or more products containing soy.

A growing body of credible medical and dietary research suggests that soy products may cause adverse medical and developmental conditions in susceptible persons, especially children—who in some instances may be affected by soy products consumed either by themselves (for instance, in baby formula) or by their mothers prior to giving birth.

The Weston A. Price Foundation is exploring the causal connection between soy and various serious conditions—see list below. We have also sought out competent attorneys in the United States and elsewhere, who may develop medical evidence in a number of these cases to pursue damages or other appropriate remedies against the manufacturers and sellers of soy products.

A partial list of medical conditions possibly attributable to soy consumption includes asthma, chronic fatigue, depression,
diabetes, heart arrhythmia, heart or liver disease, infertility and reproductive problems, irritable bowel syndrome, learning disabilities, pancreatic disorders, premature or delayed puberty, rheumatoid arthritis, thyroid conditions, uterine conditions and weight gain.

If you would like to participate in these efforts, we urge you to contact the Weston A. Price Foundation at westonaprice_
soy@verizon.net or (202) 363-4394. Upon receipt of your e-mail, we will forward you, via e-mail with attachments,
a questionnaire and release form. We urge you to complete the questionnaire, fully and honestly, to the best of your ability. Also, please sign and return the medical authorization(s) along with the questionnaire, in order that we might gather relevant medical records in those cases that warrant further investigation. Mailing address and fax number will be provided to you with the questionnaire.

PLEASE BE ADVISED that not all of these potential claims can or will be pursued, even if we conclude that you or your child may have suffered some adverse effects from the consumption of soy products. It may be too late under applicable state laws to pursue some claims; and in other cases, the parties responsible for your condition may not be adequately identified, or the recoverable damages may not warrant pursuit of the responsible parties. However, if you would like us to conduct a preliminary investigation of the circumstances of your potential claim, without cost or obligation to you, then promptly contact us at westonaprice_soy@verizon.net. We hope to be able to assist you in this matter, if our inquiry develops evidence of corporate responsibility for your medical problems or those of your child.


Press Release and Victory Action Alert

The following press release was sent to the media and all WAPF Action Alert recipients. If you would like to send this to your local newspaper, radio or television station, please email the Foundation at info@westonaprice.org to receive this document in electronic form.
FDA Says“No” to Soy
Soy Industry Giant Withdraws from
FDA Cancer Health Claim Battle

Washington, DC: The FDA has confirmed the fact that the Solae Company withdrew its petition for a soy protein and cancer health claim on October 4. Solae, a joint venture of Dupont and Bunge, had applied for a Cancer Prevention Health Claim with the intent of doubling the sales of its product, soy protein.

“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. “Had this health claim been approved, it would have created huge profits for the soy industry while putting American men, women and children at risk. Clearly Solae knew that the FDA could not approve its proposed soy protein and cancer health claim. The FDA advised Solae on at least one occasion that it had not convincingly established the claim 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 A. Price Foundation, a non-profit nutrition education foundation based in Washington, DC, to present much of the scientific evidence against soy that led to the FDA’s concerns and to Solae’s withdrawal. The Weston A. Price Foundation has been a leader in alerting the public to the fact that processed 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.

Between June 2004 and April 2005, the Weston A. Price Foundation submitted three detailed and heavily referenced
documents to the FDA that refuted Solae’s claims that soy protein prevents cancer. This summer the Foundation drew the FDA’s attention to a July 2005 health advisory issued by the Israeli Health Ministry which 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 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 learn 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 sided with 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.”

Source: http://www.westonaprice.org/soy/soy_badnews.html