Solae withdraws soy/cancer health claim petition
Nov 10,
2005
WESTON A.
PRICE FOUNDATION
INFORMATION
ALERT
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confirmed on October 4 that the Solae Company has withdrawn its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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