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Contact: Sally Fallon, President
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Press Release

Experts Dispute Soy Formula Safety

Experts dispute the findings of a recent study on soy infant formula, published in
the Journal of the American Medical Association, August 15, 2001 and widely
reported in the press as a vindication of soy formula. The research team, headed
by Dr. Brian L. Strom, called the results "reassuring" but other scientists disagree
with this conclusion.

Dr. Mary Enig, President of the Maryland Nutritionists Association, points out
that the researchers found higher rates of reproductive disorders, asthma and
allergies in those who had received soy formula as infants. "This is in line with a
number of reports in the scientific literature," said Dr. Enig. "The research team
glossed over negative findings and omitted them from the abstract and
conclusions, noting only that women who had been fed soy formula reported
slightly longer duration of menstrual

bleeding and greater discomfort with menstruation." Other gynecological
problems, which were omitted from the main body of the report, included higher
rates of cervical cancer, polycystic ovarian syndrome, blocked fallopian tubes,
pelvic inflammatory disease and hormonal disorders. In addition, although the
study did not specifically determine thyroid function, soy-fed females reported
higher rates of sedentary activity and use of weight-loss medicines, thus adding
new evidence to numerous scientific reports of soy-induced thyroid problems.

Experts were also critical of the design of the study, in which researchers
conducted telephone interviews with 282 adults fed soy formula and 563 adults
fed milk formula during controlled feeding studies at the University of Iowa
between 1965-1978. "Data derived from telephone interviews, particularly
interviews that ask a lot of subjective questions, cannot be used to draw any
meaningful conclusions," said Dr. Naomi Baumslag, Clinical Professor of
Pediatrics at Georgetown University and President of the Women' s International
Public Health Network. She noted that the study provided no information on
dose length or quantity, nor on the ages at which ingestion ended, all vital in a
study on toxicity. "The amount of phytoestrogens in soy formula can vary as much
as tenfold, depending on the way it is processed. And the soy used today is
genetically engineered, which means that it has more isoflavones in it than the soy
they were using twenty years ago."

"The question we should be asking is why are so many of our babies on soy?"
said Dr. Baumslag. "In the UK and New Zealand only 1% of babies get soy. In
the US, at least 20% get soy. It can only be because of massive influence of the
soy industry, because there is scientific evidence that soy formula can be
damaging to newborns."

The soy formula study was funded by the National Institutes of Health and the
International Formula Council and carried out under the auspices of the Fomon
Infant Nutrition Unit at the University of Iowa. The Fomon Infant Nutrition Unit is
supported by the major formula manufacturers Ross Products Division of Abbot
Laboratories, Nestle, and Mead Johnson Nutritionals. Dr. Samuel Fomon played
an important role in the development of soy infant formula. Early promotional
efforts for soy formula described it as "better than breast milk."

The questions were geared to assess reproductive disorders and age of
maturation. The average age of maturation for both sexes was the same for both
groups; however raw data that would show whether there was abnormal
clustering for early or late maturation was not given. Women were not asked
about the age of first appearance of breasts or pubic hair. Age of first wearing a
bra was given as a proxy measure for age of breast development and education
level attained as a proxy measure for intelligence. Trade school, college and post
college were lumped together as one category. No questions were asked about
digestive disorders.

Many of the negative findings for the soy-fed group were not "statistically
significant." But critics point out that the group of 282 soy-fed individuals was too
small for statistical significance to be achieved. "With so many infants now
receiving soy formula, the small differences noted in the study can affect
thousands of individuals," said Dr. Enig. In the US, an estimated 750,000 infants
per year receive soy formula. Consumer groups have voiced concern about
adverse effects reported in the scientific literature, including thyroid disorders,
asthma, digestive disorders, calcium deficiencies leading to rickets, high
manganese levels leading to brain damage and endocrine disruption. A 1986
study in Puerto Rico found that use of soy formula was strongly correlated with
premature maturation in girls. Anecdotal reports of other adverse effects include
extreme emotional behavior, learning difficulties,immune system problems,
irritable bowel syndrome, depression and disrupted sexual development in boys.

US scientists who have warned about potential dangers in the use of soy for
infants include phytoestrogen researcher Dr. Kenneth Setchell, Professor of
Pediatrics at the University of Cincinnati, and Dr. Daniel Sheehan, Director of the
US Food and Drug Administration National Center for Toxicological Research.
Setchell determined that babies on soy formula receive a daily exposure to
isoflavones (plant-based estrogens) that is 6 to 11 times higher on a body weight
basis than the dose that has undesirable hormonal effects in adults consuming soy
foods. His research showed that serum isoflavone levels in soy-fed infants were
13,000 to 22,000 times higher than those of infants fed milk-based formula.
According to Dr. Mike Fitzpatrick, a New Zealand toxicologist, babies fed
exclusively on soy formula receive the estrogenic equivalent of at least five birth
control pills per day.

Noting the adverse effects of similar high levels of isoflavones when given to
young animals, Sheehan warned of key imprinting events affecting the
development of many physical, physiological and behavioral characteristics in the
human infant. Because of this evidence, both the British and New Zealand
governments have issued warnings on the use of soy infant formula. Lynn
Goldman, MD, MPH, Professor of Environmental Health Science, Johns
Hopkins University Bloomberg School of Public Health, also voiced concerns. In
a letter to the Washington Post dated August 28, 2001, she was critical of press
reports about the study and stated that "there are ample reasons to begin to
question the safety of soy proteins in the diets of infants. There are several major
limitations to this study."