Soy-Based Infant Formula:

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Title
Soy-Based Infant Formula Concerns and
Recommendations Testimony presented to the US
Food and Drug Administration Dietary Supplements,
Additives and Ingredients, Food Biotechnology,
Contaminants and Natural Toxicants, and Infant
Formula Subcommittees December 11, 2003 Sally
Fallon, President The Weston A. Price Foundation
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Soy-Based Infant Formula
About 25 of formula-fed babies in the US receive
soy-based infant formula
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I. Soy Protein Isolate
Soy Protein Isolate (SPI) is the major ingredient
in soy-based infant formula SPI is produced using
many chemicals and at high temperatures and
pressures, causing a reduction in protein
quality. Processing reduces but does not
eliminate the many anti-nutrients naturally
occurring in soy (phytic acid, protease
inhibitors, lectins, etc.) In rats, feeding SPI
caused increased requirements for vitamins E, K,
D and B12, created deficiency symptoms of
calcium, magnesium, manganese, molybdenum,
copper, iron and zinc. (Joseph, J Rackis,
Biological and physiological Factors in
Soybeans, Journal of the American Oil Chemists
Society, January 1974, 51161A-170A) SPI does not
have Generally Recognized as Safe (GRAS) status
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Processing Toxins
TOXINS ADDED OR FORMED DURING PRODUCTION OF SOY
PROTEIN ISOLATE Nitrites - carcinogens Lysinoalan
ine - a toxin Aluminum - 10 times higher in
soy-based formula than milk-based
formula Fluoride Compounds - very high in soy
formula Free Glutamic Acid or MSG - a
neurotoxin
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II. Lack of Cholesterol
Dietary cholesterol is vital for the optimal
development of the infant. Mothers milk is very
high in cholesterol and contains an enzyme that
ensures complete assimilation of the
cholesterol. Unlike milk- and meat-based infant
formula, soy-based formula contains no
cholesterol.
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III. Phytoestrogens
Associated with endocrine disruption, depression
of immune system and thyroid depression Reproducti
ve problems, infertility, thyroid disease and
liver disease due to dietary intake of
phytoestrogens have been observed for several
species of animals including mice, rats,
cheetah, sturgeon, quail, sheep, pigs and
marmoset monkeys Children on soy-based formula
have levels of estrogens 13,000-22,000 times
higher than children on milk-based formula (Am J
Clin Nutr 1998 Dec68(6 Suppl)1453S-1461S).
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Isoflavone Levels in Formula
PHYTOESTROGENS IN DIETS OF INFANTS AND
ADULTS Average
Isoflavones Isoflavone
per Kg of Intake Body
Weight Japan (1996 survey) 10 mg 0.17
mg Japan (1998 survey) 25 mg 0.42 mg Japan
(2000 survey) 28 mg 0.47 mg In Japanese
women receiving adequate iodine, causing thyroid
suppression 38 mg 0.60 mg In American women,
causing hormonal changes after 1 month 45
mg 0.75 mg FDA recommended amount for
adults 25 mg 0.42 mg In children receiving
soy formula 38 mg 6.25 mg Assumed 60 kg
for adults, 6 kg for infants
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Pancreatic Stress
Lebenthal E and others. The development of
pancreatic function in premature infants after
milk-based and soy-based formulas. Pediatr Res
1981 Sep15(9)1240-1244. Soy formula fed to
premature babies caused in increase in digestive
enzymes compared to milk-fed babies, indicating
low digestibility of soy formula.
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Gastrointestinal Damage
Poley JR and Klein AW. Scanning electron
microscopy of soy protein-induced damage of small
bowel mucosa in infants. J Pediatr Gastroenterol
Nutr 1983 May2(2)271-87. Soy feeding caused
damage to small bowel mucosa in 2 infants. The
damage was similar to that of celiac disease and
consistent with a lectin-induced toxicity.
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Aluminum
McGraw MD and others. Aluminum content in milk
formulae and intravenous fluids used in infants.
Lancet I157 (1986). Carefully collected human
breast milk contained 5 to 20 micrograms aluminum
per liter concentrations were 10 to 20 fold
greater in most cows milk-based formulas and
100-fold greater in soy-based formulas.
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Diabetes
Fort P and others. Breast feeding and
insulin-dependent diabetes mellitus in children.
J Am Coll Nutr 19865(5)439-441. Twice as many
soy-fed children developed diabetes as those in a
control group that was breast fed or received
milk-based formula.
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Early Puberty in Girls
Freni-Titulaer LW and others. Am J Dis Child 1986
Dec140(12)1263-1267. Soy infant feeding was
associated with higher rates of early development
in girls, including breast development and pubic
hair before the age of eight, sometimes before
the age of three.
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Lead, Cadmium and Fluoride
Dabeka RW and McKenzie AD. Lead, cadmium, and
fluoride levels in market milk and infant
formulas in Canada. J Assoc Off Anal Chem
198770(4)754-7 (1987). Soy based or milk-free
formulas contained about 8-15 times more cadmium
than milk-based formulas as well as high amounts
of fluoride.
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Autoimmune Thyroid Problems
Fort P and others. Breast and soy-formula
feedings in early infancy and the prevalence of
autoimmune thyroid disease in children. J Am Coll
Nutr 19909164-167. This study documents the
association of soy formula feeding in infancy
with autoimmune thryoid problems.
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Reproductive Problems, Asthma
Strom BL and others. Exposure to soy-based
formula in infancy and endocrinological and
reproductive outcomes in young adulthood. JAMA
2001 Nov 21286(19)2402-3. Although reported
in the media as a vindication of soy infant
formula, the study actually found that soy-fed
infants had more reproductive problems and more
asthma as adults.
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Testosterone Inhibition in Males
Sharpe RM and others. Infant feeding with soy
formula milk effects on the testis and on blood
testosterone levels in marmoset monkeys during
the period of neonatal testicular activity. Hum
Reprod 2002 Jul17(7)1692-703. Infant male
marmoset monkeys were fed either soy-based or
milk-based formula. The neonatal testosterone
rise was suppressed in the soy-fed monkeys up to
70. Levels of isoflavones in the monkey diets
were 40-87 of that reported in 4-month human
infants fed a 100 soy-based formula diet. It is
therefore considered likely that similar, or
larger, effects to those shown here in marmosets
may occur in human male infants fed with SFM soy
formula milk.
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Thymic/Immune Changes
Yellaya S and others. The phytoestrogen genistein
induces thymic and immune changes a human health
concern? Proc Natl Acad Sci USA 2002 May
2899(11)7616-21. Genistein injections in
ovariectomized adult mice produce dose-responsive
decreased in thymic weight of up to 80.
Genistein decreased thymocyte numbers up to 86
and doubled apoptosis. There was a corresponding
reduction in splenic cells. The dose that caused
significant thymic and immune changes in mice was
comparable to those reported in soy-fed human
infants. These results raise the possibility
that serum genistein concentrations found in
soy-fed infants may be capable of producing
thymic and immune abnormalities, as suggested by
previous reports of immune impairments in soy-fed
infants.
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Uterine Cancer
Newbold R and others. Increased uterine cancer
seen in mice injected with genistein, a soy
estrogen, as newborns. Cancer Research 2002 Jun
161(11)4325-8. Infant mice given genistein
developed cancer of the uterus later in life.
The data suggest that genistein is carcinogenic
if exposure occurs during critical periods in a
young animals development.
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Changes in Ovaries
Jefferson WN and others. Neonatal exposure to
genistein induces estrogen receptor (ER)alpha
expressionand multioocyte follicles in the
maturing mouse ovary evidence for
Erbeta-mediated and nonestrogenic actions. Biol
Reprod 2002 Oct67(4)1285-96. Scientists at the
National Institute of Environmental Health
Sciences in North Carolina treated newly born
mice with the soy phytoestrogen genistein for the
first five days after birth. They found that
significant alterations occurred in the ovaries.
Their conclusion Given that human infants are
exposed to high levels of genistein in soy-based
foods, this study indicates that the effects of
such exposure on the developing reproductive
tract warrant further investigation.
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Demasculinization
Wisniewski AB and others. Exposure to genistein
during gestation and lactation demasculinizes the
reproductive system in rats. Journal of Urology,
April 2003 1691582-1586. Pregnant female rats
were given diets containing none, low and high
levels of genisteinthe major type of
phytoestrogen in soy. The male offspring were
thus exposed to genistein indirectly through
maternal consumption during pregnancy and
lactation. Female rats on the low-genistein diet
received between 0.1 and 1.0 mg genistein per day
while those on the high-genistein diet received
between 6.4 and 23.6 mg genistein per
daysomewhat equivalent to the exposure of
mothers consuming small amounts and large amounts
of soy. Even low-dose exposure to genistein
caused persistent demasculinization of the male
reproductive system leading to subtle but
significant changes in sexual behavior in male
offspring.
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Anxiety and Stress
Hart Hartley DC and others. The soya isoflavone
content of rat diet can increase anxiety and
stress hormone release in the male rat.
Psychopharmacology (Berl) 2003 Apr 167(1) 46-53.
This report begins with the following
statement Isoflavones form one of the main
classes of phytoestrogens and have been found to
exert both oestrogenic and anti-oestrogenic
effects on the central nervous system. The
effects have not been limited to reproductive
behaviour, but include effects on learning and
anxiety and actions on the hypothalamo-pituitary
axis. Noting that most rat chow contains soy,
investigators compared the behavior of rats given
isoflavones in their diets with those on an
isoflavone-free diet. Rats fed isoflavones spent
significantly less time in active social
interaction and had significantly elevated
stress-induced corticosterone concentrations. The
conclusion Major changes in behavioural
measures of anxiety and in stress hormones can
result from the soya isoflavone content of rat
diet. These changes are as striking as those seen
following drug administration and could form an
important source of variation between
laboratories.
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Recommendations
Soy-based infant formula should be removed from
general sales and available only by doctors
prescription Provide pediatricians with
information on recent studies indicating
detrimental effects of soy on the developing
infant Promote the development and availability
of meat-based formula for those infants unable to
tolerate milk-based formula Renewed emphasis on
breast feeding and healthy diets for
breast-feeding mothers.
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The Weston A. Price Foundation
A non-profit nutrition education foundation
promoting a return to traditional foods and
nutrient-dense diets Washington,
DC www.westonaprice.org
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Summary
Traditional diets maximized nutrients while
modern diets minimize nutrients TRADITIONAL
DIETS MODERN DIETS Foods from fertile
soil Foods from depleted soil Choice of organ
meats over muscle meats Muscle meats, few organ
meats Animal fats Vegetable oils Animals on
pasture Animals in confinement Dairy products
raw and/or fermented Dairy products
pasteurized Grains and legumes soaked/fermented Gr
ains refined and/or extruded Bone broths MSG,
artificial flavorings Unrefined sweeteners
(honey, maple syrup) Refined sweeteners Lacto-ferm
ented vegetables Canned vegetables Lacto-fermente
d beverages Modern soft drinks Unrefined
salt Refined salt Natural vitamins in foods
Synthetic vitamins
added to foods Traditional Cooking Microwave,
Irradiation Traditional seeds/Open
polination Hybrid seeds, GMO seeds