Transcript 2003-DEC-11: Oral Testimony on Soy

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
Soy-Based Infant Formula
About 25% of formula-fed babies in the US
receive soy-based infant formula
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,
51:161A-170A)
SPI does not have Generally Recognized as Safe (GRAS) status
TOXINS ADDED OR FORMED DURING
PRODUCTION
OF SOY PROTEIN
Processing
ToxinsISOLATE
Nitrites - carcinogens
Lysinoalanine - 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
II. Lack of Cholesterol
Dietary cholesterol is vital for the optimal
development of the infant.
Mother’s milk is very high in cholesterol and
contains an enzyme that ensures complete
assimilation of the cholesterol.
Unlike milk- and meat-based infant formula, soybased formula contains no cholesterol.
III. Phytoestrogens
Associated with endocrine disruption, depression of
immune system and thyroid depression
Reproductive 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 Dec;68(6 Suppl):1453S-1461S).
e
PHYTOESTROGENS
IN DIETS OF INFANTS AND ADULTS
v
Average
Isoflavones
e
Isoflavone per Kg of
Intake
Body Weight*
l
Japan (1996 survey)
10 mg
0.17 mg
s (1998 survey)
Japan
25 mg
0.42 mg
Japan (2000 survey)
28 mg
0.47 mg
IniJapanese women receiving adequate
iodine, causing thyroid suppression
38 mg
0.60 mg
In American women, causing hormonal
n changes after 1 month
45 mg
0.75 mg
FDA
25 mg
0.42 mg
F recommended amount for adults
In children receiving soy formula
38 mg
6.25 mg
o
* Assumed 60 kg for adults, 6 kg for infants
r
m
Pancreatic Stress
Lebenthal E and others. The development of
pancreatic function in premature infants after milkbased and soy-based formulas. Pediatr Res 1981
Sep;15(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.
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 May;2(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.
Aluminum
McGraw MD and others. Aluminum
content in milk formulae and intravenous fluids
used in infants. Lancet I:157 (1986).
Carefully collected human breast milk
contained 5 to 20 micrograms aluminum per
liter; concentrations were 10 to 20 fold greater in
most cow’s milk-based formulas and 100-fold
greater in soy-based formulas.
Diabetes
Fort P and others. Breast feeding and insulindependent diabetes mellitus in children. J Am Coll
Nutr 1986;5(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.
Early Puberty in Girls
Freni-Titulaer LW and others. Am J Dis Child 1986
Dec;140(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.
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
1987;70(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.
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 1990;9:164-167.
This study documents the association of soy
formula feeding in infancy with autoimmune
thryoid problems.
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 21;286(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.
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 Jul;17(7):1692-703.
Infant male marmoset monkeys were fed either soy-based or milkbased 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].”
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 28;99(11):7616-21.
Genistein injections in ovariectomized adult mice produce doseresponsive 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.”
Uterine Cancer
Newbold R and others. Increased uterine cancer
seen in mice injected with genistein, a soy estrogen,
as newborns. Cancer Research 2002 Jun
1;61(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 animal’s development.”
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 Oct;67(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.”
Demasculinization
Wisniewski AB and others. Exposure to genistein during gestation
and lactation demasculinizes the reproductive system in rats.
Journal of Urology, April 2003 169:1582-1586.
Pregnant female rats were given diets containing none, low and high
levels of genistein—the 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 day—somewhat 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.
Anxiety and Stress
HartHartley 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.”
Recommendations
Soy-based infant formula should be removed from
general sales and available only by doctor’s 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.
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
Summary
Traditional diets maximized nutrients while modern diets minimize nutrients
TRADITIONAL DIETS
Foods from fertile soil
Choice of organ meats over muscle meats
Animal fats
Animals on pasture
Dairy products raw and/or fermented
Grains and legumes soaked/fermented
Bone broths
Unrefined sweeteners (honey, maple syrup)
Lacto-fermented vegetables
Lacto-fermented beverages
Unrefined salt
Natural vitamins in foods
Traditional Cooking
Traditional seeds/Open polination
MODERN DIETS
Foods from depleted soil
Muscle meats, few organ meats
Vegetable oils
Animals in confinement
Dairy products pasteurized
Grains refined and/or extruded
MSG, artificial flavorings
Refined sweeteners
Canned vegetables
Modern soft drinks
Refined salt
Synthetic vitamins added to foods
Microwave, Irradiation
Hybrid seeds, GMO seeds