Soy-based Infant Formula:
Concerns and
Recommendations
Suha Khoury, RD
Purpose of Presentation
 To
explore safety issues related to the use of soy-based infant
formula as the main source of nutrition
 To present international regulations on the appropriate use of
soy-based infant formula
Topics of Discussion
1. Historical background
2. Safety issues and potential adverse effects
3. Views of regulatory bodies
1. Historical Background1
1909
First use of soy-based infant formula
1929
Soy-based formula was proposed for intolerance of cow’s
milk
Mid 1960’s
Soy protein isolate (SPI) used instead of soy flour
Early 1970’s
Supplementation of soy-based formula with Lmethionine
1. American Academy of Pediatrics Policy Statement, Pediatrics, 1998
2. Safety Issues and Potential Adverse Effects
2.1. Nutritional adequacy
2.2. Presence of phytoestrogens
2.3. Presence of potential carcinogens
2.4. Aluminum content
2.5. Manganese content
2.6. Allergicinity of soy
2.7. The use of genetically modified (GM) soy protein isolate
(SPI)
2.1. Nutritional Adequacy
2.1.1. Presence of soy phytates
2.1.2. Presence of protease inhibitors
2.1.3. Other nutritional factors
2.1.1. Soy Phytates
 Soybean contains highest phytic acid content of all legumes 1
 “…soy protein isolate formulas still contain 1.5% phytates” 2
 Phytates affect absorption of following minerals:
 Calcium & Phosphorous:
Until 1980, “mineral absorption from soy formulas was erratic” partly
due to “the presence of excessive soy phytates in the formula” 2
 30% phosphorus bound to phytates2
3,4,5
 Soy infant formula may result in decreased bone mineralization

Zinc: Absorption highest (41%) from human milk, lowest (14%)
from soy formula 6,7
 Manganese: Absorption doubled after dephytinizing formula8
 Iron:  bioavailability by removing phytic acid9
 Copper:  copper absorption and status by  phytate content7
 Vitamins: Use of SPI  requirements for vitamins E, K, D & B1210

1. Chitra U et al, Plant Foods Hum Nutr, 1995
2. American Academy of Pediatrics Policy Statement,
Pediatrics, 1998
3. Steichen et al, J Pediatr, 1987
4. Chan et al, Am J Dis Child, 1987
5. Hillman et al, J Pediatr, 1988
6. Sandstrom et al, Am J Dis Child, 1983
7. Lönnerdal B et al, Am J Clin Nutr, 1999
8. Davidsson L et al, Am J Clin Nutr, 1995
9. Davidsson L et al ,Pediatr Res, 1994
10. Rackis J, J Am Oil Chem Soc, 1974
2.1.2. Protease Inhibitors
 Definition: Antitrypsin, antichymotrypsin, antielastin1
 Exposure estimates:
 80% to 90% of protease inhibitor activity is removed when SPI is
heated1
 Trypsin inhibitor content of soy protein isolate can vary as much
as fivefold2
 Soybean products retain 2.5-12.5% trypsin inhibitor activity of the
whole soybean3
 Health concerns:
 Trypsin inhibitors account for 40% of the growth inhibition of
raw soy4
 Growth depressant5
 Stimulate pancreatic hyperplasia in test animals, including
carcinoma5
1.
2.
3.
4.
5.
American Academy of Peditrics Policy Statement, Pediatrics, 1998
Rackis et al, Qual Plant Foods Hum Nutr, 1985
Miyagi Y et al, J Nutr Sci Vitaminol, 1997
Liener IE , Arch Latinoam, Nutr, 1996
Liener IE, J Nutr,1995
2.1.3. Additional Factors
 Protein quality
Soy protein contains only 1/3 of available nitrogen as essential or semiessential amino acids1
 “Soy is not as good a protein source as cow's milk”2

 Presence of hemagglutinin

Growth depressant3 , might be resistant to dry heat4
 Devoid of cholesterol
Essential for brain cell development5
 Early exposure to cholesterol associated with improved fat metabolism in
later life6

 Lactose replaced by sugar
Lactose & galactose crucial for neural myelination
 Sugar is not favored because of its “potential effect on teeth and
development of inappropriate eating habits”2

 Low in chloride

Reported cases of hypochloraemic alkalosis7
1. Graham GC et al, Am J Dis Child, 1970
2. U.S. Food and Drug Administration,
http://www.fda.gov/fdac/features/596_baby.html
3. Liener IE, Crit Rev Food Sci Nutr, 1994
4. Liu K, Soybeans: Chemistry, Technology, and Utilization, 1997
5. Pond WG, Proc Soc Biol Med, 2000
6. Owen CG et al, Pediatrics, 2002
7. Linshaw MA et al, J Pediatr, 1980
2.2. Phytoestrogens
2.2.1. Definition
2.2.2. The Main Isoflavones in Soy-Based Infant Formula
2.2.3. Exposure Estimates
2.2.4. Bioavailability of Isoflavones
2.2.5. Adverse Effects of Phytoestrogens on Health
2.2.1. Definition of Phytoestrogen
“Any
plant substance or metabolite that induces biological
responses in vertebrates and can mimic or modulate the actions
of endogenous oestrogens usually by binding to oestrogen
receptors”1

Three main classes of phytoestrogens:
Isoflavones
Soybeans and soy products
Lignans
Rye, wheat, sesame seeds, flax
Coumestans
Vegetables bean sprouts, red clover,
sunflower seeds
1. Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment- Working Group on Phytpestrogens, UK
2.2.2. The Main Isoflavones in Soy Formulas1
Percentage Distribution of Total Isoflavone Equivants of the Three
Main Isoflavonoids (i.e. Genistein, Diadzein, and Glycetein), their
Glucosides, their Acetyl and Malonyl Derivatives
% isoflavonoid aglycone
equivalents
70
% Total genistein and derivatives
% Total diadzein and derivatives
% Total glycitein and derivatives
60
50
40
Brands of soy-based infant formula
A- ProSobee Soy Formula (powder)
B- Farley’s Soya Formula
C- Isomil
D- SMA Wysoy
E- Cow &Gate Infasoy
30
20
10
0
A
B
C
1. Murphy PA, J Agric Food Chem, 1997
D
E
2.2.3. Isoflavones Exposure Estimates1
Average
isofalvone
intake/day
Isoflavone
per kg body
weight*
China (1990 survey)2,3
3 mg
0.05 mg
Japan (1996 survey)4
10 mg
0.17 mg
Japan (1998 survey)5
25 mg
0.42 mg
Japan (2000 survey)6
28 mg
0.47 mg
Shown to induce goitrogenic effect in 3 months7
35 mg
0.58 mg
Causing hormonal changes in 1 month8
45 mg
0.73 mg
Increasing proliferation of breast tissue in 14 days9
45 mg
0.73 mg
FDA recommended amount10,3
24 mg
0.40 mg
Infants on soy-based formula11
34 mg
6.25 mg
* Assumed 60 kg for adults, 6 kg for infants
1. http://westonaprice.org/soy/birthcontrolbabies.html
2. Chen J et al, Diet, Lifestyle and Mortality in China, 1990
3. USDA-Iowa State University Database on the Isoflavone Content of
Foods, 1999
4. Fukutake M et al, Food Chem Toxicol, 1996
5. Nagata C et al, J Nutr, 1998
6. Nakamura Y et al, J AOAC Int, 2000
7. Ishizuki et al, Nippon Naibunpi Gakkai Zasshi, 1991
8. Cassidy A et al, Am J Clin Nutr,1994
9. McMichael-Phillips DF et al, Am J Clin Nutr 1998
10. Federal Register, October 1999
11. Setchell KD et al, Am J Clin Nutr, 1998
2.2.3. Isoflavones Exposure Estimates -con’t A
Country of Study
on Soy-based
Infant Formula
No.
Brands
analyzed
Total
isoflavone
level (mg/L)
Estimated
isoflavone intake
Age of
infant
USA1
5
32-47
4.5-8.0
N/A
USA2
6
25-30
5-12
varies
New Zealand3,4
5
N/A
3.8
3.3
2.9
1 month
2 months
4 months
Austrlia4
4
17-22
NA
United Kingdom 5
6
18-41
5.0
4.5
1-2 months
4-6months
Switzerland6
N/A
N/A
6-20
N/A
(mg/kg bw/day)
100 mg isoflavones = 1 contraceptive pill7
1. Setchell KD et al, Am J Clin Nutr, 1998
2. Murphy PA et al, J Agr Food Chem, 1997
3. Irvine CHG et al, Proc Soc Exp Biol Med, 1998
4. Knight DC et al, Paediatr Child Health, 1998
5. MAFF-UK, Nov 1998
6. Tonz O et al, Paediatricia, 1997
7. Bulletin de L’Office Federal de la Santé Publique,1992
2.2.3. Isoflavones Exposure Estimates1- con’d B













0
1
2
3
4
5
6
7
8
9 10 11 12 13
Amount of Isoflavone kg-1 body weight-1
China (1990 survey)
Japan (1996 survey)
Japan (1998 survey)
Japan (2000 survey)
Shown to induce goitrogenic effect
Causing hormonal changes and
increasing breast tissue proliferation
FDA recommended amount
Infants on soy-based infant formula
USA - Setchell et al
USA - Murphy et al
NZ - 1 month olds - Irvine et al
NZ – 2 month olds- Irvine et al
UK – 1 to 2 month olds - Reading
Switzerland - EEK
2.2.4. Bioavailability of Phytoestrogens
 Plasma concentration1,2
 Circulating concentrations of isoflavones in seven infants fed soybased formula were
13,000-22,000 times higher than plasma oestradiol concentrations in
early life Greater than in infants fed breast milk and or cow-milk
formulas
 An order of magnitude higher per bodyweight than typical plasma
concentrations of adults consuming soy foods

 Urinary excretion3
 Infants fed soy infant formulas absorb isoflavones, as evidenced
from the high but variable urinary concentrations
1. Setchell KD, Lancet, 1997
2. Setchell KD, Am J Clin Nutr, 1998
3. Cruz et al, Pediatr Res, 1994
2.2.5. Adverse Effects of Phytoestrogens
A. Thyroid Gland
A.1. Infants
A.2. Adults
A.3. Possible Mechanisms of Action
B. Sexual Development and Fertility
C. Immune System
D. Central Nervous System (CNS)
2.2.5. Adverse Effects of Phytoestrogens
A. Thyroid Gland
A.1. Effects on Thyroid Gland in Infants
1950s and 1960s:
 12 cases documented goitrogenic effect of soy flour infant
formula1,2,3 that resulted in substituting soy flour with SPI and
supplementing it with iodine 4
 Recent studies:
 Infants with congenital hypothyroidism fed soy-based infant
formula have an increased requirement for thyroxine by as much
as 18-25% 5
 A significant increase in rate of thyroid disease in subjects fed
soy-based infant formula as infants6
 Incidence of positive thyroid antibodies was 2 1/2 times
higher in formula-fed diabetic children than in breast-fed ones7
1. Hydovitz JD, N Engl J Med, 1960
2. Shepard TH et al, N Engl J Med, 1960
3. Van Wyk JJ et al, Pediatrics, 1959
4. Fomon SJ, Nutrition of normal infants, 1993
5. Jabbar et al, J Am Coll Nutr, 1997
6. Fort P et al, J Am Coll Nutr, 1990
7. Lanes et al, J Am Coll Nutr, 1986
2.2.5. Adverse Effects of Phytoestrogens
A. Thyroid Gland
A.2. Effects on Thyroid Gland in Adults
1.
2.
3.
4.
5.
Study Participants
Diet
Reported Effects
Premenopausal women1
Isoflavones (mg/day):
128
 T3
Postmenopausal women2
Isoflavones (mg/day):
65, 132
Changes in Thyroid
Binding Globulin
(TBG)
Postmenopausal women3
Isoflavones (mg/day):
56 , 90
Changes in T4 ,T3 &
TSH
Healthy Japanese men4
35 g soybeans for 3
months
Goiter in half
subjects
45 year old woman with
hypothyroidism6
Soy protein
supplement
 absorption of
levothyroxine
Duncan et al, J Clin Endocrinol Metab, 1999a
Duncan et al, J Clin Endocrinol Metab, 1999b
Persky et al, Am J Clin Nutr, 2002 Levy et al Proc Soc Exp Biol Med, 1995
Ishizuki Y et al, Nippon Naibunpi Gakkai Zasshi, 1991
Bell DS et al, EndocrPract, 2001
2.2.5. Adverse Effects of Phytoestrogens
A. Thyroid Gland
A.3. Possible Mechanisms of Action1

Isoflavones in soy-based infant formula may influence
thyroid function in infants by:





Acting as a mild goitrogen
Reducing absorption of iodine from the gut
Increasing loss of thyroxine via the enterohepatic circulation
Inhibiting the activity of thyroid peroxidase
A study found no free isoflavones in the plasma of four
infants after 4 weeks of continuous feeding on soy-based
infant formula

Huggett AC, Pridmore S, Malnoe A, Haschke F, Offord EA.
Phyto-oestrogens in soy-based infant formula. Lancet 1997 Sep
13;350(9080):815-6
1. Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment- Working Group on Phytpestrogens, UK
2.2.5. Advert Effects of Phytoestrogens
B. Effects on Development and Fertility
Participants
Diet
Results
Adults between Formula as infants:
ages of 20-341
cow-based or soybased
Infants fed soy formula had
 in duration menstrual cycles
 discomfort with menstruation
Premenopausal
women2
60 g soy protein
45 mg isoflavones
Menstrual cycle lengthened & two
main ovulation hormones reduced
Young women3
20 mg or 40 mg
isoflavones daily
80% had prolonged or shortened
menstruation
Japanese men4
Semi quantitative
food frequency
questionnaire
Serum estradiol concentration
significantly inversely correlated
with soy product intake
Peurto Rican
girls5
N/A
Positive association between soy
formula & premature thelarche
Pregnant and
lactating rats6
Genstein free, low,
or high diets
Altered masculinization of
reproductive system of offspring
1. Strom BL et al, JAMA, 2001
2. Cassidy A et al, Am J Clin Nutr, 1994
3. Watanabe S et al, Biofactors, 2000
4. Nagata C et al, Nutr Cancer, 2000
5. Freni-Titulaer LW et al, Am J Dis Child, 1986
6. Wisniewski AB et al, J Urol, 2003
2.2.5. Adverse Effects of Phytoestrogens
C. Effects on the Immune System
Participants
Diet
Effect
Women of ages Formula when infants:  Soy-based formula
20-341
cow-based or soyassociated with more use of
based
allergy and asthma drugs
1.
2.
3.
4.
Infants2
Soy-based infant
formula

Infants3
Soy-protein infant
formula

Women4
Synthetic isoflavone
derivative

Strom BL et al, JAMA, 2001
Zoppi G et al, Lancet, 1983
Zoppi G et al, J Pediatr Gastroenterol Nutr, 1982
Alexandersen P, JAMA, 2001
Reduced levels of antibodies
in response to routine
immunizations
 Increase in upper respiratory
infections and bronchitis
Immune proteins decreased
 Greater impairment in T cell
function
Depressed lymphocytes
2.2.5. Potential Effects of Phytoestrogens
D. Effects on the CNS
Study subjects
Diet
Results
Rats1
N/A
Genistein reduces DNA synthesis
in the brain and inhibits the
proliferation of brain cells
7,000 men from
Honolulu Heart
Program study2
Tofu consumption
estimated from
dietary assessment
Significant dose-dependent risk
(up to 2.4 fold) for development
of vascular dementia and brain
atrophy from consumption of
tofu
27 student
volunteers aged
22-30 years3
Diets containing
0.5 or 100 mg total
isoflavones/day
 isoflavone intake related to:
1. Yakisich JS et al, Exp Neurol, 1999
2. White LR et al, J Am Coll Nutr, 2000
3. File SE et al, Psychopharmacol, 2001
 Small improvements in tests of
short and long term memory
 Mental flexibility
 More restraintment in a selfassessment of mood
2.3. Presence of Pontential Carcinogens
 Nitrites
 Formed during spray-drying1,2
 Lysinoalanine
 Formed during alkaline processing1,2
 Phytoestrogens
 Dietary bioflavonoids may contribute to infantile leukemia3
 Genistein may be largely responsible for the development to
Infantile Acute Leukemia (IAL)4
 Genistein5,6 or soy phytoestrogens7,8 may stimulate proliferation of
breast cancer cells
 “According to their concentration in vitro genistein and daidzein
can slow up or stimulate the growth of tumorous cells” 9
1.
2.
3.
4.
5.
Life Sciences Research Office, 1979
Rackis, Qual Plant Foods Hum Nutr, 1985
Strick R et al, PNAS, 2000
Abe T, Leukemia, 1999
Dees C et al, Environ Health Perspect, 1997
6. Hsieh CY et al, Cancer Res, 1998
7. McMichael-Phillips DF et al, Am J Clin
Nutr, 1998
8. Martin PM et al, Endocrinology, 1978
9. Tonz O et al, Paediatricia, 1997
2.4. Aluminum
2.4.1. Exposure Estimates
2.4.2. Safety Issues
2.4. Aluminum
2.4.1. Exposure Estimates
Feeding
Aluminum
Content
(mug/L)1
Plasma Aluminum
Concentration
(mug/L)2
Human milk
4-65
8.6
Standard cow milk-based
formulas, 20 or 24 calories/oz
15-400
9.2
Soy-based formula
500-2400
12.5
Premature infant formula
100-900
9.7
Mean plasma aluminum concentration in soy-based formula fed infants is
45% higher than breastfed children, and 36% higher than infants fed cow
milk-based formulas
1. American Academy of Pediatrics, Pediatrics, 1996
2. Hawkins NM et al, J Pediatr Gastroenterol Nutr, 1994
2.4. Aluminum
2.4.2. Safety Issues
 Concerns associated with increased aluminum intake from
soy-based infant formula:



Interferes with a variety of cellular and metabolic processes in the nervous
system and in other tissues 1
Increased aluminum deposition in CNS 2
Osteopenia2
 Infants at increased risk of aluminum toxicity2



Preterm infants
Children with renal failure
Infants with intrauterine growth retardation
1. American Academy of Pediatrics, Pediatrics, 1996
2. Koo WWK et al, J Am Coll Nutr, 1988
2.5. Manganese
2.5.1. Exposure Estimates
2.5.2. Safety Issues
2.5. Manganese
2.5.1. Exposure Estimates
Milk
Manganese Content (µg/L)1
Breast milk
10
Cow’s milk-based formula
150
Soy milk-based formula
250
Mangnaese content of soy-based infant formula is 2400%
than that of breastmilk
1. Position of the United Soybean Board: Manganese and Soy-Based Infant Formula
2.5. Manganese
2.5.2. Safety Issues
 Human Studies
 May be present at higher levels in hair of hyperactive children and
children with learning disabilities compared with levels in normal
children1
 Chronic manganese exposure associated with poor verbal and
visual memory2
 Animal Studies
 Accumulates in the brains of animals exposed at young ages3
 Exposure to young animals can cause neurodegenerative changes4
 Neonatal manganese exposure is related to neurocognitive and
developmental deficits in rodent5
1.
2.
3.
4.
5.
Collip PJ et al, Ann Nutr Metab, 1983
Woolf A et al, Enviro Health Perspect, 2002
Dorman DC et al, J Appl Toxicol, 2000
Pappas BA et al, Neurotoxicol and Teratol, 1997
Tran TT et al, NeuroToxicol, 2002
2.6. Allergicinity of Soy
Soy is a potent allergen1
 Soy is at least as antigenic as cow's milk protein2,3
 Up to 40% of infants intolerant of cow's milk also develop soy protein
intolerance4
 Soy protein can cause intolerance reactions with gastrointestinal
symptoms & acute anaphylaxis4

Feeding soy formula from birth in infants at increased risk of
developing allergy does not have a beneficial effect2,3,5

1. Tonz O et al, Paediatricia, 1997
2. Eastham EJ et al, J Pediatr, 1978
3. Miskelly FG et al, Arch Dis Child, 1988
4. Hill DJ et al, Clin Rev Allergy, 1984
5. Gruskay FL et al, Clin Paediatr, 1982
2.7. Genetically-Modified (GM) Soy
 GM soy might contain:


Lower levels of phytoestrogens by 12-14%1
Higher trypsin inhibitor levels2,3







1.
2.
3.
4.
5.
By 27% in raw RR soy
By 18% in toasted RR soy
Lower choline levels in lecithin by 29%3
Lower levels of phenylalanine3
Double the amount of lectins (hemaglutinin)3
An additional segment of DNA4
Higher concentration of the herbicide glyphosate5
Lappé MA et al, J Med Food, 1999
Padgette SR, J Nutr, 1999
Keeler B, Los Angeles Times, 2001
Palevitz, The Scientist, 2000
Masaharu, Nagoya University, Japan, 2001
3. Position of Various Regulators
1. American Academy of Pediatrics
2. Australian College of Paediatrics
3. Food Safety Authority of Ireland
4. Joint Working Group of Canadian Paediatric Society
Nutrition Committee, Dietitians of Canada, and Health
Canada
5. New Zealand Ministry of Health
6. Swiss Federal Commission on Food
7. United Kingdom Health Authorities
3.1. American Academy of Pediatrics
 Soy-based formulas are safe and effective alternatives:
Term infants whose nutritional needs are not met from breast
milk or cow-based formula


Galactosemia and hereditary lactase deficiency

Parents seeking a vegetarian diet for term infant

Most infants with Ige-mediated allergy to cow milk protein
American Academy of Paediatrics, Paediatrics, 1998
3.1. American Academy of Pediatrics- con’d
 Soy-based formulas have no proven value in:
 Management of acute gastroenteritis for most previously-well
infants
 Prevention or management of infantile colic
 Prevention of atopic disease in healthy or high-risk infants
 Cow milk protein-induced enteropathy or enterocolitis

Soy-based formulas not designed or recommended for:
Infants with documented cow milk protein-induced enteropathy or
enterocolitis
 Preterm infants who weigh <1800 g

3.2. Australian College of Paediatrics

Soy formula is not to be indiscriminately used:
In infants with vague symptoms and signs not proven to be due to
cow’s milk protein intolerance

As prophylaxis in infants thought to be at risk of developing
allergy


Soy formula may be appropriately prescribed for:
Galactosemia
 Lactose intolerance

 The use of soy-based infant formula may not be without
side effects:
Its use may impair immunity
 The long-term effects of soy (e.g. aluminum and phytoestrogens)
are unknown

The Australian College of Paediatrics, J Paediatr Child Health, 1998
3.3. Food Safety Authority of Ireland
 Soy-based
infant formula can be used under medical
supervision for the treatment of:



Transient lactose intolerance
Galactosemia
IgE mediated cow’s milk allergy
 Soy-based
infant formula can be used under medical
supervision in infants whose parents wished to feed their
child a vegetarian diet
 Soy-based formula is not recommended for:
 Routine use in infants
 Preterm infants
 Cows’ milk protein induced enterocolitis or enteropathy
 Treatment colic
 Atopic disease
Food Safety Authority of Ireland, Recommendations for a national feeding policy, 1999
3.4. Joint Working Group of Canadian
Paediatric Society Nutrition Committee,
Dietitians of Canada, and Health Canada
 Restrict use of soy-based formulas only for infants who:
 “Cannot be fed dairy-based products for health, cultural or
religious reasons, including galactosemia or a vegan lifestyle”

Soy-based infant formula not recommended:
In the management of infants with an allergy to cows’ milk protein
 For the prevention of atopic diseases

Health Canada, Nutrition for Healthy Term Infants, 1998
3.5. New Zealand Ministry of Health
 Soy formula may be appropriately prescribed only for:
 Proven cow’s milk protein intolerance or allergy
 Lactose intolerance
 Galactosemia
Potential interaction between soy infant formula and
thyroid function to be considered:

Thyroxine replacement should be monitored closely
 Assessment of thyroid function should be considered if
satisfactory growth and development is not achieved or maintained

New Zealand Ministry of Health, Soy based infant formula, 1998
3.6. Swiss Federal Commission on Food
 Use of soya-bean products as baby foods should be
made “very restrictive” and is allowed only in a few
medical conditions:
Lactose intolerance
 Galactosemia
 (Possibly) Cow’s milk allergy

 Soya-bean products should not be used:
Routinely in preparation of food for healthy babies
 For ecological, ideological or ethical reasons

 “Hydrolyzed or lactose-free products are probably
better than those based on the soya bean”
1. Tonz O et al, Paediatricia, 1997
3.7. United Kingdom Health Authorities
 United Kingdom Department of Health - 1996
Breastfeeding is the best feeding choice and cow’s milk formulae
are preferable for most bottle-fed babies.

Babies being fed soya-based formula on a healthcare professional’s
advice should continue to do so

Babies being fed soya-based formula by choice of parents should
continue to so so, but parents should seek the advice of a healthcare
professional.

 Food Advisory Committee - 1996
Infant formulae manufacturers should investigate ways to reduce
the levels of phytoestrogens in soy-based infant formula

1. Department of Health, London, UK, 1996
2. MAFF, London, UK 1996
3.7. United Kingdom Health Authorities- con’d
Scientific Advisory Committee on Nutrition, 20031

Considers that “there is cause for concern about the use of soybased infant formula. Additionally, there is neither substantive
medical need for, nor health benefit arising from, the use soybased infant formulae.”
 Working Group of the Committee on Toxicity of
Chemicals in Food, Consumer Products and the
Environment (COT)1 – 2003

Recommends to amend the advise of the Department of Health
to read as follows: “…soy-based infant formulae be fed to infants
only when indicated clinically.”
1. Working Group of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment, 2003
http://www.food.gov.uk/multimedia/pdfs/2003-03.pdf
 “The
use of soy formulas as a
large, uncontrolled, and basically
un-monitored human infant
experiment continues unabated”.
Dr. Daniel Sheehan
National Center for Toxicological
Research of the USFDA