Suha Khoury, RD

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(No Transcript)
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Soy-based Infant Formula Concerns and
Recommendations
Suha Khoury, RD
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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

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Topics of Discussion

• Historical background
• Safety issues and potential adverse effects
• Views of regulatory bodies

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1. Historical Background1
1909 First use of soy-based infant formula
1929 Soy-based formula was proposed for intolerance of cows milk
Mid 1960s Soy protein isolate (SPI) used instead of soy flour
Early 1970s Supplementation of soy-based formula with L-methionine
1. American Academy of Pediatrics Policy
Statement, Pediatrics, 1998
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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)
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2.1. Nutritional Adequacy
2.1.1. Presence of soy phytates
2.1.2. Presence of protease inhibitors
2.1.3. Other nutritional factors
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2.1.1. Soy Phytates

• Soybean contains highest phytic acid content of
  all legumes 1
• soy protein isolate formulas still contain
  1.5 phytates2
• 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 formula2
• 30 phosphorus bound to phytates2
• Soy infant formula may result in decreased bone
  mineralization 3,4,5
• 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

Chitra U et al, Plant Foods Hum Nutr, 1995 American Academy of Pediatrics Policy Statement, Pediatrics, 1998 Steichen et al, J Pediatr, 1987 Chan et al, Am J Dis Child, 1987 Hillman et al, J Pediatr, 1988 Sandstrom et al, Am J Dis Child, 1983 Lönnerdal B et al, Am J Clin Nutr, 1999 Davidsson L et al, Am J Clin Nutr, 1995 Davidsson L et al ,Pediatr Res, 1994 Rackis J, J Am Oil Chem Soc, 1974
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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

• 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

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2.1.3. Additional Factors

• Protein quality
• Soy protein contains only 1/3 of available
  nitrogen as essential or semi-essential amino
  acids1
• Soy is not as good a protein source as cow's
  milk2
• 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 habits2
• Low in chloride
• Reported cases of hypochloraemic alkalosis7

Graham GC et al, Am J Dis Child, 1970 U.S. Food and Drug Administration, http//www.fda.gov/fdac/features/596_baby.html Liener IE, Crit Rev Food Sci Nutr, 1994 4. Liu K, Soybeans Chemistry, Technology, and Utilization, 1997 Pond WG, Proc Soc Biol Med, 2000 Owen CG et al, Pediatrics, 2002 Linshaw MA et al, J Pediatr, 1980
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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

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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 receptors1

Three main classes of phytoestrogens Three main classes of phytoestrogens
Isoflavones Soybeans and soy products Soybeans and soy products
Lignans Rye, wheat, sesame seeds, flax Rye, wheat, sesame seeds, flax
Coumestans Vegetables bean sprouts, red clover, sunflower seeds 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
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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
Total genistein and derivatives Total diadzein and derivatives Total glycitein and derivatives Brands of soy-based infant formula A- ProSobee Soy Formula (powder) B- Farleys Soya Formula C- Isomil D- SMA Wysoy E- Cow Gate Infasoy

1. Murphy PA, J Agric Food Chem, 1997

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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
http//westonaprice.org/soy/birthcontrolbabies.html Chen J et al, Diet, Lifestyle and Mortality in China, 1990 USDA-Iowa State University Database on the Isoflavone Content of Foods, 1999 Fukutake M et al, Food Chem Toxicol, 1996 Nagata C et al, J Nutr, 1998 Nakamura Y et al, J AOAC Int, 2000 Ishizuki et al, Nippon Naibunpi Gakkai Zasshi, 1991 Cassidy A et al, Am J Clin Nutr,1994 McMichael-Phillips DF et al, Am J Clin Nutr 1998 Federal Register, October 1999 Setchell KD et al, Am J Clin Nutr, 1998
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2.2.3. Isoflavones Exposure Estimates -cont A
Country of Study on Soy-based Infant Formula No. Brands analyzed Total isoflavone level (mg/L) Estimated isoflavone intake (mg/kg bw/day) 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
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 LOffice Federal de la Santé Publique,1992
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2.2.3. Isoflavones Exposure Estimates1- cond B
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
Amount of Isoflavone kg-1 body weight-1
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2.2.4. Bioavailability of Phytoestrogens

• Plasma concentration1,2
• Circulating concentrations of isoflavones in
  seven infants fed soy-based 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, 19972. Setchell KD,  Am
J Clin Nutr, 19983. Cruz et al, Pediatr Res, 1994
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2.2.5. Adverse Effects of Phytoestrogens

• 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)

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A.1. Effects on Thyroid Gland in Infants
2.2.5. Adverse Effects of Phytoestrogens A.
Thyroid Gland

• 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
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A.2. Effects on Thyroid Gland in Adults
2.2.5. Adverse Effects of Phytoestrogens A.
Thyroid Gland
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

1. Duncan et al, J Clin Endocrinol Metab, 1999a
2. Duncan et al, J Clin Endocrinol Metab, 1999b
3. Persky et al, Am J Clin Nutr, 2002 Levy et al
   Proc Soc Exp Biol Med, 1995
4. Ishizuki Y et al, Nippon Naibunpi Gakkai Zasshi,
   1991
5. Bell DS et al, EndocrPract, 2001

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A.3. Possible Mechanisms of Action1
2.2.5. Adverse Effects of Phytoestrogens A.
Thyroid Gland

• 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 13350(9080)815-6

1. Committee on Toxicity of Chemicals in Food,
Consumer Products and the Environment- Working
Group on Phytpestrogens, UK
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B. Effects on Development and Fertility
2.2.5. Advert Effects of Phytoestrogens
Participants Diet Results
Adults between ages of 20-341 Formula as infants cow-based or soy-based 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
Strom BL et al, JAMA, 2001 Cassidy A et al,  Am J Clin Nutr, 1994 Watanabe S et al, Biofactors, 2000 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
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C. Effects on the Immune System
2.2.5. Adverse Effects of Phytoestrogens
Participants Diet Effect
Women of ages 20-341 Formula when infants cow-based or soy-based Soy-based formula associated with more use of allergy and asthma drugs
Infants2 Soy-based infant formula Reduced levels of antibodies in response to routine immunizations Increase in upper respiratory infections and bronchitis
Infants3 Soy-protein infant formula Immune proteins decreased Greater impairment in T cell function
Women4 Synthetic isoflavone derivative Depressed lymphocytes

1. Strom BL et al, JAMA, 2001
2. Zoppi G et al, Lancet, 1983
3. Zoppi G et al, J Pediatr Gastroenterol Nutr,
   1982
4. Alexandersen P, JAMA, 2001

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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 Small improvements in tests of short and long term memory Mental flexibility More restraintment in a self-assessment of mood

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

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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 cells9

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 Hsieh CY et al, Cancer Res, 1998 McMichael-Phillips DF et al, Am J Clin Nutr, 1998 Martin PM et al, Endocrinology, 1978 Tonz O et al, Paediatricia, 1997
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2.4. Aluminum
2.4.1. Exposure Estimates 2.4.2. Safety Issues
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2.4. Aluminum2.4.1. 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

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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

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2.5. Manganese
2.5.1. Exposure Estimates 2.5.2. Safety Issues
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2.5. Manganese2.5.1. Exposure Estimates
Milk Manganese Content (µg/L)1
Breast milk 10
Cows 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
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2.5. Manganese2.5.2. 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. Collip PJ et al, Ann Nutr Metab, 1983
2. Woolf A et al, Enviro Health Perspect, 2002
3. Dorman DC et al, J Appl Toxicol, 2000
4. Pappas BA et al, Neurotoxicol and Teratol, 1997
5. Tran TT et al, NeuroToxicol, 2002

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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
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2.7. Genetically-Modified (GM) Soy

• GM soy might contain
• Lower levels of phytoestrogens by 12-141
• Higher trypsin inhibitor levels2,3
• By 27 in raw RR soy
• By 18 in toasted RR soy
• Lower choline levels in lecithin by 293
• Lower levels of phenylalanine3
• Double the amount of lectins (hemaglutinin)3
• An additional segment of DNA4
• Higher concentration of the herbicide glyphosate5

1. Lappé MA et al, J Med Food, 1999
2. Padgette SR, J Nutr, 1999
3. Keeler B, Los Angeles Times, 2001
4. Palevitz, The Scientist, 2000
5. Masaharu, Nagoya University, Japan, 2001

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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
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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
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3.1. American Academy of Pediatrics- cond

• 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 lt1800 g

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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 cows 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
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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 cows 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
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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
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3.5. New Zealand Ministry of Health

• Soy formula may be appropriately prescribed only
  for
• Proven cows 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
41
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) Cows 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

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3.7. United Kingdom Health Authorities

• United Kingdom Department of Health - 1996
• Breastfeeding is the best feeding choice and
  cows milk formulae are preferable for most
  bottle-fed babies.
• Babies being fed soya-based formula on a
  healthcare professionals 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
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3.7. United Kingdom Health Authorities- cond

• Scientific Advisory Committee on Nutrition, 20031
• Considers that there is cause for concern about
  the use of soy-based infant formula.
  Additionally, there is neither substantive
  medical need for, nor health benefit arising
  from, the use soy-based 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/multimedi
a/pdfs/2003-03.pdf
44

• 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