Suha Khoury, RD

Soy-based Infant Formula: Concerns

and Recommendations

Purpose of PresentationPurpose 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 DiscussionTopics of Discussion

1.1. Historical backgroundHistorical background

2.2. Safety issues and potential adverse effectsSafety issues and potential adverse effects

3.3. Views of regulatory bodiesViews of regulatory bodies

1. Historical Background1. Historical Background11

1. American Academy of Pediatrics Policy Statement, Pediatrics, 1998

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 L-methionine

2. Safety Issues and Potential Adverse 2. Safety Issues and Potential Adverse EffectsEffects

2.1. 2.1. Nutritional adequacyNutritional adequacy

2.2. 2.2. Presence of phytoestrogensPresence of phytoestrogens

2.3. 2.3. Presence of potential carcinogensPresence of potential carcinogens

2.4. 2.4. Aluminum contentAluminum content

2.5. 2.5. Manganese contentManganese content

2.6. 2.6. Allergicinity of soyAllergicinity of soy

2.7. 2.7. The use of genetically modified (GM) soy The use of genetically modified (GM) soy protein isolate (SPI)protein isolate (SPI)

2.1. Nutritional Adequacy2.1. Nutritional Adequacy

2.1.1. 2.1.1. Presence of soy phytatesPresence of soy phytates

2.1.2. 2.1.2. Presence of protease inhibitors Presence of protease inhibitors

2.1.3. 2.1.3. Other nutritional factorsOther nutritional factors

2.1.1. Soy Phytates2.1.1. 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

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

1. Chitra U et al, Plant Foods Hum Nutr, 19952. American Academy of Pediatrics Policy

Statement, Pediatrics, 19983. Steichen et al, J Pediatr, 1987 4. Chan et al, Am J Dis Child, 19875. Hillman et al, J Pediatr, 1988

6. Sandstrom et al, Am J Dis Child, 19837. Lönnerdal B et al, Am J Clin Nutr, 19998. Davidsson L et al, Am J Clin Nutr, 19959. Davidsson L et al ,Pediatr Res, 199410. Rackis J, J Am Oil Chem Soc, 1974

2.1.2. Protease Inhibitors 2.1.2. Protease Inhibitors

1. American Academy of Peditrics Policy Statement, Pediatrics, 19982. Rackis et al, Qual Plant Foods Hum Nutr, 19853. Miyagi Y et al, J Nutr Sci Vitaminol, 19974. Liener IE , Arch Latinoam, Nutr, 19965. Liener IE, J Nutr,1995

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

2.1.3. Additional Factors2.1.3. Additional Factors

1. Graham GC et al, Am J Dis Child, 19702. U.S. Food and Drug Administration,

http://www.fda.gov/fdac/features/596_baby.html3. Liener IE, Crit Rev Food Sci Nutr, 1994

4. Liu K, Soybeans: Chemistry, Technology, and Utilization, 1997

5. Pond WG, Proc Soc Biol Med, 20006. Owen CG et al, Pediatrics, 20027. Linshaw MA et al, J Pediatr, 1980

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 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

2.2. Phytoestrogens2.2. Phytoestrogens

2.2.1. 2.2.1. DefinitionDefinition

2.2.2. 2.2.2. The Main Isoflavones in Soy-Based Infant The Main Isoflavones in Soy-Based Infant FormulaFormula

2.2.3. 2.2.3. Exposure EstimatesExposure Estimates

2.2.4. 2.2.4. Bioavailability of IsoflavonesBioavailability of Isoflavones

2.2.5. 2.2.5. Adverse Effects of Phytoestrogens on HealthAdverse Effects of Phytoestrogens on Health

2.2.1. Definition of 2.2.1. Definition of PhytoestrogenPhytoestrogen

1. Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment- Working Group on Phytpestrogens, UK

“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

2.2.2. The Main Isoflavones in Soy 2.2.2. The Main Isoflavones in Soy FormulasFormulas11

0

10

20

30

40

50

60

70

% is

ofla

vono

id a

glyc

one

equi

vale

nts

A B C D E

1. Murphy PA, J Agric Food Chem, 1997

% Total genistein and derivatives

% Total diadzein and derivatives

% Total glycitein and derivatives

Brands of soy-based infant formula

A- ProSobee Soy Formula (powder)

B- Farley’s Soya FormulaC- IsomilD- SMA WysoyE- Cow &Gate Infasoy

Percentage Distribution of Total Isoflavone Equivants of the Three Main Isoflavonoids (i.e. Genistein, Diadzein, and Glycetein), their Glucosides, their Acetyl and Malonyl Derivatives

2.2.3. Isoflavones Exposure 2.2.3. Isoflavones Exposure EstimatesEstimates11

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 infants1. http://westonaprice.org/soy/birthcontrolbabies.html

2. Chen J et al, Diet, Lifestyle and Mortality in China, 19903. USDA-Iowa State University Database on the Isoflavone

Content of Foods, 19994. 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,

19918. Cassidy A et al, Am J Clin Nutr,19949. McMichael-Phillips DF et al, Am J Clin Nutr

1998 10. Federal Register, October 199911. Setchell KD et al, Am J Clin Nutr, 1998

2.2.3. Isoflavones Exposure Estimates -2.2.3. Isoflavones Exposure Estimates -con’t Acon’t 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 month2 months4 months

Austrlia4 4 17-22 NA

United Kingdom 5

6 18-41 5.0 4.5

1-2 months4-6months

Switzerland6 N/A N/A 6-20 N/A1. Setchell KD et al, Am J Clin Nutr, 19982. 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, 19977. Bulletin de L’Office Federal de la Santé Publique,1992

100 mg isoflavones = 1 contraceptive pill7

2.2.3. Isoflavones Exposure 2.2.3. Isoflavones Exposure EstimatesEstimates11- - con’d Bcon’d B

0 1 2 3 4 5 6 7 8 9 10 11 12 13

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 kgAmount of Isoflavone kg-1-1 body weight body weight-1-1

2.2.4. Bioavailability of 2.2.4. Bioavailability of PhytoestrogensPhytoestrogens

1. Setchell KD, Lancet, 19972. Setchell KD,  Am J Clin Nutr, 19983. Cruz et al, Pediatr Res, 1994

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

2.2.5. Adverse Effects of 2.2.5. Adverse Effects of PhytoestrogensPhytoestrogensA.A. Thyroid GlandThyroid Gland

A.1. A.1. InfantsInfants A.2. A.2. AdultsAdults A.3. A.3. Possible Mechanisms of Action Possible Mechanisms of Action B.B. Sexual Development and Fertility Sexual Development and Fertility C.C. Immune System Immune SystemD.D. Central Nervous System (CNS) Central Nervous System (CNS)

A.1. Effects on Thyroid Gland in InfantsA.1. Effects on Thyroid Gland in Infants

1. Hydovitz JD, N Engl J Med, 19602. Shepard TH et al, N Engl J Med, 19603. Van Wyk JJ et al, Pediatrics, 19594. Fomon SJ, Nutrition of normal infants, 1993

5. Jabbar et al, J Am Coll Nutr, 19976. Fort P et al, J Am Coll Nutr, 19907. Lanes et al, J Am Coll Nutr, 1986

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

A.2. Effects on Thyroid Gland in AdultsA.2. Effects on Thyroid Gland in Adults

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, 1999a2. Duncan et al, J Clin Endocrinol Metab, 1999b3. Persky et al, Am J Clin Nutr, 2002 Levy et al Proc Soc Exp Biol Med, 19954. Ishizuki Y et al, Nippon Naibunpi Gakkai Zasshi, 19915. Bell DS et al, EndocrPract, 2001

2.2.5. Adverse Effects of PhytoestrogensA. Thyroid Gland

A.3. Possible Mechanisms of ActionA.3. Possible Mechanisms of Action11

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. Adverse Effects of PhytoestrogensA. Thyroid Gland

B. Effects on Development and B. Effects on Development and FertilityFertility

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

2.2.5. Advert Effects of Phytoestrogens

1. Strom BL et al, JAMA, 20012. 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, 19866. Wisniewski AB et al, J Urol, 2003

C. Effects on the Immune SystemC. Effects on the Immune System

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

2.2.5. Adverse Effects of Phytoestrogens

1. Strom BL et al, JAMA, 20012. Zoppi G et al, Lancet, 19833. Zoppi G et al, J Pediatr Gastroenterol Nutr, 19824. Alexandersen P, JAMA, 2001

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

D. Effects on the CNSD. Effects on the CNS

1. Yakisich JS et al, Exp Neurol, 1999 2. White LR et al, J Am Coll Nutr, 20003. File SE et al, Psychopharmacol, 2001

2.2.5. Potential Effects of Phytoestrogens

2.3. Presence of Pontential 2.3. Presence of Pontential CarcinogensCarcinogens

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. Life Sciences Research Office, 19792. Rackis, Qual Plant Foods Hum Nutr, 19853. Strick R et al, PNAS, 20004. Abe T, Leukemia, 19995. Dees C et al, Environ Health Perspect, 1997

6. Hsieh CY et al, Cancer Res, 19987. McMichael-Phillips DF et al, Am J Clin

Nutr, 1998 8. Martin PM et al, Endocrinology, 1978 9. Tonz O et al, Paediatricia, 1997

2.4.1. 2.4.1. Exposure EstimatesExposure Estimates

2.4.2. 2.4.2. Safety IssuesSafety Issues

2.4. Aluminum

2.4. Aluminum2.4. Aluminum2.4.1. Exposure Estimates2.4.1. 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

1. American Academy of Pediatrics, Pediatrics, 1996

2. Hawkins NM et al, J Pediatr Gastroenterol Nutr, 1994

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

2.4. Aluminum 2.4. Aluminum 2.4.2. Safety Issues2.4.2. 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, 19962. Koo WWK et al, J Am Coll Nutr, 1988

2.5.1. 2.5.1. Exposure Exposure Estimates Estimates 2.5.2. 2.5.2. Safety Safety IssuesIssues

2.5. Manganese

2.5. Manganese2.5. Manganese2.5.1. Exposure Estimates2.5.1. Exposure Estimates

1. Position of the United Soybean Board: Manganese and Soy-Based Infant Formula

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

2.5. Manganese2.5. Manganese2.5.2. Safety Issues2.5.2. Safety Issues

1. Collip PJ et al, Ann Nutr Metab, 1983 2. Woolf A et al, Enviro Health Perspect, 20023. Dorman DC et al, J Appl Toxicol, 20004. Pappas BA et al, Neurotoxicol and Teratol, 19975. Tran TT et al, NeuroToxicol, 2002

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

2.6. Allergicinity of Soy2.6. 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, 19972. Eastham EJ et al, J Pediatr, 19783. Miskelly FG et al, Arch Dis Child, 19884. Hill DJ et al, Clin Rev Allergy, 19845. Gruskay FL et al, Clin Paediatr, 1982

2.7. Genetically-Modified (GM) Soy2.7. Genetically-Modified (GM) Soy

1. Lappé MA et al, J Med Food, 19992. Padgette SR, J Nutr, 19993. Keeler B, Los Angeles Times, 20014. Palevitz, The Scientist, 20005. Masaharu, Nagoya University, Japan, 2001

GM soy might contain: Lower levels of phytoestrogens by 12-14%1

Higher trypsin inhibitor levels2,3 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

3. Position of Various Regulators3. Position of Various Regulators

1.1. American Academy of Pediatrics American Academy of Pediatrics

2.2. Australian College of Paediatrics Australian College of Paediatrics

3.3. Food Safety Authority of Ireland Food Safety Authority of Ireland

4.4. Joint Working Group of Canadian Paediatric Joint Working Group of Canadian Paediatric Society Nutrition Committee, Dietitians of Canada, Society Nutrition Committee, Dietitians of Canada, and Health Canada and Health Canada

5. 5. New Zealand Ministry of Health New Zealand Ministry of Health

6.6. Swiss Federal Commission on Food Swiss Federal Commission on Food

7.7. United Kingdom Health Authorities United Kingdom Health Authorities

3.1. American Academy of Pediatrics3.1. 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- 3.1. American Academy of Pediatrics- con’dcon’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 Paediatrics3.2. Australian College of Paediatrics

The Australian College of Paediatrics, J Paediatr Child Health, 1998

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

3.3. Food Safety Authority of Ireland3.3. Food Safety Authority of IrelandSoy-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 3.4. Joint Working Group of Canadian Paediatric Society Nutrition Paediatric Society Nutrition

Committee, Dietitians of Canada, and Committee, Dietitians of Canada, and Health CanadaHealth Canada

Health Canada, Nutrition for Healthy Term Infants, 1998

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

3.5. New Zealand Ministry of Health3.5. New Zealand Ministry of Health

New Zealand Ministry of Health, Soy based infant formula, 1998

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

3.6. Swiss Federal Commission on 3.6. Swiss Federal Commission on FoodFood

1. Tonz O et al, Paediatricia, 1997

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”

3.7. United Kingdom Health 3.7. United Kingdom Health AuthoritiesAuthorities

1. Department of Health, London, UK, 19962. MAFF, London, UK 1996

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

3.7. United Kingdom Health 3.7. United Kingdom Health Authorities- Authorities- con’dcon’d

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, 2003http://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