Transcript Infant Feeding: Human Milk, Formula and Transitions

Infant Feeding: Human Milk and
Formula
Infant Feeding: History and
Perspective
• Human Milk
• Human Milk
Substitutes
• Science, Medicine and
Industry
Feeding the Infant
• Considerations
– Infant (needs, tolerance,
acceptance, safety)
– Family preferences
– Cost and availability
– Prevention, health,
development, and
programming
Feeding the Infant
• Choices:
– Human Milk
– Standard Infant Formula (Cow,
Soy)
– Hypoallergenic (hydrolysates
vs. amino acid based
– Other specialty formulas
– Beikost/solids/table foods
History
Human milk substitutes
Health and welfare Programs
Formula Industry
Human Milk Substitutes
• Early evidence of artificial feeding
• Majority of infants received breast milk
– Maternal BF
– Wet nurses
• Wealthy women
• Orphans, abandoned, “illegitimate”
• Prematurity or congenital deformities
Wet Nurses
• Work demands, societal needs, vanity, health requirements,
social diversion
• Proper selection: Questionable character-- Infant would
suck in her vices
• Wet Nurse Industry: emerging infant mortality/abuse
• Impact of industrial revolution: Wet nurses made better
money in factories
Human Milk Substitutes: Infant
Mortality
• Artificial feeding in first weeks of life
associated with 100% mortality
• 19th century infant mortality with “hand
feeding” was 88%
• Foundlings: 80%
• In Dublin Foundling hospital 1775-96: 99.6%
Science, Medicine, and Industry
Growth of child
Health and
welfare in early
20th century
Science, Medicine, and Industry
• Infant Morbidity and
Mortality
• Recognition of association
with human milk
substitutes, and infection
• Industrial development
– Storage
– Safety
– Food industry
Human Milk Substitutes
• 1920-1950’s: evaporated or fresh cow’s milk,
water and added CHO (prepared at home)
• 1950’s to present commercially prepared
infant formulas have replaced home recipes
Infant Formulas - History
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Cow’s milk is high in protein, low in CHO,
results in large initial curd formation in gut if
not heated before feeding
Early Formulas
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–
from 1920-1950 majority of non-breastfed infants received
evaporated milk formulas boiled or evaporated milk solved
curd formation problems
cho provided by corn syrup or other cho to decrease
relative protein kcals
Historical timeline
• 1900
– Pasteurization of milk
in US
– Association between
bacteria and diarrhea
• 1912
– U.S Children’s Bureau
– Public Health and
Pediatricians efforts to
improve infant/child
health and decrease
mortality
• 1920
– Intro evaporated milk
– Cod liver oil prevents
rickets
– Curd tension of milk
altered
– Increased availability
of refrigeration
– Vitamin C isolated
– Vitamin D prepared in
pure form
– Improved sanitation
Historical timeline
• 1940
– Homogenized milk
widely marketed
• 1960
– Further advances in
technology and
packaging
– Commercially prepared
infant formula becoming
increasingly popular
Interesting Milestones in Infant Nutrition
• 1784: Underwood
recommends cows milk as
alternative to breast feeding
• 1800: glass feeding bottles
• 1838: Simon determines
protein CM>BM
• 1845: Pratt patents rubber
nipple
• 1856: Borden patents
condensed milk
• 1883: Meyenberg patents
evaporated goats milk
• 1885: Meigs analyses
human milk
Interesting Milestones in Infant Nutrition
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1911: MJ introduces Dextri-maltose
1915: SMA
1920: Franklyn (Similac)
1929: MJ markets Sobee, hypoallergenic
1930-60: Concentrated liquid, hydrolysed, elemental, and
ready to feed formulas introduced
• What now?
Interesting Milestones in Infant Nutrition
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1911: MJ introduces Dextri-maltose
1915: SMA
1920: Franklyn (Similac)
1929: MJ markets Sobee, hypoallergenic
1930-60: Concentrated liquid, hydrolysed, elemental, and
ready to feed formulas introduced
• What now?
Infant Formula - History, cont.
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50s and 60s commercial formulas replaced home
preparation
1959: iron fortification introduced, but in 1971 only
25% of infants were fed Fe fortified formula
Cow’s milk feedings started in middle of first year
between 1950-1970s. In 1970 almost 70% of infants
were receiving cow’s milk.
• “No two hemispheres of any
learned professor’s brain are
equal to two healthy
mammary glands in the
production of a satisfactory
food for infants”
- Oliver Wendell Holmes
Human Milk
• Complements infant Immaturity
• Promotes maturation
– Epithelial growth factors and hormones
– Digestive enzymes - lipases and amylase
Characteristics and Advantages of
Human Milk
• Low renal solute load
• Immunologic, growth and trophic factors
– Decrease illness, infection, allergy
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Improved digestion and absorption
Nutrient Composition: CHO, Protein, Fatty Acid, etc
Cost
Other
Human Milk
• Colostrum
– Higher concentration of protein and antibodies
– Transitions around days 3-5
– Mature by day 10
Human Milk
• Nutrient composition of human milk is
remarkable for its variability, as the content of
some of the nutrients change during lactation,
throughout the day, or differ among women,
while the content of some nutrients remain
relatively constant throughout lactation.
Role of Human Milk Components in GI Development: Current
Knowledge and Future Needs: Donovan J Pediatr
2006:149:S49-S61
“ existing clinical and epidemiological studies support a
developmental advantage for breastfeeding. However, our
understanding of the mechanisms by which HM components
exert their actions within the human infant are limited by the
large number of bioactive compounds in milk and the
complexity of the potential interactions among the
components and with the developing intestine”
Human Milk Compartments
• Aqueous Phase
– Ca, Mg, Ph, Na, Cl, CO2, casein proteins, whey proteins
(lactoalbumin, lactoferrin, IgA, lysozyme, albumin) Lactose,
amino acids, water soluble vitamins
• Colloidal Dispersion
– Caseins, Ca, Ph
• Fat emulsion
– Fat (phospholipid, TG, cholesterol) protein as fat globule
membrane, enzymes, trace minerals, fat soluble vitamins,
macrophages, neutrophils, lymphocytes
Milk Synthesis
• Mammary gland contains stem cells and
highly differentiated secretory alveolar cells at
the terminal ducts. Stimulated by insulin and
HGH synergized by prolactin, these cells are
active in milk synthesis and secretion
Milk synthesis and secretion
• Exocytosis (protein, lactose, Ca/Ph, citrate)
• Fat synthesis (TG synthesized in cytoplasm and smooth
endoplasmic reticulum + precursors imported from maternal
circulation): alveolar cells synthesize SCFA
• Secretion of ions and water
• Immunoglobins transferred from extracellular
spaces
Paracellular Pathway (5th process)
• The paracellular spaces between alveolar cells
normally prevent transfer secondary to tight
junctions. If these spaces become “leaky”
plasma constituents may pass directly into the
milk.
Milk Synthesis and secretion
• Under neuroendocrine control that varies with timing and
stage of lactation
– Prolactin
– Lactogens
– Estrogen
– Thyroxine
– Growth hormone
– ACTH
– other
– Stimulus: infant suckling
Milk synthesis
• Protein: vast majority of proteins present in
human milk are specific to mammary
secretions and not identified in any quantity
elsewhere in nature:
– Immunoglobins transferred from plasma in early
stages of lactation
– De novo protein synthesis by mammary gland
Diet, milk production, and milk composition
• There is a great variation in milk composition during
a feed, from feed to feed, and even between breasts.
• The impact of dietary variation and milk composition
is unclear. Overall milk composition remains
relatively unaffected by diet variations although
there are reports to the contrary:
– DHA and ARA supplementation, vegan diet, drugs and
environmental contaminants,…..
Breast milk composition and Diet
• DHA levels of breast milk vary with diet. Increased amounts of
DHA have been found in the breast milk of mothers
consuming fish or fish oil, and with supplementation.
• Water soluble vitamins may vary with diet. Diets inadequate
in B12 or thiamin have been associated with case reports of
deficiency in infants. High intakes of Vitamin C, however, does
not appear to change the content of breast milk.
• Supplementation of fat soluble vitamins do not appear to
alter the content of breast milk
• Iron supplementation does not appear to alter the iron
content of breast milk
Influence of diet on milk composition
• Protein-energy malnutrition impacts milk volume.
Composition remains relatively unaffected
• Water soluble vitamins move readily from serum to
milk thus dietary fluctuations are more apparent
– B12 vegan, case report of beriberi…..
• Fat soluble vitamin content not improved with
supplementation
• Fatty acid composition (DHA and ARA) altered by
maternal diet and supplementation
Science and Lactation: Frank Hytten
• “ In general, it is probable that the breast has
a high priority for nutrients and that moderate
maternal under nutrition will have little effect
on milk production. But severe malnutrition,
which rarely exists without associated illhealth and other adverse circumstances, may
reduce milk yield”
Distribution of Kcals: Breast milk
% Protein
6
% Fat
52
% Carbohydrate
42
Protein:
Predominant protein of human milk is whey.
Casein/whey ratio is between 40:60 and 30:70
– Casein: proteins of the curd (low solubility at pH 4.6)
– Whey: soluble proteins (remain soluble at pH 4.6)
Lactalbumin
Lactoferrin
Secretory IgA
Lactoglobulin
Carbohydrate
• Predominant carbohydrate of breast milk is
lactose (7.3 g/dl)
• Oligosaccharides (1.2 g/dl)
– Prebiotics: nondigestible CHO that enhance the
growth of “favorable” bacteria and contribute to
the unique GI bacterial characteristics of BF infant
(bifidobacteria)
Fat
• 2.5- 4.5% Fat (provides approx 50% of calories)
• Contained in membrane enclosed milk fat globules
– Core: TG (98-99%of total milk fat)
– Membrane: phospholipids, cholesterol, protein
• DHA/ARA: wide variations
DHA/ARA concentration variation in human milk
• DHA: 0.1-1.4%
• ARA: 0.31- 0.71%
– DHA lowest in populations with high meat intake
and highest in populations with high fish intake
Breast milk and establishment of core
microbiome
• Definition: Full collection of microbes that
naturally exist within the body.
• Alterations or disruptions in core microbiome
associated with chronic illness: Crohns
disease, increased susceptibility to infection,
allergy, NEC, etc
Microbiome
• Beneficial effect for the host:
– Nutrient metabolism
– Tissue development
– Resistance to colonization with pathogens
– Maintenance of intestinal homeostasis
– Immunological activation and protection of GI
integrity
Human milk and microbiome
• Core microbiome established soon after birth
• Core microbiome of breastfeeding infant
similar to core microbiome of lactating mother
• Components of breast milk supporting
establishment of microbiome
– Prebiotics,probiotics
AAP Policy Statement: Breastfeeding and the use
of human milk
• AAP statement includes 15 recommendations
on Breastfeeding healthy term infants
including:
– Establish peripartum policies and practices
supporting breastfeeding
– Place infant skin to skin after delivery until first
feeding is accomplished
AAP Policy Statement:Recommendations
continued
– Supplements (water, glucose water, formula) should not be
given unless medically indicated
– Avoid pacifier during initiation (? Recent OHSU report)
– 8-12 feedings at the breast every 24 hours during early
weeks
– All newborn breastfeeding infants should be seen by HCP
at 3-5 days and again at 2-3 weeks of age
– All breast feeding infants should receive 200 (changed to
400) IU Vitamin D
AAP Policy Statement: Breastfeeding and the use
of human milk: Pediatrics 115 #2 2005
• Human milk is species specific and uniquely superior for infant
feeding
• Exclusive breastfeeding is the reference or normative model
against which all alternative methods must be measured in
regards to growth, development and health
• Research provides strong evidence that human milk feeding
decreases the incidence and/or severity of a number of
infectious diseases (meningitis, Otitis media, UTIs, Respiratory
tract infections, NEC, diarrhea)
AAP Policy Statement: Breastfeeding and the use
of human milk:
• Contraindications to breastfeeding
– Galactosemia
– Maternal use/exposure to certain radioactive or
chemotherapeutic agents
– Maternal abuse of “street drugs”
– Active HSV lesions of breast
– Maternal HIV (in USA)
AAP Policy Statement: Breastfeeding and
the use of human milk:
• Some studies suggest decreased incidence of SIDS, diabetes
(type 1 and 2), leukemia, obesity, hypercholesterolemia, and
allergy (asthma and atopy)
• Breastfeeding has been associated with slightly enhanced
performance on tests of cognitive development.
Newborn Visit: Breastfeeding
• Maternal care
– rest
– fluids
– relieving breast engorgement
– caring for nipples
– eating properly
• Follow-up support from the health
professional by telephone, home visit, nurse
visit, or early office visit.
Cautionary Tales
• Cooper et al. Pediatrics 1995. Increased incidence of
severe breastfeeding malnutrition and hypernatremia
in a metropolitan area.
• Rolf et al. ACTA Paediatrica 2009. A nationwide study
on hospital admissions due to dehydration in
exclusively breastfed infants in the Netherlands:its
incidence, clinical characteristics, treatment and
outcome
• Lozoff et al. J Pediatrics 2009 Higher Infant Blood Levels
with Longer Duration of Breastfeeding
Cooper.
• 5 breastfed infants admitted to Children’s hospital in
Cincinnati over 5 months period for breastfeeding
malnutrition and dehydration
– Age of admission: 5-14 days
– Weight loss at admission 23%, range 14-32%
– Serum Na: 186 mmol/L, range 161-214 (136-143 wnl)
– mothers were between the ages of 28 and 38, had prepared for breastfeeding
– 3 had inverted nipples and reported latch-on problems before discharge
– 3 families had contact with health care providers before readmission including
calls to PCP and home visit by PHN
Rolf
• Survey to determine incidence and characteristics of hospital
admission due to dehydration
• Dutch Paediatric Surveillance Unit 2003-2005 of all hospital
admissions during 1st 3 months in fully breast fed infants
• 250 reported cases.
• N= 158 (excluded cases with incomplete information or coexisting medical conditions accounting for hospitalization
Lozoff
• Our findings support the conclusions… “that this
phenomenon constitutes a potential public health problem in
areas where environmental lead exposure is continuing as
well as where environmental lead exposure has recently
declined”… Our findings do not detract from the many known
benefits of breastfeeding. Rather, they suggest that
monitoring lead concentrations in breastfed infants should be
considered….
Formula Composition
• Breast Milk as “gold standard”
– Attempt to duplicate composition of breastmilk
– ? Bioactivity, relationship, function of all factors present
in breast milk
– ? Measure outcome: growth, composition, functional
indices
Formula Categories
• Standard
– Cows milk base
– Soy base
• Elemental
– Hydrolysates
– Amino acid pased
• Other Specialty Products
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–
–
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Metabolics
PM 60/40
Low fat/MCT
Premature feeding products
Formula Brands
• Ross
– Similac/Isomil/Alimentum
• Mead Johnson
– Enfamil/Prosobee/Enfacare
• Nestle
– Good Start
• Wyeth
– Generic in USA; Gold Brands; SMA
• SHS
– NeoCate, DuoCal
Distribution of Kcals
Formula
% Protein
9
% Fat
48
% Carbohydrate
42
Vitamin and Mineral content
• NAS/FDA
• Meet levels at typical volumes ingested by
infants (@ 24-32 ounces)
– i.e. RDA/DRI
Cow’s Milk Based Formula
• Commercial formula designed to approximate
nutrients provided in human milk
• Some nutrients added at higher levels due to less
complete digestion and absorption
Milk Based Formulas
• Standard 0-12 months
– Similac with iron
– Enfamil with iron
– Good Start
Essentials/Good Start
Supreme
– Wyeth Generic
• Standard 0-12 mos with
DHA/ARA
– Similac Advance with
iron
– Enfamil Lipil with iron
– Good Start Supreme
DHA/ARA
– Wyeth formulas
Protein
• Blend of whey and casein
proteins
• 8.2-9.6% total calories
– whey proteins of human and
cow’s milk are different and have
different amino acid profiles.
• Major whey proteins of
human milk are lactalbumin
(high levels of essential aa) ,
immunoglobulins, and
lactoferrin( enhances iron
transportation)
• Cow’s milk has low levels of
these proteins and high
levels of b lactoglobulin
Cow’s Milk Based Formula: Fat & CHO
• Fat: butterfat of cow’s milk is replaced with
vegetable fat sources to make the fatty acid profile of
cow’s milk formulas more like those of human milk
and to increase the proportion of essential fatty acids
• CHO: Lactose is the major carbohydrate in most
cows’ milk based formulas.
• Meets needs of healthy infants
Milk Based Pre and Probiotic
Supplemented
• Marketed to promote digestive health and
support healthy immune fx
• Probiotic
– Bifidus BL
• Gerber Good start Protect Plus
– Lactobacillus rhamosus
• Nutramigen Lipil with Enflora
• Prebiotic
– Galactooligosaccarides (GOS)
– Similac Advance Early Shield (Triple Shield), Enfamil
Premium, Generic Brands
Infant Formulas: AAP
• Cow’s milk based formula is recommended for
the first 12 months if breast milk is not
available
Soy Formulas
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•
•
First developed in 1930s with soy flour
Early formulas produced diarrhea and
excessive gas
Now use soy protein isolate with added
methionine
Soy Formulas
• Isomil/Isomil DF /Isomil
Advance/Isomil Advance 2
• Prosobee/Prosobee Lipil/Next Step
Prosobee
• Good Start Essentials Soy/Good Start
2 Essentials Soy
• Wyeth All iron fortified
Soy Formulas
• Protein: soy protein isolate with added
methionine
• Fat: vegetables oils
• CHO: usually corn based products
Soy Formulas
Characteristics compared to Milk Based
• Higher protein (lower quality)
• Higher sodium, calcium, and
phosphorus
• Carbohydrate: Corn syrup solids, sucrose,
and/or maltodextrin; lactose free
• Fats: Long chain
• Meet needs of healthy infants
American Academy of Pediatrics Committee on Nutrition. Soy Proteinbased Formulas: Recommendations for Use in Infant Feeding.
Pediatrics 1998;101:148-153.
• Soy formulas given to 25% of infants but needed by
very few
• Offers no advantage over cow milk protein based
formula as a supplement for breastfed infants
• Provides appropriate nutrition for normal growth
and development
• Indicated primarily in the case of vegetarian families
and for the very small number of infants with
galactosemia and hereditary lactase deficiency
Possible Concerns about Soy Formulas:
AAP
• 60% of infants with cowmilk protein induced enterocolitis will
also be sensitive to soy protein - damaged mucosa allows
increased uptake of antigen.
• Contains phytates and fiber oligosacharides so will inhibit
absorption of minerals (additional Ca is added)
• Higher levels of osteopenia in preterm infants given soy
formulas
• Phytoestrogens at levels that demonstrate physiologic activity
in rodent models
• Higher aluminum levels
Health Consequences of Early Soy Consumption.
Badger et al. J Nutr. 2002
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US soy formulas made with soy protein isolate (SPI+)
SPI+ has several phytochemicals, including isoflavones
Isoflavones are referred to as phytoestrogens
Phytoestrogens bind to estrogen receptors & act as
estrogen agonists, antagonists, or selective estrogen
receptor modulators depending on tissue, cell type,
hormonal status, age, etc.
Should we be Concerned? - Badger et
al.
• No human data support toxicity of soyfoods
• Soyfoods have a long history in Asia
• Millions of American infants have been fed soy
formula over the past 3 decades
• Rat studies indicate a potential protective
effect of soy in infancy for cancer
Contraindications to Soy Formula: AAP
– preterm infants due to increased risk of
inadequate bone mineralization
– infants with cow milk protein-induced
enteropathy or enterocolitis
– most previously well infants with acute
gastroenteritis
– prevention of colic or allergy.
Elemental Formulas
• Hydrolysates
• Amino Acid Based
Protein Hydrolysate Formulas
• Alimentum Advance
• Pregestimil/Pregestimil Lipil
• Nutramigen Lipil
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Protein Casein hyrolysate + free AA’s
Fat (Alimentum and Pregestimil) Medium chain
+ Long chain triglycerides; (Nutramigen) Long
chain triglycerides
Carbohydrate: Lactose free
Hydrolysate Formulas
• Whey Hydrolysate Formula: Cow’s milk based formula in
which the protein is provided as whey proteins that have been
hydrolyzed to smaller protein fractions, primarily peptides.
This formula may provoke an allergic response in infants with
cow’s milk protein allergy.
• Casein Hydrolysate Formula: Infant formula based on
hydrolyzed casein protein, produced by partially breaking
down the casein into smaller peptide fragments and amino
acids. `
AAP Policy Statement Re: Hypoallergenic
Infant Formulas (August, 2000)
Recommendations
AAP Policy Statement Re: Hypoallergenic Infant
Formulas (August, 2000)
• Currently available, partially hydrolyzed
formulas are not hypoallergenic.
2.Formula-fed infants with confirmed cow's
milk allergy may benefit from the use of a
hypoallergenic or soy formula as described
for the breastfed infant.
Amino Acid Based
Amino Acid Based Formulas
• Elecare, Neocate, Nutramigen AA
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Protein: Free Amino Acids
Fat: Long chain and medium chain
Elecare (33% MCT), Neocate (5% MCT)
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Carbohydrate: corn syrup solids, Lactose
and sucrose free
Indications for use: Food Allergy or
intolerance to peptides or whole protein
Elemental Infant Formula
• NeoCate (SHS)
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Protein: Free Amino Acids
Fat: Long chain
Carbohydrate: Lactose Free
Indications for use: Food Allergy or
intolerance to peptides or whole
protein
Other Specialty Formulas
• Similac PM 60/40 (Ross)
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Low in Ca, P, K+ and NA; 2:1 Ca:P ratio
Used for infants with Renal Failure
• Formulas for Metabolic Disorders
• Preterm Products
• Low fat high MCT
Indications
• Cow’s milk based
– Health term infant
• Soy
– Vegetarian
– Galactosemia
• Protein Hydrolysates
– Protein intolerance/allergy
– other
• Preterm Formulas
• Post-discharge Preterm formulas
• Other Specialty Formulas
– Specific medical, metabolic indications
Know What You Are Feeding
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Caloric density, protein, fat and carbohydrate vitamin
and mineral content.
Osmolality:
Renal Solute Load: Evaluate RSL in context of solute
intake, fluid intake and output.
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Evidence Based
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Rationale

Cost and availability
Finding Up to Date Information
• www.ross.com Similac products
• www.meadjohnson.com Enfamil products
• www.verybestbaby.com Nestle products
• www.wyethnutritionals.com generic products
– www.brightbeginnings.com lower cost formulas made
by Wyeth
• www.shsna.com/html/Hypoallergenic.htm
Neocate formulas
Regulation of Infant Formula
• FDA
– Infant Formula Act
• Manufacturers
– Voluntary monitoring
• AAP, National Academy of Sciences, other
professional organizations
– Guidelines for composition and intake:
(e.g. DRI’s)
– Guidelines for preparation and handling of
formula/human milk in health care
facilities
Regulation of Infant Formulas
• Infant Formula Act:
– Manufacturing regulations
– Quality control
• Non specific testing requirements, case by case basis, growth
outcomes
– Recall Proceedures
– Nutrient content and labeling
– Panel convened 1998 and 2002 (recommended revisions
including exemptions)
Regulation of Infant Formulas
• Infant Formula Act: The purpose of the infant formula act
(1980) is to ensure the safety and nutrition of infant formulas
– including minimum and in some cases maximum levels of
specified nutrients. The act authorizes the FDA to establish
appropriate regulations for 1) new formulas, 2) formulas
entering the U.S. market, 3) major changes, revisions, or
substitutions of macronutrients 4) formulas manufactured in
new plants or processing lines, 5) addition of new
constituents 6) use of new equipment or technology 7)
packaging changes
Formula Regulation
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•
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Regulation is by the Infant Formula Act of 1980,
under FDA authority
Nutrient composition guidelines for 29 nutrients
established by AAP Committee on Nutrition and
adopted as regs by FDA
Nutrient Requirements for Infant Formulas. Federal
Register 36, 23553-23556. 1985. 21 CFR Part 107.
Infant Formula Act
• Institute of Medicine Food and Nutrition Board 3/2004
• “Although the federal regulatory processes for evaluating
the safety of food ingredients have worked well for
conventional substances, they were not designed to ensure
the needs and vulnerabilities of infants and are insufficient
to ensure the safety of new types of ingredients proposed
for infant formulas
Infant Formula Act
• “The current regulatory processed do not fully address the
unique role of formula as a food source. Formula is the only
infants’ food if they are not being breastfed. The processes
used to regulate the safety of any new additions of formula
should be tailored to these products distict role and the
special needs and susceptibilities of infants”
Infant Formula Act
• Key limitation: lack of explicit guideleines for
determining when and what safety data is
needed…..(GRAS)
• Clarification is crucial given the increasing
number of bioactive peptides and enzymens
generated from unconventional sources or
new technologies
Infant Formula Act: Points for
discussion
• Addition of DHA and ARA to formulas
• Addition of prebiotics to formula
– Present in BM
– GRAS
– Vitamin/mineral content conforms to regulation
– ? testing
Formula safety
• FDA recall list 2005-2006
Cows milk and goats milk
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Protein
RSL
Folic acid, iron, vitamin D
pasteurization