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Infant Formulas
What’s for What and What’s for
Whom???
Kathryn Camp, MS, RD, CSP
Pediatric Nutritionist
Walter Reed Army Medical Center
Today’s Presentation
History and regulation of infant
formulas
Categorize formulas by
composition and intended use
Alternate products sometimes given
to infants
Infant Formula
Product intended for use by infants that
simulates human milk or is suitable as a
complete or partial substitute for human
milk
Historical Perspective
Early attempts at artificial feeding of infants
employed the milk of other mammals
– Infant survival during the 1st few weeks of life
approached 0%
Wet nurses were employed but their
availability declined with the onset of the
Industrial Revolution
Examples of Early
Infant Feeding
Vessels
Pewter
Ceramic
Commercial Formula
Development
In 1867, Henri
Nestlé created the
first commercially
sold formula.
Banana feeder
At the end of the 19th century the gross
composition of human milk was
determined.
Recognition of low concentration of protein
in BM lead to the use of diluted cow milk
– Less mortality among infants
– But poor growth
To increase caloric density of diluted cow
milk, sugar or cereals were added
– Infants lived and grew
– Pediatrics became a medical specialty
– Mortality still remained high
Early 20th century
– Electric refrigeration and pasteurization
Significant decrease in mortality
Increased popularity of formula feeding
– Improved sanitation and milk handling
– Modifications in cow protein improved
digestibility
– Direct advertising to physicians
influenced use of formulas
– Good rubber nipples made feeding
easier
1911-- Dextri-Maltose introduced by
Mead Johnson
1915 -- a formula called synthetic
milk adapted (forerunner of Wyeth’s
SMA) required only the addition of
water
– 67 kcal/dL
– Non-fat cow milk
– Lactose
– Oleo and vegetable fat
The importance of vitamins was
recognized
– Infant formulas became suitable vehicles
– Previously common vitamin-deficiency
diseases such as scurvy and rickets became
less prevalent
Highlights in Formula History
1929--the first soy flour formula was
developed
– milk–free, lactose–free
– designed as an alternative to the home
prepared milk–based formulas of the time
– soy flour caused significant abd discomfort
1942--protein hydrolysate formula
1959—iron-fortified formula appeared
1960—appreciation of renal solute load
1965--soy protein isolate formula
1966—1st premmie formula designed to
meet the special nutritional needs of
rapidly growing low–birth–weight infants.
1971--first nutritionally complete protein
hydrolysate formula containing MCT oil.
1990’s
– lactose free cow milk-based formulas
appeared
– Nucleotides were added to some formulas
Early 2000’s
– DHA and ARA were added to both cow milk
and soy formulas
Regulation of Infant Formulas
The US was one of the last major industrialized
nation to implement federal regulations
concerning safety of infant formulas
The first FDA reference to safety of infant
formulas was in 1938
1941 first requirement for specific information to
be included on an infant formula label
No new revisions until 1971 when the results of
AAP recommendations and public hearings
included minimum requirements for protein, fat,
linoleic acid and 17 vitamins and minerals.
Infant Formula Act Passed by
Congress in 1980
Following reports in 1979 that over 100 infants
became seriously ill because of the lack of
chloride in two soy-based formulas
The new law authorized the FDA to adjust
nutritional standards for infant foods to conform
with the best available scientific knowledge.
Manufacturers are required to test their
products periodically and report to the FDA
when they do not meet the official specs.
Furthermore….Formula
Manufacturers are required to
Verify composition before a new product
goes to market
– specifying that it meets minimum (29
nutrients) and does not exceed maximum (9
nutrients) requirements
Meet “good manufacturing practices”
Maintain records for annual inspection
The FDA has the authority to recall
products that are adulterated or
misbranded
Categories of Infant formulas
Standard
– Similac, Enfamil, Carnation, Store brands
Soy
– Isomil, Prosobee, Alsoy,
Protein hydrolysates
– Pregestimil, Nutramigen, Alimentum
Elemental
– Neocate, Elecare
Premature
– Enfacare, NeoSure
“Next Step”—older infants and toddlers
Specialized
– Modified for specific medical indication
Metabolic, renal, GI disorders
Standard Formulas
Cow milk altered by
– Removing the butter fat
– Adding vegetable oils and carbohydrate
– Decreasing the protein
34 g/L to 15 g/L
– Adding vitamins, minerals, and other nutrients such
as amino acids, fatty acids, nucleotides
Whey to casein ratio varies
–
–
–
–
Major whey protein is β-lactoglobulin
Major casein protein is bovine -casein
Amino acid profile varies
Taurine and carnitine are added to some
Whey to Casein Ratio
Breast milk
% Whey
% Casein
70
30
β-casein
-lactalbumin,
lactoferrin, IgA
Enfamil
60
40
Similac
18
82
Carnation
Good Start
Soy
100
0
0
0
Standard
Formula
Features
Breast milk
–
–
–
–
–
–
–
–
20cal/oz
Human milk fat
Lactose
whey:casein 70:30
9 g/L
Iron 0.3mg/L
Vitamin D 21 IU/L
260 mOsm/kg H20
Contains DHA and AA
Enfamil/Similac/Good Start
–
–
–
–
–
–
–
–
20cal/oz
Soy, coconut, sunflower, palm
Lactose
60:40, 18:82
 15 g/L
Iron 12mg/L
Vitamin D 405 IU/L
265-300 mOsm/kg H20
DHA and AA added
Formulas still made without
Standard
Formula
Features
Breast milk
–
–
–
–
–
–
–
–
20cal/oz
Human milk fat
Lactose
whey:casein 70:30
9 g/L
Iron 0.3mg/L
Vitamin D 21 IU/L
260 mOsm/kg H20
Contains DHA and AA
Enfamil/Similac/Good Start
–
–
–
–
–
–
–
–
20cal/oz
Soy, coconut, sunflower, palm
Lactose
60:40, 18:82
 15 g/L
Iron 12mg/L
Vitamin D 405 IU/L
300 mOsm/kg H20
DHA and AA added
Formulas still made without
Low Iron Formula
PEDIATRICS Vol. 104 No. 1 July 1999, pp.119-123
AMERICAN ACADEMY OF PEDIATRICS:
Iron Fortification of Infant Formulas
Position Statement
“The manufacture of formulas with iron concentrations
less than 4.0 mg/L should be discontinued. If these
formulas continue to be made, low-iron formulas should
be prominently labeled as potentially nutritionally
inadequate with a warning specifying the risk of iron
deficiency. These formulas should not be used to treat
colic, constipation, cramps, or gastroesophageal reflux.”
Soy Formulas
Indications for use
– Milk protein intolerance (IGE mediated)
– Lactose intolerance (rare)
– Galactosemia
– Vegetarian diet
Not appropriate for
– preterm infants < 1800 grams d/t risk of
osteopenia and growth concerns
– Hereditary fructose intolerance (contains
sucrose)
Soy Formulas
Breast milk
–
–
–
–
–
–
–
–
20cal/oz
Human milk fat
Lactose
whey:casein 70:30
9 g/L
Iron 0.3mg/L
Vitamin D 21IU/L
260 mOsm/kg H20
Contains DHA and
AA
Isomil/Prosobee
– 20cal/oz
– palm olein,
soy,coconut,sunflower
– Corn syrup/sucrose
– Protein, 17 g/L
soy isolate and L-MET
– Iron 12mg/L
– Vitamin D 405 IU/L
– 200 mOsm/kg H20
– DHA and AA added
Protein Hydrolysates
Hydrolyzed casein or whey protein
Various fat blends
All are lactose free
Protein Hydrolysates
Breast milk
–
–
–
–
–
–
–
–
20cal/oz
Human milk fat
Lactose
70%whey 30%casein
9 g/L
Iron 0.3mg/L
Vit D 21 IU/L
260 mOsm/kg H20
Contains DHA and AA
Pregestimil
–
–
–
–
–
–
–
–
20cal/oz
MCT (55%), safflower, soy
corn syrup solids, corn starch
Casein Hydrolysatenonantigenic peptides
19 g/L
Iron 12mg/L
Vitamin D 405 IU/L
330 mOms/kg H20
Does not have DHA and AA
Other Hydrolysates
Alimentum Advance
– For infants and children with severe food allergies,
sensitivity to intact protein (including colic symptoms
due to protein sensitivity), protein maldigestion or fat
malabsorption
– Hydrolyzed casein + free amino acids
– 33% of fat is MCT
– 370 mOms/kg H20
– Contains DHA and ARA
– Lactose free (contains sucrose)
Nutramigen LIPIL
– hypoallergenic
– for infants who are sensitive to intact protein
in milk and soy-based formulas
– 270 mOms/kg H20
– Lactose and sucrose free
New Kid on
the Block!
Enfamil Gentlease LIPIL
– Launched in July 05
– “is a nutritionally balanced, milk-based
infant formula designed as a first switch
formula for babies who have fussiness or gas.”
– Partially broken down proteins
6-9% hydrolyzed
– Reduced lactose
1/4 of typical
– Whey:casein ratio of 60:40
– Contains DHA and ARA, “nutrients also found in
breast milk that promote brain and eye development.”
– No studies to document efficacy in the intended
population
Elemental Formulas
Indications: For infants and children who
need an amino acid-based medical food or
who cannot tolerate intact protein
– protein maldigestion or malabsorption
Short bowel syndrome
– severe or multiple food allergies
– GI tract impairment
eosinophilic esophagitis or gastroenteritis
– Lactose, sucrose, fructose, and galactosefree
Galactosemia and hereditary fructose intolerance
Elemental
5% MCT
Breast milk
–
–
–
–
–
–
–
–
20cal/oz
Human milk fat
Lactose
70%whey 30%casein
9 g/L
Iron 0.3mg/L
Vit D 21 IU/L
260 mOsm/kg H20
Contains DHA and AA
33% MCT
Neocate/Elecare
–
–
–
–
–
–
–
–
20cal/oz
MCT, safflower, soy
Corn syrup solids
100% free amino acids,
21 g/L
Iron 12mg/L
Vitamin D 500 IU/L
335 mOsm/kg H20
Do not contain DHA and
AA
Premature Formulas
NICU
– Similac Special Care
Enfamil Premature Lipil
20 and 24 kcal/oz
Available only for inpatients
Cow milk based
40% of fat is MCT
Products are not appropriate for
larger babies (2.5-3 kg) because
of higher amounts of vitamins
(esp A and D) and minerals
Premature Infants
Hospital discharge
– NeoSure
– EnfaCare
22 kcal/oz
 Pro, calcium,
phosphorus, MCT (20%)
Cow milk based
Improved growth
– Wheeler, RE. Journal of Perinatology,
16:111-116, 1996.
Others
Enfamil AR
– Milk-based standard formula
– added rice starch that thickens in the acid
environment of the stomach
– For babies who spit up frequently or need
a thickened formula
– Reduced reflux symptoms
Vanderhoof , Clin Pediatr. 2003;42:483-495.
Isomil DF
– Soy protein, soy fiber
– For firming loose, watery stools in infants
older than 6 months and toddlers.
–  duration of antibiotic-induced diarrhea
Burks, J Pediatr. 2001;139(4):578
Others
Enfamil LactoFree
– Milk-based
– Lactose and sucrose-free formula for infants
with fussiness, gas or diarrhea due to lactose
sensitivity.
– Calcium absorption was less than with lactose
containing formula but total calcium
absorption was adequate (Abrams,
AJCN;2002)
– Studies on efficacy have been mixed
Generic Formulas
Must meet requirements set
under the infant formula act
– Minimums and maximums
Less expensive
Specialized
Portagen (Mead Johnson)
– 86% MCT oil fat malabsorption, intestinal lymphatic
obstruction, or chylothorax
– 2002 recall after the death of a premature infant from
Enterbacter sakazakii contaminated formula.
– Manufacturer no longer recommends for infants
RCF (Ross) Ross Carbohydrate Free
– Infants with CHO intolerance
– Must add CHO
– Modified for the ketogenic diet
Specialized, cont:
Similac PM 60/40
– For infants with hypocalcemia
due to hyperphosphatemia
or impaired renal function.
Metabolic Formulas
– PKU, MSUD, tyrosinemia,
homocystinuria, glutaric aciduria,
PPA/MMA, urea cycle
– Ross, Mead Johnson,
Scientific Hospital Supplies
Toddler Formulas
Milk and soy based
products
for infants and toddlers
– 9-24 months
– who are eating solid foods
Contain DHA and ARA
Has > twice the calcium of
regular infant formulas
(300 mg vs 125 mg)
Alternatives to Infant Formulas
Evaporated Milk Formula
– AAP does not support its use
Poorly digested fat
Low iron and vitamin C
Excessive sodium, protein, PO4
– Preferable to unmodified cow milk
– Recipe
13 oz can
19.5 oz water
3 Tablespoons sugar or corn syrup
– Requires supplementation with vitamins A, D,
calcium, and iron
10.5 mo old female with hx
of poor growth
– 26.5 weeks gestation
– 3 mo NICU course
complicated by poor feeding,
BPD, hernia repair, seizures
Discharged on Elecare and O2
7.5 mo corrected age
– Meds—synthroid, zantac,
Poly-vi-sol, flovent, calcium
gluconate
Case
Weight--5 kg
Length-- 61.6 cm
IBW--6.5 kg
77% of IBW
Dietary data
– Family had switched to goat
milk 1 mo prior on the advice of
“someone” who said it would
provide more nutrition
– She was drinking more volume
– 1 pound weight loss in 1 month
24-hr dietary intake
– 20 oz of goat milk
(rice cereal added at
1T per 4 oz)
– 3 T baby solids
Dietary Analysis
Actual
Needed
Calories 425 (85/kg)
650 min
Protein
15-18
22 (4.4/kg)
Cal dist: For 6-12 mo
Protein
20
15
CHO
30
45-55
Fat
50
35-45
Formulas vs Goat Milk
Nutrient/8 oz
Calories
Protein, g
CHO, g
Fat, g
Sodium,mg
Iron, mg
Vitamin C,mg
Folate, μg
Vitamin D, IU
Osmolality
*Added
NeoSure
180
4.6 (10%)
18.5 (41%)
9.8 (49%)
41
2.2
18
31
86
224
Goat Milk
140
8 (23%)
11 (31%)
7 (46%)
115
0
0
80 *
100 *
339
Elecare
180
5.3 (14%)
19 (43%)
8.5 (43%)
81
3.2
16
53
77
330
Choose the appropriate formula:
Infant with galactosemia
– Isomil, Prosobee, Pregestimil, Neocate, Elecare
Infant with multiple food allergies
– Hydrolysate then Neocate, Elecare
Healthy term infant
– Enfamil or Similac
Infant with decreased pancreatic lipase and
bile salts
– Portagen
Infant with  renal fx and  electrolytes
– Similac PM 60/40
Resources
Infant Formula: Evaluating the Safety of New
Ingredients (2004)
Food and Nutrition Board, Institute of Medicine
– http://www.nap.edu/openbook/0309091500/html/
Infant Feedings: Guidelines for Preparation of
Formula and Breastmilk in Health Care
Facilities. Robbins and Beker (eds), ADA 2003
– http://www.eatright.org/Public/ProductCatalog/Search
ableProducts/104_8515.cfm
The End!