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Objectives After completing this article, readers should be able to:
1. Describe the macronutrient content of formulas used as substitutes for human milk for
term and preterm infants.
2. Identify appropriate clinical applications of infant formulas that have altered nutrient
contents based on the physiologic significance of specific changes in formula
composition.
3. Discuss the physiologic role and potential health benefits associated with four compo-
nents added to infant formulas in the past decade.
4. Delineate current regulatory guidelines that define standards for composition and
performance and safety criteria for commercial infant formulas.
Historical BackgroundDevelopment of infant formulas can be traced to the late 19th century. In 1867, Liebig
developed and marketed a product for infant feeding that contained cow milk, wheat flour,
malt flour, and potassium bicarbonate. In 1915, Gerstenberger reported a 3-year experi-
ence using “synthetic milk, adapted” that contained nonfat cow milk, lactose, oleo oils,
and vegetable oils. This product represented early understanding that cow milk required
alteration to improve its acceptability for human consumption and is considered the
precursor to modern infant formulas. (1)
Government regulation of infant formula composition in the United States began in
1941 and underwent significant expansion with passage of the Infant Formula Act of
1980, a direct and prompt response to an epidemic of a Bartterlike syndrome (hypochlo-
remic, hypokalemic metabolic alkalosis). Most cases were later attributed to consumption
of a chloride-deficient soy infant formula. The Infant Formula Act of 1980 and itsamendments in 1986 defined minimum concentrations of 29 nutrients and established
quality control standards for commercial production of infant formulas. Current standards
are summarized in the Electronic Code of Federal Regulations: Title 21:107—Infant
Formula. (2) Organic infant formulas must also meet all
standards required for United States Department of
Agriculture Organic certification.
The addition of nucleotides to infant formulas in 1999 and
long-chain polyunsaturated fatty acids (LCPUFAs) in 2002
marked a new era in infant formula development. In 2004,
anticipating continued competition among infant formula
manufacturers to develop products that mimic the com-
plexities and performance of human milk, a special commit-tee of the Food and Nutrition Board of the Institute of
Medicine proposed enhanced regulatory and research proce-
dures to assess the safety of potential new ingredients in
infant formulas. (1)
Challenges continue in ensuring the quality and safety of
commercial infant formulas. Within the past 5 years, pow-
dered infant formulas have been recognized as potential
carriers of food-borne illness after the death of an infant due
*Assistant Professor, Director Pediatric Nutrition Support Program, Department of Pediatrics, Division of Gastroenterology,
Hepatology and Nutrition, Vanderbilt University School of Medicine, Nashville, TN.†Pediatric Nutrition Support Dietitian, Department of Nutrition Services, Monroe Carell Jr Children’s Hospital at Vanderbilt,
I n f a n t F o r m u l a C o m p a r i s o n C h a r t 1 , 2 — c o n
t i n u e d
P r i m a r y P r o t e i n S o u r c e
C a r b o h y d r a t e
F a t
F e a t u r e s
W h e y :
C a s e i n
R a t i o
S o y P r o t e i n
I s o l a t e
P a r t i a l l y
H y d r o l y z e d
C a s e i n
H y d r o l y s a t e
1 0 0 %
F r e e
A m i n o
A c i d s
F u l l
L a c t o s e
R e d u c e d
L a c t o s e ( %
C a r b o h y d r a t e )
L a c t o s e -
f r e e
G l u c o s e
P o l y m e r s
G l u c o s e
P o l y m e r s /
S u c r o s e
B l e n d
A d d e d
R i c e
S t a r c h
( ) o r
S o y F i b e r
( x )
L C T / M C T
( % )
D
H A / A R A
( %
t o t a l
f a t )
O s m o l a l i t y
N u c l e o t i d e s P r e b i o t i c s P r o b i o
t i c s
S o y M i l k - b a s e d
F o l l o w - u p
F o r m u l a s
( I n t a c t P r o t e i n )
E n f a g r o w ™ S o y
N e x t S t e p ®
1 0 0 / 0
0
. 3 2 / 0 . 6 4
2 3 0
S i m i l a c G o a n d
G r o w ™ S o y
1 0 0 / 0
0
. 1 5 / 0 . 4 0
2 0 0
C o w M i l k - b a s e d
F o l l o w - u p
F o r m u l a s
( M o d i fi e d )
E n f a g r o w ™
G e n t l e a s e ®
N e x t S t e p ®
6 0 : 4 0
* 5 0 %
1 0 0 / 0
0
. 3 2 / 0 . 6 4
2 3 0
G o o d S t a r t ® 2
G e n t l e P l u s ™
1 0 0 : 0
7 0 %
1 0 0 / 0
0
. 3 2 / 0 . 6 4
2 6 5
G o o d S t a r t ® 2
P r o t e c t P l u s ®
1 0 0 : 0
7 0 %
1 0 0 / 0
0
. 3 2 / 0 . 6 4
2 6 5
G o o d S t a r t ® 2
S o y P l u s ™
1 0 0 / 0
0
. 3 2 / 0 . 6 4
1 8 0
1 N u t r i e n t c o m p o s i t i o n b a s e d o n p o w d e r e d p r o d u c t p r e
p a r e d a t 2 0 k c a l / o z ( w h e n a p p l i c a b l e ) u n l e s s o t h e r w i s e n
o t e d .
2 D i f f e r e n c e s i n n u t r i e n t c o m p o s i t i o n a n d p r o d u c t c h a r a
c t e r i s t i c s m a y v a r y a m o n g a v a i l a b l e f o r m s ( p o w d e r , l i q u i d
r e a d y - t o - u s e , l i q u i d c o n c e n t r a t e ) o f a s p e c i fi c p r o d u c t . M
a n u f a c t u r e r s m a y a l t e r s p e c i fi c i n g r e d i e n t s a t a n y t i m e ; r e f e r t o
p r o d u c t l a b e l f o r t h e m o s t u p - t o - d a t e i n f o r m a t i o n .
* F o r m u l a i s m a r k e t e d f o r m a n a g e m e n t o f “ l a c t o s e s e n s
i t i v i t y . ”
E n f a m i l ® , P r o s o b e e ® , N u t r a m i g e n ® , P r e g e s t i m i l ® , E n
f a c a r e ® , E n f a g r o w ® , E n fl o r a ® , a n d E n f a p o r t ® a r e r e g i s t e r e d t r a d e m a r k s o f M e a d J o h n s o n N u t r i t i o n , E v a n s v i l l e , I N
. P a t e n t e d N a t u r a l D e f e n s e ™ p r e b i o t i c b l e n d u s e d i n E n f a m i l
P r e m i u m ® i n c l u d e s g a l a c t o - o l i g o s a c c h a r i d e s a n d p o l y d
e x t r o s e .
L G G ® i s a t r a d e m a r k o f V a l i o , L t d .
G o o d S t a r t ® , G e n t l e P l u s ® , P r o t e c t P l u s ® , S o y P l u s ®
a r e r e g i s t e r e d t r a d e m a r k s o f S o c i e ´ t e ´ d e s P r o d u i t s N e s t l e ´ S
. A . , V e v e y , S w i t z e r l a n d . P r o b i o t i c u s e d i n G o o d S t a r t ® P
r o t e c t P l u s ® f o r m u l a s : B i fi d o b a c t e r i u m l a c t i s .
S i m i l a c ® , I s o m i l ® , E x p e r t C a r e ® , A l i m e n t u m ® , S p e c i a l C a r e ® , N e o s u r e ® , E l e c a r e ® , a n d G o a n d G r o w ® a r e r e g i s t e r e d t r a d e m a r k s o f A b b o t t N u t r i t i o n , C o l u m b u s , O H . S i m i l a c A d v a n c e ® c o n t a i n s g a l a c t o - o l i g o s a c c h a r i d e s , a p r e b i o t i c .
S i m i l a c S e n s i t i v e I s o m i l S o y ™ i n c l u d e s f r u c t o - o l i g o s a c c
h a r i d e s , a p r e b i o t i c .
P a r e n t ’ s C h o i c e ® i s a r e g i s t e r e d t r a d e m a r k o f P B M N u
t r i t i o n a l s , G e o r g i a , V T . P a r e n t ’ s C h o i c e ® A d v a n t a g e c o n
t a i n s g a l a c t o - o l i g o s a c c h a r i d e s , a p r e b i o t i c .
A R A ϭ a r a c h i d o n i c a c i d , D H A ϭ d o c o s a h e x a e n o i c a c i d , L B W ϭ l o w b i r t h w e i g h t , L C H A D ϭ l o n g - c h a i n 3 - h y d r o x y a
c y l - C o A d e h o d r o g e n a s e , L C T ϭ l o n g - c h a i n t r i g l y c e r i d e , M
C T ϭ m e d i u m - c h a i n t r i g l y c e r i d e , R T U ϭ r e a d y t o u s e .
nutrition infant formulas
Pediatrics in Review Vol.32 No.5 May 2011 183
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12. Strom BL,SchinnarR, Ziegler EE,et al. Exposure to soy-based
formula in infancy and endocrinological and reproductive out-
comes in young adulthood. JAMA. 2001;286:807–814
13. ESPGHAN Committee on Nutrition, Agostoni C, Axelsson I,
Goulet O, et al. Soy protein infant formulae and follow-on formu-
lae: a commentary by the ESPGHAN Committee on Nutrition.
J Pediatr Gastroenterol Nutr. 2006;42:352–361
14. Allen UD, McLeod K, Wang EE. Cow’s milk versus soy-based
formula in mild and moderate diarrhea: a randomized, controlledtrial. Acta Paediatr. 1994;83:183–18715. von Berg A, Filipiak-Pittroff B, Kramer U, et al. Preventiveeffect of hydrolyzed infant formulas persists until age 6 years:long-term results from the German Infant Nutritional InterventionStudy (GINI). J Allergy Clin Immunol. 2008;121:1442–144716. Greer FR, Sicherer SH, Burks AW. Effects of early nutritionalinterventions on the development of atopic disease in infants andchildren: the role of maternal dietary restriction, breastfeeding,timing of introduction of complementary foods, and hydrolyzedformulas. Pediatrics. 2008;121:183–19117. Alexander DD, Cabana MD. Partially hydrolyzed 100% whey protein infant formula and reduced risk of atopic dermatitis: a
meta-analysis. J Pediatr Gastroenterol Nutr. 2010;50:422–43018. Hill DJ, Murch SH, Rafferty K, Wallis P, Green CJ. The
efficacy of amino acid-based formulas in relieving the symptoms of
Summary• Based on strong research evidence, formulassupplemented with DHA (between 0.3% and 0.5%of total fatty acids) and at least equal amounts of ARA are beneficial for visual and neurologicaldevelopment.
• Based on strong research evidence, formulassupplemented with probiotics reduce the incidenceof clinical eczema in high-risk infants (parent orsibling who has atopy).
• Based on strong research evidence, formulassupplemented with probiotics reduce the incidenceof NEC and all-cause mortality in VLBW infants.
• Based on some research evidence, formulassupplemented with prebiotics or probiotics decreasethe risk of infections during infancy.
• Based on strong research evidence, partially orextensively hydrolyzed formulas are effective inpreventing or delaying development of atopicdermatitis in high-risk infants.
• Based on strong research evidence, thickenedformulas reduce the number of episodes of vomiting,regurgitation, and signs of GERD such as irritabilityand crying.
nutrition infant formulas
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cow’s milk allergy: a systematic review. Clin Exp Allergy. 2007;37:
808–822
19. Horvath A, Dziechciarz P, Szajewska H. The effect of
thickened-feed interventions on gastroesophageal reflux in infants:
systematic review and meta-analysis of randomized, controlled
trials. Pediatrics. 2008;122;e1268–e1277
PIR QuizQuiz also available online at: http://pedsinreview.aappublications.org.
1. Which of the following statements about infant nutrition is true?
A. Human milk contains more casein than infant formulas.B. Infants who receive increased whey protein have been shown to grow better than those who receive
primarily casein.C. Iron is absorbed better from cow milk formulas than from human milk.D. Lactose-free formulas result in decreased absorption of calcium.
E. There are no apparent negative effects from the addition of DHA and ARA to formulas.
2. Which of the following statements regarding prebiotics and probiotics is true?
A. Both have been proven to decrease the incidence of atopy.B. Prebiotics are live microorganisms.C. Probiotics are carbohydrates that stimulate bacterial growth.D. The use of probiotics has been shown to reduce the incidence of necrotizing enterocolitis.E. They should be routinely prescribed to exclusively breastfed infants.
3. The characteristic that is more typical of casein than of whey is that it:
A. Forms large curds on exposure to gastric acid.B. Is only found in trace amounts in cow milk.
C. Is resistant to precipitation.D. Is the predominant protein in human milk.E. Undergoes more rapid gastric emptying.
4. Which infant feeding is best for the prevention of atopic disease?
A. Cow milk-based formula.B. Extremely hydrolyzed formula.C. Human milk.D. Partially hydrolyzed formula.E. Soy formula.
5. Which of the following supplements has been added to formulas for the longest period of time?
A. Arachidonic acid.B. Docosahexaenoic acid.C. Iron.D. Nucleotides.E. Prebiotics.
6. A young mother has brought her newborn to your clinic for his first visit. She has heard that soy formulasare better than milk-based formulas. For which of the following conditions is soy formula indicated?
A. Allergic enteropathy.B. Colic.C. Galactosemia.D. Gastroesophageal reflux.E. Prematurity.
nutrition infant formulas
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DOI: 10.1542/pir.32-5-1792011;32;179Pediatrics in Review
J. Andres Martinez and Martha P. BallewInfant Formulas
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