Enfamil Infant is a 20 Cal/fl oz milk-based, iron-fortified, routine formula for full-term infants 0-12 months. Enfamil Infant is clinically demonstrated to foster cognitive development through 5 years of age1. Enfamil Infant is patterned after mature breast milk* and offers proven clinical outcomes in 3 key areas: brain development, immune health and growth.
* Comparison based on whey:casein ratio of typical mature breast milk (15 days to 6 months after birth). † Average level of DHA in worldwide breast milk is 0.32% ± 0.22% (mean ± standard deviation of total fatty acids) based on an analysis of 65 studies of 2,474 women2. ‡ Enfamil Infant has not been shown superior to the leading competitor in supporting mental, visual and immune system development in infants. § Studies compared infants fed Enfamil with DHA and ARA vs. discontinued Enfamil without DHA and ARA; studied before the addition of prebiotics.
Product nutrient values and ingredients are subject to change. Please see product label for current information.
|(Normal Dilution)||Per 100 Calories (5 fl oz)||Per 100 mL||Per 100 grams Powder (510 Cal)|
|Linoleic acid, mg||800||540||4000|
|(Normal Dilution)||Per 100 Calories (5 fl oz)||Per 100 mL||Per 100 grams Powder (510 Cal)|
|Vitamin A, IU||300||200||1520|
|Vitamin D, IU||60||41||300|
|Vitamin E, IU||2||1.35||10.1|
|Vitamin K, mcg||9||6.1||45|
|Thiamin (Vitamin B1), mcg||80||54||400|
|Riboflavin (Vitamin B2), mcg||140||95||710|
|Vitamin B6, mcg||60||41||300|
|Vitamin B12, mcg||0.3||0.2||1.52|
|Folic acid (Folacin), mcg||16||10.8||81|
|Pantothenic acid, mcg||500||340||2500|
|Vitamin C (Ascorbic acid), mg||12||8.1||61|
|(Normal Dilution)||Per 100 Calories (5 fl oz)||Per 100 mL||Per 100 grams Powder (510 Cal)|
|Nutrient Density||20 Calories/fl oz|
|Protein (% Calories)||8|
|Fat (% Calories)||48|
|Carbohydrate (% Calories)||44|
|Potential Renal Solute Load (mOsm/100 Calories)9||18.6|
|Potential Renal Solute Load (mOsm/100 mL)9||12.5|
|Osmolality (mOsm/kg water)||300|
Enfamil® Infant is available in powder and concentrate.
Item #: 1365A5
Description: Enfamil Infant Pwd
Unit Size: 21.1 oz Can
Prod. Yield / Unit (fl oz):
Case: 4 cans per case
Reimbursement Code: 00087-511976
Item #: 136502
Description: Enfamil Infant Powder
Unit Size: 12.5 oz can
Prod. Yield / Unit (fl oz): 90
Case: 6 cans per case
Reimbursement Code: 00087–136542
Item #: 136701
Description: Enfamil Infant Concentrated Liquid
Unit Size: 13 fl oz can
Prod. Yield / Unit (fl oz): 26
Case: 12 cans per case
Reimbursement Code: 00087–136741
Ingredients: Powder: Nonfat milk, lactose, vegetable oil (palm olein, coconut, soy and high oleic sunflower oils), whey protein concentrate and less than 2%: galactooligosaccharides||, polydextrose||, Mortierella alpina oil¶, Crypthecodinium cohnii oil#, calcium carbonate, potassium citrate, ferrous sulfate, potassium chloride, magnesium oxide, sodium chloride, zinc sulfate, cupric sulfate, manganese sulfate, potassium iodide, sodium selenite, soy lecithin, choline chloride, ascorbic acid, niacinamide, calcium pantothenate, vitamin A palmitate, vitamin B12, vitamin D3, riboflavin, thiamin hydrochloride, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, inositol, vitamin E acetate, nucleotides (cytidine 5’-monophosphate, disodium uridine 5’-monophosphate, adenosine 5’-monophosphate, disodium guanosine 5’-monophosphate), taurine, L-carnitine.
Ingredients: Concentrate: Water, nonfat milk, lactose, vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) and less than 2%: galactooligosaccharides||, polydextrose||, Mortierella alpina oil¶, Crypthecodinium cohnii oil#, whey protein concentrate, potassium citrate, calcium carbonate, calcium phosphate, magnesium phosphate, calcium chloride, sodium chloride, ferrous sulfate, sodium citrate, zinc sulfate, cupric sulfate, manganese sulfate, potassium iodide, sodium selenite, soy lecithin, mono- and diglycerides, ascorbic acid, sodium ascorbate, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, vitamin D3, vitamin B12, choline chloride, carrageenan, inositol, nucleotides (cytidine 5’ monophosphate, disodium uridine 5’-monophosphate, adenosine 5’-monophosphate, disodium guanosine 5’-monophosphate), taurine, L-carnitine.
|| A type of prebiotic. ¶ A source of arachidonic acid (ARA). # A source of docosahexaenoic acid (DHA).
Enfamil® Infant contains milk and soy.
The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, dilution, use and storage are important when preparing infant formula. Powdered infant formulas are not sterile and should not be fed to premature infants or infants who might have immune problems unless directed and supervised by a doctor. Discuss with parents which formula is appropriate for the baby.
Discuss with parents whether they need to use cooled, boiled water for mixing and whether they need to boil clean utensils, bottles and nipples in water before use.
WARNING: Do not use a microwave oven to warm formula. Serious burns may result.
Refer to the product label for the most accurate information.
Failure to follow these instructions could result in severe harm. Once prepared, infant formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 24 hours. Do not use prepared formula if it is unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use formula within 1 hour or discard.
Use the charts below for correct amounts of water and powder. Use scoop in tub or can to measure powder. Store DRY scoop in lid holder in tub or in can.
|2 fl oz bottle||2 fl oz||1 unpacked level scoop||8.8 g|
|4 fl oz bottle||4 fl oz||2 unpacked level scoops||17.6 g|
|8 fl oz bottle||8 fl oz||4 unpacked level scoops||35.2 g|
†† Each scoop adds about 0.2 fl oz to the amount of prepared formula.
READY TO USE
8 fl oz Bottles
Wash hands thoroughly with soap and water before preparing feeding bottles.
SHAKE BOTTLE WELL, remove protective seal around cap, remove cap and foil seal.
Pour into feeding bottle(s).
WARNING: Do not use a microwave oven to warm formula. Serious burns may result.
Failure to follow these instructions could result in severe harm. Opened bottles and prepared formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened bottle and/or prepared formula if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use prepared formula within 1 hour or discard.
13 fl oz Cans
Wash hands thoroughly with soap and water before preparing formula.
Clean can lid, SHAKE CAN WELL and open.
Pour desired amount of water into the bottle. Add an equal amount of concentrated liquid. Shake or stir well.
WARNING: Do not use a microwave oven to warm formula. Serious burns may result.
Failure to follow these instructions could result in severe harm. Opened bottles or cans and prepared formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 48 hours. Do not use opened containers and/or prepared formula if they are unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use prepared formula within 1 hour or discard.
Enfamil Infant provides 48% of calories as fat; similarly, human milk provides approximately 50% of calories as fat. The fat in Enfamil Infant is primarily derived from a four-oil fat blend and from single-cell oils. This combination of fats results in a fatty acid profile similar to typical mature U.S. human milk§§.
§§ Pooled mean value across nine studies of mature human milk in the U.S.
The fat blend in Enfamil Infant is composed of:
Palm olein oil (44% of total fat), which provides high levels of palmitic and oleic acids. These fatty acids are predominant in human milk.
Soy oil (19.5% of total fat), which is a good source of the essential fatty acids linoleic and alpha-linolenic acid. These fatty acids are used to form DHA and ARA, which are important for visual and mental development.
Coconut oil (19.5% of total fat), which provides medium-chain saturated fatty acids. These saturated fats are easily digested, absorbed, and utilized as a source of energy.
High-oleic sunflower oil (14.5% of total fat), which provides oleic acid. Oleic acid is an important source of energy for the infant and a component of nerve cell membranes, which are primarily formed in the first two years after birth.
A blend of DHA and ARA from single-cell oils (2.5% of total fat). This blend results in 0.32% of total fatty acids as DHA and 0.64% of total fatty acids as ARA. DHA and ARA are clinically proven to improve|||| mental and visual development and respiratory and immune outcomes.
|||| Studies compared infants fed Enfamil with DHA and ARA vs discontinued Enfamil without DHA and ARA; improvements shown to 18 months for mental and visual development and through 3 years of age for immune-related outcomes. Studied before the addition of prebiotics.
The levels of total fat and saturated, monounsaturated, and polyunsaturated fatty acids in Enfamil Infant are patterned after levels found in mature U.S. breast milk. Human milk contains, on average, between 20% and 24% of the fatty acids as palmitic acid. Using palm olein oil in the fat blend results in Enfamil Infant having palmitic acid levels similar to breast milk. Linoleic acid provides about 17% of the total fatty acids in Enfamil Infant, which is within the range of means found in average, mature U.S. breast milk (14%–19%).
¶¶ Pooled mean value across 9 studies of mature human milk in the U.S.
*** Similac and Advance are registered trademarks of an entity unrelated to Mead Johnson & Company, LLC.
DHA and ARA
Enfamil formulas have our blend of DHA and ARA, two nutrients also found in breast milk that support brain and eye development and the immune system.
The carbohydrate content in Enfamil Infant is 43.5% of total calories. The primary carbohydrate is lactose, which is the primary carbohydrate found in breast milk†††. The source of lactose in Enfamil Infant is cow's milk. Enfamil Infant also contains the prebiotic carbohydrates galactooligosaccharide (GOS) and polydextrose (PDX). GOS is synthesized from lactose and consists of short, variable-length chains of galactose ending in glucose, while PDX consists of random, highly branched glucose polymers plus sorbitol16,17. A prebiotic is defined as "a selectively fermented ingredient that allows specific changes, both in the composition and/or activity in the gastrointestinal microflora that confers benefits upon host well-being and health18." Prebiotics like GOS and PDX are added to infant formula to substitute for some of the functional properties of human milk oligosaccharides (HMO) which, after lactose and lipid, is the third most abundant and complex component in human milk.
Approximately 200 individual HMO structures have been identified19 and many are readily fermented by bifidobacteria, beneficial bacteria that typically reside in the infant gastrointestinal tract20. In addition to stimulating the growth of beneficial bacteria, HMO have been shown to support mucosal immune function by interfering with the adhesion of a variety of pathogens to epithelial cells16,21. Similar to some of the functional roles attributed to HMO, the supplementation of infant formula with GOS and PDX, or prebiotic blends containing GOS and PDX, has resulted in softer, looser stool patterns similar to that reported for breastfed infants22, increased populations of beneficial bacteria23,24, Bifidobacterium and Lactobacillus species composition closer to that of breastfed infants25, increased fecal secretory IgA26,27, and supported normal immune function28.
††† Comparison based on carbohydrate content of average mature breast milk: remainder composed of oligosaccharides.
Enfamil Infant provides 8.5% of calories as protein, derived from whey and nonfat milk. (For comparison, human milk provides 6%–7% of calories as protein.) This protein level meets the growing infant's need for protein. Similar to mature human milk, the protein in Enfamil Infant comprises 60% whey and 40%‡‡‡ casein proteins. This blend helps promote good growth and development in infants. The levels of essential amino acids in Enfamil Infant are appropriate to promote healthy growth and development.
‡‡‡ Comparison based on whey:casein ratio of typical mature breast milk (15 days to 6 months after birth).
Enfamil Infant also contains nucleotides at a level of 28 mg/L, similar to the average free nucleotide levels in human milk. Nucleotides are the building blocks of the genetic material RNA and DNA, which are integral to cell function and replication.
Vitamins and Minerals
Enfamil Infant provides vitamins and minerals at levels which meet the requirements of the Infant Formula Act and recommendations of the Life Sciences Research Organization (LSRO). These vitamin and mineral levels are appropriate to support infant growth and development.
Calcium and Phosphorus
Enfamil Infant supplies 500 mg calcium and 280 mg phosphorus per quart, the same levels as in Enfamil with DHA and ARA. This level of calcium is adequate to support bone mineralization in infants. The calcium to phosphorus ratio is 1.81:1, which is comparable to the ratio in human milk (2:1). A balanced level of calcium and phosphorus is important for adequate mineral utilization. Feeding Enfamil for the first 4 months of life was shown to result in bone mineral content and bone mineral density comparable to that of breastfed infants at 4 years of age before the addition of prebiotics15.
Enfamil Infant provides 11.5 mg iron per quart, the same level as in other Mead Johnson infant formulas. This level meets current recommendations for iron content of infant formulas. The American Academy of Pediatrics recommends that all infants who are not breastfed receive an iron-fortified formula30.
Enfamil Infant formula is patterned after average free nucleotide levels in breast milk—the gold standard.
Electrolytes—Sodium, Potassium, and Chloride
The electrolyte levels in Enfamil Infant are within the ranges specified by U.S. Food and Drug Administration regulations, as mandated by the U.S. Infant Formula Act10. The sodium, potassium, and chloride levels are 27 mg/100 Calories, 108 mg/100 Calories, and 63 mg/100 Calories, respectively.
Enfamil Infant has our blend of DHA and ARA. Studies demonstrate that infants fed Enfamil with DHA and ARA have better visual acuity, higher mental development scores, and improved respiratory outcomes than infants fed a now discontinued Enfamil® with Iron formula without DHA and ARA33-42. These improvements were shown through 18 months of age for mental and visual and to 3 years of age for immune outcomes (studied before the addition of prebiotics). Clinical studies have demonstrated that Enfamil with DHA and ARA supports growth, is well tolerated, and is safe.
A multicenter, randomized, double-blind, prospective study of 78 infants was conducted to measure how levels of DHA in formula impact red blood cell (RBC) DHA levels, which are thought to be related to brain DHA content and to visual acuity in infancy43. Infants were randomized to one of two formulas—Enfamil with DHA at 0.32% of total fatty acids or Similac® Advance®, with DHA at 0.15% of total fatty acids and a higher a-linolenic acid (ALA) content. Infants were fed their respective formula until 120 days of age. At the end of the study period, researchers measured the fatty acids in blood lipid fractions using capillary gas chromatography. Below summarizes the DHA levels in total-RBC phospholipids, RBC-phosphatidylcholine (RBC-PC), RBC-phosphatidylethanolamine (RBC-PE), and plasma phospholipids (Plasma-PL) at 120 days of age (% of total fatty acids, mean ± SE).
Blood DHA Level Results
|Higher DHA||Lower DHA||P-value|
|DHA, Total RBC||6.67 ± 0.13||4.74 ± 0.15||<0.001|
|DHA, RBC-PC||3.73 ± 0.09||2.39 ± 0.10||<0.001|
|DHA, RBC-PE||10.85 ± 0.21||7.65 ± 0.24||<0.001|
|DHA, Plasma PL||5.85 ± 0.13||4.01 ± 0.14||<0.001|
Dietary DHA intake has a dose-response relationship with infant RBC-PE DHA levels37,43-45.
ALA = a-linolenic acid PUFAs = polyunsaturated fatty acids RBC-PE = red blood cell-phosphatidylethanolamine §§§ Similac® and Advance® are registered trademarks of an entity unrelated to Mead Johnson & Company, LLC.
ALA, a precursor of DHA, is present at varying levels in infant formulas43.
Infants can convert ALA to DHA, but the conversion is highly variable and may be extremely low for some infants46,47
Enfamil with DHA and ARA demonstrated a 42% higher level of DHA in infant RBC-PE vs Similac Advance43.
Benefits of Enfamil Infant
Enfamil Infant has Natural Defense™ Dual Prebiotics—clinically shown to provide a bifidogenic effect similar to that of breast milk in infants fed our formula between 30-90 days of life5.
The mucosal immune system in the infant gut is a first line of defense against environmental pathogens48-50. Breast milk contains short- and long-chain prebiotics that nurture beneficial bacteria throughout the large intestine51. Early colonization of beneficial bacteria throughout the GI tract contributes to normal maturation of the immune system51. With more beneficial bacteria, pathogenic bacteria cannot colonize the gut or adhere to the gut epithelium as easily52.
Our proprietary Natural Defense Dual Prebiotic™ blend contains 2 types of prebiotics—GOS and PDX—designed to work in tandem to foster the growth of beneficial bacteria throughout the large intestine53. As such, the new blend is more similar to breast milk than our previous 2 g/L GOS-only formulation5.
Enfamil Infant with our Natural Defense Dual Prebiotic blend has also been clinically proven to be well tolerated and to result in intestinal flora and softer stools more similar to those of breastfed infants2,53,||||||.
|||||| Compared with those of infants fed Enfamil with DHA and ARA without prebiotics.
Two recent multi-center, double-blind, parallel-designed studies involved a total of 578 infants, ranging in age from 14 to 35 days of age. The study randomized the infants to receive Enfamil with DHA and ARA as the control or an investigational formula with GOS and PDX. Stool samples were obtained after 30 and 60 days in one study and 60, 90, and 120 days in the other study. Infants fed investigational formulas had softer stools than those fed control formula, and stools remained softer at 120 days53. In addition, the formulas were equally well tolerated and supported normal growth2,53.
It was also shown in a recent clinical study that Enfamil Infant Natural Defense Dual Prebiotic blend supports calcium status similar to that of a marketed control formula without the prebiotic blend54,55. And another study suggests prebiotic blends had a greater effect on the fecal bacteria of younger infants, implying that infant age may be a variable more important than originally expected3.
Brain and Eye Development
As we have shown, infants fed formula with higher levels of DHA have significantly higher levels of DHA in their blood. In addition, in nine published clinical studies, higher dietary DHA levels were correlated with improved visual and/or mental development. These studies were done before the addition of prebiotics to the formula33-38,42,56-63.
In one of these studies, DHA and ARA supplementation of term infants during the first year of life showed a clear difference in visual function and in total RBC lipid composition45. The study was a double-masked, randomized, controlled clinical trial involving 103 term infants who were randomly assigned to receive either Enfamil with DHA and ARA or the (now discontinued) Enfamil with Iron without DHA and ARA. Assigned diets were fed from 1-5 days through 52 weeks of life. Visual evoked potential (VEP) acuity in the group fed Enfamil with DHA and ARA was significantly better than the control group at ages 6, 17, 39, and 52 weeks. Also, the RBC-DHA concentration in the Enfamil with DHA and ARA group was more than double the control group by 17 weeks and more than triple by 39 weeks.
Formula-fed term infants who received Enfamil with DHA and ARA for 4 months had better visual acuity (equivalent to about one line higher on an eye chart) at ages 12 and 18 months when compared with similar infants who had received (now discontinued) Enfamil with Iron without DHA and ARA11,38-42. Breastfed infants who were weaned to Enfamil with DHA and ARA showed similar improvements in visual acuity. In 2 separate studies, infants who were breastfed for 6 weeks or 4-6 months and then weaned to Enfamil with DHA and ARA experienced improvements in visual acuity at 12 months of age compared with breastfed infants who were weaned at similar ages to Enfamil with Iron40,41.
Additionally, an analysis by Morale et al39, involving 243 infants, showed that infants continue to benefit from a dietary supply of DHA and ARA throughout the first year of life. Data from 4 randomized clinical trials from a single site over the last 10 years were analyzed. All trials had consistent inclusion/exclusion criteria, infant formulas, and outcome measures. The trials included a 4-month feeding trial, a 12-month feeding trial, a 6-week weaning trial, and a 4-to-6-month weaning trial. Data was also used from 2 reference groups of breastfed healthy term infants who were tested concurrently. The study showed that a longer duration of DHA/ARA supplementation was associated with better mean visual acuity at age 52 weeks (r=-0.878, P<0.001).
Infants who received Enfamil with DHA and ARA also demonstrated significantly higher mental development scores than infants who received (now discontinued) Enfamil with Iron without DHA and ARA. Term infants who received Enfamil with DHA and ARA scored 7 points higher on the Mental Development Index (MDI) of the Bayley Scales of Infant Development II at age 18 months than term infants fed (now discontinued) Enfamil with Iron without DHA and ARA30. The MDI scores of the infants fed Enfamil with DHA and ARA were not different from scores of breastfed reference infants35.
At 18 months corrected age (CA), preterm infants who received Enfamil® Premature and Enfamil® EnfaCare®, followed by Enfamil with DHA and ARA until one year CA, had significantly higher scores on the Psychomotor Development Index (PDI) of the Bayley Scales of Infant Development II than preterm infants who received the (now discontinued) same formulas without DHA and ARA64.
In a separate study, the findings of Birch and colleagues support the hypothesis that dietary supplementation with LCPUFAs in infancy may confer long-term advantages for cognitive function in later life. The key finding (figure 1) here is that children who were fed DHA+ ARA-supplemented formula had Full Scale IQ scores that did not differ significantly from breastfed children8.
¶¶¶ Significantly poorer than breastfed. Data adapted from Early Human Dev. By Birch EE, Garfield S, Castañeda Y, et al. Visual acuity at 4 years of age in a double-blind, randomized trial of long-chain polyunsaturated fatty acid-supplemented infant formula. 279-284, 2007, with permission from Elsevier.
Enfamil Infant has our blend of DHA and ARA. Clinical studies have demonstrated that Enfamil with DHA and ARA supports growth, is well tolerated, and is safe. Infants fed Enfamil with DHA and ARA experience suitable growth and development. In a study of 276 term infants, those who received Enfamil with DHA and ARA for the first year of life grew as well as infants who received (now discontinued) Enfamil with Iron without DHA and ARA65.
Infants fed Enfamil with DHA and ARA track similarly to breastfed infants in weight patterns7
A later study of preterm infants found that those who received Enfamil Premature, Enfamil EnfaCare, and Enfamil with DHA and ARA (LIPIL) until one year CA had significantly greater achieved weight from 6 months CA through 18 months CA compared with infants who received the (now discontinued) same formulas without DHA and ARA. Weights of the LIPIL group were comparable to that of full-term breastfed infants at 18 months CA. Infants in the LIPIL group also had significantly greater achieved lengths at 2, 9, and 12 months CA than infants who received (now discontinued) Enfamil without DHA and ARA. Lengths of the LIPIL group were comparable to that of the term human milk-fed infants from 9 through 18 months CA64.
Growth of Premature Infants Fed Enfamil with DHA and ARA Formulas67
* P<0.05 for breastfed full-term infants vs all preterm groups. † No significant difference (P>0.05) for Enfamil with DHA and ARA formulas vs breastfed, full-term infants, but P<0.05 for control formulas vs breastfed, full-term infants. ‡ P<0.05 for control formulas vs Enfamil with DHA and ARA formulas. From a randomized, double-blind, multicenter trial involving 245 VLBW infants and 105 breastfed, full-term infants62. Some infants in this study were fed formulas supplemented with DHA from a fish source, but data are not shown in the graph. § Enfamil Premature, Enfamil EnfaCare, and Enfamil with DHA and ARA.
Fat Absorption and Calcium Absorption and Retention
Feeding Enfamil with Iron results in appropriate fat absorption and calcium absorption and retention. Fat absorption and calcium absorption and retention were compared in a randomized balance study of Enfamil with Iron containing a previously marketed 2-oil fat blend or the 4-oil fat blend of 45% palm olein, 20% soy oil, 20% coconut oil, and 15% high oleic sunflower oil. Twenty growing premature infants weighing at least 1500 g completed the study, 10 in each group. The percent of fat absorption was not statistically different between the 4-oil blend group (84%) and the 2-oil blend group (87%)66. Fat absorption from the 4-oil blend was similar to published values for preterm infants of similar age and weight fed their own mother's milk (84%-88% from 2 studies)67,68. The amount of calcium absorbed from formula containing the 4-oil blend (38%) was also similar to the amount of calcium absorbed from the 2-oil blend (42%). There were no differences in calcium retention from the 2 formulas. The American Academy of Pediatrics has stated that infant formulas should have net calcium retention at least comparable to that from human milk69. The amount of calcium retained by infants fed Enfamil with Iron with the 4-oil fat blend was comparable to the amount retained by breastfed infants reported in the literature70‑75.
A study of 178 healthy 4-year-old children showed no difference in the bone mineral content or bone mineral density of infants who were breastfed or formula-fed with a formula containing palm olein oil15. There were 3 groups of children in the study: those who were exclusively fed either human milk, Enfamil with Iron (containing palm olein oil), or Similac® (containing no palm olein oil) during the first 4 months of life. No significant differences among the feeding groups were noted in bone mineral content or bone mineral density (P=0.51 and 0.89, respectively).
Safety and Tolerance
Enfamil Infant is well tolerated and safe. In clinical studies comparing infants fed formulas including DHA and ARA with infants fed formulas without DHA and ARA, there were no clinically significant differences in tolerance, and the addition of DHA and ARA had no effect on the incidence of adverse events64,65,76,77.
Moreover, Mead Johnson monitors all spontaneous reports on marketed infant formulas. Reports on Enfamil with DHA and ARA were compared with reports on Enfamil with Iron, and no clinically relevant differences in reports of spitting up, vomiting, diarrhea, etc. were found75. The sources of DHA and ARA in Enfamil Infant are Generally Recognized as Safe (GRAS) for use in infant formula by the U.S. Food and Drug Administration78,79.
1. Colombo J, Carlson SE, Cheatham CL, et al. Long-term effects of LCPUFA supplementation on childhood cognitive outcomes. Am J Clin Nutr. 2013;98:403-412.
2. Brenna JT, Varamini B, Jensen RG, et al. Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. Am J Clin Nutr. 2007;85:1457-1464.
3. Birch EE, Khoury JC, Berseth CL, et al. The impact of early nutrition on incidence of allergic manifestations and common respiratory illnesses in children. J Pediatr. 2010;156:902-906.
4. Scalabrin D, Mitmesser SH, Welling GW, et al. New prebiotic blend of polydextrose and galacto-oligosaccharides has a bifidogenic effect in young infants. J Pediatr Gastroenterol Nutr. 2012;54:343-352.
5. Salminen S, Endo A, Isolauri E, et al. Early gut colonization with lactobacilli and staphylococcus in infants: the hygiene hypothesis extended. J Pediatr Gastroenterol Nutr. 2016;62:80-86.
6. Ziegler E, Vanderhoof JA, Petschow B, et al. Term infants fed formula supplemented with selected blends of prebiotics grow normally and have soft stools similar to those reported for breast-fed infants. J Pediatr Gastroenterol Nutr. 2007;44:359-364.
7. Ferguson PW, Mitmesser SH, Maharaj N, et al. How is baby doing? Growth of US and Canadian infants using the Centers for Disease Control and Prevention and World Health Organization charts. Nutr Today. 2007;42:151-159.
8. Kunz C, Lönnerdal B. Re-evaluation of the whey protein/casein ratio of human milk. Acta Paediatr. 1992;81:107-112.
9. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.
10. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.
11. Koletzko B, Thiel I, Abiodun PO. The fatty acid composition of human milk in Europe and Africa. J Pediatr. 1992; 120(supple):S62-S70.
12. Data on file, Mead Johnson Nutritionals, September 2002.
13. The British Nutrition Foundation. Recommendations for intakes of unsaturated fatty acids. In: Unsaturated Fatty Acids: Nutritional and Physiological Significance: The Report of the British Nutrition Foundation's Task Force. London: Chapman & Hall; 1992:152-163.
14. Koletzko B, Agostoni C, Carlson SE, et al. Long chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001;90:460-464.
15. Young RJ, Antonson DL, Ferguson PW, et al. Neonatal and infant feeding: effect on bone density at 4 years. J Pediatr Gastroenterol Nutr. 2005;41:88-93.
16. Kunz C, Rudloff S, Baier W, et al. Oligosaccharides in human milk: structural, functional, and metabolic aspects. Annu Rev Nutr. 2000;20:699-722.
17. Craig JF, Holden JP, Auerbach MH, et al. Polydextrose as soluble fiber: physiological and analytical aspects. American Association of Cereal Chemists. 1998;43:370-376.
18. Roberfroid M. Prebiotics: the concept revisited. J Nutr. 2007;137:830S-837S.
19. Ninonuevo M, Park Y, Yin H, et al. A strategy for annotating the human milk glycome. J Agric Food Chem. 2006;54:7471-7480.
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