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PEDIATRICS Vol. 89 No. 6 June 1992 1105

AMERICAN ACADEMY OF PEDIATRICS

The Use of Whole Cow’s Milk in Infancy

Committee on Nutrition

The Committee on Nutrition continues to monitorand review nutritional issues concerning the use ofwhole cow’s milk (WCM) in the diets of infants. Thegoal of those concerned with infant nutrition is theprovision of an optimal diet. The recommendationsin this statement replace those provided in the 1983statement, “The Use of Whole Cow’s Milk in In-fancy.” The 1983 statement focused primarily on theissue of iron nutriture in infancy. In a broader context,the statement addressed a substantial number of oftencontroversial nutrition issues, defined as “researchneeds,” surrounding the appropriateness of usingwhole cow’s milk for infants during the first 12months. The purpose of this statement is to providenew recommendations on the optimal feeding of in-

fants. The use of skim milk and reduced-fat milk (eg,2% milk) remains inappropriate during the first yearof life and will not be reviewed in this statement.

REVIEW OF PREVIOUS STATEMENTS

During the last 20 years, the use of whole cow’s

milk in infancy has been discussed by the Committeeon Nutrition principally, but not exclusively, in thecontext of meeting infants’ iron needs. In 1969, anextensive commentary2 reviewed iron requirementsin infancy, and in 1971, a policy statement3 recom-mended that iron-fortified formulas be used for thefirst 1 2 months of life. Those recommendations wereprompted by a significant prevalence of iron defi-ciency in older infants associated with the extensiveuse of whole cow’s milk in later infancy. “Fluid wholemilk (available in bottle or carton) or evaporated milk,

both of which contain only trace amounts of iron, aresubstituted at the time of greatest iron need andhighest prevalence of iron deficiency anemia.”3

Several clinical studies demonstrated that feedingiron-fortified formulas to infants for the first 12months resulted in excellent iron status.47 The Com-

mittee believed that adding iron to the infant’s majorsource of calories (milk-based formula) was a practicaland effective method to alleviate the high prevalenceof iron deficiency anemia.

In 1976, the Committee on Nutrition issued astatement8 recommending the use of either iron-for-

tified formula or infant cereal during older infancy.The Committee noted the following; “Infant formulaand other heat-treated milk products are preferable

The recommendations in this statement do not indicate an exclusive course

of treatment or procedure to be followed, Variations, taking into account

individual circumstances, may be appropriate.

PEDIATRICS (ISSN 0031 4005). Copyright © 1992 by the American Acad-

emy of Pediatrics.

to fresh [pasteurized] cow’s milk as substitutes forbreast milk feeding during the first 6 to 1 2 months of

life because excessive ingestion of fresh cow’s milkmay contribute to iron deficiency by increasing gas-trointestinal blood lOS5.��8

In 1983, the Committee on Nutrition developed anew position,’ based largely on a study by Fomon et

al9 of gastrointestinal blood loss in infants aged 4 to6 months fed WCM, heat-treated WCM, or infantformula. All infants received supplemental ferroussulfate and ascorbic acid. Enteric blood loss was great-

est in WCM-fed infants younger than 4#{189}months ofage. In infants between 4’/2 and 6 months of age,there was no difference among the three groups(WCM, heat-treated WCM, or infant formula) in thenumber of guaiac-positive stools, mean hemoglobinlevels, serum iron levels, iron binding capacity, ortransferrin saturation. Consequently, the 1983statement’ suggested that whole cow’s milk couldreplace iron-fortified formulas when infants olderthan 6 months of age were consuming at least onethird of their calories from supplemental foods. Thequestion of whether feeding iron-fortified formula toinfants for the first 6 months of life would be suffi-aent to prevent iron deficiency during the next 6months when they are started on whole cow’s milkcould not be answered from the existing data.

REVIEW OF RESEARCH QUESTIONS POSED IN THE1983 STATEMENT2 ON THE “USE OF WHOLE COW’S

MILK IN INFANCY.”

Since the 1983 recommendations, several newstudies have been published that address the five

questions posed in this statement. Results of thesestudies require further refinement regarding the feed-ing recommendations for later infancy.

1. “What is the rate and variability of maturation ofinfant gastrointestinal mucosal barrier function?”

The gastrointestinal tract is immature early in life.Consequently, there is an increased transfer of intactdietary protein from the intestinal lumen into thecirculation in the immediate neonatal period, partic-ularly in preterm infants and infants who have gut�injury.dlu Although controversial, it is believed thatincreased intestinal permeability may contribute tothe high incidence of cow’s milk protein allergy, acondition that affects 0.4% to 7.5% of the infantpopulation.” There is no information to suggest thatWCM is more allergenic than infant formulas thatcontain intact cow’s milk proteins. Infants with cow’smilk protein allergy should not be fed either WCM or

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1106 USE OF WHOLE COW’S MILK

formulas containing intact WCM proteins. In nonal-lergic infants, the introduction of whole cow’s milk

should be based on digestive and nutritional consid-erations, not on the development of the mucosalbarrier.

2. “What is the relative importance of the amount andbioavailability of iron in the total diet when wholecow’s milk is substituted for iron-enriched formulaat 6 months of age? Does iron-fortified cereal meetthe infant’s need for iron?”

Six studies’2’7 based on four independent surveys(Second National Health and Nutrition ExaminationSurvey Department of Agriculture Food Consump-

tion, Ross Mothers Study, and Gerber NutritionalSurvey) have been published to date and reviewed.Five of the six studies suggest that infants fed whole

cow’s milk in later infancy have median iron intakesbelow the recommended daily allowance. These re-sults clearly indicate that an insufficient quantity ofiron-fortified infant cereal is currently incorporatedinto the diet of most infants to meet iron needs.However, infant cereal is the single largest source of

iron from infant solid foods available in the UnitedStates. Parents who feed their infants whole cow’s

milk must also judiciously select solid foods thatcontain iron.

The bioavailability of electrolytic iron, the form ofiron that is added to infant foods, remains incom-pletely defined and controversial. Furthermore, quan-

titative studies of electrolytic iron absorption havebeen conducted only with adult subjects. Electrolyticiron is produced by electrolytic deposition of iron thatis mechanically commuted to powder (grade A-131).

Fomon’8 notes that cereals marketed in the UnitedStates and Canada containing electrolytic iron arefortified with 45 mg of iron/100 g of dry weight, orapproximately 7 mg of iron/100 g of cereal as fed (ie,after dilution with milk or formula). Forbes et al,’9using a farina-based meal, demonstrated absorption

of iron of a similar particle size to be 75% that offerrous sulfate. Elwood2#{176} demonstrated that absorp-tion of commercially used iron powder in baked bread

is about 5% that of ferrous sulfate. Fomon,’8’2’ usingElwood’s data, calculated that absorbed iron frominfant cereal could only account for 0.12 mg of the

0.6 to 0.7 mg of absorbed iron that infants require

each day. Both Fomon and Elwood concluded thatwithout evidence of adequate bioavailability, the elec-trolytic iron used in infant cereals is not sufficient to

meet the iron needs of infants fed whole cow’s milk.The composition of whole cow’s milk (ie, high

calcium, high phosphorus, and low vitamin C) maydecrease the bioavailability of iron from other dietarysources such as infant cereals.22 Three studies2325compared the iron status of infants receiving iron-fortified formulas for the first 6 months of life andthen fed WCM or iron-fortified formulas in accord-

ance with the 1983 American Academy of Pediatricsrecommendations for the next 6-month period. In all

three studies, iron status was significantly poorer ininfants fed WCM.

Fortification of other infant foods, including wet-pack cereal-fruit products, grape juice, or milk forti-

fied with a highly bioavailable form of iron (ferrous

sulfate with vitamin C), but less modified than regularinfant formula, appear promising,26 but largely unex-plored in the United States. Haschke et al27 demon-strated indices of iron adequacy similar to infants fed

only iron-fortified formula using meat-containing in-fant foods fortified with ferrous sulfate and ascorbicacid that are commercially available in Austria andthe Federal Republic of Germany, but not in the

United States. Stekel et al28 in Chile studied thebioavailability of ferrous sulfate-fortified (elementaliron, 10 to 19 mg/L) low-fat and whole milks (less

modified than regular commercial formula) fed toinfants, many of whom were iron-deficient. Iron ab-

sorption from milk containing ascorbic acid (100 mgIL) ranged from 5.9% to 1 1 .3% and was not influencedby the amount of milk fat, the addition of carbohy-

drate, or acidification. Results of longitudinal fieldtrials of infants from age 3 to 1 5 months with a full-fat iron-fortified acidified milk showed effective elim-

ination of iron deficiency.29Evidence now suggests that the current feeding

practice in the United States of using iron-fortified

cereal does not meet the requirement for iron whenWCM is used during the second 6 months of life. Thismay be due to poor compliance or insufficient bio-

availability of electrolytic iron. However, providingiron-fortified formula and cereal for the first 12months, as utilized in the Women, Infants, and Chil-

then Program, has been successful in reducing iron331

3. “Can the change to cow’s milk when the infant is 6months old produce anemia from occult blood losswhen the milk is fed in excessive amounts and thereis no iron supplementation?”

This question has been the subject of additionalstudy and commentary. Both Woodruff32 andWilson33 concluded that blood loss did occur in in-fants fed WCM after 6 months of age. Following the

gastrointestinal blood loss study by Fomon et al,9Ziegler et al34 used a more sensitive assay for stoolhemoglobin in a second study of blood loss in 6-

month-old infants fed either infant formula or WCMwithout iron supplementation. Intestinal blood lossincreased in 30% of infants fed WCM but did notincrease in the formula-fed group, even though all

were previously fed iron-fortified formula or werebreast-fed in the first 6 months of life.34 One infantin the WCM group was removed from the studybecause of iron deficiency. The investigators con-cluded that infants fed WCM had a nutritionally

significant loss of iron in the stools. These studiesclearly show that blood loss will occur in a substantialpercentage of infants who receive WCM for the firsttime after 6 months of age. On the basis of theserecent results,34 Fomon and Ziegler reversed theirearlier positions,9 stating that they no longer recom-mended WCM in the second 6 months, but preferredbreast milk or iron-fortified formula for the first 12

months of life.35’36 The reasons for these recommen-dations include the substantial enteric blood loss ininfants fed WCM, the probable low bioavailability ofiron absorbed from infant cereals, and the probable


AMERICAN ACADEMY OF PEDIATRICS 1107

inhibition of iron availability in WCM due to high

concentrations of calcium and phosphorous and low

concentration of ascorbic acid.

4. “What is the relative importance of the high soluteload of whole cow’s milk in the total feedingregimen of a 6- to 12-month-old infant? For example,how much of the high-solute load of whole cow’s

milk is diluted by other foods in the diet?”

Data from several studies show that infants fed

WCM instead of infant formula have a markedlyincreased intake of sodium, potassium, chloride, andprotein.’2’6 The sodium intake (1000 mg/d) of WCM-

fed infants substantially exceeds the estimated mini-mum requirements (120 mg/d for infants from birth

to 5 months old and 200 mg/day for infants 6 to 11months old). By comparison, the median sodium in-take for formula-fed infants (7 to 1 2 months old) is580 mg/d.’2 Consequently, the renal solute load of

WCM-fed infants exceeds that of formula-fed infantsby two- to threefold (from approximately 1 25 to 300mOsm).’6 Ziegler36 calculated the potential renal sol-ute load of two hypothetical infants, 6- and 10-months-old, fed infant solids and formula versusinfant solids and WCM. When WCM replaced for-mula, the potential renal solute load increased two-

fold in the 6-month-old infant (42 vs 21 mOsm/100kcal) and nearly twofold in the 10-month-old infant(39 vs 26 mOsm/100 kcal). He concluded that bothinfants exceeded their recommended maximum (33

mOsm/100 kcal) potential renal solute load when fedWCM and that WCM feeding would narrow the

margin of safety in situations that may lead to dehy-dration. Thus, the high renal solute load of WCM wasnot diluted by other foods in the diet.

5. “What is the relative importance of the nutrients notpresent in whole cow’s milk but present in infantformula and breast milk, ie, essential fatty acids,tocopherol, ascorbic acid? How much of thesenutrients are obtained from the other foodscommonly used in the 6- to 12-month age group?”

Substitution of WCM for formula reduced the in-

take of ascorbic acid, but not below the recommended

daily allowance’2”3 However, the median intake of

linoleic acid was reduced dramatically to 1 .8% of total

energy intake, well below the recommended level of3% 1’�,16

In one study37 of 97 older infants, intake of a-tocopherol was significantly lower in WCM-fed in-fants than in formula-fed infants (3.7 ± 2.6 mg/d vs

10.9 ± 3.1 mg/d). Moreover, a-tocopherol status, asassessed by plasma concentrations, was significantly

greater in the formula-fed infants (1 . 14 ± 0.42 vs0.86 ± 0.28).

The studies of the past 7 years demonstrate the

difficulty of providing a balanced diet for older in-fants when WCM replaces breast milk or iron-forti-fied formula. Nutrients from commonly consumedsolid foods do not complement nutrients from WCM;

rather, they exaggerate the deficiencies (iron, linoleicacid, and vitamin E) and excesses (sodium, potassium,

chloride, and protein) in the infant’s diet.

NEW STUDIES ON IRON DEFICIENCY ANDBEHAVIOR

Earlier studies by Oski and co-workers38 show thatiron deficiency in infants and children is associated

with subtle behavioral differences. Additional recentstudies3942 suggest that iron deficiency in early child-

hood may lead to long-term changes in behavior thatmay not be reversed even with iron supplementation

sufficient to correct the anemia. Newly published

studies on iron deficiency and behavior show theimportance of iron deficiency in WCM-fed infants.The biochemical mechanism linking iron deficiencyand behavior may be identified from studies from

Youdim’s group in experimental animals.4345 Theseresearchers have shown that the number of dopamine

D-2 receptors in the rat brain is reduced when theexperimental animals undergo a transient period ofiron deficiency during infancy and are not subse-quently restored with iron supplementation. Al-though they require confirmation and further ampli-

fication, these studies provide a possible model of amechanism in which a transient nutritional event may

produce long-term changes in the neurologic statusof the brain of the animal studied. Additional researchis necessary to understand the implications of irondeficiency to possible brain dysfunction in humans.

SUMMARY

The pediatrician is faced with a difficult challengein providing recommendations for optimal nutrition

in older infants. Because the milk (or formula) portionof the diet represents 35% to 100% of total daily

calories and because WCM and breast milk or infantformula differ markedly in composition, the selectionof a milk or formula has a great impact on nutrientintake.

Infants fed WCM have low intakes of iron, linoleic

acid, and vitamin E, and excessive intakes of sodium,potassium, and protein, illustrating the poor nutri-

tional compatibility of solid foods and WCM. Thesenutrient intakes are not optimal and may result inaltered nutritional status, with the most dramaticeffect on iron status. Infants fed iron-fortified formula

or breast milk for the first 1 2 months of life generallymaintain normal iron status. No studies have con-cluded that the introduction of WCM into the diet at6 months of age produces adequate iron status in laterinfancy; however, recent studies have demonstratedthat iron status is significantly impaired when WCMis introduced into the diet of 6-month-old infants.

Data from studies abroad of highly iron-deficientinfant populations suggest that infants fed partiallymodified milk formulas with supplemental iron in ahighly bioavailable form (ferrous sulfate) may main-

tam adequate iron status. However, these studies donot address the overall nutritional adequacy of the

infant’s diet. Such formulas have not been studied inthe United States.

Optimal nutrition of the infant involves selectingthe appropriate milk source and eventually introduc-ing infant solid foods. To achieve this goal, the Amer-ican Academy of Pediatrics recommends that infants

be fed breast milk for the first 6 to 1 2 months. The


1108 USE OF WHOLE COW’S MILK

only acceptable alternative to breast milk is iron-fortified infant formula. Appropriate solid foodsshould be added between the ages of 4 and 6 months.Consumption of breast milk or iron-fortified formula,

along with age-appropriate solid foods and juices,during the first 1 2 months of life allows for morebalanced nutrition. The American Academy of Pedi-atrics recommends that whole cow’s milk and low-iron formulas not be used during the first year of life.

COMMFI-rEE ON NUTRITION, 1991 TO

1992

Ronald E. Kleinman, MD, ChairmanSusan S. Baker, MDEdward F. Bell, MDTerry F. Hatch, MDWilliam J. Klish, MDRudolph L. Leibel, MDJohn N. Udall, MD

Liaison RepresentativesMargaret Cheney, PhD, Bureau of

Nutritional Sciences, Canada

Joginder Chopra, MD, Food and DrugAdministration

Cynthia Ford, RD, MS.US Department of Agriculture

Van S. Hubbard, MD, NationalInstitute of Diabetes & Digestive &Kidney Diseases

Ephraim Levin, MD, National Instituteof Child Health & HumanDevelopment

Ann Prendergast, RD, MPH, Bureauof Health Care Delivery &Assistance

Micheline Ste-Marie, MD, CanadianPaediatric Society

Alice Smith, RD, American DieteticAssociation

Ray Yip, MD, MPH, Centers forDisease Control

AAP Section LiaisonRonald M. Lauer, MD, Section of

Cardiology

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AMERICAN ACADEMY OF PEDIATRICS 1109

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