Infant formula - Wikipedia

The most commonly used infant formulas contain purified cow's milk whey and casein as a protein source, a blend of vegetable oils as a fat source, lactose as a ... Infantformula FromWikipedia,thefreeencyclopedia Jumptonavigation Jumptosearch Manufacturedfooddesignedforfeedinginfants Infantformula Aninfantbeingfedfromababybottle Infantformula,babyformulaorjustformula(AmericanEnglish)orbabymilk,infantmilk,falsemilk,orfirstmilk(BritishEnglish),isamanufacturedfooddesignedandmarketedforfeedingtobabiesandinfantsunder12monthsofage,usuallypreparedforbottle-feedingorcup-feedingfrompowder(mixedwithwater)orliquid(withorwithoutadditionalwater).TheU.S.FederalFood,Drug,andCosmeticAct(FFDCA)definesinfantformulaas"afoodwhichpurportstobeorisrepresentedforspecialdietaryusesolelyasafoodforinfantsbyreasonofitssimulationofhumanmilkoritssuitabilityasacompleteorpartialsubstituteforhumanmilk".[1] Manufacturersstatethatthecompositionofinfantformulaisdesignedtoberoughlybasedonahumanmother'smilkatapproximatelyonetothreemonthspostpartum;however,therearesignificantdifferencesinthenutrientcontentoftheseproducts.[2]Themostcommonlyusedinfantformulascontainpurifiedcow'smilkwheyandcaseinasaproteinsource,ablendofvegetableoilsasafatsource[note1],lactoseasacarbohydratesource,avitamin-mineralmix,andotheringredientsdependingonthemanufacturer.[3]Inaddition,thereareinfantformulasusingsoybeanasaproteinsourceinplaceofcow'smilk(mostlyintheUnitedStatesandGreatBritain)andformulasusingproteinhydrolysedintoitscomponentaminoacidsforinfantswhoareallergictootherproteins.Anupswinginbreastfeedinginmanycountrieshasbeenaccompaniedbyadefermentintheaverageageofintroductionofbabyfoods(includingcow'smilk),resultinginbothincreasedbreastfeedingandincreaseduseofinfantformulabetweentheagesof3-and12-months.[4][5] A2001WorldHealthOrganization(WHO)reportfoundthatinfantformulapreparedinaccordancewithapplicableCodexAlimentariusstandardswasasafecomplementaryfoodandasuitablebreastmilksubstitute.In2003,theWHOandUNICEFpublishedtheirGlobalStrategyforInfantandYoungChildFeeding,whichrestatedthat"processed-foodproductsfor...youngchildrenshould,whensoldorotherwisedistributed,meetapplicablestandardsrecommendedbytheCodexAlimentariusCommission",andalsowarnedthat"lackofbreastfeeding—andespeciallylackofexclusivebreastfeedingduringthefirsthalf-yearoflife—areimportantriskfactorsforinfantandchildhoodmorbidityandmortality". Inparticular,theuseofinfantformulainlesseconomicallydevelopedcountriesislinkedtopoorerhealthoutcomesbecauseoftheprevalenceofunsanitarypreparationconditions,includinglackofcleanwaterandlackofsanitizingequipment.[6]Aformula-fedchildlivinginuncleanconditionsisbetween6and25timesmorelikelytodieofdiarrheaandfourtimesmorelikelytodieofpneumoniathanabreastfedchild.[7]Rarely,useofpowderedinfantformula(PIF)hasbeenassociatedwithseriousillness,andevendeath,duetoinfectionwithCronobactersakazakiiandothermicroorganismsthatcanbeintroducedtoPIFduringitsproduction.AlthoughC.sakazakiicancauseillnessinallagegroups,infantsarebelievedtobeatgreatestriskofinfection.Between1958and2006,therehavebeenseveraldozenreportedcasesofC.sakazakiiinfectionworldwide.TheWHObelievesthatsuchinfectionsareunder-reported.[8] Contents 1Uses,risksandcontroversies 1.1Useofinfantformula 1.2Healthrisks 1.2.1Melaminecontamination 1.2.2Otherhealthcontroversies 2Preparationandcontent 2.1Variations 2.2Nutritionalcontent 3Policy,industryandmarketing 3.1International 3.2Bycountry 3.2.1Philippines 3.2.2SouthAfrica 3.2.3UnitedKingdom 3.2.4UnitedStates 3.32022UnitedStatesBabyFormulaShortages 4History 4.1Earlyinfantfoods 4.2Rawmilkformulas 4.3Evaporatedmilkformulas 4.4Commercialformulas 4.5Genericbrandformulas 4.6Follow-onandtoddlerformulas 4.7Usagesince1970s 5Infantformulaprocessing 5.1History 5.2Currentgeneralprocedure 5.2.1Mixingingredients 5.2.2Pasteurization 5.2.3Homogenization 5.2.4Standardization 5.2.5Packaging 5.2.6Heattreatmentorsterilization 5.3Recentandfuturepotentialnewingredients 5.3.1Probiotics 5.3.2Prebiotics 5.3.3Lysozymeandlactoferrin 5.3.4Longchainpolyunsaturatedfattyacidsupplementation 6Seealso 7Notes 8References 9Furtherreading 10Externallinks Uses,risksandcontroversies[edit] Furtherinformation:Infantfoodsafety Theuseandmarketingofinfantformulahascomeunderscrutiny.Breastfeeding,includingexclusivebreastfeedingforthefirst6monthsoflife,iswidelyadvocatedas"ideal"forbabiesandinfants,bothbyhealthauthorities[6][9]—andaccordinglyinethicaladvertisingofinfantformulamanufacturers.[10] Despitetherecommendationthatbabiesbeexclusivelybreastfedforthefirst6months,lessthan40%ofinfantsbelowthisageareexclusivelybreastfedworldwide.[11]TheoverwhelmingmajorityofAmericanbabiesarenotexclusivelybreastfedforthisperiod—in2005under12%ofbabieswerebreastfedexclusivelyforthefirst6months,[9]withover60%ofbabiesof2monthsofagebeingfedformula,[12]andapproximatelyoneinfourbreastfedinfantshavinginfantformulafeedingwithintwodaysofbirth.[13] Somestudieshaveshownthatuseofformulacanvaryaccordingtotheparents'socio-economicstatus,ethnicityorothercharacteristics.Forexample,accordingtoaresearchconductedinVancouver,Canada,82.9%ofmothersbreastfeedtheirbabiesatbirth,butthenumberdifferedbetweenCaucasians(91.6%)andnon-Caucasians(56.8%),withthedifferenceessentiallyattributedtomaritalstatus,educationandfamilyincome.[14]IntheUnitedStates,mothersoflowersocio-economicstatushavebeenfoundlesslikelytobreastfeed,althoughthismaybepartlyrelatedtoadverseeffectsofgovernmentnutritionsupplementationprogramsthatprovidesubsidiesforinfantformula.[15] Theuseofhydrolysedcowmilkbabyformulaversusstandardmilkbabyformuladoesnotappeartochangetheriskofallergiesorautoimmunediseases.[16] Useofinfantformula[edit] Mainarticle:Breastfeedingcontraindications Insomecases,breastfeedingismedicallycontraindicated.Theseinclude: Mother'shealth:ThemotherisinfectedwithHIVorhasactivetuberculosis.[17]Sheisextremelyillorhashadcertainkindsofbreastsurgery,whichmayhaveremovedordisconnectedallmilk-producingpartsofthebreast.Sheistakinganykindofdrugthatcouldharmthebaby,includingbothprescriptiondrugssuchascytotoxicchemotherapyforcancertreatmentsaswellasillicitdrugs.[17] OneofthemainglobalrisksposedbybreastmilkspecificallyisthetransmissionofHIVandotherinfectiousdiseases.BreastfeedingbyanHIV-infectedmotherposesa5–20%chanceoftransmittingHIVtothebaby.[18][19][20]However,ifamotherhasHIV,sheismorelikelytotransmitittoherchildduringthepregnancyorbirththanduringbreastfeeding.A2012studyconductedbyresearchersfromtheUniversityofNorthCarolinaSchoolofMedicineshowedreducedHIV-1transmissioninhumanizedmice,duetocomponentsinthebreastmilk.[21]Cytomegalovirusinfectionposespotentiallydangerousconsequencesforpre-termbabies.[19][22]Otherrisksincludemother'sinfectionwithHTLV-1orHTLV-2(virusesthatcouldcauseT-cellleukemiainthebaby),[19][20]herpessimplexwhenlesionsarepresentonthebreasts,[20]andchickenpoxinthenewbornwhenthediseasemanifestedinthemotherwithinafewdaysofbirth.[20]Insomecasestheseriskscanbemitigatedbyusingheat-treatedmilkandnursingforabriefertime(e.g.6months,ratherthan18–24months),andcanbeavoidedbyusinganuninfectedwoman'smilk,asviaawet-nurseormilkbank,orbyusinginfantformulaand/ortreatedmilk.[23] Inbalancingtherisks,suchascaseswherethemotherisinfectedwithHIV,adecisiontouseinfantformulaversusexclusivebreastfeedingmaybemadebasedonalternativesthatsatisfythe“AFASS”(Acceptable,Feasible,Affordable,SustainableandSafe)principles.[23][24] Babyisunabletobreastfeed:Thechildhasabirthdefectorinbornerrorofmetabolismsuchasgalactosemiathatmakesbreastfeedingdifficultorimpossible.[25] Babyisconsideredatriskformalnutrition:Incertaincircumstancesinfantsmaybeatriskformalnutrition,suchasduetoirondeficiency,vitamindeficiencies(e.g.vitaminDwhichmaybelesspresentinbreastmilkthanneededathighlatitudeswherethereislesssunexposure),orinadequatenutritionduringtransitiontosolidfoods.[26]Riskscanoftenbemitigatedwithimproveddietandeducationofmothersandcaregivers,includingavailabilityofmacroandmicronutrients.Forexample,inCanada,marketedinfantformulasarefortifiedwithvitaminD,butHealthCanadaalsorecommendsbreastfedinfantsreceiveextravitaminDintheformofasupplement.[27] Personalpreferences,beliefs,andexperiences:Themothermaydislikebreast-feedingorfinditinconvenient.[28]Inaddition,breastfeedingcanbedifficultforvictimsofrapeorsexualabuse;forexample,itmaybeatriggerforposttraumaticstressdisorder.[29][30]Manyfamiliesbottlefeedtoincreasethefather'sroleinparentinghischild.[31] Mentalhealth:Thepressuretobreastfeedinmanyculturescanbesomuchthatthemother'smentalhealthmaytakeasharpdecline.Thiscanhavephysicaleffectssuchaspoorlatchingaswellasmilkdepletionandalackofconnectiontothechild.Insomecasesitisbetterforthechildtobeformulafedsothatabetterbondcanbemadebetweenmotherandchildratherthanthe‘specialbond’thatcomesfrombreastfeedingbeingtaintedbynegativebreastfeedingexperiences.Thepressuretobreastfeedinmanyculturescanincreasethelikelihoodofpostpartumdepression.[32] Absenceofthemother:Thechildisadopted,orphaned,abandoned,orinthesolecustodyofamanormalesame-sexcouple.Themotherisseparatedfromherchildbybeinginprisonoramentalhospital.Themotherhasleftthechildinthecareofanotherpersonforanextendedperiodoftime,suchaswhiletravelingorworkingabroad. Foodallergies:Themothereatsfoodsthatmayprovokeanallergicreactionintheinfant.[citationneeded] Financialpressures:Maternityleaveisunpaid,insufficient,orlacking.Themother'semploymentinterfereswithbreastfeeding.[33]Motherswhobreastfeedmayexperiencealossofearningpower.[34] Societalstructure:Breastfeedingmaybeforbidden,discouragedordifficultatthemother'sjob,school,placeofworshiporinotherpublicplaces,orthemothermayfeelthatbreastfeedingintheseplacesoraroundotherpeopleisimmodest,unsanitary,orinappropriate.[33] Socialpressures:Familymembers,suchasmother'shusbandorboyfriend,orfriendsorothermembersofsocietymayencouragetheuseofinfantformula.Forexample,theymaybelievethatbreastfeedingwilldecreasethemother'senergy,health,orattractiveness.[citationneeded][35]Conversely,societalpressurestobreastfeedcanalsoleadtomentalhealthissues.AsenseofshamefromnotbeingabletoorstrugglingtodosoequallingbeingafailurehasaconnectiontoPostpartumDepression[32] Lackoftrainingandeducation:Themotherlackseducationandtrainingfrommedicalprovidersorcommunitymembers.[citationneeded][36] Lactationinsufficiency:Themotherisunabletoproducesufficientmilk.Instudiesthatdonotaccountforlactationfailurewithobviouscauses(suchasuseofformulaand/orbreastpumps),chroniclactationinsufficiencyaffectsaround10-15%ofwomen.[37]Forabout5-8%ofwomen,milkcomingin(i.e.,lactogenesisII)maynotoccuratall,andonlydropsareproduced.[38]Alternatively,despiteahealthysupply,thewomanorherfamilymayincorrectlybelievethatherbreastmilkisoflowqualityorinlowsupply.Thesewomenmaychooseinfantformulaeitherexclusivelyorasasupplementtobreastfeeding.[citationneeded]Newresearchisshowingthatmotherswhoreportproblemswithmilkproductionhavephysicalmarkersindicatinglowmilkproduction,callingintoquestiontheassumption(called“perceivedinsufficientmilksupply”orPIMS)thatmothersareincorrectaboutthequantityofmilktheyareproducing.[39][40] Fearofexposuretoenvironmentalcontaminants:Certainenvironmentalpollutants,suchaspolychlorinatedbiphenyls,canbioaccumulateinthefoodchainandmaybefoundinhumansincludingmothers'breastmilk.[41] Howeverstudieshaveshownthatthegreatestriskperiodforadverseeffectsfromenvironmentalexposuresisprenatally.[41]Otherstudieshavefurtherfoundthatthelevelsofmostpersistentorganohalogencompoundsinhumanmilkdecreasedsignificantlyoverthepastthreedecadesandequallydidtheirexposurethroughbreastfeeding.[42] Researchonrisksfromchemicalpollutionisgenerallyinconclusiveintermsofoutweighingthebenefitsofbreastfeeding.[43][44]StudiessupportedbytheWHOandothershavefoundthatneurologicalbenefitsofbreastmilkremain,regardlessofdioxinexposure.[44][45] Indevelopingcountries,environmentalcontaminantsassociatedwithincreasedhealthrisksfromuseofinfantformula,particularlydiarrheaduetouncleanwaterandlackofsterileconditions–bothprerequisitestothesafeuseofformula–oftenoutweighanyrisksfrombreastfeeding. Lackofothersourcesofbreastmilk: Lackofwetnurses:Wetnursingisillegalandstigmatizedinsomecountries,andmaynotbeavailable.[46]Itmayalsobesociallyunsupported,expensive,orhealthscreeningofwetnursesmaynotbeavailable.Themother,herdoctor,[47]orfamilymaynotknowthatwetnursingispossible,ormaybelievethatnursingbyarelativeorpaidwet-nurseisunhygienic. Lackofmilkbanks:Human-milkbanksmaynotbeavailable,asfewexist,andmanycountriescannotprovidethenecessaryscreeningfordiseasesandrefrigeration. Healthrisks[edit] Useofinfantformulahasbeencitedforassociationwithnumerousincreasedhealthrisks.Studieshavefoundinfantsindevelopedcountrieswhoconsumeformulaareatincreasedriskforacuteotitismedia,gastroenteritis,severelowerrespiratorytractinfections,atopicdermatitis,asthma,obesity,[48]type1and2diabetes,suddeninfantdeathsyndrome(SIDS),eczemaandnecrotizingenterocolitiswhencomparedtoinfantswhoarebreastfed.[49][50][51][52]Somestudieshavefoundanassociationbetweeninfantformulaandlowercognitivedevelopment,includingironsupplementationinbabyformulabeinglinkedtoloweredI.Q.andotherneurodevelopmentaldelays;[53][54]howeverotherstudieshavefoundnocorrelation.[49]Causation,however,hasnotbeenestablishedfornegativelong-termhealtheffectsofinfantformula;studiesanalyzinghealthoutcomesforbreastfedvs.formulafedbabiesareprimarilyobservationalinnatureandareplaguedwithconfoundingfactorssuchassocioeconomicstatus,educationlevel,andmaternalpreexistingconditions(suchasobesity,whichisassociatedwithbothlowmilkproductionandchildhoodobesity).Whenconfoundingfactorsarecontrolledfor,differencesbetweenlong-termhealthofbreastfedandformulafedinfantsdecrease.[55] Melaminecontamination[edit] Mainarticle:2008Chinesemilkscandal In2008,acaseofmelaminepoisoningofinfantformulawasdiscoveredinChina,wheremilkwasdeliberatelyadulteratedwiththechemical,leadingtothedeathofsixbabies,andillnessesinmorethan300,000infants,includingcasesofacutekidneyfailure.Largequantitiesofmelaminewereaddedtowatered-downmilktogiveittheappearanceofhavingadequateproteinlevels.Someofthoseresponsibleforthepoisoningweresentencedtodeath.[56] InNovember2008,tracesofmelaminewerereportedtohavebeenfoundbytheU.S.FoodandDrugAdministrationininfantformulasoldintheUnitedStatesmadebythethreemainAmericanfirms[57][58]—AbbottLaboratories,NestléandMeadJohnson—responsiblefor90–99%oftheinfantformulamarketinthatcountry.[15][57]ThelevelsweremuchlessthanthosereportedinChina,wherelevelsofmelaminecontaminationhadreachedasmuchas2,500partspermillion,about10,000timeshigherthantherecordedUSlevels.Thesafetydatasheetformelamine(CASregistrynumber108-78-1;C3-H6-N6)recordedtheacuteoraltoxicity(medianlethaldose)at3161 mg/kgforarat. HealthCanadaconductedaseparatetestandalsodetectedtracesofmelamineininfantformulaavailableinCanada.ThemelaminelevelswerewellbelowHealthCanada'ssafetylimits,[59]althoughconcernsremainaboutthesafetyofmanufacturedfoodforinfantsandmonitoringofpotentiallydangeroussubstances.[56] Otherhealthcontroversies[edit] In1985,SyntexCorporationwasorderedtopay$27millionincompensationforthedeathsoftwoAmericaninfantswhosufferedbraindamageafterdrinkingthecompany'sbabyformula,calledNeo-mull-soy.[60]FormulasproducedbySyntexhadpreviouslybeensubjecttoamajorrecallastheywerefoundtohaveinsufficientchloridetosupportnormalinfantgrowthanddevelopment.[61] In2003,babyplant-basedformulamanufacturedbytheGermancompanyHumanaandsoldinIsraelunderthebrandRemediacausedseverevitamindeficienciesinbabies.Babieswhoconsumedtheformulawerehospitalizedwithcardiacandneurologicalsymptoms.Threeofthemdied,andatleasttwentyotherswereleftwithseveredisabilities.AninvestigationrevealedthattheformulacontainedamuchlowerquantityofThiaminethanisneededforhealthyinfantdevelopmentbecauseofamanufacturingerror.Humana'schieffoodtechnologistreceiveda30-monthprisonsentencefornegligentmanslaughterinFebruary2013overthecase.[62] In2010,AbbottLaboratoriesissuedavoluntaryrecallofaboutfivemillionSimilacbrandpowderinfantformulasthatweresoldintheUnitedStates,Guam,PuertoRicoandsomeCaribbeancountries.Therecallwasissuedafterthepresenceofa'smallcommonbeetle'wasdetectedintheproduct.[63] InCanada,NewZealandandelsewhere,publicconcernshavebeenraisedoverthecontinuedsaleandmarketingofsoy-basedformulaepotentiallycontaininghighlevelsofphytoestrogens,[64][65]linkedtoabnormalchilddevelopment[66]includingdamagetobabies'thyroidglands. InDecember2011Wal-MartrecalledaquantityofinfantformulaafterababydiedinMissouri."Weextendourdeepestcondolencestothisbabyboy'sfamilyastheytrytocometogripswiththeirloss,"saidDiannaGee,aWal-Martspokeswoman."Assoonasweheardwhathappened,weimmediatelyreachedouttothemanufactureroftheformulaandtotheDepartmentofHealthandSeniorServicestoprovideanyinformationwemayhavetohelpwiththeinvestigation."Wal-MartsaiditpulledabatchofEnfamilfromitsstoresnationwidethatmatchedthesizeandlotnumberZP1k7GoftheformulathatmayhavesickenedthebabyinMissouri,Geesaid.ThebabyformulawaspurchasedfromaWal-MartinLebanon,Missouri.Afterthepurchase,a10-day-oldinfantdiedfromararebacterialinfection,CNNaffiliateKYTVreported.Authoritiesranteststodetermineifthedeathcamefromtheformula,thewatertomaketheformulaoranyotherfactor,saidMeadJohnsonNutrition,thecompanythatmakesEnfamil."Wearehighlyconfidentinthesafetyandqualityofourproducts–andtherigoroustestingweputthemthrough,"saidChrisPerille,aMeadJohnsonNutritionspokesman.[SourceCNN] Preparationandcontent[edit] Variations[edit] Infantformulascomeinpowder,liquidconcentrate,andready-to-feedforms.Theyaredesignedtobepreparedbytheparentorcaregiverinsmallbatchesandfedtotheinfant,usuallywitheitheracuporababybottle.[6] Infantformulascomeinavarietyoftypes: Cow'smilkformulaisthemostcommonlyusedtype.Themilkhasbeenalteredtoresemblebreastmilk. Soyproteinbasedformulasarefrequentlyusedforinfantsallergictocow'smilkorlactose.Soy-basedformulascanalsobeusefuliftheparentwantstoexcludeanimalproteinsfromthechild'sdiet. Proteinhydrolysateformulascontainproteinthat'sbeenbrokendownintosmallersizesthanarethoseincow'smilkandsoy-basedformulas.Proteinhydrolysateformulasaremeantforbabieswhodonottoleratecow'smilkorsoy-basedformulas. Specializedformulasarealsoavailableforprematureinfantsandthosewithspecificmedicalconditions.[67] Manufacturersandhealthofficialsadviseitisveryimportanttomeasurepowdersorconcentratesaccuratelytoachievetheintendedfinalproductconcentration;otherwise,thechildwillbemalnourished.Itisadvisablethatallequipmentthatcomesintocontactwiththeinfantformulabecleanedandsterilizedbeforeeachuse.Properrefrigerationisessentialforanyinfantformulawhichispreparedinadvance. Indevelopingcountries,formulaisfrequentlypreparedimproperly,resultinginhighinfantmortalityduetomalnutritionanddiseasessuchasdiarrheaandpneumonia.Thisisduetolackofcleanwater,lackofsterileconditions,lackofrefrigeration,illiteracy(sowritteninstructionscannotbefollowed),poverty(dilutingformulasothatitlastslonger),andlackofeducationofmothersbyformuladistributors.TheseproblemsandresultingdiseaseanddeathareakeyfactorinoppositiontothemarketinganddistributionofinfantformulaindevelopingcountriesbynumerouspublichealthagenciesandNGOs(discussedinmoredetailatNestléboycottandInternationalCodeofMarketingofBreast-milkSubstitutes). Nutritionalcontent[edit] Besidesbreastmilk,infantformulaistheonlyothermilkproductwhichthemedicalcommunityconsidersnutritionallyacceptableforinfantsundertheageofoneyear(asopposedtocow'smilk,goat'smilk,orfollow-onformula).Supplementingwithsolidfoodinadditiontobreastmilkorformulabeginsduringweaning,andmostbabiesbeginsupplementingaboutthetimetheirfirstteethappear,usuallyaroundtheageofsixmonths. Althoughcow'smilkisthebasisofalmostallinfantformula,plaincow'smilkisunsuitedforinfantsbecauseofitshighcaseincontentandlowwheycontent,anduntreatedcow'smilkisnotrecommendedbeforetheageof12months.Theinfantintestineisnotproperlyequippedtodigestnon-humanmilk,andthismayoftenresultindiarrhea,intestinalbleedingandmalnutrition.[68]Toreducethenegativeeffectontheinfant'sdigestivesystem,cow'smilkusedforformulaundergoesprocessingtobemadeintoinfantformula.Thisincludesstepstomakeproteinmoreeasilydigestibleandalterthewhey-to-caseinproteinbalancetooneclosertohumanmilk,theadditionofseveralessentialingredients(oftencalled"fortification",seebelow),thepartialortotalreplacementofdairyfatwithfatsofvegetableormarineorigin,etc. ThenutrientcontentofinfantformulaforsaleintheUnitedStatesisregulatedbytheFoodandDrugAdministration(FDA)basedonrecommendationsbytheAmericanAcademyofPediatricsCommitteeonNutrition.ThefollowingmustbeincludedinallformulasproducedintheU.S.:[69] Protein Fat Linoleicacid Vitamins:A,C,D,E,K,thiamin(B1),riboflavin(B2),B6,B12 Niacin Folicacid Pantothenicacid Calcium Minerals:magnesium,iron,zinc,manganese,copper Phosphorus Iodine Sodiumchloride Potassiumchloride Carbohydrates Carbohydratesareanimportantsourceofenergyforgrowinginfants,astheyaccountfor35to42%oftheirdailyenergyintake.Inmostcow'smilk-basedformulas,lactoseisthemainsourceofcarbohydratespresent,butlactoseisnotpresentincow'smilk-basedlactose-freeformulasnorspecializednon-milkproteinformulasorhydrolyzedproteinformulasforinfantswithmilkproteinsensitivity.Lactoseisalsonotpresentinsoy-basedformulas.Therefore,thoseformulaswithoutlactosewilluseothersourcesofcarbohydrates,suchassucroseandglucose,dextrins,andnaturalandmodifiedstarches.Lactoseisnotonlyagoodsourceofenergy,italsoaidsintheabsorptionofthemineralsmagnesium,calcium,zincandiron.[70] Humanmilkoligosaccharides(HMOs) HMOsarenaturallyoccurringsugarsfoundinhumanbreastmilk,theyimprovetheimmunesystemandactasnutrientstobeneficialgutbacteria.[71]Somemanufacturersalsousehumanmilkoligosaccharidesasamoderninfantformulasupplementtogiveadditionalhealthbenefitstotheirproducts,howevertheyarenotfoundalltypesofformula.[72] Nucleotides Nucleotidesarecompoundsfoundnaturallyinhumanbreastmilk.Theyareinvolvedincriticalmetabolicprocesses,suchasenergymetabolismandenzymaticreactions.Also,asthebuildingblocksofdeoxyribonucleicacid(DNA)andribonucleicacid(RNA),theyareessentialfornormalbodyfunctions.Comparedtohumanbreastmilk,cow'smilkhaslowerlevelsofthenucleotidesuridine,inosine,andcytidine.Therefore,severalcompaniesthatproduceinfantformulahaveaddednucleotidestotheirinfantformulas.[70] Othercommonlyusedingredients: Emulsifiersandstabilizers:Ingredientsaddedtopreventtheseparationoftheoilfromthewater(anditssolublecomponents)intheinfantformula.Somecommonlyusedemulsifiersincludemonoglycerides,diglycerides,andgums.[69] Diluents:Skimmilkiscommonlyusedastheprimarydiluentinmilk-basedliquidformulatoprovidethebulkofthevolume.Incontrast,purifiedwateristhemostcommonlyuseddiluentinmilk-freeformulations.[69] Policy,industryandmarketing[edit] Thepolicy,regulatoryandindustryenvironmentssurroundingtheinfantformulamarketvarytremendouslybetweencountries. International[edit] Mainarticle:InternationalCodeofMarketingofBreast-milkSubstitutes Seealso:Nestléboycott TheInternationalCodeofMarketingofBreast-milkSubstitutesisaninternationalhealthpolicyframeworkadoptedbytheWorldHealthAssemblyoftheWHOin1981regardinginfantformulamarketing,includingstrictrestrictionsonadvertising.[73]Itsimplementationdependsonthelawsofdifferentcountriesandthebehaviorofinfantformulamanufacturers–thecodehasnopoweritself.Legislationandcorporatebehaviorvarysignificantlybetweencountries:atleast84countrieshaveenactednationallegislationimplementingallormanyoftheprovisionsoftheCodeand14countrieshavedraftlawsawaitingadoption;[74]whereaselsewhereneithertheCodenoritsprinciplesarefollowedbygovernmentsorformulamanufacturers. PracticesthatarebannedintheCodeincludemostadvertising,claiminghealthbenefitsforformula,andgivingfreesamplestowomenabletobreastfeed–thislatterpracticeisparticularlycriticizedbecauseitcaninterferewithlactation,creatingdependenceonformula,withoutpropereducationonensuringcontinuedbreaststimulationwhileformulaisbeingused.Inmanycountriesfreesamplesofinfantformulahavebeenprovidedtohospitalsfordecades;infantformulaisoftentheonlyproductroutinelyprovidedfreeofchargetohospitals.[75]TheBabyFriendlyHospitalInitiative(BFHI)aimstoreduceandeliminatethiscontroversialpractice;however,thereisincreasingcriticismoftheBFHI'srigidityinlimitinguseofinfantformula,whichcanbeanappropriatetreatmentforcommonconditionssuchassuboptimalintakejaundice,andmaycausemotherstofeelpressuredorguiltedintobreastfeeding.[76][77][78] Bycountry[edit] Philippines[edit] InfantformulaisoneofthetopthreeconsumercommoditiesinthePhilippines,andamongthemostimportedproducts.[79]AnnualsalesamounttosomeUS$469millionannually.US$88millionisspentonadvertisingtheproduct.[80] Infantformulamarketinghasbeenregulatedsincethe1987ExecutiveOrder51or"MilkCode",[81]whichregulated,butdidnotban,practicessuchasadvertisingandprovidingfreesamples.Shortlyafteritwasenacted,Wyethintroduced"follow-onformula",whichwasnotinthepurviewoftheMilkCodewhichpredateditsmarketentry. In2006,theDepartmentofHealthbannedtheadvertisingofinfantformulaandthepracticeofprovidingfreesamples,regardlessofintendedagegroup(intheRevisedImplementingRulesandRegulationsofExecutiveOrder51,orRIRR).[82]ThenewregulationwaschallengedbytheinfantformulaindustryintheSupremeCourt.Initiallythechallengewasdismissed,butthisdecisionwasreversedfollowingindustrypressureandacontroversialletterbyAmericanbusinessleaderThomasDonahue,[83]thenPresidentandCEOoftheUSChamberofCommerce,resultingintheregulationbeingsuspendedandadvertisingcontinuing.[79][81][82][84] TheGuardiannewspaperreportswidespreadillegaladvertisingandmarketingofformulamilkcontrarytoWorldHealthOrganizationguidelines.Doctorsandmidwivesareencouragedtopromotefeedingbabiesformulamilk,advertisingalsotargetsmothersdirectly.Babiesgetsickandsometimesdiebecausepoormotherscannotsterilizebottles.[85] SouthAfrica[edit] InSouthAfrica,thereisamovetowardsplainpackagingofinfantformula[86]underR991oftheFoodstuffs,CosmeticsandDisinfectantsAct;asof6December2013,Regulation7(SaleandPromotion)isforce,whereasRegulations2-6(primarilywithrespecttolabelling)arescheduledtocomeintoforceon6December2014. OneofthekeyrequirementsasperRegulation3.1.A.iiiisaconspicuousmessagestating“[t]hisproductshallonlybeusedontheadviceofahealthprofessional”. UnitedKingdom[edit] IntheUnitedKingdom,infantformulaadvertisinghasbeenallowedsince1995;[87]advertisingfor"follow-onformula"islegal,whichhasbeencitedasaloopholeallowingadvertisingofsimilarlypackagedformula.[88] UnitedStates[edit] IntheUnitedStates,infantformulaisbothheavilymarketed—thecountryhasnotadoptedtheCode,norisitbeingsystematicallyimplementedbymanufacturersfordomesticmarketing[89]—andevenheavilysubsidizedbythegovernment:atleastonethirdoftheAmericanmarketissupportedbythegovernment,[90]withoverhalfofinfantformulasoldinthecountryprovidedthroughtheSpecialSupplementalNutritionProgramforWomen,Infants,andChildren(knownasWIC).[15] Accordingtosurveys,over70%oflargeU.S.hospitalsdispenseinfantformulatoallinfants,apracticeopposedbytheAmericanAcademyofPediatricsandinviolationoftheCode.[91]TheGerberProductsCompanybeganmarketingitsbrandofinfantformuladirectlytothepublicinOctober1989,whiletheCarnationCompanybeganmarketingGoodStartinfantformuladirectlytothepublicinJanuary1991.[91] InfantformulacostsareasignificantfractionoftheWICprogramcosts:21%post-rebateand46%pre-rebate.[15]FormulamanufacturersaregrantedaWICmonopolyinindividualstates.[15]Meanwhile,breastfeedingratesaresubstantiallylowerforWICrecipients;[92]thisispartlyattributedtoformulabeingfreeofchargetomothersintheWICprogram,whoareoflowersocio-economicstatus.[15]ViolationsoffederalpolicyhavealsobeenfoundintermsofinfantformulacompanyadvertisingusingtheWICtrademark,toreachbothWICandnon-WICparticipants.[92]InrecentyearsWIChasbeenexpandingitsbreastfeedingpromotionstrategies,includingprovidingsubsidiesforclientswhousemilkbanks.[93] 2022UnitedStatesBabyFormulaShortages[edit] SupplychaindisruptionsrelatedtothegovernmentresponsetotheCOVID-19pandemicintheUnitedStateshavebeenreported[94]asresponsibleforcausingwidespreadshortagesofinfantformulaintheUnitedStates,asofMay2022.Thiscontrastswithfarlesssevereshortagesofinfantformulaaroundtheglobe.ReasonmagazinereportedthatthiswaslargelytheresultofFoodandDrugAdministration(FDA)processesdelayingapprovalofotherwisesafeinfantformulafromEuropeorothersourcesabroad,whichmightotherwisehaveeaseddemandforinfantformulatensionsintheUnitedStates.FromReason:U.S.officialscouldhavemadesuchshortageslesslikelybyapprovingbabyformulathatiswidelyavailableinEurope,butperusual,theFoodandDrugAdministration(FDA)hasotherpriorities.Theagencyhasalonghistoryoftakingforever—yearsandyearsandyears—toapprovefoodsandmedicationsthatEuropeanofficialshavealreadydecidedareperfectlysafeforhumanconsumption.(Oneparticularlygoodexample:sunblock.)Thisisyetanotherinalonglineoffailures:BoththeFDAandtheCentersforDiseaseControlandPrevention(CDC)screweduptheearlyapprovalprocessforCOVID-19testing.[94] Asaresultoftheshortages,onMay16,2022,theFDAannouncedthatitwouldtemporarilyeaseenforcementofsomelabelingrulestoallowtheimportationofforeignformulas.FDACommissionerRobertCaliffstated,"Today'sactionpavesthewayforcompanieswhodon'tnormallydistributetheirinfantformulaproductsintheU.S.todosoefficientlyandsafely.WeanticipatethatthoseproductsthatcanquicklymeetsafetyandnutritionstandardscouldhitU.S.storesinamatterofweeks."[95]FormerFDAassociatecommissioner,PeterPitts,assertsthattheFDA'sregulatoryschemeisatleastpartiallytoblamefortheshortage.Pittsstates,"ThedifferencebetweenEuropeanbabyformulaandAmericanbabyformula,moreorless,isthatthelabelingisdifferent.TheknotingettingthatproductintotheU.S.isn'tsafety,it'saregulatoryissue.Idon'twanttosayit'sanittyissue,butit'scertainlysomethingtheFDAcouldhavejumpedonalotquicker."[96] Amidandpriortotheformulashortages,WomanandInfantChildren(WIC)centersinGeorgiaandNorthCarolinaweredisposingofinfantformula.[97][98]ThiswasdoneundertheUSDA'srecommendationthatunused,returnedWICinfantformulaweretobedisposedofuponreturn.[99]DespiteanattemptbytheUSDAtowalkbackthisrecommendationbystatingthatitisarecommendationratherthanarequirement,theUSDAconfirmsthatitwillnotreversethisrecommendation,evenamidtheformulashortage.[100]Asaresult,fromOctober2021throughMay2022,16,459cansofbabyformulaweredestroyedbyWICclinicsinGeorgiaandanunknownamountofbabyformulacansweredestroyedinNorthCarolinaandotherUSStates. OnJuly6,2022,theFDAannouncedthatitwouldchangeitsrulestoallowforeignformulamanufacturerstopermanentlyimporttheirgoodsintotheU.S.,potentiallyreducingtheseverityoftheshortage.[101]CriticsoftheFDAnotethatthisdoesnotremovetheregulationsentirelyandthatthisshortagehasbeenself-imposedbytheFDAfromthestart.[102]Additionally,criticsnotethatifaformulamakerpassesEUregulations,thisshouldbegoodenoughfortheFDAtoallowimportationofthatformula. CriticsoftheFDA'sregulatorypolicynotethattheregulatoryschemesurroundingEuropeanformulasisnotbornefromascience-baseddesiretoprotectchildren,butratheraninfluencethattheUSdairyindustryhasontheagency.[103][104]CriticsalsonotethatiftherewereanissuewithEuropeanformulas,theissuewouldbewidespreadamongtheEuropeanbabiesthatregularlyconsumetheformula.[105][104] History[edit] TheWabanakiandotherNativeAmericantribalnationsofNorthAmericamadeaninfantformulafromnutsandcornmeal.[106]ElizabethHansonwascapturedbyWabanakiin1725andaNativeAmericanwomanshowedHansonhowtomakethisinfantformulaandsheincludedthisinhercaptivitynarrative. Earlyinfantfoods[edit] In1865,thefirstinfantfoodwasinvented.[107] Throughouthistory,motherswhocouldnotbreastfeedtheirbabieseitheremployedawetnurse[108]or,lessfrequently,preparedfoodfortheirbabies,aprocessknownas"drynursing".[108][109]Babyfoodcompositionvariedaccordingtoregionandeconomicstatus.[109]InEuropeandNorthAmericaduringtheearly19thcentury,theprevalenceofwetnursingbegantodecrease,whilethepracticeoffeedingbabiesmixturesbasedonanimalmilkroseinpopularity.[110][111]PosteradvertisementforNestle'sMilkbyThéophileAlexandreSteinlen,1895Thistrendwasdrivenbyculturalchangesaswellasincreasedsanitationmeasures,[112]anditcontinuedthroughoutthe19thandmuchofthe20thcentury,withanotableincreaseafterElijahPrattinventedandpatentedtheIndia-rubbernipplein1845.[108][113]Asearlyas1846,scientistsandnutritionistsnotedanincreaseinmedicalproblemsandinfantmortalitywasassociatedwithdrynursing.[110][114]Inanattempttoimprovethequalityofmanufacturedbabyfoods,in1867,JustusvonLiebigdevelopedtheworld'sfirstcommercialinfantformula,Liebig'sSolubleFoodforBabies.[115]ThesuccessofthisproductquicklygaverisetocompetitorssuchasMellin'sFood,Ridge'sFoodforInfantsandNestlé'sMilk.[116] Rawmilkformulas[edit] Asphysiciansbecameincreasinglyconcernedaboutthequalityofsuchfoods,medicalrecommendationssuchasThomasMorganRotch's"percentagemethod"(publishedin1890)begantobedistributed,andgainedwidespreadpopularityby1907.[108]Thesecomplexformulasrecommendedthatparentsmixcow'smilk,water,cream,andsugarorhoneyinspecificratiostoachievethenutritionalbalancebelievedtoapproximatehumanmilkreformulatedinsuchawayastoaccommodatethebelieveddigestivecapabilityoftheinfant.[4] A1915advertisementfor"Nestlé'sFood" Atthedawnofthe20thcenturyintheUnitedStates,mostinfantswerebreastfed,althoughmanyreceivedsomeformulafeedingaswell.Home-made"percentagemethod"formulasweremorecommonlyusedthancommercialformulasinbothEuropeandtheUnitedStates.[117]Theywerelessexpensiveandwerewidelybelievedtobehealthier.However,formula-fedbabiesexhibitedmorediet-associatedmedicalproblems,suchasscurvy,ricketsandbacterialinfectionsthanbreastfedbabies.By1920,theincidenceofscurvyandricketsinformula-fedbabieshadgreatlydecreasedthroughtheadditionoforangejuiceandcodliveroiltohome-madeformulas.BacterialinfectionsassociatedwithformularemainedaproblemmoreprevalentintheUnitedStatesthaninEurope,wheremilkwasusuallyboiledpriortouseinformulas.[117] Evaporatedmilkformulas[edit] Inthe1920sand1930s,evaporatedmilkbegantobewidelycommerciallyavailableatlowprices,andseveralclinicalstudiesintheperiodsuggestedthatbabiesfedevaporatedmilkformulathrivedaswellasbreastfedbabies.[108][118] Thesestudies,accompaniedbytheaffordablepriceofevaporatedmilkandtheavailabilityofthehomeiceboxinitiatedatremendousriseintheuseofevaporatedmilkformulas.[4]Bythelate1930s,theuseofevaporatedmilkformulasintheUnitedStatessurpassedallcommercialformulas,andby1950overhalfofallbabiesintheUnitedStateswererearedonsuchformulas.[108] Commercialformulas[edit] Inparallelwiththeenormousshift(inindustrializednations)awayfrombreastfeedingtohome-madeformulas,nutritionscientistscontinuedtoanalyzehumanmilkandattemptedtomakeinfantformulasthatmorecloselymatcheditscomposition.[4]Maltoseanddextrinswerebelievednutritionallyimportant,andin1912,theMeadJohnsonCompanyreleasedamilkadditivecalledDextri-Maltose.Thisformulawasmadeavailabletomothersonlybyphysicians.In1919,milkfatswerereplacedwithablendofanimalandvegetablefatsaspartofthecontinueddrivetoclosersimulatehumanmilk.ThisformulawascalledSMAfor"simulatedmilkadapted."[108] Inthelate1920s,AlfredBosworthreleasedSimilac(for"similartolactation"),andMeadJohnsonreleasedSobee.[108]Severalotherformulaswerereleasedoverthenextfewdecades,butcommercialformulasdidnotbegintoseriouslycompetewithevaporatedmilkformulasuntilthe1950s.ThereformulationandconcentrationofSimilacin1951,andtheintroduction(byMeadJohnson)ofEnfamil(for"infantmilk")in1959wereaccompaniedbymarketingcampaignsthatprovidedinexpensiveformulatohospitalsandpediatricians.[108]Bytheearly1960s,commercialformulasweremorecommonlyusedthanevaporatedmilkformulasintheUnitedStates,whichallbutvanishedinthe1970s.Bytheearly1970s,over75%ofAmericanbabieswerefedonformulas,almostentirelycommerciallyproduced.[4] Whenbirthratesinindustrialnationstaperedoffduringthe1960s,infantformulacompaniesheightenedmarketingcampaignsinnon-industrializedcountries.Unfortunately,poorsanitationledtosteeplyincreasedmortalityratesamonginfantsfedformulapreparedwithcontaminatedwater.[119]Additionally,aWHOhascitedover-dilutingformulapreparationsasresultingininfantmalnourishment.[120]Organizedprotests,themostfamousofwhichwastheNestléboycottof1977,calledforanendtounethicalmarketing.Thisboycottisongoing,asthecurrentcoordinatorsmaintainthatNestléengagesinmarketingpracticeswhichviolatetheInternationalCodeofMarketingofBreast-milkSubstitutes. Genericbrandformulas[edit] Inadditiontocommerciallymarketedbrands,genericbrands(orstorebrands)ofinfantformulawereintroducedintheUnitedStatesin1997,firstbyPBMProducts.TheseprivatelabelformulasaresoldbymanyleadingfoodanddrugretailerssuchasWal-Mart,Target,Kroger,Loblaws,andWalgreens.AllinfantformulabrandsintheUnitedStatesarerequiredtoadheretotheFoodandDrugAdministration(FDA)guidelines.AsreportedbytheMayoClinic:“aswithmostconsumerproducts,brand-nameinfantformulascostmorethangenericbrands.Butthatdoesn'tmeanthatbrand-name[Similac,Nestle,Enfamil]formulasarebetter.Althoughmanufacturersmayvarysomewhatintheirformularecipes,theFDArequiresthatallformulascontainthesamenutrientdensity.”[121] Similarly,inCanadaallinfantformulasregardlessofbrandarerequiredtomeetstandardssetbyHealthCanada.[122] Follow-onandtoddlerformulas[edit] Follow-onortoddlerformulasaresoldforages6monthsto3years(wheninfantsaretypicallybreastfed).IntheUS,atransitionformulaismarketedforchildrenfromage9to24months,andatoddlermilkissoldforchildrenage12to26months.[123]Inbothcases,theingredientsarepowderedmilk,cornsyrupandotheraddedsugars,vegetableoil,andsalt.[124][125] Toddlerformulasarenotnutritionallycomplete,noraretheysubjecttothesameregulationsorfoodlabelinglawsasinfantformula.[123]Criticshavearguedthatfollow-onandtoddlerformulaswereintroducedtocircumventtheregulationsregardinginfantformulaandhaveresultedinconfusingadvertising.[88] Anearlyexampleoffollow-onformulawasintroducedbyWyethinthePhilippinesin1987,followingtheintroductioninthiscountryofregulationsoninfantformulaadvertising,butwhichdidnotaddressfollow-onformulas(productsthatdidnotexistatthetimeoftheirdrafting).[81]Similarly,whileinfantformulaadvertisingisillegalintheUnitedKingdom,follow-onformulaadvertisingislegal,andthesimilarpackagingandmarketresultsinfollow-onadvertisementsfrequentlybeinginterpretedasadvertisementsforformula.[88](Seealsoindustryandmarketing,below.) Theseproductshavealsorecentlyfallenundercriticismforcontributingtothechildhoodobesityepidemicinsomedevelopedcountriesduetotheirmarketingandflavoringpractices.[126]Thedrinksarealsoexpensive.[125]Althoughusuallynotquiteasexpensiveasinfantformula,[124]theycancostfourtimesthepriceofcow'smilk.[125] Usagesince1970s[edit] Sincetheearly1970s,industrialcountrieshavewitnessedaresurgenceinbreastfeedingamongnewbornsandinfantsto6monthsofage.[5]Thisupswinginbreastfeedinghasbeenaccompaniedbyadefermentintheaverageageofintroductionofotherfoods(suchascow'smilk),resultinginincreaseduseofbothbreastfeedingandinfantformulabetweentheagesof3–12months.[4][5] Theglobalinfantformulamarkethasbeenestimatedat$7.9billion,[90]withNorthAmericaandWesternEuropeaccountingfor33%ofthemarketandconsideredlargelysaturated,andAsiarepresenting53%ofthemarket.[127]SouthEastAsiaisaparticularlylargefractionoftheworldmarketrelativetoitspopulation.[127]Infantformulaisthelargestsegmentofthebabyfoodmarket,[127]withthefractiongivenasbetween40%[127]and70%.[90] Leadinghealthorganizations(e.g.WHO,U.S.CentersforDiseaseControlandDepartmentofHealthandHumanServices)areattemptingtoreducetheuseofinfantformulaandincreasetheprevalenceofbreastfeedingfrombirththrough12to24monthsofagethroughpublichealthawarenesscampaigns.[9][128][129][130]Thespecificgoalsandapproachesofthesebreastfeedingpromotionprograms,andthepolicyenvironmentsurroundingtheirimplementation,varybycountry.Asapolicybasicframework,theInternationalCodeofMarketingofBreast-milkSubstitutes,adoptedbytheWHO'sWorldHealthAssemblyin1981,requiresinfantformulacompaniestoprefacetheirproductinformationwithstatementsthatbreastfeedingisthebestwayoffeedingbabiesandthatasubstituteshouldonlybeusedafterconsultationwithhealthprofessionals.[73]TheBabyFriendlyHospitalInitiative(BFHI)alsorestrictsusebyhospitalsoffreeformulaorotherinfantcareaidsprovidedbyformulacompanies.(SeealsoPolicysectionbelow.)WhiletheCodewasintendedtorestrictinappropriatemarketingofinfantformula,notaccesstoit,parentshavecomplainedofbeinglecturedormadetosignwaiversimplyingformulawouldharmtheirbabiesinBFHIhospitals.[131] Infantformulaprocessing[edit] History[edit] Dates Events 1867 Aformulacontainingwheatflour,cow'smilk,maltflour,andpotassiumbicarbonatewasdeveloped.[132] 1915 Apowderformofinfantformulawasintroduced,containingcow'smilk,lactose,oleooils,andvegetableoils.[132] 1929 Soyformulawasintroduced.[132] 1935 Proteinwasaddedbecauseitwasbelievedcow'smilkproteincontentwaslowerthanhumanmilkproteincontent;proteinat3.3–4.0g/100kcalwasadded.[132] 1959 Ironfortificationwasintroducedbecausealargeamountofiron(~80%)isusedtoexpandtheredbloodcellmassinagrowinginfant.Infantswithbirthweightsbetween1500and2500grequire2 mg/kgofironperday.Infantswithweightsoflessthan1500grequire4 mg/kgperday.[132][133] 1962 Thewhey:caseinratiowasmadesimilartohumanmilkbecauseproducerswereawarethathumanmilkcontainsahigherratioofwheyprotein,andcow'smilkcontainsahigherratioofcasein.[132] 1984 Taurinefortificationwasintroducedbecausenewborninfantslacktheenzymesneededtoconvertandformtaurine.[132][134] Late1990 Nucleotidefortificationwasintroducedintoinfantformulabecausenucleotidescanactasgrowthfactorsandmayenhancetheinfantimmunesystem.[132] Early2000 Polyunsaturatedfattyacidfortificationwasintroduced.Polyunsaturatedfattyacids,suchasdocosahexaenoicacid(DHA)andarachidonicacid(ARA),wereaddedbecausethosefattyacidsplayanimportantroleininfantbraindevelopment.[132] Currentgeneralprocedure[edit] Themanufacturingprocessmaydifferfordifferenttypesofformulamade;thereforethefollowingisthegeneralprocedureforliquid-milkbasedformulas:[69] Mixingingredients[edit] Primaryingredientsareblendedinlargestainlesssteeltanksandskimmilkisaddedandadjustedto60 °C.Then,fats,oilsandemulsifiersareadded.Additionalheatingandmixingmayberequiredtogetproperconsistency.Next,minerals,vitamins,andstabilizinggumsareaddedatvariouspoints,dependingontheirsensitivitytoheat.Thebatchistemporarilystoredandthentransportedbypipelinestopasteurizationequipmentwhenmixingiscomplete.[69] Pasteurization[edit] Thisisaprocessthatprotectsagainstspoilagebyeliminatingbacteria,yeastsandmolds. Itinvolvesquicklyheatingandthencoolingoftheproductundercontrolledconditionswhichmicro-organismscannotsurvive.Thebatchisheldataround85–94 °Cforapproximately30secondswhichisnecessarytoadequatelyreducemicro-organismsandpreparetheformulaforfilling.[69] Homogenization[edit] Thisisaprocesswhichincreasesemulsionuniformityandstabilitybyreducingsizeoffatandoilparticlesintheformula.Itisdonewithavarietyofmixingequipmentthatappliessheartotheproductandthismixingbreaksfatandoilparticlesintoverysmalldroplets.[69] Standardization[edit] StandardizationisusedtoensurethatthekeyparameterslikepH,fatconcentrationandvitaminsandmineralcontentarecorrect.Ifinsufficientlevelsofthesearefound,thebatchisreworkedtoachieveappropriatelevels.Afterthisstep,thebatchisreadytobepackaged.[69] Packaging[edit] Packagingdependsonmanufacturerandtypeofequipmentused,butingeneral,liquidformulaisfilledintometalcanswithlidscrimpedintoplace.[69] Heattreatmentorsterilization[edit] Finally,infantformulasareheattreatedtomaintainthebacteriologicqualityoftheproduct.Thiscanbedonetraditionallybyeitherretortsterilizationorhigh-temperatureshort-time(HTST)treatment.Recently,ultrahigh-temperaturetreatedformulahasbecomemorecommonlyused.Ifpowderedformulaismade,thenspraydryingwouldberequiredinaddition.[135]Retortsterilizationisatraditionalretortsterilizationmethodthatuses10-15minstreatmentat118 °C.[135]Ultrahigh-temperature(UHT)isamethodthatusesabrief(2–3seconds)treatmentat142 °C.Becauseoftheshorttimeused,thereislittleproteindenaturation,buttheprocessstillensuressterilityofthefinalproduct.[135] Recentandfuturepotentialnewingredients[edit] Probiotics[edit] Randomized,controlledtrialscompletedinthe2000shaveshownlimitedandshorttermclinicalbenefitsfortheuseofprobioticsininfants’diet.[136]A2018clinicalstudyusingthemultistrainDeSimoneFormulationprobioticshowedithelpedsomeinfantsreducesymptomsofinfantcolic.[137]Thesafetyofprobioticsingeneralandininfants,especiallypreterminfants,hasbeeninvestigatedinalimitednumberofcontrolledtrials.Thefindingsthusfarsuggestprobioticsaregenerallysafe,thoughtheresearchispreliminaryandhasyettoprovidedefinitiveconclusions.[136] Prebiotics[edit] Prebioticsareundigestiblecarbohydratesthatpromotethegrowthofprobioticbacteriainthegut.Humanmilkcontainsavarietyofoligosaccharidesbelievedtobeanimportantfactorinthepatternofmicrofloracolonizationofbreastfedinfants.Becauseofvariety,variability,complexityandpolymorphismoftheoligosaccharidecompositionandstructure,itiscurrentlynotfeasibletoreproducetheoligosaccharidecomponentsofhumanmilkinastrictlystructuralfashion.[138] TheEuropeanSocietyofPediatricGastroenterology,Hepatology,andNutritionCommitteeonNutritionfoundevidencetosupportshorttermeffectsofingestingprebioticsonstoolmicrofloraofinfantswithincreasedinthenumberofbifidobacteria.Babiescanbeatriskofdehydrationwiththeinductionofsofterstools,iftheyhavethekidneyimmaturityand/orapoorabilitytoconcentrateurine.[138]Areductionofpathogenshasbeenassociatedwiththeconsumptionofprebiotics.[138]However,therewasnoevidencetosupportmajorclinicalorlong-termbenefits.[136]Therefore,thereislittleevidenceofbeneficialeffectsofprebioticsindietaryproducts.[136] Lysozymeandlactoferrin[edit] Lysozymeisanenzymethatisresponsibleforprotectingthebodybydamagingbacterialcellwalls.Lactoferrinisaglobular,multifunctionalproteinthathasantimicrobialactivity.Comparedtohumanmilk,cow'smilkhasasignifactlylowerlevelsoflysozymeandlactoferrin;therefore,theindustryhasanincreasinginterestinaddingthemintoinfantformulas.[132] Longchainpolyunsaturatedfattyacidsupplementation[edit] Somemanufacturershavebegunsupplementingformulamilkwithlong-chainpolyunsaturatedfattyacids(LCPUFA).ThecurrentevidencesuggeststhattheremaybelittleornodifferencebetweenformulamilkwithandwithoutLCPUFAsupplementationintermsofbabies'visualfunction,physicalgrowthorneurodevelopment.[139] Seealso[edit] 2022UnitedStatesinfantformulashortage 2008Chinesemilkscandal Babyfood Babybottle Breastfeeding Breastmilk Childdevelopment Daigou Dairyallergy Listofdairyproducts Notes[edit] ^Asof1915.[3] References[edit] ^U.S.FoodandDrugAdministration.Whatisaninfantformula. ^Wells,J.C.K.Nutritionalconsiderationsininfantformuladesign.SeminarsinFetal&NeonatalMedicine,1(1):19–26(February1996). ^abInstituteofMedicine;FoodNutritionBoard;CommitteeontheEvaluationoftheAdditionofIngredientsNewtoInfantFormula(2004).3ComparingInfantFormulaswithHumanMilk-InfantFormula:EvaluatingtheSafetyofNewIngredients-TheNationalAcademiesPress.nap.edu.doi:10.17226/10935.ISBN 978-0-309-09150-3.PMID 25009867.RetrievedApril3,2018. 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Furtherreading[edit] Ahern,GraceJ.,etal."Advancesininfantformulascience."Annualreviewoffoodscienceandtechnology10(2019):75-102.online Almeida,CristineCouto,etal."Bioactivecompoundsininfantformulaandtheireffectsoninfantnutritionandhealth:asystematicliteraturereview."Internationaljournaloffoodscience2021(2021)online. Guo,Mingruo,ed.Humanmilkbiochemistryandinfantformulamanufacturingtechnology(2020).online Hastings,Gerard,etal."Sellingsecondbest:howinfantformulamarketingworks."GlobalizationandHealth16.1(2020):1-12.online Martin,CamiliaR.,Pei-RaLing,andGeorgeL.Blackburn."Reviewofinfantfeeding:keyfeaturesofbreastmilkandinfantformula."Nutrients8.5(2016):279+online. Rosenberg,Alyssa."TheU.S.shouldneverhaveanotherbabyformulashortage"WashingtonPostOct6,2022 Externallinks[edit] IsadoraB.Stehlin."InfantFormula:SecondBestbutGoodEnough".U.S.FDA.ArchivedfromtheoriginalonDecember26,2007. 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