Dietary supplement - Wikipedia

A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. ... A supplement can ... Dietarysupplement FromWikipedia,thefreeencyclopedia Jumptonavigation Jumptosearch Productthatprovidesadditionalsourceofnutrients "Foodsupplement"redirectshere.Forfoodadditionsthataltertheflavor,colororlongevityoffood,seeFoodadditive. Theexamplesandperspectiveinthisarticlemaynotrepresentaworldwideviewofthesubject.Youmayimprovethisarticle,discusstheissueonthetalkpage,orcreateanewarticle,asappropriate.(April2020)(Learnhowandwhentoremovethistemplatemessage) Asapill Asacapsule Asatablet AsasoftgelcapsuleusedforfishoilorlargeamountsofvitaminE Asashakeandbottledpowder Productionofcodliveroil,oneofthefirstdietarysupplementproductsmanufacturedinthe18thcentury[1] Adietarysupplementisamanufacturedproductintendedtosupplementone'sdietbytakingapill,capsule,tablet,powder,orliquid.[2]Asupplementcanprovidenutrientseitherextractedfromfoodsourcesorthataresyntheticinordertoincreasethequantityoftheirconsumption.Theclassofnutrientcompoundsincludesvitamins,minerals,fiber,fattyacids,andaminoacids.Dietarysupplementscanalsocontainsubstancesthathavenotbeenconfirmedasbeingessentialtolife,butaremarketedashavingabeneficialbiologicaleffect,suchasplantpigmentsorpolyphenols.Animalscanalsobeasourceofsupplementingredients,suchascollagenfromchickensorfishforexample.Thesearealsosoldindividuallyandincombination,andmaybecombinedwithnutrientingredients.TheEuropeanCommissionhasalsoestablishedharmonizedrulestohelpinsurethatfoodsupplementsaresafeandappropriatelylabeled.[3] Creatinganindustryestimatedtohavea2020valueof$140.3billion,[4]therearemorethan50,000dietarysupplementproductsmarketedintheUnitedStates,[5]whereabout50%oftheAmericanadultpopulationconsumesdietarysupplements.Multivitaminsarethemostcommonlyusedproductamongtypesofdietarysupplements.[6]TheUnitedStatesNationalInstitutesofHealthstatesthatsupplements"maybeofvalue"forthosewhoarenutrientdeficientfromtheirdietandreceiveapprovalfromtheirmedicalprovider.[7] IntheUnitedStates,itisagainstfederalregulationsforsupplementmanufacturerstoclaimthattheseproductspreventortreatanydisease.Companiesareallowedtousewhatisreferredtoas"Structure/Function"wordingifthereissubstantiationofscientificevidenceforasupplementprovidingapotentialhealtheffect.[8]Anexamplewouldbe"_____helpsmaintainhealthyjoints",butthelabelmustbearadisclaimerthattheFoodandDrugAdministration(FDA)"hasnotevaluatedtheclaim"andthatthedietarysupplementproductisnotintendedto"diagnose,treat,cureorpreventanydisease",becauseonlyadrugcanlegallymakesuchaclaim.[8]TheFDAenforcestheseregulationsandalsoprohibitsthesaleofsupplementsandsupplementingredientsthataredangerous,orsupplementsnotmadeaccordingtostandardizedgoodmanufacturingpractices(GMPs). Contents 1Definition 2Types 2.1Vitamins 2.2Minerals 2.3Proteinsandaminoacids 2.4Bodybuildingsupplements 2.5Essentialfattyacids 2.6Naturalproducts 2.7Probiotics 2.8Fertility 2.9Prenatal 3Industry 4Adulteration,contaminationandmislabeling 5Regulatorycompliance 6Adverseeffects 7Societyandculture 7.1Publichealth 7.2Legalregulation 7.2.1UnitedStates 7.2.2EuropeanUnion 7.3FraudulentproductsduringtheCOVID-19outbreak 8Research 8.1Databases 8.2Qualityandsafety 8.3Populationmonitoring 8.4Clinicalstudies 8.5Absenceofbenefit 8.6Reportingbias 8.7Future 9Seealso 10References 11Furtherreading 12Externallinks Definition IntheUnitedStates,theDietarySupplementHealthandEducationActof1994providesthisdescription:"TheDietarySupplementHealthandEducationActof1994(DSHEA)definestheterm“dietarysupplement”tomeanaproduct(otherthantobacco)intendedtosupplementthedietthatbearsorcontainsoneormoreofthefollowingdietaryingredients:avitamin,amineral,anherborotherbotanical,anaminoacid,adietarysubstanceforusebymantosupplementthedietbyincreasingthetotaldietaryintake,oraconcentrate,metabolite,constituent,extract,orcombinationofanyoftheaforementionedingredients.Furthermore,adietarysupplementmustbelabeledasadietarysupplementandbeintendedforingestionandmustnotberepresentedforuseasconventionalfoodorasasoleitemofamealorofthediet.Inaddition,adietarysupplementcannotbeapprovedorauthorizedforinvestigationasanewdrug,antibiotic,orbiologic,unlessitwasmarketedasafoodoradietarysupplementbeforesuchapprovalorauthorization.UnderDSHEA,dietarysupplementsaredeemedtobefood,exceptforpurposesofthedrugdefinition."[9] PerDSHEA,dietarysupplementsareconsumedorally,andaremainlydefinedbywhattheyarenot:conventionalfoods(includingmealreplacements),medicalfoods,[10]preservativesorpharmaceuticaldrugs.Productsintendedforuseasanasalspray,ortopically,asalotionappliedtotheskin,donotqualify.FDA-approveddrugscannotbeingredientsindietarysupplements.Supplementproductsareorcontainvitamins,nutritionallyessentialminerals,aminoacids,essentialfattyacidsandnon-nutrientsubstancesextractedfromplantsoranimalsorfungiorbacteria,orintheinstanceofprobiotics,arelivebacteria.Dietarysupplementingredientsmayalsobesyntheticcopiesofnaturallyoccurringsubstances(example:melatonin).Allproductswiththeseingredientsarerequiredtobelabeledasdietarysupplements.[11]Likefoodsandunlikedrugs,nogovernmentapprovalisrequiredtomakeorselldietarysupplements;themanufacturerconfirmsthesafetyofdietarysupplementsbutthegovernmentdoesnot;andratherthanrequiringrisk–benefitanalysistoprovethattheproductcanbesoldlikeadrug,suchassessmentisonlyusedbytheFDAtodecidethatadietarysupplementisunsafeandshouldberemovedfrommarket.[11] Types Vitamins PharmaciesandsupermarketsintheU.S.sellalargevarietyofvitamindietarysupplements. Mainarticle:Vitamin Avitaminisanorganiccompoundrequiredbyanorganismasavitalnutrientinlimitedamounts.[12]Anorganicchemicalcompound(orrelatedsetofcompounds)iscalledavitaminwhenitcannotbesynthesizedinsufficientquantitiesbyanorganismandmustbeobtainedfromthediet.Thetermisconditionalbothonthecircumstancesandontheparticularorganism.Forexample,ascorbicacid(vitaminC)isavitaminforanthropoidprimates,humans,guineapigsandbats,butnotforothermammals.VitaminDisnotanessentialnutrientforpeoplewhogetsufficientexposuretoultravioletlight,eitherfromthesunoranartificialsource,astheysynthesizevitaminDinskin.[13]Humansrequirethirteenvitaminsintheirdiet,mostofwhichareactuallygroupsofrelatedmolecules,"vitamers",(e.g.vitaminEincludestocopherolsandtocotrienols,vitaminKincludesvitaminK1andK2).Thelist:vitaminsA,C,D,E,K,Thiamine(B1),Riboflavin(B2),Niacin(B3),PantothenicAcid(B5),VitaminB6,Biotin(B7),Folate(B9)andVitaminB12.Vitaminintakebelowrecommendedamountscanresultinsignsandsymptomsassociatedwithvitamindeficiency.Thereislittleevidenceofbenefitwhenvitaminsareconsumedasadietarysupplementbythosewhoarehealthyandhaveanutritionallyadequatediet.[14] TheU.S.InstituteofMedicinesetstolerableupperintakelevels(ULs)forsomeofthevitamins.ThisdoesnotpreventdietarysupplementcompaniesfromsellingproductswithcontentperservinghigherthantheULs.Forexample,theULforvitaminDis100 µg(4,000IU),[15]butproductsareavailablewithoutprescriptionat10,000IU. Minerals Mainarticle:Mineral(nutrient) Mineralsaretheexogenouschemicalelementsindispensableforlife.Fourminerals–carbon,hydrogen,oxygen,andnitrogen–areessentialforlifebutaresoubiquitousinfoodanddrinkthatthesearenotconsiderednutrientsandtherearenorecommendedintakesfortheseasminerals.Theneedfornitrogenisaddressedbyrequirementssetforprotein,whichiscomposedofnitrogen-containingaminoacids.Sulfurisessential,butforhumans,notidentifiedashavingarecommendedintakeperse.Instead,recommendedintakesareidentifiedforthesulfur-containingaminoacidsmethionineandcysteine.Therearedietarysupplementsthatprovidesulfur,suchastaurineandmethylsulfonylmethane. Theessentialnutrientmineralsforhumans,listedinorderbyweightneededtobeattheRecommendedDietaryAllowanceorAdequateIntakearepotassium,chlorine,sodium,calcium,phosphorus,magnesium,iron,zinc,manganese,copper,iodine,chromium,molybdenum,seleniumandcobalt(thelastasacomponentofvitaminB12).Thereareothermineralswhichareessentialforsomeplantsandanimals,butmayormaynotbeessentialforhumans,suchasboronandsilicon.Essentialandpurportedlyessentialmineralsaremarketedasdietarysupplements,individuallyandincombinationwithvitaminsandotherminerals. Althoughasageneralrule,dietarysupplementlabelingandmarketingarenotallowedtomakediseasepreventionortreatmentclaims,theU.S.FDAhasforsomefoodsanddietarysupplementsreviewedthescience,concludedthatthereissignificantscientificagreement,andpublishedspecificallywordedallowedhealthclaims.AninitialrulingallowingahealthclaimforcalciumdietarysupplementsandosteoporosiswaslateramendedtoincludecalciumsupplementswithorwithoutvitaminD,effectiveJanuary1,2010.Examplesofallowedwordingareshownbelow.Inordertoqualifyforthecalciumhealthclaim,adietarysupplementmustcontainatleast20%oftheReferenceDietaryIntake,whichforcalciummeansatleast260 mg/serving.[16] "Adequatecalciumthroughoutlife,aspartofawell-balanceddiet,mayreducetheriskofosteoporosis." "Adequatecalciumaspartofahealthfuldiet,alongwithphysicalactivity,mayreducetheriskofosteoporosisinlaterlife." "AdequatecalciumandvitaminDthroughoutlife,aspartofawell-balanceddiet,mayreducetheriskofosteoporosis." "AdequatecalciumandvitaminDaspartofahealthfuldiet,alongwithphysicalactivity,mayreducetheriskofosteoporosisinlaterlife." Inthesameyear,theEuropeanFoodSafetyAuthorityalsoapprovedadietarysupplementhealthclaimforcalciumandvitaminDandthereductionoftheriskofosteoporoticfracturesbyreducingboneloss.[17] TheU.S.FDAalsoapprovedQualifiedHealthClaims(QHCs)forvarioushealthconditionsforcalcium,seleniumandchromiumpicolinate.[18]QHCsaresupportedbyscientificevidence,butdonotmeetthemorerigorous“significantscientificagreement”standardrequiredforanauthorizedhealthclaim.IfdietarysupplementcompanieschoosetomakesuchaclaimthentheFDAstipulatestheexactwordingoftheQHCtobeusedonlabelsandinmarketingmaterials.Thewordingcanbeonerous:"Onestudysuggeststhatseleniumintakemayreducetheriskofbladdercancerinwomen.However,onesmallerstudyshowednoreductioninrisk.Basedonthesestudies,FDAconcludesthatitishighlyuncertainthatseleniumsupplementsreducetheriskofbladdercancerinwomen."[19] Proteinsandaminoacids Mainarticles:Protein(nutrient)andAminoacid Protein-containingsupplements,eitherready-to-drinkoraspowderstobemixedintowater,aremarketedasaidstopeoplerecoveringfromillnessorinjury,thosehopingtothwartthesarcopeniaofoldage,[20][21]toathleteswhobelievethatstrenuousphysicalactivityincreasesproteinrequirements,[22]topeoplehopingtoloseweightwhileminimizingmuscleloss,i.e.,conductingaprotein-sparingmodifiedfast,[23]andtopeoplewhowanttoincreasemusclesizeforperformanceandappearance.Wheyproteinisapopularingredient,[21][24][25]butproductsmayalsoincorporatecasein,soy,pea,hemporriceprotein.Ameta-analysisfoundamoderatedegreeofevidenceinfavorofwheyproteinsupplementsuseasasafeandeffectiveadjuncttoanathlete'strainingandrecovery,includingbenefitsforendurance,averagepower,musclemass,andreducedperceivedexerciseintensity.[26] AccordingtoUSandCanadianDietaryReferenceIntakeguidelines,theproteinRecommendedDietaryAllowance(RDA)foradultsisbasedon0.8gramsproteinperkilogrambodyweight.Therecommendationisforsedentaryandlightlyactivepeople.[27][28][29]Scientificreviewscanconcludethatahighproteindiet,whencombinedwithexercise,willincreasemusclemassandstrength,[30][31][32]orconcludetheopposite.[33]TheInternationalOlympicCommitteerecommendsproteinintaketargetsforbothstrengthandenduranceathletesatabout1.2–1.8g/kgbodymassperday.[22]Onereviewproposedamaximumdailyproteinintakeofapproximately25%ofenergyrequirements,i.e.,approximately2.0to2.5g/kg.[28] Thesameproteiningredientsmarketedasdietarysupplementscanbeincorporatedintomealreplacementandmedicalfoodproducts,butthoseareregulatedandlabeleddifferentlyfromsupplements.IntheUnitedStates,"mealreplacement"productsarefoodsandarelabeledassuch.Thesetypicallycontainprotein,carbohydrates,fats,vitaminsandminerals.Theremaybecontentclaimssuchas"goodsourceofprotein","lowfat"or"lactosefree".[34]Medicalfoods,alsonutritionallycomplete,aredesignedtobeusedwhileapersonisunderthecareofaphysicianorotherlicensedhealthcareprofessional.[35][10]Liquidmedicalfoodproducts–forexample,Ensure–areavailableinregularandhighproteinversions. Proteinsarechainsofaminoacids.Nineoftheseproteinogenicaminoacidsareconsideredessentialforhumansbecausetheycannotbeproducedfromothercompoundsbythehumanbodyandsomustbetakeninasfood.Recommendedintakes,expressedasmilligramsperkilogramofbodyweightperday,havebeenestablished.[27]Otheraminoacidsmaybeconditionallyessentialforcertainagesormedicalconditions.Aminoacids,individuallyandincombinations,aresoldasdietarysupplements.Theclaimforsupplementingwiththebranchedchainaminoacidsleucine,valineandisoleucineisforstimulatingmuscleproteinsynthesis.Areviewoftheliteratureconcludedthisclaimwasunwarranted.[36]Inelderlypeople,supplementationwithjustleucineresultedinamodest(0.99 kg)increaseinleanbodymass.[37]Thenon-essentialaminoacidarginine,consumedinsufficientamounts,isthoughttoactasadonorforthesynthesisofnitricoxide,avasodilator.Areviewconfirmedbloodpressurelowering.[38]Taurine,apopulardietarysupplementingredientwithclaimsmadeforsportsperformance,istechnicallynotanaminoacid.Itissynthesizedinthebodyfromtheaminoacidcysteine.[39] Bodybuildingsupplements ThissectionisanexcerptfromBodybuildingsupplement.[edit] Bodybuildingsupplementsaredietarysupplementscommonlyusedbythoseinvolvedinbodybuilding,weightlifting,mixedmartialarts,andathleticsforthepurposeoffacilitatinganincreaseinleanbodymass.Bodybuildingsupplementsmaycontainingredientsthatareadvertisedtoincreaseaperson'smuscle,bodyweight,athleticperformance,anddecreaseaperson'spercentbodyfatfordesiredmuscledefinition.Amongthemostwidelyusedarehighproteindrinks,pre-workoutblends,branched-chainaminoacids(BCAA),glutamine,arginine,essentialfattyacids,creatine,HMB,wheyprotein,ZMA,andweightlossproducts.[40][41]Supplementsaresoldeitherassingleingredientpreparationsorintheformof"stacks"–proprietaryblendsofvarioussupplementsmarketedasofferingsynergisticadvantages. Essentialfattyacids Mainarticle:Essentialfattyacids Fishoilisacommonlyusedfattyacidsupplementbecauseitisasourceofomega-3fattyacids.[42]Fattyacidsarestringsofcarbonatoms,havingarangeoflengths.Iflinksareallsingle(C-C),thenthefattyacidiscalledsaturated;withonedoublebond(C=C),itiscalledmonounsaturated;iftherearetwoormoredoublebonds(C=C=C),itiscalledpolyunsaturated.Onlytwofattyacids,bothpolyunsaturated,areconsideredessentialtobeobtainedfromthediet,astheothersaresynthesizedinthebody.The"essential"fattyacidsarealpha-linolenicacid(ALA),anomega-3fattyacid,andlinoleicacid(LA),anomega-6fattyacid.[42][43]ALAcanbeelongatedinthebodytocreateotheromega-3fattyacids:eicosapentaenoicacid(EPA)anddocosahexaenoicacid(DHA). Plantoils,particularlyseedandnutoils,containALA.[42]FoodsourcesofEPAandDHAareoceanicfish,whereasdietarysupplementsourcesincludefishoil,krilloilandmarinealgaeextracts.TheEuropeanFoodSafetyAuthority(EFSA)identifies250 mg/dayforacombinedtotalofEPAandDHAasAdequateIntake,witharecommendationthatwomenpregnantorlactatingconsumeanadditional100to200 mg/dayofDHA.[44]IntheUnitedStatesandCanadaareAdequateIntakesforALAandLAovervariousstagesoflife,buttherearenointakelevelsspecifiedforEPAand/orDHA.[45] SupplementationwithEPAand/orDHAdoesnotappeartoaffecttheriskofdeath,cancerorheartdisease.[46][47]Furthermore,studiesoffishoilsupplementshavefailedtosupportclaimsofpreventingheartattacksorstrokes.[48]In2017,theAmericanHeartAssociationissuedascienceadvisorystatingthatitcouldnotrecommenduseofomega-3fishoilsupplementsforprimarypreventionofcardiovasculardiseaseorstroke,althoughitreaffirmedsupplementationforpeoplewhohaveahistoryofcoronaryheartdisease.[49] ManufacturershavebeguntoincludelongchainpolyunsaturatedfattyacidsDHAandarachidonicacid(AA)intotheirformulamilkfornewborns,however,a2017reviewfoundthatsupplementationwithDHAandAAdoesnotappeartobeharmfulorbeneficialtoformula-fedinfants.[50] Naturalproducts Mainarticle:Naturalproduct Seealso:Phytochemical,Herbalism,andTraditionalChinesemedicine St.John'swortpetalsusedinnaturalproductsupplements Dietarysupplementscanbemanufacturedusingintactsourcesorextractsfromplants,animals,algae,fungiorlichens,includingsuchexamplesasginkgobiloba,curcumin,cranberry,St.John’swort,ginseng,resveratrol,glucosamineandcollagen.[51][52][53]Productsbearingpromotionalclaimsofhealthbenefitsaresoldwithoutrequiringaprescriptioninpharmacies,supermarkets,specialistshops,militarycommissaries,buyersclubs,directsellingorganizations,andtheinternet.[52]Whilemostoftheseproductshavealonghistoryofuseinherbalismandvariousformsoftraditionalmedicine,concernsexistabouttheiractualefficacy,safetyandconsistencyofquality.[54][55][56]Canadahaspublishedamanufacturerandconsumerguidedescribingquality,licensing,standards,identities,andcommoncontaminantsofnaturalproducts.[57] In2019,salesofherbalsupplementsjustintheUnitedStatesalonewere$9.6billion,withthemarketgrowingatapproximately8.6%peryear,[58]withcannabidiolandmushroomproductsalesasthehighest.[59]Italy,Germany,andEasternEuropeancountrieswereleadingconsumersofbotanicalsupplementsin2016,withEuropeanUnionmarketgrowthforecasttobe$8.7billionby2020.[60] Probiotics Mainarticle:Probiotic Claimedbenefitsofusingprobioticsupplementsarenotsupportedbysufficientclinicalevidence.[61][62][63]Meta-analysisstudieshavereportedamodestreductionofantibiotic-associateddiarrheaandacutediarrheainchildrentakingprobiotics.[64]Thereislimitedevidenceinsupportofadultsusingmono-strainandmulti-straincontainingprobioticsforthealleviationofsymptomsassociatedwithirritablebowelsyndrome.[65]Probioticsupplementsaregenerallyregardedassafe.[66] Fertility Mainarticle:Fertility Ameta-analysisprovidedpreliminaryevidencethatmentreatedwithsupplementscontainingselenium,zinc,omega-3fattyacids,coenzymeQ10orcarnitinesreportedimprovementsintotalspermcount,concentration,motility,andmorphology.[67]Areviewconcludedthatomega-3takenthroughsupplementsanddietmightimprovesemenqualityininfertilemen.[68]A2021reviewalsosupportedselenium,zinc,omega-3fattyacids,coenzymeQ10orcarnitines,butwarnedthat"excessiveuseofantioxidantsmaybedetrimentaltothespermaticfunctionandmanyoftheover-the-countersupplementsarenotscientificallyproventoimprovefertility."[69] Thereislowqualityandinsufficientevidencefortheuseoforalantioxidantsupplementsasaviabletreatmentforsubfertilewoman.[70]Areviewprovidedevidencethattakingdehydroepiandrosteronebeforestartinganinvitrofertilizationseriesmayincreasepregnancyratesanddecreasemiscarriagelikelihood.[71] Prenatal Mainarticle:Prenatalvitamins Prenatalvitaminsaredietarysupplementscommonlygiventopregnantwomentosupplynutrientsthatmayreducehealthcomplicationsforthemotherandfetus.Althoughprenatalvitaminsarenotmeanttosubstitutefordietarynutrition,prenatalsupplementationmaybebeneficialforpregnantwomenatriskofnutrientdeficienciesbecauseofdietlimitationsorrestrictions.ThemostcommoncomponentsinprenatalvitaminsincludevitaminsB6,folate,B12,C,D,E,ironandcalcium.[72] SufficientintakeofvitaminB6canlowertheriskofearlypregnancylossandrelievesymptomsofmorningsickness.[73][74]Folateisalsoanessentialnutrientforpregnantwomentopreventneuraltubedefects.[73]In2006,theWorldHealthOrganizationendorsedtherecommendationforwomenofchild-bearingagetoconsume400microgramsoffolatethroughthedietdailyifplanningapregnancy.[75]A2013reviewfoundfolicacidsupplementationduringpregnancydidnotaffectthemother'shealthotherthanariskreductiononlowpre-deliveryserumfolateandmegaloblasticanemia.[76]ThereislittleevidencetosuggestthatvitaminDsupplementationimprovesprenataloutcomesinhypertensivedisordersandgestationaldiabetes.[77][78]EvidencedoesnotsupporttheroutineuseofvitaminEsupplementationduringpregnancytopreventadverseevents,suchaspretermbirth,fetalorneonataldeath,ormaternalhypertensivedisorders.[79][80] Ironsupplementationcanlowertheriskofirondeficiencyanemiaforpregnantwomen.[81]In2020,theWorldHealthOrganizationupdatedrecommendationsforadequatecalciumlevelsduringpregnancytopreventhypertensivedisorders.[82][83] Industry In2020,theAmericanmarketfordietarysupplementswasvaluedat$140.3billion,[4]withtheeconomicimpactintheUnitedStatesfor2016estimatedat$122billion,includingemploymentwagesandtaxes.[84]A2020analysisprojectedthattheglobalmarketforvitaminsanddietarysupplementproductswouldreach$196.6billionby2028,wherethegrowthinmarketsizeislargelyattributedtorecenttechnologicaladvancementsinproductmanufacturing,increaseddemandforproductsadvertisedashealthy,increasedproductavailability,andpopulationaging.[85] Adulteration,contaminationandmislabeling Overtheperiod2008to2011,theGovernmentAccountabilityOffice(GAO)oftheUnitedStatesreceived6,307reportsofhealthproblems(identifiedasadverseevents)fromuseofdietarysupplementscontainingacombinationofingredientsinmanufacturedvitamins,mineralsorothersupplementproducts,[86]with92%oftestedherbalsupplementscontainingleadand80%containingotherchemicalcontaminants.[87]Usingundercoverstaff,theGAOalsofoundthatsupplementretailersintentionallyengagedin"unequivocaldeception"tosellproductsadvertisedwithbaselesshealthclaims,particularlytoelderlyconsumers.[87]ConsumerReportsalsoreportedunsafelevelsofarsenic,cadmium,leadandmercuryinseveralproteinpowderproducts.[88]TheCanadianBroadcastingCorporation(CBC)reportedthatproteinspiking,i.e.,theadditionofaminoacidstomanipulateproteincontentanalysis,wascommon.[89]ManyofthecompaniesinvolvedchallengedCBC'sclaim.[90] A2013studyonherbalsupplementsfoundthatmanyproductswereoflowquality,onethirddidnotcontaintheactiveingredient(s)claimed,andonethirdcontainedunlistedsubstances.[91]Inageneticanalysisofherbalsupplements,78%ofsamplescontainedanimalDNAthatwasnotidentifiedasaningredientontheproductlabels.[55]Insomebotanicalproducts,undeclaredingredientswereusedtoincreasethebulkoftheproductandreduceitscostofmanufacturing,whilepotentiallyviolatingcertainreligiousand/orculturallimitationsonconsuminganimalingredients,suchascow,buffaloordeer.[55]In2015,theNewYorkAttorneyGeneral(NY-AG)identifiedfourmajorretailerswithdietarysupplementproductsthatcontainedfraudulentandpotentiallydangerousingredients,requiringthecompaniestoremovetheproductsfromretailstores.[92]AccordingtotheNY-AG,onlyabout20%oftheherbalsupplementstestedcontainedtheplantsclaimed.[92]ThemethodologyusedbytheNY-AGwasdisputed.ThetestinvolveslookingforDNAfragmentsfromtheplantsnamedasthedietarysupplementingredientsintheproducts.OnescientistsaidthatitwaspossiblethattheextractionprocessusedtocreatethesupplementsremovedordestroyedallDNA.This,however,wouldnotexplainthepresenceofDNAfromplantssuchasriceorwheat,thatwerenotlistedasingredients.[92] Astudyofdietarysupplementssoldbetween2007and2016identified776thatcontainedunlistedpharmaceuticaldrugs,manyofwhichcouldinteractwithothermedicationsandleadtohospitalization.[93]86%oftheadulteratedsupplementsweremarketedforweightlossandsexualperformance,withmanycontainingprescriptionerectiledysfunctionmedication.Musclebuildingsupplementswerecontaminatedwithanabolicsteroidsthatcanleadtohealthcomplicationsaffectingthekidney,theheart,andcausegynecomastia.[94]Multiplebodybuildingproductsalsocontainedantidepressantsandantihistamines.Despitethesefindings,fewerthanhalfoftheadulteratedsupplementswererecalled.[93] Regulatorycompliance TheEuropeanCommissionhaspublishedharmonizedrulesonsupplementproductstoassureconsumershaveminimalhealthrisksfromusingdietarysupplementsandarenotmisledbyadvertising.[95] IntheUnitedStatesandCanada,dietarysupplementsareconsideredasubsetoffoods,andareregulatedaccordingly.TheU.S.FoodandDrugAdministration(FDA)monitorssupplementproductsforaccuracyinadvertisingandlabeling.DietarysupplementsareregulatedbytheFDAasfoodproductssubjecttocompliancewithcurrentGoodManufacturingPractices(CGMP)andlabelingwithscience-basedingredientdescriptionsandadvertising.[96][97]WhenfindingCGMPoradvertisingviolations,FDAwarninglettersareusedtonotifymanufacturersofimpendingenforcementaction,includingsearchandseizure,injunction,andfinancialpenalties.[98]Examplesbetween2016and2018ofCGMPandadvertisingviolationsbydietarysupplementmanufacturersincludedseveralwithillegalcompositionsoradvertisingofvitaminsandminerals.[99][100][101] TheU.S.FederalTradeCommission,whichlitigatesagainstdeceptiveadvertisinginmarketedproducts,[102]establishedaconsumercentertoassistreportsoffalsehealthclaimsinproductadvertisingfordietarysupplements.[103]In2017,theFTCsuccessfullysuedninemanufacturersfordeceptiveadvertisingofdietarysupplements.[104] Adverseeffects IntheUnitedStates,manufacturersofdietarysupplementsarerequiredtodemonstratesafetyoftheirproductsbeforeapprovalisgrantedforcommerce.[105]Despitethiscaution,numerousadverseeffectshavebeenreported,[86]includingmusclecramps,hairloss,jointpain,liverdisease,andallergicreactions,with29%oftheadverseeffectsresultinginhospitalization,and20%inseriousinjuriesorillnesses.[86]Thepotentialforadverseeffectsalsooccurswhenindividualsconsumemorethanthenecessarydailyamountofvitaminsormineralsthatareneededtomaintainnormalbodyprocessesandfunctions.[106]TheincidenceofadverseeffectsreportedtotheFDAweredueto"combinationproducts"thatcontainmultipleingredients,whereasdietarysupplementscontainingasinglevitamin,mineral,lipidproduct,andherbalproductwerelesslikelytocauseadverseeffectsrelatedtoexcesssupplementation.[86] Amonggeneralreasonsforthepossibleharmfuleffectsofdietarysupplementsare:a)absorptioninashorttime,b)manufacturingqualityandcontamination,andc)enhancingbothpositiveandnegativeeffectsatthesametime.[56]Theincidenceofliverinjuryfromherbalanddietarysupplementsisabout16–20%ofallsupplementproductscausinginjury,withtheoccurrencegrowinggloballyovertheearly21stcentury.[107]Themostcommonliverinjuriesfromweightlossandbodybuildingsupplementsinvolvehepatocellulardamagewithresultingjaundice,andthemostcommonsupplementingredientsattributedtotheseinjuriesaregreenteacatechins,anabolicsteroids,andtheherbalextract,aegeline.[107]Weightlosssupplementshavealsohadadversepsychiatriceffects.[108]Somedietarysupplementsmayalsohaveadverseinteractionswithprescriptionmedicationsthatmayenhancesideeffectsordecreasetherapeuticeffectsofmedications.[109] Societyandculture Publichealth Workdonebyscientistsintheearly20thcenturyonidentifyingindividualnutrientsinfoodanddevelopingwaystomanufacturethemraisedhopesthatoptimalhealthcouldbeachievedanddiseasespreventedbyaddingthemtofoodandprovidingpeoplewithdietarysupplements;whilethereweresuccessesinpreventingvitamindeficiencies,andpreventingconditionslikeneuraltubedefectsbysupplementationandfoodfortificationwithfolicacid,notargetedsupplementationorfortificationstrategiestopreventmajordiseaseslikecancerorcardiovasculardiseaseshaveprovedsuccessful.[110] Forexample,whileincreasedconsumptionoffruitsandvegetablesarerelatedtodecreasesinmortality,cardiovasculardiseasesandcancers,supplementationwithkeyfactorsfoundinfruitsandvegetable,likeantioxidants,vitamins,orminerals,donothelpandsomehavebeenfoundtobeharmfulinsomecases.[111][112]Ingeneral,asof2016,robustclinicaldataislacking,thatshowsthatanykindofdietarysupplementationdoesmoregoodthanharmforpeoplewhoarehealthyandeatingareasonabledietbutthereiscleardatashowingthatdietarypatternandlifestylechoicesareassociatedwithhealthoutcomes.[113][114] Asaresultofthelackofgooddataforsupplementationandthestrongdatafordietarypattern,publichealthrecommendationsforhealthyeatingurgepeopletoeataplant-baseddietofwholefoods,minimizingprocessedfood,saltandsugarandtogetexercisedaily,andtoabandonWesternpatterndietsandasedentarylifestyle.[115][116]: 10  Legalregulation UnitedStates Mainarticle:RegulationoffoodanddietarysupplementsbytheU.S.FoodandDrugAdministration TheregulationoffoodanddietarysupplementsbytheU.S.FoodandDrugAdministration(FDA)isgovernedbyvariousstatutesenactedbytheUnitedStatesCongress.PursuanttotheFederalFood,Drug,andCosmeticActandaccompanyinglegislation,theFDAhasauthoritytooverseethequalityofsubstancessoldasfoodintheUnitedStates,andtomonitorclaimsmadeinthelabelingaboutboththecompositionandthehealthbenefitsoffoods. SubstanceswhichtheFDAregulatesasfoodaresubdividedintovariouscategories,includingfoods,foodadditives,addedsubstances(man-madesubstanceswhicharenotintentionallyintroducedintofood,butneverthelessendupinit),anddietarysupplements.ThespecificstandardswhichtheFDAexercisesdifferfromonecategorytothenext.Furthermore,theFDAhasbeengrantedavarietyofmeansbywhichitcanaddressviolationsofthestandardsforagivencategoryofsubstances. Dietarysupplementmanufactureisrequiredtocomplywiththegoodmanufacturingpracticesestablishedin2007.TheFDAcanvisitmanufacturingfacilities,sendWarningLetters[100]ifnotincompliancewithGMPs,stopproduction,andifthereisahealthrisk,requirethatthecompanyconductarecall.[117]Onlyafteradietarysupplementproductismarketed,maytheFDA'sCenterforFoodSafetyandAppliedNutrition(CFSAN)reviewtheproductsforsafetyandeffectiveness.[118] EuropeanUnion TheEuropeanUnion's(EU)FoodSupplementsDirectiveof2002requiresthatsupplementsbedemonstratedtobesafe,bothindosagesandinpurity.[119]OnlythosesupplementsthathavebeenproventobesafemaybesoldintheEUwithoutprescription.Asacategoryoffood,foodsupplementscannotbelabeledwithdrugclaimsbutcanbearhealthclaimsandnutritionclaims.[120] ThedietarysupplementsindustryintheUnitedKingdom(UK),oneofthe28countriesinthebloc,stronglyopposedtheDirective.Inaddition,alargenumberofconsumersthroughoutEurope,includingoveronemillionintheUK,andvariousdoctorsandscientists,hadsignedpetitionsby2005againstwhatareviewedbythepetitionersasunjustifiedrestrictionsofconsumerchoice.[121]In2004,alongwithtwoBritishtradeassociations,theAllianceforNaturalHealth(ANH)hadalegalchallengetotheFoodSupplementsDirective[122]referredtotheEuropeanCourtofJusticebytheHighCourtinLondon.[123] AlthoughtheEuropeanCourtofJustice'sAdvocateGeneralsubsequentlysaidthatthebloc'splantotightenrulesonthesaleofvitaminsandfoodsupplementsshouldbescrapped,[124]hewaseventuallyoverruledbytheEuropeanCourt,whichdecidedthatthemeasuresinquestionwerenecessaryandappropriateforthepurposeofprotectingpublichealth.ANH,however,interpretedthebanasapplyingonlytosyntheticallyproducedsupplements,andnottovitaminsandmineralsnormallyfoundinorconsumedaspartofthediet.[125]Nevertheless,theEuropeanjudgesacknowledgedtheAdvocateGeneral'sconcerns,statingthattheremustbeclearprocedurestoallowsubstancestobeaddedtothepermittedlistbasedonscientificevidence.Theyalsosaidthatanyrefusaltoaddtheproducttothelistmustbeopentochallengeinthecourts.[126] FraudulentproductsduringtheCOVID-19outbreak DuringtheCOVID-19pandemicintheUnitedStates,theFDAandFederalTradeCommission(FTC)warnedconsumersaboutmarketingscamsoffraudulentsupplementproducts,includinghomeopathicremedies,cannabidiolproducts,teas,essentialoils,tincturesandcolloidalsilver,amongothers.[127][128]ByAugust2020,theFDAandFTChadissuedwarningletterstodozensofcompaniesadvertisingscamproducts,whichwerepurported"tobedrugs,medicaldevicesorvaccines.Productsthatclaimtocure,mitigate,treat,diagnoseorpreventdisease,butarenotprovensafeandeffectiveforthosepurposes,defraudconsumersofmoneyandcanplaceconsumersatriskforseriousharm"[127][129][130] Research ExamplesofongoinggovernmentresearchorganizationstobetterunderstandthepotentialhealthpropertiesandsafetyofdietarysupplementsaretheEuropeanFoodSafetyAuthority,[3]theOfficeofDietarySupplementsoftheUnitedStatesNationalInstitutesofHealth,[7][131]theNaturalandNon-prescriptionHealthProductsDirectorateofCanada,[132]andtheTherapeuticGoodsAdministrationofAustralia.[133]Togetherwithpublicandprivateresearchgroups,theseagenciesconstructdatabasesonsupplementproperties,performresearchonquality,safety,andpopulationtrendsofsupplementuse,andevaluatethepotentialclinicalefficacyofsupplementsformaintaininghealthorloweringdiseaserisk.[131] Databases Ascontinualresearchonthepropertiesofsupplementsaccumulates,databasesorfactsheetsforvarioussupplementsareupdatedregularly,includingtheDietarySupplementLabelDatabase,[5]DietarySupplementIngredientDatabase,[134]andDietarySupplementFactsSheetsoftheUnitedStates.[135]InCanadawherealicenseisissuedwhenasupplementproducthasbeenprovenbythemanufacturerandgovernmenttobesafe,effectiveandofsufficientqualityforitsrecommendeduse,aneight-digitNaturalProductNumberisassignedandrecordedinaLicensedNaturalHealthProductsDatabase.[136]TheEuropeanFoodSafetyAuthoritymaintainsacompendiumofbotanicalingredientsusedinmanufacturingofdietarysupplements.[137] In2015,theAustralianGovernment'sDepartmentofHealthpublishedtheresultsofareviewofherbalsupplementstodetermineifanyweresuitableforcoveragebyhealthinsurance.[138]Establishingguidelinestoassesssafetyandefficacyofbotanicalsupplementproducts,theEuropeanMedicinesAgencyprovidedcriteriaforevaluatingandgradingthequalityofclinicalresearchinpreparingmonographsaboutherbalsupplements.[139]IntheUnitedStates,theNationalCenterforComplementaryandIntegrativeHealthoftheNationalInstitutesofHealthprovidesfactsheetsevaluatingthesafety,potentialeffectivenessandsideeffectsofmanybotanicalproducts.[140] Qualityandsafety Toassuresupplementshavesufficientquality,standardization,andsafetyforpublicconsumption,researcheffortshavefocusedondevelopmentofreferencematerialsforsupplementmanufacturingandmonitoring.[137][141]High-doseproductshavereceivedresearchattention,[131][142]especiallyforemergencysituationssuchasvitaminAdeficiencyinmalnutritionofchildren,[143]andforwomentakingfolatesupplementstoreducetheriskofbreastcancer.[144] Populationmonitoring IntheUnitedStates,theNationalHealthandNutritionExaminationSurvey(NHANES)hasinvestigatedhabitsofusingdietarysupplementsincontextoftotalnutrientintakesfromthedietinadultsandchildren.[131]Overtheperiodof1999to2012,useofmultivitaminsdecreased,andtherewaswidevariabilityintheuseofindividualsupplementsamongsubgroupsbyage,sex,race/ethnicity,andeducationalstatus.[145]Particularattentionhasbeengiventouseoffolatesupplementsbyyoungwomentoreducetheriskoffetalneuraltubedefects.[146][147] Clinicalstudies Limitedhumanresearchhasbeenconductedonthepotentialfordietarysupplementationtoaffectdiseaserisk.Examples: vitaminD–acuterespiratorytractinfections[148] iron–maternalirondeficiencyanemiaandadverseeffectsonthefetus[149] folate–strokeandcardiovasculardiseases[150] multiplesupplements–noevidenceofbenefittolowerriskofdeath,cardiovasculardiseasesorcancer[151] A2017academicreviewindicatedarisingincidenceofliverinjuryfromuseofherbalanddietarysupplements,particularlythosewithsteroids,greenteaextract,ormultipleingredients.[107] Absenceofbenefit Thepotentialbenefitofusingessentialnutrientdietarysupplementstolowertheriskofdiseaseshasbeenrefutedbyfindingsofnoeffectorweakevidenceinnumerousclinicalreviews,suchasforcardiovasculardiseases,[151]cancer,[151]HIV,[152]ortuberculosis.[153] Reportingbias Areviewofclinicaltrialsregisteredatclinicaltrials.gov,whichwouldincludebothdrugsandsupplements,reportedthatnearlyhalfofcompletedtrialsweresponsoredwhollyorpartiallybyindustry.[154]Thisdoesnotautomaticallyimplybias,butthereisevidencethatbecauseofselectivenon-reporting,resultsinsupportofapotentialdrugorsupplementingredientaremorelikelytobepublishedthanresultsthatdonotdemonstrateastatisticallysignificantbenefit.[154][155]Onereviewreportedthatfewerthanhalfoftheregisteredclinicaltrialsresultedinpublicationinpeer-reviewedjournals.[156] Future 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"UsingDietarySupplementsWisely".U.S.NationalCenterforComplementaryandIntegrativeHealth. vteDietarysupplementsTypes Bodybuildingsupplement Energydrink Energybar Fattyacids Herbalsupplements Minerals Prebiotics Probiotics(Lactobacillus Bifidobacterium) Proteinsupplements Vitamins Vitaminsandchemicalelements("minerals") Retinol(VitaminA) Bvitamins Thiamine(B1) Riboflavin(B2) Niacin(B3) Pantothenicacid(B5) Pyridoxine(B6) Biotin(B7) Folicacid(B9) Cyanocobalamin(B12) Ascorbicacid(VitaminC) ErgocalciferolandCholecalciferol(VitaminD) Tocopherol(VitaminE) Naphthoquinone(VitaminK) Calcium Choline Chromium Cobalt Copper Fluorine Iodine Iron Magnesium Manganese Molybdenum Phosphorus Potassium Selenium Sodium Sulfur Zinc Othercommoningredients AAKG β-hydroxyβ-methylbutyrate Carnitine Chondroitinsulfate Codliveroil Coppergluconate Creatine Dietaryfiber Echinacea Ephedra Fishoil Folicacid Ginseng Glucosamine Glutamine Grapeseedextract Guarana Ironsupplements Japanesehoneysuckle Krilloil Lingzhi Linseedoil Lipoicacid Milkthistle Melatonin Redyeastrice Royaljelly Sawpalmetto Spirulina StJohn'swort Taurine Wheatgrass Wolfberry Yohimbine Zincgluconate Relatedarticles CodexAlimentarius Enzyte Hadacol Herbaltea Nutraceutical Multivitamin Nutrition vteHumannutritionandhealthydiets Mainarticles Diet Cuisine Dietitian Hunger Leptin Meal Nutrition Obesity Staplefood DietingBasictypes Omnivore Plant-based Regionaldiets Western Mediterranean Sustainablediets Lowcarbon Planetaryhealth Religiousdiets Buddhist Christian Hindu Islamic Jain Jewish Rastafari Sikh Vegetarianismandveganism Fruitarianism Meatanalogue Milksubstitute Rawvegan Tofu Semi-vegetarianism Pescetarian Pollotarian Supplementdiets Bodybuildingsupplements Mealreplacement Therapeuticfood Non-soliddiets Liquiddiets Very-low-caloriediet Specificrestrictions Calorierestriction Cardiacdiet Diabeticdiet Fluidrestrictiondiet Gluten-free Gluten-freeandcasein-free Intermittentfasting Low-sodium Low-FODMAP Low-carbohydrate Low-fat Low-fiber/low-residuediet Monotrophicdiet NPO Renaldiet Softdiet Specificcarbohydrate Otherdiets Entomophagy Cottonball Pica DASH Inuit MIND Time-restrictedfeeding Rawfoodism U.S.military Faddiets Cambridge Macrobiotic MasterCleanse Junkfood Superfood Slow-Carb Listofdiets Dietfood NutritionAminoacids Alanine Arginine Asparagine Asparticacid Cysteine Glutamicacid Glutamine Glycine Histidine Isoleucine Leucine Lysine Methionine Phenylalanine Proline Selenocysteine Serine Threonine Tryptophan Tyrosine Valine Vitamins VitaminA VitaminB1 VitaminB2 VitaminB3 VitaminB5 VitaminB6 VitaminB7 VitaminB9 VitaminB12 VitaminC VitaminD VitaminE VitaminK Minerals Calcium Chlorine Chromium Cobalt Copper Iodine Iron Magnesium Manganese Molybdenum Nickel Phosphorus Potassium Selenium Sodium Vanadium Zinc Nutritionaladvice 5ADay DairyCouncilofCalifornia Foodpyramid Fruits&Veggies–MoreMatters Healthyeatingpyramid LatinAmericanDietPyramid Frenchparadox MediterraneanDietPyramid MyPlate MyPyramid VegetarianDietPyramid Category Commons Cookbook Foodportal,Healthandfitnessportal Authoritycontrol:Nationallibraries France(data) Germany Israel UnitedStates Latvia Japan Retrievedfrom"https://en.wikipedia.org/w/index.php?title=Dietary_supplement&oldid=1085177913" Categories:DietarysupplementsHiddencategories:CS1maint:multiplenames:authorslistCS1errors:missingperiodicalCS1errors:deprecatedparametersArticleswithshortdescriptionShortdescriptionmatchesWikidataWikipediaindefinitelysemi-protectedpagesArticleswithlimitedgeographicscopefromApril2020ArticleswithexcerptsCommonscategorylinkisonWikidataArticleswithBNFidentifiersArticleswithGNDidentifiersArticleswithJ9UidentifiersArticleswithLCCNidentifiersArticleswithLNBidentifiersArticleswithNDLidentifiersArticlescontainingvideoclips Navigationmenu Personaltools NotloggedinTalkContributionsCreateaccountLogin Namespaces ArticleTalk English Views ReadViewsourceViewhistory More Search Navigation MainpageContentsCurrenteventsRandomarticleAboutWikipediaContactusDonate Contribute HelpLearntoeditCommunityportalRecentchangesUploadfile Tools WhatlinkshereRelatedchangesUploadfileSpecialpagesPermanentlinkPageinformationCitethispageWikidataitem Print/export DownloadasPDFPrintableversion Inotherprojects WikimediaCommons Languages العربيةAsturianuBosanskiCatalàČeštinaDanskDeutschΕλληνικάEspañolEsperantoEuskaraفارسیFrançaisGalego한국어हिन्दीHrvatskiBahasaIndonesiaItalianoעבריתJawaҚазақшаLatviešuLietuviųMagyarМакедонскиBahasaMelayuNederlands日本語NorskbokmålNorsknynorskPolskiPortuguêsRomânăРусскийSimpleEnglishSlovenščinaکوردیСрпски/srpskiSrpskohrvatski/српскохрватскиSuomiSvenskaதமிழ்ไทยTürkçeУкраїнськаTiếngViệt中文 Editlinks