What You Need to Know about Dietary Supplements | FDA

Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes. Dietary supplements are marketed in forms ... Skiptomaincontent SkiptoFDASearch Skiptointhissectionmenu Skiptofooterlinks Inthissection: Buy,Store&ServeSafeFood Buy,Store&ServeSafeFood FoodFactsforConsumers FoodSafetyinYourKitchen EverydayFoodSafetyforYoungAdults Home Food ResourcesforYou(Food) Consumers Buy,Store&ServeSafeFood WhatYouNeedtoKnowaboutDietarySupplements Buy,Store&ServeSafeFood Print&Share(PDF:246KB) EnEspañol(Spanish) DietarySupplementscanbebeneficialtoyourhealth—buttakingsupplementscanalsoinvolvehealthrisks.TheU.S.FoodandDrugAdministration(FDA)doesnothavetheauthoritytoreviewdietarysupplementproductsforsafetyandeffectivenessbeforetheyaremarketed. You’veheardaboutthem,mayhaveusedthem,andmayhaveevenrecommendedthemtofriendsorfamily.Whilesomedietarysupplementsarewellunderstoodandestablished,othersneedfurtherstudy.Readonforimportantinformationforyouandyourfamilyaboutdietarysupplements. Beforemakingdecisionsaboutwhethertotakeasupplement,talktoyourhealthcareprovider.Theycanhelpyouachieveabalancebetweenthefoodsandnutrientsyoupersonallyneed. Whataredietarysupplements? Dietarysupplementsincludesuchingredientsasvitamins,minerals,herbs,aminoacids,andenzymes.Dietarysupplementsaremarketedinformssuchastablets,capsules,softgels,gelcaps,powders,andliquids. Whatarethebenefitsofdietarysupplements? Somesupplementscanhelpassurethatyougetenoughofthevitalsubstancesthebodyneedstofunction;othersmayhelpreducetheriskofdisease.Butsupplementsshouldnotreplacecompletemealswhicharenecessaryforahealthfuldiet–so,besureyoueatavarietyoffoodsaswell. Unlikedrugs,supplementsarenotpermittedtobemarketedforthepurposeoftreating,diagnosing,preventing,orcuringdiseases.Thatmeanssupplementsshouldnotmakediseaseclaims,suchas“lowershighcholesterol”or“treatsheartdisease.”Claimslikethesecannotbelegitimatelymadefordietarysupplements. Arethereanyrisksintakingsupplements? Yes.Manysupplementscontainactiveingredientsthathavestrongbiologicaleffectsinthebody.Thiscouldmakethemunsafeinsomesituationsandhurtorcomplicateyourhealth.Forexample,thefollowingactionscouldleadtoharmful–evenlife-threatening–consequences. Combiningsupplements Usingsupplementswithmedicines(whetherprescriptionorover-the-counter) Substitutingsupplementsforprescriptionmedicines Takingtoomuchofsomesupplements,suchasvitaminA,vitaminD,oriron Somesupplementscanalsohaveunwantedeffectsbefore,during,andaftersurgery.So,besuretoinformyourhealthcareprovider,includingyourpharmacistaboutanysupplementsyouaretaking. SomeCommonDietarySupplements Calcium Echinacea FishOil Ginseng Glucosamineand/or ChondroitinSulphate Garlic VitaminD St.John’sWort SawPalmetto Ginkgo GreenTea Note:TheseexamplesdonotrepresenteitheranendorsementorapprovalbyFDA. backtotop Whoisresponsibleforthesafetyofdietarysupplements? FDAisnotauthorizedtoreviewdietarysupplementproductsforsafetyandeffectivenessbeforetheyaremarketed. ThemanufacturersanddistributorsofdietarysupplementsareresponsibleformakingsuretheirproductsaresafeBEFOREtheygotomarket. IfthedietarysupplementcontainsaNEWingredient,manufacturersmustnotifyFDAaboutthatingredientpriortomarketing.However,thenotificationwillonlybereviewedbyFDA(notapproved)andonlyforsafety,noteffectiveness. Manufacturersarerequiredtoproducedietarysupplementsinaqualitymannerandensurethattheydonotcontaincontaminantsorimpurities,andareaccuratelylabeledaccordingtocurrentGoodManufacturingPractice(cGMP)andlabelingregulations. Ifaseriousproblemassociatedwithadietarysupplementoccurs,manufacturersmustreportittoFDAasanadverseevent.FDAcantakedietarysupplementsoffthemarketiftheyarefoundtobeunsafeoriftheclaimsontheproductsarefalseandmisleading. HowcanIfindoutmoreaboutthedietarysupplementI’mtaking? Dietarysupplementlabelsmustincludenameandlocationinformationforthemanufacturerordistributor. Ifyouwanttoknowmoreabouttheproductthatyouaretaking,checkwiththemanufacturerordistributorabout: Informationtosupporttheclaimsoftheproduct Informationonthesafetyandeffectivenessoftheingredientsintheproduct. HowcanIbeasmartsupplementshopper? Beasavvysupplementuser.Here’show: Whensearchingforsupplementsontheinternet,usenoncommercialsites(e.g.NIH,FDA,USDA)ratherthandependingoninformationfromsellers. Ifclaimssoundtoogoodtobetrue,theyprobablyare.Bemindfulofproductclaimssuchas“worksbetterthan[aprescriptiondrug],”“totallysafe,”orhas“nosideeffects.” Beawarethatthetermnaturaldoesn’talwaysmeanssafe. Askyourhealthcareproviderifthesupplementyou’reconsideringwouldbesafeandbeneficialforyou. Alwaysremember–safetyfirst! ReportProblemstoFDA NotifyFDAiftheuseofadietarysupplementcausedyouorafamilymembertohaveaseriousreactionorillness(evenifyouarenotcertainthattheproductwasthecauseoryoudidnotvisitadoctororclinic). Followthesesteps: Stopusingtheproduct. Contactyourhealthcareprovidertofindouthowtotakecareoftheproblem. ReportproblemstoFDAineitheroftheseways: ContacttheConsumerComplaintCoordinatorinyourarea. FileasafetyreportonlinethroughtheSafetyReportingPortal. Learnmoreaboutdietarysupplements. backtotop Contentcurrentasof: 02/17/2022 RegulatedProduct(s) DietarySupplements Buy,Store&ServeSafeFood FoodFactsforConsumers FoodSafetyinYourKitchen EverydayFoodSafetyforYoungAdults BacktoTop