Dietary Supplements | FDA

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FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of ... Skiptomaincontent SkiptoFDASearch Skiptointhissectionmenu Skiptofooterlinks Inthissection: Food DietarySupplements DietarySupplementProducts&Ingredients HowtoReportaProblemwithDietarySupplements InformationforConsumersonUsingDietarySupplements InformationforIndustryonDietarySupplements NewDietaryIngredients(NDI)NotificationProcess Home Food DietarySupplements Food FDAregulatesbothfinisheddietarysupplementproductsanddietaryingredients.FDAregulatesdietarysupplementsunderadifferentsetofregulationsthanthosecovering"conventional"foodsanddrugproducts.UndertheDietarySupplementHealthandEducationActof1994(DSHEA): Manufacturersanddistributorsofdietarysupplementsanddietaryingredientsareprohibitedfrommarketingproductsthatareadulteratedormisbranded. ThatmeansthatthesefirmsareresponsibleforevaluatingthesafetyandlabelingoftheirproductsbeforemarketingtoensurethattheymeetalltherequirementsoftheFederalFood,Drug,andCosmeticActasamendedbyDSHEAandFDAregulations. FDAhastheauthoritytotakeactionagainstanyadulteratedormisbrandeddietarysupplementproductafteritreachesthemarket. What'sNewinDietarySupplements Linkstoconstituentupdates,pressreleases,andotheractionstakenondietarysupplementsandproductsmarketedasdietarysupplements,includingwarninglettersandrecalls. DietarySupplementProducts&Ingredients Informationonselecteddietarysupplementproducts,ingredients,andothersubstances. HowtoReportaProblemwithDietarySupplements Learnhowconsumers,healthcareproviders,andotherscanreportacomplaint,concern,orproblemrelatedtodietarysupplements.Includeslinkstoguidancefordietarysupplementmanufacturers,packers,anddistributors. InformationforConsumersonUsingDietarySupplements Includesconsumerupdates,informationfromotheragencies,andothereducationalmaterialsfordietarysupplementusers. InformationforIndustryonDietarySupplements Resourcesandlinksforsubmissionsfornewdietaryingredientnotificationsandstructure/functionclaimnotifications,applications,guidancesandregulations,andotheritemsofinteresttoindustrymembers. NewDietaryIngredientsNotificationProcess Backgroundinformationforindustry,instructionsforsubmittingpremarketnotifications,andlinkstorelevantguidanceandFederalRegisterdocuments. Structure/FunctionClaimNotificationforDietarySupplements Backgroundinformationforindustry,instructionsforsubmittingnotifications,andlinkstorelevantguidanceandFederalRegisterdocuments. ContactFDA OfficeofDietarySupplementPrograms,HFS-810 FoodandDrugAdministration 5001CampusDr CollegePark,MD20740 TocontacttheOfficeofDietarySupplementPrograms,email:[email protected] ToreachFDA’sFoodandCosmeticsInformationCenter,call:1-888-SAFEFOOD(1-888-723-3366) Contentcurrentasof: 02/18/2022 RegulatedProduct(s) DietarySupplements DietarySupplements DietarySupplementProducts&Ingredients HowtoReportaProblemwithDietarySupplements InformationforConsumersonUsingDietarySupplements InformationforIndustryonDietarySupplements NewDietaryIngredients(NDI)NotificationProcess BacktoTop



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