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1、INTRODUCTIONto21CFR111:DIETARYSUPPLEMENTS21CFR111简介：膳食补充剂Iappreciatetheopportunitytospeaktoyourgrouptoday.我很高兴有机会向在座的各位发言。IwanttostartbybrieflytalkingaboutthreelawspassedbytheU.S.CongresswhichhaveestablishedthelegalframeworkwithinwhichFDAoperates.ThefirstoftheselawsistheFederalFood,Drug,and
2、CosmeticAct(FD&CAct).TwootherlawsaretheDietarySupplementHealthandEducationAct(orDSHEA)andtheDietarySupplementandNonprescriptionDrugConsumerActbothofwhichamendedtheFD&CAct.FDAdevelopsregulationsbasedonthelawssetforthintheFD&CActandotherlawsunderwhichFDAoperates.我想首先简要地谈论一下在美国国会通过的三部法律，FDA正是这
3、些法律建立的法律框架内进行运作的。第一部法律是《联邦食品，药品和化妆品法》（FD&CAct）。另外两部法律是膳食补充品健康教育法（DSHEA）和膳食补充剂和非处方药消费者保护法,两个法律都补充了食品，药品和化妆品法。在上述FDA赖以运作的三部法律基础上，FDA制定了相关规章。ItisoneoftheseregulationswhichIamgoingtodiscussthisafternoon.ThatisTitle21Part111oftheCodeofFederalRegulationswhichisentitled“CurrentGoodManufacturing,Pa
4、cking,Labeling,orHoldingOperationsforDietarySupplements”orasthisregulationisalsoknown“theDietarySupplementGMP’s”.BeforeItalkabouttheDietarySupplementGMP’s,IneedtofirsttalkabouttheDietarySupplementHealthandEducationAct.我今天下午要讨论的正是这些规章之一。这是标题21部的联邦规例,标题是“膳食补充剂现行优良制造，包装，标签，或控股经营”,亦称为“膳食补充的GMP”
5、。在我谈论的膳食补充剂GMP之前，我有必要先讲一下膳食补充剂健康教育法。InOctober1994,theDietarySupplementHealthandEducationAct(DSHEA)wassignedintolawbyPresidentClinton.UnderDSHEA,adietarysupplementisdefinedasaproducttakenbymouththatcontainsa“dietaryingredient”intendedtosupplementthediet.The“dietaryingredients”intheseproducts
6、mayinclude:vitamins,minerals,herbsorotherbotanicals,aminoacids,andsubstancessuchasenzymes,organtissues,glandulars,andmetabolites.Dietarysupplementscanalsobeextractsorconcentrates,andmaybefoundinmanyformssuchastablets,capsules,softgels,gelcaps,liquids,orpowders.Theycanalsobeinotherforms,such
7、asabar,butiftheyare,informationontheirlabelmustnotrepresenttheproductasaconventionalfoodorasoleitemofamealordiet.Whatevertheirform,DSHEAplacesdietarysupplementsinaspecialcategoryunderthegeneralumbrellaof“foods,”notdrugs.DSHEAalsorequiresthateverysuppleme
