食品FDA注册---保健品FDA注册相关问题

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1、FDARegistration-FAQsforFoodR.1DoesFSMArequireafoodfacilitytosubmitadditionalregistrationinformationtoFDAinorderforthefacilitytoreceiveafoodfacilityregistrationnumber?为了获得食品工厂登记号码FSMA要求食品机构向FDA提交其他注册信息吗？Yes.Section102ofFSMAamendssection415(a)(2)oftheF

2、D&CActbyrequiringfoodfacilitiestosubmitregistrationstoFDAcontainingadditionalinformation.Specifically,aregistrationforadomesticfacilityisrequiredtocontainthee-mailaddressforthecontactpersonofthefacility,orforaforeignfacility,theemailaddressoftheUnite

3、dStatesagentforthefacility.AllfoodfacilityregistrationsarerequiredtocontainanassurancethatFDAwillbepermittedtoinspectthefacilityatthetimesandinthemannerpermittedbytheFD&CAct.Additionally,ifdeterminednecessarybyFDA,registrationsarerequiredtocontaininf

4、ormationregardingotherapplicablefoodcategories,asdeterminedappropriatebyFDA,forfoodsmanufactured/processed,packed,orheldatregisteringfacilities.是的。FSMA第102节修改FD＆C法案第415（a）（2）条要求食品工厂向FDA提交含有附加信息来注册。具体来说，国内工厂的注册必须包含工厂联系人的电子邮件地址，或国外的工厂需要美国代理人的电子邮件地址。所有食

5、品工厂注册都必须包含一项保证，FDA将允许按照FD＆C法允许的时间和方式检查工厂。此外，如果FDA认为有必要，注册必须包含FDA所适用的其他适用食品类别的信息，用于在注册工厂生产/加工，包装或持有的食品。R.2WillfoodfacilitiesalreadyregisteredwithFDAundersection415oftheFD&CActberequiredtorenewtheirregistrations?已经根据FD＆C法第415条登记的FDA食品工厂是否需要更新注册？Yes.All

6、foodfacilitiesthatarerequiredtoregisterwithFDAundersection415oftheFD&CActmustrenewtheirregistrationswithFDA,everyotheryear,duringtheperiodoftimebeginningonOctober1andendingonDecember31ofeacheven-numberedyear.是的。所有根据FD＆C法第415条向FDA注册的食品工厂必须更新其FDA注册，每隔一

7、年，从10月1日开始到每个偶数年12月31日的时间段。R.3Hasthescopeofwhoisrequiredtoregisterundersection415oftheFD&CActchanged?根据FD＆C法第415条要求注册的范围是否发生变化？Atthistime,thesametypesoffoodfacilitiesthatwererequiredtoregisterwithFDAundersection415oftheFD&CActbeforeFSMAarerequiredtor

8、egisterwithFDAandrenewsuchregistrations.Thosefacilitiesaredomesticandforeignfacilitiesthatmanufacture,process,pack,orholdfoodforhumanoranimalconsumptionintheUnitedStates.Section103(c)ofFSMAdirectsFDAtoconductarulemakingto“clarifytheactivitiesthatarei