Yintoni ekufuneka ikwaziwe ngabathumeli bezinto kwamanye amazwe Ubhaliso lwe-FDA lweZithambiso?

UMthetho woLawulo lweZithambiso zoHlaziyo ka-2022 (i-MoCRA) umele ulwandiso olubalulekileyo lwegunya le-US Food and Drug Administration (FDA) lokulawula izithambiso ukusukela oko kwapasiswa uMthetho we-Federal Food, Drug, and Cosmetic (FD&C) ngo-1938. Kubangenisi abangenisa iimveliso zezithambiso eMelika, ukuqonda ezi mfuno zintsha kubalulekile ukuze kuthintelwe ukulibaziseka kokuthunyelwa, izohlwayo, kunye nemingcele yokufikelela kwimarike. Esi sikhokelo sinika umbono opheleleyo wento ekufuneka abangenisi bayazi malunga nokubhaliswa kwezithambiso ze-FDA phantsi kwe-MoCRA.

Yintoni iMoCRA kwaye Kutheni Ibalulekile Kubathumeli Bempahla?

I-MoCRA iguqule imeko-bume yolawulo lwezithambiso ngokutshintsha inkqubo yokubhalisa ngokuzithandela yangaphambili ngeemfuno ezinyanzelekileyo. Ngaphambi kwe-MoCRA, iNkqubo yoBhaliso lweZithambiso zokuzithandela ye-FDA (i-VCRP) yayinezibonelelo ezibhalisiweyo ezingama-5,176 kuphela kunye neemveliso ezidwelisiweyo ezingama-35,102. Ukusukela nge-1 kaJanuwari 2025, i-FDA ibike ukwanda okuphantse kuphindwe ngama-20, kunye nokubhaliswa kwezibonelelo zezithambiso ezisebenzayo ezingama-9,528 kunye noluhlu lweemveliso zezithambiso ezikhethekileyo ezingama-589,762.

Kwabangenisi, olu tshintsho luthetha ukuba ukuthobela imithetho akusekho mfuneko. Izinto zokuthambisa ezingenisiweyo kufuneka zithobele imithetho nemigaqo efanayo esebenza kwiimveliso eziveliswe ekhaya. Ukuthunyelwa okungathotyelwanga kusenokungavunyelwa ukungena, kulibaziseke, okanye kuxhomekeke kwizenzo zokunyanzeliswa.

Iimfuneko eziphambili ze-MoCRA zabaThengisi belizwe

1. Ubhaliso lweZiko

Phantsi kweMoCRA, zonke iziko ezenza okanye ezicubungula iimveliso zobuhle ukuze zisasazwe eMelika kufuneka zibhalise kwi-FDA. Oku kuquka iziko zangaphandle ezithumela eMelika. Ubhaliso kufuneka luhlaziywe kabini ngonyaka (rhoqo emva kweminyaka emibini).

Kubalulekile kubaThengisi:

·Ubhaliso kufuneka lugqitywe nge-portal yokungenisa nge-elektroniki ye-FDA's Cosmetics Direct

·Iziko ngalinye lifuna inombolo ye-FDA Establishment Identifier (FEI)

·Ulwazi lobhaliso kufuneka luhlaziywe zingadlulanga iintsuku ezingama-60 emva kotshintsho

·Imihla yokuhlaziya isekelwe kumhla wokuqala wokubhalisa (umz., ukuba ubhalisiwe nge-20 kaFebruwari 2024, ukuhlaziywa kufuneka kugqitywe nge-20 kaFebruwari 2026)

2. Uluhlu lweeMveliso

"Umntu onoxanduva"—ochazwa njengomvelisi, umpaki, okanye umsasazi ogama lakhe livela kwileyibhile yemveliso—kufuneka abhale imveliso nganye yezithambiso ethengiswayo kwi-FDA. Oku kuquka ukubonelela ngezithako zemveliso kunye nokuhlaziya ulwazi minyaka le.

Amanqaku aphambili kubaThengisi bempahla kwamanye amazwe:

Uluhlu lwemveliso kufuneka lubandakanye inombolo ye-FEI yesakhiwo ngasinye apho imveliso yenziwa okanye icutshungulwa khona

Uluhlu kufuneka luthunyelwe ngeCosmetics Direct

Uhlaziyo kufuneka lwenziwe minyaka le okanye xa ulwazi lwemveliso lutshintsha

3. Ukukhululwa kwiMicimbi yaMashishini Amancinci

I-MoCRA ayiwakhululi amashishini amancinci athile kwiimfuno zobhaliso lwezakhiwo kunye noluhlu lwemveliso. Ishishini lifaneleka njenge "shishini elincinci" ukuba intengiso yalo yonyaka ephakathi eMelika kwiminyaka emithathu edlulileyo ingaphantsi kwe-$1,000,000.

Imida ebalulekileyo:

Olu xolelo alusebenzi kwiindawo ezenza okanye ezicubungula iimveliso ezithile zokuthambisa, kuquka ezo zidibana rhoqo ne-mucus membrane yeliso, iimveliso ezifakwe emzimbeni, okanye iimveliso ezenzelwe ukusetyenziswa ngaphakathi.

Amashishini amancinci asalindeleke ukuba agcine imigangatho ephambili yokhuseleko kunye nokuthobela imithetho

Olu xolelo lusebenza kubhaliso nakuluhlu kuphela—ezinye iimfuno ezifana nokuqinisekiswa kokhuseleko zisasebenza

4. Ubungqina boKhuseleko

I-MoCRA ifuna ukuba umntu onoxanduva abe nesiqinisekiso esaneleyo sokhuseleko kwimveliso nganye yokuthambisa. Nangona i-FDA ingamiseli indlela ethile yokwenza izinto, ifuna ubungqina obuxhasa ukhuseleko lwemveliso phantsi kweemeko eziqhelekileyo okanye ezibonakala kwangaphambili zokusetyenziswa.

Kwabangenisa impahla kwamanye amazwe:

Iirekhodi zovavanyo mazigcinwe kwaye zifumaneke ukuze zihlolwe yi-FDA

Izongezo zombala zifuna imvume yangaphambi kokuba zithengiswe

Iimveliso ezineTalc zifuna iziqinisekiso zovavanyo lwe-asbestos

5. Ingxelo yeziganeko ezimbi

Umntu onoxanduva kufuneka axele ngeziganeko ezimbi kakhulu ezinxulumene nokusetyenziswa kweemveliso zobuhle eMelika kwi-FDA zingadlulanga iintsuku ezili-15 zokusebenza.

Inkcazo yeSiganeko esibi kakhulu:
Isiganeko esibi kakhulu seso sikhokelela ekufeni, amava asongela ubomi, ukulaliswa esibhedlele esibhedlele, ukukhubazeka okuqhubekayo okanye okukhulu, ukukhubazeka kokuzalwa, usulelo, okanye ukonakala okubalulekileyo (kubandakanya ukurhawuzelelwa okunzulu nokungapheliyo, ukutsha kwenqanaba lesibini okanye lesithathu, ukulahleka kweenwele okuphawulekayo, okanye utshintsho oluqhubekayo okanye olubalulekileyo kwinkangeleko).

6. Imfuneko ye-Arhente yaseMelika

Izakhiwo zangaphandle kufuneka zichonge kwaye zigcine i-Arhente yase-US esebenzayo enoxanduva lonxibelelwano lwe-FDA, iirekhodi zokuthobela imithetho, kunye nokulungelelanisa iziganeko ezimbi. Le arhente isebenza njengendawo yokunxibelelana ne-FDA kwiziko langaphandle kwaye kufuneka ifumaneke ngamaxesha omsebenzi.

Oko Abangenisi Abangafunekiyo Ukuba Bakwenze

Kubalulekile ukuqonda oko i-MoCRA ingakufuniyo:

·Iimveliso kunye nezithako zezithambiso azifuni mvume yangaphambi kokuba zithengiswe yi-FDA, ngaphandle kwezongezo zemibala

·Iifemu ezingenisa iimveliso ezithathwa njengezithambiso kuphela azinyanzelekanga ukuba zibhalise kwi-FDA—imfuneko yokubhalisa isebenza kubavelisi kunye nabaprosesa, kungekhona abangenisa ngokwabo.

·Nangona kunjalo, abathumeli-mpahla kufuneka baqinisekise ukuba abavelisi abasebenza nabo babhalisiwe ngokufanelekileyo kwaye iimveliso zidweliswe ngokufanelekileyo

Inkqubo yokungenisa impahla kunye nokuthotyelwa kwemithetho yezemali

I-FDA isebenzisana ngokusondeleyo ne-US Customs and Border Protection (CBP) ukujonga ukungeniswa kwezinto kwamanye amazwe. Izithambiso ezingenisiweyo zijongwa yi-CBP ngexesha lokungena.

Iimfuno eziphambili zeLogistics:

·Ukuthunyelwa kwezinto zokuthambisa kufuna isaziso se-FDA kwangaphambili ngenkqubo ye-ACE

·Uthutho lweenqwelo-moya nolweelwandle kufuneka lubandakanye amaxwebhu e-MoCRA okuqinisekisa ukususwa kwerhafu

·Ikhowudi ye-HS 3304 (iimveliso zobuhle) ihambelana nokuhlolwa kokuthobela i-FDA

·Iileyibhile mazibhalwe ngesiNgesi kubathumeli baseMelika

Iimpazamo eziqhelekileyo ekufuneka uziphephe:

·Ukutsiba ubhaliso lwesakhiwo ngaphambi kokuthunyelwa

·Uluhlu lwezithako olungaphelelanga

·Ukungahoyi uvavanyo lokhuseleko lwezithambiso zeeleyibhile zabucala

·Akukho saziso sangaphambili malunga nokuhanjiswa kweenqwelo-moya

·Iilebhile eziphelelwe lixesha ezingenalo ulwazi lwe-MoCRA

Iimfuneko zokulebhelisha phantsi kweMoCRA

Imithetho emitsha yokulebhelisha ifuna ukuthotyelwa ngokuchanekileyo ukuze kuphumelele uhlolo lwerhafu:

·Faka inombolo yobhaliso lwesikhungo kwiileyibhile

· Dwelisa ngokucacileyo izinto ezibangela i-allergen ezifana neziqholo

·Ubungakanani obupheleleyo kunye neenkcukacha zomenzi ziyimfuneko

·Iilebhile zesiNgesi ziyafuneka kuzo zonke izinto ezingeniswayo

·Izilumkiso malunga neengozi ze-talc, i-lead, okanye i-asbestos

Ukunyanzeliswa kunye nezohlwayo

I-FDA iwandise kakhulu amandla ayo okunyanzelisa umthetho phantsi kwe-MoCRA:

·Ukumiswa kobhaliso lwesakhiwo ukuba iimveliso zinokubangela iziphumo ezibi zempilo

·Igunya lokurhoxisa elinyanzelekileyo ukuba umntu onoxanduva uyala ukubuyisa imveliso ngokuzithandela

·Igunya lokufikelela kwiirekhodi ukuze lihlole iirekhodi zokhuseleko

·Ukuba ubhaliso lwesakhiwo lumisiwe, ngumthetho ongavumelekanga ukusasaza okanye ukuthengisa iimveliso zobuhle ezivela kweso sakhiwo eMelika.

I-FDA inyuse ngamandla amanyathelo okunyanzelisa umthetho, kuquka izilumkiso, ukubuyiswa kweemveliso, kunye nezicelo zamanyathelo okulungisa ngokukhawuleza. Uhlalutyo lwango-2024 lutyhile ukuba ama-48% ezithako zokugcoba ezingenisiweyo ezithengiswa kubathengisi abangama-25 abaphambili eMelika azizange zithobele iimfuno zobhaliso kunye noluhlu lwe-MoCRA, nto leyo egxininisa ukubaluleka kokuthobela imithetho ngokukhawuleza.

Amanyathelo Asebenzayo Kwabangenisi Bempahla Evela Kumanye Amazwe

Ukuqinisekisa ukuthotyelwa kwemithetho kunye nokungena kakuhle kwimarike:

·Qinisekisa ubhaliso lomenzi wakho – Qinisekisa ukuba amaqabane akho okuvelisa angaphandle abhalisiwe kwi-FDA kwaye aneenombolo ze-FEI ezisebenzayo

·Qinisekisa uluhlu lweemveliso – Qinisekisa ukuba umntu onoxanduva ubhalise zonke iimveliso kwi-FDA

·Khetha i-Arhente yaseMelika – Ukuba usebenza nabavelisi bamanye amazwe, qiniseka ukuba bane-Arhente yaseMelika esebenzayo

·Hlola iilebheli – Qinisekisa ukuba zonke iilebheli ziyahlangabezana neemfuno zeMoCRA, kuquka ulwimi lwesiNgesi kunye nokuchazwa okufanelekileyo kwezinto ezibangela i-allergen

·Gcina amaxwebhu okhuseleko – Gcina iirekhodi zobungqina bokhuseleko kunye neziqinisekiso zovavanyo zifumaneka lula

·Ukuseka iinkqubo zokuxela iziganeko ezimbi – Qinisekisa ukuba kukho inkqubo yokuxela iziganeko ezimbi ezinzulu zingadlulanga iintsuku ezili-15 zokusebenza

·Sebenzisana namaqabane athobela imithetho yezothutho – Hlanganisa uxwebhu lwe-MoCRA kumaxwebhu okuthutha impahla ukuze kuthintelwe ukulibaziseka kwerhafu

Isiphelo

I-MoCRA imele ixesha elitsha lokujonga ngokwemithetho izinto zokuthambisa ezingeniswa eMelika. Kubangenisi, ukuqonda nokuthobela ezi mfuno kubalulekile ukuze kuthintelwe ukulibaziseka okubizayo, izohlwayo, kunye nemingcele yokufikelela kwimarike. Ngokusebenza namaqabane okuvelisa athobela imithetho, ukugcina amaxwebhu afanelekileyo, kunye nokuhlala unolwazi malunga nohlaziyo lwemithetho, abangenisi banokuhamba kule ndawo intsha ngempumelelo kwaye baqinisekise ukuba iimveliso zabo zifikelela kubathengi baseMelika ngaphandle kokuphazamiseka.

I-FDA iyaqhubeka nokuhlaziya izikhokelo zayo kunye neenkqubo zokungenisa iimveliso nge-elektroniki, ngoko ke abathumeli kufuneka bajonge rhoqo i-portal ye-FDA's Cosmetics Direct kwaye babonisane neengcali zomthetho ukuze bahlale benolwazi ngeemfuno ezitshintshayo.

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