Muva nje, i-FDA ikhiphe imihlahlandlela yokugcina yokufakwa kuhlu kwezindawo zezimonyo nemikhiqizo, futhi yethule ingosi entsha yezimonyo ebizwa ngokuthi 'Izimonyo Direct'. Futhi, i-FDA yamemezela izidingo eziyisibopho zokubhaliswa kwesikhungo sezimonyo nokufakwa kuhlu kwemikhiqizo kusukela ngomhlaka-1 Julayi 2024, ukuze kuqinisekiswe ukuthi amabhizinisi alawulwayo anesikhathi esanele sokulungiselela nokuhambisa ulwazi.
1. Imithethonqubo
1)Umthetho Wokulawulwa Kwezimonyo Wesimanje wezi-2022, (i-MoCRA)
2)I-Federal Food, Drug and Cosmetic Act (FD&C Act)
3)I-Fair Packaging and Labeling Act (FPLA)
2. Ububanzi besicelo
Ngokomthetho wase-US, izimonyo zichazwa njengezinto ezisetshenziswayo, ezisatshalaliswayo, ezifuthwayo, noma ezisetshenziswa ngenye indlela emzimbeni womuntu ukuze zihlanzeke, zinhle, zithuthukise ukukhanga, noma ukushintsha ukubukeka.
Ngokukhethekile, kuhlanganisa okokuthambisa isikhumba, isiqholo, i-lipstick, i-nail polish, izimonyo zamehlo nezobuso, i-shampoo yokuhlanza, i-perm, udayi wezinwele nesiqedaphunga, kanye nanoma iyiphi into esetshenziswa njengesithako sezimonyo. Insipho akuzona ezezimonyo.
3. Ukwahlukanisa
Ngokusho kwe-MoCRA, i-FDA yezimonyo yase-US ihlukanisa izimonyo ngezigaba ezilandelayo:
-Imikhiqizo yezingane: okuhlanganisa ishampu yezingane, impushana yokunakekelwa kwesikhumba, ukhilimu wobuso, uwoyela noketshezi.
-Imikhiqizo yokugeza: kufaka phakathi usawoti wokugeza, amafutha, umuthi, i-foam agent, ijeli yokugeza, njll.
-Izimonyo zamehlo: njengepensela yamashiya, i-eyeliner, ithunzi lamehlo, ukugeza amehlo, ukukhipha izimonyo zamehlo, ubumnyama beso, njll.
Izimonyo ezinemiphumela ekhethekile, njenge-anti wrinkle, whitening, weight loss, njll., zidinga ukubhaliswa njengezidakamizwa ze-OTC ngesikhathi esifanayo. Kufanele kuqashelwe ukuthi le mithetho emisha isebenza kuzimonyo ezithunyelwa emakethe yase-US.
Ukubhaliswa kwe-FDA
I-MoCRA ayigcinanga nje ngokungeza lezi zidingo ezintsha ezilandelayo, okuhlanganisa ukusungulwa kwesistimu yabantu abanomthwalo wemfanelo wezimonyo, ukubika okuyisibopho kokusabela okubi kakhulu, ukuhambisana ne-Good Manufacturing Practice (GMP), ukubhaliswa kwefekthri nokubhaliswa kohlu lwemikhiqizo, ukuhlinzeka ngezitifiketi ezanele zokuphepha, kodwa. iphinde idinga ukuthi ilebula imakwe ngolwazi lomuntu onomthwalo wemfanelo, izinto ezingezwani nomzimba, ukusetshenziswa kochwepheshe kwezitatimende zomkhiqizo, ukuthuthukiswa kanye nokukhululwa kwezindlela zokutholwa kwe-asbestos ezimonyoni eziqukethe i-talcum powder, nokuhlolwa kwengozi yokuphepha kanye nokuhlolwa kwesigaba sokuphuma kwezilwane kwe-PFAS kwezimonyo. .
Ngaphambi kokusetshenziswa kwe-MOCRA, abakhiqizi/abapakishi bezimonyo bangabhalisa izindawo zabo zefekthri ne-FDA ngoHlelo Lokubhaliswa Kwezimonyo Lokuzithandela lwe-US FDA (VCRP), futhi i-FDA ayinazo izimfuneko eziyisibopho zalokhu.
Kodwa ngokusetshenziswa kwe-MOCRA kanye nomnqamulajuqu osondelayo, zonke izinkampani ezithengisa izimonyo e-United States kufanele zibhalise izindawo zazo zokukhiqiza ne-FDA futhi zibuyekeze ulwazi lwazo lokubhalisa njalo ngemva kweminyaka emibili, okuhlanganisa igama, imininingwane yokuxhumana, njll. Izikhungo ezingaphandle kwe-United States. Amazwe nawo ayadingeka ukuthi anikeze imininingwane nemininingwane yokuxhumana yama-ejenti angaphakathi kwe-United States. Kuphinde kube nolunye ulwazi olwengeziwe okudingeka lugcwaliswe, olufana nolwazi lwenkampani yomzali, uhlobo lwebhizinisi, izithombe zokupakishwa, izixhumanisi zekhasi lewebhu lomkhiqizo, noma ngabe izimonyo ezichwepheshile, ikhodi ye-Dun&Bradstreet yomuntu onomthwalo wemfanelo, njll. Akuphoqelekile ukugcwalisa in. Izinsiza zezimonyo ezikhona kufanele zibhalise ne-FDA phakathi nonyaka owodwa ngemva kokukhishwa kwemithetho emisha, futhi isikhathi sokubhaliswa kwezindawo ezintsha zezimonyo siphakathi kwezinsuku ezingu-60 zokuzibandakanya ekucubunguleni nasekukhiqizeni izimonyo.
Ilebhu yokuhlola ye-BTF, inkampani yethu inamalabhorethri ahambisana nogesi, izimiso zokuphepha Ilabhorethri, Ilabhorethri yefrikhwensi yomsakazo, Ilabhorethri yebhethri, Ilabhorethri yamakhemikhali, I-SAR Laboratory, I-HAC Laboratory, njll. Sithole iziqu nokugunyazwa okufana ne-CMA, CNAS, CPSC, A2LA, I-VCCI, njll. Inkampani yethu inethimba lobunjiniyela bezobuchwepheshe abanolwazi nochwepheshe, elingasiza amabhizinisi ukuxazulula inkinga. Uma unezidingo ezifanele zokuhlola nezitifiketi, ungathintana ngqo nabasebenzi bethu bokuhlola ukuze uthole amakhotheshini anemininingwane yezindleko kanye nolwazi lomjikelezo!
Umbiko wokuhlola we-FDA
Isikhathi sokuthumela: Aug-21-2024
