Malunga ne-FDA
"ICongress ixhobise i-FDA ukuba ilawule iimveliso zecuba ngokubeka iliso kwisayensi ukukhusela uluntu kwimiphumo eyingozi yokusetyenziswa kwecuba," utshilo uMkomishinala we-FDA obambeleyo uJanet Woodcock."Ukuqinisekisa ukuba iimveliso zecuba ezitsha ziyavavanywa yi-FDA yinxalenye ebalulekileyo yenjongo yethu yokunciphisa izifo ezinxulumene necuba kunye nokufa. Siyazi ukuba iimveliso zecuba ezinencasa zinomtsalane kakhulu kubantu abatsha, ngoko ke ukuvavanya impembelelo yokusetyenziswa kwecuba enokubakho okanye okwenyani abantu abatsha bangoyena nobangela wokumisela ukuba zeziphi iimveliso ezinokuthengiswa.
Eli nyathelo liphawula inkqubela phambili ebalulekileyo ekufumaneni inani elingazange libonwe ngaphambili le-9 kaSeptemba 2020, ixesha eliyalelwe yinkundla ukuba lifake izicelo zentengiso ezithathwa njengeemveliso ezintsha zecuba, kunye nomhla wokugqibela wokujongana nokusetyenziswa kolutsha.
I-FDA ifumene izicelo ezivela kwiinkampani ezingaphezu kwama-500 ezibandakanya ngaphezu kwe-6.5 yezigidi zeemveliso zecuba.Ngelixa i-arhente ikhuphe ezinye izenzo ezingalunganga kwezinye izicelo, le yisethi yokuqala ye-Mdos i-FDA ekhuphe izicelo ezihlangabezana nenxalenye yophononongo lwezenzululwazi olubambekayo lokuphononongwa kwangaphambili.I-arhente izibophelele ekutshintsheni imarike yangoku ukuya kwimarike apho zonke iimveliso ze-ENDS ezikhoyo ezithengiswayo ziboniswa ukuba "zilungele ukukhusela impilo yoluntu".
Ngomhla we-27 ka-Agasti, i-FDA yamemezela ukuba iyala izicelo ze-55,000 ze-premarket zecuba (PMTAS) ezivela kubenzi abathathu abancinci be-e-cigarette ngenxa yokuba behlulekile ukubonelela ubungqina bokuba bakhusela impilo yoluntu.
I-FDA ifumene ~ 6.5 yezigidi zezicelo ze-PMTA ze-e-cigarettes ngomhla wokugqibela we-9 Septemba, ishiya ~ 2 yezigidi zezicelo zingachazwanga, ngaphandle kwe-~ 4.5 yezigidi zezicelo (i-JD Nova Group LLC) ezaziswe ngaphambili njengezingafikeleli iimfuno.Ngezicelo ezingama-55, 000 ezikhatyiweyo ngeli xesha, ngaphantsi kwe-1.95 yezigidi zihlala zingabhengezwa.Ngaphezu koko, izenzo ze-FDA zibonisa ukuba ayinakuvuma nayiphi na i-oyile ye-e-cigarette yebhotile enencasa ngaphandle kwecuba.Kwiiveki ezimbini phambi kokuphela kwexesha loxolelo ngoSeptemba 9, 2021, oku kusenokuthetha ukuba phantse yonke i-PMTAS eseleyo iya kukhatywa.
Namhlanje, i-US Food and Drug Administration ikhuphe imiyalelo yokuqala yokuthengisa i-Denial (Mdos) ye-electronic Nicotine Delivery System (ENDS) iimveliso emva kokumisela ukuba izicelo ezivela kubafaki-zicelo abathathu malunga ne-55,000 enencasa yeemveliso ze-ENDS ziswele ubungqina obaneleyo benzuzo kubantu abadala abatshayayo.Kwanele ukoyisa isoyikiso sempilo yoluntu esivezwa ngamanqanaba abhaliweyo kunye nawothusayo okusetyenziswa kolutsha kwezo mveliso.I-JD Nova Group LLC, i-Great American Vapes kunye ne-Vapor Salon yi-ENDS engenacuba, iquka i-Apple Crumble, uGqr. Cola kunye neCinnamon Toast Cereal.
Iimveliso ze-ENDS ezinencasa zifuna ubungqina obuqinileyo
Iimveliso ezifunekayo kwisicelo sangaphambili sentengiso ye-MDO zinokungaziswa okanye zisiwe ukuze kwaziwe urhwebo lwamazwe ngamazwe.Ukuba imveliso sele ikwimarike, kufuneka isuswe kwimarike okanye kumngcipheko wokunyanzeliswa.I-MDO ebhengezwe namhlanje ayibandakanyi zonke iimveliso ze-ENDS ezingeniswe yinkampani;izicelo zabaseleyo zisaqwalaselwa.I-FDA yayikhe yazisa enye yeenkampani, i-JD Nova Group LLC, ukuba isicelo sayo semveliso yecuba esele sithengisiwe esinxulumene neemveliso zayo ezimalunga nezigidi ezi-4.5 ayizange ihlangabezane neemfuno zesicelo semveliso entsha yecuba efuna ugunyaziso lokuthengisa.
"Iimveliso ze-ENDS ezikhethiweyo zithandwa kakhulu ngabantu abancinci, ngaphezu kwe-80 ipesenti yabasebenzisi be-e-cigarette abaneminyaka eyi-12 ukuya kwi-17 basebenzisa enye yale mveliso." yeemveliso zabo kubantu abadala abatshayayo iyodlula imingcipheko ebalulekileyo eyaziwayo kubantu abadala abaselula,” watsho uMitch Zeller, umalathisi weZiko leeMveliso zeCuba leFDA. Uxanduva luphezu kwabafaki-zicelo ukuba banike ubungqina bokuba ukuthengiswa kweemveliso zabo kuyahlangabezana nomgangatho osemthethweni “woneleyo. ukhuseleko lwempilo yoluntu". Ukuba akukho bungqina obaneleyo okanye abanelanga, i-FDA ijonge ukukhupha umyalelo wokwala ukuthengisa ofuna imveliso isuswe emarikeni okanye isuswe emarikeni.
I-FDA ilumkisa ngaphezu kwe-15 yezigidi zeemveliso
Ngasekupheleni kwenyanga ephelileyo, i-FDA yalumkisa iinkampani ezineemveliso ezingaphezu kwezigidi ezili-15 ukuba zisuse iimveliso ze-e-cigarette ezingagunyaziswanga kwintengiso:
I-FDA namhlanje ikhuphe ileta yesilumkiso kwinkampani ethengisa iimveliso zecuba ezifakwe kuluhlu lwe-FDA, kubandakanywa ne-e-liquids ezininzi ezikhethiweyo, ukuthengiswa ngokungekho mthethweni kweemveliso ze-elektroniki ze-Nicotine Delivery System (ENDS) ngaphandle kwelayisensi.Eli nyathelo libonisa ukuzibophelela okuqhubekayo kwe-arhente ekuqinisekiseni ukuba iimveliso zecuba ezithengiswayo zithobela umthetho wokukhusela ngcono ulutsha kunye nempilo yoluntu.
Iileta ezilumkisayo zisisiphumo sokubekw' esweni okuqhubekayo kunye nokubeka iliso kwi-Intanethi ukuphulwa kwemithetho nemimiselo yecuba.I-FDA ifuna ukuba bonke abavelisi kunye nabathengisi beemveliso zecuba bazi ukuba siyaqhubeka sijonga imarike ngokusondeleyo kwaye siya kubamba iinkampani ziphendule ngokuphulwa.
I-FDA iya kuqhubeka nokubeka phambili iinkampani ekujoliswe kuzo ezithengisa i-ENDS ngaphandle kogunyaziso oluyimfuneko kwaye azizange zifake isicelo se-premarket kwi-arhente, ngakumbi ezo zinokusebenzisa okanye ziqalise iimveliso zolutsha. "
Namhlanje, i-FOOD kunye noLawulo lweDrugs luthumele ileta yesilumkiso kwi-Visible Vapors LLC, inkampani yasePennsylvania eyenza kwaye isebenze iwebhusayithi ethengisa iimveliso ze-nicotine Delivery System (ENDS) ye-elektroniki,
kuquka i-e-cigarettes kunye ne-e-liquids, ukubaxelela, Akukho mthethweni ukuthengisa ezi mveliso zecuba zitsha ngaphandle kokugunyaziswa kwangaphambili, ngoko azinakuthengiswa okanye zisasazwe eUnited States.Inkampani ayizange ingenise nasiphi na isicelo seMveliso yeCuba yentengiso (PMTA) ngomhla we-9 kaSeptemba 2020 umhla wokugqibela.
Ukuqala ngo-Agasti 8, 2016, izicelo zokuphononongwa kwangaphambili kweemveliso ezithile zecuba ezithathwa njengezintsha, kubandakanywa i-e-cigarettes kunye ne-e-liquids, kufuneka zingeniswe kwi-FDA ngoSeptemba 9, 2020, ngokomyalelo wenkundla.
Ileta yesilumkiso ekhutshwe namhlanje ikhankanya iimveliso ezithile, kuquka i-Visible Vapors Irish Potato 100mL kunye neVisible Vapors Peanutbutter Banana Bacon Maple (Inkosi) 100mL, Inkampani ineemveliso ezingaphezu kwezigidi ezili-15 ezidweliswe kunye ne-FDA kwaye kufuneka iqinisekise ukuba zonke iimveliso zayo zithobela imimiselo federal, kuquka iimfuno review premarket.
Ngokuhambelana nezinto eziphambili zokunyanzeliswa kwe-arhente, emva kwe-9 kaSeptemba, 2020, i-FDA iya kubeka phambili ukunyanzeliswa kwayo nayiphi na imveliso ye-ENDS eqhubelekayo ukuthengiswa kwaye ayikafumani sicelo semveliso.
Phakathi kukaJanuwari noJuni ka-2021, i-FDA yathumela iileta ezilumkisayo ezili-131 kwiinkampani ezithengisa okanye ezisasaza ngaphezulu kwe-1,470,000 engagunyaziswanga ENDS engakhange ingenise izicelo zentengiso yezi mveliso ngomhla wokugqibela we-9 kaSeptemba.
Iinkampani ezifumana ileta yesilumkiso evela kwi-FDA kufuneka zingenise impendulo ebhaliweyo phakathi kweentsuku zokusebenza ze-15 zokufumana ileta echaza isenzo sokulungiswa kwenkampani, kubandakanywa nomhla wokuphulwa komthetho kunye / okanye umhla wokuhanjiswa kwemveliso.Bakwafuna ukuba iinkampani ziqhubeke nokuthobela izicwangciso zexesha elizayo phantsi koMthetho woKutya, iChiza kunye neCosmetic Act
Ixesha lokuposa: Oct-15-2021
