Uhambo luka-JUUL lwe-PMTA: I-PMTA Yokuqala Yethulwa nguJuul Njengesixazululo Sezobuchwepheshe Sezinkinga Zezempilo Yomphakathi

I-PMTA ye-JUUL

NgoJulayi 19, 2023, uJuul Labs, okuyinkampani yokuqala kagwayi we-elekthronikhi, yamemezela ukuthunyelwa kwesicelo sayo sokuqala somkhiqizo kagwayi we-Premarket Tobacco Product (PMTA) yesikhulumi sabo somphunga sesizukulwane esilandelayo ku-US Food and Drug Administration (FDA). Ngomnyakazo omusha ohlanganisa ukucatshangelwa kwezempilo kanye nobuchwepheshe obuthuthukisiwe, uhlelo lokusebenza lwenkampani lufaka idivayisi entsha kanye nama-pods amasha afakwe ugwayi ekugxilweni kwe-nicotine engu-18 mg/mL. Inkundla futhi yethula ubuchwepheshe obuqhutshwa yidatha obugxile ekukhawuleleni ukufinyelela kwabasebenzisi abasebancane.

 

Uhambo luka-JUUL lwe-PMTA

UKirk Phelps, oyiChief Product Officer, ugcizelele ukuthi ukuqamba okusha kufakwe ku-DNA yenkampani. “Inkundla yethu yesizukulwane esilandelayo iyisixazululo sezobuchwepheshe ezinseleleni ezimbili zempilo yomphakathi - ukushintsha abantu abadala ababhemayo kusukela kugwayi ovuthayo kanye nokukhawulela ukufinyelela kwabancane emikhiqizweni yomhwamuko. Lesi kumane kuyisiqalo sohlelo lwethu lokucwenga nokuthuthukisa ubuchwepheshe obusha emakethe yase-US nangale kwayo. Inhloso yethu wukuqeda ugwayi ovuthayo futhi sinqande ukusetshenziswa kwezingane ezincane,” kusho uPhelps.

 

Yasungulwa okokuqala e-UK ngo-2021 njengoHlelo lwe-JUUL2, le nkundla yomusi esezingeni eliphezulu inikeza umuzwa othuthukisiwe womhwamuko kwababhemayo abadala. Izici zayo ezihlukile zifaka ukuqinisekiswa kwe-Pod ID ukuze kubhekwane nenkinga yemikhiqizo yomgunyathi, kanye nobuchwepheshe bokuqinisekisa ubudala bokunciphisa ukusetshenziswa kwezingane.

 

Izici zale nkundla ethuthukisiwe, eziye zaziswe ngemininingwane yabantu abadala, zifaka:

 

  • Umphunga othembeke kakhulu oqhudelana nogwayi ovuthayo.
  • Idivayisi ene-Bluetooth efakwe ibhethri elikhulu, elihlala isikhathi eside kanye “nesistimu yokukhanya ehlakaniphile” eyazisa abasebenzisi ngempilo yebhethri futhi i-e-liquid Izinga.
  • Ama-pods asanda kuklanywa, amelana ne-tamper athuthukisa ukulethwa kwe-aerosol.
  • Isici sokushisisa esidala esithuthukisa ukusebenza komkhiqizo kanye nokunemba kokulawula izinga lokushisa.
  • I-chip ye-ID ye-Pod ehlukile evimbela ukusetshenziswa komgunyathi ongekho emthethweni nama-pod ahambisanayo nedivayisi yesizukulwane esilandelayo.
  • Uhlelo lokusebenza lweselula nolwewebhu olunika amandla ubuchwepheshe bokuqinisekisa ubudala, okuhlanganisa ukukhiya idivayisi, futhi luhlinzeka ngolwazi lomkhiqizo wesikhathi sangempela kanye nemininingwane yokusetshenziswa kubathengi abaqinisekiswa ngobudala, ngokuvikelwa kobumfihlo bedatha okuhamba phambili embonini.

 

Ucwaningo lokuqala lokuziphatha Kuhlelo lwe-JUUL2 e-UK lubonisa ukutholwa nokushintsha okukhulu phakathi kwabantu abadala ababhemayo, nabasebenzisi abangaphezu kuka-32% bashintshe ngokuphelele kugwayi ovuthayo ezinyangeni eziyisithupha ngemva kokuthenga umkhiqizo. Naphezu kwempumelelo ye-JUUL System emakethe manje, eye yasiza abantu abadala ababhemayo base-US abangaphezu kwezigidi ezingu-2 ukuthi bashintshe, iJuul Labs izimisele ngokwazisa ubuchwepheshe bayo obusha kubantu ababhemayo abadala abalinganiselwa ezigidini ezingu-28 ezweni abasasebenzisa ugwayi ovuthayo. imbangela ehamba phambili yokufa okungagwemeka.

 

“Isizukulwane sethu esilandelayo isiteji somhwamuko I-PMTA yakhelwe phezu kobuchwepheshe obusha obuthuthukisa izinjongo zezempilo zomphakathi. Isayensi ephoqayo ngemuva kwayo ikhombisa inzuzo ecacile yezempilo yomphakathi, isidingo sokuthola ukugunyazwa kokumaketha, ”kusho uJoe Murillo, oyiChief Regulatory Officer. "Sibheke ngabomvu ukusebenzelana ne-FDA kulo lonke lolu hlelo lokubukeza ngenkathi silwela ukufezekisa leli thuba elibalulekile lokunciphisa ukulimala."

Uhambo luka-JUUL lwe-PMTA

Lokhu kuhanjiswa kwe-PMTA kwakha ingxenye ebalulekile yesu elibanzi le-Juul Lab lokuhlinzeka ngezinye izindlela ezisebenzayo, ezisekelwa isayensi kwababhemayo abadala ukuze bahlukane nogwayi ovuthayo. Inkampani futhi iyaqhubeka nemizamo yokunqanda ukusetshenziswa kwezingane ngokwethula nokwenza ngcono izixazululo zobuchwepheshe.

Uhambo luka-JUUL lwe-PMTA, i-PMTAIJuul Labs njengamanje ikhalaza ngesinqumo se-FDA sokuhlala nokugunyazwa Kohlelo lweJUUL. Inkampani imile kwelokuthi izothola ukugunyazwa kokumaketha uma isinqumo sesisekelwe ebufakazini besayensi, ngaphandle kokugxambukela kwezepolitiki.

 

Umgomo wenkampani wokuthuthukisa impilo yomphakathi ubonakala ekuzinikeleni kwayo ekusungulweni kwemikhiqizo emisha nasekukhiqizeni ubufakazi besayensi. Bazibophezela ukuthi bazoqhubeka nokuhola lo mkhakha ngezisombululo ezintsha, belwela ukuqeda ugwayi ovuthayo ukuze kuthuthukiswe impilo yomphakathi.

 

Ngezansi isifinyezo sokuthunyelwa kwe-PMTA kaJuul Labs kuze kube manje(uhambo luka-JUUL lwe-PMTA):

 

  • Ama-PMTA Ohlelo Lwe-JUUL Olumakethwa Njengamanje - Athunyelwe ngoJulayi 2020; okwamanje, isikhalazo sokuphatha sisalindile futhi imikhiqizo ye-JUUL isatholakala kubantu abadala ababhemayo.
  • Ama-PMTA Omuthi Omusha Kagwayi njengengxenye Yohlelo Lwe-JUUL Ohweba Ngamanje - Athunyelwe ngoDisemba 2022; okwamanje esabuyekezwa.
  • Ama-PMTA we-Next-Generation Vapor Platform - Athunyelwe ngoJulayi 2023; okwamanje kusalinde ukubuyekezwa kokwamukelwa.

 

Link: https://www.juullabs.com/next-generation-platform-pmta/

Irely william
About the Author: Irely william

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