I-FDA ivumela ukuThengiswa kweeMveliso ze-E-Cigarette, ukuMakisha uGunyaziso lokuqala lohlobo lwalo yi-Arhente.

I-Arhente iphinda ikhanyele izicelo zeeMveliso eziNgcobileyo ngenxa yokungaphumeleli ukubonakalisa ukuba iNtengiso yezi Mveliso iya kufaneleka kuKhuseleko lweMpilo yoluntu.

Namhlanje, i-US Food and Drug Administration ibhengeze ukuba igunyazise ukuthengiswa kweemveliso ezintathu ezintsha zecuba, iphawula iseti yokuqala yenkqubo yokuhanjiswa kwe-nicotine ye-elektroniki (ENDS) ekhe yagunyaziswa yi-FDA ngeSicelo seMveliso yeCuba ePhambili (PMTA) indlela. .I-FDA ikhuphe intengiso inike iiodolo kwiRJ Reynolds (RJR) Vapor Company ngesixhobo sayo se-Vuse Solo esivaliweyo se-ENDS kunye ne-e-liquid pods ezikhapha icuba, ngokukodwa, i-Vuse Solo Power Unit, i-Vuse Replacement Cartridge Original 4.8% G1, kunye ne-Vuse Replacement Cartridge Eyokuqala 4.8% G2.Njengoko iNkampani ye-RJR Vapor ingenise idatha kwi-FDA ebonise ukuba ukuthengiswa kwezi mveliso kufanelekile kukhuseleko lwempilo yoluntu, ugunyaziso lwanamhlanje luvumela ukuba ezi mveliso zithengiswe ngokusemthethweni e-US.

“Ugunyaziso lwanamhlanje linyathelo elibalulekileyo lokuqinisekisa ukuba zonke iimveliso zecuba ezitsha zihlolwa yiFDA eyomeleleyo nengokwenzululwazi.Idatha yomenzi ibonisa iimveliso zayo ezinencasa yecuba zinokuba luncedo kubantu abadala abatshayayo abatshintshela kwezi mveliso - nokuba ngokupheleleyo okanye ngokuncipha okukhulu kokusetyenziswa kwecuba - ngokunciphisa ukuchaneka kwabo kwiikhemikhali eziyingozi, utshilo uMitch Zeller, JD, umlawuli we-FDA's. Iziko leeMveliso zeCuba.“Kufuneka sihlale siluphaphele olu gunyaziso kwaye sizakubeka esweni ukuthengiswa kweemveliso, kubandakanywa nokuba inkampani iyasilela ukuthobela naziphi na iimfuneko zolawulo okanye ukuba kuvela ubungqina obubambekayo bokusetyenziswa okubalulekileyo ngabantu ababengazange basebenzise imveliso yecuba ngaphambili, kuquka nolutsha. .Sizakuthatha amanyathelo afanelekileyo, kubandakanya nokurhoxisa ugunyaziso. "

Ngaphantsi kwendlela ye-PMTA, abavelisi kufuneka babonise kwi-arhente ukuba, phakathi kwezinye izinto, ukuthengiswa kwemveliso entsha yecuba kuya kufaneleka kukhuseleko lwempilo yoluntu.Ezi mveliso zafunyaniswa ukuba ziyahlangabezana nalo mgangatho kuba, phakathi kwengqwalasela engundoqo ezininzi, i-arhente yagqiba ukuba abathathi-nxaxheba abasebenzisa iimveliso ezigunyazisiweyo kuphela baye bachanabeka kwizinto ezimbalwa ezinobungozi nezinokuba yingozi (HPHCs) ezivela kwii-aerosols xa kuthelekiswa nabasebenzisi beesigarethi ezivuthayo.Uvavanyo lwe-toxicological lukwafumanise ukuba ii-aerosols zeemveliso ezigunyazisiweyo zinetyhefu kakhulu kunemidiza etshisiweyo ngokusekelwe kuthelekiso lwedatha olukhoyo kunye neziphumo zophononongo olungekho kliniki.Ukongeza, i-FDA ithathele ingqalelo imingcipheko kunye neenzuzo kubemi bebonke, kubandakanya abasebenzisi kunye nabasebenzisi abangasebenzisi iimveliso zecuba, kwaye okubalulekileyo, ulutsha.Oku kubandakanya ukuphononongwa kwedatha ekhoyo malunga nokuba nokwenzeka kokusetyenziswa kwemveliso ngabantu abatsha.Kuba ezi mveliso, i-FDA wagqiba ukuba inzuzo enokubakho ukuba abatshayayo ukutshintsha ngokupheleleyo okanye ukunciphisa kakhulu ukusebenzisa kwabo umdiza, kuya kugqithisa umngcipheko kulutsha, ukuba umenzi-sicelo ulandela iimfuno post-intengiso ejolise ekunciphiseni ukuvezwa ulutsha kunye nokufikelela kwiimveliso.

Namhlanje, i-FDA ikwakhuphe i-10 yee-odolo zokukhanyela ukuthengisa (MDOs) kwiimveliso ze-ENDS ezinencasa ezifakwe phantsi kophawu lwe-Vuse Solo yi-RJR.Ngenxa yolwazi oluyimfihlo lwemiba yolwazi, i-FDA ayizixeli esidlangalaleni iimveliso ezithile ezinencasa.Ezi mveliso ziphantsi kwe-MDO kwisicelo se-premarket ayinakwaziswa okanye iziswe ukwazisa kurhwebo lwamazwe ngamazwe.Ukuba kukho nawuphi na kubo osele ekwimarike, kufuneka asuswe emarikeni okanye kunyanzeliso lomngcipheko.Abathengisi kufuneka baqhagamshelane ne-RJR ngayo nayiphi na imibuzo malunga neemveliso kwi-inventri yabo.Le arhente isavavanya isicelo senkampani semveliso enencasa ye menthol phantsi kohlobo lwe Vuse Solo.

I-FDA iyazi ukuba i-2021 National Youth Tobacco Survey (NYTS) ifumene malunga ne-10 yeepesenti yabafundi bezikolo eziphakamileyo abasebenzisa i-e-cigarettes ebizwa ngokuba yi-Vuse njengophawu lwabo lwesiqhelo.I-arhente ithatha le datha nzulu kakhulu kwaye ithathele ingqalelo imingcipheko kulutsha xa iphonononga ezi mveliso.Ubungqina bukwabonise ukuba, xa kuthelekiswa nabasebenzisi beemveliso ze-ENDS ezingezo zecuba, abantu abatsha abanakufane baqalise ukusebenzisa iimveliso ze-ENDS ezinencasa yecuba baze batshintshele kwiimveliso ezinomngcipheko ophezulu, njengecuba elivuthayo.Idatha ikwacebisa ukuba uninzi lolutsha kunye nabantu abadala abancinci abasebenzisa i-ENDS baqala ngeencasa ezifana neziqhamo, iilekese okanye iminti, hayi incasa zecuba.Ezi datha zomeleza isigqibo se-FDA sokugunyazisa iimveliso ezinencasa yecuba ngenxa yokuba ezi mveliso azithandeki kangako kulutsha kwaye zigunyazisa ezi mveliso zinokuba luncedo kubasebenzisi becuba abadala abatshintshela ngokupheleleyo kwi-ENDS okanye banciphise kakhulu ukusetyenziswa kwecuba.

Ukongeza, ugunyaziso lwanamhlanje lubeka imiqathango engqongqo yokuthengisa kwinkampani, kubandakanywa izithintelo zentengiso yedijithali kunye nezithintelo zentengiso zikanomathotholo kunye nomabonwakude, ukunciphisa kakhulu amathuba okuba ulutsha luvezwe kwintengiso yecuba yezi mveliso.Inkampani ye-RJR Vapor iphinda ifuneke ukuba inike ingxelo rhoqo kwi-FDA ngolwazi malunga neemveliso kwiimarike, kubandakanywa, kodwa kungaphelelanga apho, uphando oluqhubekayo nolugqityiweyo lwabathengi, ukukhangisa, izicwangciso zokuthengisa, idatha yokuthengisa, ulwazi kubasebenzisi bangoku kunye nabatsha, utshintsho lwemveliso kunye namava angalunganga.

I-FDA inokunqumamisa okanye irhoxise umyalelo wokuthengisa okhutshwe phantsi kwendlela ye-PMTA ngenxa yezizathu ezahlukeneyo ukuba i-arhente inquma ukuthengiswa okuqhubekayo kwemveliso "ayisafanelekanga ukukhusela impilo yoluntu," njengokuba kukho into ebalulekileyo. ukwanda kolwaluko lolutsha.

Ngelixa isenzo sanamhlanje sivumela iimveliso zecuba ukuba zithengiswe e-US, oko akuthethi ukuba ezi mveliso zikhuselekile okanye "ivunyiwe yi-FDA."Zonke iimveliso zecuba ziyingozi kwaye zikhobokisa kwaye abo bangasebenzisi iimveliso zecuba akufanele baqalise.

Izicelo ezininzi ze-ENDS kunye nezinye ezithathwa njengemveliso yecuba emitsha kwimarike ukususela ngo-Agasti 8, i-2016 yayifuneka ukuba ifakwe kwi-FDA ngoSeptemba 9, 2020. I-arhente ithathe inyathelo ngaphezu kwe-98% yezicelo ezifakwe ngaloo mhla wokugqibela. .Oku kuquka ukukhupha ii-MDOs ngaphezulu kwesigidi esinye seemveliso ze-ENDS ezingenabungqina obaneleyo bokuba inzuzo kubantu abadala abatshayayo abasebenzisa iimveliso zencasa iyakuyoyisa inkxalabo yempilo yoluntu ebangelwe kukubhalwe kakuhle kunye nesibheno esikhulu seemveliso kulutsha.Kutshanje, i-FDA ithumele isampula yesigqibo seMDO isishwankathelo.Le sampuli ayibonisi ingqiqo yesigqibo kwisenzo ngasinye se-MDO esithathwe yi-FDA.

I-arhente iya kuqhubeka nokukhupha izigqibo kwizicelo, njengoko kufanelekile, kwaye izimisele ukusebenza ukuguqula indawo yokuthengisa yangoku ukuya kwindawo apho zonke iimveliso ze-ENDS ezifumanekayo ezithengiswayo zibonise ukuba ukuthengiswa kwemveliso "ifanele ukukhuselwa kwempilo yoluntu." .”