I-Ejensi Iphinda Yenqabe Izicelo Zemikhiqizo Enambithekayo Ngokuhluleka Ukukhombisa ukuthi Ukumakethwa Kwale Mikhiqizo Kuzofaneleka Ukuze Kuvikelwe Impilo Yomphakathi.
Namuhla, i-US Food and Drug Administration imemezele ukuthi igunyaze ukuthengiswa kwemikhiqizo emisha emithathu kagwayi, okumaka isethi yokuqala yemikhiqizo ye-electronic nicotine delivery system (ENDS) eyake yagunyazwa yi-FDA ngokusebenzisa indlela ye-Premarket Tobacco Product Application (PMTA) .I-FDA ikhiphe ukumaketha yanikeza ama-oda ku-RJ Reynolds (RJR) Vapor Company ngomshini wayo we-Vuse Solo ovaliwe we-ENDS kanye namaphodi e-e-liquid afakwe ugwayi, ikakhulukazi, i-Vuse Solo Power Unit, i-Vuse Replacement Cartridge Original 4.8% G1, kanye ne-Vuse Replacement Cartridge Okwangempela okungu-4.8% G2.Njengoba i-RJR Vapor Company ithumele idatha ku-FDA ebonise ukuthi ukumakethwa kwale mikhiqizo kufanele ukuze kuvikelwe impilo yomphakathi, ukugunyazwa kwanamuhla kuvumela le mikhiqizo ukuthi ithengiswe ngokusemthethweni e-US.
“Ukugunyazwa kwanamuhla kuyisinyathelo esibalulekile sokuqinisekisa ukuthi yonke imikhiqizo emisha kagwayi ihlolwa yi-FDA ngemakethe yemakethe eqinile.Imininingwane yomkhiqizi ikhombisa ukuthi imikhiqizo yayo enambitheka kagwayi ingazuzisa abantu abadala abayimilutha ababhemayo abashintshela kule mikhiqizo - mhlawumbe ngokuphelele noma ngokuncipha okukhulu kokusetshenziswa kukagwayi - ngokunciphisa ukuchayeka kwabo kumakhemikhali ayingozi," kusho uMitch Zeller, JD, umqondisi we-FDA's. Isikhungo Semikhiqizo Yogwayi.“Kumele sihlale sikuqaphile lesi sigunyazo futhi sizoqapha ukumakethwa kwemikhiqizo, okuhlanganisa nokuthi inkampani iyehluleka yini ukuthobela noma yiziphi izidingo zomthetho noma uma kuvela ubufakazi obubambekayo bokusetshenziswa okubalulekile kwabantu abebengawusebenzisi ngaphambilini umkhiqizo kagwayi, okuhlanganisa nentsha. .Sizothatha izinyathelo ezifanele, okuhlanganisa nokuhoxisa ukugunyazwa.”
Ngaphansi kwendlela ye-PMTA, abakhiqizi kufanele bakhombise ejensi ukuthi, phakathi kwezinye izinto, ukumaketha komkhiqizo omusha kagwayi kuzofaneleka ukuze kuvikelwe impilo yomphakathi.Le mikhiqizo itholwe ihlangabezana naleli zinga ngoba, phakathi kokucatshangelwa okubalulekile okumbalwa, i-ejensi inqume ukuthi ababambiqhaza bocwaningo abasebenzise imikhiqizo egunyaziwe kuphela bachayeke ezingxenyeni ezimbalwa eziyingozi nezingase zibe yingozi (ama-HPHC) ezivela kuma-aerosol uma kuqhathaniswa nabasebenzisi bakagwayi oshile.Ukuhlola okunobuthi kuphinde kwathola ukuthi ama-aerosol emikhiqizo egunyaziwe anobuthi obuncane kakhulu kunogwayi ovuthayo ngokusekelwe ekuqhathanisweni kwedatha etholakalayo kanye nemiphumela yocwaningo olungagunyaziwe.Ukwengeza, i-FDA icabangele ubungozi nezinzuzo kumphakathi wonkana, okuhlanganisa abasebenzisi nabangewona abasebenzisi bemikhiqizo kagwayi, futhi okubalulekile, intsha.Lokhu kufaka phakathi ukubuyekezwa kwedatha etholakalayo mayelana namathuba okusetshenziswa komkhiqizo ngabantu abasha.Kule mikhiqizo, i-FDA inqume ukuthi inzuzo engaba khona kwababhemayo abashintsha ngokuphelele noma abanciphisa kakhulu ukusebenzisa kwabo ugwayi, izodlula ingozi entsheni, inqobo nje uma umfakisicelo elandela izimfuneko zangemuva kokumaketha okuhloswe ngazo ukunciphisa ukuchayeka kwentsha nokufinyelela emikhiqizweni.
Namuhla, i-FDA iphinde yakhipha ama-oda ayi-10 okuphika ukumaketha (ama-MDO) emikhiqizweni ye-ENDS enongiwe ethunyelwe ngaphansi kohlobo lwe-Vuse Solo yi-RJR.Ngenxa yezindaba eziyimfihlo ezingaba khona zezohwebo, i-FDA ayidaluli esidlangalaleni imikhiqizo ethile enambitheka.Le mikhiqizo engaphansi kwe-MDO yohlelo lokusebenza lwemakethe angeke yethulwe noma ilethwe ukuze yethulwe kwezohwebo phakathi kwezifundazwe.Uma ngabe kukhona phakathi kwabo osekuvele kukhona emakethe, kufanele basuswe emakethe noma ukuqinisa ubungozi.Abathengisi kufanele bathinte i-RJR nganoma yimiphi imibuzo mayelana nemikhiqizo ekuluhlu lwabo.Lesi sikhungo sisacubungula isicelo senkampani semikhiqizo efakwe i-menthol ngaphansi kohlobo lwe-Vuse Solo.
I-FDA iyazi ukuthi i-2021 National Youth Tobacco Survey (NYTS) ithole cishe amaphesenti ayi-10 abafundi besikole samabanga aphezulu okwamanje abasebenzisa ugwayi we-elekthronikhi obizwa ngokuthi i-Vuse njengomkhiqizo wabo ojwayelekile.I-ejensi ithatha le datha njengento ebaluleke kakhulu futhi icabangele ubungozi entsheni lapho ibuyekeza le mikhiqizo.Ubufakazi buphinde babonisa ukuthi, uma kuqhathaniswa nabasebenzisi bemikhiqizo ye-ENDS engafakwanga ugwayi, mancane amathuba okuthi abantu abasha baqale ukusebenzisa imikhiqizo ye-ENDS efakwe ugwayi bese beshintshela emikhiqizweni eyingozi kakhulu, njengogwayi ovuthayo.Idatha iphinda iphakamise ukuthi intsha eningi nentsha yabantu abadala abasebenzisa i-ENDS baqala ngezinongo ezifana nezithelo, uswidi noma iminti, hhayi izinambitheka zikagwayi.Le datha iqinisa isinqumo se-FDA sokugunyaza imikhiqizo enambitheka kagwayi ngenxa yokuthi le mikhiqizo ayikhangi kangako entsheni futhi ukugunyaza le mikhiqizo kungase kube usizo kubasebenzisi bakagwayi oshisiwe abadala abashintshela ngokuphelele ku-ENDS noma abanciphisa kakhulu ukusetshenziswa kukagwayi.
Ukwengeza, ukugunyazwa kwanamuhla kubeka imingcele eqinile yokuthengisa enkampanini, okuhlanganisa imikhawulo yokukhangisa kwedijithali kanye nemikhawulo yokukhangisa emsakazweni nethelevishini, ukunciphisa kakhulu amathuba okuba intsha ichayeke ekukhangiseni ugwayi wale mikhiqizo.I-RJR Vapor Company nayo iyadingeka ukuthi ibike njalo ku-FDA ngolwazi oluphathelene nemikhiqizo esemakethe, okuhlanganisa, kodwa kungagcini nje, ezifundweni eziqhubekayo neziqediwe zocwaningo lwabathengi, ukukhangisa, izinhlelo zokumaketha, idatha yokuthengisa, ulwazi lwabasebenzisi bamanje nabasha, izinguquko zokukhiqiza kanye nomuzwa ongemuhle.
I-FDA ingase imise okwesikhashana noma ihoxise i-oda lokumaketha elikhishwe ngaphansi kwendlela ye-PMTA ngenxa yezizathu ezihlukahlukene uma i-ejensi inquma ukuthi ukuqhubeka ukumakethwa komkhiqizo “akusafaneleki ukuvikela impilo yomphakathi,” njengokuthi uma kunokuthile okubalulekile. ukwanda kokuthwasa kwentsha.
Nakuba isenzo sanamuhla sivumela ukuthi imikhiqizo kagwayi ithengiswe e-US, akusho ukuthi le mikhiqizo iphephile noma “igunyazwe yi-FDA.”Yonke imikhiqizo kagwayi iyingozi futhi iyalutha futhi labo abangasebenzisi imikhiqizo kagwayi akufanele baqale.
Izicelo ze-ENDS eminingi neminye emisha ethathwa njengemikhiqizo kagwayi emakethe kusukela ngomhla ka-Aug. 8, 2016 bekumele ihanjiswe ku-FDA ngoSepthemba 9, 2020. I-ejensi ithathe isinyathelo phezu kuka-98% wezicelo ezithunyelwe ngalowo mnqamulajuqu. .Lokhu kuhlanganisa ukukhishwa kwama-MDO emikhiqizo ye-ENDS enambitheka engaphezu kwesigidi ebintula ubufakazi obanele bokuthi inzuzo yabantu abadala ababhemayo abasebenzisa imikhiqizo ye-flavour inganqoba ukukhathazeka kwezempilo komphakathi okubangelwa ukukhanga okubhalwe kahle nokukhulu kwemikhiqizo entsheni.Muva nje, i-FDA ithumele isifinyezo sesinqumo se-MDO esiyisampula.Lesi sampula asibonisi isizathu sesinqumo sesenzo se-MDO ngasinye esithathwe yi-FDA.
I-ejensi izoqhubeka nokukhipha izinqumo mayelana nezicelo, ngokufanelekile, futhi izibophezele ekusebenzeleni ukuguqula indawo yemakethe yamanje ibe yileyo lapho yonke imikhiqizo ye-ENDS etholakalayo ukuze ithengiswe ibonise ukuthi ukumakethwa komkhiqizo “kufanele ukuvikela impilo yomphakathi. .”
Isikhathi sokuthumela: Jan-10-2022
