FDA Yemerera Kwamamaza Ibicuruzwa bya E-Itabi, Kumenyekanisha Uruhushya rwambere rwubwoko bwikigo

Ikigo kandi kirahakana ibyifuzo byibicuruzwa bifite uburyohe bwo kunanirwa kwerekana ko Kwamamaza ibyo bicuruzwa byaba byiza mukurinda ubuzima rusange

Uyu munsi, Ubuyobozi bw’ibiribwa n’ibiyobyabwenge muri Amerika bwatangaje ko bwemeye kwamamaza ibicuruzwa bitatu bishya by’itabi, bikaba bibaye icyiciro cya mbere cy’ibicuruzwa bya elegitoroniki byohereza ibicuruzwa (ENDS) byemewe na FDA binyuze mu nzira ya Premarket Itabi ry’ibicuruzwa (PMTA) .FDA yatanze isoko ryahaye uruhushya RJ Reynolds (RJR) Vapor Company kubera Vuse Solo yafunze igikoresho cya ENDS kandi iherekeza amashanyarazi ya e-fluide itabi, byumwihariko, Vuse Solo Power Unit, Vuse Gusimbuza Cartridge Umwimerere 4.8% G1, na Cartridge yo Gusimbuza Vuse. Umwimerere 4.8% G2.Nkuko uruganda rwa RJR Vapor rwatanze amakuru kuri FDA yerekanaga ko kwamamaza ibicuruzwa bikwiriye kurengera ubuzima rusange, uburenganzira bwuyu munsi butuma ibyo bicuruzwa bigurishwa byemewe muri Amerika

“Uruhushya rw'uyu munsi ni intambwe y'ingenzi mu gutuma ibicuruzwa byose by'itabi bisuzumwa neza na FDA.Amakuru yakozwe n’uruganda yerekana ibicuruzwa byayo birimo itabi bishobora kugirira akamaro abantu banywa itabi bakuze bahindukirira ibyo bicuruzwa - haba mu buryo bwuzuye cyangwa bikagabanuka cyane ku kunywa itabi - mu kugabanya ingaruka ziterwa n’imiti yangiza, ”ibi bikaba byavuzwe na Mitch Zeller, JD, umuyobozi wa FDA. Ikigo cyibicuruzwa byitabi.Ati: “Tugomba gukomeza kuba maso kuri uru ruhushya kandi tuzakurikirana iyamamazwa ry'ibicuruzwa, harimo niba sosiyete itubahirije ibisabwa n'amategeko cyangwa niba hari ibimenyetso bifatika byagaragaye ko byakoreshejwe cyane n'abantu batigeze bakoresha ibicuruzwa by'itabi, harimo n'urubyiruko. .Tuzafata ingamba uko bikwiye, harimo no gukuraho uruhushya. ”

Mu nzira ya PMTA, abayikora bagomba kwereka ikigo ko, mubindi, kwamamaza ibicuruzwa bishya byitabi byaba bikwiye kurengera ubuzima bwabaturage.Ibicuruzwa byagaragaye ko byujuje ubuziranenge kuko, mubitekerezo byinshi byingenzi, ikigo cyemeje ko abitabiriye ubushakashatsi bakoresheje ibicuruzwa byemewe gusa bahuye n’ibintu bike byangiza kandi bishobora kwangiza (HPHCs) biva kuri aerosole ugereranije n’abakoresha itabi ryaka.Isuzuma ry’uburozi ryasanze kandi ibicuruzwa byemewe bya aerosole bifite ubumara buke ugereranije n’itabi ryaka hashingiwe ku kugereranya amakuru aboneka hamwe n’ibisubizo by’ubushakashatsi butari ubwa kliniki.Byongeye kandi, FDA yatekereje ku ngaruka n’inyungu ku baturage muri rusange, harimo abakoresha n’abatayikoresha ibicuruzwa by’itabi, cyane cyane urubyiruko.Ibi byari bikubiyemo gusubiramo amakuru aboneka kubyerekeranye no gukoresha ibicuruzwa nurubyiruko.Kuri ibyo bicuruzwa, FDA yemeje ko inyungu zishobora guterwa n’abanywa itabi bahindura burundu cyangwa bagabanya cyane itabi ry’itabi, ryarusha ingaruka urubyiruko, mu gihe uwasabye gukurikiza ibisabwa nyuma y’isoko rigamije kugabanya urubyiruko no kubona ibicuruzwa.

Uyu munsi, FDA kandi yatanze amabwiriza 10 yo guhakana ibicuruzwa (MDOs) kubicuruzwa bya ENDS biryoshye byatanzwe munsi ya Vuse Solo na RJR.Bitewe nibibazo byamakuru byubucuruzi byihishwa, FDA ntabwo itangaza kumugaragaro ibicuruzwa byihariye.Ibicuruzwa bigengwa na MDO kubisabwa mbere ntibishobora gutangizwa cyangwa gutangwa kugirango byinjizwe mubucuruzi bwibihugu.Niba hari kimwe muri byo kimaze kuba ku isoko, kigomba kuvanwa ku isoko cyangwa kubahiriza ingaruka.Abacuruzi bagomba kuvugana na RJR nibibazo byose bijyanye nibicuruzwa byabo.Ikigo kiracyasuzuma icyifuzo cy’isosiyete ku bicuruzwa bifite uburyohe bwa menthol munsi ya Vuse Solo.

FDA izi neza ko Ubushakashatsi bwakozwe ku rwego rw’igihugu mu 2021 (NYTS) bwerekanye ko hafi 10 ku ijana by’abanyeshuri biga mu mashuri yisumbuye ubu bakoresha e-itabi ryitwa Vuse nk'ikirango cyabo gisanzwe.Ikigo gifata aya makuru cyane kandi kigatekereza ingaruka ku rubyiruko iyo rusuzuma ibicuruzwa.Ibimenyetso byagaragaje kandi ko, ugereranije n’abakoresha ibicuruzwa bitarimo itabi rya ENDS, urubyiruko ntirushobora gutangira gukoresha ibicuruzwa bya ENDS bifite itabi hanyuma bigahinduka ku bicuruzwa bishobora guteza akaga, nk’itabi ryaka.Aya makuru yerekana kandi ko benshi mu rubyiruko n’abakiri bato bakoresha ENDS batangirana nuburyohe nkimbuto, bombo cyangwa mint, ntabwo ari uburyohe bwitabi.Aya makuru ashimangira icyemezo cya FDA cyo kwemerera ibicuruzwa bifite itabi kubera ko ibyo bicuruzwa bidashimisha urubyiruko kandi kwemerera ibyo bicuruzwa bishobora kugirira akamaro abakoresha itabi ryakuze bakuze bahindura ENDS cyangwa bikagabanya cyane itabi ryabo.

Byongeye kandi, uruhushya rwuyu munsi rushyiraho ingamba zikomeye zo kwamamaza ku isosiyete, harimo guhagarika kwamamaza ku buryo bwa interineti kimwe no guhagarika amaradiyo na televiziyo, kugira ngo bigabanye cyane amahirwe y’urubyiruko rwerekanwa n’itabi ryamamaza ibicuruzwa.Isosiyete ya RJR Vapor isabwa kandi gutanga raporo buri gihe muri FDA hamwe namakuru ajyanye nibicuruzwa ku isoko, harimo, ariko ntibigarukira gusa, ubushakashatsi burambye kandi bwuzuye bwubushakashatsi bwabaguzi, kwamamaza, gahunda yo kwamamaza, amakuru yo kugurisha, amakuru kubakoresha ubu n'abashya, gukora impinduka nuburambe bubi.

FDA irashobora guhagarika cyangwa gukuraho itegeko ryamamaza ryatanzwe munsi yinzira ya PMTA kubwimpamvu zitandukanye mugihe ikigo cyemeje ko gukomeza ibicuruzwa bitakiri "bikwiye kurengera ubuzima rusange," nkaho hari akamaro gakomeye kwiyongera mu gutangiza urubyiruko.

Nubwo ibikorwa byuyu munsi byemerera ibicuruzwa by itabi kugurishwa muri Amerika, ntibisobanura ko ibyo bicuruzwa bifite umutekano cyangwa "FDA byemewe."Ibicuruzwa byose byitabi byangiza kandi birabaswe kandi abadakoresha ibicuruzwa byitabi ntibagomba gutangira.

Gusaba ENDS n’ibindi bicuruzwa bishya by’itabi ku isoko guhera ku ya 8 Kanama 2016 byasabwaga koherezwa muri FDA bitarenze ku ya 9 Nzeri 2020. Ikigo cyafashe ingamba zirenga 98% by’ibisabwa byatanzwe n’icyo gihe ntarengwa. .Ibi bikubiyemo gutanga MDOs kubicuruzwa birenga miriyoni biryoheye bya ENDS bidafite ibimenyetso bihagije byerekana ko inyungu ku banywa itabi bakuze bakoresha ibicuruzwa by uburyohe byatsinda impungenge zubuzima rusange bwatewe nubushakashatsi bwanditse kandi bushimishije cyane kubicuruzwa.Vuba aha, FDA yashyizeho icyitegererezo cy'icyemezo cya MDO.Uru rugero ntirugaragaza ishingiro ryicyemezo kuri buri gikorwa cya MDO cyakozwe na FDA.

Ikigo kizakomeza gutanga ibyemezo kubisabwa, nkuko bikwiye, kandi byiyemeje gukora kugirango hahindurwe isoko iriho ubu aho ibicuruzwa byose bya ENDS biboneka kugurishwa byagaragaje ko kwamamaza ibicuruzwa "bikwiriye kurengera ubuzima bwabaturage . ”