Agency Ikukananso Kufunsira kwa Zinthu Zowoneka Bwino Chifukwa Cholephera Kuwonetsa Kuti Kutsatsa Kwazinthu Izi Kungakhale Koyenera Kuteteza Zaumoyo Wa Anthu.
Lero, bungwe la US Food and Drug Administration lalengeza kuti lavomereza kugulitsidwa kwa zinthu zitatu zatsopano za fodya, zomwe zikuwonetsa seti yoyamba yamagetsi operekera chikonga (ENDS) omwe avomerezedwa ndi FDA kudzera munjira ya Premarket Tobacco Product Application (PMTA). .A FDA adapereka zotsatsa zidapereka malamulo ku RJ Reynolds (RJR) Vapor Company chifukwa cha chipangizo chake cha Vuse Solo chotseka ENDS komanso kutsagana ndi ma e-liquid pods okongoletsedwa ndi fodya, makamaka, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, ndi Vuse Replacement Cartridge Choyambirira 4.8% G2.Monga RJR Vapor Company idapereka zambiri ku FDA zomwe zikuwonetsa kuti kutsatsa kwazinthuzi ndikoyenera kuteteza thanzi la anthu, chilolezo chamasiku ano chimalola kuti zinthuzi zizigulitsidwa mwalamulo ku US.
“Zilolezo za masiku ano ndi sitepe lofunika kwambiri poonetsetsa kuti fodya aliyense watsopano akuwunikidwa ndi a FDA motsimikiza za malonda ake.Zomwe wopanga amapanga zikuwonetsa kuti zinthu zomwe zimakomedwa ndi fodya zitha kupindulitsa osuta achikulire omwe amasiya kusuta - mwina kwathunthu kapena kuchepetsa kwambiri kusuta - pochepetsa kukhudzidwa kwawo ndi mankhwala owopsa," adatero Mitch Zeller, JD, director of the FDA's. Center for Fodya Products."Tiyenera kukhala tcheru ndi chilolezochi ndipo tidzayang'anira malonda a malonda, kuphatikizapo ngati kampani ikulephera kutsata malamulo aliwonse kapena ngati pali umboni wodalirika wogwiritsira ntchito fodya ndi anthu omwe sanagwiritsepo ntchito fodya, kuphatikizapo achinyamata. .Tichitapo kanthu momwe tingathere, kuphatikizapo kuchotsa chilolezocho. "
Pansi pa njira ya PMTA, opanga ayenera kuwonetsa ku bungweli kuti, mwa zina, kugulitsa fodya watsopano kungakhale koyenera kuteteza thanzi la anthu.Zogulitsazi zidapezeka kuti zimakwaniritsa mulingo uwu chifukwa, mwazinthu zingapo zazikulu, bungweli lidatsimikiza kuti ochita nawo kafukufuku omwe adagwiritsa ntchito zovomerezeka zokha adakumana ndi zinthu zochepa zovulaza komanso zomwe zingakhale zovulaza (HPHCs) zochokera kumafuta opangira mpweya poyerekeza ndi ogwiritsa ntchito ndudu zoyaka.Kuwunika kwa toxicological kunapezanso kuti ma aerosols ovomerezeka ndi ocheperako kuposa ndudu zopsereza kutengera kufananizira komwe kulipo komanso zotsatira za kafukufuku wosagwirizana ndi zamankhwala.Kuphatikiza apo, a FDA adaganizira za kuwopsa ndi zopindulitsa kwa anthu onse, kuphatikiza ogwiritsa ntchito ndi osagwiritsa ntchito fodya, komanso chofunikira kwambiri, achinyamata.Izi zidaphatikizanso kuwunikanso zomwe zilipo za kuthekera kogwiritsa ntchito mankhwalawa ndi achinyamata.Pazinthu izi, a FDA adatsimikiza kuti phindu lomwe lingakhalepo kwa osuta omwe amasintha kapena kuchepetsa kwambiri kusuta kwawo, likhoza kupitilira chiwopsezo cha achinyamata, malinga ngati wopemphayo atsatira zomwe akufuna pambuyo pa kutsatsa zomwe cholinga chake ndi kuchepetsa kuwonekera kwa achinyamata ndi mwayi wopeza zinthuzo.
Masiku ano, a FDA adaperekanso malamulo 10 okana malonda (MDOs) pazinthu zamtundu wa ENDS zomwe zaperekedwa pansi pa mtundu wa Vuse Solo ndi RJR.Chifukwa chazidziwitso zachinsinsi zazamalonda, a FDA sakuwulula poyera zinthu zomwe zakhudzidwa.Zogulitsazi zomwe zili pansi pa MDO kuti zigwiritsidwe ntchito pogulitsiratu sizingayambitsidwe kapena kuperekedwa kuti zidziwitso zamalonda apakati.Ngati aliyense wa iwo ali kale pamsika, ayenera kuchotsedwa pamsika kapena kukhazikitsa ziwopsezo.Ogulitsa akuyenera kulumikizana ndi RJR ndi mafunso aliwonse okhudzana ndi zinthu zomwe ali nazo.Bungweli likuwunikabe momwe kampaniyo ikugwiritsira ntchito mankhwala opangidwa ndi menthol pansi pa mtundu wa Vuse Solo.
A FDA akudziwa kuti kafukufuku wa 2021 National Youth Tobacco Survey (NYTS) adapeza pafupifupi 10 peresenti ya ophunzira akusekondale omwe pakali pano amagwiritsa ntchito ndudu zotchedwa Vuse monga mtundu wawo wanthawi zonse.Bungweli limatenga izi mozama kwambiri ndikuganizira zoopsa kwa achinyamata powunika zinthuzi.Umboniwo unanenanso kuti, poyerekeza ndi omwe amagwiritsa ntchito zinthu za ENDS zosakometsera fodya, achinyamata sangayambe kugwiritsa ntchito mankhwala a ENDS omwe amawotchedwa ndi fodya kenako n’kuyamba kugwiritsa ntchito zinthu zoopsa kwambiri, monga ndudu zopsereza.Deta ikuwonetsanso kuti achinyamata ndi achinyamata ambiri omwe amagwiritsa ntchito ENDS amayamba ndi zokometsera monga zipatso, maswiti kapena timbewu tonunkhira, osati kununkhira kwa fodya.Izi zimalimbikitsa lingaliro la FDA lololeza mankhwala opangidwa ndi fodya chifukwa mankhwalawa sakhala osangalatsa kwa achinyamata ndipo kuvomereza mankhwalawa kungakhale kopindulitsa kwa anthu akuluakulu omwe amasuta fodya omwe amasinthiratu ku ENDS kapena kuchepetsa kwambiri kusuta kwawo.
Kuphatikiza apo, chilolezo chamasiku ano chimayika ziletso zokhwima pakampani, kuphatikiza zoletsa zotsatsa pakompyuta komanso zoletsa zotsatsa pawailesi ndi wailesi yakanema, kuti achepetse kwambiri kuthekera kwa achinyamata kutengera kutsatsa kwa fodya pazinthu izi.Kampani ya RJR Vapor ikufunikanso kuti ipereke lipoti pafupipafupi ku FDA ndi chidziwitso chokhudza zinthu zomwe zili pamsika, kuphatikiza, koma osati malire, maphunziro opitilira ndi omaliza a kafukufuku wa ogula, kutsatsa, mapulani otsatsa, zogulitsa, zambiri za ogwiritsa ntchito pano ndi atsopano, kusintha kwakupanga ndi zokumana nazo zoyipa.
A FDA atha kuyimitsa kapena kuchotseratu lamulo lotsatsa lomwe laperekedwa pansi pa njira ya PMTA pazifukwa zosiyanasiyana ngati bungwe likuwona kuti kutsatsa kwazinthu sikulinso "koyenera kuteteza thanzi la anthu," monga ngati pali vuto lalikulu. kuwonjezeka kwa chiyambi cha achinyamata.
Ngakhale zomwe zikuchitika masiku ano zimaloleza kuti fodya azigulitsidwa ku US, sizitanthauza kuti zinthuzi ndi zotetezeka kapena "zovomerezedwa ndi FDA."Fodya zonse ndi zovulaza komanso zosokoneza bongo ndipo omwe sagwiritsa ntchito fodya sayenera kuyamba.
Zofunsira zambiri za ENDS ndi zinthu zina zatsopano zomwe zimaganiziridwa kuti ndi fodya pamsika kuyambira pa Aug. 8, 2016 zidayenera kutumizidwa ku FDA pofika Seputembara 9, 2020. Bungweli lachitapo kanthu pazopitilira 98% za mapulogalamu omwe adatumizidwa pofika nthawi yomaliza. .Izi zikuphatikizanso kupereka ma MDO pazinthu zopitilira miliyoni imodzi za ENDS zomwe zinalibe umboni wokwanira kuti phindu kwa osuta achikulire omwe amagwiritsa ntchito zokometserazo lingagonjetse nkhawa zaumoyo wa anthu chifukwa cholembedwa bwino komanso chidwi chachikulu cha mankhwalawa kwa achinyamata.Posachedwapa, FDA idatumiza chidule cha chisankho cha MDO.Chitsanzochi sichikuwonetsa zifukwa za chisankho cha MDO chilichonse chotengedwa ndi FDA.
Bungweli lipitiliza kupereka zisankho pazofunsira, ngati kuli koyenera, ndipo likudzipereka kuti lisinthe msika wapano kukhala womwe zinthu zonse za ENDS zomwe zimagulitsidwa zawonetsa kuti kutsatsa kwazinthuzo "ndikoyenera kuteteza thanzi la anthu. .”
Nthawi yotumiza: Jan-10-2022
