Agency Zvakare Inoramba Zvikumbiro zveFlavored Zvigadzirwa zvekutadza Kuratidza kuti Kushambadzira kweZvigadzirwa Izvi Kunenge Kwakakodzera Kuchengetedzwa Kwehutano Hwevanhu.
Nhasi, US Food and Drug Administration yakazivisa kuti yabvumidza kutengeswa kwezvinhu zvitatu zvitsva zvefodya, zvichimaka seti yekutanga yemagetsi nicotine delivery system (ENDS) zvigadzirwa zvichambopihwa mvumo neFDA kuburikidza nePremarket Tobacco Product Application (PMTA) nzira. .Iyo FDA yakapa kushambadzira yakapa maodha kuRJ Reynolds (RJR) Vapor Kambani yeVuse Solo yakavharwa ENDS mudziyo uye inoperekedza fodya-yakanhuhwirira e-liquid pods, kunyanya, Vuse Solo Power Unit, Vuse Replacement Cartridge Yekutanga 4.8% G1, uye Vuse Replacement Cartridge Yekutanga 4.8% G2.Sezvo RJR Vapor Kambani yakaendesa data kuFDA yakaratidza kuti kushambadzira kwezvinhu izvi kwakakodzera kuchengetedzwa kwehutano hweveruzhinji, mvumo yanhasi inobvumira zvigadzirwa izvi kuti zvitengeswe zviri pamutemo muUS.
“Mvumo yanhasi idanho rakakosha rekuona kuti zvinhu zvitsva zvese zvefodya zvinoongororwa neFDA zvakasimba, zvesainzi.Mashoko emugadziri anoratidza zvigadzirwa zvefodya zvinogona kubatsira vanhu vakuru vakapindwa muropa nefodya vanochinja kune zvigadzirwa izvi - zvachose kana nekudzikisira kukuru kwekushandisa fodya - nekuderedza kuratidzwa kwavo kumakemikari anokuvadza," akadaro Mitch Zeller, JD, director weFDA's. Center for Fodya Zvigadzirwa.“Tinofanira kuramba takangwarira nemvumo iyi uye tichaongorora kutengeswa kwefodya, kusanganisira kuti kambani inotadza kutevedzera zvinodiwa nemutemo here kana kuti pakabuda umboo hwechokwadi hwekushandiswa kwakanyanya nevanhu vasina kumboshandisa fodya, kusanganisira vechidiki. .Tichatora matanho sezvakakodzera, kusanganisira kubvisa mvumo. "
Pasi pechirongwa chePMTA, vanogadzira fodya vanofanira kuratidza kusangano iri kuti, pakati pezvimwe zvinhu, kutengeswa kwefodya itsva kwakakodzera mukuchengetedzwa kweutano hweveruzhinji.Zvigadzirwa izvi zvakawanikwa zvichisangana nechiyero ichi nekuti, pakati pezvakawanda zvakakosha, sangano rakaona kuti vatori vechikamu muzvidzidzo vakashandisa zvigadzirwa zvakatenderwa chete vakaoneswa kune zvishoma zvinokuvadza uye zvinogona kukuvadza (HPHCs) kubva kumaaerosols zvichienzaniswa nevashandisi vefodya yakapiswa.Iyo toxicological assessment yakawanawo kuti maaerosols ezvigadzirwa zvakatenderwa haana muchetura zvakanyanya pane wefodya yakapiswa zvichibva pakuenzaniswa kwedata uye mhedzisiro yezvidzidzo zvisiri zvekiriniki.Pamusoro pezvo, iyo FDA yakafunga nezve njodzi uye mabhenefiti kune ruzhinji rwevanhu, kusanganisira vashandisi nevasiri vashandisi vezvigadzirwa zvefodya, uye zvakakosha, vechidiki.Izvi zvaisanganisira ongororo ye data iripo pamusoro pekugona kushandiswa kwechigadzirwa nevechidiki.Kune zvigadzirwa izvi, iyo FDA yakafunga kuti iyo inogona kubatsira kune vanoputa vanochinja zvachose kana zvakanyanya kuderedza kushandisa kwavo fodya, yaizopfuura njodzi kune vechidiki, chero munyoreri achitevera mushure mekushambadzira zvinodiwa kudzikisa kuratidzwa kwevechidiki uye kuwana zvigadzirwa.
Nhasi, iyo FDA yakapawo gumi mirairo yekuramba kushambadzira (MDOs) yemhando yeENDS zvigadzirwa zvakaunzwa pasi peVuse Solo brand neRJR.Nekuda kwezvingangoitika zvakavanzika zveruzivo zvekutengesa, iyo FDA haisi kuburitsa pachena izvo zvakanakirwa zvigadzirwa.Izvi zvigadzirwa zviri pasi peMDO yepremarket application zvinogona kusaunzwa kana kuunzwa kuti zvipinzwe mukutengeserana pakati penyika.Kana mumwe wavo atove pamusika, anofanira kubviswa pamusika kana kuisa njodzi.Vatengesi vanofanirwa kubata RJR nemibvunzo ipi nezve zvigadzirwa mune yavo hesita.Sangano iri richiri kuongorora kunyorera kwekambani iyi zvigadzirwa zvine menthol-flavored pasi pechiratidzo cheVuse Solo.
Iyo FDA inoziva kuti 2021 National Youth Tobacco Survey (NYTS) yakawana ingangoita gumi muzana yevadzidzi vechikoro chesekondari avo parizvino vanoshandisa e-fodya inonzi Vuse semhando yavo yenguva dzose.Iyo agency inotora iyi data zvakanyanya uye inoona njodzi kune vechidiki kana ichiongorora zvigadzirwa izvi.Humbowo hwakaratidzawo kuti, zvichienzaniswa nevashandisi vezvinhu zvisiri zvefodya zveENDS, vechidiki kashoma kuti vatange kushandisa zvigadzirwa zveENDS zvinopiswa nefodya vobva vachinja kune zvinogadzirwa zvine njodzi, zvakaita sefodya yakapiswa.Iyo data zvakare inoratidza kuti vechidiki vazhinji uye vechidiki vechidiki vanoshandisa ENDS vanotanga nekunaka semichero, siwiti kana mint, uye kwete flavour yefodya.Idzi data rinosimbisa danho reFDA rekubvumidza zvigadzirwa zvefodya nekuti zvigadzirwa izvi hazvifadze vechidiki uye kupa mvumo yezvigadzirwa izvi zvinogona kubatsira kune vakuru vanopisa fodya vanochinja zvachose kuENDS kana kuderedza zvakanyanya kushandisa kwavo fodya.
Pamusoro pezvo, mvumo yemazuva ano inoisa zvirango zvakasimba zvekutengesa kukambani, kusanganisira zvirambidzo zvekushambadzira kwedhijitari pamwe nekurambidza kushambadza kweredhiyo neterevhizheni, kuderedza zvakanyanya mukana wevechidiki kushambadza fodya yezvigadzirwa izvi.RJR Vapor Kambani inosungirwawo kuzivisa nguva dzose kuFDA neruzivo nezve zvigadzirwa pamusika, zvinosanganisira, asi kwete kuganhurirwa, inoenderera uye yakapedzwa zvidzidzo zvekutsvaga kwevatengi, kushambadzira, zvirongwa zvekushambadzira, data rekutengesa, ruzivo rwevashandisi vezvino nevatsva, kuchinja kwekugadzira uye zviitiko zvakashata.
Iyo FDA inogona kumisa kana kubvisa chirevo chekushambadzira chakapihwa pasi penzira yePMTA nekuda kwezvikonzero zvakasiyana kana iyo agency ikaona kuenderera mberi kwekushambadzira kwechigadzirwa "hakuchakodzere kuchengetedzwa kwehutano hweveruzhinji," sekunge paine zvakakosha. kuwedzera mukutanga kwevechidiki.
Nepo chiito chanhasi chichibvumira zvigadzirwa zvefodya kuti zvitengeswe kuUS, hazvireve kuti zvigadzirwa izvi zvakachengeteka kana kuti "FDA yakatenderwa."Zvese zvigadzirwa zvefodya zvinokuvadza uye zvinopinda muropa uye avo vasingashandisi zvigadzirwa zvefodya havafanirwe kutanga.
Zvikumbiro zvemaENDS akawanda uye zvimwe zvitsva zvinonzi zvigadzirwa zvefodya pamusika kubva muna Aug. 8, 2016 zvaifanirwa kuendeswa kuFDA naSept. 9, 2020. Sangano ratora matanho pamusoro pe98% yezvikumbiro zvakaunzwa nenguva iyoyo. .Izvi zvinosanganisira kuburitsa maMDO ezvigadzirwa zveENDS zvinodarika miriyoni zvakashaya humbowo hwakakwana hwekuti kubatsira kune vanhu vakuru vanoputa vakashandisa zvinonhuhwira zvinokunda dambudziko rehutano reveruzhinji rinounzwa nekunyatso nyorwa uye kukwezva kukuru kwezvigadzirwa kune vechidiki.Munguva pfupi yapfuura, FDA yakatumira sampuli yeMDO sarudzo pfupiso.Sample iyi hairatidze chikonzero chesarudzo kune yega yega MDO chiito chakatorwa neFDA.
Iyo agency icharamba ichipa sarudzo pazvikumbiro, sezvinokodzera, uye yakazvipira kushanda kushandura musika wazvino kuenda kune iyo yese ENDS zvigadzirwa zviripo kutengeswa zvakaratidza kuti kushambadzira kwechigadzirwa "kwakakodzera kuchengetedzwa kwehutano hweveruzhinji. .”
Nguva yekutumira: Jan-10-2022
