Munguva yekuongorora kwePMTA, iyo Chikafu neDrug Administration (FDA) yakapa "Ramba Kuisa" tsamba kuna JD Nova Group, iyo kambani yevabereki yemhando. Vapolocity, musi wa9 August. Izvi zvakakonzerwa nekushaikwa kwemishumo yeEnvironmental Assessment (EA) muzvinyorwa zvinosvika miriyoni zvina nemazana mashanu zvakaunzwa nekambani. Sangano rakabva ratonga kuti zvigadzirwa zvakakodzera zvinofanira kubviswa pamusika.
wokutanga premarket fodya chigadzirwa application (PMTA) zvakatenderwa neFDA zvakadzokera muna 2015, apo zvigadzirwa zve snus zvemakambani masere eSweden zvakabvumidzwa kutengeswa kuUS Mumakore achangopfuura, FDA yakawedzera hutongi hwayo hwechikakananda kune indasitiri yevaping.
Izvi zvinobva mukushushikana kuri kukura pamusoro pekukanganisa kwakaipa kwechikakananda pahuropi hwevana huri kukura, uye njodzi yayo yekuwedzera kusabatika kwevana kune izvo zvinopinda muropa. Sezvinotaurwa neFDA, mafambiro ayo akakosha kuchengetedza "pwere kubva pahupenyu hunogona kuitika hwekupindwa muropa nicotine."
Gore rapfuura, FDA yakaraira kuti vese vanogadzira vaping vatumire maPTMA ezvigadzirwa zvavo pamberi paGunyana 9, 2020. Zvikasadaro, vanofanirwa kubvisa zvigadzirwa zvese pamusika. Iyo FDA inoongorora zvikumbiro mumatanho mana:
Chekutanga, iyo FDA inoitisa cheki yekuti zvikumbiro zvakatumirwa zvinouya zvakakwana nezvinhu zvinodiwa;
Chechipiri, iyo agency inofaira zvikumbiro zvinosanganisira mune zvinodiwa zvinhu;
Chechitatu, iyo FDA inotanga kuongororwa kwakadzama kwezvikumbiro zvakaiswa;
Pakupedzisira, inoburitsa runyorwa rwezvikumbiro zvakatenderwa.
Iyo FDA's yekuongorora maitiro yakatanga kurongerwa kuvhara musi wa9 Gunyana 2021, inotora gore chairo. Zvisinei, panogona kuva nekushandurwa kwehurongwa. Zvinoenderana neyakatumirwa neFDA muna Chivabvu 2021, iyo agency yakagamuchira anopfuura mamirioni matanhatu zvikumbiro.
Nenguva yakamira yakadai, mushandi weFDA akatenda "mukana weFDA wekuongorora zvese zvakagamuchirwa naSep 9, 2021, wakadzikira." Iyo agency iri kufunga nezve kushandisa hungwaru hwayo kuwedzera nguva yekuongorora.
Vamwe vagadziri vevaping uye vatengesi vakagara pamapini netsono. Kunze kweJD Nova's 4.5 miriyoni zvikumbiro, kune mamwe mamirioni maviri kubva kusingaverengeki mafemu evape ari kumirira kuongororwa. Iyo FDA yakambotonga kuti kana chikumbiro chisina kuiswa munaGunyana 2 gore rino, chingaonekwa sechisiri pamutemo kushambadzira kana kutengesa chigadzirwa chine chekuita.
Parizvino matsamba e "filling" esangano akatumirwa kune vamwe chete vevagadziri, avo kunyorera kwavo kunofukidza 138,000 zvigadzirwa zvevape. Izvi zvinoreva kuti maapplication aya ave kuda kupinda muchikamu chinotevera che "substantive review". Nekudaro, hapana kana chimwe chigadzirwa chevaping chakagamuchira mvumo yekupedzisira yeFDA.
Pane isingasviki mwedzi mumwe kuti uende pamberi paGunyana 9. Asi kumakambani evape asina chaanzwa kubva kuFDA, inguva yakaoma kumamiriro ekunze.
