Juul akamhan'arira FDA kuti ivape mukana kune marekodhi anodiwa kuti inzwisise kuti sei zvese zviripo zveJuul zvigadzirwa zviri pasi peiyo agency yekuramba kushambadzira (MDO). Dunhu reColumbia reUS District Court akagamuchira chichemo musi weChipiri.
Juul akakurudzira dare kuti ritore uye richengetedze hutongi hwenyaya iyi kudzamara FDA yaenderana nezvikumbiro zvaJuul's FOIA uye nemimwe mirairo yedare, pamwe nekuda kuti sangano iri ritenderedze mapepa arikutsvagwa uye rorambidza kunyima rumwe ruzivo rwakakodzera mune ramangwana. .
Maitiro eFDA anoshamisa ane hukama neJuul's PMTA
Iyo FDA yakapa MDO yezvigadzirwa zveJuul zuva raitevera, zvichibva pakupomera kuri pachena kuti Juul's $100 miriyoni premarket fodya yekushandisa (PMTAs) yakasiya zvakakosha zvakawanikwa muhupfu. The FDA pakutanga leaked yayo kuuya chiito kuWall Street Journal muna June 22. The FDA akaongorora PMTAs yekambani kweanoda kusvika makore maviri uye aiva nekodzero kubudisa kushaikwa tsamba chero nguva kana inokosha mashoko akanga asiri chokwadi.
Kumbomira kwenguva pfupi kwekuraira kwakakumbirwa naJuul uye kwakapihwa neDC Circuit Court of Appeals musi waChikumi 24, rimwe zuva mushure mekunge FDA yapa MDO. Iyo FDA yakazogomera ikaparura kugara kwayo kuJuul musi wa5 Chikunguru, mavhiki maviri mushure mekunge dare ramboirambidza kushandisa MDO yayo, ichiti "yakasarudza kuti pane zvinonetsa zvesainzi zvakasiyana nechikumbiro cheJUUL zvinoda kuongororwa." Nekudaro, iyo FDA haina kubvisa MDO yayo sezvakaitika kune mamwe mabhizinesi akaita seTurning Point Brands, kunyangwe yakapa pekugara uye kuvimbisa kuwedzera PMTA ongororo.
Kuedza kwaJuul's FOIA kwakamhanyira muchipingamupinyi
Juul Labs akakoka Rusununguko rweRuzivo Mutemo (FOIA) kukumbira kuwanikwa kwesainzi chirango chekuongorora uye mamwe magwaro ane chekuita neJuul's PMTAs kuti vadzidze zvakawanda nezve maitiro nemaitiro eFDA. 115 chete pamapeji mazana maviri nemakumi mapfumbamwe neshanu iyo FDA yakatsunga kuve yakakosha kuchikumbiro chaJuul's FOIA ndiyo ichapihwa zvizere, uye mazhinji emapepa achinyimwa nekuda kwe "sarudzo yehungwaru."
Imwe yezvisingabvumidzwe kuti masangano emubatanidzwa angashandise kuratidza kunyima magwaro kubva kune zvikumbiro zveFOIA iropafadzo yehungwaru. Maererano neNational Law Review, kuregererwa kunobvumira dare rakaita seFDA kuramba zvikumbiro zveFOIA zve "pre-decision" uye "decision" ruzivo kuitira "kuvimbisa kuti masangano ehurumende anokwanisa kuita hurukuro dzakajeka uye dzakavhurika mukuita kwavo sarudzo."
Juul anonzi anga aine hurukuro dzisina kurongeka neFDA, asi "kunyangwe FDA ichigara ichiburitsa zvinhu izvi pakuita sarudzo dzekutengesa kune zvimwe zvigadzirwa zvefodya, iyo agency yakatora rombo rekuita zvehungwaru uye yakaramba kupa ruzivo rumwe chete" kuna Juul, sekureva kwedare rayo reChipiri. kufaira. Pamusoro pezvo, mubatanidzwa wakwidza nyaya kune FDA administratively; zvisinei, nenguva yakatarwa nesangano iri munaGunyana 13 kuti igadziriswe, kukwidzwa kwacho kwakanga kusati kwawana mhinduro.
Sekureva kwaJuul, rombo rekuita nemaune "rakagadzirirwa kukurudzira gakava rakavhurika remitemo mukati memasangano." "Hazvina kumboitirwa kuchengetedza basa resangano resainzi zvakavanzika kubva kune veruzhinji."
Mashoko api achaburitswa nemagwaro akasiiwa? Juul anofunga nemoyo wese kuti vanogona kuratidza kuti FDA yakashaya chikonzero chesainzi chekuramba chikumbiro chavo. Zvingave zvakakosha. Nehurombo, ivo havazoburitsa nhaurirano dzerunhare pakati peFDA Commissioner Robert Califf nevamiriri vemitemo vakaita seIllinois Senator Dick Durbin, avo vakatsiga vakasundidzira FDA kurambidza Juul kunyangwe zvakawanikwa nesainzi.
"Nenguva isipi, tichafumura kuti huwori hwakanganisa sei sarudzo dzeFDA," akadaro Amanda Wheeler, purezidhendi weAmerican Vapor Manufacturers Association.
