UJuul umangalela i-FDA ukuthi iyinikeze ukufinyelela kumarekhodi adingekayo ukuze iqonde ukuthi kungani yonke imikhiqizo ekhona yeJuul ingaphansi kwe-oda le-ejensi lokuphika (i-MDO). INkantolo Yesifunda Yase-U.S. yase-Columbia wathola isikhalazo ngolwesibili.
UJuul unxuse inkantolo ukuthi ithathe futhi igcine amandla okuphatha icala kuze kube i-FDA ivumelana nezicelo zikaJuul's FOIA neminye imiyalo yenkantolo, kanye nokudinga ukuthi i-ejensi iguqule amaphepha afunwayo futhi iyivimbele ekugodleni olunye ulwazi olufanele esikhathini esizayo. .
Ukuziphatha okuyinqaba kwe-FDA maqondana ne-PMTA kaJuul
I-FDA inikeze i-MDO yemikhiqizo ekhona kaJuul ngosuku olulandelayo, ngokusekelwe ezimangalweni ezisobala zokuthi izicelo zikaJuul eziyizigidi eziyizinkulungwane ezingu-$100 zikagwayi (PMTAs) ziye zashiya okutholakele okubalulekile kwe-toxicological. I-FDA iqale yaputshuza isenzo sayo esizayo ku-Wall Street Journal ngoJuni 22. I-FDA ibuyekeze ama-PMTA enkampani cishe iminyaka emibili futhi yayinelungelo lokukhipha incwadi yokushoda nganoma yisiphi isikhathi uma idatha ebalulekile ibingekho ngempela.
Ukumiswa kwesikhashana kwe-oda kucelwe uJuul futhi kwavunyelwa yiNkantolo Yesifunda Yamacala Amacala yase-D.C. ngoJuni 24, usuku olulodwa ngemva kokuba i-FDA ikhiphe i-MDO. I-FDA igcine igobile futhi yakhipha ukuhlala kwayo eJuul ngoJulayi 5, emasontweni amabili ngemva kokuba inkantolo iyivimbele okwesikhashana ukuthi isebenzise i-MDO yayo, ithi “yayinqume ukuthi kukhona ukukhathazeka okungokwesayensi okuhlukile esicelweni se-JUUL okudinga uphenyo olwengeziwe.” Kodwa-ke, i-FDA ayizange iyihoxise i-MDO yayo njengasendabeni yamanye amabhizinisi afana ne-Turning Point Brands, naphezu kokukhipha isikhathi sokuhlala nokuthembisa ukubuyekezwa okwengeziwe kwe-PMTA.
Imizamo kaJuul ye-FOIA yangena enkingeni
UJuul Labs ucele uMthetho Wenkululeko Yolwazi (FOIA) ukuze ucele ukufinyelela ekuhlolweni kwezigwegwe zesayensi kanye neminye imibhalo ephathelene nama-PMTA kaJuul ukuze ufunde kabanzi mayelana nezinqubo nezenzo ze-FDA. Amakhasi ayi-115 kuphela kwangu-292 i-FDA enqume ukuhambisana nesicelo sikaJuul's FOIA azonikezwa ngokugcwele, futhi iningi lamaphepha ligodliwe ngenxa "yelungelo lenqubo yezingxoxo."
Okunye okungafakwa izinhlangano zikahulumeni ezingase zikusebenzise ukuze zithethelele ukubamba amadokhumenti ezicelweni ze-FOIA yilungelo lenqubo yezingxoxo. Ngokusho kweNational Law Review, ukukhululwa kuvumela indikimba efana ne-FDA ukuthi yenqabe izicelo ze-FOIA zolwazi "lwesinqumo sangaphambi kwesinqumo" kanye "nolwazi" ukuze "luqinisekise ukuthi izinhlangano zikahulumeni ziyakwazi ukuhlanganyela ezingxoxweni ezingagwegwesi nezivulekile ezinqubweni zazo zokuthatha izinqumo."
Kubikwa ukuthi uJuul ubuye waba nezingxoxo ezingekho emthethweni ne-FDA, kodwa "nakuba i-FDA ihlale ikhipha lezi zinto lapho yenza izinqumo zokumaketha kweminye imikhiqizo kagwayi, le nhlangano isebenzise ilungelo lenqubo yamabomu futhi yenqaba ukunikeza uJuul imininingwane efanayo" kuJuul, ngokusho kwenkantolo yayo yangoLwesibili. ukugcwalisa. Ukwengeza, inkampane yanxusa i-FDA ngokokuphatha; nokho-ke, ngomnqamulajuqu ogunyazwe yile nhlangano wangoSepthemba 13 ukuze kuxazululwe, isikhalazo besingakayitholi impendulo.
NgokukaJuul, ilungelo lenqubo yokuxoxisana "lenzelwe ukukhuthaza izingxoxo ezivulekile zenqubomgomo ngaphakathi kwama-ejensi." "Akuzange kuhloswe ukuthi kugcinwe imfihlo yomsebenzi we-ejensi yesayensi emphakathini jikelele."
Iluphi ulwazi oluzovezwa amadokhumenti asusiwe? UJuul ucabanga ngobuqotho ukuthi bangakhombisa ukuthi i-FDA ibintula izizathu zesayensi zokwenqaba isicelo sabo. Kungaba okubalulekile. Ngeshwa, ngeke badalule izingxoxo zocingo phakathi kukaKhomishana we-FDA uRobert Califf kanye nabenzi bomthetho abafana noSenator wase-Illinois u-Dick Durbin, abaye bacindezela ngokuqinile i-FDA ukuthi ivimbele uJuul naphezu kokutholwe kokubuyekezwa kwesayensi.
"Ngokuhamba kwesikhathi, sizodalula ukuthi ingakanani inkohlakalo eye yaba nomthelela ekukhethweni kwe-FDA," kusho u-Amanda Wheeler, umongameli we-American Vapor Manufacturers Association.
