Ropa Rakaipa Pakati peFDA uye Big Fodya

FDA uye JUUL

Chikafu & Drug Administration yakaratidza kuenderera mberi nekuisa nzira dzekudzivirira kuputa uye kushandisa nicotine pakati pevadiki kwemakore-kunyanya kurambidzwa kwa2020 kune fruity flavour yeJuul vapes-zvisinei, kuedza kwayo. mira zvakakwana Juul Labs kubva mukugadzira pamwe nekugoverwa kwemidziyo yevaping muna Chikumi chiratidzo chakajeka chehuremu hwehutongi hweBiden hwekusundidzira kune vanogadzira fodya yemagetsi. Juul zvigadzirwa zvinogona kuwanikwa izvozvi-a dare remubatanidzwa rakadzorwa iyo FDA inorambidza zuva mushure mekutaura kwayo-asi hondo haina pese padyo nemhedzisiro yayo.

Aka hakasi kekutanga FDA iri kunanga chikamu chefodya, uye pakupedzisira bhizinesi refodya yemagetsi. Sangano reAmerican Lung Association rakakonzera chirongwa chemutemo wekurwisa kuputa mumatunhu ega ega pakati pemakore ekuma1960 nema2000 asi vakabudirira mukubudirira kushoma muCongress.pakati pavo kuva mutemo wa1989 wakaita kuti zvisave pamutemo kuputa pandege dzese dzepamba). Mishumo yekutanga yesainzi muma1950 yakaratidza kuti kuputa fodya kwakabatana negomarara kwakakonzera hova nhatu dzematare makuru eFodya.

Vagadziri vefodya vakapukunyuka nhevedzano yokutanga yemhaka kupfurikidza nokubudirira kupikisa mutoro nokuda kwokuregeredza kugadzira nokutengesa; zvisinei, chikamu chechipiri chakawedzerwa nekunzwa kwe1992 kwenhoroondo yeDare Repamusorosoro Cipollone v. Liggett. Mhosva yacho yakagadza muenzaniso wakasunda vanhu kumhan’arira vagadziri vefodya avo vaishandisa mashoko “asina kururama” uye “okunyengera” kuti vashambadzire zvigadzirwa zvavo, kana kuti izvo zvaisazivisa mhomho pamusoro pezvinorehwa noutano pakusvuta.

Mafungu echitatu ematare akakunda zvakanyanya. Muna 1998, Chibvumirano cheMaster Settlement Agreement (MSA) chakasainwa pakati pemagweta makumi mashanu nemaviri munharaunda nematunhu uye mana emakambani makuru anogadzira fodya muUnited States- achigadzira. kutongwa kukuru kwematare edzimhosva munhoroondo yeUS Chinangwa chikuru cheMSA chaive chekununura mabhiriyoni emadhora akange ashandiswa mukutarisira zvirwere zvine chekuita nehutsi uye kutongerwa kumatare ehurumende akati wandei. Zvakare, chibvumirano ichi chakasimbisa mitemo pamusoro pekushambadzira fodya uye kurambidza kushambadzira kune vanhu vari pasi pemakore gumi nemasere.

Sangano reAmerican Cancer Society (pamwe chete neDhipatimendi reRuramisiro reUnited States nevachuchisi vakasiyana-siyana) vakakunda mudare apo vagadziri vapfumbamwe vanotungamirira fodya vakapomerwa mhosva yokubiridzira vanhu pamwe nokutsausa vanhu nemaune kwemakore pamusoro pezvinorehwa neutano pakuputa. Vanopomerwa - pakati pavo makambani makuru-nguva seAltria naPhilip Morris - - vakamanikidzwa kugovera mashoko ekurapa kusanganisira nhamba yenzufu dzinokonzerwa nekuputa fodya pazuva uye pagore pamwe nekupindwa muropa nechikakananda.

Kutevera 2009 Tobacco Control Act, iyo FDA yakabvisa mitemo yekushambadzira uye yakakwidza chiyero chemutero pamapakiti efodya, richiva nhamburiko yokutanga yakabatanidzwa inotungamirirwa nesangano rehurumende kupinza nzvero yakasimba muindasitiri yefodya. Yakashongedzerwa nesimba rekudzora kugadzirwa, kugovera, uye kushambadza kwezvigadzirwa zvefodya, iyo FDA yakatanga kutonga chikamu ichi ichida. yakanyanya kurongeka premarket application uye inoda zvakakodzera machira ekunyevera ezvigadzirwa zvisina hutsi.

Hurukuro pamusoro pekusvuta pakati pevechiri kuyaruka yamutsa ruzhinji rwematanho emubatanidzwa. Zvakawanikwa neTobacco Control Act, zvakabudiswa panguva apo zera repamutemo rokusvuta raiva nemakore 18 zvichikwira, zvakaratidza kuti anenge mushandisi mutsva wose wefodya ari pasi pezera repamutemo rokusvuta. tenga zvigadzirwa. Muongororo yakaitwa muna 2013 nerubatsiro rweCenters for Disease Control and Prevention, zvakaonekwa kuti mukana wevechiri kuyaruka vasina diploma rechikoro chesekondari kupinda mukusvuta kupfuura chero boka rezera.

Kuvandudzwa uye kushandiswa kwakapararira kweelectronic nicotine delivery systems (ENDS) inozivikanwa zviri nani se "vaping" kana "e-fodya" inoisa mberi chimwe chigumbuso cheFDA. Muna 2015, Juul akapinda mumusika uye mukati memakore matatu ekutanga ekushanda kwayo, kutengesa kwayo kwakakwira kusvika pamadhora mabhiriyoni 1.969 muna 2018 kubva pamadhora mazana maviri nemakumi matanhatu emamiriyoni. Munguva iyi, kwakanga kune kusimuka mukuputa e-cigarette pakati pevana kusvika 20.8% muna 2018 kubva pa11.7%. Vabereki vainetsekana, muna 2018, vakamhan'ara Juul nekuda kwekushambadzira zvigadzirwa zvayo nenzira inokwezva vana, uye. kuferefeta kwakaitwa neFDA paJuul zvichitevera kutengeswa zvisiri pamutemo kwezvigadzirwa zvayo izvo zvakaburitswa sechinzvimbo chefodya. Pakazosvika 2021, 2,339 mhosva yakanga yakamhan'arwa naJuul nekuda kwekushambadzira kwayo kunotsausa, uye nyaya dzakasiyana siyana nevabereki vevechidiki vakawana matambudziko emapapu nekuda kwemhepo. Iyo FDA, muna Chikumi, yakauya nekuraira kwekuramba kushambadzira iyo yakataura iyo kambani "isina kukwana uye inopokana data" yezvigadzirwa.

juul

Nekugadzikana donha mukuputa pakati pevakuru muUS kubva 2005 (kusvika 12.5% ​​muna 2020 kubva pa20.9%) pamwe nechiyero chekuputa pakati pevechiri kuyaruka, nyanzvi dzakaenda kunyevera pamusoro pehuwandu hwazvino hwevadiki vari kuita vaping. Ongororo yakaitwa neNational Youth Tobacco yakaratidza kuti mwero wekushandiswa kwefodya pakati pevadzidzi vekusekondari rakaramba kusvika pa25.6% muna 2006 zvichidzika kubva pa34.5% muna 2000. Muna 2021, mutengo wakaderera kusvika ku13.4% yevadzidzi vekusekondari. Sekutaura kweFDA'S, 7.6% yevadzidzi vepakati nesekondari vakaudzwa kuti vanoshandisa fodya yemagetsi kupfuura chero ipi zvayo yefodya.

Pakutanga, apo Juul akanga achigadzirira kupinda mumusika muna 2015, FDA - mukuedza kutakura kupararira kwekugadzirwa kwefodya yemagetsi - yakagadzira mitemo mitsva muna 2016. Mitemo yacho yakanangana nevagadziri ve-e-fodya vakanga vane zvigadzirwa zvavo pamasherufu. mushure me 8 Nyamavhuvhu 2016, vachibvumidza kuti pane zvese "zvinofungidzirwa" zvigadzirwa zvefodya (kusanganisira nicotine gels, fodya, uye e-fodya) izvo zvinoenderana nerondedzero yeFDA yechigadzirwa "chitsva", vagadziri vaifanirwa kuendesa premarket mvumo kune FDA ichangoburwa 9 Gunyana 2020 kuti vaenderere mberi nemabasa avo. Pakazosvika Kukadzi 2021, 230 vaive vakatumira zvikumbiro yezvigadzirwa zve4.8 kuFDA kuti zvigadziriswe. Izvo zvishoma zvaidiwa kuti zvibvumirwe zvevaping zvigadzirwa zvaive izvo kushanda nesimba kuchengetedza hutano hwevanhu, iyo, maererano neFDA, inoshandura kuva nemimwe mitsva yefodya yakachengeteka.

Iyo FDA muna 2021 yakavimbisa kuvhura dhizaini yakanangana nechero ENDS zvigadzirwa zvevagadziri vakatadza kuendesa zvikumbiro zvavo. Kunyangwe kune vagadziri vanga vatumira pre-market chigadzirwa chefodya application (PMTA), hazvina chokwadi kana vachizowana mvumo kubva kuFDA. The FDA yakaramba Zvikumbiro zvinodarika zviuru makumi mashanu nezvishanu zvevagadziri vemichina yekupfungaira muna Nyamavhuvhu sezvo makambani asina kukwanisa kupa humbowo hweimwe nzira yefodya ine hutano. Ndiro raive mavambo ekuramba mirairo yekushambadzira (MDOs) mukati mechikamu chefodya yemagetsi: Iyo FDA yakapa chinyararire mirairo yekuramba kune vanopfuura mazana maviri nemakumi matanhatu e-e-fodya vanogadzira.

Dr. Hasmeena Kathuria, chiremba uye nyanzvi yekutsamira chikakananda kuBoston Medical Center, akataura kuti aiomerera kuti FDA haifanire kubvumidza zvigadzirwa zvefodya zvine mutowo, zvakaita sezvigadzirwa zvementhol kuti zvipiwe mvumo isati yatengeswa sezvo zvinonaka zvine basa guru mukupesvedzera vechidiki pakushandisa fodya. Chirevo cheFDA chakaratidza izvozvo inenge 85% yevadiki vemagetsi efodya vanofarira akanga ashandisa zvinwiwa zvechikakananda.

Kthuria akawedzera kuti kutevera njodzi yevechidiki pakusarudza nzira yekudzikisa njodzi kune fodya yemagetsi pakati pevakuru, chiyero chepamusoro chekushandisa e-cigarette pakati pevechidiki chinotsigira hurongwa hwekugadzirisa zvakanyanya. Kunyange zvazvo e-cigarettes yakawanikwa seimwe nzira yekusvuta, vanhu vose havashandisi fodya yemagetsi senzira yekurapa kurega kusvuta.  

Juul's MDO yanga isiri yekutanga kupihwa kune anogadzira e-fodya, asi nekuda kwemukurumbira wayo uye kubatana kune yakakura indasitiri yefodya, ingangove yakanyanya kukosha. Altria, muridzi wefodya yeMarlboro, akatenga 35% yeJuul shares muna 2018. Chibvumirano chacho chakasvika madhora mabhiriyoni gumi nemaviri. kukwidza kukosha kwaJuul kumadhora makumi matatu nemasere emadhora. Kukosheswa kwaJuul kwakawira kune zvinosiririsa madhora bhiriyoni 1.3 muna 2022, uye stock yeAltria ikozvino yangokosha chikamu chidiki chekudyara kwayo kwekutanga.

Tichitarisira kuongororwa kwakadzama kwekushandiswa kwekambani, FDA yakamisa MDO yezvigadzirwa zveJuul musi waChikunguru 5, 2022. Juul akati iyo FDA yakaita "zvinoshamisa uye zvisiri pamutemo" hunhu nekuramba 6,000-mapeji application yesainzi nehutano. -based data uye panzvimbo kurerekera kumanikidziro ezvamatongerwe enyika. Kunyange zvazvo chiri chokwadi kuti Dr. Robert Califf, mutungamiriri weFDA, akanga asati ambotaura chero mitemo yemitemo pamusoro pekugadzirisa e-cigarettes, haasiwo anoenderana nechikamu. MaDemocrat akakurudzira mitemo yakasimba yefodya uye vanopikisa e-fodya vanosanganisira Illinois Sen. Dick Durbin pamwe neRep. Raja Krishnamoorthi. Durbin akakurudzira Califf kusiya basa kana anga asina kugadzirira kukanganisa zvigadzirwa zvisiri pamutemo e-fodya mavhiki mashoma FDA isati yaedza kubvisa Juul pamusika, ichiti "Dr. Califf anotya zvakajeka hasha dzeBig Fodya kupfuura mutongo wenhau.

Kunyangwe ramangwana raJuul risina chokwadi, hazvina chokwadi kuti kurambidzwa kwacho kuchagara kwenguva yakareba. Pamusoro pe30 vape vagadziri vari kumhan'arira FDA nechikonzero chekuti maPMTA avo akarambwa nekuda kwezvikonzero "zvisinganzwisisike" uye "zvisina basa", zvisinei nenhoroondo refu yeFDA yekuramba nekukurumidza pre-market chigadzirwa chefodya (PMTAs). Munguva yakapfuura, pakambomhan'arwa, FDA yakapidigura danho rayo ndokubvumidza maPMTA maviri kumabhizinesi maviri akasiyana, ichiti vaive vawana "ruzivo rwakakosha rusina kuongororwa nenzira kwayo."

Nekudaro, nekuda kwekushaikwa kwedata renguva refu pamusoro pezvinogona kukuvadza hutano mhedzisiro, nyanzvi dzekurapa dzinoramba dzichipa zano pamusoro pekushandisa e-fodya. Nyangwe tsvakurudzo yenguva pfupi inoratidza kuti e-fodya inogona kubatsira kuputa kwehupenyu hwese kumira, hapana humbowo hwekuti zvigadzirwa hazvina chepfu pane yakajairika midzanga. Iyo FDA ichiripo isina kuvimbiswa chero e-fodya semubatsiri wekurega kusvuta. Sechiremba wemapapu, Kathuria akawedzera kuti, "Ndinogara ndichiraira varwere vangu kuti vasapinze zvinhu zvinopisa kana kupiswa mumapapu avo, kunyanya kana vatova nechirwere chemapapu. Ndinogara ndichiraira varwere vangu kuti vasiye kuputa uye kuputa.

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