I-Food & Drug Administration ikhombise ngokuqhubekayo izindlela zokuvimbela ukubhema nokusebenzisa i-nicotine phakathi kweminyaka engaphansi kweminyaka—ikakhulukazi ukuvinjelwa kuka-2020 kokunambitheka kwezithelo kwama-vapes kaJuul-nokho, imizamo yawo ayeke ngokwanele IJuul Labs evela embonini kanye nasekusatshalalisweni kwemishini yokukhipha umusi ngoJuni iyinkomba ecacile yezinga lokuzimisela kwabaphathi be-Biden ngokumelene nabakhiqizi bakagwayi we-elekthronikhi. Imikhiqizo yeJuul ingafinyelelwa njengamanje—a inkantolo yombuso ihoxisiwe ukuvinjelwa kwe-FDA ngosuku ngemuva kokumenyezelwa kwayo-kodwa impi ayisondeli esiphethweni sayo.
Akukhona okokuqala i-FDA iqondise emkhakheni kagwayi, futhi ekugcineni ibhizinisi likagwayi we-elekthronikhi. I-American Lung Association yenza umkhankaso womthetho wokulwa nokubhema ezifundazweni ngazinye phakathi kweminyaka yawo-1960 no-2000 kodwa yaphumelela empumelelweni embalwa nje kuCongress (phakathi kwazo okungumthetho wango-1989 owakwenza kwaba emthethweni ukubhema kuzo zonke izindiza zasekhaya). Imibiko yokuqala yesayensi phakathi neminyaka yawo-1950 eyabonisa ukuthi ukubhema ugwayi kwakuhlobene nomdlavuza kwabangela imifudlana emithathu yamacala kagwayi Omkhulu.
Abakhiqizi bakagwayi basinda ochungechungeni lwamacala okuqala ngokuphikisana ngempumelelo nesibopho sokukhiqiza nokumaketha budedengu; nokho, isigaba sesibili sasheshiswa ngokulalelwa kweNkantolo Ephakeme yomlando ka-1992 Cipollone v. Liggett. Leli cala labeka isibonelo esashukumisela abantu ukuba bavulele abakhiqizi bakagwayi amacala abasebenzisa izitatimende “ezingalungile” kanye “nokukhwabanisa” ukuze bakhangise ngemikhiqizo yabo, noma ababetshela amanga uquqaba ngemiphumela yezempilo yokubhema.
Igagasi lesithathu lamacala lanqoba kakhulu. Ngo-1998, kwasayinwa i-Master Settlement Agreement (MSA) phakathi kwabameli abangama-52 ezindaweni nasezifundeni kanye nabakhiqizi bakagwayi abakhulu abane e-United States—okwenze ukuthi ukuxazululwa kwamacala amakhulu kunawo wonke emlandweni wase-US Inhloso eyinhloko ye-MSA kwakuwukuhlenga izigidigidi zamarandi ezazichithiwe ekunakekeleni izifo eziphathelene nokubhema nokubhekana namacala amaningi ombuso. Futhi, isivumelwano saqinisekisa imithetho mayelana nezikhangiso zikagwayi futhi savimbela ukumaketha kubantu abangaphansi kweminyaka engu-18.
I-American Cancer Society (kanye noMnyango Wezobulungiswa wase-US kanye nabashushisi abahlukahlukene) yawina icala enkantolo lapho abakhiqizi bakagwayi abaphambili abayisishiyagalolunye bebekwe amacala okukhwabanisa nokudukisa ngamabomu umphakathi iminyaka eminingi mayelana nemithelela yezempilo yokubhema. Abasolwa - phakathi kwabo okuyizinkampani ezinkulu ezifana no-Altria noPhilip Morris - baphoqeleka ukuthi babelane izitatimende zokwelapha kuhlanganise nenani lokufa okubangelwa ukubhema ugwayi ngosuku kanye nonyaka kanye nokulutheka kwe-nicotine.
Ngokulandela uMthetho Wokulawula Ugwayi ka-2009, i-FDA yaqeda imithetho yokumaketha kanye inyuse izinga lentela kumaphakethe kagwayi, iba umzamo wokuqala ohlangene owenziwa isikhungo sikahulumeni sokugxilisa ukucutshungulwa okuqinile embonini kagwayi. Ihlonyiswe ngamandla okulawula ukukhiqizwa, ukuhlinzeka, kanye nokukhangisa kwemikhiqizo kagwayi, i-FDA yaqala ukuphatha lo mkhakha ngokufuna izinhlelo zokusebenza ze-premarket eziphelele kakhulu futhi idinga okufanelekile amalebula okuxwayisa ngemikhiqizo engenantuthu.
Ingxoxo emayelana nokubhema phakathi kwentsha ichukumise iningi lezinyathelo zombuso. Okutholwe yi-Tobacco Control Act, eyanyatheliswa ngesikhathi lapho iminyaka esemthethweni yokubhema yayineminyaka engu-18 nangaphezulu, yabonisa ukuthi cishe wonke umuntu osanda kubhema ungaphansi kweminyaka esemthethweni yokubhema. buy imikhiqizo. Ocwaningweni olwenziwa ngo-2013 ngosizo lweCenters for Disease Control and Prevention, kwatholakala ukuthi amathuba okuthi intsha engenazo idiploma yesikole samabanga aphezulu ingene ekubhemeni kunanoma yiliphi iqembu lobudala.
Ukuthuthukiswa nokusetshenziswa okusabalele kwezinhlelo zokulethwa kwe-nicotine zikagesi (ENDS) ezaziwa kangcono ngokuthi "i-vaping" noma "i-e-cigarettes" kubeka phambili isikhubekiso esengeziwe se-FDA. Ngo-2015, uJuul wangena emakethe futhi phakathi neminyaka emithathu yokuqala yokusebenza kwayo, ukuthengiswa kwayo kwakhuphuka ukuya ku-$1.969 billion ngo-2018 isuka ku-$260 million. Phakathi naleso sikhathi, kwakukhona ukuphakama ekubhemeni kwe-e-cigarette phakathi kwezingane kuya ku-20.8% ngo-2018 isuka ku-11.7%. Abazali abakhathazekile, ngo-2018, bamangalela uJuul ngokukhangisa imikhiqizo yakhe ngendlela eheha izingane, futhi uphenyo lwenziwa yi-FDA kuJuul kulandela ukumakethwa okungekho emthethweni kwemikhiqizo yayo eyethulwe esikhundleni sikagwayi. Ngo-2021, 2,339 amacala yayifakwe kuJuul ngokumaketha kwayo okudukisayo, kanye namacala ahlukahlukene abazali bentsha eyaba nezinkinga zamaphaphu ngenxa yokuphefumula umoya. I-FDA, ngoJuni, yaqhamuka nomyalelo wokwenqaba ukuthengisa owawucaphuna “idatha enganele nephikisanayo” yenkampani yemikhiqizo.
Ngokuzinzile ukwehla ekubhemeni phakathi kwabantu abadala e-US kusukela ngo-2005 (kufika ku-12.5% ngo-2020 kusuka ku-20.9%) kanye nezinga lokubhema phakathi kwentsha, ochwepheshe baye baqhubeka nokuxwayisa ngenani eliphezulu lamanje labantwana abancane abathintekayo ekuphefumuleni. Ukuhlola okwenziwa i-National Youth Tobacco kwembula ukuthi izinga lokusetshenziswa komkhiqizo kagwayi phakathi kwabafundi basesikoleni esiphakeme inqatshiwe yaya ku-25.6% ngo-2006 isuka ku-34.5% ngo-2000. Ngo-2021, izinga lehlile ku-13.4% wabafundi basesikoleni esiphakeme. Njengombiko we-FDA, I-7.6% yabafundi besikole esiphakathi nesesekondari kubikwe ukuthi basebenzisa ugwayi we-electronic ngaphezu kwanoma yimiphi eminye imikhiqizo kagwayi.
Ekuqaleni, ngenkathi uJuul elungiselela ukungena emakethe ngo-2015, i-FDA - emzamweni wokuqukatha ukwanda kokukhiqizwa kukagwayi we-elekthronikhi--yasungula imithetho emisha ngo-2016. Imithethonqubo yayiqondiswe kubakhiqizi be-e-cigarette ababenemikhiqizo yabo emashalofini. ngemuva komhla ziyisi-8 kuNcwaba wezi-2016, egunyaza ukuthi kuyo yonke imikhiqizo kagwayi “ethathwayo” (okuhlanganisa namajeli e-nicotine, ogwayi, nama-e-cigarette) ethobela incazelo ye-FDA yomkhiqizo “omusha”, abakhiqizi kwakudingeka ukuthi bahambise ukugunyazwa kwemakethe yangaphambili I-FDA yakamuva ngomhlaka-9 Septhemba 2020 ukuze iqhubeke nokusebenza kwayo. NgoFebhuwari 2021, babengu-230 izicelo ezifakiwe ngemikhiqizo engu-4.8 eya ku-FDA ukuze icutshungulwe. Isidingo esincane sokugunyazwa kwemikhiqizo eshisayo kwakuyi- ukusebenza kahle ukuvikela impilo yomphakathi, okusho ukuthi, ngokwe-FDA, okuhumushela ekubeni nezinye izindlela eziphephile zikagwayi.
I-FDA ngo-2021 yathembisa ukwethula uhlaka oluqondise noma yimiphi imikhiqizo ye-ENDS yabakhiqizi abahlulekile ukuhambisa izicelo zabo. Ngisho nakubakhiqizi ababethumele izicelo zomkhiqizo kagwayi wangaphambi kwemakethe (PMTA), akuqiniseki ukuthi bazokuthola yini ukugunyazwa okuvela ku-FDA. I I-FDA yenqaba izicelo zemikhiqizo engaphezu kuka-55,000 yemikhiqizo yabakhiqizi abathathu bemishini yokukhipha umoya ngo-Agasti njengoba izinkampani zingakwazi ukunikeza ubufakazi bezinye izindlela ezinempilo zogwayi. Leso kwakuyisiqalo se-marketing denial orders (MDOs) ngaphakathi komkhakha kagwayi we-elekthronikhi: I-FDA ilethe ngokuthula imiyalo yokuphika kubakhiqizi abangaphezu kuka-260 be-e-cigarette.
UDkt Hasmeena Kathuria, udokotela kanye nochwepheshe bokuxhomeka ku-nicotine e-Boston Medical Center, uthe wayemi kwelokuthi i-FDA akufanele igunyaze imikhiqizo kagwayi enongiwe, njengemikhiqizo ye-menthol ukuze igunyazwe ngaphambi kokumaketha njengoba ama-flavour adlala indima enkulu ekuthonyeni intsha ekusetshenzisweni kukagwayi. Umbiko we-FDA wabonisa lokho cishe ama-85% abantu abathanda ugwayi we-elekthronikhi abancane wayesebenzise imikhiqizo ye-nicotine enongiwe.
U-Kthuria wengeze ngokuthi ngemva kwenhlekelele yentsha lapho kunqunywa indlela yokunciphisa ubungozi ekubhemeni ugwayi we-elekthronikhi phakathi kwabantu abadala, izinga eliphezulu lokusebenzisa ugwayi we-elekthronikhi phakathi kwentsha lisekela uhlaka lokulawula olunemingcele kakhulu. Ngisho noma ugwayi we-elekthronikhi utholakale ungenye indlela yokubhema, umphakathi jikelele awusebenzisi ugwayi we-electronic njengendlela yokwelapha yokuyeka ukubhema.
I-MDO kaJuul bekungeyona eyokuqala eyanikezwa umenzi kagwayi we-elekthronikhi, kodwa ngenxa yodumo nokuxhumana kwayo nemboni enkulu kagwayi, cishe iyona ebaluleke kakhulu. U-Altria, umnikazi kagwayi waseMarlboro, uthenge amasheya angu-35% kaJuul ngo-2018. Isivumelwano sifinyelele ku-$ 12.8 billion, ikhuphule inani likaJuul ku-$38 billion. Inani likaJuul lehle laya ku-$1.3 billion edabukisayo ngo-2022, kanti isitoko sika-Altria manje sesizobiza ingxenye encane nje yokutshalwa kwezimali kwaso kwasekuqaleni.
Ngokulindele ukuhlolwa okuphelele kwesicelo senkampani, i-FDA imise ngokusemthethweni i-MDO yemikhiqizo kaJuul ngoJulayi 5, 2022. UJuul wathi i-FDA izibandakanya ekuziphatheni "okungajwayelekile nokuphambene nomthetho" ngokwenqaba isicelo samakhasi ayi-6,000 sesayensi nempilo. idatha esekelwe futhi esikhundleni salokho ukukhothamela ingcindezi yezombangazwe. Nakuba kuyiqiniso ukuthi uDkt. Robert Califf, umqondisi we-FDA, wayengakaze aphakamise noma yiziphi iziqondiso zenqubomgomo ekulawuleni ugwayi we-elekthronikhi, naye akahambisani nomkhakha. Amademokhrasi amele imithetho eqinile kagwayi futhi amelene nogwayi we-elekthronikhi ahlanganisa iSen. Dick Durbin yase-Illinois kanye noRep. Raja Krishnamoorthi. Durban wanxusa UCaliff uzosula esikhundleni uma wayengakakulungeli ukwephula imikhiqizo kagwayi engekho emthethweni emasontweni ambalwa ngaphambi kokuba i-FDA izame ukususa uJuul emakethe, ithi “uDkt. Ngokusobala uCaliff wesaba intukuthelo yeBig Tobacco ngaphezu kwesinqumo somlando.”
Yize ikusasa likaJuul lingaqinisekile, kuyangabazeka ukuthi ukwenqatshelwa kuzohlala isikhathi eside. Bangaphezu kuka-30 abakhiqizi be-vape bamangalela i-FDA ngezizathu zokuthi ama-PMTA abo enqatshiwe ngenxa yezizathu “ezingenangqondo” kanye “ezingenangqondo,” naphezu komlando omude we-FDA wokwenqaba ngokushesha izicelo zomkhiqizo kagwayi wangaphambi kwemakethe (PMTAs). Esikhathini esedlule, lapho kufakwa amacala, i-FDA yasichitha isinqumo sayo futhi yagunyaza ama-PMTA amabili amabhizinisi amabili ahlukene, ithi bathole “ulwazi olubalulekile olungahlolisiswanga ngokufanelekile.”
Kodwa-ke, ngenxa yokuntuleka kwedatha yesikhathi eside emiphumeleni yezempilo engaba yingozi, ochwepheshe bezokwelapha bayaqhubeka nokweluleka ngokumelene nokusebenzisa i-e-cigarettes. Nakuba ucwaningo lwesikhashana iphakamisa ukuthi i-e-cigarettes ingasiza ababhemayo impilo yonke ukuba bayeke, abukho ubufakazi obuqand' ikhanda bokuthi imikhiqizo ayinabo ubuthi obuncane kunogwayi ovamile. I-FDA isekhona akuqinisekisiwe noma yimuphi ugwayi we-e njengosizo lokuyeka ukubhema. Njengodokotela wamaphaphu, uKathuria wanezela, “Ngihlale ngeluleka iziguli zami ngokumelene nokuhogela amaphaphu izinto ezishisayo noma ezishile, ikakhulukazi uma sezivele zinesifo samaphaphu esicashile. Ngihlale ngeluleka iziguli zami ukuthi ziyeke ukubhema nokushunqisa.
