Laba ugwayi wokuqala oshisiwe ozogunyazwa njengama-MRTP kanye nemikhiqizo kagwayi yesibili iyonke ukuthola ama-oda "wokuguqulwa kokuchayeka", okubavumela ukuthi bakhangiswe njengezinezinga elincishisiwe, noma ezethulwe ukuchayeka okuncishisiwe, entweni.
“Inhloso yethu wukuthola izindlela zokunqanda izifo nokufa okuhlobene nogwayi. Siyazi ukuthi abantu abadala abathathu kwabane ababhemayo bafuna ukuyeka futhi idatha ekule mikhiqizo ibonisa ukuthi ingasiza abantu abadala ababhemayo abayimilutha ukuthi baguquke bahlukane nogwayi oshiswa umlutha kakhulu,” kusho uMitch Zeller, JD, umqondisi we-FDA's Center for Tobacco Products. “Ukuba nezinketho ezifana nale mikhiqizo ezigunyaziwe namuhla, ezine-nicotine encane futhi okungenzeka zinciphise ukuncika ku-nicotine, kungase kusize abantu abadala ababhemayo. Ukube abantu abadala ababhemayo bebengalutheki kangako ugwayi ovuthayo, bebengabhema kancane futhi bangase bachayeke kumakhemikhali ayingozi abangela izifo nokufa okuhlobene nogwayi.”
Imiyalo yokuguqulwa kokuchayeka igunyaza ngokukhethekile umenzi ukuthi amakethe i-“VLN King” kanye ne-“VLN Menthol King” ngezimangalo ezithile ezincishisiwe zokuchayeka eziphathelene ne-nicotine, okuhlanganisa:
• “I-nicotine engaphansi ngo-95%.
• “Isiza ukunciphisa ukusetshenziswa kwakho kwe-nicotine.”
• “…Yehlisa kakhulu ukusetshenziswa kwakho kwe-nicotine.”
Uma usebenzisa noma yiziphi izimangalo zokuchayeka ezincishisiwe kulebula yomkhiqizo, ilebula noma ukukhangisa, inkampani kufanele ifake, "Ikusiza ukuthi ungabhemi kancane." I-FDA iphinde income ukuthi ukulebula nokukhangisa kufake isitatimende, “I-Nicotine iyalutha. Ukuncipha kwe-nicotine AKUSHO ukuphepha. Wonke ugwayi ungadala izifo nokufa.” Umkhiqizi futhi kudingeka alebule amaphakheji ngesisodwa sezitatimende ezine eziyisixwayiso ngogwayi njengoba kudingwa yi-Federal Cigarette Labeling and Advertising Act; isibonelo, “Isexwayiso sikaDokotela Jikelele Ohlinzayo: Ukubhema Kubangela Umdlavuza Wamaphaphu, Isifo Senhliziyo, I-Emphysema, Futhi Kungase Kube Nkimbi Ukukhulelwa.”
Ngaphandle kwesenzo sanamuhla, le mikhiqizo ayithathwa njengephephile noma “igunyaziwe yi-FDA.” Ayikho imikhiqizo kagwayi ephephile, ngakho abantu, ikakhulukazi intsha, okwamanje abangayisebenzisi imikhiqizo kagwayi akufanele baqale ukuyisebenzisa noma yimuphi omunye umkhiqizo kagwayi. Imiyalo yokuguqulwa kokuchayeka ayivumeli inkampani ukuthi yenze noma yiziphi izimangalo eziguquliwe zengcuphe noma iziphi izitatimende ezicacile noma ezishiwoyo eziveza noma ezingadukisa abathengi ekukholweni ukuthi imikhiqizo ivunyelwe noma ivunyelwe yi-FDA, noma ukuthi i-FDA ibona imikhiqizo njengefanele. iphephile ukusetshenziswa ngabathengi. Lawa ma-oda awavumeli inkampani ukuthi imakethe le mikhiqizo ngezimangalo zokwelapha noma zokuyekwa.
Ekubuyekezweni kwezicelo ze-MRTP ze-22nd Century Group, Inc., i-FDA yahlola idatha evela kukho kokubili inkampani kanye nokuhlolwa kwe-FDA yathola ukuthi amazinga e-nicotine kugwayi kanye nentuthu evamile kagwayi we-VLN angaphansi okungenani ngama-96% kuneningi elidayiswayo. nezinhlobo zikagwayi ezijwayelekile ezihamba phambili ezimakethe.
Ngaphezu kwalokho, ukubuyekezwa kwe-FDA kokuziphatha kanye nesayensi yemithi yathola ukuthi ngokubhema ngokukhethekile ugwayi onokuqukethwe kwe-nicotine okwehlisiwe okufanayo noma okufanayo njengogwayi we-VLN, abathengi banganciphisa ukuchayeka kwabo ku-nicotine cishe ngama-95%. Idatha iphinde yabonisa ukuthi kungenzeka ukuthi ukusebenzisa le mikhiqizo kunciphisa ukuncika ku-nicotine, okulindeleke ukuthi kuholele ekwehliseni isikhathi eside kokuchayeka kutshwala obuhlobene nokubhema obuhambisana nokugula nokufa ngokunciphisa ukubhema. Ucwaningo olushicilelwe lubonise ukuthi ukunciphisa kakhulu inani likagwayi ababhemayo ngosuku kuhlotshaniswa nengozi ephansi yomdlavuza wamaphaphu nokufa, nokuncipha okukhulu kukagwayi ngosuku okuholela engozini encane. Ukwengeza, njengoba kudingekile ukuze kugunyazwe, i-FDA ithole ukuthi izinhlelo zokusebenza zisekela ukuqonda kwabathengi kwezimangalo zokuthi ugwayi we-VLN unamazinga aphansi kakhulu e-nicotine kunabanye ugwayi.
Ukugunyazwa kwale mikhiqizo kudinga ukuthi inkampani yenze ukubhekwa kwemakethe yangemuva kanye nezifundo ukuze inqume ukuthi imibandela yokugunyazwa yale miyalo yokuguqulwa kokuchayeka iyaqhubeka nokuhlangabezwana nayo, okuhlanganisa nokuhlola ukusetshenziswa phakathi kwentsha.
Le mikhiqizo futhi ingaphansi kwezidingo ze-postmarket kanye nemikhawulo eyabekwa ngaphambilini kuma-oda ayo okuthengiswa komkhiqizo kagwayi wasemakethe kaDisemba 2019. Ikakhulukazi, ukukhawulela ukufinyelela kwentsha emikhiqizweni kanye nokunciphisa ukuchayeka kwentsha ekukhangiseni nasekukhuthazeni, ukukhangisa okunikezwe ama-oda kwabeka imingcele eqinile yokuthi imikhiqizo imakethwa kanjani—ikakhulukazi ngamawebhusayithi kanye nezinkundla zokuxhumana—ngokuhlanganisa izimfuneko zokuthi ukukhangisa kuqondiswe. kubantu abadala abaneminyaka esemthethweni ukuthenga imikhiqizo kagwayi.
Inkampani kufanele icele futhi ithole ukugunyazwa okuvela ku-FDA ukuze iqhubeke imaketha imikhiqizo ngolwazi olufanayo lokuchayeka oluguquliwe ngemva kokuphelelwa yisikhathi kwama-oda okuqala okuguqulwa kokuchayeka eminyakeni emihlanu. I-FDA futhi ingase ihoxise eyokuqala, nanoma yimiphi imiyalo engase ibe khona, yokuguqulwa kokuchayeka uma i-ejensi inquma ukuthi, phakathi kwezinye izinto, imiyalo ayisalindelekile ukuthi izuzise impilo yabantu bebonke; isibonelo, ngenxa yokusetshenziswa kwemikhiqizo yintsha noma ababekade bebhema, noma ukwehla kwenani lababhemayo abashintsha ngokuphelele emikhiqizweni.
Ekufinyeleleni ukuzimisela kwanamuhla, i-FDA icabangele kokubili isimo samanje esisemthethweni sikagwayi we-menthol kanye nesayensi etholakalayo ebonisa ukuthi le mikhiqizo ethile ingasiza ababhemayo abayimilutha banciphise ukusetshenziswa kwabo kwe-nicotine kanye nenani likagwayi abawubhemayo ngosuku. I-FDA izibophezele ekuqhubekeleni phambili nenqubo yokwenza umthetho yokuvimbela i-menthol njengesinambitheki esiphawulekayo kugwayi kanye nakho konke ukunambitheka okunezimpawu zikagwayi futhi isalokhu isendleleni yokukhipha imithetho ehlongozwayo entwasahlobo ka-2022.
