I-FDA Ivumela Ukumakethwa Kwemikhiqizo Emisha Kagwayi Omlomo ngokusebenzisa Indlela Yokufaka Isicelo Somkhiqizo Wokumakethe Kagwayi

I-Data Show Intsha, Abangabhemi, kanye Nabake Ababhema Makwenzeke Ukuba Baqalise Noma Baphinde Baphinde Basebenzise Ugwayi Ngale Mikhiqizo.

Namuhla, i-US Food and Drug Administration imemezele ukuthi igunyaze ukuthengiswa kwemikhiqizo emisha kagwayi omlomo ekhiqizwa yi-US Smokeless Tobacco Company LLC ngaphansi kwegama lomkhiqizo elithi Verve.Ngokusekelwe ekubuyekezweni okuphelele kwe-FDA kobufakazi besayensi obutholakalayo kuzicelo zomkhiqizo kagwayi wemakethe yemakethe (PMTAs), i-ejensi inqume ukuthi ukumakethwa kwale mikhiqizo kuzohambisana nezinga elisemthethweni, “elifanele ukuvikelwa kwezempilo yomphakathi.”Lokhu kufaka phakathi ukubuyekezwa kwedatha ebonisa ukuthi intsha, abangabhemi kanye nalabo ababekade bebhema mancane amathuba okuba baqalise noma baphinde baqalise ukusetshenziswa kukagwayi ngale mikhiqizo.Imikhiqizo emine yilena: I-Verve Discs Blue Mint, i-Verve Discs Green Mint, i-Verve Chews Blue Mint, kanye ne-Verve Chews Green Mint.

“Ukuqinisekisa ukuthi imikhiqizo emisha kagwayi ihlolwa ngokuqinile yi-FDA kuyingxenye ebalulekile yenjongo yethu yokuvikela umphakathi—ikakhulukazi izingane.Yize lena kuyimikhiqizo enambitheka ye-mint, idatha ethunyelwe ku-FDA ikhombisa ubungozi bokuthi intsha ithole le mikhiqizo iphansi, futhi imikhawulo eqinile yokuthengisa izosiza ukuvikela ukuchayeka kwentsha,” kusho uMitch Zeller, JD, umqondisi weSikhungo Semikhiqizo Kagwayi se-FDA. ."Okubalulekile, ubufakazi bubonisa ukuthi le mikhiqizo ingasiza abantu ababhemayo abasebenzisa imikhiqizo eyingozi kakhulu ukuba bashintshele emkhiqizweni onamakhemikhali angaba yingozi ambalwa."

Imikhiqizo ye-Verve imikhiqizo kagwayi ngomlomo equkethe i-nicotine etholakala kugwayi, kodwa ayinawo ugwayi osikiwe, ogayiwe, oyimpuphu noma wamaqabunga.Yonke imikhiqizo emine iyahlafunwa bese ilahlwa, kunokuba igwinywe, uma umsebenzisi eseqedile ngomkhiqizo.Ama-disc nama-chews ahluka ngokwengxenye ngokuthungwa kwawo.Zombili ziyaguquguquka, kodwa ama-disc aqinile, futhi okuhlafunwayo kuthambile.Le mikhiqizo yenzelwe abasebenzisi bakagwayi abadala.

Ngaphambi kokugunyaza imikhiqizo emisha kagwayi ngendlela ye-PMTA, i-FDA kufanele, ngokomthetho, icabangele, phakathi kwezinye izinto, amathuba okuthi abasebenzisi bakagwayi bamanje bayeke ukusebenzisa imikhiqizo kagwayi kanye namathuba okuthi abangawusebenzisi baqale ukusebenzisa imikhiqizo kagwayi.Ucwaningo lubonisa amathuba amancane okuthi intsha, abangabhemi, noma ababekade bebhema bangaqala noma baqalise kabusha ukusetshenziswa kukagwayi ngemikhiqizo ye-Verve.Abasebenzisi bamanje bemikhiqizo ye-Verve kanye nabasebenzisi abashintshela ngokuphelele emikhiqizweni ye-Verve ngokuvamile bachayeka ezintweni ezimbalwa eziyingozi nezingase zibe yingozi uma kuqhathaniswa nogwayi neminye imikhiqizo kagwayi ongenantuthu.I-ejensi ithumele isifinyezo sesinqumo esiqhubeka sichaza isisekelo sokukhipha ama-oda okuthengisa ale mikhiqizo emine.

Izigunyazo zokuthengisa ezikhishwe namuhla zivumela imikhiqizo emine kagwayi ukuthi ithengiswe ngokusemthethweni noma isatshalaliswe e-United States, kodwa akusho ukuthi imikhiqizo iphephile noma “igunyazwe yi-FDA,” njengoba ingekho imikhiqizo kagwayi ephephile.

Ukwengeza, i-FDA ibeka imingcele eqinile yokuthi imikhiqizo ye-Verve imakethwa kanjani, okuhlanganisa namawebhusayithi kanye nezinkundla zokuxhumana, ukusiza ukuqinisekisa ukuthi ukumaketha kuqondiswe kubantu abadala kuphela.I-FDA izohlola idatha entsha etholakalayo mayelana nemikhiqizo ngokusebenzisa amarekhodi okuthengisa ngeposi nemibiko edingekayo kuhlelo lokumaketha.Inkampani idingeka ukuthi ibike njalo ku-FDA ngolwazi oluphathelene nemikhiqizo emakethe, okuhlanganisa, kodwa kungagcini lapho, izifundo zocwaningo lwabathengi eziqhubekayo neziqediwe, ukukhangisa, izinhlelo zokumaketha, idatha yokuthengisa, ulwazi lwabasebenzisi bamanje nabasha, izinguquko zokukhiqiza. kanye nezimo ezimbi.

I-FDA izohoxisa i-oda lokumaketha uma inquma ukuthi ukuqhubeka ukumakethwa komkhiqizo akusafanele ukuvikela impilo yomphakathi, isibonelo, ngenxa yokuthathwa okubalulekile komkhiqizo yintsha.

I-ejensi iyaqhubeka nokubuyekeza imakethe yezinkulungwane zezicelo zomkhiqizo kagwayi futhi isazimisele ukuxhumana nomphakathi mayelana nenqubekelaphambili, okuhlanganisa nokukhishwa kwama-oda okuphikiswa kokumakethwa kwemikhiqizo kagwayi enothosiwe engaphezu kwesigidi engenabo ubufakazi obanele bokuthi inenzuzo. kubantu abadala ababhemayo okwanele ukunqoba ukukhathazeka kwezempilo komphakathi okubangelwa ukunxusa okubhaliwe kanye nokukhulu kwemikhiqizo enjalo entsheni.