Ngesikhathi Sokubuyekezwa kwe-PMTA, i-Food and Drug Administration (FDA) ikhiphe incwadi ethi “Refuse to File” eya ku-JD Nova Group, okuyinkampani engumzali yomkhiqizo. I-Vapolocity, ngo-August 9. Lokhu kungenxa yokuntuleka kwemibiko edingekayo ye-Environmental Assessment (EA) ezicelweni eziyizigidi ezi-4.5 ezifakwe yile nkampani. Ngokushesha i-ejensi yanquma ukuthi imikhiqizo efanele kufanele ikhishwe emakethe.
Okokuqala isicelo somkhiqizo kagwayi wemakethe (PMTA) okugunyazwe yi-FDA kubuyele emuva ku-2015, lapho imikhiqizo eminingana ye-snus yezinkampani eziyisishiyagalombili zase-Swedish igunyazwe ukuthi ithengiswe e-US Eminyakeni yamuva nje, i-FDA yelulele ukulawula kwayo okuqinile emikhiqizweni ye-nicotine embonini yokukhipha umphunga.
Lokho kubangelwa ukukhathazeka okwandayo ngemithelela engemihle ye-nicotine ebuchosheni bezingane obukhulayo, kanye nengozi yayo yokwandisa ukuba sengozini kwezingane entweni enjalo eluthayo. Njengoba i-FDA isho, izinyathelo zayo zibalulekile ekuvikeleni “intsha ekuphileni okungaba umlutha we-nicotine.”
Ngonyaka odlule, i-FDA yayala ukuthi bonke abakhiqizi be-vaping balethe ama-PTMA emikhiqizo yabo ngaphambi kukaSepthemba 9, 2020. Uma kungenjalo, kufanele bakhiphe yonke imikhiqizo emakethe. I-FDA ibuyekeza izicelo ngezinyathelo ezine:
Okokuqala, i-FDA yenza isheke lokuthi izicelo ezithunyelwe ziza ziphelele yini nezinto ezidingekayo;
Okwesibili, i-ejensi ifaka izicelo ezifaka ezintweni ezidingekayo;
Okwesithathu, i-FDA iqala ukubuyekezwa okuqinile kwezicelo ezifakiwe;
Ekugcineni, ikhipha uhlu lwezicelo ezigunyaziwe.
Inqubo yokubuyekeza ye-FDA ekuqaleni yayihlelelwe ukuthi ivalwe ngoSepthemba 9, 2021, okuthathe unyaka owodwa impela. Nokho, kungase kube noshintsho lwepulani. Ngokusho kokuthunyelwe yi-FDA ngoMeyi 2021, le nhlangano yathola izicelo ezingaphezu kwezigidi eziyisi-6.
Ngomnqamulajuqu onjalo, abasebenzi be-FDA bakholelwa ukuthi "amathuba okuthi i-FDA ibuyekeze zonke izicelo ezitholwe ngoSepthemba 9, 2021, aphansi kakhulu." I-ejensi icabanga ngokusebenzisa ukuqonda kwayo ukuze inwebe isikhathi sokubuyekeza.
Abanye abakhiqizi be-vaping nabahlinzeki bahlezi phezu kwezikhonkwane nezinaliti. Ngaphandle kwezicelo ze-JD Nova eziyizigidi ezi-4.5, kunezinye izigidi ezi-2 ezivela ezinkampanini ezingenakubalwa ze-vape ezikleliswe ukuzobuyekezwa. Phambilini i-FDA inqume ukuthi uma isicelo singafakwanga ngoSepthemba 9 nonyaka, kuzothathwa njengokungekho emthethweni ukumaketha noma ukuthengisa umkhiqizo othintekayo.
Kuze kube manje izincwadi “zokugcwalisa” zale nhlangano sezithunyelwe kuphela kwabanye babakhiqizi, izicelo zabo ezihlanganisa imikhiqizo ye-vape eyi-138,000 sezizonke. Lokho kusho ukuthi lezi zinhlelo zokusebenza sezizongena esigabeni esilandelayo "sokubuyekeza okuqinile". Kodwa-ke, awukho nowodwa umkhiqizo we-vaping othole ukugunyazwa kokugcina kwe-FDA.
Kusasele isikhathi esingaphansi kwenyanga eyodwa ngaphambi kukaSepthemba 9. Kodwa kumafemu e-vape angezwa lutho ku-FDA, isikhathi esinzima sezulu.
