I-FDA Kafushane: I-FDA Ixwayisa Amafemu Ngokuqhubeka Nokumaketha Imikhiqizo kagwayi we-E Ngemuva Kokunqatshwa Kwezigunyazo

“I-FDA inomthwalo wemfanelo wokuqinisekisa ukuthi imikhiqizo emisha kagwayi ifakwa ohlelweni olufanele lokubuyekezwa kwemithetho ukuze inqume ukuthi iyahlangabezana yini nezindinganiso zomthetho wezempilo yomphakathi ngaphambi kokuba idayiswe.Uma umkhiqizo ungahlangabezani nezinga elithile i-ejensi ikhipha umyalo owenqaba isicelo sokumaketha.Akukho emthethweni ukumaketha umkhiqizo omusha kagwayi e-United States ongenakho ukugunyazwa kokumaketha okuvela ku-FDA.

Okunye esikubeke eqhulwini wukuqinisekisa ukuthi abakhiqizi banesibopho sokumaketha imikhiqizo kagwayi engagunyaziwe.Isenzo sanamuhla sibonisa ukuthi sibeka phambili ukuphoqelelwa kwabakhiqizi bomkhiqizo kagwayi abathole isenzo esibi esicelweni sabo, esifana ne-Marketing Denial Order noma isaziso se-Refuse to File futhi baqhubeke nokuthengisa leyo mikhiqizo engagunyaziwe ngokungemthetho, kanye nemikhiqizo abakhiqizi abahlulekile ngenxa yayo. ukuhambisa isicelo sokumaketha.

Kungumthwalo wethu ukwenza isiqiniseko sokuthi abakhiqizi bemikhiqizo kagwayi bayahambisana nomthetho ukuze bavikele impilo yomphakathi futhi sizoqhubeka nokubamba izinkampani ukuthi ziphendule ngokwephula umthetho.”

Ulwazi Olwengeziwe

● Namuhla, i-US Food and Drug Administration ikhiphe izincwadi zesexwayiso eziya ezinkampanini ezingu-20 ngokuqhubeka nokudayisa ngokungemthetho imikhiqizo ye-electronic nicotine delivery system (ENDS) okusihloko se-Marketing Denial Orders (MDOs).Lezi yizincwadi zokuqala eziyisixwayiso ezikhishelwe imikhiqizo engaphansi kwezinqumo ze-MDO ezicelweni zabo zomkhiqizo kagwayi osemakethe (PMTAs).

● I-FDA iphinde yakhipha izincwadi eziyisixwayiso namuhla zokumakethwa okungekho emthethweni kwemikhiqizo kagwayi enkampanini eyodwa ethole izinqumo ze-Refuse to File (RTF) ku-PMTA yayo, inkampani eyodwa ethole izinqumo ze-RTF ne-MDO ku-PMTA yazo, kanye nezinkampani eziyisithupha ezingazange zithumele. noma yiziphi izinhlelo zokusebenza ze-premarket.

● Sekukonke, lezi zinkampani ezingama-28 zibhale isamba esihlanganisiwe semikhiqizo engaphezu kuka-600,000 ne-FDA.

● Kusukela ngomhla ka-Sept. 23, i-FDA ikhiphe inani lama-MDO angu-323, okubalelwa ngaphezu kwemikhiqizo engu-1,167,000 ye-ENDS enongiwe.

● I-FDA izoqhubeka nokubeka phambili ukuphoqelela ukusetshenziswa kwezinkampani ezimaketha imikhiqizo ye-ENDS ngaphandle kokugunyazwa okudingekayo–ikakhulukazi leyo mikhiqizo okungenzeka isetshenziswe intsha noma iqale ukusetshenziswa.