I-FDA ngokufutshane: I-FDA ilumkisa iifemu ngokuQhubekeka nokuthengisa iimveliso ze-E-cigarette emva kokuba i-Arhente Yaliwe Ugunyaziso.

“I-FDA inoxanduva lokuqinisekisa ukuba iimveliso zecuba ezitsha zifakwa kwinkqubo efanelekileyo yolawulo lokujonga ukuba ziyayifezekisa na imigangatho yezempilo yoluntu yomthetho phambi kokuba zithengiswe.Ukuba imveliso ayihambelani nomgangatho othile ngoko i-arhente ikhupha umyalelo wokukhanyela isicelo sokuthengisa.Akukho mthethweni ukuthengisa imveliso entsha yecuba eUnited States engenasigunyaziso sentengiso esivela kwi-FDA.

Enye yezinto zethu eziphambili ngokubaluleka kukuqinisekisa ukuba abavelisi banoxanduva lokuthengisa iimveliso zecuba ezingagunyaziswanga.Inyathelo lanamhlanje libonisa ukuba sibeka phambili ukunyanzeliswa ngokuchasene nabavelisi bemveliso yecuba abafumene isenzo esingalunganga kwisicelo sabo, esifana noMyalelo woKwala ukuThengiswa okanye ukwala ukuFayila isaziso kwaye siqhubeke nokuthengisa ngokungekho mthethweni ezo mveliso zingagunyaziswanga, kunye neemveliso abasileleyo kuzo abavelisi. ukungenisa isicelo sokuthengisa.

Luxanduva lwethu ukuqinisekisa ukuba abenzi bemveliso yecuba bayawuthobela umthetho wokukhusela impilo yoluntu kwaye siza kuqhubeka sibeka iinkampani uxanduva ngokwaphula umthetho.”

Iinkcukacha ezongezelelweyo

● Namhlanje, i-US Food and Drug Administration ikhuphe iileta ezilumkisayo kwiinkampani ezingama-20 ngokuqhubeka nokuthengisa ngokungekho mthethweni i-electronic nicotine delivery system (ENDS) iimveliso ezinomxholo weMarketing Denial Orders (MDOs).Ezi ziileta zokuqala ezilumkisayo ezikhutshelwe iimveliso ezixhomekeke kumiselo lwe-MDO kwizicelo zazo zemveliso yecuba yentengiso (PMTAs).

● I-FDA iphinde yakhupha iileta ezilumkisayo namhlanje malunga nokuthengiswa ngokungekho mthethweni kweemveliso zecuba kwinkampani enye ethe yafumana iRefuse to File (RTF) umiselo kwi-PMTA yayo, inkampani enye eyafumana umiselo lwe-RTF kunye ne-MDO kwi-PMTA yazo, kunye neenkampani ezintandathu ezingazange zingenise. naziphi na izicelo zentengiso.

● Ngokudibeneyo, ezi nkampani zingama-28 zidwelise isimbuku esidityanisiweyo seemveliso ezingaphezu kwama-600,000 kunye ne-FDA.

● Ukususela ngoSeptemba 23, i-FDA ikhuphe inani elipheleleyo le-MDO ye-323, ibala ngaphezu kwe-1,167,000 yeemveliso ze-ENDS ezikhethiweyo.

● I-FDA iya kuqhubeka ukubeka phambili ukunyanzeliswa ngokuchasene neenkampani ezithengisa iimveliso ze-ENDS ngaphandle kogunyaziso olufunekayo-ingakumbi ezo mveliso ezinokubakho zokusetyenziswa okanye ukuqaliswa kolutsha.