FDA Mwachidule: A FDA Achenjeza Makampani Kuti Apitilize Kugulitsa Zafodya Za E-fodya Pambuyo Bungwe Lakana Zilolezo

“A FDA ndiwo ali ndi udindo wowonetsetsa kuti fodya watsopano akutsatiridwa ndi ndondomeko yoyenera kuti adziwe ngati akukwaniritsa mfundo za umoyo wa anthu asanagulitsidwe.Ngati chinthu sichikukwaniritsa mulingo womwewo ndiye kuti bungweli limapereka lamulo lokana kutsatsa.Ndizosaloledwa kugulitsa fodya watsopano ku United States yemwe alibe chilolezo chotsatsa kuchokera ku FDA.

Chimodzi mwazinthu zofunika kwambiri zomwe timayika patsogolo ndikuwonetsetsa kuti opanga aziyankha mlandu pakugulitsa fodya wosaloledwa.Zomwe zachitika lero zikuwonetsa kuti tikuyika patsogolo kulimbikitsa anthu opanga fodya omwe adalandirapo zoyipa pakugwiritsa ntchito kwawo, monga Marketing Denial Order kapena Refuse to File notification ndikupitilizabe kugulitsa zinthu zosaloledwa, komanso zinthu zomwe opanga adalephera. kutumiza ntchito yotsatsa.

Ndi udindo wathu kuwonetsetsa kuti opanga fodya akutsatira malamulo oteteza thanzi la anthu ndipo tipitiliza kuyimba mlandu makampani ophwanya malamulo.”

Zina Zowonjezera

● Masiku ano, bungwe la US Food and Drug Administration lapereka makalata ochenjeza makampani 20 kuti apitirizebe kugulitsa mopanda lamulo zinthu za electronic nicotine delivery system (ENDS) zomwe zimatchedwa Marketing Denial Orders (MDOs).Awa ndi makalata ochenjeza oyambilira kuperekedwa kwa zinthu zomwe zikutsatiridwa ndi MDO pazantchito zawo zogulira fodya (PMTAs).

● A FDA adaperekanso makalata ochenjeza lero za malonda oletsedwa a fodya ku kampani imodzi yomwe inalandira zigamulo za Refuse to File (RTF) pa PMTA yawo, kampani imodzi yomwe inalandira zigamulo za RTF ndi MDO pa PMTA yawo, ndi makampani asanu ndi limodzi omwe sanapereke. mapulogalamu aliwonse amsika.

● Onse pamodzi, makampani 28 ameneŵa atchula zinthu zonse zopitirira 600,000 pamodzi ndi FDA.

● Pofika pa Seputembara 23, a FDA apereka chiwerengero cha 323 MDOs, zomwe zimapanga zoposa 1,167,000 zopangidwa ndi ENDS zokometsera.

● A FDA apitiriza kuika patsogolo zokakamiza makampani amene amagulitsa zinthu za ENDS popanda chilolezo chofunidwa—makamaka mankhwala amene achinyamata angathe kuzigwiritsa ntchito kapena angoyamba kumene.