Za FDA
"Congress idapatsa FDA mphamvu zowongolera fodya pogwiritsa ntchito uyang'aniro wa sayansi kuti atetezere anthu ku zotsatira zoyipa za kusuta fodya," adatero Woyang'anira Commissioner wa FDA Janet Woodcock."Kuwonetsetsa kuti fodya watsopano akuwunikidwa ndi FDA ndi gawo lofunika kwambiri la cholinga chathu chochepetsera matenda okhudzana ndi fodya ndi imfa. Tikudziwa kuti fodya wokometsera amakopa kwambiri achinyamata, kotero kuwunika zotsatira za kusuta fodya kapena kusuta kwenikweni pa fodya. achinyamata ndiye chinthu chofunikira kwambiri pozindikira kuti ndi zinthu ziti zomwe zingagulitsidwe.
Izi zikuwonetsa kupita patsogolo kwakukulu pakulandila chiwerengero chomwe sichinachitikepo tsiku lomaliza la Seputembara 9, 2020 lidalamula khothi kuti alembe zofunsira zomwe amapeza kuti ndizogulitsa fodya watsopano, komanso tsiku lomaliza loti achinyamata agwiritse ntchito zokometsera.
A FDA alandila zopempha kuchokera kumakampani opitilira 500 omwe amagulitsa fodya wopitilira 6.5 miliyoni.Ngakhale bungweli lidaperekanso zoyipa zina pamapulogalamu ena, iyi ndi gulu loyamba la Mdos lomwe FDA idapereka pazofunsira zomwe zimakwaniritsa gawo lowunika lasayansi pakuwunikanso kwa msika.Bungweli ladzipereka kusintha msika wapano kupita kumsika komwe zinthu zonse za ENDS zomwe zimagulitsidwa zikuwonetsedwa kuti ndi "zoyenera kuteteza thanzi la anthu".
Pa Ogasiti 27, a FDA adalengeza kuti idakana zofunsira 55,000 za fodya wamba (PMTAS) kuchokera kwa opanga atatu ang'onoang'ono a e-fodya chifukwa adalephera kupereka umboni woti amateteza thanzi la anthu.
A FDA adalandira ~ 6.5 miliyoni zofunsira PMTA za ndudu za e-fodya pofika tsiku lomaliza la Seputembara 9, kusiya ~ 2 miliyoni zofunsira osalengezedwa, kupatula ~ 4.5 miliyoni zofunsira (JD Nova Group LLC) zomwe zidadziwitsidwa kale kuti sizinakwaniritse zofunikira.Ndi mapempho 55, 000 akanidwa nthawi ino, osakwana 1.95 miliyoni amakhalabe osalengezedwa.Kuonjezera apo, zochita za FDA zimasonyeza kuti sizingavomereze mafuta amtundu wa e-fodya omwe amakoma osati fodya.Patatsala milungu iwiri kuti nthawi yachisomo ithe pa Seputembara 9, 2021, izi zitha kutanthauza kuti pafupifupi onse otsala a PMTAS adzakanidwa.
Masiku ano, bungwe la US Food and Drug Administration linapereka malamulo oyambirira oletsa kutsatsa (Mdos) pazinthu zapakompyuta za Nicotine Delivery System (ENDS) atazindikira kuti zofunsira kwa atatu ofunsira pafupifupi 55,000 zopangidwa ndi ENDS zokometsera zinalibe umboni wokwanira wopindulitsa kwa osuta achikulire.Zokwanira kuthana ndi chiwopsezo chaumoyo wa anthu chobwera chifukwa cha zolembedwa komanso zowopsa za achinyamata omwe amagwiritsa ntchito mankhwalawa.JD Nova Group LLC, Great American Vapes ndi Vapor Salon ndizopanda fodya ENDS, Zimaphatikizapo Apple Crumble, Dr. Cola ndi Cinnamon Toast Cereal.
Zogulitsa za Flavoured ENDS zimafuna umboni wolimba
Zogulitsa zomwe zimafunikira kuti mulembetse malonda a MDO mwina sizingayambitsidwe kapena kuperekedwa kuti muyambitse malonda apakati.Ngati katunduyo ali kale pamsika, ayenera kuchotsedwa pamsika kapena pangozi yokakamiza.MDO yolengezedwa lero sikuphatikiza zinthu zonse za ENDS zoperekedwa ndi kampani;ofunsira ena onse akali kuganiziridwa.A FDA anali atauzapo kale kampani imodzi, JD Nova Group LLC, kuti ntchito yake yogulitsa fodya yomwe isanagulitsidwe yokhudzana ndi zinthu zake pafupifupi 4.5 miliyoni sinakwaniritse zofunikira pakufunsira kwa fodya watsopano wofuna chilolezo chotsatsa.
"Zopangira zokometsera za ENDS zimatchuka kwambiri ndi achinyamata, ndipo oposa 80 peresenti ya ogwiritsa ntchito ndudu ya e-fodya azaka za 12 mpaka 17 amagwiritsa ntchito imodzi mwazinthuzi. "Makampani omwe akufuna kupitiriza kugulitsa malonda awo a ENDS ayenera kukhala ndi umboni wodalirika kuti phindu lomwe lingakhalepo. a mankhwala awo a osuta achikulire amaposa ngozi zazikulu zodziŵika kwa achichepere,” anatero Mitch Zeller, mkulu wa FDA’s Center for Tobacco Products. chitetezo cha umoyo wa anthu." Ngati palibe umboni wokwanira kapena wosakwanira, a FDA akufuna kupereka lamulo loletsa malonda kuti katunduyo achotsedwe pamsika kapena achotsedwe pamsika.
FDA imachenjeza zopitilira 15 miliyoni
Chakumapeto kwa mwezi watha, a FDA adachenjeza makampani omwe ali ndi zinthu zopitilira 15 miliyoni kuti achotse zinthu zosaloledwa zafodya pamsika:
A FDA lero apereka kalata yochenjeza ku kampani yomwe imagulitsa fodya wotchulidwa ndi FDA, kuphatikizapo ma e-zamadzimadzi ambiri okometsera, pofuna kugulitsa zinthu zamagetsi za Nicotine Delivery System (ENDS) popanda chilolezo.Izi zikusonyeza kudzipereka kwa bungweli poonetsetsa kuti fodya amene amagulitsidwa akutsatira malamulo pofuna kuteteza achinyamata komanso thanzi la anthu.
Makalata ochenjezawa ndi zotsatira za kuyang'anira kosalekeza komanso kuyang'anitsitsa pa intaneti pa kuphwanya malamulo ndi malamulo a fodya.FDA ikufuna kuti onse opanga ndi ogulitsa malonda a fodya adziwe kuti tikupitiriza kuyang'anitsitsa msika ndipo tidzayankha makampani chifukwa cha kuphwanya malamulo.
FDA ipitiliza kuika patsogolo makampani omwe amagulitsa ENDS popanda chilolezo ndipo sanapereke fomu yofunsira ku bungweli, makamaka omwe angagwiritse ntchito kapena kuyambitsa zinthu zachinyamata.
Masiku ano, bungwe la FOOD and Drug Administration linatumiza kalata yochenjeza kwa Visible Vapors LLC, kampani ya ku Pennsylvania yomwe imapanga ndikugwiritsa ntchito webusaitiyi yogulitsa mankhwala a nicotine Delivery System (ENDS),
kuphatikiza ndudu za e-fodya ndi ma e-zamadzimadzi, kuwauza kuti, Ndikosaloledwa kugulitsa fodya watsopanowu popanda chilolezo chamsika, kotero kuti sangathe kugulitsidwa kapena kugawidwa ku United States.Kampaniyo sinapereke fomu ya Fodya ya Premarket (PMTA) pofika tsiku lomaliza la Seputembara 9, 2020.
Kuyambira pa Ogasiti 8, 2016, zofunsira zowunikiranso zinthu zina zafodya zomwe zikuwoneka zatsopano, kuphatikiza ndudu za e-fodya ndi ma e-zamadzimadzi, ziyenera kutumizidwa ku FDA pofika Seputembara 9, 2020, malinga ndi lamulo la khothi.
Kalata yochenjeza yomwe yatulutsidwa lero idatchulapo zinthu zina, kuphatikiza Visible Vapors Irish Potato 100mL ndi Visible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL, Kampaniyo ili ndi zinthu zopitilira 15 miliyoni zomwe zidalembedwa ndi FDA ndipo ziyenera kuwonetsetsa kuti zogulitsa zake zonse zikutsatira. malamulo aboma, kuphatikiza zofunikira zowunikiranso malonda.
Mogwirizana ndi zomwe bungweli likukhazikitsa patsogolo, pambuyo pa Seputembara 9, 2020, FDA idzayika patsogolo kukakamiza zinthu zilizonse za ENDS zomwe zikupitilizabe kugulitsidwa ndipo sizinalandire ntchito.
Pakati pa Januware ndi Juni 2021, a FDA adatumiza makalata 131 ochenjeza kumakampani omwe akugulitsa kapena kugawa zopitilira 1,470,000 zosaloledwa ENDS zomwe sizinapereke zofunsira kwazinthuzi pofika tsiku lomaliza la Seputembara 9.
Makampani omwe amalandira kalata yochenjeza kuchokera ku FDA ayenera kulemba yankho lolemba mkati mwa masiku 15 ogwira ntchito atalandira kalata yofotokoza zomwe kampaniyo yakonza, kuphatikizapo tsiku lomwe kuphwanyako kunathetsedwa ndi/kapena tsiku limene katunduyo anagawira.Akufunanso makampani kuti apitilize kutsatira mapulani amtsogolo pansi pa Federal Food, Drug and Cosmetic Act
Nthawi yotumiza: Oct-15-2021
