Mayelana ne-FDA
“ICongress inikeze i-FDA amandla okulawula imikhiqizo kagwayi ngokusebenzisa ukwengamela kwesayensi ukuze kuvikelwe umphakathi emiphumeleni eyingozi yokusebenzisa ugwayi,” kusho Ibamba likaKhomishana we-FDA uJanet Woodcock."Ukuqinisekisa ukuthi imikhiqizo emisha kagwayi iyahlolwa yi-FDA kuyingxenye ebalulekile yomgomo wethu wokunciphisa ukugula nokufa okuhlobene nogwayi. Siyazi ukuthi ugwayi onephunga elimnandi ukhanga kakhulu entsheni, ngakho ukuhlola umthelela wokusebenzisa ugwayi okungenzeka noma wangempela intsha iyisici esibalulekile ekunqumeni ukuthi yimiphi imikhiqizo engathengiswa."
Lesi senzo siphawula inqubekelaphambili ebalulekile ekutholeni inani elingakaze libonwe lezicelo ngaphambi komnqamulajuqu onqunywe yinkantolo wangomhla zi-9 kuSepthemba, 2020 wokufaka izicelo zasemakethe ezithathwa njengemikhiqizo emisha kagwayi, kanye nomnqamulajuqu wokubhekana nokusetshenziswa kwentsha kwezithako zokudla.
I-FDA ithole izicelo ezivela ezinkampanini ezingaphezu kuka-500 ezikhava imikhiqizo kagwayi engaphezu kwezigidi ezingu-6.5.Nakuba i-ejensi ikhiphe ezinye izenzo ezingezinhle kwezinye izinhlelo zokusebenza, leli isethi yokuqala ye-Mdos i-FDA eyikhiphile yezinhlelo zokusebenza ezihlangabezana nengxenye enkulu yokubuyekezwa kwesayensi yokubuyekezwa kwemakethe yangaphambi kwemakethe.I-ejensi izibophezele ekushintsheni imakethe yamanje iye emakethe lapho yonke imikhiqizo ye-ENDS etholakalayo ukuze ithengiswe iboniswa "ifanele ukuvikela impilo yomphakathi".
Ngo-Agasti 27, i-FDA yamemezela ukuthi yenqabe izicelo zikagwayi we-premarket (PMTAS) ezingu-55,000 ezivela kubakhiqizi bakagwayi abathathu abancane ngoba behlulekile ukunikeza ubufakazi bokuthi bavikela impilo yomphakathi.
I-FDA ithole ~ 6.5 million izicelo ze-PMTA zikagwayi we-elekthronikhi ngomnqamulajuqu wangoSepthemba 9, okushiya ~ izicelo eziyizigidi ezi-2 zingamenyezelwa, ngaphandle kwezicelo eziyizigidi ezingu-~ 4.5 (JD Nova Group LLC) ezake zazisiwe ngaphambilini ngokuthi azihlangabezani nezidingo.Njengoba izicelo ezingu-55, 000 zinqatshiwe kulokhu, zingaphansi kwezigidi ezingu-1.95 ezisalokhu zingamenyezelwa.Ngaphezu kwalokho, izenzo ze-FDA ziphakamisa ukuthi ingase ingavumeli noma yimuphi uwoyela we-e-cigarette osebhodleleni onambitheka ngaphandle kukagwayi.Emavikini amabili ngaphambi kokuphela kwesikhathi somusa ngoSepthemba 9, 2021, lokhu kungase kusho ukuthi cishe yonke i-PMTAS esele izokwenqatshwa.
Namuhla, i-US Food and Drug Administration ikhiphe ama-oda e-Marketing Denial orders (Mdos) okuqala emikhiqizo ye-electronic Nicotine Delivery System (ENDS) ngemva kokunquma ukuthi izicelo zabenzi bezicelo ezintathu zemikhiqizo ecishe ibe ngu-55,000 ye-ENDS enambitheka azinabo ubufakazi obanele benzuzo kubantu abadala ababhemayo.Kwanele ukunqoba usongo lwezempilo yomphakathi olubangelwa amazinga abhalwe phansi nashaqisayo okusetshenziswa kwentsha yemikhiqizo enjalo.I-JD Nova Group LLC, i-Great American Vapes kanye ne-Vapor Salon yi-ENDS engenawo ugwayi, Ihlanganisa i-Apple Crumble, uDkt. Cola kanye neCinnamon Toast Cereal.
Imikhiqizo e-Flavored ENDS idinga ubufakazi obuqinile
Imikhiqizo edingekayo ekufakweni kwesicelo sangaphambi kwemakethe ye-MDO ingase ingethulwa noma ilethwe ukuze kwethulwe ukuhweba phakathi kwezifunda.Uma umkhiqizo usuvele usemakethe, kufanele ususwe emakethe noma ube sengcupheni yokuphoqelelwa.I-MDO emenyezelwe namuhla ayifaki yonke imikhiqizo ye-ENDS ethunyelwe yinkampani;izicelo zabanye zisacutshungulwa.I-FDA yayikade yazise enye yezinkampani, i-JD Nova Group LLC, ukuthi isicelo sayo somkhiqizo kagwayi osemakethe ohlobene nemikhiqizo yawo elinganiselwa ezigidini ezingu-4.5 ayizange ihlangabezane nezimfuneko zokufaka isicelo somkhiqizo omusha kagwayi ofuna ukugunyazwa ukumakethwa.
"Imikhiqizo ye-ENDS enongiwe ithandwa kakhulu yintsha, ngamaphesenti angaphezu kwangu-80 abasebenzisi baka-e-cigarette abaneminyaka engu-12 kuya ku-17 basebenzisa owodwa wale mikhiqizo. "Izinkampani ezifisa ukuqhubeka nokuthengisa imikhiqizo yazo ye-ENDS ebabazekayo kufanele zibe nobufakazi obuthembekile bokuthi izinzuzo ezingaba khona. emikhiqizweni yabo yabantu abadala ababhemayo idlula izingozi ezibalulekile ezaziwayo entsheni esikhulile,” kusho uMitch Zeller, umqondisi weSikhungo Semikhiqizo Kagwayi se-FDA. Umthwalo usemahlombe abenzi bezicelo ukunikeza ubufakazi bokuthi ukuthengiswa kwemikhiqizo yabo kuhlangabezana nezinga elingokomthetho “lokwaneleyo. ukuvikela impilo yomphakathi". Uma bungekho ubufakazi obanele noma obunganele, i-FDA ihlose ukukhipha umyalelo wokwenqaba ukumaketha odinga ukuthi umkhiqizo ususwe emakethe noma ukhishwe emakethe.
I-FDA ixwayisa ngemikhiqizo engaphezu kwezigidi ezingu-15
Ngasekupheleni kwenyanga edlule, i-FDA yaxwayisa izinkampani ezinemikhiqizo engaphezu kwezigidi ezingu-15 ukuthi zisuse imikhiqizo ye-e-cigarette engagunyaziwe emakethe:
I-FDA namuhla ikhiphe incwadi eyisixwayiso eya enkampanini ethengisa imikhiqizo kagwayi esohlwini lwe-FDA, okuhlanganisa noketshezi oluningi olunambithekayo lwe-e, ngokuthengiswa okungekho emthethweni kwemikhiqizo ye-electronic Nicotine Delivery System (ENDS) ngaphandle kwelayisensi.Lesi senzo sibonisa ukuzibophezela okuqhubekayo kwe-ejensi ekuqinisekiseni ukuthi imikhiqizo kagwayi ethengiswayo ithobela umthetho ukuze kuvikelwe kangcono intsha kanye nempilo yomphakathi.
Izincwadi eziyisixwayiso ziwumphumela wokuqapha okuqhubekayo kanye nokuqapha kwe-inthanethi ukwephulwa kwemithetho neziqondiso zikagwayi.I-FDA ifuna bonke abakhiqizi nabathengisi bemikhiqizo kagwayi bazi ukuthi siyaqhubeka nokubhekisisa imakethe futhi sizobeka izinkampani icala ngokwephula umthetho.
I-FDA izoqhubeka nokubeka phambili izinkampani eziqondisayo ezithengisa i-ENDS ngaphandle kokugunyazwa okudingekayo futhi azizange zifake isicelo semakethe enkampanini, ikakhulukazi lezo ezingase zisebenzise noma ziqalise imikhiqizo yentsha. "
Namuhla, i-FOOD and Drug Administration ithumele incwadi eyisixwayiso ku-Visible Vapors LLC, inkampani yasePennsylvania eyenza futhi esebenzise iwebhusayithi ethengisa imikhiqizo ye-electronic nicotine Delivery System (ENDS),
okuhlanganisa ugwayi we-elekthronikhi nama-e-liquids, ubatshela ukuthi, Akukho emthethweni ukuthengisa le mikhiqizo emisha kagwayi ngaphandle kwemvume yemakethe, ngakho ayikwazi ukuthengiswa noma ukusatshalaliswa e-United States.Inkampani ayizange ilethe isicelo soMkhiqizo Kagwayi wemakethe (PMTA) ungakafiki umhlaka-9 Septhemba 2020.
Kusukela ngomhla ka-8 Agasti 2016, izicelo zokubuyekezwa kwemakethe yemikhiqizo ethile kagwayi ethathwa njengezintsha, okuhlanganisa ugwayi we-elekthronikhi nama-e-liquid, kufanele zithunyelwe ku-FDA ngoSepthemba 9, 2020, ngokomyalelo wenkantolo.
Incwadi yesixwayiso ekhishwe namuhla iveze imikhiqizo ethile, okuhlanganisa iVisible Vapors Irish Potato 100mL kanye neVisible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL, Le nkampani inemikhiqizo engaphezu kwezigidi eziyi-15 esohlwini lwe-FDA futhi kufanele iqinisekise ukuthi yonke imikhiqizo yayo iyahambisana. imithetho kahulumeni, okuhlanganisa nezimfuneko zokubuyekezwa kwemakethe.
Ngokuvumelana nezinto ezibalulekile zokuphoqelela ze-ejensi, ngemva komhla ka-9 Septhemba 2020, i-FDA izobeka kuqala ukusetshenziswa komthetho ngokumelene nanoma yimuphi umkhiqizo we-ENDS oqhubeka ukumakethwa futhi ongakasitholi isicelo somkhiqizo.
Phakathi kukaJanuwari noJuni 2021, i-FDA yathumela izincwadi zesexwayiso ezingu-131 ezinkampanini ezithengisa noma ezisabalalisa ngaphezu kuka-1,470,000 ENDS ezingagunyaziwe ezingazange zithumele izicelo zokudayisa zale mikhiqizo ngomnqamulajuqu wangoSepthemba 9.
Izinkampani ezithola incwadi eyisixwayiso evela ku-FDA kufanele zithumele impendulo ebhaliwe zingakapheli izinsuku zebhizinisi eziyi-15 zithole incwadi esho isenzo sokulungisa senkampani, okuhlanganisa idethi ukuphulwa komthetho okuyekwa ngayo kanye/noma idethi umkhiqizo owasatshalaliswa ngayo.Futhi zidinga izinkampani ukuthi ziqhubeke nokuthobela izinhlelo zesikhathi esizayo ngaphansi kweFederal Food, Drug and Cosmetic Act
Isikhathi sokuthumela: Oct-15-2021
