Ibyerekeye FDA
Komiseri w'agateganyo wa FDA, Janet Woodcock, yagize ati: "Kongere yahaye FDA uburenganzira bwo kugenzura ibicuruzwa by'itabi binyuze mu kugenzura siyanse kugira ngo birinde abaturage ingaruka mbi ziterwa no kunywa itabi.""Kureba ko FDA isuzumwa n'ibicuruzwa bishya by'itabi ni kimwe mu bigize intego yacu yo kugabanya indwara ziterwa n'itabi n'urupfu. Turabizi ko ibicuruzwa by'itabi biryoshye bikurura urubyiruko, bityo rero tukareba ingaruka ziterwa no gukoresha itabi ku buryo nyabwo. urubyiruko ni ikintu cy'ingenzi mu kumenya ibicuruzwa bishobora kugurishwa. "
Iki gikorwa kigaragaza iterambere ryinshi mu kwakira umubare utari warigeze uboneka mbere y’itariki ya 9 Nzeri 2020 itangwa n’urukiko igihe ntarengwa cyo gutanga ibyifuzo by’ibicuruzwa by’itabi, ndetse n’igihe ntarengwa cyo gukemura ikibazo cy’urubyiruko.
FDA yakiriye ibyifuzo byamasosiyete arenga 500 ikubiyemo ibicuruzwa byitabi birenga miliyoni 6.5.Mugihe ikigo cyatanze ibindi bikorwa bibi kubisabwa bimwe, iyi niyo seti ya mbere ya Mdos FDA yatanze kubisaba byujuje igice kinini cyo gusuzuma siyanse yo gusuzuma.Ikigo cyiyemeje guhindura isoko iriho ku isoko aho ibicuruzwa byose bya ENDS biboneka bigurishwa "bikwiye kurengera ubuzima rusange".
Ku ya 27 Kanama, FDA yatangaje ko yanze ko hajyaho 55,000 by'itabi (PMTAS) ku bantu batatu bato bakora e-itabi kubera ko bananiwe gutanga ibimenyetso byerekana ko barinze ubuzima rusange.
FDA yakiriye miliyoni 6.5 za PMTA zo gusaba e-itabi bitarenze itariki ya 9 Nzeri, hasigara ~ miliyoni 2 zisabwa, usibye gusaba miliyoni 4.5 (JD Nova Group LLC) zari zaramenyeshejwe ko zitujuje ibisabwa.Hamwe nibisabwa 55 000 000 byanze iki gihe, abatageze kuri miliyoni 1.95 ntibakomeza gutangazwa.Ikirenzeho, ibikorwa bya FDA byerekana ko bidashobora kwemerera amavuta ya e-itabi yuzuye icupa uretse itabi.Ibyumweru bibiri mbere yuko igihe cyubuntu kirangira ku ya 9 Nzeri 2021, ibi bivuze ko PMTAS isigaye hafi ya yose izangwa.
Uyu munsi, Ubuyobozi bw’ibiribwa n’ibiyobyabwenge muri Amerika bwatanze amabwiriza ya mbere yo Kwamagana ibicuruzwa (Mdos) kubicuruzwa bya elegitoroniki ya Nikotine (ENDS) nyuma yo kwemeza ko ibyifuzo byabasabye batatu kubicuruzwa bya ENDS bigera ku 55.000 bidafite ibimenyetso bifatika byerekana inyungu ku banywa itabi.Birahagije kunesha ubuzima rusange bwatewe nurwego rwanditse kandi ruteye ubwoba rwo gukoresha ibicuruzwa nkibi.JD Nova Group LLC, Great American Vapes na Vapor Salon ni ENDS itagira itabi, Harimo Apple Crumble, Dr. Cola na Cinnamon Toast Cereal.
Ibicuruzwa biryoshye bya ENDS bisaba ibimenyetso bifatika
Ibicuruzwa bisabwa kuri PRE-isoko ya MDO ntishobora gutangizwa cyangwa gutangwa kugirango tumenye ubucuruzi bwibihugu.Niba ibicuruzwa bimaze kuba ku isoko, bigomba kuvanwa ku isoko cyangwa ibyago byo kubahiriza.MDO yatangajwe uyumunsi ntabwo ikubiyemo ibicuruzwa byose bya ENDS byatanzwe nisosiyete;gusaba kubisigaye biracyasuzumwa.FDA yari yabanje kumenyesha imwe mu masosiyete, JD Nova Group LLC, ko ibicuruzwa by’itabi mbere y’ibicuruzwa bifitanye isano n’ibicuruzwa bigera kuri miliyoni 4.5 bitujuje ibyangombwa bisabwa kugira ngo ibicuruzwa bishya by’itabi bisaba uruhushya rwo kwamamaza.
"Ibicuruzwa bifite uburyohe bwa ENDS bikundwa cyane n’urubyiruko, aho abarenga 80 ku ijana by'abakoresha e-itabi bafite hagati y’imyaka 12 na 17 bakoresha kimwe muri ibyo bicuruzwa." Isosiyete yifuza gukomeza kugurisha ibicuruzwa byayo bya ENDS igomba kuba ifite ibimenyetso bifatika byerekana ko inyungu zishobora kubaho. ku bicuruzwa byabo ku banywa itabi bakuze birenze ingaruka zizwi ku rubyiruko rukuze, "ibi bikaba byavuzwe na Mitch Zeller, umuyobozi w'ikigo cya FDA gishinzwe ibicuruzwa by’itabi. Inshingano iri ku basaba gutanga ibimenyetso byerekana ko kugurisha ibicuruzwa byabo byujuje ubuzimagatozi" bihagije " kurengera ubuzima rusange ". Niba hari ibimenyetso bidahagije cyangwa bidahagije, FDA irashaka gutanga icyemezo cyo guhakana ibicuruzwa gisaba ibicuruzwa ku isoko cyangwa kuvanwa ku isoko.
FDA iraburira ibicuruzwa birenga miliyoni 15
Mu mpera z'ukwezi gushize, FDA yihanangirije ibigo bifite ibicuruzwa birenga miliyoni 15 kuvanaho ibicuruzwa bya e-itabi bitemewe ku isoko:
Uyu munsi FDA yatanze ibaruwa yo kuburira isosiyete igurisha ibicuruzwa byitabi byashyizwe ku rutonde rwa FDA, harimo na e-fluide nyinshi, kugirango bigurishwe mu buryo butemewe n’ibicuruzwa bya Nikotine (ENDS) bitemewe.Iki gikorwa cyerekana ko ikigo gikomeje guharanira ko ibicuruzwa by’itabi bigurishwa byubahiriza amategeko arengera urubyiruko n’ubuzima rusange.
Amabaruwa yo kuburira ni ibisubizo byo gukomeza gukurikirana no gukurikirana interineti kurenga ku mategeko n'amabwiriza y'itabi.FDA irashaka ko abayikora n'abacuruza ibicuruzwa byitabi bamenya ko dukomeje gukurikiranira hafi isoko kandi tuzabibazwa kubihohotera.
FDA izakomeza gushyira imbere ibigo byibasira ENDS nta ruhushya rukenewe kandi ntabwo byatanze icyifuzo mbere yikigo, cyane cyane gishobora gukoresha cyangwa gutangiza ibicuruzwa byingimbi. "
Uyu munsi, Ubuyobozi bw’ibiribwa n’ibiyobyabwenge bwohereje ibaruwa iburira kuri Visible Vapors LLC, isosiyete ikorera muri Pennsylvania ikora kandi ikora urubuga rugurisha ibicuruzwa bya elegitoroniki ya nikotine (ENDS),
harimo e-itabi na e-fluid, ubabwira, Birabujijwe kugurisha ibyo bicuruzwa bishya byitabi utabanje kubiherwa uruhushya, bityo ntibishobora kugurishwa cyangwa gukwirakwizwa muri Amerika.Isosiyete ntiyigeze itanga icyifuzo cy’ibicuruzwa by’itabi (PMTA) bitarenze ku ya 9 Nzeri 2020.
Guhera ku ya 8 Kanama 2016, isuzuma ryibanze ku bicuruzwa bimwe na bimwe by’itabi bifatwa nkibishya, harimo e-itabi na e-fluid, bigomba gushyikirizwa FDA bitarenze ku ya 9 Nzeri 2020, nk’uko byemejwe n’urukiko.
Ibaruwa yo kuburira yasohotse uyu munsi yerekanye ibicuruzwa byihariye, birimo Visible Vapors Ikirayi 100mL na Visible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL, Isosiyete ifite ibicuruzwa bisaga miliyoni 15 byashyizwe ku rutonde na FDA kandi bigomba kwemeza ko ibicuruzwa byayo byose byubahiriza. amabwiriza ya federasiyo, harimo ibisabwa mbere yo gusuzuma.
Dukurikije ibyihutirwa by’ikigo, nyuma yitariki ya 9 Nzeri 2020, FDA izashyira imbere gushyira mu bikorwa ibicuruzwa byose bya ENDS bikomeje kugurishwa kandi ntibyakiriwe neza.
Hagati ya Mutarama na Kamena 2021, FDA yohereje amabaruwa yo kuburira 131 ku masosiyete agurisha cyangwa akwirakwiza ENDS zirenga 1.470.000 zitabifitiye uburenganzira bwo gutanga ibicuruzwa mbere y’ibicuruzwa bitarenze ku ya 9 Nzeri.
Amasosiyete yakiriye ibaruwa yo kuburira yatanzwe na FDA agomba gutanga igisubizo cyanditse mugihe cyiminsi 15 yakazi uhereye igihe yakiriye ibaruwa ivuga ibikorwa byo gukosora isosiyete, harimo itariki ihohoterwa ryahagaritswe na / cyangwa itariki ibicuruzwa byatanzwe.Barasaba kandi ibigo gukomeza kubahiriza gahunda zizaza hakurikijwe itegeko ry’ibiribwa, ibiyobyabwenge n’amavuta yo kwisiga
Igihe cyo kohereza: Ukwakira-15-2021
